moleculardiagnosticsfor oncology&personalized medicine€¦ ·...
TRANSCRIPT
MolecularDiagnosticsforOncology&PersonalizedMedicine
_RegistrationDocument2010
2 MDxHealthRegistrationDocument2010 MDxHealthRegistrationDocument2010 3
Contents
ContentsRisksRelatedtotheBusiness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42010RegistrationDocument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121. KeyFinancials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142. ActivitiesofMDxHealth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.1. CompanyOverviewandHistory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172.2. Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202.2.1. MolecularDiagnosticsinCancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202.2.2. ClinicalDiagnosticsProgram(ClinicalDx). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212.2.3. Pharmaco-DiagnosticsProgram(PharmacoDx). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262.3. SalesandMarketingStrategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282.4. Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292.5. StrategicPartners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302.5.1. PharmacoDxPartners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302.5.2. MolecularDiagnosticsPartners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312.5.3. ResearchMarket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322.6. Technologyandplatform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 332.7. GroupStructure/Subsidiaries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352.8. HumanResources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 362.9. LegalProceedings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372.10. GovernmentRegulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372.10.1.Health,SafetyandEnvironment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372.10.2.ProductRegulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372.11. Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382.12. InvestmentPolicy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382.13. RecentTrendsandEvents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3. CorporateGovernanceStatement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403.1. GeneralProvisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 413.1.1. BoardofDirectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 413.1.2. Chairman. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 413.1.3. IndependentDirectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423.1.4. CompositionoftheBoardofDirectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433.1.5. CommitteesoftheBoardofDirectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 453.1.6. ProcessForEvaluatingtheBoard,itsCommittees,anditsIndividualDirectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 473.2. ExecutiveManagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483.2.1. ChiefExecutiveOfficer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483.2.2. OtherMembersofExecutiveManagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483.2.3. CompositionoftheManagementTeam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483.2.4. 2010RemunerationReport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 503.3. SharesandWarrantsHeldbyDirectorsandExecutiveManagement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 563.4. InternalControlAndRiskManagementSystems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 573.5. ComplianceWithAndDeviationsFromThe2009BelgianCorporateGovernanceCode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583.6. ConflictsofInterestandRelatedParties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 593.7. DealingCode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 593.8. StatutoryAuditor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4. TheCompany,ItssharesandShareholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 604.1. Name,RegisteredOfficeandIncorporation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 614.2. CompanyPurpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
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4.3. HistoryofShareCapital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 614.4. AuthorizedCapital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 644.5. RightsAttachedtoShares. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 654.5.1. DividendRights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 654.5.2. PreferentialSubscriptionRights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 654.5.3. VotingRights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 654.5.4. RightstoParticipateandVoteatShareholder’sMeetings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 654.6. Anti-TakeoverProvisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 674.6.1. Takeoverbids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 674.6.2. Squeezeout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 684.6.3. Sell-outRight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 684.7. NotificationofImportantParticipation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 684.8. Shareholdership. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 694.9. Warrants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 694.10. Outstandingfinancialinstruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 724.11. PayingAgentServices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 734.12. SharePriceEvolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5. AuditedConsolidatedFinancialStatements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 745.1. Consolidatedannualaccounts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 755.1.1. Condensedconsolidatedstatementofcomprehensiveincome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 755.1.2. Consolidatedstatementoffinancialposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765.1.3. Consolidatedcashflowstatement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 775.1.4. Consolidatedstatementofchangesinshareholders’equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 785.1.5. Notestoconsolidatedfinancialstatements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 785.2. Managementdiscussionandanalysisoffinancialconditionandresultsofoperations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1095.3. ReportoftheBoardofDirectorsontheconsolidatedfinancialstatements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1125.3.1. Discussionandanalysisoftheconsolidatedfinancialstatementsof2010,2009,and2008. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1125.3.2. Capitalincreasesandissuanceoffinancialinstruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1145.3.3. Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1145.3.4. Servicesperformedbytheauditor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1145.3.5. Subsequentevents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1145.3.6. Research&Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1155.3.7. Disclosureswithintheframeworkofthetakeoverdirective(seealsosection4.5and4.6ofthe
RegistrationDocument) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1165.4. Statutoryauditor’sreport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1195.4.1. Statutoryauditor’sreporttothegeneralmeetingofshareholdersofMDxHealthSAontheconsolidated
financialstatementsfortheyearendedDecember31,2010. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1195.4.2.Statutoryauditor’sreporttothegeneralmeetingofshareholdersofMDxHealthontheconsolidated
financialstatementsfortheyearendedDecember31,2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1205.4.3. Statutoryauditor’sreporttothegeneralmeetingofshareholdersofMDxHealthontheconsolidated
financialstatementsfortheyearendedDecember31,2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
6. StatutoryFinancialStatements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1226.1. Statutoryincomestatement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1236.2. Statutorybalancesheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1246.3. Accountingpolicies(BelgianGAAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1266.4. ReportoftheBoardofDirectorsonthestatutoryfinancialstatements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
7. BusinessGlossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Contents
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theeventwhereMDxHealthdoesraisetherequiredfunding,itmayencounterdifficultiesordelaysinbuildingoracquiringa U.S. based service lab and, subsequently, it may lack theresources to properly operate the facility. Furthermore, thelab concerned may not receive or maintain the necessaryaccreditation and regulatory approvals nor the support ofthe medical and reimbursement community. In addition,the U.S. government and reimbursement authorities maychangetheregulationofthisindustryinamannerthatmaybedetrimentaltoMDxHealthorincreasethecoststolaunchandcommercializeitstests.MDxHealthdoesnotexpecttobeabletostartperformingdirectsalesofitsfirstproductviaitsownCLIA-certifiedU.S.laboratorybefore2012.
MDxHealth plans on building a U.S. sales force and/or onpartnering with companies with existing sales forces incertain fields. Finding, motivating and retaining qualifiedsalespersonnelwillbeimportanttothecommercialsuccessoftheproducts.
MDxHealth plans on seeking reimbursement of its U.S.testing services via existing CPT codes (Current ProceduralTerminology) and may eventually request product-specificreimbursementcodes.ThereisnoguaranteethatMDxHealth’sproductswillreceivefulloradequatereimbursementorthatsuchreimbursementlevelswillnotchangeinthefuture.
TosellitsservicesandtestsviaaU.S.lab,MDxHealthwill,inaddition to lab facilities and qualified lab personnel, needtoacquirelabequipmentandtechnologylicenses.Theleveland availability of such resources and their costmay havea significant impact on the Company’s ability to realize itsnewbusinessobjectives.Certainnew instrumentationmayrequirecGMPcertificationand/orotherregulatoryclearanceto support the U.S. lab and commercial development of
RecentlyrevisedbusinessmodelThebusinessmodelofMDxHealthhasrecentlyconsiderablychanged. During 2010, MDxHealth decided to shift from adiscoverylicensecompanytoacommercialclinicaldiagnosticcompany(seesection2.1).ThepreviousbusinessmodeloftheCompany focused on the out-licensing of cancer screeningapplicationsandthediscoveryofnewbiomarkersinexchangeforeventual royalty fees in the long term.Cancerscreeningapplicationsoftentakemanyyearstodevelop,togetapprovedand to produce revenues. This out-licensing strategy leftthe Company excessively dependent on third parties forthe development and commercialization of its technologyandproducts.With thenewbusinessmodel,MDxHealth isseeking to retain control of the end-development, launch,promotion, and sales of its core products. To carry-out thedistributionof itsproducts,MDxHealthintendstoestablishacommerciallaboratoryandhireasalesforceintheUnitedStates. In addition to continuing its Pharmaco-Diagnostics(companiondiagnosticsdevelopmentandcontractservices)business,MDxHealthwill now focus its clinical diagnosticsbusinessonthreecancers:prostate,lungandcolon.Moreover,thegeographicalemphasis formarketentryof itsproductswillbeprimarilyintheU.S.whichMDxHealthconsidersthemainfuturemarketformoleculardiagnostics.IfMDxHealthisnotsuccessfulinaccomplishinganyoftheaboveobjectives,itmaynotbeabletodevelopand/orcommercializetestsandproducts,raisecapital,expanditsbusiness,generaterevenuesorevencontinueitsoperations.
MDxHealth intends tosell itsproductsprimarily in theU.S.asatestingserviceviaitsownU.S.basedlaboratoryfacility.Atthedateofthisdocument,MDxHealthdoesnotownnoroperateaU.S. service lab.MDxHealthmayneverdisposeofthenecessaryfunds–tobuildoracquireitsownlaboratory.In
RisksRelatedtotheBusinessThefollowingriskfactorsmayaffectthebusiness,theoperatingperformanceandthefinancialconditionandresultsofMDxHealthaswellasthevalueofaninvestmentinthesharesofMDxHealth.
Prospectiveinvestorsshouldcarefullyreadtheentireregistrationdocumentandshouldpayparticularattentiontotheriskfactorssetforththerein.AdditionalrisksanduncertaintiesofwhichMDxHealthiscurrentlynotawareorwhichMDxHealthdoescurrentlynotconsidertobematerialcouldalsomateriallyandadverselyimpactitsbusiness,itsoperationsanditsfinancialsituationoritsresults.
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recognizedasincometodate.HowevertheCompanywilllikelyreimburseEUR124,878onagrantpaymentitreceivedforaprojectthatwasdiscontinuedandforwhichnorevenuewasever recognizedby theCompanyand forwhichaprovisionhasbeenmadeinthefinancialaccounts.
At December 31, 2010, MDxHealth had cash and cashequivalents of Euro 10.6 million compared to a balance ofEuro18milliononeyearearlier.TheCompanyhasnofinancialdebt.The net cash burnwas Euro 7.4million in 2010. Cashandcashequivalentsrepresented73%of the totalassetsatDecember31,2010comparedto73%oneyearearlier.
LossMakingCompanyMDxHealth has incurred operating losses since inception(EUR64millionuntil endDecember2010)andhaspaidnodividends. MDxHealth may never realize revenues fromplannedproductsandservices,achieveorsustainprofitability,reduce future operating losses, or pay dividends. Theextraordinarygeneralshareholders’meetingofJune21,2010,approved the reduction of the share capital ofMDxHealthin the amount of EUR 43.5 million by incorporation ofaccumulated losses without a reduction in the number ofoutstanding shares. The Company expects to continue toincurlossesinthenear-tomid-term.
MDxHealth uses the Euro currency for financial reportingpurposes. However, MDxHealth already has some of itsoperatingcostsinU.S.Dollarsandexpectstohavealargeshareof its futurecostsand revenues inU.S.Dollars.Unfavorablefluctuations in the exchange rate between the Euro andtheU.S.DollarcouldhaveamaterialnegativeimpactonthefinancialresultsofMDxHealth.
MDxHealth expects to grow and expand the scope of itsbusinessincertainproductareas,includingexpansionofitsdevelopmentefforts.FuturegrowthwillrequireMDxHealthto implementand improve itsmanagerial, operational andfinancial systems and procedures. MDxHealth also intendstosecureadditionaladequatelabandofficefacilitiesintheU.S.foritsfuturegrowth.IfMDxHealthisnotabletomanageits growth effectively, it may be difficult to implement itsbusinessstrategyandearnrevenue.
MDxHealth may from time to time have to ceaseprojects or operations in certain areas due to the needto re-allocate resources to the most promising projectsor areas. Discontinuance of certain projects or areas ofoperations may result in one-time extra costs and could
the Company’s tests. Finding suitable suppliers may be achallenge.Ifthesesuppliescannotbefound,MDxHealthwillhave tobring theseproductsunder itsownquality system,requiringadditionalworkand resourcesaswell as causingdelays.Forthecurrentproductsindevelopmentandplannedfor commercialization in the next few years, MDxHealthexpectstohavetopayroyaltiestoJohnsHopkinsUniversityandotherparties.Notallof these royalty ratesare fixedatthistime.TheseroyaltiesmayhaveanegativeimpactonthemarginsoftheCompany.
AvailabilityofCapitalMDxHealthrequiresadditional funding topursue itsnewlydefined business objectives and to continue its operationsinthemediumtolongterm.ThelevelofMDxHealth’sfuturefinancingneedswilldependonmanyfactors, includingtheprogress, costsand timingof its researchanddevelopmentactivities,thecostsandtimingofsettingupaU.S.laboratoryfacility,thecostsandtimingofobtainingregulatoryapproval,thecostsofobtaining,maintainingandenforcingitspatentsandother intellectualproperty rights, the costsand timingofmaintainingorobtainingmanufacturingforitsproducts,the costs and timing of establishing sales and marketingcapabilities and the terms and timing of establishingcollaborations,licenseagreementsandotherpartnerships.
MDxHealth’sabilitytoraiseadditionalfundswilldependonfinancial,economicandmarketconditionsandotherfactors,overwhichitmayhavenoorlimitedcontrol,andMDxHealthcannotguaranteethatadditionalfundswillbeavailabletoitwhennecessaryoncommerciallyacceptableterms,ifatall.IntheeventwhereMDxHealthraisesfundsthroughtheissuanceofequitysecurities,thiswilldiluteitsshareholders.MDxHealthmayfurtherseekfundsthroughcollaborationsandlicensingarrangements,whichmayrequireittorelinquishsignificantrightstoitsproduct-generatingplatformsortograntlicensesontermswhicharenotfavorabletoMDxHealth.Ifadequatefunds are not available on commercially acceptable termswhen needed, MDxHealth may be forced to delay, reduceor terminate the development or commercialization of itsproducts,ascurrentlyenvisaged,oritmaybeunabletotakeadvantageoffuturebusinessopportunities.
MDxHealthhasreceivedgovernmentgrantstocoverpartofthecostsofcertainR&Dprojectsandexpectsthesegrantstobelimitedinthefuture.SomeofthesegrantsmaybelostorneedtoberepaidiftheCompanydoesnotabidebythetermsandconditionsofsuchgrants.TheCompanyisnotawareofanyreasonstorepaypartorallofanygrantsthathavebeen
RiskRelatedtotheBusiness
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adequate patient samples, this could have a detrimentaleffectontheresearchanddevelopmentplansofMDxHealth,ontheregulatoryapprovalofMDxHealth’sproducts,andontheeventualcommercializationoftheproducts.Furthermore,MDxHealth and its collaborators abide by regulations forthecollectionofhumansamples.Theseregulations includeobtaining patient consent, maintaining the confidentialityof the patient identification, obtaining approval of clinicaltrials of institutional (hospital) review boards and/orethical committees, andobtaininganynecessary insuranceprotection. If MDxHealth and its collaborators were to failto abide by such regulations or if the regulations were tochangeinanunfavorableway,thiscouldhinderMDxHealth’sresearchanddevelopmentplansandactivities.
Additionally, MDxHealth’s ability to promote, market anddistribute its products and its ability to obtain sufficientcoverageorreimbursementfromthird-partypayerssuchasMedicaremayimpactthecommercialsuccessofitsproducts.Ifmedicalpractitionersdonotorderitstests,MDxHealthwilllikelynotbeabletocreatedemandforitsproductsinsufficientvolume for MDxHealth to become profitable. To generatedemand,MDxHealthwill need to createmarket awarenessofMDxHealth’sproductsandservicesbyvisitingthemedicalcommunity (e.g., oncologists, surgeons and pathologists),through scientific publications, presentations at medicalconferencesandthroughcommercialpartners.Furthermore,thecommercialsuccessofMDxHealthwilldependinpartonthe degree towhichMDxHealth’s products are reimbursedby public health administrations, private health insurers,managedcareorganizationsandotherorganizations.Thereisuncertaintyaroundthereimbursementstatusandfutureregulatory environment of some of MDxHealth’s products,whichmayresultininsufficientreimbursementlevels.
CompetitionMDxHealthfacessignificantcompetitionat the levelof thetechnology itusesaswell asat the level of theproducts itintends to sell (see section 2.2).With respect to technologycompetition, other molecular technologies such as DNAmutationanalysis,RNAexpressionanalysis,andsequencingare also targeting the oncology market. Furthermore,other companies are also developing products that detectaberrant gene methylation in cancer. In addition, newservices or products using new technologies developed byother companies could adversely affect the demand forMDxHealth’sproducts.Withrespecttoproductcompetition,some of the cancer segments targeted by MDxHealth are
damage the relationship with partners involved in thediscontinued projects. IfMDxHealth is not able tomanagethediscontinuanceofcertainprojectsorareasofoperationinaneffectiveandsuccessfulmanner,thiscouldleadtosomeextracostsfortheCompany.
Thehistoricalfinancial lossesofMDxHealth, theCompany’scurrent cash position and the general economic climate,together with the refocus from being a discovery licensecompany toacommercialclinicaldiagnosticcompanyhaveledMDxHealthtoredirectitsR&Dprojectstoasmallercoreset of advanced projects. If MDxHealth does not succeedin realizing its re-focused core business objectives (whichwill require the successful raising of new funds), then theCompany may need to further downsize its activities andobjectivesandmayevenneed toconsiderdiscontinuingallorpartofthem.
MarketAcceptanceUponcommercialization,MDxHealth’sproductsmaynot,oronly with a substantial delay, gain acceptance by patients,physiciansandotherhealthcareprofessionals.IfMDxHealth’stestsfailtogainmarketacceptance,thismayhaveamaterialadverseimpactonMDxHealth’sabilitytogeneraterevenuesand achieve profitability. Market acceptance and speed ofmarketpenetrationofMDxHealth’sproductswilldependon,amongotherthings,productperformance,competition,safety,cost-effectiveness, convenience and ease of administration,reimbursement,non-invasiveaspectoftest,easeofhandlingandshippingofthesamplesaswellasitsotheradvantagesoverothertests.
MDxHealth is dependent on the results of clinical studiestodemonstratethevalidationof itsproducts.TheresultsofclinicalstudiesmaynotshowthatMDxHealthproductsaddvaluecomparedtoexistingmethods,whichcouldnecessitatesignificantfinancialandotherresourcesforfurtherresearchand development, whereby commercialization of productscould be delayed or may never occur. When runningits clinical studies, MDxHealth relies on the availabilityof clinical samples in the respective bio-banks and thecollaboration of medical centers and their researchers tosupply human samples for evaluation. Future studiesmayrequire prospective sample collection,whichwould requireadditional time, expense and effort in the recruitmentsubjectsandsponsorshipofaclinical trial. IfMDxHealthorany of its collaborators are unable to access sufficient and
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fromestablishedproceduresandnewentrantstothefieldinlungcancer.
For colon cancer, MDxHealth can expect competition fromMyriad Genetics, Genomic Health and Agendia B.V. BothMyriad and Genomic Health have recently launched theircoloncancerLDTassays.MDxHealthwillalsofacecompetitionfromestablishedproceduresandnewentrantstothefield.
ForMDxHealthPharmaco-Diagnostic(companiondiagnostics)commercial activities targeting pharma companies,MDxHealth faces competition from numerous companieswithdifferentmethylationplatformsordifferentmoleculardiagnostictechnologiessuchDNAmutation,sequencingandRNAexpression.TheMDxHealthMGMTtestforbraincanceris inphase IIIclinical trialswithMerckSeronoandisfacinglimitedcompetition.
RegulatoryRiskAkeyelementofMDxHealth’snewstrategytofocusprimarilyon sales in the U.S. is its plan to introduce its products asLaboratory Developed Tests (LDTs) through a U.S.-basedlab facility certified under the U.S. Clinical LaboratoryImprovementAmendmentsof1988(CLIA),ratherthanseekinga more comprehensive pre-market clearance or productapprovalfromtheU.S.FoodandDrugAdministration(FDA).CLIAregulatesallU.S.laboratoriesandtestsbyrequiringtheybecertifiedbythefederalgovernmentandthattheycomplywithvariousoperational,personnel,facilitiesadministration,quality,andproficiencyrequirementsintendedtoensurethatlaboratorytestingservicesareaccurate,reliable,andtimely.
ToobtainandrenewaCLIAcertificatefor itsU.S. lab,whichmay require renewal every two years, the Company willbe regularly subject to survey and inspection to assesscompliance with program standards and may be subjectto additional random inspections. Standards for testingunderCLIAarebasedonthelevelofcomplexityofthetestsperformed by the laboratory. Laboratories performing highcomplexity testing are required to meet more stringentrequirements than laboratories performing less complextests. Allmolecular diagnostic tests are considered as highcomplexity tests. CLIA certification is a prerequisite to beeligibleforreimbursementunderMedicareandMedicaid.InadditiontoCLIArequirements, theCompanywillbesubjecttovariousstatelaws.CLIAallowsastatetoadoptlaboratoryregulationsthataremorestringentthanthoseunderfederal
servedbytraditionaldiagnostics.Suchtraditionaldiagnosticstests are often widely used and are relatively inexpensive.MDxHealth’sproductsandtestsmaytaketimetoormaynotbeabletochangetraditionalmedicalpracticeandtests.
For the prostateConfirmMDx tissue-based testMDxHealthisnotawareofthepresenceofadirectcompetitiveproducton themarket yet.ThePCA-3 test fromGen-Probe, aurine-basedtest,isontheU.S.marketasanLDT.ThistestanalyzesRNA, has some limitations and likely targets a differentmarketsegment.EpigenomicsAGhasdevelopedapotentialprostate cancer testsusingadifferent versionof theGSTPigene. Epigenomics has out-licensed their marker to QuestDiagnostics Inc. and Predictive Biosciences Inc. For bothcompanies thedevelopmentstate, theapplication(urineortissue),aswellasthedateofapotentiallaunchoftheirtestsare currently unknown. SourceMDx Inc. has a blood-basedgene expression test in development, but since they areprivatelyheld,itisunknownwhentheywillbringtheirtesttomarket. To the knowledge of MDxHealth, no head-to-headcomparison studies with any competing products havebeenpublished.
For the Prostate InformMDx MDxHealth knows of onealternative LDT product on themarket called Prostate Px+fromAureonLaboratoriesInc.,howeverthisisnotamolecularassay. This privately held company has not published anysales figures and it is unknown towhat extent the test isbeingusedbyphysicians.BothGenomicHealthandMyriadGeneticshaveannouncedthattheyaredevelopingprognosticLDT’s,buttheyhavenotannouncedwhentheirproductswillbelaunchedinthemarket.
For its ConfirmMDx lung cancer test, MDxHealth facespotential competition from (i) a test being developed byEpigenomicsAGwhichhaspublishedlimiteddataontheirtest,and(ii)byimprovedscreeningtechniquesbeingevaluatedbydifferentuniversities.Nohead-to-headcomparisonhasbeenperformedbetweentheMDxHealthtestandotherpotentialcompetitive technologies. For its InformMDx text for lungcancer,MDxHealthisnotawareofanyexistingcompetition.EpigenomicshaslaunchedinEuropeamethylationbasedtestforlungcancercalledEpiproLung.Thisdiagnostictestisusedforpatientssuspectedoflungcancer,howeverthiskitisnotFDAclearedandnotofferedintheU.S..TheMDxHealthLungInformMDxtestcurrentlyunderdevelopmentisdesignedtoidentifyStage1lungcancerpatientsthathaveahighriskofrecurrence. The Companymay face additional competition
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subject to limitations on their indicated uses andmay bewithdrawnfromthemarket if theyareshowntobeunsafeorineffective.
MDxHealthis,ormaybecome,subjecttonumerousongoingregulatoryregulations,suchasenvironmental,healthandsafetylawsandprivacylaws.Thecostsofcompliancewithapplicableregulations,requirementsorguidelinescouldbesubstantial,and failure to comply could result in sanctions, includingfines, injunctions, civil penalties, denial of applications formarketingapprovalofcertainproducts,delays,suspensionorwithdrawalofapprovals,licenserevocation,seizuresorrecallsofproducts,operatingrestrictionsandcriminalprosecutions,anyofwhichcouldsignificantlyincreaseMDxHealth’scosts,delaythedevelopmentandcommercializationofitsproductcandidates and substantially impair its ability to generaterevenuesandachieveprofitability.
RelianceonKeyPersonnelandCollaboratorsMDxHealth depends on its ability to recruit and retain keypersonnel, and failure to do so may impact its ability toexecuteitsbusinessstrategy.IfMDxHealthisnotabletoretainits keymanagersand scientists, thismaydelay its researchanddevelopmentandfuturecommercialactivitiesandmayadversely impact the ability of MDxHealth to implementits business strategy. AsMDxHealth advances its programsand expands its business, itmay seek to recruit additionalpersonnel with expertise in areas such as reimbursementandsalesandmarketing.Ifrecruitmentandretentioneffortsareunsuccessful,MDxHealthmaynotbeabletoachieveitsobjectivesinatimelymanner,ifatall.
MDxHealthalsoreliesonandexpectstocontinuetorelyonclinicalscientificcollaboratorstocontributetoitsbiomarkerdiscovery program, biomarker validation and clinical trialstudies. If any ofMDxHealth’s collaboratorswere tobreachorterminatetheiragreementwithMDxHealthorotherwisefail to conduct their collaborative activities successfullyand in a timely manner, the research, development orcommercialization of the products contemplated by thecollaborationcouldbedelayedorterminated.
MDxHealth’srelationshipswithleadingphysicians,scientistsand research institutions are necessary to establishMDxHealth’s testsas thefuturestandardofcare forcancerdiagnosis,prognosisandprediction. IfsomeofMDxHealth’skey collaborators determine that MDxHealth tests are not
law,andanumberofstates,includingWashington,NewYork,Maryland, Pennsylvania, Rhode Island, and California, haveimplementedtheirownlaboratoryregulatoryschemes.Statelaws may require that laboratory personnel meet certainqualifications, specify certain quality controls, or prescriberecordmaintenancerequirements.
Three products that include MDxHealth’s technology arealready being commercialized as service tests in the U.S.as LDTs via Laboratory Corporation of America (LabCorp).Although the FDA previously claimed the authority toregulateLDTsthatarevalidatedbythedevelopinglaboratoryand performed only by that laboratory, it has generallyexercisedenforcementdiscretionanddidnotseektoregulatethe majority of tests developed and performed by highcomplexityCLIA-certified laboratories. In July2010,however,the FDA indicated that it was reviewing the regulatoryrequirements applying to LDTs. The FDA has not indicatedthe exact timingnor thenature of the changes, if any, buthasindicatedthatthecommunicationmaycomein2011.Inviewofthesedevelopments,therecanbenoassurancethatFDAregulation,includingpre-marketrevieworapproval,willnotberequiredinthefutureforLDTsapplyingMDxHealth'stechnology. If pre-market review or approval is required,the business of MDxHealth could be negatively impactedbecauseitsfutureCLIA-certifiedlaboratorymayberequiredto stop offering these LDTs pending pre-market clearanceor approval. Furthermore, approval under one CLIA licensedoesnotguaranteeapprovalunderanother,asapprovalsarelinked to validation studiesperformedby theCLIA-certifiedlaboratoryofferingtheLDT.IfnewstringentregulationofLDTs(including regulation of non-complex assays such as thoseof MDxHealth) was to be implemented in the short termby theU.S. regulatoryauthorities,and,more inparticular if,aspart thereof,MDxHealthwouldbe requested to conductadditional clinical trials, for which it would need samples,thenthatcouldleadtodelaysorfailuretoobtainnecessaryregulatoryapproval,whichcoulddelaycommercializationoftheMDxHealthproductsandincreasethecostsofdevelopingtheproducts.
In Europe,MDxHealthmust obtain a CEMarking andmayinsomecasesneedmarketingapproval from theEuropeanMedicine Agency (EMEA) before it can commercialize itsproductcandidatesasdiagnostickits.Changesinregulatoryapproval policies or enactment of additional regulatoryapproval requirementsmay delay or prevent the Companyfrom obtaining marketing approval for its diagnostic kitsor LDTs. Even after regulatory approval, products may besubject to post-marketing or vigilance studies or may be
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MDxHealth has entered, and may enter into additionalpartnershipagreementswithdifferentcompaniestocombinecomponentsof technologies fromthevariouspartners intooneormorejointproducts.Difficultiesencounteredbyoneormoreofthepartnersmayadverselyimpactthejointproductorproducts,evenifsuchdifficultiesareunrelatedtothejointproductorproducts.
In 2003,MDxHealth entered into a license agreementwithOrtho-Clinical Diagnostics (OCD) for certain methylationtechnology. If OCD were to grant sub-licenses of certaintechnology, dating back to before 2003 and licensed fromtheJohnsHopkinsUniversity, tocertain thirdpartiesorusethetechnologyitself,thenthiscouldhinderthecompetitivepositionofMDxHealth.
Inordertomoreefficientlycommercializeitstests,MDxHealthhas entered into a number of partnerships with referencelaboratories and diagnostic companies granting rights toofferproductsbasedonMDxHealthtechnologies(seesection2.2.2).WhileMDxHealthreceivesroyaltiesandotherfeesfromthesalesofitssublicenseesonthesetests,markers,anduseoftechnologyifitspartnersincreasetheirsalesbeyondexpectedlevels(incompetitionwithMDxHealth’stestsunderthesameindication),thenMDxHealthmayrealizelowerthanexpectedrevenuesfromitsownplannedproductsandservices,andassuchitmaynotachieveorsustainprofitability.
IntellectualPropertyRisksMDxHealth’s success is dependent on the continuous andeffective protection of its own and in-licensed intellectualproperty. If MDxHealth or its licensing partners fail toefficientlyprotecttheirintellectualproperty,MDxHealthwillbeunabletopreventthirdpartiesfromusingproprietaryorin-licensed technologiesandsuch thirdpartieswillbeabletocompetemoreeffectivelyagainstMDxHealth.Thepatentsof theCompanyhavea lifeof20yearsand theexpirydatemay vary by region in theworld.The earliest patent on anindividualbiomarkerexpiresin2014.
It isnot certain thatanyofMDxHealth’s currentlypendingor future patent applications will result in issued patents,or that any patents issued or licensed to MDxHealth willnotbechallenged,invalidatedorheldunenforceable.Issuedpatentsmaynotbebroadenoughtoprovideanymeaningfulprotection. Furthermore, MDxHealth cannot rule out thatthe U.S. may not acquire, under its so-called march-inrights, a non-exclusive, irrevocable, paid-up license under
superior to available tests or that alternative technologieswouldbemoreeffectiveintheearlydetectionorpersonalizedtreatment of cancer, it may be difficult to continue thenecessaryrelationshipswithleadingscientistsandresearchinstitutions and to establish MDxHealth’s products as thefuturestandardofcareforcancerdiagnosis.ThiswouldlimitMDxHealth’srevenuegrowthandprofitability.
RelianceonCommercialPartnersMDxHealth’s rights to use technologies licensed fromthird parties are conditional on compliance with certainrequirements. When MDxHealth in-licenses or acquirestechnology from thirdparties, it is, generally, (i) required toabidebycertaintermsandconditionsinordertomaintainitsrightstothetechnologyand(ii)dependentontheprotection,prosecution,maintenanceandenforcementoftheintellectualproperty rights by the licensors. Failure by MDxHealth torespectsuchtermsandconditionsmayresult in lossof theexclusivityonthetechnologyorlossofrightstothetechnologywhich could prevent it from developing,manufacturing orsellingitsproductsorcouldallowcompetitiontoaccessthetechnology and thereby limit or prevent MDxHealth fromdeveloping,manufacturingorsellingproductsutilizingthattechnology.JohnsHopkinsUniversity(JHU)istheinventorofa key technology in the field of genemethylation, the coreMSP technology, of certain methylation-specific diagnosticmarkersandtheirapplication,andofother,non-methylationrelatedtechnologyforgeneticcancerdiagnosis.InconnectionwiththeCompany’sformationin2003,MDxHealthreceivedaworldwideexclusivelicensefromJHUtousethismethylationtechnology. This license and other similar licenses canbe revoked by JHU in certain cases of material breach byMDxHealth of the terms and conditions of the licenseagreements,particularlybyfailingtoreportonandpayfeesrelatedtotheunderlyingpatents.
MDxHealthhasentered,andintendstocontinuetoenter,intopartnership agreements with diagnostic companies for itsscreening products;with pharmaceutical companies for itscompaniondiagnosticbiomarkerdiscoverycapabilities,assaydevelopment capabilities, and clinical trial testing services;and with research kit companies for its research marketproducts.Ifcertainofthesecompaniesweretofailtouseorcommercialize,ordelaytheusageorcommercializationof,thelicensedtechnologyortheproductsorservicesofMDxHealth,thiscouldreducetherevenuesofMDxHealthsignificantly.
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anyofMDxHealth’spatentrights.March-inrightsallowtheU.S. government, under certain conditions, to revoke theexclusivityofpatentswhicharebasedonresearchfundedbytheU.S.federalgovernment.
ThecurrentorfutureintellectualpropertyclaimsofMDxHealthmay be challenged, and new patents of third parties mayaffect MDxHealth’s freedom to operate. MDxHealth mayincursubstantialcoststoprotectandenforceitspatentsanditsin-licensedrights.Inordertoprotectorenforceitspatentrights,MDxHealthmayinitiateactionsagainstthirdparties.Third partiesmay also initiate actions againstMDxHealth.Any actions regarding patents could be financially costly,could divert the management and key personnel from itsbusiness,andcouldputMDxHealth’spatentsatriskofbeinginvalidatedornarrowlyinterpreted.
MDxHealth also relies on trade secret protection andcontractualrestrictionstoprotectitsproprietarytechnology.Thisonlyprovideslimitedprotectionandmaynotadequatelyprotect MDxHealth’s rights. Typically, MDxHealth requiresits employees and third parties to sign confidentialityagreementsandemployeestoalsosignagreementsassigningto MDxHealth all intellectual property arising from theirworkforMDxHealth.Nevertheless, thesemeasuresmaynotbeeffective inprotectingMDxHealth’s intellectualpropertyrights.
Theability ofMDxHealth to freely exploit or out-license itstechnology may be curtailed by the terms and conditionsof certain in-licensing agreements and of certain subsidyagreements. These agreements sometimes limit how andwherethetechnologymaybeexploited.
LiabilityRiskThe use or misuse of MDxHealth’s products in testing,and the sale, marketing and use of future products basedthereon may expose MDxHealth to liability claims. TheCompany’sbusinessexposes it topotentialproduct liabilityrisks inherent in the testing, marketing and processing ofpredictive,orpersonalizedmedicalproducts.Additionally,theCompany’sintentiontoestablishandoperateaCLIA-certifiedlabtoprovideitstestsexposesittopossiblelitigationbasedon malpractice, data aggregation errors, or misdiagnoses.The assertion of liability claims against MDxHealth couldresult in a substantial cost to, and diversion of efforts andmanagementattentionby,MDxHealth.IfMDxHealthcannot
successfullydefend itself againstproduct liability claims, itmay incur substantial liabilities or be required to limit orcancelthecommercializationofitsproducts.
Furthermore, MDxHealth’s collaborators may face similarliability claims. Any assertion of such claims againstMDxHealth’scollaboratorscouldadverselyaffectMDxHealth’scollaborations with such parties. While under certaincircumstancesMDxHealthmaybeentitledtobeindemnifiedagainstlossesbyitscorporatecollaborators,indemnificationmaynotbeavailableoradequateforMDxHealthshouldanyclaimarise.Furthermore,althoughMDxHealthcurrentlyhasaproductliabilityinsurancepolicy,thereisnoguaranteethatthecoverage issufficientor thatMDxHealthwillbeable tomaintainsuchinsuranceinthefutureorthatitwillbeabletofindalternativeinsurancecoverageonreasonableterms.
For clinical and other patient trials, MDxHealth and itscollaborators may face liability claims from patientsparticipatinginorsupplyingsamplesforthetrials.AlthoughMDxHealth currently has liability insurance policies for itstrials,thereisnoguaranteethatthecoverageissufficientorthatMDxHealthwillbeable tomaintainsuch insurance inthefutureorthatitwillbeabletofindalternativeinsurancecoverageonreasonableterms.
StrategyExecutionRiskMDxHealth is dependentonnumerous factors to carry-outitsstrategy,someofwhichmaybebeyonditscontrol.
Aspartof thenewstrategy,MDxHealth intends todevelopand commercialize clinical diagnostic tests, performPharmaco-Diagnostic research, provide testing services,and develop companion diagnostic tests in collaborationwith thepharmaceutical industry (pharmacogenomics). Forits Pharmaco Diagnostics activities, MDxHealth will oftenbe dependent on the pharmaceutical partner for patientsamples, drug development, and drug regulatory approvaland commercialization and itmay take a long time beforeeither the drug or the companion diagnostic are approvedforcommercialization, ifatall. InordertocommercializeitsClinicalDiagnostics tests,MDxHealthwillneed topublicizetimely and relevant validation studies to facilitate theacceptance of these tests in the medical community, gainaccess toandoperateaU.S.CLIA-certified lab,andbuildupasalesforceandthenecessarycommercialsupportservicesandinfrastructure.
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In order to implement the new strategy, MDxHealth hashad torestructure theCompany, itsactivities, itspersonnel,anditssites.Thishasresultedincertainone-offcostswhichhave been largely reflected in the 2009 and 2010 financialstatementsoftheCompany.
Since the inception of the Company,MDxHealth has neverbeenthetargetofanylitigationnorhasitsoughttorecuperatedamages or cease activities by third parties. However, therestructuring actions could result in unforeseeable costsor damages from areas such as (i) possible litigation fromdiscontinued collaborations, projects, or personnel, (ii) lossofknow-howfromdiscontinuedpersonnelandcollaboratorswhomaynowworkwith competitors, and (iii) requests forreimbursement of subsidies due to discontinued projects,sites,oremploymentlevels,orinsufficientfuturespendingataregionallevel.Further,MDxHealthissubjecttoanumberofrisksandchallengesthatspecificallyrelatetoitsinternationaloperations. In addition to MDxHealth’s headquarters inLiège, Belgium and its subsidiaries in Ghent, Belgium andDurham,UnitedStates, theCompany intends toestablishaCLIA-certified lab facility in theU.S. IfMDxHealth isunabletomanage the challenges associatedwith its internationaloperations,thegrowthofitsbusinesscouldbelimited.
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MDxHealth,mayturnouttobemateriallydifferentfromanyfuture results, performance or achievements expressed orimpliedbysuchstatementsandestimates.
Giventheseuncertainties,thepubliciscautionednottoplaceany undue reliance on such forward-looking statements.Furthermore, these forward-looking statements andestimates aremade only as of the date of this document.MDxHealth disclaims any obligation to update any suchforward-looking statements or estimates to reflect anychangeintheCompany’sexpectationswithregardthereto,oranychangeinevents,conditionsorcircumstancesonwhichanysuchstatementorestimateisbased,excepttotheextentrequiredbyBelgianlaw.
AvailabilityoftheRegistrationDocumentTheRegistrationDocumentisavailabletothepublicfreeofchargeuponrequestto:
MDxHealthSAAttention:InvestorRelationsTour5GIGANiveau+3Avenuedel’Hôpital114000Liège,Belgium
Email:[email protected]
An electronic version of the Registration Document is alsoavailableonMDxHealth’swebsite:(www.mdxhealth.com).
PostingthisRegistrationDocumentontheinternetdoesnotconstituteanoffertosellorasolicitationofanoffertobuyanyofthesharestoanypersoninanyjurisdictioninwhichitisunlawfultomakesuchofferorsolicitationtosuchperson.
LanguageofthisRegistrationDocumentMDxHealth (formerly known as OncoMethlyome Sciences)prepared this Registration Document in English and it hasbeen translated into French. Both the English and Frenchversions are legally binding. MDxHealth has verified theconsistency between the English and French versions andassumesresponsibilityforthetranslation.
ResponsibilityforthisRegistrationDocumentTheBoardofDirectorsofMDxHealth, representedbyall itsmembersreferredtoinChapter3,assumestheresponsibilityforthecontentsofthisRegistrationDocument.TheBoardofDirectors declares that, having taken all reasonable care toensurethatsuchisthecase,theinformationcontainedinthisdocumentis,tothebestofitsknowledge,inaccordancewiththefactsandcontainsnoomissionlikelytoaffectitsimport.
Forward-LookingStatementsThis prospectus contains forward-looking statements andestimateswithrespecttotheanticipatedfutureperformanceofMDxHealthandthemarketinwhichitoperates.Certainofthesestatementsandestimatescanberecognizedbytheuseofwordssuchas,withoutlimitation,“believes”,“anticipates”,“expects”,“intends”,“plans”,“seeks”,“estimates”,“may”,“will”and “continue” and similar expressions. Actual events aredifficult to predict andmay depend upon factors that arebeyond the Company's control. Therefore, actual results,the financial condition, performance or achievements of
2010RegistrationDocumentThisdocumentisaRegistrationDocumentwithinthemeaningofarticle28oftheBelgianlawofJune16,2006onpublicofferingofinvestmentinstrumentsandontheadmissionofinvestmentinstrumentstolistingonaregulatedmarket(“Loidu16juin2006relativeauxoffrespubliquesd’instrumentsdeplacementetauxadmissionsd’instrumentsdeplacementàlanégociationsurdesmarchésréglementés”/“Wetvan16juni2006opdeopenbareaanbiedingvanbelegginsinstrumenten en de toelating van beleggingsinstrumenten tot de verhandeling op een gereglementeerdemarkt”).OnFebruary22,2011,theBelgianBanking,Finance,andInsuranceCommission(CBFA)approvedtheEnglishversionofthisdocumentinaccordancewitharticle23oftheabove-mentionedlaw.
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2010RegistrationDocument
Theelectronicversionmaynotbecopied,madeavailableorprintedfordistribution.OtherinformationonthewebsiteoftheCompanyoronanyotherwebsitedoesnotformpartoftheRegistrationDocument.
OtherAvailableInformationMDxHealthmust file its (restatedandamended)articlesofassociationandall otherdeeds that are tobepublished intheAnnexes to the Belgian Official Gazette with the clerk’soffice of the commercial court of Liège (Belgium), wherethey are available to the public. A copy of the articles ofassociation is also available on the Company’s website(www.MDxHealth.com).
InaccordancewithBelgianlaw,theCompanymustprepareannual audited statutory and consolidated financialstatements.Theannualstatutoryandconsolidatedfinancialstatements and the reports of the Board of Directors andstatutoryauditorrelatingtheretoarefiledwiththeBelgianNational Bank, where they are available to the public.Furthermore, theCompanyhas topublishsummariesof itsannual and semi-annual financial statements, as well asinterim management statements in accordance with the
Belgian Royal Decree of November 14, 2007 relating to theobligations of issuers of financial instruments admitted totrading on a Belgian regulatedmarket (“Arrêté royal relatifauxobligationsdesémetteursd’instrumentsfinanciersadmisàlanégociationsurunmarchéréglementé”/“Koninklijkbesluitbetreffende de verplichtingen van emittenten van financiëleinstrumenten die zijn toegelaten tot de verhandeling opeen gereglementeerde markt”). These documents are madeavailableontheCompany’swebsite.
TheCompanymustalsodisclosepricesensitiveinformationandcertainotherinformationtothepublic.Inaccordancewiththe afore-mentioned Belgian Royal Decree of 14 November2007 relating to the obligations of issuers of financialinstruments admitted to trading on a Belgian regulatedmarket,such informationanddocumentationwillbemadeavailablethroughtheCompany’swebsite,pressreleasesandthecommunicationchannelsofEuronextBrussels.
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1. KeyFinancials
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KeyFinancials
Condensedconsolidatedstatementofcomprehensiveincome 2010 2009 2008Revenues 2,536 2,548 3,024Grossprofit 2,166 2,369 2,781Researchanddevelopmentexpenses 6,812 13,089 10,999Selling,generalandadministrativeexpenses 3,745 4,011 3,107Otheroperatingincome/expenses -25 0 1OperatingProfit/(Loss)(EBIT) (8,366) (14,731) (11,326)Financialincome 222 450 1,143Financialexpenses 85 20 9Incometaxes 24 0 0Netprofit/(Loss) (8,253) (14,301) (10,192)
Consolidatedstatementoffinancialposition 2010 2009 2008ASSETSTotalnon-currentassets 1,109 1,976 4,660Totalcurrentassets 13,310 22,776 34,392Ofwhichcashandcashequivalents 10,593 18,032 30,601Totalassets 14,419 24,752 39,052LIABILITIESANDSHAREHOLDERS’EQUITYTotalequity 10,723 18,800 32,643Non-currentliabilities 626 557 1,252Currentliabilities 3,070 5,395 5,157Totalliabilitiesandshareholders’equity 14,419 24,752 39,052
ConsolidatedCashFlowStatement 2010 2009 2008Operatingcashflow (8,129) (12,798) (9,313)Investingcashflow 686 118 (1,619)Financingcashflow 0 109 8,473Netchangeincashandcashequivalents (7,443) (12,571) (2,459)Cashandcashequivalentsatendofperiod 10,593 18,032 30,601
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2.ActivitiesofMDxHealth
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ActivitiesofMDxHealth
MDxHealth’s European headquarters are located in Liège,Belgium and its U.S. headquarters is located in Durham,NorthCarolina,U.S.Attheendof2010,MDxHealthemployedatotalof37employees.
STRATEGYSUMMARY
MDxHealth develops and commercializes advanced testsfor the diagnosis, prognosis and personalized treatment ofcancerusingitspatentedmoleculartechnology,MethylationSpecific PCR ( MSP). This DNA-based MSP technology,originallydevelopedatJohnsHopkinsUniversity,iscombinedwith individual patented genes (“biomarkers”) that whenmethylated or non-methylated in patient tumor samples,aid physicians with the diagnosis of cancer, the likelyprogressionofcancer,ortheresponsivenessofthecancertocertaintherapies.MDxHealthtypicallycombinesonetothreebiomarkersinasingletesttoprovidearesulttothephysiciananditstestsdonotrequireanalgorithmforinterpretation.
ThebusinessmodelofMDxHealthhasrecentlyconsiderablychanged. During 2010, MDxHealth decided to shift from adiscoverylicensecompanytoacommercialclinicaldiagnosticcompany. The previous business model of the Companyfocusedontheout-licensingofcancerscreeningapplicationsandthediscoveryofnewbiomarkersinexchangeforeventualroyalty fees in the long term.Cancerscreeningapplicationsoften take many years to develop, to get approved andto produce revenues. This out-licensing strategy left theCompany excessively dependent on third parties for thedevelopment and commercialization of its technology andproducts. For example, the Company previously licensedprostateandbraincancerbiomarkersandtheMSPtechnologyto Laboratory Corporation of America (LabCorp). AlthoughLabCorplaunchedlaboratory-basedprostateandbraincancertissuetestingservicesintheU.S.in2008,itdoesnotappeartobeactivelypromoting theservicesor investingresourcestosponsorclinicaltrialsfurthervalidatingtheutilityofsuchteststothemarket.
Under the previous business model, the Company spentsignificant fundsseeking todevelopcancerscreening tests.Screening tests are generally being used for the generalpopulation to identify the presence of cancer or likelycancer. The results of the screening test typically requirefollow-up procedures to confirm a screening test outcome.
2.1. CompanyOverviewandHistoryMDxHealth (formerly known as OncoMethylome Sciences)is a molecular diagnostics company that develops andcommercializes advanced tests and products for cancerassessment and the personalized treatment of patients.Specifically,MDxHealthoffers:
Clinical Diagnostics (ClinicalDx) products: Providingphysicianswithinnovativeandmeaningfulassayswhichaidintheidentificationandtreatmentoftheircancerpatients.
Pharmaco-Diagnostics(PharmacoDx)productsandservices:Collaborating with pharmaceutical companies on thedevelopmentofcompaniondiagnostics,biomarkerdiscovery,andclinicaltrialtesting.
Out-licensing opportunities on certain technologies:Providingopportunitiesforspecializedcompaniestolicensecertain of MDxHealth’s technology for cancer screeningapplicationsorfortheresearchmarket.
MDxHealthwasfoundedinJanuary2003andhasdevelopeda considerable portfolio of intellectual property (IP) and arobustproductpipeline.InrelationtoitsClinicalDxactivities,MDxHealth is focusedoncommercializingproprietary testsfor three cancer types: prostate, colorectal, and lung. TheCompany’s research and clinical development activities areoften carried out in collaboration with world-renownedcancer research institutes. For its PharmacoDx activities,the Company leverages its MSP technology and portfolioof biomarkers to assist pharmaceutical companies withbiomarkerdiscovery,assaydevelopment,clinicaltrialsandco-developmentof companiondiagnosticswhile retaining thediagnosticrightstocompaniontestsdeveloped.MDxHealthiscollaboratingwithanumberofpharmaceuticalcompaniesintheareaofpersonalizedmedicine,developingcompaniondiagnosticswithcompaniessuchasMerckSerono,Pfizer,GSKBiologicals, and Roche. Additionally, the Company has out-licensedpatentedbiomarkersanditsMSPtechnologyplatformforcancerscreeningapplicationsandresearchpurposesforbladder,cervicalandcolon to independentcancerreferencelaboratories such as Exact Sciences, Predictive BiosciencesandSelf-Screen.
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besentbycouriertotheCompany’sCLIAservicelabandthetestresultswillbesentbytheCompanytothephysician.Ata laterstage,MDxHealthmayconsidersellingsuch tests inEuropeasCE-markedkitsviaadistributorandout-licensingthe applications in other regions of theworld. In thenear-future,theseClinicalDxtestsareexpectedtobethecoredriveroftherevenuesandvaluationoftheCompany.Theprincipalproducts that fall into this category are (i) the ProstateConfirmMDxandInformMDxtests,(ii)theLungConfirmMDxand InformMDx tests, and (iii) the Colon InformMDx test.MDxHealth is also carrying out early-stage research on abladderaggressivenesstest.
2.Pharmaco-Diagnostic (PharmacoDx) solutions. Alsoknown as companion diagnostics, PharmacoDx tests assistthe physician in prescribing the right therapy to the rightpatient based on the genomic profile of that patient. Byexamining specific genes MDxHealth, together with itspharmaceuticalpartners,hopestoidentifywhichpatientsaremost likely to respondpositively toanadministeredcancertherapy.MDxHealth typically files for patent protection onthese predictive biomarkers or works with pharmaceuticalcompanies to discover new jointly patented biomarkers.MDxHealthintendstosellitsPharmacoDxtestsviaitsownU.S.CLIA labor its ISO-certifiedEuropeanlabtopharmaceuticalcompanies and doctors performing research during thedevelopmentstageofthedrugs.Ifadrugbecomesapprovedalongside a PharmacoDx test, then MDxHealth intends toofferthetestviaitsownU.S.CLIAlaborviapartners.Currentlynodrug is jointlyapprovedwithanMDxHealthcompaniondiagnostic test; but if regulatory approval is obtained, therevenue from such tests to MDxHealth could increasesignificantly. Further, the Company expects that marketpenetrationcouldbeaccelerated,asthesalesrepresentativesof the pharmaceutical company that developed thecompanion drug could promote the PharmacoDx test tophysicians in conjunction with MDxHealth’s own directsales force.MDxHealth’s PharmacoDx tests in developmentare: (i) the MGMT test for brain cancer as a companiondiagnostic test with the expectation it will be included intheCilengitidedruglabel(alreadyinfinalstagesofaphaseIII trialwithMerckSerono), (ii) a testbeingdevelopedwithPfizerforPARPinhibitordrugs,and(iii)testsbeingdevelopedwith GSK Biologicals for the immunotherapeutics cancer(vaccine)program.
3.Pharmaco-Diagnostic (PharmacoDx) services.MDxHealthoffersPharmacoDxservicesandsupport topharmaceutical
Comparedtothenumberofpeoplescreenedforcancer,fewoftheindividualsactuallytestedarefoundtohaveacancer.Screening tests requireorhaveextensiveandcostlyclinicaltrials,FDAapproval,akitformat,ahighlevelofautomation,are charged at lower prices, achieve lower reimbursementlevels, and take many years for approval and adoption. Tofacilitate screening procedures and patient compliance,screening tests are usually based on non-invasive samplesandmethods(blood,stool,urine,orimaging).
MDxHealth is now focused on diagnostic and prognosticteststoassistphysiciansinimprovingthecareofpatients.Allof thetests indevelopmentbyMDxHealthare tissue-basedtestsforpatientssuspectedofcancerorclinicallydiagnosedwithcancer.Thesetestscanonlybeusedinqualified(CLIA-certified) laboratories.MDxHealth intends tocommercializeits testsasLaboratory-DevelopedTests (LDTs).With thenewbusinessmodel, MDxHealth is seeking to have full controlof theend-development, launch,promotion,andsalesof itscore products. To carry-out the distribution of its products,MDxHealthintendstoestablishacommerciallaboratoryandhireasalesforceintheUnitedStates.
For its outsourced screening products and biomarkers,MDxHealthhasformed,andintendstocontinuetodevelop,alliances with pharmaceutical, bio-pharmaceutical anddiagnosticcompanies,aswellasacademicinstitutions.
MDxHealth’s existing and future solutions comprise4categories:
1.Clinical Diagnostic (Clinical Dx) solutions assist thephysician to detect, diagnose, and treat cancer patients.These testsarebeingdevelopedbyMDxHealthwithaviewto being sold directly to physicians via a direct sales forceand via a company-operated U.S. CLIA-certified lab in theform of laboratory-developed tests (LDTs). MDxHealth doesnotanticipateneedingFDA-approval for these tests. In July2010,theFDAindicatedthatitwasreviewingtheregulatoryrequirementsapplyingtoLDTs,thustherecanbenoassurancethatFDAregulation,includingpre-marketrevieworapproval,willnotberequiredinthefutureforLDTs.MDxHealthintendsto conduct additional clinical trials to support the clinicaladoption of these tests and to certify the tests in its ownCLIAservicelab.TheCompanyexpectstheteststobelargelyreimbursed with already existing CPT (Current ProceduralTerminology) reimbursement codes. These ClinicalDx testswillbeprimarilytissue-basedtests.Thebiopsymaterialwill
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test.Themainout-licensingdeals (all non-exclusive) in theresearchmarket include the technology licenses to QiagenNV,Takara,andMerckSerono(Millipore)forMSPresearchkits.None of these out-licensing deals are currently generatingmaterialrevenuesforMDxHealthnoraretheyexpectedtodosointhecomingfewyears.Oncethetechnologyapplicationsarelicensed-out,MDxHealthhasnoorinsignificanton-goingcosts associated with these applications. These out-licensetransactions are expected to facilitate the Company’s newstrategy,permittingMDxHealthtobetterfocusitsresourcesonitscoreproductsandservices.
In addition to the foregoing out-licenses of its non-coreproducts,inanefforttomoreefficientlycommercializeitstests,MDxHealthpreviouslyenteredintoanumberofpartnershipswith reference laboratories and diagnostic companiesgranting rights to offer products based on MDxHealth’score technologies. The main strategic out-licensing dealsinclude:(i)technologylicensetoLabCorpforuseinlaboratoryservicetestingforprostatecancer(non-exclusive)andMGMTbraincancer(exclusive)intheU.S.andCanada,and(ii)non-exclusive technology license to Veridex LLC for prostatecancerlaboratorytestingservices.WhileMDxHealthreceivesroyaltiesandotherfeesfromthesalesofitssublicenseesonthese tests, markers, and use of technology, if its partnersincrease their sales beyond expected levels (in competitionwith MDxHealth’s tests under the same indication), thenMDxHealthmayrealize lowerthanexpectedrevenuesfromitsownplannedproductsandservices.However,MDxHealth’snewstrategyhasbeendesignedconsideringtheexistenceofthesepre-existingout-licensingagreements.Webelievethatthesepre-existinglicenseagreementswillnotlimitthenewbusinessstrategy.
MDxHealth carries out its product development andpharmaceutical clinical service testing via its ISO-certifiedcentral laboratory based inBelgium.MDxHealth intends tosellitsClinicalDxandPharmacoDxtestsintheU.S.asLDTsviaitsownU.S.CLIA-certified lab.MDxHealthdoesnotyetownsuchaCLIA-certifiedlabnordoesithavesalesrepresentativesintheUnitedStates,howeverit intendstostartbuildingoracquiringsuchcapabilitiesduringthecourseof2011.
and other drug development companies at all stages ofthe drug/diagnostic (i.e. theranostic) development process,including(i)biomarkerdiscovery,selectionandoptimization,(ii) bioinformatics, (iii) validation of companion diagnosticassaysand(iv)clinicaltrialtesting.MDxHealth’sPharmacoDxservices, provided to both existing collaborators and oncontracted services basis, generated the majority of therevenueofMDxHealthin2010andareexpectedtobealargepart of revenues in thenear future. Regulatory authorities,suchastheU.S.FDA,havestartedtorequirepharmaceuticalcompanies to integrate biomarker identification and othercompanion diagnostics tools into the drug developmentprocess, particularly in connectionwith targeted therapies,to ensure safety and efficacy, and control costs. As a result,pharmaceuticalcompaniesincreasinglyrelyonPharmacoDxtests to stratify patients for clinical trials (i.e. select thosepatients for whom the drug under investigationwould bemost effective). This allows pharmaceutical companies toconductclinicaltrialsfasterandwithsmallerpatientcohorts.Basedonitsproprietaryportfolioofmethylationbiomarkersand platform technology, MDxHealth is often able totransitionbiomarkersidentifiedforitsservicecustomersintocandidates for MDxHealth-owned companion diagnostictests for commercial development (in collaboration withitscustomers).
4.Out-Licensed technology and biomarkers for clinicaland research applications. The Company’s new strategyis focused on the development and commercialization ofits own clinical diagnostic tests, however the Companywill continue toout-license itsMSP technologyandcertainbiomarkers for non-core applications. MDxHealth has out-licensed its MSP technology and certain biomarkers forits non-core products to third party companies that mayincorporate the technology andmarkers into the productstheyaredevelopingforboththeclinicalandresearchmarket.Inreturn,MDxHealthmayreceivecertainmilestonefeesandroyalties on the eventual sales of tests and products thatincorporate its technology. Themain out-licensing deals intheclinicalmarketinclude:(i)exclusivetechnologylicensetoExactSciencesInc.foruseinastool-basedcolorectalcancerscreeningtestintheU.S.,(ii)non-exclusivetechnologylicensetoVeridexLLCforuseinlaboratoryservicetestingforblood-based colorectal cancer screening, (iii) exclusive technologylicense to Predictive BioSciences Inc. for use in urine- andplasma-based bladder cancer detection and monitoringtestsintheU.S.,and(iv)non-exclusivetechnologylicensetoSelf-ScreenBVforuseinacervicalcancerscreeningortriage
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2.2. Activities2.2.1. MolecularDiagnosticsinCancer
Leveraging the patented MSP methylation technology,MDxHealth is developing and intends to commercializea robust pipeline of diagnostic, prognostic and predictivemoleculardiagnostictestsformultiplecancertypes.
MDxHealth developsmolecular diagnostic tests based onits patented DNA Methylation platform integrating itsproprietary DNA biomarkers. These assays deliver highlyaccurateresultsandcanbeperformedonavarietyoftissuetypes including formalin-fixed paraffin embedded (FFPE),fresh/frozentissue,urine,plasma,serum,sputum,broncho-alveolarlavagesandstoolusingcommerciallyavailablePCRequipment. The Company’s technology is able to detect a
Foreachcancertype,theCompanyintendstoofferacombinationofdifferentassaysasdefinedbelow:
CLINICALDIAGNOSTICS(ClinicalDx)
PHARMACO-DIAGNOSTICS(PharmacoDx)
ConfirmMDx InformMDx PredictMDxOur“Confirm”productswillserveasanaidforphysicianstoassessthepresenceorabsenceofcancer
Our“Inform”productswillprovideprognosticassessmenttodistinguishbetweenaggressiveandnon-aggressivetumors
Our“Predict”productswillprovidepredictiveinformationtoindicatewhichdrugortreatmentregimenislikelytobemosteffectivefortheindividualpatient
Allofthesetestsareintendedtoimproveontheexistingdiagnosticprocessforpatientswithcancerwhileminimizingtheneedforinvasiveandcostlyproceduresincancer-freeindividuals.
fewcancercellsinalargebackgroundofnormalcellsfoundintissueandinvarioustypesofbodilyfluidssuchasurineand sputum. Therefore, the technology is well suited todetectcancerinitsearlieststagesofdevelopment,allowingforearliermoresuccessfulandcost-effectivetreatment.
MDxHealth’s ClinicalDx pipeline includes diagnostic andprognostic molecular diagnostic assays (ConfirmMDxand InformMDx tests) for prostate, colon and lung cancer.MDxHealth’s PharmacoDx pipeline includes predictivetests (PredictMDx) designed to work in conjunction withpharmaceutical or biotech drugs, and currently focus ona variety of cancers areas including: brain (MGMT), lung,colorectal and breast cancer. In addition, the Company hasnumerousotherbiomarkersformanyadditionalcancertypesreadyfordevelopment.
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alreadyhasbiomarkersandpublisheddataintheseproductareas, the main efforts going forward will be on productdevelopmentratherthanresearch.Atend-2010,MDxHealth’smain diagnostic products presented the following statusofadvancement:
2.2.2. ClinicalDiagnosticsProgram(ClinicalDx)
(i) MDxHealth’sProstateCancerPortfolioProstatecanceristhemostfrequentcancerinmen,withoneoutofsixmenbeingdiagnosedwithprostatecancerduringtheir lifetime.1Annually thereareapproximately 30millionmen screened by the Prostate-Specific Antigen (PSA)2,3 testresulting in approximately 1.5 million abnormal PSA testresults (>4.0)4 leading to over 900,000 biopsy procedures,5of which 217,000 are diagnosed with prostate cancer with32,000 annual deaths.6 Although prostate cancer is one ofthe deadliest cancers in men, its accurate diagnosis and
1 U.S.DepartmentofHealthandHumanServices,CentersforDiseaseControlandPrevention(CDC)
2 UseoftheProstate-SpecificAntigenTestamongU.S.Men-Findingsfromthe2005NationalHealthInterviewSurvey,Rossetal,CancerEpidemiolBiomarkersPrev2008
3 CostAnalysisofScreeningfor,Diagnosing,andStagingProstateCancer,Ekwuemeetal,PrevChronicDis,CDC2007
4 ScreeningforProstateCancer:U.S.PreventiveServicesTaskForce,Linetal.,AnnInternMed.2008
5 PrevalenceofTMPRSS2-ERGFusionProstateCanceramongMenintheUnitedStates,Mosqueraetal,ClinCancerRes2009
6 AmericanCancerSociety,Inc.,SurveillanceandHealthPolicyResearch2010
follow-up remain a challenge and come at a considerablecost to thehealthcare system.Approximately $4.4billion isspentannuallyonscreening,diagnosingandstagingandanadditional $9.9 billion is spent annual on treatment thesepatients, totalingnearly$15billionbeingspentannuallyonprostatecancer in theU.S.alone.3,7Annually,over$4billionis spent on pharmaceuticals for prostate cancer, which isexpectedtoincreaseto$8.7billionby2019.8
Despite documented false-positive rates, the AmericanUrologicalAssociationhasrecommendedthePSAbloodtestas thegold standard for screeningmenover theageof40,combinedwithaDigitalRectalExam(DRE).Forpatientswitharisingand/orPSAscore≥4.0,abiopsyisroutinelyperformedtodetermineifthepatienthasprostatecancer.Theurologisttypicallyusesan18gaugeneedle toobtainbetween8to12tissuecoresasperthestandardofcare.9
7 NationalCancerInstituteTrendsProgressReport-2009/2010Updated
8 ProstateCancerMarketSnapshot,ThePinkSheet,Nov22,2010.ElsevierBusinessIntelligencePublicationsandProducts
9 Optimalbiopsystrategiesforthediagnosisandstagingofprostatecancer,Pateletal,CurrentOpinioninUrology:May2009
Our Clinical Diagnostic tests are designed to aid in theassessmentof thepresenceorabsenceofcancerorprovideindicationsofcancerrecurrenceoraggressiveness.
On October 18, 2010, MDxHealth announced that itsClinicalDx Programwill focus on threemajor cancer areas:
ClinicalDiagnosticsProgram
ProductResearch Development Commercial
Discovery Feasibility Verification Validationstudies
ImplementationTrials
PivotalTrials
ProstateCancer
ConfirmMDX
InformMDX
LungCancer
ConfirmMDX
InformMDX
ColonCancer
InformMDX
Note:adefinitionoftheabovepipelinestepscanbefoundintheglossary
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However, literature suggests these scores canbe subjectiveresultinginover-gradingandover-treatmentofsomepatients,while conversely under-grading and under-treatment ofotherpatients14.Asaresult,urologistsandtheirpatientsareconfrontedwith thedifficultdecisionofchoosing themostappropriatetherapy.Allofthecurrentpatientmanagementandtreatmentoptionsposepotentialrisksandsideeffects.Patientsplacedon“activesurveillance”or“watchfulwaiting”areat riskofprogressivedisease if their cancerwasunder-graded by pathology, whereas patients treated by radicalprostatectomycommonlysuffersideeffectsofincontinenceand impotence. Patients treatedwith radiation therapyareat increased riskofdevelopinganother formof cancerandmorbidity, a high cost to pay if the patient’s cancer wasover-graded by pathology and the disease may not haveprogressed.
A recent case study reported in the New England Journalof Medicine illustrates the lack of consensus on how totreat prostate cancer patients with low to intermediaterisk pathology results. The survey of over 2,000 U.S.-basedurologistsaskedhowtheywouldtreatanotherwisehealthy63oldmalediagnosedwithprostatecancerandaGleasonScoreof6(intermediaterisk)intwooftwelvecorebiopsyspecimenstaken.Morethanonethird,37%indicatedtheywouldperformaradicalprostatectomy,36%answeredtheywouldtreatwithradiation therapy and the remaining 27% responded theywouldplacethepatienton“activesurveillance.”15
TheAmericanUrologicalAssociation,thepremierprofessionalassociationfor theadvancementofurologicpatientcare intheU.S.,hascalledfornewbiomarkers indicatingbiologicalaggressiveness “critical to the management of this diseasewith itshighlyvariableclinicalbehavior, further stating that“…because of the potential for significant over-detection andovertreatment of prostate cancer, integrating biomarkers ofaggressivenesswithearlydetectionprogramsisdesirable.”16
14 FactorsPredictingProstaticBiopsyGleasonSumUnderGrading,Stackhouseetal,J.Urology2009
15 ManagementofProstateCancer—PollingResults,ClinicalDecisions,NEnglJMed2009
16 GuidelinefortheManagementofClinicallyLocalizedProstateCancer:AmericanUrologicalAssociation2007Update
Importantly,anabnormalPSAresultcanoftenbecausedbyotherfactorsincludingage,infection,inflammation,orotherbenignconditionssuchasbenignprostatichypertrophy(BPH).Thisleadstotheinclusionofmanynon-cancerpatientsbeingsubjectedtoprostatebiopsies(false-positivePSA).Therateofcancerdetection inpatientsbiopsied isapproximately25%,leavingapproximately75%withanegativeresultforcancerbyroutinehistologyandpathologyreview.(~900,000annualbiopsies,lessthe217,000diagnosedcases=~25%).10-11
An elevated PSA and/or abnormal DRE places them athigh risk of cancer and as a result they undergo a biopsyprocedure,howeverdue to thenatureof randomsamplingand the limitations of histology, many patients may havecancerundetectedbypathologicalreview.Studiesbyurologyand pathology opinion leaders, and experienced by mostpracticing urologists, report that initial prostate biopsyhistopathologyhasa~25%false-negativerate.12Giventhesereportedfalse-negativehistologyrates,patientswithnegativebiopsy results, and their urologists, are often left with asenseofanxiety.Theseresultsposeadiagnosticdilemmaforurologists and their patients, leadingmanymen to receive2nd,3rdandsometimes4threpeatbiopsyprocedurestorule-outthepresenceofcancer.13
Patients identified as positive for cancer on the initialor subsequent biopsy are assigned a Gleason score (GS)characterizing the primary and secondary grade of tumorpresent.Scoresforeachsectionrangefrom1to5,andcombinedcreatetheGleasonscorerangingfromGS2toGS10.Notallcancersdetectedareclinicallysignificant,somepatientsareclassifiedashaving lowto intermediateriskofprogression,withGleasonscoresof2-6,makingthemlikelycandidatesfornon-interventional“active surveillance,”whereasothers areclassifiedwithmoreaggressivedisease,withGleasonscoresrangingfrom7-10,meritingradicaltherapy.
10 PrevalenceofTMPRSS2-ERGFusionProstateCanceramongMenUndergoingProstateBiopsyintheUnitedStates,Mosqueraetal.ClinCancerRes2009
11 Kleinetal.JClinOncol2005
12 Predictingcancerfollowingadiagnosisofhigh-gradeprostaticintraepithelialneoplasiaonneedlebiopsy:dataonmenwithmorethanonefollow-upbiopsy.Epsteinetal,AmJSurgPathol.2001Aug;25(8):1079-85
13 StrategiesforRepeatProstateBiopsies,MarthaTerris,CurrentProstateReports2009
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MDxHealth is developing two products for prostate cancerto augment the accuracy of current diagnostic methodsand tohelp identifypotentiallyaggressivedisease toaid intreatmentselection:
ConfirmMDx“Rule-in” men with an initial negative biopsy result for•immediate repeat biopsy and testing, thereby helping todiagnose the 20-30% of prostate cancers missed by theinitialprocedure(false-negativebiopsyresults).“Rule-out” otherwise healthy, cancer-free men from•undergoing unnecessary repeat biopsies or excessivescreeningprocedures.
InformMDxIdentifies prostate cancer patients with indolent disease,•whomaybesafelymanagedpresentlywithouttreatment–reducinganxiety,sideeffects,andhealthcarecosts.Identifies patients with aggressive prostate cancer who•require immediate treatment –ensuring timely andappropriatetreatmentforimprovedpatientoutcome.
ConfirmMDx for prostate cancer is designed to addressthe diagnostic dilemma faced by negative biopsy results.Approximately75%ofmenwhoundergoaninitialprostatebiopsy due to elevated PSA and/or abnormal digital rectalexam (DRE) are found to have a negative biopsy (approx.650,000 to 680,000 out of the ~900,000 men biopsiedannuallyintheU.S.).17Ofthesenegativebiopsies,potentially25-30%arefalse-negatives,therebydelayingcriticaltreatment.Prostate biopsies still missmany cancers and thus cannotconclusively rule-out healthymen from further testing. Asdoctorsareunabletosaywithconfidencethatthesepatientsarecancer-free,activefollow-upincludingre-biopsyisoftenrecommendedresultinginunnecessarytestingonmorethan600,000cancer-freemenannuallyintheU.S.alone,manyofwhomaredestined toapainfulcycleof repeatbiopsies foryears to come.TheConfirmMDx testwill assistphysicians,with very high sensitivity18 and negative predictive value(NPV)of96%,19torule-outthepresenceofcancerinthevastmajoritymenwhileidentifyingthosemenwhomhavecancerpresent,supportingre-biopsyandpossibletreatment.
17 PrevalenceofTMPRSS2-ERGFusionProstateCanceramongMenUndergoingProstateBiopsyintheUnitedStates,Mosqueraetal.ClinCancerRes2009
18 ProstateCancerDetectedbyMethylatedGeneMarkersinHistopathologicallyCancer-NegativeTissuesfromMenwithSubsequentPositiveBiopsies,Troyeretal.,CancerEpidemiologyBiomarkers2009
19 DNAmethylationasabiomarkertoevaluateinitialhistologicallynegativeprostatebiopsies,Trocketal.,ASCOGUCancerSymp2007
InformMDx for prostate cancerwill aid in the prognosis ofmen diagnosed with a Gleason Score ranging from 2 – 6,consideredlowtointermediateriskforprogression(~160,000men annually).20The testwill help stratify thesemen intotwo riskgroups: thosewithaggressivediseasewho requireimmediatetreatmentandthosewithmoreindolentdiseasewhomaybe safelymonitoredby“active surveillance,” thuspotentially avoiding the side effects of impotence andincontinence as a result of radical prostatectomy or risksassociatedwithradiationtherapy.
TheMDxHealthtissue-basedtestsarebasedonthedetectionof patent-protected methylated genes. Methylation of theGST-Pigenehasbeenshowntobeaconsistentabnormalityfoundinprostatecancers.APCandRARβ2methylationarealsofrequentlyfoundinprostatecancerandhavedemonstrateda“field effect” aiding in the identification of biopsieswithfalse-negativehistopathologicalresults.21
MDxHealth has extensive validation data for the prostateConfirmMDx test and intends to commercialize it in theU.S.asanLDTviaitsownoperatedCLIAlabstartingin2012.The MDxHealth prostate InformMDx test requires furthervalidation and is not expected to be launched on the U.S.market as an LDT until late 2012 or early 2013. Additionalstudies are underway to further validate the use ofMDxHealth’stestsandtheiradoptionbyurologistsforearlyprostatecancerdetectionandprognosis.MDxHealthintendsto bring its enhanced test to the market together with afocusedmarketing strategyanddirect sales force targetingurologistsandpathologists.
Inorder tomoreefficientlycommercialize itsprostatetests,MDxHealthpreviouslygrantedasub-license tosomeof theprostatecancermarkersandMSPtechnologytoLabCorpandtoVeridexLLC.LabCorphasbeencommercializingaprostatetissue test since mid-2008 with limited sales volume todateandVeridexhasnotyetcommercialized its test.WhileMDxHealthreceivesroyaltiesandotherfeesfromthesalesofitssublicenseesonthesetests,markers,anduseoftechnologyif its partners increase their sales beyond expected levels(in competition with MDxHealth’s tests under the sameindication),thenMDxHealthmayrealizelowerthanexpectedrevenuesfromitsownplannedproductsandservices.
For the prostateConfirmMDx tissue-based testMDxHealthisnotawareofthepresenceofadirectcompetitiveproduct
20ContemporaryRiskProfileofProstateCancerintheUnitedStates,Shaoetal,JNCI2009
21 Quantitative,SpatialResolutionoftheEpigeneticFieldEffectinProstateCancer,Mehrotraetal,TheProstate2007
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Lungcancermaybeseenonchestradiographsandcomputedtomography (CT scans). The diagnosis is confirmed with abronchoscopyorCT-guidedbiopsy.Treatmentandprognosisdependuponthehistologicaltypeofcancer,thestage(degreeof spread), and the patient's performance status. Currentlungcancertreatmentsincludesurgery,chemotherapyand/orradiation.
MDxHealthisdevelopingtwoproductsinthelungcancerfieldto improve the accuracy of standard diagnostic proceduresforearlydetectionof lungcancerandtoaddresstheriskofrecurrenceinpatientswithStageIdisease:
ConfirmMDxforLungCancer–isamoleculartestdesignedforthediagnosticevaluationofroutinelycollectedbronchoscopyand/orsputumsamples.Atthetimeoffirstbronchoscopyandinapproximately30%ofthesuspectedcancercases,cytologyandhistologydonotprovide conclusive results. Inconclusiveresults lead to unnecessary, time consuming and costlyadditional procedures. The ConfirmMDx test is designed toprovide physicianswith increased accuracy in assessing thepresenceorabsenceofcancer.
InformMDx for Lung Cancer – is a molecular test whichprovides physicianswith a risk assessment of Stage I lungcancerpatients,confirmingwhetherornotthepatientisatlow risk or high risk of recurrence. Adjuvant chemotherapyaftersurgeryisnotrecommendedforthe15%(NCISEER2010)oflungcancerpatientsthatarediagnosedwithStageIdiseaseas this therapy is costly and toxic. However approximately30%(Brocketal.NEnglJMed2008)ofpatientswithresectedStageIlungcancersufferdiseaserecurrencewhichisusuallyfatal.Thereisaneedfordiagnosticteststoassesstheriskofrecurrenceandtoidentifywhichearlystagepatientsshouldreceive adjuvant chemotherapy. The InformMDx test, whenusedinconjunctionwithotherclinicalriskfactors,willhelpphysicians determine which patients may benefit frommoreaggressivetreatment,includingchemotherapy.
UsingtheCompany’spatentedMSPmethylationtechnology,Johns Hopkins Medical Center identified prospectivebiomarkers associated with the characterization andevaluation of early stage lung cancer aggressiveness in anexploratoryclinicaltrialin2007.TheCompanyhaslicensedtheexclusiverightstothesemarkersfromJHUforthisindication.Results from this initial clinical trial led to apublication intheNewEnglandJournalofMedicine.Additionalstudiesareunderway to validate the use of these tests this assay forearly detection and lung cancer recurrence risk, collecting
on the market. The PCA-3 test from Gen-Probe, a urine-basedtest,isontheU.S.marketasanLDT.ThistestanalyzesRNA, has some limitations and likely targets a differentmarketsegment.EpigenomicsAGhasdevelopedapotentialprostate cancer testsusingadifferent versionof theGSTPigene. Epigenomics has out-licensed their marker to QuestDiagnostics Inc. and Predictive Biosciences Inc. For bothcompanies the development state, the application (urineor tissue),aswellas thedateofapotential launchof theirtests are currently unknown. SourceMDx Inc. has a blood-based gene expression test in development, but since theyareprivatelyheld, it isunknownwhen theywillbring theirtest to market. To the knowledge of MDxHealth, no head-to-head comparison studies with any competing productshavebeenpublished.
For the prostate InformMDx, MDxHealth knows of onealternative LDT product on themarket called Prostate Px+fromAureonLaboratoriesInc.,howeverthisisnotamolecularassay. This privately held company has not published anysales figures and it is unknown towhat extent the test isbeingusedbyphysicians.BothGenomicHealthandMyriadGeneticshaveannouncedthattheyaredevelopingprognosticLDT’s,buttheyhavenotannouncedwhentheirproductswillbelaunchedinthemarket.
(ii) MDxHealth’sLungCancerPortfolioGlobally, lung cancer remains the leading cause of cancer-related death with an estimated 157,300 cancer deaths for2010 in the United States alone. (American Cancer Society,CancerFactsandFigures2010).
Early diagnosis of lung cancer for patients at high risk ofrecurrence is a clear unmet medical need. The AmericanCancer Society projected a total of 220,520 people werediagnosed with lung cancer during 2010 in the U.S..The diagnosis of lung cancer presents many challenges.Whensickandsymptomaticpatientsarebeingscreenedforcancer,diagnosticfindingsareofteninconclusiveandfailtodetectthepresenceofmalignancyinpatientswithsuspectedcancer.
U.S.incidenceofLungCancer 220,520/YearEuropeincidenceofLungCancer 388,753/YearGlobalincidenceofLungCancer 1,608,055/Year
Source:ACS2010,GLOBOCAN2008
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andtestingtumorsamplesfrompatientswhoarefollowedforclinicaloutcomeafter initial treatmentsurgery for lungcancer.
For its ConfirmMDx lung cancer test, MDxHealth facespotential competition from (i) a test being developed byEpigenomicsAGwhichhaspublishedlimiteddataontheirtest,and(ii)byimprovedscreeningtechniquesbeingevaluatedbydifferentuniversities.Nohead-to-headcomparisonhasbeenperformedbetweentheMDxHealthtestandotherpotentialcompetitive technologies. For its InformMDx text for lungcancer,MDxHealthisnotawareofanyexistingcompetition.EpigenomicshaslaunchedinEuropeamethylationbasedtestforlungcancercalledEpiproLung.Thisdiagnostictestisusedforpatientssuspectedoflungcancer,howeverthiskitisnotFDAclearedandnotofferedintheU.S..TheMDxHealthLungInformMDxtestcurrentlyunderdevelopmentisdesignedtoidentifyStage1lungcancerpatientsthathaveahighriskofrecurrence. The Companymay face additional competitionfromestablishedproceduresandnewentrantstothefieldinlungcancer.
(iii) MDxHealth’sColonCancerPortfolioWith639,000deathsworldwideperyear,coloncanceristhefourthmostcommonformofcancerintheUnitedStatesandthethirdleadingcauseofcancer-relateddeathintheWesternworld.(WorldHealthOrganization)
U.S.incidenceofColorectalCancer 142,570/Year(allstages)EuropeincidenceofColorectalCancer 432,414/Year(allstages)GlobalincidenceofColorectalCancer 1,235,108/Year(allstages)
Source:ACS2010,GLOBOCAN2008
Colorectal cancers arise from adenomatous polyps in thecolon.Thesemushroom-shapedgrowthsareusuallybenign,but some develop into cancer over time. Localized coloncancerisusuallydiagnosedthroughcolonoscopy.
MDxHealth is developing twoproducts in the colon cancerfield to help identify aggressive disease and to aid intreatmentdecisions.TheClinicalDxproduct(theInformMDxtest for colon cancer) is described below, whereas theColonPredictMDx PharmacoDx product is described in thePharmacogenomicssection2.2.3.).
InformMDx for colon cancer – is a molecular prognostictest which helps physicians assess the aggressiveness of apatient’stumorandriskofrecurrenceaftersurgery.ThetestoffersanewmethodforidentificationofStageIIcoloncancerpatientswhoare likely to recurandwhomaybenefit fromadjuvanttreatment,includingchemotherapy.
Current colon cancer treatment for patients with localizeddiseaseincludessurgery,followedinmanycasesbyadjuvantchemotherapy.TheuseofchemotherapyinStageIItumorsisstillasubjectofdebate.StageIIcoloncancerissubjectivelytreatedbasedonariskassessmentthatutilizesfewestablishedclinical andpathologicmarkers currently available.MostofStageIIcancerpatientsarecuredbysurgeryalone,andonlya small percentage, approximately 25%, (Baddi et al, TheOncologist2005)willexperiencediseaserecurrenceandmaybenefitfromchemotherapy.ColonInformMDx,inconjunctionwith traditional risk factors, will help physicians identifythosepatientswhomaybeatincreasedriskofrecurrenceandwould potentially benefit frommore aggressive treatmentincludingchemotherapy.
PredictMDx for colon cancer – is a molecular test whichprovidesphysicianswithvaluableinformation,inconjunctionwithtraditionalriskfactors,onthelikelihoodthatapatientwillbenefitfromtheuseofIrinotecanbasedchemotherapycocktails.
About 20% of colon cancer patients are diagnosed withmetastatic,StageIVdisease.StageIVcoloncancerisusuallytreated with chemotherapy cocktails containing eitherOxaliplatin (FOLFOX) or Irinotecan (FOLFIRI). These tworegimens have similar efficacy, but have different toxicityprofiles. There is a need for biomarkers that predict thetherapyregimentowhichthepatientwillrespondandthathelpreduceneedlesstoxicity.PredictMDxwillaidoncologiststo make an informed decision between Oxaliplatin andIrinotecanbasedtreatmentcourses.
The MDxHealth colon cancer tests are patent-protectedand not yet commercially available. Additional studies areunderway to validate the use of these tests for predictionusingsamplesfrompatientswhoarefollowed-upafterinitialtreatmentforcoloncancer.
For colon cancer, MDxHealth can expect competition fromMyriadGenetics Inc., GenomicHealth Inc. and Agendia B.V.Both Myriad and Genomic Health have recently launched
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their colon cancer LDT assays. MDxHealth will also facecompetitionfromestablishedproceduresandnewentrantstothefield.
2.2.3. Pharmaco-DiagnosticsProgram(PharmacoDx)
The cost of cancer care continues to rise and challengehealthcare budgets throughout theworld. Better targetingofexpensivechemotherapiesisneededtooptimizeexistingresourcesandpatientoutcomes.
MDxHealth believes that it is well positioned to become akeysourceofDNAmethylation-basedsolutionsforoncology.MDxHealth’sPharmacoDxprogramisdesignedtohelp:
PhysiciansandHealthcareProviders:Distinguishbetweendrugrespondersandnon-responders•Personalizethetreatmentofeachindividualpatient•Optimizetreatmentoptionsandpatientoutcomes•
PharmaceuticalCompanies:Identifyanddeveloptargeteddrugtherapies•Demonstratehigherdrugefficacyrates•Expeditetheregulatoryapprovalofdrugs•Reducetheoverallcostsofdrugdevelopment.•
Theopportunitytoapplydiagnosticstoimprovetherapeutictreatments(theranostics)issignificantespeciallyinoncology.On average, oncology therapeutics exhibit efficacy rates ofapproximately 25% (Spear et al., Trends Mol Med 2001). Theconsequencesof lowresponseratesareenormousin termsof quality of life and cost of care, forcing patients to seekadditionaltreatmentoptionsandcontendwithmedicalbillsfrom ineffective treatments. The successful application ofmethylation-basedbiomarkerscanhaveasignificantimpactonimprovingtreatmentsoutcomesinthefieldofoncology.
MDxHealth’s PharmacoDx program aims at providingpersonalized treatment solutions designed to assistphysicians in more effectively treating cancer. The termsCompanionDiagnosticsorTheranosticsareusedtodescribeadiagnostictestthatisspecificallylinkedtoaknowndrug,vaccineorothertherapeutic.Thislinkagecouldbeimportantinthetherapeuticapplicationandclinicaloutcomeofadrug(personalizedmedicine)oran important componentof thedrug development process because Companion Diagnosticassays predict which drug or treatment regimen is likelytobemost effective for a specificpatient. By analyzing themolecularmake-upoftheindividualpatient’stumor,thegoal
ofpredictivetestsistoprovideinformationtothephysicianforarationaloptimizationofeachpatient’sdrugtherapy.
(i) PharmacoDxServicesMDxHealth’s PharmacoDx program is designed to delivermore effective diagnostic opportunities for pharmaceuticalcompaniesinsupportoftheirdrugdevelopmentprograms.Regulatoryauthorities,suchas theU.S.FDA,havestarted torequirepharmaceutical companies to integrate companiondiagnostics into thedrugdevelopmentprocess,particularlyin connection with targeted therapies, to ensure safetyand efficacy, and control costs. As a result, pharmaceuticalcompaniesincreasinglyrelyoncompaniondiagnosticteststostratifypatientsforclinicaltrials(i.e.selectthosepatientsforwhomthedrugunderinvestigationwouldbemosteffective).This allows pharmaceutical companies to conduct clinicaltrialsfasterandwithsmallerpatientcohorts.
Anincreasingnumberofexamplesofpairingadiagnostic(Dx)testtoatherapeutic(Rx)drugarearising.Patientadvantagesinclude: improving median survival and overall responserates to chemotherapy. For pharmaceutical companies,advantages include: fast-trackapprovalwith theFDAbasedonthetest/drugcombinationdata,provingthatstudyingasubsetofrespondersbasedonatheranosticscanshortenthedrugdevelopmentandapproval times.Regulatoryagencies(FDA and EMEA) are encouraging the use of biomarkers(theranostics) in prescribing decisions. The FDA and EMEAare pushing for biomarker testing to be performed priortoprescribing certaindrugsand the FDAhas even recentlystarted reporting a table of genomic biomarkers that itconsidersvalidinguidingtheclinicaluseofapproveddrugs.
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The PharmacoDx testing services that MDxHealth offerssupport all stages of the drug/diagnostic (i.e. theranostic)development process, including (i) biomarker discovery,
selectionandoptimization,(ii)bioinformatics,(iii)validationofcompaniondiagnosticassaysand(iv)clinicaltrialtesting.
BiomarkerDiscovery
AssayDevelopment
TestingServices
Identifycandidategenesutilizing
NextGenerationSequencing(MBD2)
Identifycandidategenesutilizingbioinformaticssoftware
IdentifycandidategenesutilizingMSPArrays
DevelopquantitativeMSPassays(includingDEEPNextGeneration
Sequencing)
Analyzevalidatedmarkerson
clinicalsamples
of samples. Precompiled arrays, called prediction arrays,containing all DNA damage and response genes have beentestedonmanydifferentsampletypesrangingfromcelllinesand xenografts to primary samples of different origin andmatched normals. In addition to MSP, MDxHealth typicallyrunsdeepsequencingprofilesonprimarymaterialtolockthepositionoftheprimersby454bisulphitesequencing.
Clinical trial service testing – Several pharmaceuticalcompanies, such as Merck Serono and Roche, haveincorporatedtheMGMTtestintoclinicaltrialsfornewbraincancertherapies.WiththeresultsofthesePharmacoDxtrialsandmany others underway, it is anticipated that patientswith advanced brain and other cancers will ultimately betreatedwith targeted therapieswith the goal of improvedsurvivalbenefitandoverallpatientoutcomes.
(ii) PharmacoDxProductsMDxHealth’s PharmacoDx products include predictive(PredictMDx) tests designed to work hand in hand withpharmaceutical or biotech drugs. MDxHealth is currentlyfocused on a number of areas: brain (MGMT), colon, breastand ovarian cancer. In addition, MDxHealth has numerousproprietary biomarkers for other cancer types readyfordevelopment.
SomeexamplesofthePharmacoDxservicesthatMDxHealthcanofferinclude:
Biomarker discovery, Genome-wide epigenetic profiling,selection and optimization – Epigenetic treatment followedbyexpressionarrays(pharmacologicalunmasking)identifiestranscripts under control of methylation. This approach,which results in genes that are functionally respondingto the treatment by being re-expressed, has providednumerous novel cancer-specific methylation events overthepastdecade.Genome-wideepigeneticprofilingisbeingcomplemented by MBD2_Seq, which is more open-ended,asnopriorprobesneedtobespottedonanarray,resultinginatruegenome-wideepigeneticprofile.Theworkflowhasbeen further perfected and downsized in order to handlesmallfreshclinicalsamples.Byapplyingitshigh-throughputbiomarker identification platform, MDxHealth is helpingvariouspharmaceuticalcompanies,suchasGlaxoSmithKlineBiologicalsandAbbott,todiscoverandevaluatemethylationbiomarkers that will identify those patients most likely torespondtocancertreatmentsindevelopment.
Candidate Genes Approach MSP (methylation specific PCR) –MSPallowstheexaminationofhundredsgenesonhundreds
Pharmaco-DiagnosticPipeline
ProductResearch Development Commercial
Discovery Feasibility Verification Validationstudies
ImplementationTrials
PivotalTrials
BrainCancer
PredictMDX
ColonCancer
PredictMDX
Breast&OvarinCancer
PredictMDX
Note:adefinitionoftheabovepipelinestepscanbefoundintheglossary
EpigenomeAnalysis
BioinformaticsToolbox
ArrayScreening
BiomarkerValidation
ClinicalTesting
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Predict MDx for Glioblastoma (Brain Cancer) –MDxHealth’smostadvancedcompaniondiagnosticisatestforpredictingpatientresponsetoalkylatingagents,aclassofchemotherapydrugs.ThetestassessesthemethylationstatusoftheMGMTgene,whichiscorrelatedwithresponsetodrugtherapy.
A landmarkstudypublished inThe New England Journal ofMedicineinMarch2005reportedonthemethylationstatusofMGMTintumortissuesfrompatientswithadvancedbraintumors. In this study, and numerous others, patients withtumorsthatweremethylatedforMGMTwerefarmorelikelyto have a favorable response to standard alkylating agenttherapythanthosewithunmethylatedMGMT.
TheMGMTgene is a crucialDNA repair gene.MDxHealth’sMGMTassaydeterminesthemethylationstatusoftheMGMTgeneintumortissue,andcanbeusedasapredictiveassayforthe treatmentofbrain cancer.TheMDxHealthMGMTgenetesthasbeenshownonthousandsofpatientstheabilitytodistinguish which cancer patients are likely to respond tothemostcommonlyusedclassofbraincancerdrugscalledalkylating agents. This patented methylated gene test isattractive to pharmaceutical companies developing newbrain cancer drugs, since they canmore easily target theirnewdrugstothepatientswhousuallydonotrespondtothetraditionalalkylatingagentdrugregime.MDxHealth’sMGMTtest is currently being used in amulti-center brain cancerclinicaltrialtoconfirmtheutilityofthisbiomarkerinroutineclinicalpractice.
Underanexclusiveservice-testinglicenseforNorthAmericareceivedfromMDxHealth,LabCorpcurrentlycommercializestheLDT(laboratorydevelopedtest)versionoftheMGMTtestinNorthAmerica.MDxHealth’snewstrategyhasbeendesignedtakinginmindthispre-existingout-licensingagreementtoLabCorp.WebelievethatitwillnotlimittheCompany’snewbusiness strategy, as the Company has retained exclusiverightsto(i)selltheMGMTteststopharmaceuticalcompaniesperforming clinical trials (ii) develop and commercializeMGMTkitsand(iii)developanFDAapprovedassaythatcanbesoldglobally.
PredictMDx for Colon Cancer – Amolecular testwhich aidsthe physician to make an informed decision between theuseofOxaliplatinandIrinotecanbasedtreatmentregimens.Colon PredictMDx, in conjunction with traditional riskfactors, provides physicians with valuable information onthelikelihoodthatanadvancedstagecolorectalcancerpatientwillbenefitfromtheuseofIrinotecanbasedchemotherapycocktails.
About 20% of colon cancer patients are diagnosed withmetastatic, Stage IV disease (NCI SEER Data 2010). Stage IVcoloncancerisusuallytreatedwithchemotherapycocktailscontainingeitherOxaliplatin(FOLFOX)orIrinotecan(FOLFIRI).Thesetworegimenshavesimilarefficacy,buthavedifferenttoxicityprofiles.There isaneedforbiomarkers thatpredicttowhichtherapyregimenthepatientwillrespondandColonPredictMDxwillprovidethisinformation.
For MDxHealth Pharmaco-Diagnostic (companiondiagnostics) commercial activities targeting pharmacompanies, MDxHealth faces competition from numerouscompanies with methylation technology or differentmolecular diagnostic technologies such DNA mutation,sequencingandRNAexpression.TheMDxHealthMGMTtestforbraincancerisinphaseIIIclinicaltrialswithMerckSeronoandisfacinglimitedcompetition.
2.3. SalesandMarketingStrategyMDxHealth intends tobring its clinicaldiagnosticproductsto the market in the form of laboratory-developed tests(LDTs). LDTs require less time to develop than IVDs (In-VitroDiagnostickits)whichrequireFDAapproval.Afterdevelopingprototypeproductsanddemonstratingtheclinicalutilityofthemethylationmarkersforagivenapplication,MDxHealthintends to commercialize its products through its ownCLIA lab following assay validation according to existingregulationsandgoodlaboratorypractices.Adirectsalesandmarketing force will be hired in the U.S. to commercializeMDxHealth’sclinicalandcompaniondiagnosticproductsontheU.S.market,themaingeographicalfocusgoingforward.Inthenear-future,thesediagnostictestscouldbecomeakeydriveroftherevenuesandvaluationoftheCompany.
Atalaterdate,MDxHealthmayconsidersellingsuchproductsinEuropeasCE-markedreagentkitsviaadistributorandout-licensingtheapplicationsinotherregionsoftheworld.Inthecaseofkitpartners,thepartnerswilltypicallyperformfinalassaydevelopment,regulatoryclinicaltrials,manufacturing,anddistributionoftheproduct.
MDxHealth’s clinical diagnostic tests will initially be solddirectly tophysiciansviaadirectsalesandmarketingforcein the U.S., the Company’s main geographical focus goingforward. The principal products that fall into this categoryare(i)theProstateConfirmMDxandInformMDxtests,(ii)theLungConfirmMDx and InformMDx tests, and (iii) theColonInformMDx test.TheCompanydoesnotanticipateneedingFDA-approvalfor these tests. InJuly2010, theFDAindicated
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that itwasreviewingtheregulatoryrequirementsapplyingtoLDTs,thustherecanbenoassurancethatFDAregulation,includingpre-marketrevieworapproval,willnotberequiredinthefutureforLDTs.MDxHealthintendstoconductadditionalclinical trials to demonstrate the tests’ clinical efficacy andutility as well as support the adoption of these tests. TheCompany will perform the required internal correlationand validations studies to certify the tests’ performancein itsCLIAservice lab.TheCompanyexpects the tests tobelargelyreimbursedwithalreadyexistingCPTreimbursementcodes.Theseclinicaldiagnostictestswillbeprimarilytissue-basedtests.ThebiopsymaterialwillbesentbycouriertotheCompany’sCLIAservicelabandthetestresultswillbesentbytheCompanytothephysician.
MDxHealth’s Pharmaco-Diagnostic program generated themajorityoftherevenueofMDxHealthin2010andisexpectedtobealargepartofrevenuesinthenearfuture.MDxHealth’shas several “companion diagnostic” tests in development:(i) theMGMT test for brain cancer (currently in a phase IIItrialwithMerckSerono)presentedtotheFDAinQ42010ataPre-IDEmeetingasacompaniondiagnostic testwith theexpectation to be included in the label of the Cilengitidedrug,(ii)atestbeingdevelopedwithPfizerforPARPinhibitordrugs,and(iii)testsbeingdevelopedwithGSKBiologicalsfortheimmunotherapeuticscancer(vaccine)program.
MDxHealth’s Pharmaco-Diagnostic services program offersPharmacoDx services and support to pharmaceutical andotherdrugdevelopmentcompaniesatallstagesofthedrug/diagnostic development process, including (i) biomarkerdiscovery,selectionandoptimization, (ii)bioinformatics, (iii)validation of companion diagnostic assays and (iv) clinicaltrial testing. MDxHealth’s PharmacoDx services, providedto both existing collaborators and on contracted servicesbasis, generated themajorityof the revenueofMDxHealthin2010andareexpectedtobealargepartofrevenuesinthenearfuture.MDxHealth,incollaborationwithitscustomers,transitions biomarkers identified for its service customersintocandidatesforMDxHealth-ownedcompaniondiagnostictestsforcommercialdevelopment.
Inthefieldofprostatecancer,MDxHealth’sproductprogramfacescompetitionfromestablishedproceduresandpotentialnewentrantstothefield.Today,onemolecularmethylation-basedprostate tissue test licensedbyMDxHealth ison theU.S. market through LabCorp (Laboratory Corporation ofAmerica). Epigenomics AG is developing urine- and tissue-basedprostate testsbasedonDNAmethylation technologyandhasout-licensedthetissuetesttocertainU.S.CLIAlabs.Gen-Probe Inc. has developed the PCA-3 urine based test
that is currently offered through a CLIA lab in the U.S. Intheareaof lungcancer,MDxHealthfacescompetitionfromestablished procedures and new entrants to the field. Inthe area of colorectal cancer diagnostics, MDxHealth facescompetitionfromestablishedproceduresandnewentrantstothefield.InthefieldofPharmaco-Diagnostics(companiondiagnostics),MDxHealthfacescompetitionfromcompanieswith various molecular diagnostic technologies such DNAmutation, sequencing andRNA expression.TheMDxHealthMGMTtestforbraincancerisinphaseIIIclinicaltrialswithMerckSeronoand is facing limitedcompetition.Pharmaco-diagnosticcompetitorscanalsobecollaborators,dependingonthedrugandpathwaysunderinvestigation.Howevertheimportanceofmethylationintherespectivecancerpathwayshas increased significantly in the last five years. Also thenumber of drugs being developed targeting methylationrelatedepigeneticmarkersisincreasing.
MDxHealth out-licenses its screening products andbiomarkers.Currentlyitsmainout-licensingdealsintheareaofscreeningincludetechnologylicensestovariousstrategicpartnersinthefollowingareas:stool-basedcolorectalcancerscreening,blood-basedcolorectalcancerscreening,prostatecancer tests, urine-based bladder cancer detection andmonitoringtests,cervicalcancerscreeningortriagetest,andprostateandbraincancer testing.MDxHealthhasalsoout-licenseditsMSPtechnologyandcertainbiomarkerstothirdpartykitcompanieswhomayincorporatethetechnologyandmarkers into theproducts they sell to the researchmarket,suchasacademic researchers.Themainout-licensingdealsincludetechnologylicensesforMSPresearchkits.Inexchangefortheselicenses,MDxHealthtypicallynegotiatesmilestonepaymentsup-front,aswellasroyaltyandmilestonepaymentsforfutureproductsales.Out-licensingisnotacorestrategyoftheCompanyand,assuch,noneoftheseout-licensingdealsare currently generatingmaterial revenues for MDxHealthnoraretheyexpectedtodosointhenext2years.Oncethetechnology applications are licensed-out, MDxHealth hasno or insignificant on-going costs associated with theseapplications.Furtherdiscussionsarounditsstrategicpartnersareoutlinedinthesectiononstrategicpartners.
2.4. ReimbursementMDxHealthgeneratesand intends togenerate its revenuesfromproductsalesandcontract researchanddevelopmentservice arrangements. Substantially all of the Company’shistoricalrevenueshavebeenderivedfromroyaltiesonout-licenseagreementsandservicesrenderedunderPharmacoDxdevelopment and clinical trials service testing. In the U.S.
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CLIA laboratory setting, and with its offering of ClinicalDxproducts,MDxHealthintendstobillpayorssuchasMedicare,private health insurers, managed care organizations andotherthird-partyorganizationsupongenerationanddeliveryofapatienttestresulttotheorderingphysician.
MDxHealth plans on seeking reimbursement of its U.S.productofferingsviaexistingCPTcodes(CurrentProceduralTerminology) and may eventually request product-specificreimbursement codes. As such, MDxHealth will takeassignment of benefits and the risk of collection with thethird-party payor. MDxHealth will bill the patient directlyforamountsowed,asrequiredbylocallawsandregulations,for co-pays and deductibles or after multiple requests forpayment have been denied or only partially paid by theinsurance carrier. MDxHealth will pursue case-by-casereimbursementwherepoliciesarenot inplaceorpaymenthistoryhasnotbeenestablished.
In order to obtain commercial success with its products,MDxHealth will need to obtain sufficient coverage orreimbursement from third-party payors such as Medicare,private health insurers, managed care organizations andother third-party organizations. MDxHealth will seek torecruit additional personnel with expertise in areas suchas reimbursement. MDxHealth will need to create marketawareness of MDxHealth’s products and services byvisiting themanaged care organizations, through scientificpublications, presentations at medical conferences andthroughcommercialpartners.
Additionally,CLIAcertificationisaprerequisitetobeeligibleforreimbursementunderMedicareandMedicaid.StandardsfortestingunderCLIAarebasedonthelevelofcomplexityofthetestsperformedbythelaboratory.Laboratoriesperforminghighcomplexitytestingarerequiredtomeetmorestringentrequirements than laboratories performing less complextests where a CLIA certificate is required. Most moleculardiagnostic tests are considered high complexity tests. Inaddition to CLIA requirements, MDxHealth will be subjectto various state laws requiring that laboratory personnelmeet certain qualifications, specify certain quality controls,or prescribe recordmaintenance requirements.MDxHealthwillbe regularly subject to surveyand inspection toassesscompliancewithprogramstandardsandmaybesubject toadditionalrandominspections.
2.5. StrategicPartners2.5.1. PharmacoDxPartners
MDxHealth collaborates with a range of pharmaceuticalcompanies in the identification and development ofbiomarkers for potential use as companion diagnostics fortheirtherapeuticdrugsorvaccines.MDxHealthusuallyderivesrevenuesfromprovidingR&Dandclinicaltestingservicestothesepartners.The identityof thesepartners isnotalwaysdisclosed. In addition to the pharmaceutical collaborationsdescribed in detail below, MDxHealth has entered intocollaborations in this manner with other pharmaceuticalcompaniessuchasAbbottLaboratories,F.Hoffmann-LaRocheLtd.,andPfizer.
MerckSeronoIn 2008, MDxHealth entered into a licensing and testingagreementwithMerck KGaA of Darmstadt, Germany (nowMerckSerono).Underthetermsoftheagreement,MDxHealthprovidesMGMTgenepromotermethylationtestingservicesforMerck'sclinicaltrialprogramofCilengitide.TheMDxHealthMGMTtestisbeingusedintwoMerckclinicaltrialstogetherwith itsdrugCilengitideforpatientswithnewlydiagnosedbrain tumors (glioblastomas), including a Phase III clinicaltrial (CENTRIC) and Phase II clinical trial (CORE). Patientselectionfor theseMerck trials isbasedontheMGMTgenepromotermethylationstatusoftheirtumortissue.
Aspartoftheagreement,Merckobtainedarightofreferenceto the MDxHealth MGMT test in its packaging insert (i.e.drug label) for Cilengitide, andMDxHealth agreed to granttoMerckaworldwide,indefiniteduration,andnon-exclusivelicense to use the results of the MDxHealth MGMT genepromoter methylation assay for optimizing glioblastomamultiforme (GBM) treatmentwithCilengitide. In return forsuchcommitment,Merckagreed toassistMDxHealth in itsdevelopmenteffortsfortheMGMTAssay,aswellastocertainlabelingobligationsinfavorofMDxHealth.Underthetermsoftheagreement,therightstotheMGMTassayareretainedexclusivelybyMDxHealth.
Pfizer,Inc.In2010,MDxHealthentered intoacollaborationagreementwith Pfizer to pursue the identification and developmentof anMDxHealth biomarker predicting response to Pfizer’scancer drug candidate for PARP inhibition, PF-01367338.Newcastle University (UK) is also participating in thecollaboration.ThecollaborationisassessingthepotentialtodevelopanMDxHealthtestasacompaniondiagnostictestto
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guidetreatmentdecisionsintreatmentofovarianandbreastcancerswiththePfizerdrugcandidate.
Under the termsof theagreement,MDxHealth isprovidingmarker discovery, assay development and clinical trialtesting services to Pfizer, and will retain rights to theeventualcommercialcompaniondiagnostictest.Inaddition,the partners have announced their mutual intentionto ultimately set up a high throughput platform that isclinicallyvalidatedtorapidlytestforepigeneticdefectsinkeyDNAdamagerepair (DDR)genestosupport thedesignandimplementationofclinicaltrialstoenablethedevelopmentofoptimized,targetedtherapies.
Schering-PloughIn2005,MDxHealthenteredintoacollaborationandlicenseagreement with Schering-Plough Corporation. Under thelicense, Schering-Plough received a worldwide, indefiniteduration, and non-exclusive right from MDxHealth to usethe results of theMDxHealthMGMT assay to evaluate themethylationstatusoftheMGMTgeneinpatientstreatedorto be treatedwith temozolomide or other Schering-Ploughproducts. Under the terms of the agreement, the rights tothe MGMT assay are retained exclusively by MDxHealth.MDxHealthreceivedanupfrontlicensepayment,amilestonepayment and is entitled, subject to certain conditions, tofurther milestone payments and sample processing feesfromSchering-Plough.
Underthecollaboration,MDxHealthprovidesMGMTtestingservicesforcertainofSchering-Plough’sclinicaltrialsinvolvingtemozolomide,includingamulti-center,international,phaseIIIclinicaltrialforbraincancer,aswellasotherclinicaltrialsoutsideofbraincancer.
GlaxoSmithKlineBiologicals(GSK)In 2010, MDxHealth expanded its existing relationshipwith GlaxoSmithKline Biologicals (GSK) to pursue thedevelopmentandtestingofnewcompaniondiagnosticteststhatcanpotentiallybeusedwithGSK’simmunotherapeuticoncologyprogram.MDxHealth’scollaborationwithGSKwasinitiatedin2007underaWallonia-BioWingrantconcerningmutualresearchintheimmunotherapeuticoncologyfield.Under the expanded agreement signed in 2010, GSK iscollaboratingwithMDxHealthtoassessthepotentialuseofoneofMDxHealth’sDNAmethylationspecificPCRbiomarkersinGSK’simmunotherapydevelopmentprogram.
2.5.2. MolecularDiagnosticsPartners
ExactSciencesIn2010,MDxHealthenteredintoanexclusivelicenseagreementwithExactSciencesCorporationforstool-basedscreeningofcolorectal cancer. Under the terms of the agreement, ExactSciences obtained exclusive, worldwide rights to use up totwo ofMDxHealth’s DNAmethylation biomarkers in stool-baseddetectionofcolorectalcancer,aswellasnon-exclusiveaccesstoMDxHealth’sMSPplatformtechnologyforusewiththosebiomarkers.Inreturn,MDxHealthreceivedanupfrontlicensepaymentandisentitledtoreceive,subjecttocertainconditions,milestonepaymentsandroyaltiesonnetsales.
In January 2011, following Exact Sciences’ completion ofpreliminary studies, MDxHealth announced the electionby Exact Sciences to include an MDxHealth methylationbiomarker, together with MDxHealth’s MSP platformtechnology, in Exact Sciences’ ColoGuard stool-based DNAcolon cancer screening test. This confirmation triggered amilestonepaymenttoMDxHealthfromExactSciences.
VeridexIn December 2010, MDxHealth entered into two non-exclusive licenses withVeridex LLC (a Johnson & JohnsonCompany)fortheuseofcertainofMDxHealth’sproprietaryDNAmethylationproductsincolorectalandprostatecancerscreening. Under the agreements, Veridex licensed non-exclusive rights for the performance of service testing atits own laboratories worldwide using MDxHealth’s DNAmethylation biomarkers for use in blood-based detectionof colorectal cancer, as well as tissue- and urine-baseddetection of prostate cancer. In return, MDxHealth isentitledtoreceive,subjecttocertainconditions,milestonepayments and royalties on net sales. The new licenseagreements replace prior agreements first entered intowith Veridex LLC in 2004 granting exclusive worldwiderights to prostate cancer testing services and kits. Theselicensegrants toVeridexwere the result of anagreementbetween MDxHealth and Ortho-Clinical Diagnostics, Inc.(OCD,aJohnson&JohnsonCompany)thatwasenteredintoin 2003, when MDxHealth acquired certain methylationmarkers and technology from Tibotec-Virco (a Johnson &JohnsonCompany).Underthetermsofthis2003agreement,MDxHealthagreedtofirstoffer toOCDtheexclusiverightto license, at commercially reasonable terms, any productinthehumaninvitrodiagnosticsfieldthatcontainsthosetechnologycomponents thatwereonceownedbyTibotec-
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Virco. Since 2003, MDxHealth has offered products underthis first right to license option in the fields of prostate,lung, colon, cervical, brain and bladder cancer, of whichVeridexhasexerciseditslicenserightsonlyforprostateandblood-basedcolon,eachonanon-exclusivebasisforservicetesting.
LabCorpIn 2008, MDxHealth granted to Laboratory Corporationof America (LabCorp) a royalty bearing sublicense to theMGMTtest(exclusivelicensefortheNorthAmericanmarketonly,ofindefiniteduration,andforservicetestingonly).Todate,theMGMTtestssalesbyLabCorpremainverylimitedsince theU.S.market use of the test is still essentially forpharmaceutical clinical trials for which the rights havebeen retained by MDxHealth. In 2008, MDxHealth alsoentered into an agreement to supply reagents to LabCorpforitscolorectalcancerscreeningtest(ColoSure).Thesalesof theColoSure test remain very limited since thiswhole-stool test is not FDA-approved and is not reimbursed byMedicare.In2007,LabCorpobtainedanon-exclusivelicenseto perform laboratory-based diagnostic testing services inNorth America on prostate tissue samples using selectedMDxHealth’s DNA methylation biomarkers. Sales of thisprostate test remain limited as LabCorp does not appeartobeactivelypromotingtheservicesorinvestingresourcestosponsorclinicaltrialsfurthervalidatingtheutilityofthetest. In 2008, LabCorp began to commercialize the threeafore-mentionedtestsinNorthAmerica.
PredictiveBiosciencesIn 2010, MDxHealth entered into an exclusive licenseagreement with Predictive Biosciences for diagnosticapplications in bladder cancer. Under the terms of theagreement, Predictive Biosciences obtained exclusive rightsintheUnitedStatesfortheuseofanumberofMDxHealth’sDNA methylation biomarkers in bladder cancer testing ofurine, blood and other bodily fluids. MDxHealth retainedexclusiveworldwiderightstothesemarkersintissue-basedbladdercancertests.Inreturn,MDxHealthreceivedanupfrontlicensepaymentandisentitledtoreceive,subjecttocertainconditions,milestonepaymentsandroyaltiesonnetsales.
2.5.3. ResearchMarket
MSPPlatformTechnologyTo support the increasing worldwide adoption of ourMSP (methylation-specific PCR) platform technology,MDxHealthhasgrantednon-exclusivelicensestoanumberof multinational corporations to supply research-use kitsdesigned for use on the MSP platform. Licensees includeMillipore (a division of Merck Serono), Qiagen and Takara,eachofwhichhaveobtainedroyaltybearing,non-exclusive,worldwide,andofindefinitedurationsublicensestotheMSPmethylation platform technology for use in the scientificresearch market only. MDxHealth receives a royalty fee onallcurrentandfuturesalesforthismarketsegment.
AcademicandClinicalCollaboratorsMDxHealthcollaboratesonresearchandclinicaldevelopmentwithmanyoftheworld’sleadingcancerresearchinstitutes.These important relationships provide the Company withadditional resources and expertise for clinical markervalidation aswell as access to patient samples for testing.ThelargenumberofacademicinstitutionsandgovernmentmedicalcentersandorganizationsintheU.S.andEurope,withwhichMDxHealthcollaboratesonaregularbasis,includetheJohnsHopkinsUniversityMedicalInstitutions(U.S.),LovelaceRespiratoryResearchInstitute(U.S.),DukeUniversityMedicalCenter (U.S.), theGROW Instituteat theUniversityHospitalof Maastricht (The Netherlands), and the University ofLiège(Belgium).
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2.6. TechnologyandplatformMDxHealth'stechnologyplatformiscalledMSP(Methylation-Specific-PCR),whichisapatentedDNA-basedtechnologythatfunctionsonstandardcommercialPCRequipment.MSPisapowerfulandaccurateplatformwiththeability todetectasingle cancer cell among thousands of healthy cells in any
type of bodily fluid or tissue. MDxHealth has patents andotherintellectualpropertyrightsontheMSPplatformandonabroadportfolioofbiomarkerstargetedatindividualgenesthatareusedinitsdifferentproducts.
MDxHealthTechnology
MDxHealth uses a molecular (gene-based) technology toimprove cancer diagnosis and treatment. Individual genes(DNAbiomarkers)inthehumanbodycanbecomemodifiedinthepresenceofcancer.MDxHealthhastheabilitytoidentifythese modifications at the genomic level providing thephysicianswithatooltoaidinthediagnosisofcancer,assesstheriskofrecurrence(metastasis)ofthecancer,andpredictanindividualpatient’slikelyresponsetocancertreatment.
DNA methylation is a valuable tool for assessing cancerbecause methylated DNA biomarkers occur in almost allmalignancies.GenemethylationisacontrolmechanismthatregulatesgeneexpressioninDNAandoccurswhenamethylgroupisaddedtooneof thefourbuildingblocksofDNA,acytosine. In severaldiseases,however, thepromoter regionsthat carry the instructions to produce an essential proteincan be over- or hypermethylated, effectively inhibitingprotein production. Hypermethylation of genes, such astumor suppressor genes, is associated with the presenceand development of most cancers. And while changes inDNAmethylationwere initially thought to be the result ofcancerous transformations, it is increasingly believed thatitplaysanactive,causativerole.
Thepatternofgenehypermethylationintumorcellsisoftenspecific to the tissueof originand canbeused to improvecancer detection, assess risk of recurrence, and predict atumor’sresponsetotherapy.
MethylationSpecificPCR(MSP)
The components ofMDxHealth’smolecular tests consist ofamethylationtechnologyplatformforsensitivedetectionofmethylationinDNA(knownas“MSP”or“Methylation-Specific-PCR”), as well as a number of cancer specific methylationmarkers.
Precise mapping of DNA methylation patterns in CpGislands has become essential for understanding diversebiological processes such as the regulation of imprintedgenes, X chromosome inactivation, and tumor suppressorgenesilencinginhumancancer.MSPcanrapidlyassessthemethylationstatusofvirtuallyanygroupofCpGsiteswithinaCpGisland,independentoftheuseofmethylation-sensitiverestrictionenzymes.AnMSPassayentailsinitialmodificationof DNA by sodium bisulfite, converting all unmethylated,but not methylated, cytosines to uracil, and subsequentamplification with primers specific for methylated versusunmethylatedDNA.MSPrequiresonlysmallquantitiesofDNA,issensitive to0.1%methylatedallelesofagivenCpGisland
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locus,andcanbeperformedonDNAextractedfromformalin-fixed paraffin-embedded samples (FFPE). MSP eliminatesthe false-positive results inherent to previous PCR-basedapproaches, which relied on differential restriction enzymecleavagetodistinguishmethylatedfromunmethylatedDNA.
PatentsandLicensing
MDxHealth believes that its patent portfolio places theCompany in a highly competitive position in the realm ofmolecular cancer diagnostics. MDxHealth holds exclusiverightstoabroadarrayofmorethan45issuedand90pendingpatents in multiple countries worldwide covering themethylation technologyplatformandmultiplemethylationgeneticmarkers.MDxHealthcontinuestobeattheforefrontof researching andunderstanding the link between cancerand methylation and how this link can be translated intomeaningfulclinicaldiagnosticandPharmacoDxproducts.
Core to MDxHealth's intellectual property portfolio isthe patent family covering the Methylation-Specific
Polymerase chain reaction (MSP) process, which representsagroundbreakingadvanceinappliedgenomics.MethlylatedDNA-based measurement, combining the MSP platformwith target biomarkers, enables meaningful comparisonsofgeneexpressionresponsesinavarietyofpre-clinicalandclinicalsettings.
BelowisaselectedsummaryofMDxHealth’spatentportfolio,brokeninto3groupsofpatents.Thefirstgroupofpatentsisfoundationalmoleculartechnologypatentsthathaveissuedin the U.S., Japan, Canada, Israel and the major Europeancountries. The second group of patents focuses on cancerspecificbiomarkerpanelsfor tumordetectionandprofilingandincludesover10grantedpatentsandover45internationalpendingpatents.
DetectionTechnology–Methylation-SpecificPCR(“MSP”)
Title PatentReferenceNoMSPTechnology Methodofdetectionofmethylatednucleicacidusingagentswhich
modifyunmethylatedcytosineanddistinguishmodifiedmethylatedandnon-methylatednucleicacids(WO,EP:Methylation-SpecificDetection)
WO97/46705
NestedMethylation-SpecificPolymeraseChainReactionCancerDetectionMethod
WO02/18649
AmplifluorTechnology Nucleicacidamplificationoligonucleotideswithmolecularenergytransferlabelsandmethodsbasedthereon
WO98/02449
MethyLighttechnology ProcessforhighthroughputDNAmethylationanalysis WO00/70090
HeavyMethyltechnology Highlysensitivemethodforthedetectionofcytosinemethylationpatterns
WO02/072880
Microarraytechnology MethodfordeterminingthedegreeofmethylationofdefinedcytosinesingenomicDNAinthesequencecontext5'-CpG-3'
WO02/18632
MethodforproducingcomplexDNAmethylationfingerprints WO99/28498Oligomer-arraywithPNA-and/orDNA-oligomersonasurface WO01/38565
Scorpionpatentrights MethodforthedetectionofcytosinemethylationsinDNA EP1654388
MDxHealth’s process for detecting methylation in DNA,called Methylation-Specific PCR, was invented at JohnsHopkins University. The detection technology is extremelysensitive, which is necessary when looking for early-stagecancer, as only one to ten tumor cellsmay be present in asample containing thousands of healthy cells. Patents ontheMSPtechnologyhavebeengrantedinkeymarketssuchas Europe, United States, Canada, and Japan. In addition,theMDxHealthmethylation technologyportfoliocomprisespatentfamiliesonvariousimprovementsonMSPtechnology.
Therearevariouspatentscoveringthemethylationdetectiontechnology and their duration varies per region and perpatent.Thepatentsof theCompanyhavea lifeof 20 yearsand the expiry date may vary by region in the world. Theearliest patent on an individual biomarker expires in 2014.Themethylationdetectionpatentsare in-licensed from theJohnsHopkinsUniversityandfromtheLovelaceRespiratoryResearchInstitute.
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MethylationMarkersforTumorProfiling
TitleProstateCancermarkers GeneticDiagnosisofProstateCancer
MethodofDetectionofProstateCancerNeoplasiaDiagnosticCompositionsandMethodsofUseEpigeneticTestsforProstateCancer
ColonCancermarkers MethylationmarkersforearlydetectionandprognosisofcoloncancersEarlydetectionandprognosisofcoloncancerImprovedmethodsofdetectingcolorectalcancerEpigeneticchangeinselectedgenesandcancerEarlydetectionandprognosisofcoloncancersImprovedmethodsofdetectingcolorectalcancerImproveddetectionofgeneexpression
OtherCancermarkers MethodofPredictingtheClinicalResponsetoChemotherapeuticTreatmentwithAlkylatingAgentsNovelmethylationmarkerHIN-1,atumorsuppressorgeneImprovedmethylationdetectionImproveddetectionofMAGE-AexpressionMethylationmakersandmethodsofuseMethylationmarkerspredictivefordrugresponse
LungCancerMarkers Detectionandprognosisoflungcancer
Methylation markers are genes that are known to beabnormallymethylatedincancer.MDxHealthhasaportfolioofownedorin-licensedmethylationmarkers.Manyofthesemarkershavebeenshowntobehighlysensitiveandspecificinoncologyapplicationsandhavebeen, inmany instances,describedinpeer-reviewedjournals.Therearevariouspatentscovering themethylationmarkersand theirdurationvariesperregionandperpatent.Theearliestpatentsexpireinsomeregionsin2014andthepatentlifeonothersinfilingmaybe
upto20years.Somemarkerpatentsarein-licensed,somearejointly-owned,andsomearefiledsolelybyMDxHealth.
MDxHealthconsiderspatentprotectionofthetechnologies,on which its products are based, to be a key factor to itssuccess.The intellectualpropertyportfolioofMDxHealth ismanagedby an in-house intellectual property team,whichworks in close collaborationwith qualified external patentattorneysbothinEuropeandtheUnitedStates.
MDxHealthSA
MDxHealth,Inc. OncoMethylomeSciencesBV MDxHealthPharmacoDxbvba
2.7. GroupStructure/SubsidiariesMDxHealthSAhasthreesubsidiaries:(i)OncoMethylomeSciencesBV,afullyownedcompany,incorporatedunderthelawsofTheNetherlands,withregisteredofficeatTour5GIGA,Avenuedel’Hôpital11,4000Liège,(ii)MDxHealthInc.,afullyownedcompany,incorporatedunderthelawsofDelaware,U.S.,withregisteredofficeat2505MeridianParkway,Suite310,Durham,NC27713,U.S.and(iii)MDxHealthPharmacoDxBVBA,afullyownedcompany, incorporatedunder the lawsofBelgium,withregisteredofficeatTechnologiepark4,VIBBio-Incubator,9052Zwijnaarde/Ghent,Belgium.
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2.8. HumanResourcesOnDecember31,2010,MDxHealthhad37employees,68%ofwhom contributed to research and development activities.MDxHealthselects talentedpeople toparticipateanddriveitsdevelopmentprograms.TheCompany’sscientificstaffhasexpertise inmolecular biology, PCR and oncology amongstother disciplines. 56% of the research & developmentpersonnelholdPhDdegrees.
MDxHealth recognizes that the Company’s success largelydependsonitshumancapital.Itprovidesretentionincentivestoemployees, includinganemployeestockoptionprogram.Morethan76%ofMDxHealth’semployeesareparticipantsintheCompany’sstockoptionplan.
Therewas a decrease in theheadcount from2009 to 2010duethefollowingmainreasons:
As announced in at the end of 2009, the Company re-•focused its activities and pursued several cost-cuttinginitiatives which led to the departure of some of thepersonnelin2010.During 2010, the Company closed its Amsterdam lab site•upon decision to discontinue its colon cancer screeningprogram. The Company also transferred its Amsterdambased PharmacoDx clinical testing services to Liège tofurtherconcentrateitslabfacilitiesandactivities.The Company also reduced headcount in several•departments due to the new focus on a few core cancerapplications rather than pursuing the previous strategyof a very broad portfolio of many early-stage projectsparticularlyinscreeningapplications.TheCompanynowithasa focusonpersonalisedmedicine testswhichrequiredifferentandmorestream-linedexpertiseandresources.
TotalHeadcountEvolution Dec31,2010 Dec31,2009 Dec31,2008Total 37 66 65HeadcountEvolutionbyEducationLevel Dec31,2010 Dec31,2009 Dec31,2008PhD 14 19 17UniversityDegree 16 26 26HigherEducation/Non-University 7 21 22HighSchoolLevel 0 0 0Total 37 66 65HeadcountEvolutionbyDepartment Dec31,2010 Dec31,2009 Dec31,2008Research&Development 25 50 50Sales,General,andAdministrative 12 16 15
Total 37 66 65HeadcountEvolutionbyGroupEntity Dec31,2010 Dec31,2009 Dec31,2008MDxHealthSA(Belgium) 23 25 24MDxHealthPharmaco-DiagnosticsBVBA(Belgium) 7 16 16OncoMethylomeSciencesBV(TheNetherlands) 1 15 15MDxHealthInc.(USA) 6 10 10Total 37 66 65
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2.9. LegalProceedingsTodate,MDxHealthisnotinvolvedinanylegalproceeding.
2.10.GovernmentRegulation2.10.1. Health,SafetyandEnvironment
EachMDxHealthofficeandlaboratoryisgovernedbythelocallawsonhealth,safety,andtheenvironment.MDxHealthmakesitaprioritytoensurethehealthandsafetyofitsemployees,andtominimizeitsimpactontheenvironment.Assuch,theCompanyisincomplianceinallmaterialrespectsofhealth,safety and environmental legislation and has obtained allnecessarypermitstoconductitscurrentbusiness.
2.10.2.ProductRegulation
MDxHealthintendstobringitsproductstothemarketinitiallyviatestingservicesperformedbyacommercialCLIA-certifiedlaboratory in theUnited States. At a later date,MDxHealthmay itself orwithpartnersoffer the tests in EuropeasCE-marked kits or in the U.S. as FDA-approved kits; howeverthepriority in thenear-futurewillbe thedevelopmentandcommercializationofU.S.-CLIAservicetests.
CommercializationoftestingservicesinservicelaboratoriesintheUnitedStatesisgovernedbyqualitysystemprovisionsoutlinedinthecongressionalClinicalLaboratoryImprovementAmendments CLIA. When tests are commercialized asdiagnostickits in theUnitedStates, they require regulatoryapproval by the Food and Drug Administration (FDA). InEurope,diagnostictestkitsmustbeartheregulatoryCE-mark,whichisanassertionthattheproductisinconformancewiththeEuropeanUnionIn-VitroDiagnosticsDirective.
It is MDxHealth’s intention to seek directly the necessaryapprovalwhenneeded.IthasrecentlyhiredaVPRegulatoryAffairs & Quality Assurance and has begun a number ofregulatoryinitiatives.MDxHealthiscurrentlyintheprocessofupgradingitsISO9001facilityinLiègetoCLIA.ThiswillallowMDxHealth to provide clinically relevant tests and servicestoclientsworldwide.TheCLIAcertificatewill regulateworkperformed and will define standards covering personnel,facilities administration, quality systems and proficiencytesting. Tomaintain its CLIA certificate,MDxHealthwill besubject to survey and inspection every two years to assessclientswithprogramstandardswhichmaychangeovertime.MDxHealthcurrentlyenvisagesestablishingaCLIA-certified
labintheUnitedStates.ThelawsrequiredforrenewalofCLIAcertificatesarethesameintheU.S.asinBelgium.
In addition to CLIA requirements, the Company will besubjecttovariousstatelaws.CLIAprovidesthatastatemayadopt laboratory regulations that aremore stringent thanthoseunderfederal law,andanumberofstates,havedoneso.Currently thestatesofWashington,NewYork,Maryland,Pennsylvania, Rhode Island, Florida and California, haveimplementedsuchregulationlicenseprocedures.Statelawssimilartofederallawsmayrequirethatlaboratorypersonnelmeet certain qualifications, specify certain quality controls,or prescribed recordmaintenance requirements as well asproficiencytesting.
Laboratory-developed tests (LDTs) are tests which are usedsolelywithinonelaboratoryandwhicharenotdistributedorsoldtoanyotherlabsorhealthcarefacilities.LDTsstillmustgothroughrigorousvalidationproceduresandmeetseveralcriteriabeforeresultsareusedfordecisionsregardingpatientcare. Several governmental and non-governmental entitiesregulateandguidethedevelopmentandvalidationofLDTs.The federal government, through the Centers forMedicareand Medicaid Services (CMS) and the CLIA highly regulatedevelopment, evaluation, and use of lab-developed assays.CLIAstatesthatlaboratoriesmustdemonstratehowwellanLDTtestperformsusingcertainperformancestandards.
Although LDTs are not FDA-approved for marketing, someofthereagents,controls,andequipmentusedinthesetestsmay be manufactured by a third party, and may be FDA-approved.FDA’spositiononregulationofLDTsisevolving:thereviewofthe510(k)processandpromotionof"research-useonly"devicesandLDTsareontheagency'sagenda.Additionalmolecularly-targeted assays are still being developedby numerous companies across the spectrum of cancertypes (e.g., Genomic Health’s Oncotype DX® and CarisDx’sTargetNow™).
Historically,FDAhaspracticed“enforcementdiscretion”overLDTs but is currently taking the initiative to change. FDAbegan reviewing the more complex assays run in a CLIAsettingseveralyearsagoas theyhavebeenstrugglingwiththescopeandmethodologyofpotentialLDTregulation.Testswhichrequiredmultipleregulatedcomponents(instruments,reagents, test platform) and software or an algorithm tointerpret results, were targeted for review and evaluation(e.g.Agendia’sMammaPrint®geneexpressiontestforbreastcancerrecurrence).
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Initially, laboratoriesmanufactured LDTs thatwere simple,well-understood laboratory testsor testswhichdiagnosedrarediseasesandconditionsthatwereintendedtobeusedby physicians and pathologistswithin a single institutionin which both were actively part of patient care. Thesetests were ordinarily either well-characterized, low-riskdiagnosticsorforrarediseasesforwhichadequatevalidationwouldnotbefeasibleandthetestswerebeingusedtoservetheneeds of the local patient population. In addition, thecomponentsoftraditionalLDTswereregulatedindividuallybyFDAasASRs(analytespecificreagents)orotherspecificorgeneralreagents,and the testswere (andarecurrently)developedandofferedinCLIAhigh-complexitylaboratorieswithextensiveexperienceinusingthetests.
Today, many LDTs use complex elements that may not beFDA-regulated. Further, these testsareoftenused toassesshigh-risk but relatively common diseases and conditionsand to guide critical treatment decisions. Some LDTs areperformedingeographicallydistantcommerciallaboratoriesinsteadofwithinthepatient’shealthcaresettingunderthesupervisionofapatient’spathologistandtreatingphysician.Inaddition,evenwhenFDA-approved testsareavailablefora disease or condition, laboratories often continue to useLDTs thathavenotbeen reviewedby theagency. Finally, anincreasing number of LDT manufacturers are corporationswith publicly traded assets rather than hospitals or publichealth laboratories, which represents a significant shiftin the typesof testsdevelopedand thebusinessmodel fordevelopingthem.
At this time, FDA believes that a risk-based application ofoversighttoLDTsistheappropriateapproachtoachievethedesired public health benefits. FDA is evaluating feedbackfrom stakeholders, including laboratory professionals,clinicians, patients, and industry, to define the issues thatpose thegreatest risk to thepublichealth. It is anticipatedthat regulation requirementswill be established sometimein2011.
2.11. FacilitiesLiège,BelgiumMDxHealth’s registered and main administrative officeand assay development facility is based in Liège, Belgium.MDxHealth currently leases 899m2 of research and officespaceintheGigatoweroftheLiègeUniversityHospitalsite(CentreHospitalierUniversitaire,“CHU”).
Durham,UnitedStatesMDxHealth, Inc., theCompany’sU.S. subsidiary, leasesofficefacilitieslocatedatSuite310,2505MeridianParkway,Durham,NorthCarolina27713,UnitedStates.
Ghent,BelgiumMDxHealth PharmacoDx bvba, the Company’s Belgiansubsidiary,leasesofficeandlabfacilitiesplussharesadditionalfacilities at theBio-Incubator, located atTechnologiepark 4,VIBBio-Incubator,9052Zwijnaarde/Ghent,Belgium.
2.12. InvestmentPolicyMDxHealth has not made firm commitments on materialinvestments.However the Company intends to increase itscapitalexpenditures,preferably in2011 to set-upandequipaU.S.CLIA-certifiedservicelab.TheCompanyexpectstoleasefacilitiesfortheCLIAlabandestimatesthatthecoststoequiptheinitiallabinfrastructureandobtainallnecessarypermitswillbeunderEUR1million.TheCompanyestimatesthatthetimerequiredtoset-upanoperationalCLIA-certifiedlabislessthan12months.Atthedateofthisdocument,theCompanyhasnotentered intoany commitmentsorobligationswithrespecttotheCLIAlabfacilities.
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2.13. RecentTrendsandEventsTherearenosignificantrecenttrendsbetweenendofthefiscalyear2010andtheprintingofthisregistrationdocument.
In 2011, theCompanymade the followingnormal courseofbusinessannouncements:
Exact Sciences Inc. confirmed that itwould proceedwith•the in-licensing and development of its stool-basedcolorectalcancerscreeningtestusing2biomarkersandtheMSPtechnologyofMDxHealth.Thisconfirmationtriggeredthe payment of a milestone fee to MDxHealth, but thismilestoneamountwillhavenosignificant impacton thefinancialresultsoftheCompany.MDxHealthsignedanagreementwithPfizertocollaborate•on the development of a companion diagnostic for Parpinibitors,adrugusedtotreatbreastandovariancancers.Thefinancialtermsoftheagreementhavenotbeendisclosed.TheagreementincludedasignaturefeetoMDxHealththathadnosignificantimpactonthecurrentfinancialresultsoftheCompany.PredictiveBiosciencesInc.publishedtheirfirstperformance•datausingMDxHealthbiomarkersandtechnology.
With regard to trends that are reasonably likely to have amaterialeffectonMDxHealthin2011,MDxHealthbelievesthefollowingcanbenoted:
MDxHealth will pursue the validation of its prostate•products in 2011 with a target to launch them in 2012-2013.The release of thenext externally-generated clinicalvalidationstudyisexpectedinQ22011.In 2011, revenues are expected to remain stable and are•expectedtoincluderevenuesprimarilyfromservicetestingand R&D services for pharmaceutical companies, andgrants. Commercial revenues from the direct sales in theU.S. of theCompany’s firstprostateproduct are expectedin2012.Total operating costs are expected to remain consistent•withthoseof2010.Capitalexpendituresareexpectedtoincreasefortheset-up•ofaU.S.CLIAservicelabinQ42011.The cash burn is expected to remain stable with that•of2010.TheCompanyannouncedonNovember4,2010thatitintends•toseeknewfundingin2011foritson-goingoperations,forfurtherproductdevelopmentincludingadditionalclinicaltrials,and for the roll-outof its commercialoperations intheU.S.includingtheset-upofaU.S.CLIAservicelab.In2011,theCompanyintendstostartrecruitingasalesforce•fordirectsalesofitsproductsintheU.S.
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3.CorporateGovernanceStatement
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3.1.2. Chairman
The chairman of the Board of Directors is responsible fortheleadershipoftheBoardofDirectors.Thechairmantakesthenecessarymeasurestodevelopaclimateoftrustwithinthe Board of Directors, contributing to open discussion,constructivedissentandsupportforthedecisionsoftheBoardof Directors. The chairman promotes effective interactionbetween the Board and the Executive Management. Thechairman establishes a close relationship with the CEO,providing support and advice, while fully respecting theexecutiveresponsibilitiesoftheCEO.
The Board of Directors appoints a chairman amongst thenon-executive directors. Currently,Mr. Edward L. Erickson isthechairmanoftheBoardofDirectors.
3.1.1. BoardofDirectors
TheBoardofDirectors’roleistopursuethelong-termsuccessoftheCompanybyprovidingentrepreneurialleadershipandenabling risks to be assessed and managed. The Board ofDirectors acts as a collegiate body. Pursuant to the BelgianCompanyCodeandthearticlesofassociationoftheCompany,theBoardofDirectorsshouldbecomposedofatleastthreedirectors. In accordance with the principles of corporategovernance,theBoardofDirectorswill,totheextentpossible,becomposedofatleastfivedirectorsofwhichatleastthreedirectorsareindependentdirectors.Totheextentpossible,atleasthalfoftheBoardshallconsistofnon-executivedirectors.Currently, the Board of Directors comprises 7 directors, ofwhich3are independentdirectorsand6arenon-executivedirectors.ThedirectorsoftheCompanyareappointedbythegeneralshareholders’meeting.
The Board of Directors is a collegial body, and deliberatesandmakesdecisionsassuch.ExcludingtheBoardcommitteemeetings, throughout 2010 the Board of Directors met10times.Alldirectorswerepresentorrepresentedforthese10meetings,exceptforDr.BobPinedowhomissed3meetingsandMr. Alain Parthoenswhomissed 1meeting. Dr. PinedoandMr.ParthoensresignedfromtheBoardofDirectorsinthecourseof2010.
3.1. GeneralProvisionsThischapter3summarizesthemainrulesandprinciplesofMDxHealth’sCorporateGovernanceCharter.ThecompletecharterisavailableontheMDxHealthwebsite,atwww.MDxHealth.com.
The Company’s corporate governance charterwas adopted in accordancewith the recommendations set out intheBelgianCorporateGovernanceCode2009(the“2009Code”),issuedonMarch12,2009bytheBelgianCorporateGovernanceCommittee(replacingthe2004edition).TheCompanyhasadoptedthe2009Codeasitsreferencecode.The2009Codeisbasedona“complyorexplain”system.Belgianlistedcompaniesshouldfollowthe2009Code,butcandeviatefromitsprovisionsandguidelines(thoughnotfromtheprinciples)providedtheydisclosethejustificationsforsuchdeviation.MDxHealthcomplieswiththeprinciplesofBelgianCodeforCorporateGovernance,butbelievesthatcertaindeviationsfromitsprovisionsarejustifiedinviewoftheCompany’sparticularsituation.Withtheentryintoforceof the lawof6April2010, it is (i)notpossible todeviatefromsomeprovisionsof theCodeand(ii) it iscompulsorytoindicatetheprovisionsoftheCodethatwerenotcompliedwithduringtheyearandtoprovideanexplanationofthereasonsfornon-compliance.ThedeviationsofMDxHealthareexplainedinthisChapter3andarevalidunderthelawof6April,2010.
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havenotbeena shareholder or employeeof the current8.or previous statutory auditor of the Company or oneof its affiliates during the three-year period precedingtheirelection;
arenotanexecutivememberof theadministrativebody9.ofanothercompanyinwhichanexecutivedirectoroftheCompanyisanon-executivememberoftheadministrativebodyormemberofthesupervisorybody,andhavenootherimportant ties with executive directors of the Companythroughpositionswithothercompaniesorbodies;and
3.1.3. IndependentDirectors
EffectiveasofJanuary8,2009,newrulesenteredintoforcefor Belgian publicly-listed companies with respect to thecriteriafortheindependenceofdirectors(article526teroftheBelgianCompanyCode).
The three independentMDxHealth directors listed in table3.1.4 meet these new definitions for independence whichincludethefollowingcriteria:
have not held a position as an executive member of1.an administrative body, as a member of the executivecommittee or as a person charged with the dailymanagementoftheCompanyoroneofitsaffiliatesduringthefive-yearperiodprecedingtheirelection;
havenotexercisedmorethanthreesuccessivemandatesas2.non-executivedirectoroftheCompany,withamaximumoftwelveyears;
havenotbeenmembersoftheExecutiveManagementof3.theCompanyoroneofitsaffiliates,duringthethree-yearperiodprecedingtheirelection;
have not received a compensation or other significant4.advantageofafinancialnaturefromtheCompanyoroneofitsaffiliates,withtheexceptionofthetantièmesandthecompensation theymay receiveorhave receivedasnon-executivememberoftheadministrativebodyormemberofthesupervisorybody;
donotownanyrightsrelatingtosharesrepresenting10%5.ormore of the total share capital or of a class of sharesoftheCompany.Iftheyownlessthan10%:(i)suchrights,togetherwith other rights held by companies controlledby the director concerned may not equal or exceed10%, or (ii) thedisposal of such shares or the exercise ofthe rights attached thereto may not be subject to anycontractual arrangement or unilateral undertaking fromtheindependentdirectors;
donot representa shareholder that satisfies the criteria6.setforthunderpoint5;
have not or have not had during the past fiscal year a7.significantbusinessrelationshipwiththeCompanyoroneof itsaffiliates,directlyorasshareholder,memberof theadministrative body or the Executive Management of aCompanyorpersonwhohassucharelationship;
do not have a close family member (meaning a spouse10.or legalpartnerorrelativeup to theseconddegree)whois amemberof theadministrativebodyor the executivecommittee, who is charged with the daily managementor who is a member of the Executive Management ofthe Company or one of its affiliates, or who does notcomplywithanyoftheothercriteriamentionedinpoints1to9above.
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CorporateGovernanceStatement
3.1.4. CompositionoftheBoardofDirectors
MDxHealthshareholdersappointedthreenewindependentdirectorsonMay28,2010.
ThetablebelowdescribesthecompositionoftheBoardofDirectorsasofthedateofthisRegistrationDocument.
Name AgeonDec31,2010 Position TermStart(1) TermEnd(2) Professional
Address
Mr.EdwardL.Erickson 64 chairman,non-executive
independentdirector
2010 2013 Tour5GIGA,Av.del’Hôpital11,
4000Liège,Belgium
Dr.JanGroen 51 executivedirector 2010 2013 Tour5GIGA,Av.del’Hôpital11,
4000Liège,Belgium
INGBelgiumNV/SA,representedbyMr.DenisBiju-Duval
54 non-executivedirector 2003 2013 Marnixlaan24,1000Brussels,
Belgium
Dr.KarinLouiseDorrepaal 49 non-executivedirector(independentprior
toQ42009)
2007 2013 VanEeghenlaan7,1071ELAmsterdam,TheNetherlands
Mr.MarkMyslinski 55 non-executiveindependentdirector
2010 2013 Tour5GIGA,Av.del’Hôpital11,
4000Liège,Belgium
HildeWindelsBVBArepresentedbyMrs.HildeWindels
45 non-executiveindependentdirector
2010 2013 Tour5GIGA,Av.del’Hôpital11,
4000Liège,Belgium
EdmonddeRothschildInvestmentPartners,representedbyMr.RaphaëlWisniewski
40 non-executivedirector 2005 2013 47,RueduFaubourgSaint-Honoré,
75401ParisCedex8,France
(1) Alldirectorswereappointedorre-appointedbytheordinarygeneralshareholders’meetingheldonMay28,2010foratermofthreeyears.
(2)Thetermofthemandatesofthedirectorswillexpireimmediatelyaftertheannualgeneralshareholders’meetingheldonMay31,2013.
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GroenisasupervisoryBoardMemberofIBLInternationalB.V.Dr.GroenholdsaPh.D.degree from theErasmusUniversityRotterdam and published more than 125 papers ininternational scientific journals in the field of clinicaldiagnostics.
Mr.DenisBiju-DuvalworksforINGsince2001.He isamanagingdirectorat INGPrivate Equity. He has extensiveexperienceinstrategicconsultingattheBoston Consulting Group and morethan 13 years in the private equityindustrybothinFranceandinBelgium.Mr. Biju-Duval is currently head of
corporateinvestmentsforINGBelgiumandaBoardMemberof various portfolio companies including BioAlliance,Environnement, and Numeca Software, and previously atDevgen.Mr.Biju-DuvalisaFrenchnationalandholdsadegreein chemical engineering from INSA Lyon and aM.B.A. fromHEC-ISA.
Dr. Karin Dorrepaal is senior vicepresident corporate strategy andacquisitions at DSM and holds asupervisory BoardMember position atErgo Versicherungsgruppe. Until 2004,Dr. Dorrepaal was a vice president ofBooz & Company, ManagementConsultants, where she specialized
in the pharmaceutical industry and advised on issuesregarding strategy, sales, marketing and supply chain.Dr. Dorrepaal then served on the executive Board ofSchering AG, where she was responsible for Schering'sGlobalBusinessUnitDiagnosticImagingaswellasitsSupplyChain and Procurement.Dr.Dorrepaal receivedher Ph.D. inmedicine from the Free University of Amsterdam and herMBA from the Erasmus University Rotterdam School ofManagement.
Mr. Mark Myslinski is currently SVP ofDiagnostics at Hologic Inc. Previously,Mr. Myslinski was CEO of RedPathIntegrated Pathology, Inc and was aJohnson&Johnsonexecutivewherehisresponsibilitiesincludedbuildinganew,worldwide evidence-based medicinefunction for the ortho-clinical
diagnosticsunit.Forfiveyears,Mr.Myslinskiwasalsogeneral
Thefollowingparagraphscontainbriefbiographiesofeachofthedirectorsorincaseofcorporateidentitiesbeingdirector,theirpermanentrepresentatives,withanindicationofothermandates as member of administrative, management orsupervisorybodies inother companiesduring thepreviousfive years (with the exception of the subsidiaries of theCompany):
Mr.EdwardL.Ericksonhasover25yearsof executive level experience indiagnostics, therapeutics, and lifescience research products. He wasrecently appointed President Directorand CEO of Saladax Biomedical, Inc.,a privately-held diagnostic companydevelopingandcommercializingassays
for measuring therapeutic drug levels in patients. Prior tojoining Saladax, he served as President and CEO ofBioNanomatrix,Inc.,aprivategenomicscompanydevelopingand commercializing proprietary DNA analysis systems.Previously, he was the chairman, President and CEO ofCellatope Corporation, a private company developingdiagnostic products in the field of autoimmune diseases.Prior to that, he served in top leadership roles, includingpresident, CEO and/or chairman, of three venture-capitalbackedmedicalproducts companies, Immunicon,DepoTechandCholestech,which successfully completed initialpublicofferingsunderhis leadership. Earlier inhis career, heheldsenior executive positions at The Ares-Serono Group andAmersham International. Mr. Erickson is also a director ofMetabolon. He holds an MBA from the Harvard GraduateSchoolofBusinessAdministrationandB.S.andM.S.degreesfromtheIllinoisInstituteofTechnology.
Dr.JanGroenjoinedMDxHealthin2010andhasmorethan25yearsofexperienceintheclinicaldiagnosticindustry,withaparticular focus on emergingtechnologies,productdevelopmentandcommercialization. Dr. Groen waspreviouslythepresidentofAgendia,Inc.andCOOofAgendiaB.V.,responsiblefor
their United States and European diagnostic operations,respectively. Prior to this, he served as vice-president ofresearch&developmentatFocusDiagnostics,Inc.,asubsidiaryof Quest Diagnostics, in California. Dr. Groen has heldnumerousmanagementandscientificpositionsatViroClinicsB.V., the Erasmus Medical Center, and Akzo-Nobel. Dr. Jan
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sanctionbyanystatutoryorregulatoryauthority(includinganydesignatedprofessionalbody),exceptfor(i)Mr.EdwardErickson who was CEO, chairman, and also held otherexecutiveandnon-executivepositionsthroughJune2007attheCompanyImmuniconCorporationpriortoitsfilingfor bankruptcy in June 2008, for which the bankruptcytrusteehasinitiatedlegalproceedingsagainstMr.Ericksonandotherdirectorsandmanagersofthebankruptcompanyand (ii) Mr. RaphaelWisniewski who was a director at 2companieswhichwereliquidatedin2008,NautilusBiotechandAndroclusTherapeuticshas ever been disqualified by a court from acting as a•memberoftheadministrative,managementorsupervisorybodiesofanycompanyorfromactinginthemanagementorconductofaffairsofanycompany.
3.1.5. CommitteesoftheBoardofDirectors
The Board of Directors of MDxHealth has set up twopermanent committees, the audit committee and thenomination and remuneration committee.The committeesare advisory bodies only and the decision-making remainswithinthecollegialresponsibilityoftheBoardofDirectors.
AuditCommittee
EffectiveasofJanuary8,2009,newrulesenteredintoforceforBelgianpublicly-listedcompanieswith respect to (i) theestablishment and tasks of the audit committee, (ii) thecriteria for the independenceofdirectors (see section 3.1.3),and (iii) the appointment of and dismissal of statutoryauditors(seesection3.6).
With respect to the new rules covering the establishmentof the audit committee, the following is applicable toMDxHealth:
MDxHealthhashadanAuditCommitteeinplacesincethe•Company’sinception.According to the new rules, MDxHealth wouldmeet the•size criteria in order to operatewithout a separate auditcommittee, but the Company has chosen to continueoperatingwithaseparateauditcommittee.The new rules require that the audit committee be•composed of non-executive directors, which is and hasalwaysbeenthecaseforMDxHealth’sauditcommittee.Thenewrulesrequirethattheauditcommitteebecomposed•of at least one independent director with the necessarycompetenceinauditingandaccounting,whichisandhasalwaysbeenthecaseforMDxHealth’sauditcommittee.Mrs.HildeWindelsmeetsthecriteriaofindependence:•
manager of Veridex, a division focused on molecular andcellulardiagnostics thatachievedrapidsalesgrowthunderMr.Myslinski'stenure.Mr.Myslinskialsoheldexecutiverolesintheventure-backedstart-upsInterscopeTechnologiesandPrecisionTherapeutics,bothfocusedonthefieldofpathologywithanemphasisoncancer.
Mrs. Hilde Windels is currently theCFOofPronotaandSEPSPharmaandaBoard Member of Flanders Bio. Shewas Devgen’s CFO from 1999 to 2008.During that period she was part ofthe Management Team that raisedEUR30millioninventurecapitalfundingandthatlatertooktheCompanypublic
raising further funds on Euronext Brussels. Previously shewasresponsibleforcommercialbankingatINGBankinoneofitsBelgianregionalsectors.Sheholdsadegreeineconomics(“handelsingenieur”)fromtheUniversityofLeuven.
Mr. Raphael Wisniewski is a partnerat Edmond de Rothschild InvestmentPartners. Previously, Mr. Wisniewskiworked in the investment bankingdivisionsatGoldmanSachsInternationaland Salomon Smith Barney and in thefinance department at Générale deSanté International. He is a director at
Genticel, Regado Biosciences, Poxel, Novagali Pharma,Implanet,EOSImagingandPangenetics.Mr.Wisniewskiholdsa degree from HEC and a D.E.A. in Economics and FinancefromIEPParis.
Litigation statement concerning the directors or theirpermanentrepresentatives
At the date of this registration document, none of thedirectors,orincaseofcorporateentitiesbeingdirector,noneof their permanent representatives, of the Company, otherthanthoseindicatedintheparagraphbelow,hasforatleastthepreviousfiveyears:
anyconvictioninrelationtofraudulentoffenses;•heldanexecutivefunctionintheformofaseniormanager•or a member of the administrative, management orsupervisory bodies of any company at the time of orpreceding any bankruptcy, receivership or liquidation, orhasbeensubjecttoanyofficialpublicincriminationand/or
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for the audit of the consolidated financial statements,and in particular the provision of additional services totheCompany.
The followingdirectorsare currentlymembersof theauditcommittee: Hilde Windels, chairman; ING Belgium NV/SA,representedbyMr.DenisBiju-Duval,non-executivedirector;andDr.KarinLouiseDorrepaal,non-executivedirector.
Theauditcommitteeisacollegialbody,anddeliberatesandmakesdecisionsassuch.Theauditcommitteemetthreetimesin2010.Allmembersoftheauditcommitteewerepresentorrepresentedatallmeetings,exceptKarinDorrepaalwhodidnotattendonemeeting.
NominationandRemunerationCommittee
TheActofApril6,2010relating to the improvementof thecorporate governance for publicly listed companies andautonomous governmental companies, and amending theregulationrelatingtoprofessionalprohibitionsinthebankingandfinancialsector(“Loivisantàrenforcerlegouvernementd’entreprisedanslessociétéscotéesetlesentreprisespubliquesautonomes et visant à modifier le régime des interdictionsprofessionelles dans le secteur bancaire et financier” / “Wettot versterking van het deugdelijk bestuur bij de genoteerdevennootschappen en de autonome overheidsbedrijven en totwijzigingvanderegelinginzakehetberoepsverbodindebank-en financiële sector”) introducedanewarticle 526quater intheBelgianCompanyCoderequiringqualifyingpubliclylistedcompanies toestablisha remunerationcommitteeas fromthefirstaccountingyearstartedafterthedateofpublicationofsaidAct(i.e.April23,2010).
Withrespecttothesenewrulescoveringtheestablishmentof the remunerationcommittee, the following isapplicabletoMDxHealth:
Althoughthislegalobligationtoestablisharemuneration•committeewould only apply forMDxHealth as from theaccountingyearstartedonJanuary1,2011,MDxHealthhashad a nomination and remuneration committee in placesincetheCompany’sIPOinJune2006.Accordingtothenewrules,MDxHealthwouldmeetthesize•criteriainordertooperatewithoutaseparatenominationandremunerationcommittee,buttheCompanyhaschosento continue operating with a separate nomination andremunerationcommittee.
SheisinherfirstmandateontheBoardofMDxHealth•andhasneverheldanyExecutiveManagementpositionwiththeCompany.She owns no shares in the Company and is the•beneficiary of some Company warrants as disclosedinsection3.3.Shefulfillstheothercriteriaofindependenceaslisted•insection3.1.3.Mrs. Hilde Windels meets the criteria of necessary•competenceinauditingandaccounting:She has been the CFO of Devgen NV, a publicly-•listed company, forwhich shehandled its IPO and itsfinancialreporting.She is currently the CFO of 2 privately-held•healthcarecompanies.Shehasbeenacommercialbanker.•Sheholdsadegreeineconomics.•
MDxHealth’sauditcommitteemustbecomposedofatleastthree members and is limited to non-executive directors.Thecommitteeappointsachairmanamongst itsmembers.The chairman of the Board of Directors should not chairthecommittee.
The role of the audit committee is to assist the Board ofDirectors in fulfilling its financial, legal and regulatorymonitoringresponsibilities.ThecommitteereportsregularlytotheBoardofDirectorsontheexerciseofitsduties,identifyinganymatters in respect ofwhich it considers that action orimprovementisneeded,andmakingrecommendationsastothestepstobetaken.TheauditreviewandthereportingonthatreviewcovertheCompanyanditssubsidiariesasawhole.ThespecifictasksoftheauditcommitteeareoutlinedintheCompany’sgovernancecharterandincludethefollowing:
tomonitorthefinancialreportingprocess;•to monitor the effectiveness of the Company’s internal•controlandriskmanagementsystems;to monitor the Company’s internal control and risk•management;tomonitortheinternalaudit(whereapplicable)andrelated•activities;tomonitorthestatutoryauditoftheannualstatutoryand•consolidated financial statements, including the follow-up of questions and recommendations by the statutoryauditorand,asthecasemaybe,theauditorresponsiblefortheauditoftheconsolidatedfinancialstatements;toreviewandmonitor the independenceof thestatutory•auditor, and, as the casemay be, the auditor responsible
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CorporateGovernanceStatement
3.1.6. Process For Evaluating the Board, itsCommittees,anditsIndividualDirectors
Every year the Board of Directors will, under the lead ofits Chairman, assess its size, composition, performanceand those of its committees, as well as the contributionofeachdirector.
Thisevaluationprocesshasfiveobjectives:
assessinghow theBoardofDirectors and its committees•operate,checking that the important issues are suitablyprepared•anddiscussed,checkingtheBoard’sandcommittees’currentcomposition•againstthedesiredcomposition,evaluatingtheactualcontributionofeachdirector’swork,•thedirector’spresenceatBoardandcommitteemeetingsand his involvement in discussions and decision-making,andevaluatingwhetherthefeesandcostsofthefullBoardand•individualdirectorsis inlinewiththeperformanceoftheCompanyandtheperformanceoftheindividualdirector
TheChairmancanorganizeanindividualmeetingwitheachdirectortodiscusstheseitems,includingthedirector’sownperformanceandtheperformanceofhiscolleaguedirectors.The conclusions resulting from these individual meetingswillbesubmittedtotheBoardbytheChairman.
An individualevaluationofeachdirectorwillbeconductedeveryyearaspartoftheglobalevaluationoftheBoardandeach time the Board considers his or her nomination forreappointment by the General Shareholders’ Meeting. Thenon-executivedirectorsshouldassesstheirinteractionwiththeExecutiveManagementat leastonceayear.To thisendthey will meet at least once a year in the absence of theexecutivedirectors.
The new rules require that the nomination and•remuneration committee be composed of non-executivedirectors, which is and has always been the case forMDxHealth’snominationandremunerationcommittee.
MDxHealth’s nomination and remuneration committeemust be composed of at least three members and mustbe composed exclusively of non-executive directors. Thecommitteeappointsachairmanamongst itsmembers.ThechairmanoftheBoardofDirectorscanchairthecommittee,butshouldnotchair thecommitteewhendealingwith thedesignation of his successor. The CEO should participateto themeetings of the committee when it deals with theremunerationofotherexecutivemanagers.
The role of the nomination and remuneration committeeistomakerecommendationstotheBoardofDirectorswithregard to the electionofdirectors, the remunerationpolicyfornon-executivedirectorsandtheresultingproposalstobesubmitted to the shareholders’meeting, the remunerationpolicy for Executive Management, and to review andperiodically update an overall remuneration policy for allpersonnel and directors of the Company. The committee’stasks are further described in the Company’s corporategovernancecharter.
Thefollowingdirectorsaremembersofthenominationandremuneration committee: Edward Erickson, independentdirector, Mark Myslinski (chairman of the committee)independent director, and ING BelgiumNV/SA, representedbyMr.DenisBiju-Duval,non-executivedirector.
Thenominationandremunerationcommittee isacollegialbody, and deliberates and makes decisions as such.Thenominationand remunerationcommitteemet2 timesin 2010. All of the committeemembers attended all of thecommitteemeetings.
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The main tasks of the Executive Management are toorganizetheirdepartmentinaccordancewiththeguidelinesdetermined by the CEO and to report to the CEO on theoperationandactivitiesoftheirdepartment.
3.2.3. CompositionoftheManagementTeam
ThecompositionoftheManagementTeamissetoutbelowandreflectsthesituationatthedateofthisreport.
Name PositionAgeonDec31,
2010Dr.JanGroen* ChiefExecutiveOfficer
(CEO)51
Mr.PhilipDevine* ChiefFinancialOfficer(CFO)
44
Dr.JamesClark*
Mr.JoeSollee*
Mr.ChristopherThibodeau*
Vice-PresidentofResearch&Development
Vice-PresidentofCorporateandLegalAffairs
VicePresidentofCommercialOperations
42
46
40
Dr.MelissaA.Thompson
Vice-PresidentRegulatoryAffairsand
QualitySystems
56
*:ForCorporateGovernancepurposes,thesemanagersaredesignatedasexecutive
managerswhereasthefulllistaboveisdesignatedasthemanagementteam.
TheExecutiveManagementdoesnotconstituteanexecutivecommittee (comité de direction / directiecomité)within themeaningofarticle524bisoftheBelgianCompanyCode.
3.2. ExecutiveManagementThe Board of Directors has appointed the Executive Management of the Company. The terms of reference of the ExecutiveManagementhavebeendeterminedbytheBoardofDirectorsincloseconsultationwiththeCEO.
EffectiveApril26,2010Dr.JanGroenwasappointedasCEOofMDxHealth.
Thekeymanagementpositionsin2010areillustratedbelow:
Mr.ChrisThibodeauVPCommercial
Operations
Mr.JoeSolleeVPLegalAffairs
Dr.JamesClarkVPR&D
Dr.MelissaThompsonVPRegulatoryAffairs
&QualitySystems
Decofisprl,representedby
Mr.PhilipDevineCFO
Dr.JanGroenCEO
3.2.1. ChiefExecutiveOfficer
TheCEO isappointed,andcanberemoved,by theBoardofDirectorsoftheCompany.
TheCEO is chargedby theBoardofDirectorswith theday-to-daymanagement of the Company and is therefore alsomanagingdirectoroftheCompany.Inthisfunction,theCEOhasthefollowinggeneralresponsibilities:
the implementation of the decisions of the Board of•Directors,withinthestrategy,planning,valuesandbudgetsapprovedbytheBoardofDirectors,overseeingthedifferentcentraldepartmentsandbusiness•units of the Company, and reporting to the Board ofDirectorsontheiractivities,the development of proposals for the Board of Directors•relatingtostrategy,planning,finances,operations,humanresources and budgets, and othermatters that are to bedealtwithattheleveloftheBoardofDirectors.
The specific tasks of the CEO are further described in theCompany’scorporategovernancecharter.
3.2.2. OtherMembersofExecutiveManagement
TheothermembersoftheExecutiveManagement,beingtheheads of themain activities and central departments (andtheirdivisions)ofMDxHealth,areappointedandremovedbytheCEOincloseconsultationwiththeBoardofDirectorsoftheCompany.
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diagnostics within both GSK-Biologicals and ResponseGenetics. AtGSK-BiologicalshewasTechnologygroupheadfor cancer vaccines and was involved in the developmentof a companion diagnostic. At Response Genetics, as ChiefOperatingOfficer,he ledtheteamthatsuccessfullyappliedforCLIAlaboratoryandtestcertificationaswellasCEmarkingofproductsinEurope.
James Clark holds a Ph.D. in Biochemistry from GlasgowUniversityinScotlandandaBSCinMicrobiologyfromHeriot–WattUniversityinEdinburgh.
Mr. Joseph Sollee, Vice President ofCorporateandLegalAffairsMr. Sollee has provided legal counselto MDxHealth since its inception in2003, and in April 2008 joined theManagement Team. Prior to joiningthe Company, Mr. Sollee served asSpecial Counsel with the law firm of
Kennedy Covington (now K&LGates), where he led the LifeSciencesPracticeGroup.Mr.Solleehasmorethan10yearsofexperienceinthebiotechindustry,andhasheldseniorlegalandmanagementpositionsatTrianglePharmaceuticalsandTherapyEdge. In addition, he has practiced as a corporateattorney in theWashingtonD.C. legal firmSwidler&BerlinandasaninvestmentbankeratSmithBarneyinNewYork.
Mr. Sollee received a Juris Doctorate in Law and aMastersdegreeinInternationalLawfromDukeUniversity,aBAdegreefrom Harvard University, and has been awarded New York,WashingtonD.C.andNorthCarolinalegalbarcertifications.
Mr. Christopher Thibodeau, VicePresidentofCommercialOperationsChris Thibodeau joined MDxHealth inSeptember2010andbringsover15yearsof sales, marketing and commercialleadershipexperienceinthediagnosticsarena. As Vice President CommercialOperations, he is responsible for
developing and executing MDxHealth’s key strategic sales&marketingandbusinessdevelopment initiatives. Prior tojoiningMDxHealth,Mr.ThibodeauservedasSeniorDirectorof Marketing at Agendia Inc., Vice President of Sales andMarketingforNumiraBiosciences,NationalDirectorofSalesU.S.LABS(anindustryleaderincancerdiagnosticandgenomictestingservices);andsalesandmarketingmanagementrolesatVentanaMedical.
FollowingarebiographiesoftheExecutiveManagement.
Dr. Jan Groen, Chief Executive OfficerDr. Jan Groen joined MDxHealth inApril2010andhasmorethan25yearsofexperience in the clinical diagnosticsindustry, with a particular focus onemerging technologies, productdevelopment and commercialization.Dr.Groenwaspreviously thepresident
of Agendia, Inc. and COO of Agendia B.V., responsible fortheir United States and European diagnostic operations,respectively. Prior to this, he served as VP of Research &DevelopmentatFocusDiagnostics,Inc.,asubsidiaryofQuestDiagnostics, in California. Dr. Groen has held numerousmanagement and scientific positions at ViroClinics B.V.,the ErasmusMedical Center, andAkzo-Nobel.Dr. JanGroenisasupervisoryBoardMemberofIBLInternationalB.V.
Dr. Groen holds a Ph.D. degree in Medical Microbiologyfrom the Erasmus University Rotterdam, a BSc in ClinicalLaboratory Studies and has published more than 125papers in international scientific journals in the field ofclinicaldiagnostics.
Mr.PhilipDevine,ChiefFinancialOfficerMr. Devine (representing Decofi sprl)joined MDxHealth at the inception ofthe Company as a co-founder. Prior tojoiningMDxHealth,Mr.DevineservedasCFOofTibotec-Virco,wherehemanagedthe sale of this bio-tech company toJohnson&Johnson.Previously,hewasa
manager at themanagement consulting firmMcKinsey&Company and an auditor at Deloitte & Touche, where heconducted numerous mergers and acquisitions, led initialpublic offerings, and served both small and Fortune500companies.
Mr.DevineearnedhisCPAlicenseinMassachusetts,anMBAdegreewithhonorsfromINSEAD,anMSAdegreewithhighesthonorsfromBentleyCollegeandaBAdegreefromDartmouthCollege.
Dr. James Clark , Vice President ofResearch&DevelopmentJames Clark joined MDxHealth inNovember 2010. Dr. Clark has in thepast been extensively involved in thedevelopment and commercializationof biomarkers and companion
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that corresponds to market practice and expectations forsmall,listedcompaniesinthebiotechnologyfield.
The non-executive directors are remunerated based on apre-defined fixed per diem fee for attendance per BoardmeetingorperBoardcommitteemeeting.Thefeelevelistheperdiemapprovedatthelastgeneralshareholders’meetingconcerning this matter. A record of Board attendance ismaintained by the secretary to the Board of Directors, thisrecord is then double-checked by the Board of DirectorsandconfirmedbytheacceptanceoftheBoardminutes.Theindependent or formerly-independent directors, who havenot held an executive position within the Company, alsoreceiveafixedannualretainerfeeinadditiontotheperdiemfeeforattendingBoardorBoardcommitteemeetings.
Non-executive Board Members who provide services tothe Company outside of the formal Board meetings orBoard committee meetings, must have their work andfees pre-approved by the non-conflicted members of theremuneration and nomination committee. The fee levelmustbe less than theperdiem fee level for attendance tothe Boardmeetings and Board committeemeetings.Thesefeesarethensubmittedforapprovalattheensuingannualgeneral shareholders’ meeting. During the course of 2010,only2non-executivedirectorsreceivedfeesinadditiontothefixedannualretainerfeeandtheperdiemfeeforattendancetoBoardorBoard committeemeetings.Dr.KarinDorrepaalreceivedEUR3,000andMr.RobertTimminsreceivedfeesofEUR12,000ofsuchservice fees in2010.Theseserviceswererenderedduringthefirstquarterof2010whentheCompanyneeded extra assistance in the change of the businessmodel of the Company. Dr. Karin Dorrepaal continues tobe a director ofMDxHealth andMr. BobTimminswas notre-nominated at the May 2010 shareholders’ meeting.Annually, the nomination and remuneration committeereviewsthefeelevelspaidtodirectorsandcomparesthemtofeelevelspaidatothercomparablecompanies.
Grantsofwarrantstodirectorsarerecommendedbythenon-conflicted members of the nomination and remunerationcommittee,reviewedbytheBoardofDirectorsandsubmittedto the general shareholders’ meeting for approval. Non-executivedirectorsmaybeentitledtowarrants.Suchwarrantsmust be approved by a general shareholders’meeting.Thewarrantsareusedtoattract,motivate,andretainkeytalentat the director level. The number of warrants granted tonon-executive directors has remained low compared tothe number of total outstanding security instruments.Theinformationonthewarrantsheldbythedirectorsisdisclosed
Mr.ThibodeauholdsaBAdegreefromtheEastStroudsburgUniversityinPennsylvaniaandstudiedFrenchattheFacultédesLettresinNancy,France.
Dr.MelissaA.Thompson,CT(ASCP),VicePresidentofRegulatoryAffairs&QualitySystemMelissa joined MDxHealth in August2010 and has more than 25 years ofexperience in the pharmaceutical,medical device, and moleculardiagnosticsindustries.Shehasprovided
extensive consultative services in diagnostics to leadingcompanies such as Johnson & Johnson, Wyeth, Inverness,and Affymetrix, as well start-ups like Signature GenomicLaboratories, Prognomix, Allegro Diagnostics, and ExonHitTherapeutics.ShehasfosteredmultipleproductsthroughU.S.FoodandDrugAdministrationapproval,andhasadditionalbackgroundinclinicalresearchandclinicaltrialdesign.
Melissa Thompson holds a Ph.D. in OrganizationalManagement fromConcordiaUniversity and anMBA fromTempleUniversity,Philadelphia,PA.
Litigationstatementconcerningthemanagement
TheCompanyisnotawareofanyconvictionofanymemberof the Executive Management in the previous five yearsfor fraud or indictable offences, or of any involvement inbankruptcy,latepayment,orforcedliquidation.EachExecutiveManagementTeammemberhasrepresentedthatheorshehasnotbeenconvictedinthepreviousfiveyearsforfraudorindictableoffences,orofanyinvolvementinbankruptcy,latepayment,orforcedliquidation.
3.2.4.2010RemunerationReport
Thefollowingreporthasbeenpreparedbytheremunerationand nomination committee and approved by the Board ofDirectorsofMDxHealth.Thereportispreparedinaccordancewith appendix F 9.3/2 of the 2009 Belgian CorporateGovernanceCode.
3.2.4.1 Procedurefor(i)developingaremunerationpolicyfornon-executivedirectorsandexecutivemanagersand(ii)settingthelevelofremunerationfornonexecutivedirectorsandexecutivemanagers
The Board of Directors proposes to the annual generalshareholders’meetinganaggregate remunerationpackage
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CorporateGovernanceStatement
to Board meetings. Travel expenses will be reimbursedat economy class rate, except where pre-approvedotherwise. The directors’ mandate may be terminated “adnutum” (at any time) without any form of compensation.MDxHealth has not made any loans to the members oftheBoardofDirectors.
3.2.4.2 Remunerationpolicyforexecutivemanagers:
The remuneration of the members of the ExecutiveManagement is determined by the Board of Directors uponrecommendation by the nomination and remunerationcommittee, after recommendation by the CEO to suchcommittee.
TheremunerationoftheExecutiveManagementisdesignedtoattract,retainandmotivateexecutivemanagers.Thelevelandstructureoftheremunerationaresubjecttoanannualreviewby thenominationand remuneration committee totake into accountmarket practice.The annual review doesnotprovidemechanismsforautomaticadjustments,exceptforchangesthatarelegallyrequired.
The remuneration of the members of the ExecutiveManagementconsistsofthefollowingelements:
Eachmemberof theExecutiveManagementisentitledto•abasicfixedremunerationdesignedtofitresponsibilities,relevantexperienceandcompetences,inlinewithmarketratesforequivalentpositions.TheCompanypaysavariableremunerationdependenton•the Executive Management member meeting individualand/orteamobjectives.EachmemberoftheExecutiveManagementmaybeoffered•the possibility to participate in a stock based incentivescheme, in accordance with the recommendations setby the nomination and remuneration committee, afterrecommendationbytheCEOtosuchcommittee.EachmemberoftheExecutiveManagementwhoisasalaried•employeemaybeentitled toanumberof fringebenefits,whichmayincludeparticipatinginadefinedcontributionpension or retirement scheme, disability insurance, acompanycar,amobiletelephone,internetaccessand/oralaptopcomputeraccordingtogeneralCompanypolicy,andothercollectivebenefits(suchashospitalizationinsuranceandmealvouchers).
In 2010, all the members of the Executive Management(excluding the CFO) were engaged on the basis of anemployment contract. The employment contracts aregenerally for an indefinite term, with a trial period. The
in section 3.3. Non-executive directors are not entitled tobonuses,fringebenefitsorpensionbenefits.
Executive directors are remunerated in the same manneras executive managers. These individuals receive a fixedremuneration plus a variable bonus that is linked to theirpersonal achievements and the achievements of theCompany.Theydonot receiveanyadditional remunerationfortheexerciseoftheirBoardmandate.TheCEOhasavariablebonus and a fixed annual bonus of EUR22,000. The fixedremunerationlevel,thevariablebonus,andtheobjectivesarereviewedby thenomination and remuneration committee,comparedtoindustryandmarketlevels,andconfirmedbytheBoardofDirectors.TheBoardofDirectorssetstheCompanyobjectives and thepersonal objectives of theCEO.TheCEOsetsthepersonalobjectivesoftheotherexecutivemanagers.The CEO recommends grants of warrants, bonuses andchanges, if any, in the fixed remuneration of executivemanagerstothenominationandremunerationcommittee.Thenominationandremunerationcommitteereviewstheserecommendations and compares them to industry andmarketpractices.Thenomination&remunerationcommitteethenproposesthewarrantgrants,bonusesandremunerationchanges,ifany,totheBoardofDirectorsforapproval.
For the executive director positions, the nomination andremuneration committee proposes remuneration changesand bonuses, if any to the Board of Directors for approval.The remuneration policy of directors was modified in thecourse of the reported year. The remuneration packageapproved at the annual general shareholders’ meetingofMay 28, 2010 isEUR15,000asanannual retainer fee forindependent directors or former independent directorswho have not held executive positions at the Company,plusthefollowingadditionalfeepermeetingheld:
EUR• 3,000perattendanceataBoardorcommitteemeetingbythechairmanoftheBoardEUR• 2,000perattendanceofaBoardorcommitteemeetingforindependentdirectorsorformerindependentdirectorswhohavenotheldexecutivepositionsattheCompanyEUR• 1,000perattendanceataBoardorcommitteemeetingforanyotherdirectorThechairmanoftheauditcommitteeshallreceive• EUR2,500perattendanceatameetingoftheauditcommittee.
The above-mentioned amounts are on a full day basisand the effective fee permeeting is a pro rata in case themeeting does not last a full day apart from the aboveremuneration,directorswillbeentitledtoareimbursementof out-of-pocket expenses actually incurred to participate
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employment contracts may be terminated at any time bythe Company, subject to a severance payment in linewithmarketstandards.Theemploymentcontractsinclude,whereappropriate, non-competition undertakings, as well asconfidentialityandIPtransferundertakings(thatwill trytoseekmaximumprotectionoftheCompany’sinterests,underapplicablelawsandsubjecttotheemployee’sagreement).
In 2010, the CFO was engaged on the basis of a servicearrangement. This service contract can be terminated atany time, subject to certain pre-agreed notice periods orcompensations. Executive members who are engaged onthebasisofaservicescontractdonotreceivefringebenefits,exceptthattheymaybeprovidedwithamobilephoneandlaptop computeraccording togeneralCompanypolicy, andtheyqualify for reimbursementof expenses incurredwhilecarryingouttheirprofessionalresponsibilities.
AmajorityoftheExecutiveManagementTeamwashiredinthecourseof2010andassuchdidnotperformafullyearofservicesin2010.
Remuneration of executive managers is based on theirexperience, know-how, education, skills, responsibilities,
and performance. The remuneration is closely linked toperformance. Bonuses, if any, are linked to identifiableobjectives and to special projects. Non-performers arenot retained in the Company. The majority of the annualremuneration is a fixed compensation amount. There isno minimum nor maximum variable bonus.Warrants canperiodicallybeawardedtoemployees,primarilyasaretentionandmotivationtool.Warrantstypicallyvestovertime(subjecttothebeneficiaryremainingwiththeCompany)andcanonlybeexercisedafteraspecificperiodoftime,exceptwheretheCompanydecidesotherwise.Therewasnosignificantchangeintheremunerationpolicyin2010.NobonuseswereawardedtotheManagementTeamin2010,withtheexceptionoftheCEO.
3.2.4.3 Non-executive director remuneration and otherbenefits:
The following table provides the 2010 compensation ofthe non-executive directors in function at the date of thisdocument
NamePosition1
Pro-rataofannual
retainerfee2(EURK)
Boardmeetingattendance
fees(EURK)
Committeeattendance
fees(EURK)
Otherservices3
(EURK)Total4
(EURK)EdwardErickson NED-ChairmanBoard 9 10 1 0 20KarinDorrepaal NED–memberAC 9 9 1 3 22
RaphaelWisniewski NED–memberAC - 4 1 0 5DenisBiju-Duval NED–memberAC&NRC - 4 1 0 5
MarkMyslinski NED–ChairmanNRC 9 5 1 0 15HildeWindels NED–ChairmanAC 9 7 1 0 17
Totalforcurrentnon-executiveBoardMembers 36 39 6 3 84
Notes:1: “NED”=Non-ExecutiveDirector,“ED”=ExecutiveDirector,“AC”=AuditCommittee,“NRC”=Nomination&RemunerationCommittee.
2: FixedannualretainerfeeswerecommencedonMay28,2010followingtheshareholderapprovalofthenewremunerationpolicyfordirectors
3: KarinDorrepaalwasremuneratedonaperdiembasisforextraworktoassisttheBoardandCompany.
4: Excludesexpensereimbursementandwarrants.15,000newwarrantsweregrantedtonon-executivedirectorsin2010(5,000toEdwardErickson,5,000toMarkMyslinski,
and5,000toHildeWindels).Nootherformofremunerationexistsfordirectors.
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CorporateGovernanceStatement
Duringthecourseof2010,thecompositionoftheBoardofDirectorswaschanged.Thetablebellowprovidesremunerationpaidtodirectorswhoresignedduring2010.Allthedirectorsbelowarenon-executivedirectors,withtheexceptionofHermanSpoldersbvbawhowastheformerCEOoftheCompany.
Name Position1Pro-rata
ofannualretainerfee2
(EURK)
Boardmeetingattendance
fees(EURK)
Committeeattendance
fees(EURK)
Otherservices3
(EURK)Total4
(EURK)RobertTimmins NED–Chairman
Board,ChairmanNRC– 3 0 12 15
HermanSpoldersbvba ED - 2 0 0 2AlainParthoens NED–memberAC 4 7 1 0 12
BobPinedo NED–memberNRC - 1 0 0 1GerardVaillant NED–memberNRC - 5 0 0 5
Totalforresigneddirectors 4 18 1 12 35
Notes:1: “NED”=Non-ExecutiveDirector,“ED”=ExecutiveDirector,“AC”=AuditCommittee,“NRC”=Nomination&RemunerationCommittee.
2: FixedannualretainerfeeswerecommencedonMay28,2010followingtheshareholderapprovalofthenewremunerationpolicyfordirectors.
3: RobertTimminswasremuneratedonaperdiembasisforextraworktoassisttheBoardandCompany.
4: Excludesexpensereimbursementandwarrants.Nowarrantsweregrantedtodirectorswhoresignedin2010.Nootherformofremunerationexistsforthesedirectors.
During the course of 2010, the Company has not deviatedfromitsremunerationpolicyforthenon-executivedirectors.Thetotalremunerationandbenefitspaidtothealldirectors(bothexecutiveandnon-executivedirectors,andincludingtheCEOremuneration)in2010,2009,and2008wasEUR436,000,EUR519,000, and EUR518,000 respectively (gross amount,excludingVATandstockbasedcompensation).
On May 23, 2006, the Board of Directors decided, withapplicationofArticle523oftheBelgianCompanyCode,thattheCompanywillindemnifythedirectorsagainstanyclaimby a third party based on directors’ liability, except in theeventofgrossnegligenceandwillfulmisconduct.Thereforethe Company has taken out directors’ liability insurance.Theinsurancepolicywasrenewedin2010.
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3.2.4.4 Executivedirectorremunerationandotherbenefits:
RemunerationearnedbytheCEOforthereportedyear
Dr. Jan Groen was hired as CEO starting April 26, 2010.HisisremuneratedonthebasisofhisExecutiveManagementpositionandnotforhispositionasanexecutivedirectoroftheCompany.Excludingthevalueofwarrants,theremunerationandbenefitsprovidedtotheCEOin2010werecomprisedofthefollowingfortheeightmonthsofservicein2010:
Euro(EUR)thousands
Fixedgrossremuneration1 278Bonusespaidandawarded(gross)2 15
Pensionbenefits 9Otherbenefits3 15
Total 317
Notes:1: TotalcosttotheCompany,Includingemployersocialsecuritycontributionsand
vacationpayaccrual.
2: Excludesvalueof30,000warrantstheBoardofDirectorshasagreedtoissue
totheCEOasabonusfor2010performance.Thesewarrantshavenotyetbeen
issuedasofthedateofthisreport.
3: Includescompany-paidhousing,companycar,mealvouchers,andothersimilar
benefits. Excludes reimbursement of normal professional expenses such as
telephone and company travel expenses. Excludes value of 130,000 warrants
alreadycreated,issued,andacceptedin2010.
Dr.JanGroenholdsnosharesintheCompanybutuponbeinghired in 2010hewas granted 130,000newwarrants in theCompany. The warrants were granted at the extraordinarygeneralshareholders’meetingofJune21,2010andhavethefollowingcharacteristics:
Exercise price of• EUR2.07 (one option gives right to buyoneshare)Vesting: straight-line on a quarterly basis over 4 years•(novestingiflessthanoneyearofserviceoremploymentisprovided)Durationofoptions:5years•
The IFRS share-based compensation of the stock optionsgrantedin2010amountstoEUR137,000.
AttheBoardmeetingofDecember7,2010,thenon-conflictedmembersof theBoardofDirectorsagreed to the followingbonusfortheperformanceofDr.JanGroenin2010:
EUR• 15,000 (pro-rata of the fixed annual bonus ofEUR22,000)30,000newwarrants(employeestockoptions)tobecome•immediately vested upon issuance of the options. At thedate of this report, these warrants have still not beencreatednorissued.Theexercisepricewillbebasedonthe30-day average market price prior to their issuance. TheIFRS value of thesewarrants cannot be calculated at thedateofthisreport
During the course of 2010, the Company has not deviatedfromitsremunerationpolicyfortheexecutivedirector.
3.2.4.5 RemunerationearnedbytheotherExecutiveManagers
The 2010 combined remuneration package of the 4 otherExecutiveManagementTeammembers(excludingtheCEO),including employer taxes, was EUR559,000. Some of thesemanagers were hired in 2010 andwere only employed forpartoftheyear.
Euro(EUR)thousands
Fixedgrossremuneration1 503Bonusespaidandawarded(gross)2 0
Pensionbenefits 10Otherbenefits3 46
Total 559
Notes:1: Includesemployertaxesandvacationpayaccrual.ExcludesVAT.
2: ExcludesvalueofwarrantstheBoardofDirectorshasagreedtoissueto
certainotherexecutivemanagers.Thesewarrantshavenotyetbeenissuedas
ofthedateofthisreport.
3: Includesforsomeindividualsacompanycar,mealvouchers,andothersimilar
benefits.Excludesreimbursementofnormalprofessionalexpensessuchas
telephoneandcompanytravelexpenses.
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CorporateGovernanceStatement
The 2010 combined remuneration package of the 4 otherExecutiveManagementTeammembers(excludingtheCEO),includingemployertaxes,wasEUR559,000.Severalofthesemanagerswerehiredin2010andwereonlyemployedforpartoftheyear.ThetotalremunerationandbenefitspaidtotheExecutiveManagementTeammembers (including theCEO)in2010,2009and2008wasEUR0.9million,EUR2.19million,and EUR1.97million, respectively (gross amount, excludingVATandstockbasedcompensation). In theaforementionedfigures,theservicefeesandBoardfeesofthemanagershiredon the basis of a service agreement are includedwith thesalariesoftheotherManagementTeammembers.Thetotalamountpaidin2010decreasedcomparedtopreviousyearsdueto(i)thesizeoftheManagementTeamwasreducedfrom10to5individualsin2010,and(ii)severaloftheManagementTeammembersin2010onlyservedforapartoftheyear.
ThetotalservicefeespaidtotheCEOin2010,2009and2008were EUR317 thousand, EUR366 thousand, and EUR405thousand, respectively (gross amount, excluding VAT andstockbasedcompensation).ThecurrentCEOonlyservedfor8monthsoftheyearin2010.
In 2010, no warrants were issued to the other executivemanagers.However, theCompanyhas contractually agreedto issue new warrants to certain managers. Upon hiringcertain executive managers in 2010 and during the BoardmeetingofDecember7,2010,theBoardagreedtograntnewwarrants(employeestockoptions)tocertainmanagersoftheCompany.The totalnumberofwarrants forotherexecutivemanagersisTheCompanyandtheBoardhavecommittedtoissuenewwarrantstoseniormanagers,aslistedbelow,butasofthedateofthisreporttheyhavestillnotbeencreatednorissued.
Mr.ChristopherThibodeau: 65,000(“OtherExecutiveManager”)
Dr.MelissaThompson: 20,000(ManagementTeammember)
Mr.JosephBigley: 20,000(othermanager)Dr.JamesClark: 20,000(“OtherExecutive
Manager”)Mr.JosephSollee: 20,000(“OtherExecutive
Manager”)Bioinformatrixbvba,
representedbyDr.WimvanCriekinge:
20,000(othermanager)
Decofisprl,representedbyMr.PhilipDevine:
30,000(“OtherExecutiveManager”)
Whencreatedandissuedthesewarrantswilllikelyhavethefollowingcharacteristics:
Exercise price based on the 30-daymarket average price•in theperiodpreceding theircreation(onewarrantsshallentitleitsownertoacquireoneshare);Vesting:straight-lineonaquarterlybasisover4years (no•vesting if less than one year of service or employmentis provided) although the vesting period may start on adateearlier thanthedateof thecreationandissuanceofthewarrants;Durationofwarrants:10years.•
In the course of 2010, no warrants or other rights wereexercised by or lapsed for the executive managers. In thecourse of 2010, no bonus was paid to the other executivemanagers, other than the CEO. During the course of 2010,theCompanyhasnotdeviatedfromitsremunerationpolicyfortheexecutivemanagers.
3.2.4.6 Special provisions of the contractual relationshipoftheExecutiveManagers
Noneoftheexecutivemanagershasacontractualagreementtoreceivemorethan12months’remunerationincaseofseverance.The Company has not materially deviated from itsremunerationpolicyduringthefinancialreportedyear.
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3.3. SharesandWarrantsHeldbyDirectorsandExecutiveManagementThe tables below provide an overview of the shares and warrants held by the non-executive directors and by ExecutiveManagement.
WhilesomeoftheinstitutionalshareholdersalsoserveasaBoardMembers(seesections3.1.4and4.8),noneoftheirrespectivepermanentrepresentativesownanysharesorwarrantsintheCompany.AsfarasisknownbytheCompany,thenon-executivedirectorsholdthefollowingfinancialinstrumentsinMDxHealth:
AsatDec31,2010 Shares Warrants Totalsharesandwarrants
Number %oftotalsharesoutstanding Number %offully
dilutedshares Number %offullydilutedshares
Mr.EdwardErickson 0 0.00% 5,000 0.04% 5,000 0.04%Mr.MarkMyslinksiMrs.HildeWindels
00
0.00%0.00%
5,0005,000
0.04%0.04%
5,0005,000
0.04%0.04%
Dr.KarinDorrepaal 0 0.00% 15,000 0.11% 15,000 0.11%Total 0 0.00% 30,000 0.23% 30,000 0.23%
The tablebelowprovidesanoverviewof thesharesandwarrantsheldby theExecutiveManagement, including theexecutivedirectors.Thenumbersmentioned in the tablebelowdonot include thewarrants referred to in section 3.2.4.6 thathavenotyetbeencreatedand/or issuedbutwhichtheCompanyhasagreedtocreateandissueto theexecutivemanagersassetforththerein.
AsatDec31,2010 Shares Warrants Totalsharesandwarrants
Number %oftotalsharesoutstanding Number %offullydiluted
shares Number %offullydilutedshares
Dr.JanGroen(1) 0 0.00% 130,000 0.95% 130,000 0.95%OtherExecutive
Managers(1)10,000 0.08% 42,190 0.31% 52,190 0.38%
OthermembersoftheManagementTeam(1)
0 0% 0 0% 0 0%
Total 10,000 0.08% 172,190 1.26% 182,190 1.33%
(1)TheotherexecutivemanagersandmembersoftheManagementTeamareidentifiedinsection3.2.3above.
Asdisclosedinsection3.2.4.6,theBoardin2010hasawarded135,000warrantstothe4otherexecutivemanagers,howeverthesewarrantshavenotyetbeencreatednorissued.Thesewarrantsarenotincludedintheabovetablebutiftheyhadbeenissuedwouldrepresent0.97%ofthefullydilutednumberofshares.Asdisclosedinsection3.2.4.6,theBoardin2010hasawarded20,000warrantstoanothermemberoftheManagementTeam,howeverthesewarrantshavenotyetbeencreatednorissued.Thesewarrantsarenotincludedintheabovetable.
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3.4. InternalControlAndRiskManagementSystems
The Company has implemented a number of standardcontrolandmanagementsystemsforacompanyof itssizeandindustrysector.
AttheBoardofDirectorslevel,thereisaperiodicreviewandapprovalofthefollowingmaintopics:
Overallstrategyandstrategicoptions•5-yearbusinessplanandcompanygoals•Ensuingyearbudgetandtargets•Comparisonofactualresultsandbudgetedfigures•Material in-licensing and out-licensing opportunities•anddealsMaterialsupplier,contractor,andpartnershipopportunities•anddealsHiring,motivation,andretentionofkeytalent•Remunerationandbenefits•Reviewandapprovalofpressreleases•Financialstatements•Internalcontrols•
Management of the Company is organized on the basis ofplans,departments,projects,andcorrespondingbudgetsandtargets.Progressonthecoreprojects,budgets,andplansarereviewed on a periodic basis. Themanagement has clearlyaligned responsibilitiesasdescribed in the jobdescriptionswhicharepreparedforallemployeesoftheCompany.
Asetofmeasureshasbeentakentoassurethequalityofthefinancialandmanagementinformation,amongstothers:
the appointment of qualified personnel in key positions•withallentitiesoftheCompany;the definition of a set of standard procedures for key•activities such as steps for the approval, purchasingandpaymentofservicesandgoods;therequestfortheexternalauditorstopayspecialattention•toareaswithspecificcompanyandindustryrisk;therequestforspecializedconsultantstoassistindesigning•and/orreviewingkeyprocedures,systems,orreports;the audit committee or individual directors periodically•reviewandareconsultedonkeymattersandproceduresandwhenneededexternalspecialistassistanceissought.
A significant part of the Company’s funds are spent onresearch and development projects. To ensure control and
managementofsuchprojects,theCompanyhasanumberofmeasures,amongstothers:
use of design-control procedures in the development of•allproductseach project has its specific development plan which is•periodicallyupdatedandreviewedR&D and commercial services are performed in an•ISO-certifiedlaboratoryexternal experts are used for advising on the projects•(market research studies, scientific advisory Board,clinicaladvisors,etc.)bothin-houseandexternalintellectualpropertyspecialists•managetheIPportfolioaudits of its laboratory facilities are performed by•externalspecialistsandbybigpharmaceuticalcompaniesusingtheCompany’sservicesenvironmental, safety, and security permits are•obtained where necessary and staff is trained onrelevantprocedures
ThelegaldepartmentofMDxHealthundersupervisionoftheCEO,togetherwiththeManagementTeamhassetupinternalproceduresinordertoensurethatactsperformedwithinorbytheCompanyareincompliancewiththeexistinglawsandexternalregulations.ThemanagementisalsoresponsibletocomplywithinternalregulationsandtheBoardofDirectorsisensuring that themanagement isrespecting thegeneralpoliciesandthecorporateplans.
The risks, which the Company is subject to, have beendiscussed at the start of this document. Riskswith respecttoinfrastructure–suchasfire,unwantedaccessandpowerfailures – have been minimized by taking appropriatemeasures. Forassetswhichare crucial for thecontinuityoftheCompany,beingitequipmentforR&Dorstoredhumansamples,measureshavebeen taken tominimize theriskofloss ordestructionof suchassets.Next to avoiding risks inthisrespect,wherepossible,insurancehasbeentakentocoverlossoftheseassets,alwaysbasedhoweveronaneconomicaljustificationwhereby therisk isevaluatedagainst thepricetoinsuretherisk.Withrespecttocomplyingwithregulationsconcerning safety at work, working with biotechnologicalmaterialandenvironmentalmattersingeneral,appropriatemeasures were taken within the Company to guaranteecompliancewiththeseregulationsandtooperatewithandwithintherequiredpermitsinthisrespect.
The IT department is responsible for the continuity of theplatforms used by the Company to support its operationsaswellasfortheimplementationofsystemaccesscontrols
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andsafelystoringdata.AppropriatemeasuresweretakentoassurethecontinuityoftheoperationsoftheCompanytakingintoaccounttherequirementsofthedifferentdepartments.
AllemployeesoftheCompanyareinstructedontherulesandpoliciesoftheCompanyviaabookletofworkrules,thetermsoftheiremploymentcontracts,standardoperatingproceduresdefinedbytask/area,andbynumerousdocuments(suchastheDealingCode)thataredistributedandexplainedtothepersonnel. The directors and key consultants are subjectedtothesamestandardproceduresandruleswhenandwhereappropriate.
The IP-portfolio, for the protection of knowledge andproprietarytechnology,isactivelymanagedbyevaluatingonaregularbasisthecoststomaintainsuchprotectionversusthebenefitsofdoingthis.Furthermoreitisclearlycommunicatedtoemployeesonhowtodealwithconfidential information(andrulesareinplaceonhowtosharesuchinformationwiththirdparties.
The Board periodically reviews and provides instructionsto the Management Team on how to manage credit risks,interest risks, exchange risks, and liquidity risks. As anexample, theBoardhasgiven instructionsonwhat typeoffinancialinstrumentstheCompanycanplaceitscashandonwhichitisnotallowedtodoso.Themanagementalsoseeksexternalspecializedadviceonmanagingsuchrisks.
3.5. ComplianceWithAndDeviationsFromThe2009BelgianCorporateGovernanceCode
MDxHealth has adopted the 2009 Belgian CorporateGovernanceCodeasitsreferencecode.Itcompliestoalargeextent with the provisions of this Code, but believes thatcertain deviations are justified in view of the Company’sspecific situation. In line with the “comply-or-explain”principle of said Code, it should be noted thatMDxHealthdoesnotfullycomplywiththefollowingprovisions:
Given the size of the Company, no internal audit•functionexistsatthistime.Given the size of the Company, the Board will strive to•includeamajorityofindependentBoardMembersontheauditcommitteeandonthenominationandremunerationcommittee, but may deviate from such a majority ofindependents on such committees if, in the reasonableopinion of the Board, a different composition can bringmorerelevantexperienceandexpertisetosuchcommittee.In 2010, the audit committee was only composed of oneindependent director who is also the chairman of thecommittee.Although, according to the 2009 Code, non-executive•directors should not be entitled to performance-relatedremuneration such as bonuses, stock related long-termincentive schemes, fringe benefits or pension benefits,the Board of Directors is however of opinion that, for acompany of the size of MDxHealth, it may be necessaryto issuewarrants to non-executive directors,with a viewto attracting directors with the relevant expertise andexperience. All non-executive directors currently havebeenawardedwarrants.
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3.6. ConflictsofInterestandRelatedParties
Article523oftheBelgianCompanyCodeprovidesforaspecialprocedure within the Board of Directors in the event of apossibleconflictofinterestofoneormoredirectorswithoneormoredecisionsor transactionsby theBoardofDirectors.In theeventofaconflictof interest, thedirectorconcernedhas to informhis fellowdirectors of his conflict of interestinadvanceof theconflictandmustact inaccordancewithrelevantrulesof theCompanyCode.Foranoverviewof thevarious conflicts of interest, please refer to the statutoryreportoftheBoardofDirectors(section6.4).
Article 524 of the Belgian Company Code provides for aspecial procedure that applies to intra-group or relatedparty transactionswith affiliates. The procedure applies todecisionsortransactionsbetweentheCompanyandaffiliatesoftheCompanythatarenotasubsidiaryoftheCompany.ItalsoappliestodecisionsortransactionsbetweenanyoftheCompany’ssubsidiariesandsuchsubsidiaries’affiliatesthatarenotasubsidiaryoftheCompany.Theproceduredoesnotapply todecisionsor transactions in theordinarycourseofbusinessatcustomarymarketconditions,andtransactionsordecisionswithavalueoflessthan1%oftheconsolidatednetassetsoftheCompany.Suchtransactionshavenotoccurred.
Presently,MDxHealth is not aware of anypotential conflictof interest between the duties that the members of itsBoard of Directors and of its Management Team owe toMDxHealth, on theonehand, and theirprivate interestsorotherduties,ontheotherhand.
3.7. DealingCodeThe rulesandprocedures thatapplywhenBoardMembersand executive managers deal in MDxHealth securities aredefined in theCompany’sDealingCode.The codeprohibitsBoard Members and executive managers from dealingwith MDxHealth securities during periods prohibited byapplicable laws and regulation or during specific closedperiods announced by the Company. The dealing codeis available in its entirety on the Company’s website(www.MDxHealth.com).
3.8. StatutoryAuditorBDO Réviseurs d'Entreprises Soc. Civ. SCRL, a civil company,having the form of a cooperative company with limited
liability (société coopérative à responsabilité limitée/coöperatieve vennootschap met beperkte aansprakelijkheid)organized and existing under the laws of Belgium, withregisteredofficeatDaVincilaan9, 1935Zaventem,Belgium,representedbyMr.BertKegelswasre-appointedonMay29,2009asthestatutoryauditoroftheCompanyforatermof3 yearsending immediatelyafter the closingof theannualshareholder’smeetingtobeheldMay25,2012.BDOhasbeenthestatutoryauditorsinceJanuary10,2003.Mr.BertKegelshasrepresentedBDOsinceMay29,2009.
The proposal of the Board ofDirectors to elect the auditoris submitted to the general shareholders’ meeting uponproposalbytheauditcommittee.
The statutory auditor and, as the casemay be, the auditorresponsible for the audit of the consolidated financialstatements, confirms annually in writing to the auditcommittee his or her independence from the Company,discloses annually to the audit committee any additionalservices provided to the Company, and discusses with theaudit committee the threats to his or her independenceand the safeguards applied to mitigate those threats asdocumentedbyhimorher.
The Company paidEUR62 thousand in fees to the auditorin2010.Thefeesarebrokendownasfollows:statutoryauditfeeof• EUR31thousandaudit fee for consolidated and stand-alone financials•ofEUR25thousandothermissionsfor• EUR6thousand.
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4.TheCompany,ItssharesandShareholders
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TheCompany,ItssharesandShareholders
the acquisition, disposal, exploitation, commercialization•and management of intellectual property, property andusage rights, trademarks,patents,drawings, licensesandanyotherformofknowhow.
TheCompanyisalsoauthorizedtoengageintoallcommercial,industrial, financial and real estate transactions,which aredirectlyor indirectly related to,or thatmaybebeneficial totheachievementof,itscorporatepurpose.
It can, by means of subscription, contribution, merger,collaboration, financial participation or otherwise, takeinterests or participate in any company, existing or to beincorporated, undertakings, businesses and associations inBelgiumorabroad.
TheCompanycanmanage,re-organizeorselltheseinterestsand canalso, directly or indirectly, participate in theBoard,Management, control and dissolution of companies,undertakings, business andassociations inwhich ithasaninterestoraparticipation.
TheCompanycanprovideguaranteesandsecurityinterestsforthebenefitofthesecompanies,undertakings,businessesand associations, act as their agent or representative, andgrantadvances,credit,mortgagesorothersecurities.
4.3. HistoryofShareCapitalAttheendof2010,theissuedcapitalofMDxHealthamountedtoEUR10,517,661.90representedby13,185,614commonshareswithoutnominalvalue.
Nonewshareswereissuedin2010.TheExtraordinaryGeneralShareholders’meetingof June21,2010approved theformalreductionofthesharecapitalinaccordancewitharticle614of the Belgian Company Code through the incorporation(and neutralization) of (accumulated) sustained losses asdemonstrated from the approved annual accounts as perDecember 31, 2009, without reducing the total number ofissuedandoutstandingshares,inordertoimprovetheratiooftheCompany’snetassetsvis-à-visitssharecapital.Therefore,thesharecapitalwasreducedbyEUR43,483,535.37,bringingthesharecapitalfromEUR54,001,197.27toEUR10,517,661.90.
4.1. Name,RegisteredOfficeandIncorporation
The Company was incorporated on January 10, 2003 underthenameOncoGenomeSciences(andlaterOncoMethlylomeSciences) for an unlimited duration. At the occasion ofthe extraordinary general shareholders’ meeting held onOctober 5, 2010 the Company’s name was changed intoMDxHealth. The Company has the legal form of a publiclimited liability company (société anonyme – SA / naamlozevennootschap–NV)organizedandexistingunderthelawsofBelgium.PursuanttotheBelgianCompanyCode,theliabilityoftheshareholdersislimitedtotheamountoftheirrespectivecommitted contribution to the capital of the Company.The Company’s registered office is located at Tour 5 GIGA,Avenuedel’Hôpital11,B-4000Liège,Belgium.
The Company is registered with the Registry ofLegal Persons (registre des personnes morales – RPM /rechtspersonenregister – RPR) under company numberRPM/RPR0479.292.440(Liège).
4.2. CompanyPurposeThecorporatepurposeofMDxHealthissetforthinarticle3ofitsarticlesofassociationandreadsasfollows:
TheCompany’scorporatepurposeistoengageinBelgiumandabroad,initsownnameandonbehalfofthirdparties,aloneorincollaborationwiththirdparties,inthefollowingactivities:
all forms of research and development on or involving•biologicalcellsandorganisms(includinggenemethylation)andchemicalcompounds,aswellas the industrializationandcommercializationoftheresultsthereof;the research and development of biotechnological or•derivative products that could have a market value inapplications related to human and animal healthcare,diagnostics, pharmacogenomics and therapeutics, basedamongstotherthingsonthetechnologyofgenetics,geneticengineeringanddetection,chemistryandcellbiology;thecommercializationoftheaforementionedproductsand•applicationdomains;
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ThetableandnotesbelowprovideanoverviewofthehistoryofMDxHealth’ssharecapitalsinceitsincorporation.
Date Transaction Numberofshares
issued
Issuepriceper
share(EUR)
Issuepriceper
sharepoststock-split
(EUR)
Capitalincrease
(EUR)
Sharecapitalaftertransaction
(EUR)
ShareIssuance
Premiumaftertransaction
(EUR)
Aggregate#ofshares
aftercapitalincrease
IncorporationJan10,2003 Incorporation(1) 202,975 0.30 0.06 61,500.00 61,500.00 0 202,975PhaseIFinancingRoundDecember20,2002(PreferredAShares)Feb7,2003 Capitalincreaseincash(2) 197,025 20.00 4.00 3,940,500.00 4,002,000.00 0 400,000June30,2003 Capitalincreaseincash(3) 33,333 20.00 4.00 666,660.00 4,668,660.00 0 433,333Sep30,2003 Capitalincreaseincash(4) 218,139 22.31 4.46 4,866,681.09 9,535,341.09 0 651,472June20,2004 Capitalincreaseincash(5) 195,504 23.87 4.77 4,666,680.48 14,202,021.57 0 846,976PhaseIIFinancingRoundOctober19,2005(PreferredBShares)Oct28,2005 Capitalincreaseincash(6) 375,000 24.00(7) 4.80(7) 9,000,000.00 23,202,021.57 0 1,221,976Mar31,2006 Capitalincreaseincash(8) 193,548 31.00 6.20 5,999,988.00 29,202,009.57 0 1,415,524StockSplitMay23,2006 Stocksplit5/1 / / / / / 0 7,077,620InitialPublicOfferingandExerciseofOver-AllotmentWarrantsJune30,2006 Capitalincreaseincash(9) 2,933,334 7.50 7.50 22,000,005.00 51,202,014.57 0 10,010,954June30,2006 Capitaldecrease(10) / / / -10,217,809.00 40,984,205.57 0 10,010,954June30,2006 Capitalincreasethrough
exerciseofwarrants(11)440,000 7.50 7.50 1,817,200.00 42,801,405.57 1,482,800.00 10,450,954
ExerciseofWarrantsApr18,2007 Capitalincreasethrough
exerciseofwarrants(12)182,560 4.70 4.70 747,666.16 43,549,071.73 1,593,731.31 10,633,514
PrivatePlacementOct19,2007 Capitalincreaseincash(13) 1,063,351 10.00 10.00 4,354,954.02 47,904,025.75 7,872,287.29 11,696,865ExerciseofWarrantsOct25,2007 Capitalincreasethrough
exerciseofwarrants(14)50,837 4.73 4.73 208,202.93 48,112,228.68 7,904,487.77 11,747,702
ExerciseofWarrantsApr24,2008 Capitalincreasethrough
exerciseofwarrants(15)61,120 4.59 4.59 250,316.96 48,362,545.64 7,934,871.81 11,808,822
Nov5,2008 Capitalincreasethroughexerciseofwarrants(16)
19,375 4.73 4.73 79,350.31 48,441,895.95 7,947,140.25 11,828,197
PrivatePlacementDec18,2008 Capitalincreaseincash(17) 1,332,877 6.29 6.29 5,458,797.75 53,900,693.70 10,872,138.83 13,161,074ExerciseofWarrantsApr17,2009 Capitalincreasethrough
exerciseofwarrants(18)24,540 4.49 4.49 100,503.57 54,001,197.27 10,881,808.74 13,185,614
ReductionofShareCapitalJune21,2010 ShareCapitalreduction(19) / / / / 10,517,661,90 10,881,808.74 13,185,614CurrentSituationPerstatutoryaccounts 10,517,661,90 10,881,808.74 13,185,614PerIFRSconsolidatedaccounts(20) 10,517,661,90 10,881,808.74 13,185,614
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(9) OnMay23,2006,thegeneralshareholders’meetingoftheCompanydecidedtoincreasetheCompany’ssharecapitalwiththeissuanceofnewsharesinconnectionwithaninitialpublicoffering.ThecapitalincreasewascompletedonJune30,2006.Atthesametime,allexistingsharesoftheCompanywereconvertedintoordinaryshares.
(10)OnMay23,2006,thegeneralshareholders’meetingoftheCompanydecidedtodecreasetheCompany’ssharecapitalwithanamountofEUR10,217,809throughincorporationoflosses.ThecapitaldecreasewascompletedonJune30,2006.
(11) OnMay23,2006,thegeneralshareholders’meetingoftheCompanydecidedtocreateanover-allotmentwarrant.Theover-allotmentwarrantwasgrantedtoINGBelgiumNV/SAandFortisBankNV/SAtocoverover-allotmentsinconnectionwiththeinitialpublicofferingbytheCompany.OnJune30,2006,thesharecapitalwasincreasedthroughexerciseof440,000over-allotmentwarrantsandtheissuanceof440,000newordinaryshares.
(12) OnApril18,2007,182,560newshareswereissuedforanaggregateissuepriceofEUR858,597.47withrespecttotheexerciseofwarrantsinMarch2007.TheexercisedwarrantswerevestedwarrantsrelatedtotheWarrantPlansof2004,2005,andMarch2006whichhadbeengrantedtoemployees,directors,andconsultants.
(13) OnOctober19,2007,1,063,351newshareswereissuedforanaggregateissuepriceofEUR10,633,510.00withrespecttoaprivateplacementofnewshareswithinstitutionalandqualifiedinvestors.
(14) OnOctober25,2007,50,837newshareswereissuedforanaggregateissuepriceofEUR240,403.19withrespecttotheexerciseofwarrantsinSeptember2007.TheexercisedwarrantswerevestedwarrantsrelatedtotheWarrantPlansof2004,2005,March2006,November2007,andApril2007whichhadbeengrantedtoemployees,directors,andconsultants.
(15) OnApril24,2008,61,120newshareswereissuedforanaggregateissuepriceofEUR280,701.00withrespecttotheexerciseofwarrantsinMarch2008.TheexercisedwarrantswerevestedwarrantsrelatedtotheWarrantPlansof2004andMarch2006whichhadbeengrantedtoemployeesandconsultants.
(16)OnNovember5,2008,19,375newshareswereissuedforanaggregateissuepriceofEUR91,618.75withrespecttotheexerciseofwarrantsinSeptember2008.TheexercisedwarrantswerevestedwarrantsrelatedtotheWarrantPlansof2004,2005,andMarch2006whichhadbeengrantedtoemployees,directorsandconsultants
(17) OnDecember18,2008,1332,877newshareswereissuedforanaggregateissuepriceofEUR8,383,796.33withrespecttoaprivateplacementofnewshareswithinstitutionalandqualifiedinvestors.
(18)OnApril17,2009,24,540newshareswereissuedforanaggregateissuepriceofEUR110,173.48withrespecttotheexerciseofwarrantsinMarch2009.TheexercisedwarrantswerevestedwarrantsrelatedtotheWarrantPlansof2004andMarch2006whichhadbeengrantedtoemployeesandconsultants.
(19)OnJune21,2010,theExtraordinaryGeneralShareholders’meetingapprovedtheformalreductionofthesharecapitalinaccordancewitharticle614oftheBelgianCompanyCodethroughtheincorporation(andneutralization)of(accumulated)sustainedlossesasdemonstratedfromtheapprovedannualaccountsasperDecember31,2009,withoutreducingthetotalnumberofissuedandoutstandingshares,inordertoimprovetheratiooftheCompany’snetassetsvis-à-visitssharecapital.Therefore,thesharecapitalwasreducedbyEUR43,483,535.37,bringingthesharecapitalfromEUR54,001,197.27toEUR10,517,661.90.
(20)FortheconsolidatedIFRSaccounts,theIPOexpensesofJune30,2006andtheexpensesoftheprivateplacementofOctober2007andDecember2008wererecordedasareductioninthesharecapital,whereastheywererecordedasanexpenseforthestatutoryaccounts.
Notes(1) ThesharesweresubscribedtobyBBLNV/SA(INGBelgiumNV/SA)
(202,974shares)andPolyTechnosVentureFundIIGmbH&CoKG(1share).OnJanuary30,2003,200,000sharesweretransferredtothemanagementandconsultantsoftheCompany.Ofthese200,000shares,199,999sharesweretransferredbyBBLNV/SA(INGBelgiumNV/SA)and1sharewastransferredbyPolyTechnosVentureFundIIGmbH&CoKG.
(2) ThesharesweresubscribedtobyBBLNV/SA(INGBelgiumNV/SA)(97,025shares),PolyTechnosVentureFundIIGmbH&CoKG(11,833shares),PolyTechnosVentureFundIILP(47,500shares),PolyTechnosVentureFundBeteiligungsGmbH(6,667shares),PolyTechnosPartners&TeamGmbH(667shares),TechnowalSA(16,667shares),Sociétéd’InvestissementduBassinLiégois(SIBL)SA(8,333sharesandSociétédeDéveloppementetdeParticipationduBassindeLiège(Meusinvest)SA(8,333shares).Atthesameoccasion,twodifferentclassesofshareswerecreated,i.e.,thecommonsharesandthepreferredAshares.Allsharesissuedatthisoccasionand2,975sharesissuedatincorporationwerereclassifiedaspreferredAshares.Theremaining200,000sharesarecommonshares.
(3) TheshareswereallsubscribedtobyLifeSciencesPartnersIIB.V.(4) ThesharesweresubscribedtobyINGBelgiumNV/SA(89,646
shares),PolyTechnosVentureFundIIGmbH&CoKG(4,997shares),PolyTechnosVentureFundIILP(20,062shares),PolyTechnosVentureFundBeteiligungsGmbH(2,816shares),PolyTechnosPartners&TeamGmbH(281shares),TechnowalSA(14,940shares),SIBLSA(7,471shares),MeusinvestSA(7,471shares),LifeSciencesPartnersIIB.V.(61,490shares)andMr.PierreHochuli(8,965shares).
(5) ThesharesweresubscribedtobyINGBelgiumNV/SA(83,787shares),PolyTechnosVentureFundIIGmbH&CoKG(7,435shares),PolyTechnosVentureFundIILP(29,850shares),PolyTechnosVentureFundBeteiligungsGmbH(4,190shares),PolyTechnosPartners&TeamGmbH(419shares),TechnowalSA(13,965shares),SIBLSA(6,982shares),MeusinvestSA(6,982shares)andLifeSciencesPartnersIIB.V.(41,894shares).
(6) ThesharesweresubscribedtobyINGBelgiumNV/SA(105,658shares),PolyTechnosVentureFundIIGmbH&CoKG(9,376shares),PolyTechnosVentureFundIILP(37,641shares),PolyTechnosVentureFundBeteiligungsGmbH(5,284shares),PolyTechnosPartners&TeamGmbH(528shares),TechnowalSA(19,484shares),MeusinvestSA(9,742shares),LifeSciencesPartnersIIB.V.(58,453shares),Mr.PierreHochuli(3,834shares),BioDiscoveryIIFCPR(100,000shares),InnovationDiscovery3FCPI(10,500shares),SogéInnovationEvolution2FCPI(9,750shares)andSogéInnovationEvolution4FCPI(4,750shares).
(7) TheissuepricewasEUR24(orEUR4.80afterstocksplit),beingEUR16.77(orEUR3.35afterstocksplit),beingthefractionalvalueoftheshares,increasedwithEUR7.23(orEUR1.45afterstocksplit),beingtheissuepremium,pershare.ThetotalamountoftheissuepremiumwasimmediatelyincorporatedinthesharecapitaloftheCompany.
(8) ThiscapitalincreasewasexecutedpursuanttoandinaccordancewiththetermsandconditionsofanagreemententeredintoonOctober19,2005withrespecttothePhaseIIfinancinground.ThesharesweresubscribedtobyINGBelgiumNV/SA(54,533shares),PolyTechnosVentureFundIIGmbH&CoKG(2,420shares),PolyTechnosVentureFundIILP(9,714shares),PolyTechnosVentureFundBeteiligungsGmbH(14,996shares),PolyTechnosPartners&TeamGmbH(137shares),TechnowalSA(10,056shares),MeusinvestSA(5,028shares),LifeSciencesPartnersIIB.V.(30,169shares),Mr.PierreHochuli(1,979shares),BioDiscoveryIIFCPR(51,613shares),InnovationDiscovery3FCPI(5,419shares),SogéInnovationEvolution2FCPI(5,032shares)andSogéInnovationEvolution4FCPI(2,452shares).
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Assoonas theBoardofDirectorswillhave increased theb.sharecapital, inoneormoretransactions,foranamountequal tothemaximumamountprovidedabove, thentheBoardofDirectorscanonly,totheextentpossible,furtherincrease the share capital in one or more transactionsbeyondthisinitialmaximumamount,providedthatsuchincreaseisapprovedbyatleasttwothirdsofthemembersof the Board of Directors, and provided further that theincrease takes placewithin the framework of any of thefollowing transactions: (i) the issuance of stock basedremuneration or incentive plans, such as stock optionplans, stock purchase plans or other plans, for directors,management and personnel of the Company or itssubsidiaries or (ii) the issuance of financial instrumentsin consideration of the acquisition of shares, assets andliabilitiesorcombinationsofshares,assetsandliabilitiesofcompanies,undertakings,businessandassociationsor(iii)the issuanceof financial instruments in considerationoftheacquisitionoflicensesorrightsonintellectualproperty(whether registered or unregistered intellectual propertyrights,orapplicationsthereof),suchaspatents,copyrights,data base rights and design rights, and know-how ortradesecretsor (iv) the issuanceof financial instrumentsin consideration of entering into partnerships or otherbusinessassociations.
By virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the BoardofDirectors has also been expressly authorized to increasethe share capital in one or more transactions following anotificationby theBelgianBanking, Finance and InsuranceCommission that ithasbeen informedofapublic takeoverbid on the Company’s financial instruments, throughcontributions in cashwith cancellationor limitationof thepreferentialsubscriptionrightsoftheshareholders(includingforthebenefitofoneormorewelldefinedpersonswhoarenotemployeesoftheCompany)orthroughcontributionsinkind,withissuanceofshares,warrantsorconvertiblebonds,subject to the terms and conditions provided for in theBelgianCompanyCode.TheBoardofDirectors canexercisethispowerforthesameperiodasmentionedabove.
At the date of this document, the Board of Directors hasnot used the above described (renewed) powers under theauthorizedcapital.
4.4. AuthorizedCapitalBy virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the Boardof Directors has been expressly authorized to increase theshare capital in one ormore transactionswith an amountofuptoEUR10,517,661.90(the“AuthorizedCapitalAmount”),subject to certain limitations and conditions describedbelow.TheBoard ofDirectors can exercise this power for aperiodstartingonthedateofthepublicationoftherelevantresolutionoftheextraordinarygeneralshareholders'meetingintheAnnexestotheBelgianOfficialGazetteandendingonthe date of the annual general shareholders' meeting tobeheld in2012which shall resolveon theannualaccountsrelatingtotheaccountingyearendingonDecember31,2011.Thisauthorizationmaybe renewed inaccordancewith therelevantlegalprovisions.
The capital increases towhich canbedecidedaccording tothis authorization, can take place in accordance with themodalities thatare tobedecidedby theBoardofDirectors,includingbymeansofcontributionincashorinkind,withinthelimitsaspermittedbytheBelgianCompanyCode,throughconversion of reserves and issuance premiums, with orwithoutissuanceofnewshares,withorwithoutvotingrights,throughissuanceofconvertiblebonds,subordinatedornot,throughissuanceofwarrantsorbondstowhichwarrantsorothertangiblevaluesareattached,and/orthroughissuanceofothersecurities,suchassharesintheframeworkofastockoptionplan.
Intheframeworkoftheuseofitspowerswithintheframeworkoftheauthorizedcapital,theBoardofDirectorscanlimitorcancelthepreferentialsubscriptionrightoftheshareholdersin the interest of the Company, subject to the limitationsand in accordancewith the conditions provided for by theBelgian Company Code. This limitation or cancellation canalsooccur to thebenefitof theemployeesof theCompanyand its subsidiaries, and, to the extent permitted by law,to thebenefit of oneormore specificpersons thatarenotemployeesoftheCompanyoritssubsidiaries.
ThepoweroftheBoardofDirectorstoincreasetheshareissubjecttothefollowingspecialrestrictionsandconditions:
TheBoardofDirectorsisauthorizedtoincreasethesharea.capitalforwhateverpurposeorwhatevertransactionthatthe Board of Directors deems appropriate or necessaryprovidedandtotheextentthatthetotalamountoffundsraised (consisting of capital contribution and issuancepremium)doesnotexceedEUR18,000,000.
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The shareholders canalsodecide toauthorize theBoardofDirectorstolimitorcancelthepreferentialsubscriptionrightwithintheframeworkoftheauthorizedcapital,subjecttothetermsandconditionssetforthintheBelgianCompanyCode.
4.5.3. VotingRights
EachshareholderoftheCompanyisentitledtoonevotepershare. There are no different categories of shares. Votingrightscanbesuspendedinrelationtoshares:
whichwerenotfullypaidup,notwithstandingtherequest•theretooftheBoardofDirectorsoftheCompany;towhichmore than oneperson is entitled, except in the•eventasinglerepresentativeisappointedfortheexerciseofthevotingright;which entitle their holder to voting rights above the•threshold of 3%, 5%, or any multiple of 5% of the totalnumber of voting rights attached to the outstandingfinancial instrumentsof theCompanyon thedateof therelevantgeneralshareholders’meeting,exceptintheeventwheretherelevantshareholderhasnotifiedtheCompanyandtheCBFAatleast20dayspriortothedateofthegeneralshareholders’meetingonwhichheorshewishestovoteofitsshareholdingexceedingthethresholdsabove;andofwhich thevotingrightwassuspendedbyacompetent•courtortheCBFA.
4.5.4. RightstoParticipateandVoteatShareholder’sMeetings
Annualgeneralshareholders’meetingThe annual general shareholders’ meeting is held at theregisteredofficeoftheCompanyorattheplacedeterminedin the notice convening the shareholders’ meeting. Themeeting is held every year on the last Friday ofMay at 10a.m.Attheannualgeneralshareholders’meeting,theBoardofDirectorssubmitstheauditedstatutoryandconsolidatedfinancial statements and the reports of the Board ofDirectors andof the statutory auditorwith respect theretototheshareholders.Theshareholders’meetingsubsequentlydecidesontheapprovalofthestatutoryfinancialstatements,theproposedallocationof theCompany’sprofitor loss, thedischarge from liability of the directors and the statutoryauditor, and, when applicable, the (re-)appointment orresignationof thestatutoryauditorand/orofallor certaindirectors and their remuneration. Other items may alsobe put on the agenda of the annual general shareholders’meetingfortheshareholderstoresolveupon.Inaddition,asrelevant,theannualgeneralshareholders'meetingmustalso
4.5. RightsAttachedtoShares4.5.1. DividendRights
AllsharesparticipateinthesamemannerintheCompany’sprofits (if any). Pursuant to theBelgianCompanyCode, theshareholders can in principle decide on the distribution ofprofits with a simple majority vote at the occasion of theannual general shareholders’ meeting, based on the mostrecent audited statutory financial statements, preparedin accordance with the generally accepted accountingprinciplesinBelgiumandbasedona(non-binding)proposaloftheCompany’sBoardofDirectors.TheCompany’sarticlesof association also authorize the Board of Directors toissue interim dividends on profits of the current financialyear subject to the terms and conditions of the BelgianCompanyCode.
DividendscanonlybedistributediffollowingthedeclarationandissuanceofthedividendstheamountoftheCompany’snet assets on the date of the closing of the last financialyearasfollowsfromthestatutoryfinancialstatements(i.e.,the amount of the assets as shown in the balance sheet,decreasedwith provisions and liabilities, all as prepared inaccordance with Belgian accounting rules), decreased withthenon-amortizedcostsofincorporationandextensionandthenon-amortizedcostsforresearchanddevelopment,doesnot fallbelowtheamountof thepaid-upcapital, increasedwith the amount ofnon-distributable reserves. In addition,priortodistributingdividends,5%ofthenetprofitsmustbeallottedtoalegalreserve,untilthelegalreserveamountsto10%ofthesharecapital.
The right to payment of dividends on registered anddematerialized shares expires five years after the Board ofDirectorsdeclaredthedividendpayable.
4.5.2. PreferentialSubscriptionRights
In theeventofacapital increase incashwith issueofnewshares, or in the event of an issue of convertible bonds orwarrants, the shareholders have a preferential right tosubscribetothenewshares,convertiblebondsorwarrants,prorataofthepartofthesharecapitalrepresentedbythesharesthattheyalreadyhave.Thegeneralshareholders’meetingcandecidetolimitorcancelthispreferentialsubscriptionright,subject to special reporting requirements. Such decisionneedstosatisfythesamequorumandmajorityrequirementsasthedecisiontoincreasetheCompany’ssharecapital.
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are personally notified by letter at least 15 days prior tothemeeting.
FormalitiestoattendthegeneralmeetingAll holders of shares, warrants or bonds (if any) issued bythe Company can attend shareholders’ meetings. Onlyshareholders,however,canvoteatshareholders’meetings.Inordertoattendthegeneralshareholders’meeting,holdersofdematerializedinstrumentsmustdepositacertificateissuedbyarecognizedaccountholderwiththeclearingagencyforthe financial instrumentsconcernedor theclearingagencyitself, confirming thenumberof financial instruments thathave been registered in the name of the holder concernedandstatingthatthesefinancialinstrumentsareblockeduntilafter the date of the generalmeeting.The certificatemustbedepositedattheCompany’sregisteredofficeoranyotherplace indicated in the notice convening the shareholders’meetingatthelatestfourbusinessdayspriortothemeeting.Holdersofbearerinstrumentsinphysicalformmustdeposittheir financial instruments at the Company’s registeredoffice or any other place indicated in the notice conveningtheshareholders’meetingwithinthesameterm.Holdersofregistered instruments must be registered in the relevantregister book and, where applicable, can be requested toinformtheBoardofDirectorsatthelatestfourbusinessdayspriortotheshareholders’meetingwhethertheywillattendtheshareholders’meeting.
RegistrationdateThearticlesofassociationalsoallow theBoardofDirectorsto specify a registration date in the notice convening theshareholders’meeting.IftheBoardofDirectorsdecidestosetaregistrationdateinthenotice,onlyshareholderswhohavesharesat24:00hours(CentralEuropeanTime,GMT+1)ontheregistrationdatemayparticipateandvotewithsuchsharesat the shareholders’ meeting, regardless of the number ofsharesthattheyholdontheactualdateoftheshareholders’meeting.Thespecifiedregistrationdatecanbenoearlierthan15calendardays,andnolaterthan5businessdays,beforethedateof the shareholders’meeting. If theBoardofDirectorsdecides to seta registrationdate, thenotice convening theshareholders’meetingmustbepublished(i)intheAnnexestotheBelgianOfficialGazette,(ii)anewspaperwithnationwidedistribution in Belgiumand (iii) thewebsite ofMDxHealthatleast24dayspriortotheregistrationdate(or,ifasecondmeetingisrequiredandifthedateofthesecondmeetingwasmentionedinthenoticeconveningthefirstmeeting,atleast17dayspriortotheregistrationdateforthesecondmeeting).
decide on the approval of provisions of service agreementstobeenteredintowithexecutivedirectors,membersof themanagement committee and other executives providing(as the casemay be) for severance payments exceeding 12months' remuneration (or, subject to a motivated opinionby theremunerationcommittee, 18months' remuneration).Asfromtheannualmeetingtobeheldin2012,shareholders'meetingmustalsodecideseparatelyontheapprovaloftheremunerationreportincludedintheannualreport.
Specialandextraordinarygeneralshareholders’meetingsThe Board ofDirectors or the statutory auditor can, at anygiven time when the interest of the Company so requires,convene a special or extraordinary general shareholders’meeting.Suchshareholders’meetingmustalsobeconvenedevery time one ormore shareholders holding at least 20%of the Company’s share capital so demand. Shareholdersthatdonotholdatleast20%oftheCompany’ssharecapitaldo not have the right to have the general shareholders’meetingconvened.Shareholdersthatholdatleast5%oftheCompany’s share capital can,however, submit to theBoardof Directors proposals to add or amend agenda items forthegeneral shareholders’meeting. Suchproposalsmustbesubmitted sufficiently in advance to the convening of thegeneralshareholders’meeting.
NoticesconveningthegeneralmeetingThenoticeconveningthegeneralshareholders’meetingmustindicate the agenda, place, date, and time of themeeting,and theproposedresolutions thatwillbesubmitted to themeeting.Themeeting cannotdeliberateandvoteon itemsthatarenotmentionedontheagenda,unlessallshareholdersarepresentorrepresentedanddecideunanimouslytoplacesuch itemson the agenda. In the absence of a registrationdate (see below), the notice must be published in (i) theAnnexestotheBelgianOfficialGazette,(ii)anewspaperwithnationwide distribution in Belgium and (iii) the websiteofMDxHealthat least24daysprior to themeeting (or, ifasecond meeting is required and if the date of the secondmeeting was mentioned in the notice convening the firstmeeting,atleast17dayspriortotheregistrationdateforthesecondmeeting).ApublicationintheAnnexestotheBelgianOfficialGazetteandonthewebsiteofMDxHealthsufficesfornoticesconveningtheannualgeneralshareholders’meetingif suchmeeting takesplace in Liègeandon theplace,dateandhour referred to above and if the agenda is limited tothe submission of the financial statements, the reports oftheBoardofDirectorsandstatutoryauditorrelatingthereto,andthedischargefromliabilityofthedirectorsandstatutoryauditor.Theholdersofregisteredshares,warrantsandbonds
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relevant competition authorities, where such approval islegallyrequiredfortheacquisitionofMDxHealth.
Inaddition,as soonasapersonorgroupofpersonsactingin concert, holdingmore than 30% of the voting securitiesissuedbyMDxHealthwould(whetherthroughanacquisitionor a subscription etc.) be holding more than 30% of thevotingrightbearingsecurities,theoutstandingvotingrightsbearingorvotingrightsconferringsecuritiesofMDxHealthwill become subject to a takeoverbid, at aprice compliantwiththeprovisionsoftheBelgiantakeoverlegislation.
There are several provisions of Belgian Company law andcertainotherprovisionsofBelgianlaw,suchastheobligationto disclose important shareholdings (see under Section 4.7below)andmergercontrol,thatmayapplytoMDxHealthandwhichmaymakeanunfriendlytenderoffer,merger,changeinmanagementorotherchangeincontrol,moredifficult.TheseprovisionscoulddiscouragepotentialtakeoverattemptsthatothershareholdersmayconsidertobeintheirbestinterestandcouldadverselyaffectthemarketpriceoftheCompany’sshares.Theseprovisionsmayalsohavetheeffectofdeprivingtheshareholdersoftheopportunitytosell theirsharesatapremium.
Inaddition,theBoardofDirectorsofBelgiancompaniesmayincertaincircumstances,andsubject topriorauthorizationby the shareholders, deter or frustrate public takeover bidsthrough dilutive issuances of equity securities (within theframeworkoftheauthorizedcapital–seeSection4.4above)orthroughsharebuy-backs(i.e.,purchaseofownshares).
Normally, the authorization of the Board of Directors toincrease the share capital of the Company within theauthorized capital through contributions in cash withcancellation or limitation of the preferential right of theexistingshareholders issuspendedasof thenotification tothe Company by the CBFA of a public takeover bid on thesecuritiesoftheCompany.Thegeneralshareholders’meetingcan,however,authorizetheBoardofDirectorstoincreasethesharecapitalbyissuingsharesinanamountofnotmorethan10%oftheexistingsharesoftheCompanyatthetimeofsuchapublic takeoverbid. SuchauthorizationhasbeengrantedtotheBoardofDirectorsoftheCompanybydecisionoftheextraordinaryshareholders’meetingonFebruary18,2011.
The Board of Directors ofMDxHealthwas not granted theauthorizationtopurchaseownsharesincaseofathreateningseriousdisadvantagetotheCompany.
PowerofattorneyEachshareholderhastherighttoattendageneralshareholders’meetingandtovoteatthegeneralshareholders’meetinginpersonorthroughaproxyholder.Theproxyholderdoesnotneedtobeashareholder.TheBoardofDirectorscanrequesttheparticipantstothemeetingtouseamodelofpowerofattorney(withvotinginstructions),whichmustbedepositedattheCompany’sregisteredofficeatleastfourbusinessdayspriortothemeeting.
QuorumandmajoritiesIn general, there is no quorum requirement for a generalshareholders’ meeting and decisions are generally passedwith a simple majority of the votes of the shares presentand represented. Capital increases not decided by theBoard ofDirectorswithin the framework of the authorizedcapital,decisionswithrespecttotheCompany’sdissolution,mergers,de-mergersandcertainotherreorganizationsoftheCompany,amendments to thearticlesofassociation (otherthananamendmentof thecorporatepurpose),andcertainothermattersreferredtointheBelgianCompanyCodedonotonlyrequirethepresenceorrepresentationofatleast50%ofthesharecapitaloftheCompanybutalsotheapprovalofatleast75%ofthevotescast.AnamendmentoftheCompany’scorporatepurpose, requires theapprovalofat least80%ofthe votes cast at a general shareholders’ meeting, whichinprinciple canonly validlypass such resolution if at least50%of the share capital of theCompany andat least 50%of the profit certificates, if any, are present or represented.In the eventwhere the required quorum is not present orrepresented at the first meeting, a second meeting needsto be convened through a new notice. The second generalshareholders’ meeting can validly deliberate and decideregardlessofthenumberofsharespresentorrepresented.
4.6. Anti-TakeoverProvisions4.6.1. Takeoverbids
PublictakeoverbidsonMDxHealth’ssharesandothervotingsecurities(suchaswarrantsorconvertiblebonds,ifany)aresubject to thesupervisionby theCBFA.Public takeoverbidsmustbemadeforallofMDxHealth’svotingsecurities,aswellasforallothersecurities thatentitle theholders thereof tothe subscription to, the acquisition of or the conversion innewvoting securities. Prior tomakingabid, abiddermustissueanddisseminateaprospectus,whichmustbeapprovedby the CBFA. The bidder must also obtain approval of the
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4.7. NotificationofImportantParticipation
The Belgian Company Code, applicable legislation and theCompany’sarticlesofassociationprovidethateverynaturalpersonorlegalentityacquiringortransferringsharesorotherfinancial instruments of a listed company that entitle theholderthereoftovotingrights,whetherornotrepresentingtheCompany’ssharecapital(suchaswarrants,stockoptions,or automatic convertible bonds, if any),must , within fourEuronext business days following the transaction, notifytheCompanyandtheCBFAofthetotalnumberoffinancialinstrumentsthatheorsheholdseachtimewhere,asaresultof the acquisition or transfer, the total number of votingfinancial instruments exceeds or falls belowa threshold of3%,5%,10%or15%(oreverysubsequentmultipleof5%)ofthetotalnumberoffinancialinstrumentsoftheatthemomentofthetransaction.
Allpersonsactingindividuallymustmakethenotification.Itmustalsobemadebyaffiliatedpersonsorpersonsactinginconcertwithrespecttotheholding,acquisitionortransferofvotingfinancialinstruments.Inthatevent,thevotingfinancialinstruments of the affiliated persons or persons acting inconcertmustbe combined for thepurposeof determiningwhether a threshold is passed. The forms to make theaforementioneddisclosures,aswellas furtherexplanationscanbefoundonthewebsiteoftheCBFA(www.cbfa.be).
The CBFA and the commercial court can suspend votingrightsattachedtovotingfinancialinstrumentsthathavenotbeendisclosed inaccordancewith theforegoingprovisions.Inaddition, thepresidentof the commercial court canalsoorder the saleof the financial instruments toa thirdparty.In any event, shareholders cannot vote at shareholders’meetingswithmorevotingrightsthantheyhavenotifiedinaccordancewith theabove rulesat least 20daysprior toashareholders’meeting.
4.6.2. Squeezeout
Pursuanttoarticle513of theBelgianCompanyCode,or theregulations promulgated thereunder, a person or entity,or different persons or entities acting alone or in concert,who,togetherwiththeCompany,own95%ofthesecuritiesconferringvotingrightsinapubliccompany,canacquirethetotalityof thesecuritiesconferring (potential) voting rightsin that company following a squeeze-out offer. The sharesthatarenotvoluntarilytenderedinresponsetosuchofferaredeemedtobeautomaticallytransferredtothebidderattheendof theprocedure.At theendof theoffer, theCompanyisnolongerdeemedapubliccompany,unlessbondsissuedby the Company are still spread among the public. Theconsideration for the securitiesmust be in cash andmustrepresent thefairvalueas tosafeguard the interestsof thetransferringshareholders.
4.6.3. Sell-outRight
Holdersofsecuritiesconferring(potential)votingrightsmayrequireanofferorwho,actingaloneorinconcert,followingatakeoverbid,owns95%ofthevotingcapitalor95%ofthesecuritiesconferringvotingrightsinapubliccompanytobuytheir securities at the price of the bid, upon the conditionthat the offeror has acquired, through the bid, securitiesrepresentingatleast90%ofthevotingcapitalsubjecttothetakeoverbid.
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outstandingwarrantsunderthisstockoptionplanto16,633at December 31, 2007. In the course of 2008, 8,125 of thesewarrantswere exercised, bringing the total of outstandingwarrantsunderthisstockoptionplanto8,508atDecember31,2008.Inthecourseof2009,4,508ofthesewarrantswereexercisedand4,000ofthesewarrantsexpiredwithoutbeingexercisedandwerethusterminated.AtDecember31,2008,allwarrantsunderthisplanhavebeenexercisedorterminated.Nowarrantsremainexercisableorgrantableunderthisstockoptionplan.
On July 12, 2005, the Company’s Board of Directors issued15,000 warrants pursuant to a stock option plan in theframeworkoftheauthorizedcapital.Allthesewarrantsweregranted for free to employees, directors and independentserviceprovidersof theCompanyand its subsidiaries. Eachwarrant entitles its holder to subscribe to one commonshare of the Company at a subscription price equal to thesubscription price paid at the occasion of themost recentcapitalincreaseprecedingtheissuanceofthewarrants.Thewarrants have a term of 5 years. They become exercisablein cumulative tranches of 25%per year, i.e., 25%as of theirissuance,50%asof thefirstanniversarydate,75%asof thesecondanniversarydateand100%asofthethirdanniversarydate of the issuance, provided that the beneficiary hasprovidedatleastoneyearofservice.15,000ofthesewarrantshavebeengrantedtothebeneficiariesunderthestockoptionplan. During the course of 2007, 9,900 of these warrantswere exercised, bringing the total of outstandingwarrantsunder this stockoptionplan to5,100atDecember31, 2007.Inthecourseof2008,2,500ofthesewarrantswereexercised,
4.9. WarrantsThissectionprovidesanoverviewoftheoutstandingwarrantsasofDecember31,2010.Thewarrantswerecreatedwithinthecontextofstockbasedincentiveplansforemployees,directorsandconsultantsoftheCompany.
OnMay12,2004,theshareholders’meetingoftheCompanyissued 30,000 warrants pursuant to a stock option plan.Accordingtothisstockoptionplan,thewarrantsaregrantedfor free to employees, directors and independent serviceprovidersoftheCompanyanditssubsidiaries.EachwarrantentitlesitsholdertosubscribetoonecommonshareoftheCompany at a subscription price equal to the subscriptionpricepaidattheoccasionofthemostrecentcapitalincreasepreceding the issuance of thewarrants.Thewarrants havea term of 5 years. They become exercisable in cumulativetranches of 25% per year, i.e., 25% as of their issuance,50% as of the first anniversary date, 75% as of the secondanniversarydateand100%asof the thirdanniversarydateoftheissuance,providedthatthebeneficiaryhasprovidedatleastoneyearofservice.29,750ofthesewarrantshavebeengrantedtothebeneficiariesunderthestockoptionplan.The250 remainingwarrants became null and void on June 30,2004.Inthecourseof2006,500warrants(outofthe29,750thatweregranted)weremoreovercancelled(technically,havebecome definitively unexercisable) following the departureof an employee of OncoMethylome Sciences BV, bringingthe total of outstanding warrants under this stock optionplan to29,250atDecember 31, 2006. In the courseof 2007,12,617ofthesewarrantswereexercised,bringingthetotalof
4.8. ShareholdershipThe table belowprovides an overview of the shareholders that have notified the Company of their ownership ofMDxHealthsecurities.TheoverviewisbasedonthemostrecenttransparencydeclarationssubmittedtotheCompany.
Shareholder(orPartyrepresentingshareholders)
Numberofshares
%ofoutstanding
sharesSituation
asofNotification
received
IDinvestPartners(ex-AGFPrivateEquity) 794,912 6.03% Dec18,2008 Dec18,2008APGAlgemenePensioenGroepNV 559,102 4.24% Feb3,2010 Feb10,2010LifeSciencesPartnersIIBV 1,411,195 10.70% Sept1,2008 Oct17,2008EdmonddeRothschildInvestmentPartners 1,263,915 9.59% Dec18,2008 Dec18,2008INGBelgiumNV/SA(privateequitydept) 2,147,610 16.29% Aug4,2009 Aug42009FortisInvestmentManagement 481,539 3.65% Mar13,2009 Mar16,2009TotalofNotifiedShares 6,658,273 50.50%TotalOutstandingShares 13,185,614 100.00%
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Attheshareholders’meetingofMay23,2006,itwasdecidedthat, as a result of the stock-split, each existingwarrant atthatdate,upontheexercisethereof,wouldentitletheownerthereoftofive(5)newshares.
OnNovember8, 2006, theBoardofDirectors issued47,500warrants under the framework of the authorized capitalfor the benefit of the employees of the Company and itssubsidiaries.EachwarrantentitlesitsholdertosubscribetooneshareoftheCompany.ThewarrantsaregrantedforfreeandcanbeexercisedatapriceequaltotheaverageclosingpriceoftheCompany’ssharesaslistedonEuronextBrusselsduringatermof30dayspriortothedateoftheirgrant,oranyotherpricedeterminedbytheBoardofDirectors.Theexercisepricecan,however,neverbelowerthanthefractionalvalueoftheshares.Thewarrantshaveatermof10yearsandbecomeexercisableincumulativetranchesof25%peryear,providedthatthebeneficiaryhasprovidedatleastoneyearofservice.All47,500warrantshavebeengrantedandaccepted.Duringthe course of 2007, 938 of these warrants were cancelled(technically, have become definitively unexercisable)followingthedepartureofthebeneficiariespriortovestingofthewarrants.Alsoduringthecourseof2007,187ofthesewarrantswere exercised, bringing the total of outstandingwarrantsunderthisstockoptionplanto46,375atDecember31,2007.Duringthecourseof2008,nofurtherwarrantswerecancelled nor exercised, leaving the total of outstandingwarrantsunchangedat46,375atDecember31,2008.Duringthe course of 2009, no further warrants were cancelledand no further warrants were exercised, leaving the totalof outstanding warrants at 46,375 at December 31, 2009.During the course of 2010, 2,718 warrants were cancelledand no further warrants were exercised, leaving the totalofoutstandingwarrantsat43,657atDecember31,2010.Nowarrantsremaingrantableunderthisstockoptionplan.
OnApril18,2007,theBoardofDirectorsissued55,100warrantsundertheframeworkoftheauthorizedcapitalforthebenefitof theemployeesof theCompanyanditssubsidiaries.Eachwarrant entitles itsholder to subscribe toone shareof theCompany. The warrants are granted for free and can beexercisedatapriceequaltotheaverageclosingpriceoftheCompany’s shares as listed on Euronext Brussels during atermof30dayspriortothedateoftheirgrant.Thewarrantshaveatermof10yearsandbecomeexercisableincumulativetranchesof 25%per year, provided that thebeneficiaryhasprovided at least one year of service. All 55,100 warrantshavebeengrantedandaccepted.Duringthecourseof2007,
bringingthetotalofoutstandingwarrantsunderthisstockoptionplanto2,600atDecember31,2008. In thecourseof2009, none of thesewarrantswere exercised, bringing thetotal of outstandingwarrantsunder this stock optionplanto 2,600atDecember 31, 2009. In the course of 2010, noneof these warrants were exercised, and the non-exercisedwarrantsexpiredbringingthetotalofoutstandingwarrantsunderthisstockoptionplantozeroatDecember31,2010.Nowarrants remain exercisable or grantable under this stockoptionplan.
OnMarch 8, 2006, the Board of Directors of the Companyapproved an additional stock option plan providing forthe issuance of up to 66,700 warrants of the Company.The warrants are granted for free to employees, directorsand independent service providers of theCompany and itssubsidiaries.Eachwarrantentitlesitsholdertosubscribetoonecommonshareof theCompanyata subscriptionpriceequal to the subscription price paid at the occasion of themost recent capital increase preceding the issuance of thewarrants.Thewarrantshaveatermof10years.Theybecomeexercisable incumulative tranchesof25%peryear, i.e., 25%asoftheirissuance,50%asofthefirstanniversarydate,75%asof thesecondanniversarydateand 100%asof the thirdanniversarydateoftheissuance,providedthatthebeneficiaryhas provided at least one year of service.The shareholders’meetingoftheCompanyhasissued66,700warrantspursuanttothisstockoptionplanonMarch22,2006.Allthese66,700warrants have beengranted to the beneficiariesunder thestockoptionplan.Duringthecourseof2007,2,000ofthesewarrantswerecancelled(technically,havebecomedefinitivelyunexercisable) following the departure of the beneficiariesprior to thevestingof thewarrants.Alsoduring thecourseof2007,24,100ofthesewarrantswereexercised,bringingthetotalofoutstandingwarrantsunderthisstockoptionplanto40,600atDecember31,2007.Duringthecourseof2008,1,337additionalwarrantswerecancelledand5,474wereexercised,bringingthetotalofoutstandingwarrantsunderthisstockoptionplanto33,789atDecember31,2008.Duringthecourseof 2009, 1,100 additionalwarrantswere cancelled and 400were exercised, bringing the total of outstandingwarrantsunderthisstockoptionplanto32,288atDecember31,2009.During the course of 2010, nowarrantswere exercised norcancelled,bringingthetotalofoutstandingwarrantsunderthis stock option plan to 32,288 at December 31, 2010. Nowarrantsremaingrantableunderthisstockoptionplan.
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2009, 8,625 of thesewarrantswere cancelled, bringing thetotal of outstandingwarrantsunder this stock optionplanto 39,500atDecember 31, 2009.During the courseof 2010,7,188warrantswerecancelledandnofurtherwarrantswereexercised,leavingthetotalofoutstandingwarrantsat32,312atDecember 31, 2010.Nowarrants remaingrantableunderthisstockoptionplan.
On January 27, 2009, the Board of Directors issued 120,500warrants under the framework of the authorized capitalfor the benefit of the employees of the Company and itssubsidiaries.EachwarrantentitlesitsholdertosubscribetooneshareoftheCompany.ThewarrantsaregrantedforfreeandcanbeexercisedatapriceequaltotheaverageclosingpriceoftheCompany’ssharesaslistedonEuronextBrusselsduringatermof30dayspriortothedateoftheirgrant.Thewarrants have a term of 10 years and become exercisablein cumulative tranches of 25% per year, provided that thebeneficiaryhasprovidedatleastoneyearofservice.116,600warrants have been granted and accepted. The remaining3,900warrants became null and void on January 27, 2009.During the course of 2010, 22,657 warrants were cancelledand no further warrants were exercised, leaving the totalofoutstandingwarrantsat93,943atDecember31,2010.Nowarrantsremaingrantableunderthisstockoptionplan.
OnJune21,2010,theshareholders’meetingoftheCompanyissued145,000warrantstodirectorsoftheCompanypursuantto a stock option plan. Each warrant entitles its holder tosubscribe to one share of the Company. The warrants aregrantedforfreeandcanbeexercisedatapriceequaltotheaverage closing price of the Company’s shares as listed onEuronextBrusselsduringatermof30dayspriortothedateoftheirgrant.Thewarrantshaveatermof5yearsandbecomeexercisableincumulativetranchesof25%peryear,providedthatthebeneficiaryhasprovidedatleastoneyearofservice.All 145,000warrants have been granted and accepted. Thetotaloutstandingwarrantsunderthisstockoptionplanwere145,000atDecember31,2010.Nowarrantsremaingrantableunderthisstockoptionplan.
125 of thesewarrants were exercised, bringing the total ofoutstandingwarrantsunderthisstockoptionplanto54,975atDecember31,2007.Duringthecourseof2008,3,812warrantswerecancelled,bringingthetotalofoutstandingwarrantsto51,163atDecember31,2008.During thecourseof2009,738warrantswere cancelled, bringing the total of outstandingwarrantsto50,425atDecember31,2009.Duringthecourseof2010,6,314warrantswerecancelledandnofurtherwarrantswereexercised,leavingthetotalofoutstandingwarrantsat44,111 at December 31, 2010. No warrants remain grantableunderthisstockoptionplan.
OnMay25,2007,theshareholders’meetingoftheCompanyissued50,000warrantstodirectorsandaconsultantoftheCompany pursuant to a stock option plan. Each warrantentitlesitsholdertosubscribetooneshareoftheCompany.Thewarrantsaregrantedforfreeandcanbeexercisedataprice equal to the average closing price of the Company’ssharesaslistedonEuronextBrusselsduringatermof30dayspriortothedateoftheirgrant.Thewarrantshaveatermof5yearsandbecomeexercisableincumulativetranchesof25%peryear,providedthatthebeneficiaryhasprovidedatleastone year of service. All 50,000warrants have beengrantedand accepted. The total outstanding warrants under thisstockoptionplanwere50,000atDecember31,2009.Duringthe course of 2010, 10,313 warrants were cancelled and nowarrants were exercised, leaving the total of outstandingwarrantsat39,687atDecember31,2010.Nowarrantsremaingrantableunderthisstockoptionplan.
OnMay30,2008,theBoardofDirectorsissued61,000warrantsundertheframeworkoftheauthorizedcapitalforthebenefitof theemployeesof theCompanyanditssubsidiaries.Eachwarrant entitles itsholder to subscribe toone shareof theCompany. The warrants are granted for free and can beexercisedatapriceequaltotheaverageclosingpriceoftheCompany’s shares as listed on Euronext Brussels during atermof30dayspriortothedateoftheirgrant.Thewarrantshaveatermof10yearsandbecomeexercisableincumulativetranchesof 25%per year, provided that thebeneficiaryhasprovidedat leastoneyearof service.49,000warrantshavebeengrantedandaccepted.Theremaining12,000warrantsbecame null and void onMay 30, 2008. During the courseof 2008, 875 of these warrants were cancelled, bringingthe total of outstanding warrants under this stock optionplan to 48,125 at December 31, 2008. During the course of
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Thetablebelowgivesanoverview(asatDecember31,2010)ofthestockoptionplansdescribedabove.Thetableshouldbereadtogetherwiththenotesreferredtobelow.
Grant Issuedate Grantdate Term(years)
Numberof
warrantsissued(1)
Numberofwarrants
granted(1)
Numberofwarrants
exercised(1)
Exerciceprice
(EUR)(2)Cancelled
warrants(3)Outstanding
warrants
2004 May12 May12 5 150,000 148,750 126,250 4,46 22,500 02005 July12 July12 5 75,000 75,000 62,000 4,77 13,000 0
2006(I) March22 March22 10 333,500 333,500 149,870 4,80 22,190 161,4402006(II) November8 October2 10 47,500 47,500 187 7,72 3,656 43,6572007(I) April18 January4 10 55,100 55,100 125 10,87 10,864 44,1112007(II) May25 May25 5 50,000 50,000 0 11,42 10,313 39,6872008 May30 May30 10 61,000 49,000 0 9,10 28,688 32,3122009 January27 January2 10 120,500 116,600 0 6,32 26,557 93,9432010 June21 June21 5 145,000 145,000 0 2,07 0 145,000
Total 1,037,600 1,020,450 338,432 137,768 560,150(1) Foreasyreference,thenumberofwarrantshasalreadybeenmultipliedbyfive(5)totakeintoaccountthe5-for-1stocksplitimpactingonlywarrantsgrantedandcreated
beforeMay2006.Asaconsequenceofthestocksplit,one(1)warrantwillentitletheownerthereoftofive(5)shares.
(2)Foreasyreference,theexercisepricehasalreadybeendividedbyfive(5)totakeintoaccountthe5-for-1stocksplitimpactingonlywarrantsgrantedandcreated
beforeMay2006.
(3)Cancelledduetonon-grantofcertainwarrantsorduetodepartureofbeneficiarypriortovestingofwarrants.
4.10.OutstandingfinancialinstrumentsThetablebelowprovidesanoverviewoftheissuedandoutstandingvotingfinancialinstrumentsatDecember31,2010.Thenumbersbelowtakeintoaccountthestocksplit(sharesandwarrants)decideduponbytheshareholders’meetingofMay23,2006.
Numberofvotingrights(A)Actualvotingrightsattachedto:SharesissuedpriortoJanuary1,2010 13,185,614TotalA 13,185,614
(B)Potentialfuturevotingrightsattachedtosharesrepresentingthesharecapitaltobeissuedupontheexerciseofwarrantsthathavealreadyvested:
WarrantsissuedonMay12,2004 0WarrantsissuedonJuly12,2005 0WarrantsissuedonMarch22,2006 161,400WarrantsissuedonNovember8,2006 43,657WarrantsissuedonApril18,2007 42,594WarrantsissuedonMay25,2007 37,187WarrantsissuedonMay30,2008 21,812WarrantsissuedonJanuary27,2009 48,661WarrantsissuedonJune21,2010 0TotalB 355,351Total(A)+(B) 13,540,965
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(C)Potentialfuturevotingrightsattachedtosharesrepresentingthesharecapitaltobeissuedupontheexerciseofwarrantsthathavenotyetvestedandarestillconditional:
WarrantsissuedonMay12,2004 0WarrantsissuedonJuly12,2005 0WarrantsissuedonMarch22,2006 0WarrantsissuedonNovember8,2006 0WarrantsissuedonApril18,2007 1,517WarrantsissuedonMay25,2007 2,500WarrantsissuedonMay30,2008 10,500WarrantsissuedonJanuary27,2009 45,282WarrantsissuedonJune21,2010 145,000TotalC 204,799Total(A)+(B)+(C) 13,745,764
Asmentioned in section 3.2.4.5, the Company has in 2010 entered into commitments to create and issue up to 195,000newwarrants.Atthedateofthisdocument,these195,000newwarrantshavenotyetbeencreatednorissued(andarenotincludedintheabovetable).
4.11. PayingAgentServicesThefinancialserviceforthesharesoftheCompanyisprovidedbyINGBank.Shareholdersshouldinformthemselvesaboutthecoststhatotherfinancialintermediariesmaychargeinconnectionwithpayingagencyservices.
4.12.SharePriceEvolutionMDxHealthsharepriceevolutionin2010isillustratedinthetablebelow.
Thetablebelowdepictsthehighestandlowestquarterlysharepriceandtheaveragedailyvolumein2010.
MDxHealth(Brussels+Amsterdam) 1Q10 2Q10 3Q10 4Q10 FY10HighPrice 4.34EUR 2.83EUR 2.01EUR 1.95EUR 4.34EURLowPrice 2.60EUR 1.69EUR 1.69EUR 1.45EUR 1.45EURAveragedailyvolume 12,736 43,369 28,298 25,673 27,506
1.25
1.75
2.25
2.75
3.25
3.75
4.25
4.75
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5.AuditedConsolidatedFinancialStatements
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AuditedConsolidatedFinancialStatements
5.1. ConsolidatedannualaccountsThe following consolidated accounts are drawn up in accordance with International Financial Reporting Standards (IFRS) asadoptedintheEU.Theaccountingpoliciesandnotesareanintegralpartoftheseconsolidatedfinancialstatements.ThefollowingconsolidatedaccountsdifferfromthestatutoryannualaccountsoftheCompany,whichhavebeenpreparedinaccordancewithBelgianGAAP.
Thefinancialstatementsinthissection5oftheRegistrationDocumenthavebeenapprovedandauthorizedforissuebytheBoardofDirectorsatitsmeetingofFebruary18,2011.ThefinancialstatementshavebeensignedbyDr.JanGroen,executivedirector,onbehalfof theBoardofDirectors.The financial statementswillbesubmitted to theshareholders for their finalapprovalat theannualgeneralshareholders’meetinginMay2011.
5.1.1. Condensedconsolidatedstatementofcomprehensiveincome
YearsendedDecember31ThousandsofEuro(EUR)exceptpershareamounts Notes 2010 2009 2008Productandserviceincome 1,968 1,031 1,403Governmentgrantincome 5.1.5.2 568 1,517 1,621Revenues 2,536 2,548 3,024Costofgoods&servicessold 370 179 243Grossprofit 2,166 2,369 2,781Researchanddevelopmentexpenses 5.1.5.3 6,812 13,089 10,999Selling,generalandadministrativeexpenses 5.1.5.3 3,745 4,011 3,107Otheroperatingincome 131 0 0Otheroperatingexpenses 106 0 1Totaloperatingcharges 10,532 17,100 14,107OperatingProfit(EBIT) (8,366) (14,731) (11,326)Financialincome 5.1.5.5 222 450 1,143Financialexpenses 5.1.5.5 85 20 9Profit/(Loss)beforetaxes (8,229) (14,301) (10,192)Incometaxes 24 0 0NetProfit/(Loss)fortheyearfromcontinuingoperations (8,253) (14,301) (10,192)Profit/(Loss)fortheyearfromdiscontinuedoperations 0 0 0Profit/(Loss)fortheyearfromcontinuingoperations (8,253) (14,301) (10,192)
YearsendedDecember31ThousandsofEuro(EUR)exceptpershareamounts Notes 2010 2009 2008OthercomprehensiveincomeExchangedifferencesarisingontranslationofforeignoperations
6 0 (43)
Othercomprehensiveincomefortheyear(netoftax) 0 0 (43)Totalcomprehensiveprofit/(loss)fortheyear(netoftax) (8,247) (14,301) (10,235)
Basicearningspershare(EPS)EUR 5.1.5.7 Usingweightedaveragenumberofshares (0.63) (1.09) (0.86) Usingendofperiodnumberofshares (0.63) (1.08) (0.77)
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5.1.2. Consolidatedstatementoffinancialposition
ASSETS
YearsendedDecember31ThousandsofEuro(EUR) Notes 2010 2009 2008ASSETSIntangibleassets 5.1.5.8 47 49 1,644Property,plantandequipment 5.1.5.9 579 1,022 1,429Financialassets 5.1.5.10 0 500 500Grantsreceivable(>1year) 5.1.5.12 483 405 1,087Non-currentassets 1,109 1,976 4,660Grantsreceivable(<1year) 5.1.5.12 771 2,674 2,412Tradereceivables 5.1.5.11 1,058 533 369Prepaidexpensesandothercurrentassets 5.1.5.11 888 1,537 1,010Cashandcashequivalents 5.1.5.13 10,593 18,032 30,601Currentassets 13,310 22,776 34,392TOTALASSETS 14,419 24,752 39,052
LIABILITIES&SHAREHOLDERS’EQUITY
YearsendedDecember31ThousandsofEuro(EUR) Notes 2010 2009 2008EQUITYANDLIABILITIESSharecapital 5.1.5.15 10,518 51,089 50,989Issuancepremium 5.1.5.15 10,882 10,882 10,872Accumulatedprofit/(loss) (4,572) (30,842) (20,650)Resultoftheyear (8,253) (14,301) (10,192)Share-basedcompensation 5.1.5.19 2,151 1,981 1,633Translationreserves (3) (9) (9)Totalequity 10,723 18,800 32,643Grantspayable(>1year) 5.1.5.12 483 406 1,088Advanceonroyalties 141 151 164Long-termleasedebt 5.1.5.16 2 0 0Non-currentliabilities 626 557 1,252Currentportionofleasedebt 5.1.5.16. 2 0 1Tradepayables 5.1.5.17 1,556 2,681 2,524Grantspayable(<1year) 5.1.5.12 786 1,162 1,953Othercurrentliabilities 5.1.5.17 726 1,552 679Currentliabilities 3,070 5,395 5,157TOTALEQUITYANDLIABILITIES 14,419 24,752 39,052
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AuditedConsolidatedFinancialStatements
5.1.3. Consolidatedcashflowstatement
YearsendedDecember31ThousandsofEuro(EUR) Notes 2010 2009 2008CASHFLOWSFROMOPERATINGACTIVITIESOperatingProfit/(Loss) (8,366) (14,731) (11,326)Depreciation,amortizationandimpairmentresults 5.1.5.8/9 348 2,298 1,004Share-basedcompensation 5.1.5.19 170 348 281Interestpaid 0 0 (3)(Gain)/Lossondisposaloffixedassets 112Incometaxes (24)(Increase)/decreaseinaccountsreceivable(1) 1,952 (256) 102Increase/(decrease)inaccountpayable(2) (2,321) (457) 629Totaladjustments 237 1,933 2,013Netcashprovidedby/(usedin)operatingactivities (8,129) (12,798) (9,313)CASHFLOWSFROMINVESTINGACTIVITIES(Purchase)/Saleoffinancialassets 5.1.5.10 635 0 (500)Proceedfromsaleoffixedassets 58Interestreceived 5.1.5.5 87 434 1,075Otherfinancialprofit/(loss) 5.1.5.9 (23) (20) 62Purchaseofproperty,plantandequipment 5.1.5.8 (48) (261) (223)Purchaseofintangibleassets (23) (35) (2,033)Netcashprovidedby/(usedin)investingactivities 686 118 (1,619)CASHFLOWSFROMFINANCINGACTIVITIESPaymentsonlong-termleases 0 (1) (2)Proceedsfromissuanceofshares(netofissuecosts) 0 110 8,475Netcashprovidedby/(usedin)financingactivities 0 109 8,473Netincrease/(decrease)incashandcashequivalents (7,443) (12,571) (2,459)Cashandcashequivalentsatbeginningofyear 18,032 30,601 33,103EffectonExchangeratechanges 5.1.5.13 4 2 (43)Cashandcashequivalentsatendofperiod 10,593 18,032 30,601
(1)=longtermgrantsreceivable+shorttermgrantsreceivable+tradereceivables+prepaidexpensesandothercurrentassets
(2)=advanceonroyalties+longtermgrantspayable+tradepayables+shorttermgrantspayable+othercurrentliabilities
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5.1.4. Consolidatedstatementofchangesinshareholders’equity
AttributabletoequityholdersoftheCompany
ThousandsofEuro(EUR) Numberofshares
Sharecapital&issuancepremium
Retainedearnings
Share-basedcompensation
Translationreserves Totalequity
BalanceatJanuary1,2008 11,747,702 53,386 (20,650) 1,352 34 34,122Totalcomprehensiveincome (10,192) (43) (10,235)
Issuanceofshares 1,413,372 8,756 8,756SPOcostsagainstcapital (281) (281)
Share-basedcompensation 281 281BalanceatDecember31,2008 13,161,074 61,861 (30,842) 1,633 (9) 32,643
BalanceatJanuary1,2009 13,161,074 61,861 (30,842) 1,633 (9) 32,643Totalcomprehensiveincome (14,301) 0 (14,301)
Issuanceofshares 24,540 110 110Share-basedcompensation 348 348
BalanceatDecember31,2008 13,185,614 61,971 (45,143) 1,981 (9) 18,800
BalanceatJanuary1,2010 13,185,614 61,971 (45,143) 1,981 (9) 18,800Totalcomprehensiveincome (8,253) 6 (8,247)
Accumulatedlossesagainstcapital
(40,571) 40,571 0
Share-basedcompensation 170 170BalanceatDecember31,2010 13,185,614 21,400 (12,825) 2,151 (3) 10,723
Companyisknownas“DNAMethylation”andhasbeenwidelyconfirmedbytheCompanyandmanyindependentscientists,doctors,andjournalsthroughouttheworld.
Since 2003, MDxHealth has licensed-out a number ofmethylation markers and its technology for specificapplications to third-party commercial laboratories ordiagnostickitcompaniesforthemtodistributetheproduct.These out-licensed products are primarily cancer screeningapplications. Starting in 2010,MDxHealth has retained therights to certainproducts (primarily personalizedmedicineapplications) which it intends to commercialize itself viaa commercial laboratory in the United States. MDxHealthalsoperformsmarkerdiscovery,assaydevelopment,andclinicaltrialtrialsservicesforpharmaceuticalcompaniesinsearchofapotentialcompaniondiagnostictestfortheironcologytherapy.TheMDxHealthgroupofcompanieshasitsparentcompany,headquarters, and main laboratory in Belgium, but alsooperates via threewholly-ownedsubsidiaries in theUnitedStates,BelgiumandTheNetherlands.Theoperatingactivitiesof the Netherlands subsidiary were ceased in the third
5.1.5. Notestoconsolidatedfinancialstatements
5.1.5.1 Generalinformation
MDxHealth SA is a limited liability company incorporatedinBelgium.
MDxHealth is a biotechnology company founded in2003 which is focused on using a novel and proprietarymolecular technology for developing and commercializingproducts and services for personalized oncology medicineto assistphysicianswith thediagnosis of cancer, prognosisof recurrence risk, and prediction of response to a specifictherapy. The Company has in-licensed, discovered andpatentedanextensiveportfoliooftechnologiesandgeneticmarkers which it uses to develop molecular diagnosticproducts and personalizedmedicine tests for the oncologymarket. The research and development work is done bothin-house and through collaboration agreements with anextensiveinternationalnetworkofleadingoncologyexpertsandmedicalcenters.Themolecular technologyusedby the
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AuditedConsolidatedFinancialStatements
AllamountsarepresentedinthousandsofEuros(EUR)unlessotherwiseindicated,roundedtothenearestEUR1.000.
Thefinancialstatementshavebeenpreparedonthehistoricalcost basis. Any exceptions to the historical cost conventionaredisclosedinthevaluationrulesdescribedhereafter.
The financial statements have been established assumingtheCompanyisagoingconcern.TheCompanyhasgeneratedlosses since its inception, which is inherent to the currentstage of the Company’s business life cycle as a biotechcompany. To date, the Company has ended each year withcash, investments available for sale or committed fundingthatexceededmore thanoneyearof cashneeds.Basedonthecurrentcashavailability, theCompanybelieves that thefuture research programs and company activities can beguaranteedformorethanoneyear.
Changesinaccountingpolicyanddisclosures
a)NewandamendedstandardsadoptedbytheGroupDuringthecurrentyear,MDxHealthhasadoptedallthenewand revised Standards and Interpretations issued by theInternational Accounting Standards Board (IASB) and theInternationalFinancialReportingInterpretationsCommittee(IFRIC) of the IASB that are relevant to its operations andeffectivefortheaccountingperiodcommencingonJanuary1,2010.MDxHealthhasnotappliedanynewIFRSrequirementsthatarenotyeteffectivein2010.
ThefollowingnewStandards,InterpretationsandAmendmentsissuedbytheInternationalFinancialReportingInterpretationsCommitteeareeffectiveforthecurrentperiod:
ImprovementstoIFRSs(IssuedinApril2009);•IFRS1(revised2009)additionalexemptionsfor•first-timeadopters;IFRS2(revised2009)Share-basedPayment–Group•Cash-settledShare-basedPaymenttransactions;IFRS3(revised2008)BusinessCombinations•–comprehensiverevisiononapplyingtheacquisitionmethod;IAS27(revised2008)ConsolidatedandSeparate•FinancialStatements–ConsequentialamendmentsarisingfromamendmentstoIFRS3;IAS28(revised2008)InvestmentsinAssociates•–ConsequentialamendmentsarisingfromamendmentstoIFRS3;
quarterof2010upontheirtransfertothelaboratoryfacilitiesinBelgium.MDxHealth’sregisteredandmainadministrativeoffice and assay development facility is based in Liège,Belgium (Tour 5 GIGA, Avenue de l’Hôpital 11, 4000 Liège).MDxHealth, Inc., theCompany’sU.S.subsidiary, is locatedatSuite 310, 2505 Meridian Parkway, Durham, North Carolina27713, United States. MDxHealth PharmacoDx bvba, theCompany’sBelgiansubsidiary, is locatedatTechnologiepark4, VIB Bio-Incubator, 9052 Zwijnaarde/Ghent, Belgium. TheCompany’sNetherlandssubsidiary,OncoMethylomeSciencesBV,hasitslegaladdressatislocatedatTour5GIGA,Avenuedel’Hôpital11,4000Liège.
The consolidated financial statements are presented inEurobecause that is the currencyof theprimaryeconomicenvironmentinwhichtheCompanyoperates.
5.1.5.2 Accountingpolicies
UseofestimatesandjudgmentsMDxHealth’s consolidated financial statements have beenprepared in accordance with the International FinancialReporting Standards (IFRS) as issued by the InternationalAccounting Standards Board (IASB), as adopted by theEuropeanUnionuptoDecember31,2010.
Thepreparationof financialstatements inaccordancewithIFRSsasadoptedbytheEUrequirestheuseofcertaincriticalaccounting estimates and management judgment in theprocessofapplying theCompany’saccountingpolicies thataffects the reported amounts of assets and liabilities anddisclosure of the contingent assets and liabilities at thedateof thefinancialstatementsandthereportedamountsof revenue and expenses during the reporting period. Theareas involvingahigherdegreeof judgmentor complexity,or areas where assumptions and estimates are significanttotheconsolidatedfinancialstatementsaredisclosedinthefollowingNotes:
Note5.1.5.6.:Taxes•Note5.1.5.19:Warrantplans•
BasisofpreparationandstatementofcomplianceTheprincipalaccountingpoliciesappliedinthepreparationof the above consolidated financial statements are set outbelow.Thesepolicieshavebeenconsistentlyappliedtoalltheyearspresented,unlessotherwisestated.
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Foreigncurrencytranslation
Functionalandpresentationcurrency:Items included in the financial statements of each of thegroup’s entities are measured using the currency of theprimaryeconomicenvironmentinwhichtheentityoperates(functionalcurrency).TheconsolidatedfinancialstatementsarepresentedinEuro,whichistheCompany’sfunctionalandpresentationcurrency.
Transactionsandbalances:TransactionsincurrenciesotherthanEuroarerecordedattheratesofexchangeprevailingonthedatesofthetransactions.Ateachbalancesheetdate,themonetaryassetsandliabilitiesthataredenominatedinforeigncurrenciesaretranslatedattheratesprevailingonthebalancesheetdate.Non-monetaryassetsandliabilitiescarriedatfairvaluethataredenominatedin foreign currencies are translated at the rates prevailingat thedatewhen thefairvaluewasdetermined.Gainsandlossesarisingontranslationareincludedinnetprofitorlossfor the period, except for exchange differences arising onnon-monetaryassetsandliabilitieswherethechangesinfairvaluearerecognizeddirectlyinequity.
On consolidation, the assets and liabilities of the group’sforeignoperationsaretranslatedatexchangeratesprevailingon the balance sheet date. Income and expense items aretranslated at the average exchange rates for the period.Exchangedifferencesarising, ifanyareclassifiedas incomeorasexpenseintheperiodinwhichtheoperationisdisposedof.
Segmentinformation
The Company does not distinguish different segments,neither business nor geographical segments since at thistime the majority of revenues are generated from clinicallaboratory service testing. In 2010, themajority of productandservicerevenuesweregeneratedfromthesaleofclinicaltestingservicestopharmaceuticalcompaniesevaluatingthebiomarkersofMDxHealthaspotentialcompaniondiagnostictests.TheseservicetestingrevenueswereprimarilygeneratedfromtheperformanceoftestingintheCompany’sEuropeanISO-certifiedcommerciallaboratory.
Revenuerecognition
Substantially all of the Company’s revenues are generatedfromtechnologyout-licensingdeals,productandservicesalesorroyaltiesonsuchsales,researchanddevelopmentservice
IAS31(revised2008)InvestmentsinJointVentures–•ConsequentialamendmentsarisingfromamendmentstoIFRS3;IAS39(revised2009)FinancialInstruments:Recognition•andMeasurement;IFRIC17DistributionofNon-cashAssetstoOwners;•IFRIC18TransfersofAssetsfromCustomers.•
Their adoption has not led to any major changes inMDxHealth’saccountingpolicies.
b)StandardsandInterpretationsissuedbutnotyeteffectiveinthecurrentperiodTheCompanyelectednot toearlyadopt the followingnewStandards, Interpretations and Amendments, which havebeenendorsedbythebytheEUbutarenotyetmandatoryasperDecember31,2010:
ImprovementstoIFRSs(IssuedinMay2010);•IAS24(revised2009)RelatedPartyDisclosures–Revised•definitionofrelatedparties,applicableforannualperiodsbeginningonorafterJanuary1,2011;IAS32(revised2009)Financialinstruments:Presentation•–Amendmentsrelatingtoclassificationofrightsissues,applicableforannualperiodsbeginningonorafterFebruary1,2010;IFRIC14MinimumFundingRequirementsandtheir•Interaction,applicableforannualperiodsbeginningonorafterJanuary1,2011;IFRIC19ExtinguishingFinancialLiabilitieswithEquity•Instruments,applicableforannualperiodsbeginningonorafterJuly1,2010;
Noneof theseareexpectedtohaveasignificant impactonthefinancialstatementoftheCompany.
Basisofconsolidation
The consolidated financial statements incorporate thefinancial statements of MDxHealth SA (Belgium legalentity), OncoMethylome Sciences BV (Netherlands legalentity),MDxHealthPharmacoDxBVBA (Belgian legal entity)andMDxHealth Inc. (UnitedStates legalentity)madeuptoDecember31,eachyear.MDxHealthSA(Belgium)incorporatedMDxHealth Inc. (U.S.)asawholly-ownedsubsidiary in2003,OncoMethylome Sciences BV (Netherlands) in 2004, andMDxHealth PharmacoDx BVBA in 2007. These subsidiariesare included following the full consolidation method. Allintra-grouptransactions,balances,incomeandexpensesareeliminatedinconsolidation.
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AuditedConsolidatedFinancialStatements
Deferred revenue represents amounts received prior torevenuebeingearned.
Research&developmentcosts
The Company considers that the regulatory and clinicalrisksinherenttothedevelopmentofitsproductsprecludeitfromcapitalizingdevelopmentcosts.Developmentcostsarecapitalizedtotheextentthatallconditionsforcapitalizationhave been satisfied. In the consolidated IFRS financialstatements of MDxHealth, no research and developmentcostshavebeencapitalized.
Property,plantandequipment
Property, plant and equipment are stated at historical costlessaccumulateddepreciationand impairment.Repairandmaintenancecostsarechargedtotheincomestatementasincurred.Gainsandlossesonthedisposalofproperty,plantand equipment are included in other income or expenses.Depreciationischargedsoastowriteoffthecostorvaluationofassetsovertheirusefullives,usingthestraight-linemethod,onthefollowingbasis:
Equipment:5years•IThardwareandsoftware:3years•Furniture:5years•Vehicles:5years•Leaseholdimprovements:inlinewiththelease•agreementperiod
Intangibleassets
Acquired patents and software licenses are measuredinternallyatpurchasecostandareamortizedonastraight-linebasisovertheirestimatedusefullivesonthefollowingbasis:
Patents:shorterof5yearsortheremainingpatentlife.•Software:shorterof5yearsorthesoftwarelicenseperiod.•
Costsrelatedtopatentswhicharein-licensedareexpensedasincurred.Costsrelatedtothefiling,maintenanceanddefenseof patents are expensed as incurred. Internal and externalresearch and development program costs are expensed asincurred.
Leases
Leases are classified as finance leaseswhenever the termsoftheleasetransferssubstantiallyall therisksandrewards
fees,andgovernmentgrants.Mostcommercialagreementsincludeup-frontfees,milestonefees,androyaltyfees.
LicensefeesarerecognizedwhentheCompanyhasfulfilledall conditions and obligations. The license fee will not berecognized if the amount cannot be reasonably estimatedand if thepayment isdoubtful. Licenseup-front (signaturefees) and non-refundable fees for access to prior researchresults and databases are recognized when earned, if theCompany has no continuing performance obligations andallconditionsandobligationsarefulfilled(thismeansafterthedeliveryoftherequiredinformation).
If the Company has continuing performance obligationstowardsthefees,thefeewillberecognizedonastraightlinebasisoverthecontractualperformanceperiod.
Milestonefeesarerecognizedasrevenuewhentheamountof the milestone fee is determinable and the earningprocess andmeasures relative to themilestone have beenfullycompleted.
Royalties will be generated by the sales by third partiesof products or services which incorporate the Company’sproprietary technology. Royalties are recognized as revenueonce the amounts due can be reliably estimated based onthe saleof theunderlyingproductsand servicesandwhenthecollectionof the royalties canbe reasonablyassured. Insituationswherethereisadequatefinancialinformationonsales, royalties are recorded based on the reports receivedfromthelicenseeorbasedonreliablyestimatedsalesiftheinformationhasnotbeenreceived.
Research and development service fees are recognizedas revenue over the life of the research agreement as therequiredservicesareprovidedandcostsare incurred.Theseservicesareusuallyintheformofadefinednumberoffull-timeequivalents(FTE)ataspecifiedrateperFTE.
GovernmentgrantsarerecognizedasrevenueoverthelifeofthegrantastherequiredorplannedactivitiesareperformedandtherelatedcostsincurredandwhenthereisreasonableassurancethattheCompanywillcomplywiththeconditionsof thegrant.Thegrantsareusually in the formofperiodicprogress payments. Grants related to assets are deductedfrom the assets acquired. The grants are recognized asincome,overtheusefullifeoftherelatedasset,startingfromthemoment theasset isusedby theCompany,bywayofareduceddepreciationcharge.
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an impairment loss is recognized as income, unless therelevantassetiscarriedatre-valuatedamount,inwhichcasethe reversal of the impairment is treated as a revaluationincrease.
Inventories
Inventoriesarestatedatthelowerofcostandnetrealizablevalue.Costcomprisesmerelypurchasecosts,astheinventoryconsists solely of raw materials. Raw materials are notordinarily interchangeable and they are as such accountedforusingthespecificidentificationoftheirindividualcost.
The Company does not account for work in progress andfinished products, as the production process is very shortand finished goods are shipped to customers immediately,thereafterresultinginnosuchitemsonthebalancesheetatyear-endforanyoftheperiodsreported.
Tradereceivables
Tradereceivablesdonotcarryanyinterestandarestatedattheirminimalvalueasreducedbyappropriateallowancesforirrecoverableamount.
Grantsreceivableandgrantspayable
Whenagovernmentgrant isallocated, theCompanybooksthefullamountasbothareceivableandapayable.Noincomeisrecognizedwhenthegrantisapproved,butisfullydeferredat thatpoint.When it is received, the receivable is reducedbytheamount.Whenthegrantisrecognizedasincome,thepayableisreducedbytheamount.Thegrantisonlyrecordedasapayable/receivablewhen(i)thegranthasbeenapprovedbythegrantingparty,(ii)theamountsaremeasurable,and(iii)theCompanybelievesitwillmeettheconditionsnecessarytobeabletoreceive/usethegrant.
Cashandcashequivalents
Cashandcashequivalentsarecarriedinthebalancesheetatnominalvalue.Forthepurposesofthecashflowstatements,cashandcashequivalentscomprisecashonhand,depositsheldoncallwithbanks,othershorthighlyliquidinvestmentsand bank overdrafts. In the balance sheet, bank overdrafts,ifany,areincludedinborrowingsincurrentliabilities.
Taxation
Deferred income tax is provided in full using the“balance sheet liability method”, on temporary differences
ofownership to the lessee.Allother leasesareclassifiedasoperatingleases.
AssetsheldunderfinanceleasesarerecognizedasassetsoftheCompanyattheirfairvalueor,iflower,atthepresentvalueof the minimum lease payments, each determined at theinceptionofthelease.Thecorrespondingliabilitytothelessorisincludedinthebalancesheetasafinanceleaseobligationsoastoachieveaconstantrateofinterestontheremainingbalanceoftheliability.Financechargesareexpensed.
Rentalspayableunderoperatingleasesarechargedtoincomeona straight-linebasis over the termof the relevant lease.Benefitsreceivedandreceivableasanincentivetoenterintoan operating lease are also spread on a straight-line basisovertheleaseterm.
Impairmentoftangibleandintangibleassets
At each balance sheet date and at each interim reportingdate, the Company reviews the carrying amount of itstangibleandintangibleassetstodeterminewhetherthereisanyindicationthatthoseassetshavesufferedanimpairmentloss. If any such indication exists, the recoverable amountof the asset is estimated in order to determine the extentof the impairment loss (if any).Where the asset does notgeneratecashflowsthatareindependentfromotherassets,theCompanyestimatestherecoverableamountofthecash-generating unit to which the asset belongs. An intangibleassetwithanindefiniteuseful lifeis testedforimpairmentannuallyandateachinterimreportingdate,andwheneverthere is an indication that the asset might be impaired.Recoverableamount is thehigherof fair value less costs tosell and value in use. The estimated future cash flows arediscounted to their present value using a pre-tax discountrate that reflects current market assessments of the timevalueofmoneyandtherisksspecifictotheasset.
Iftherecoverableamountofanassetorcashgeneratingunitisestimatedtobelessthanthecarryingamount,thecarryingamountoftheassetisreducedtoitsrecoverableamount.Animpairment loss is recognized as an expense immediately,unless the relevant asset is carried at re-valued amount,in which case the impairment is treated as a revaluationdecrease.Wherean impairment loss subsequently reverses,thecarryingamountoftheassetisincreasedtotherevisedestimateofitsrecoverableamount,butsothattheincreasedcarrying amount does not exceed the carrying amountthatwouldhavebeendeterminedhadno impairment lossbeen recognized for the asset in prior years. A reversal of
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AuditedConsolidatedFinancialStatements
Retirementbenefitschemesandemployeesavingsschemes
Paymentstodefinedcontributionretirementbenefitschemesare charged as an expense as they fall due. Payments todefinedcontributionemployeesavingsschemesarechargedasanexpenseas theyfalldue.TheCompanydoesnotoffernoroperateanydefinedbenefitschemesforitsemployees.
Share-based compensation plans for personnel, directorsandbusinessassociates.
TheCompanyhasshare-basedcompensation(stockoption)plans for personnel, directors and business associates. Thefairvalueof theemployeeservices received for thegrantedcompensation plans are measured as an expense. Thecorrespondingcreditisrecordeddirectlyintoequity.
The total cost to be charged as an expense over thevestingperiod ismeasuredat the fair valueof thegrantedcompensation plans. The estimate of the number ofcompensationplanswhichwillbevested is revisedateachreportingdate.Thechange inestimateswillberecordedasexpensewithacorrespondingcorrectioninequity.
The received amount, less directly attributable transactioncosts,will be recordedas share capital and sharepremiumwhenthecompensationplansareexercised.
between the carrying amount of assets and liabilities forfinancial reporting purposes and the amounts used fortaxationpurposes.
The amount of deferred tax provided is based on theexpectedmannerorrealizationofsettlementofthecarryingamountof assets and liabilities,using tax rates enactedorsubstantiallyenactedatthebalancesheetdate.Deferredtaxassetsrelatingtotaxlossescarriedforwardarerecognizedtotheextentthatitisprobablethattherelatedtaxbenefitswillberealized.Currently,nodeferredtaxassetisrecognizedonthebalancesheet.
Tradepayables
Tradepayablesarenotinterestbearingandarestatedattheirnominalvalue.
Equityinstruments
EquityinstrumentsissuedbytheCompanyarerecordedintheamountoftheproceedsreceived,netofdirectissuecosts.
Derivativeinstruments
The Company has not used any derivative financialinstruments.
FinancialAssets
Investments classified as available for sale financial assets,arecurrentandnon-currentinvestmentscomprisingunlistedequityshares.Theyarestatedatfairvalue,exceptwherefairvaluecannotbeestablishedreliablyinwhichcasethesecuritiesarecarriedatcost.Anyresultantgainorlossoninvestmentsmeasuredatfairvalueisrecognizedinarevaluationreservein equity with the exception of impairment losses whicharerecognizeddirectlyinprofitandloss.Theseinvestmentsareheldwiththeobjectiveofrealizingacapitalgainfromafuturesale.Allpurchaseandsaleoffundsarerecognizedatthedateofsettlement.Investmentsarereviewedperiodicallyand revalued by the Directors on a case by case basis.Financial assets are assessed for indicators of impairmentat each reporting period. Financial assets are impairedwhere there isobjectiveevidence thatasa resultofoneormore events that occurred after the initial recognition ofthe financial asset, the estimated future cash flows of theinvestmenthavebeenimpaired.Forunlistedsharesclassifiedasavailableforsaleasignificantorprolongeddeclineinthefair value of the security below its cost is considered to beobjectiveevidenceofimpairment.
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5.1.5.3 Operatingresult
Resultfromoperationshasbeenarrivedataftercharging:
a.Researchanddevelopmentexpenditures
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Personnelcosts 5.1.5.4 3,619 3,714 3,549Labconsumables 306 945 831Externalresearchanddevelopmentcollaboratorfees
1,667 3,912 4,242
Patentandlicensefees 347 331 247Depreciationandamortization
338 2,281 1,000
Otherexpenses 535 1,906 1,129Total 6,812 13,089 10,999
R&Dexpendituresdecreased in2010asa resultof thecostcuts initiated and announced in the second half of 2009andpursuedthroughout2010.Personnelcostswerereducedprimarily as a result of the closure of the Netherlandslaboratoryfacilityin2010andtoareductionofthenumberofpersonnelthroughouttheGroup.ExternalR&Dcollaboratorfeesdecreased in2010asa resultof thediscontinuationofcertainprojects,suchascancerscreeningtrials.Depreciationandamortizationexpensesdecreased in2010asaresultoflower capital expenditures in recent years and primarilyto the one-time accelerated amortization of an intangibleassetwhichoccurredin2009butnotin2010.Thisintangibleassetconsistedof intellectualpropertywhichwasacquiredin January2008butwhichbyend-2009wasunlikely tobeusednor to generate near-term revenues or profits for theCompanyasaresultofthere-focusingstrategyannouncedinNovember2009.ThecoreproductsnowindevelopmentareunlikelytousetheintellectualpropertyacquiredinJanuary2008and thus thedecisionwas taken toceasecapitalizingthisintellectualpropertyasanassetonthebalancesheet.
b.Selling,generalandadministrativeexpenses
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Personnelcosts 5.1.5.4 1,847 2,063 1,599Depreciation 37 17 4Professionalfees 1,211 878 891Otherexpenses 650 1,053 613Total 3,745 4,011 3,107
SG&A expenses have remained stable in 2010 and includeprimarilycostsforthegeneralmanagementoftheCompany,such as the finance, marketing, sales, and other similaractivities.With the announced change in strategy in 2010wherebytheCompanywillpursuedirectsalesofcertainofitsproductsviaacommerciallaboratoryintheUnitedStates,theSG&Aexpensesareexpectedtoincreasestartingin2011.
5.1.5.4 Personnelcosts
YearsendedDecember31Thenumberofemployeesattheendoftheyearwas: 2010 2009 2008
Management(headcount) 5 10 10Laboratorystaff(headcount) 23 44 44SG&Astaff(headcount) 9 12 11Total 37 66 65
Theiraggregateremunerationcomprised:ThousandsofEuro(EUR)
2010 2009 2008
Wagesandsalaries 4,185 4,286 3,658Socialsecuritycosts 403 366 502Pensioncosts 167 185 149Othercosts 711 940 839Total 5,466 5,777 5,148
Followingacostreductionprogramannouncedinthesecondhalfof2009andtoachangeinstrategyannouncedin2010,the Company reduced its employment levels in 2010. Theemployment levels were reduced primarily through theclosureof the laboratory facility in theNetherlands in2010andtocertainpersonnelreductionsatothersites.The2010personnel costdecrease in termsofpercentagewasnot aslargeasthepercentagedecreaseintheheadcountnumbersdue to theone-timecostsand indemnitiesassociatedwiththedepartureofpersonnelin2010andtothetimingofthedepartures.Wagesandsalariesincreasedin2009comparedto 2008 due to several new hires at the end of 2008. Thewagesandsalariesincreasein2009isalsopartlyexplainedbythere-focusingprogramannouncedonNovember5,2009whichledtotheplannedterminationofsomeemployeesin2010andanindemnitycostatend-2009.Socialsecuritycostsdecreased in 2009due to larger reductions allowedby theDutch and Belgian governments for social security chargesonpersonnelinvolvedinR&D.
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5.1.5.5 Financeincome/(costs)
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Interestonbankdeposits 74 40 79Interestoncommercialpaper 0 40 373Gainonsalesofliquidassets 13 370 623Gainonsalesoffinancialassets
135 0 0
Foreignexchangegain/(loss) (62) (27) 68Otherfinancialgain/(loss) (23) 7 (9)Netfinancialresults 137 430 1,134
For theyearsendedDecember31,2010,2009and2008, thegainonsalesof liquidassetsarosefromgainsonamoney-marketaccountandonsalesoftradableshares.Themoney-market account is invested in short-term interest bearingandpublicly-tradedobligationswithhighratings.In2010,thesaleoftheequitystakeinSignatureDiagnosticsAG(formerlyshownon thebalancesheetasa financialasset)generatedagainofEUR 135 thousand.Foraccountingpurposes, theseliquid assets are considered as a cash equivalent on thebalancesheetandinthecashflowstatementsasgeneratingcash flows from investing activities in terms of interestincome.
5.1.5.6 Taxes
Thereisnocurrenttaxaccountedforinanyoftheperiodspresented.Thefollowingtableprovidesareconciliationofthedeferredtaxestotheprofitandlossstatement.
Balanceat IncomeStatement Balanceat31-Dec-10 2010 2009 2008 01-Jan-08
Taxlossescarriedforward (73,683) (10,369) (17,727) (12,433) (33,134)Purchaseofintangibleassets (7,035) 0 (590) (530) (5,915)Depreciationofintangibleassets
6,998 17 2,586 850 3,544
GovernmentgrantNL 0 0 0 (38) 38Totaldeductibletemporarydifference
(73,720) (10,352) (15,731) (12,151) (35,487)
Deferredtaxes@34% 25,058 3,519 5,347 4,131Unrecognizedopeningbalanceofdeferredtaxasset
21,539 16,192 12,061
Deferredtaxoftheyear 3,519 5,347 4,131DeferredtaxesatDecember31 25,058 25,058 21,539 16,192 12,062
The Company has not recorded deferred net tax assets onthebasisthatatDecember31,2010,2009and2008noprofitswererealizedandthelackofguaranteesthatitwillgenerateprofits in the futurewhich could be offset against currentlosses.
Thedeferredtaxesarecalculatedonthefollowingitems:
Taxlossesaspertaxreturn.ThefinancialfiguresunderIFRS•are not necessarily the same as the local GAAP financialfiguresusedfortaxdeclarations.Taxlossesaspertaxreturnrefers toaccounting rulesof the taxauthoritieswhich incertaincasesdifferfromIFRSaccountingrules;
In the statutory accounts, the costs related to certain•researchanddevelopmentwerecapitalizedandamortizedon a straight-line basis over a period of 5 years, startingat January 1, 2003. In the IFRS statements developmentcosts are capitalized to the extent that all conditionsfor capitalization have been satisfied (currently no R&Dis capitalized in the Company’s IFRS accounts). In 2009,the Company decided to consider these R&D costs as anexpenseandtoalignthestatutoryaccountswiththeIFRSaccounts.
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5.1.5.7 Losspershare
Basiclosspershareiscalculatedbydividingthenetresultattributabletoshareholdersbytheweightedaveragenumberofsharesoutstanding during the year.
YearsendedDecember312010 2009 2008
Resultforthepurposeofbasiclosspershare,beingnetloss(ThousandsofEuro(EUR))
(8,253) (14,301) (10,192)
Numberofshares 13,185,614 13,178,555 11,840,177Weightedaveragenumberofsharesforthepurposeofbasiclosspershare(assumingstocksplitinallperiods)Basiclosspershare(inEuro(EUR)) (0.63) (1.09) (0.86)
AtDecember31,2010,2009and2008,theCompanyhasdilutivepotentialsharesintheformofwarrants.UnderIAS33,nodisclosureisrequiredofthedilutedresultpershare,sinceaslongastheCompanyisreportinganetloss,thewarrantshaveananti-dilutiveeffectratherthanadilutiveeffect.
5.1.5.8 Intangibleassets
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008GrossvalueAtJanuary1 2,561 2,526 493Additions 23 35 2,033Disposals (5)ImpairmentGrossvalueatDecember31 2,579 2,561 2,526AccumulatedamortizationAtJanuary1 (2,512) (882) (420)Additions (21) (17) (465)Disposals 2Relatedtosubsidy 0 0 3Impairment 0 (1,213)AccumulatedamortizationatDecember31 (2,533) (2,512) (882)NetvalueatDecember31 47 49 1,644
Theintangibleassetconsistsofintellectualpropertyrightsandsoftwarelicenses.
These investments are being amortized on a straight-line basis over 3-5 years, unless an impairment is noted during theperiodicassessmentoftheseassets.AnintangibleassetconsistingofintellectualpropertywasacquiredinJanuary2008butbyDecember2009itwasdeemedunlikelytobeusednortogeneratenear-termrevenuesorprofitsfortheCompanyasaresultofthere-focusingstrategyannouncedinNovember2009.ThecoreproductsnowindevelopmentareunlikelytousetheintellectualpropertyacquiredinJanuary2008andthusthedecisionwastakenin2009toceasecapitalizingthisintellectualpropertyasanassetonthebalancesheet.
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5.1.5.9 Tangibleassets
ThousandsofEuro(EUR) Laboratoryequipment Furniture IT
equipmentLeasehold
improvements TOTAL
GrossvalueAtJanuary1,2008 2,021 187 445 157 2,811
Openingcurrencyexchangerate (3) (3)Additions 113 9 104 4 229Disposals (6) (1) (7)
GrossvalueatDecember31,2008 2,128 195 546 161 3,030Accumulatedamortization
AtJanuary1,2008 (664) (66) (317) (16) (1,063)Openingcurrencyexchangerate (1) (1)
Additions (403) (46) (76) (29) (554)Relatedtosubsidy 12 1 2 15
Disposals 1 1 2AccumulatedamortizationatDecember31,2008 (1,054) (111) (391) (45) (1,601)
NetvalueatDecember31,2008 1,074 84 155 116 1,429
ThousandsofEuro(EUR) Laboratoryequipment Furniture IT
equipmentLeasehold
improvements TOTAL
GrossvalueAtJanuary1,2009 2,128 195 546 161 3,030
Openingcurrencyexchangerate -1 -1Additions 217 3 31 11 262Disposals
GrossvalueatDecember31,2009 2,345 198 576 172 3,291Accumulatedamortization
AtJanuary1,2009 (1,054) (111) (391) (45) (1,601)Openingcurrencyexchangerate 1 1 2
Additions (411) (19) (97) (28) (555)Relatedtosubsidy 5 1 6
Disposals (121) (121)AccumulatedamortizationatDecember31,2009 (1,581) (129) (487) (72) (2,269)
NetvalueatDecember31,2009 764 69 89 100 1,022
ThousandsofEuro(EUR) Laboratoryequipment Furniture IT
equipmentLeasehold
improvements TOTAL
GrossvalueAtJanuary1,2010 2,345 198 576 172 3,291
Openingcurrencyexchangerate 1 2 3Additions 31 6 11 2 50Disposals (459) (77) (69) (37) (648)
GrossvalueatDecember31,2010 1,917 128 520 138 2,703Accumulatedamortization
AtJanuary1,2010 (1,581) (129) (487) (72) (2,269)Openingcurrencyexchangerate (1) (2) (2)
Additions (248) (20) (48) (9) (325)Disposals 363 45 51 14 473
AccumulatedamortizationatDecember31,2010 (1,466) (105) (486) (67) (2,2124)NetvalueatDecember31,2010 451 23 34 71 579
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5.1.5.12 Grantsreceivable
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008BEWallonia:ETBbladdersubsidy
770 0 0
BEWallonia:LungcancersubsidyExtension
0 1,180 1,180
BEWallonia:Lungcancersubsidy
0 0 0
BEWallonia:BioWin
327 874 1,191
BEWallonia:EuroTransBio–Bladder
0 0 0
BEFlanders:IWT
0 0 103
NLSenterNovem:Coloncancersubsidy
0 361 361
NLSenterNovem:EuroTransBio–Colon
0 375 375
NLCTMMAirforce–Lung/Head&Neck
58 100 100
NLCTMMDecode–Colon 99 189 189Totalgrantsreceivables 1,254 3,079 3,499Morethanoneyear 483 405 1,087Lessthanoneyear 771 2,674 2,412Totalgrantsreceivables 1,254 3,079 3,499
In2008,theCompanyreceivedgrantsfromtheWalloonregionforlungcancerresearch(extensionofthefirstgrantreceivedin2005)andfromtheDutchgovernmentforseveralprojects:for colon cancer R&D forwhich theCompany received twogrants,andonegrantforacombinationoflungandthehead&neckcancerR&D.Nonewgrantswerereceivedin2009.In2010,theCompanywasawardedonenewgrant,theWallonia/EuroTransBiograntforR&Donbladdercanceraggressivenessmarkers.Withthechangeinchangeinstrategyannouncedin2010,theCompanyhaspursuedfewersubsidizedearly-stageresearchprojects.Asaconsequencethegrantbalanceshavedecreasedin2010.Furtherdetailonthegrantsisavailableinsection5.1.5.21(E)ofthisdocument.
5.1.5.13 Cashandcashequivalents
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2007Cashatbankandinhand 10,593 18,032 30,601Totalcashandcashequivalents
10,593 18,032 30,601
ThebankbalancesandcashheldbytheCompanyandshort-term bank deposits have an originalmaturity of less than3months.Thecarryingamountoftheseassetsapproximatestheir fair value. These cash and cash equivalents have norestrictionuponthem.
5.1.5.10 Financialassets
On January 30, 2008, the Company took aminority equitystakeinSignatureDiagnosticsAG(SD),adiagnosticsstart-upcompanyusingRNA-based technologies. In2009and2008,the financial assetswere recorded on the balance sheet atthepricepaidbyMDxHealthforthesharesissuedbySD.SDisaprivately-heldcompanyandthereisnoactivemarketforits shares. In 2010, the equity stake in SDwas sold and theaccountbalancehasbeenreducedtozero.
5.1.5.11 Tradeandotherreceivables
a.Tradereceivables
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Tradeaccountsreceivable 1,058 533 369Totaltradeaccountsreceivable 1,058 533 369
Trade receivables mainly consist of fees due from thecustomers of the Company. The trade accounts receivablebalancesatend-2009andend-2010werecomposedmainlyof services provided to pharmaceutical companies in thefourthquarterofthoseyears.Outofthetotaltradereceivablebalanceattheendof2010,EUR132thousandaremorethan60daysoutstanding,whereasalltherestisoutstandingforless than 60 days. No provision for doubtful accounts hasbeenmadein2010.
b.Otherreceivables
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Prepayments 225 286 304Deposits 27 19 27RecoverableVAT 481 982 555Inventories 108 82 99Other 47 208 25Totalprepaidexpensesandothercurrentassets
888 1,537 1,010
The Company considers that the carrying amount of tradeand other receivables approximates their fair value. TherecoverableVATbalancedecreased in 2010due to the 2010closureofthelabfacilityintheNetherlandsandtheresultingreducedintercompanyservicesbetweentheparentcompanyandtheDutchsubsidiarythatpreviouslycreatedsignificantrecoverableVATbalances.
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andrevenuesoftheCompanyasapercentageoftheoverallcostsandrevenuesstartingin2012.
The monetary items at December 31, 2010 in U.S. Dollarsare composed of cash on hand of $127 thousand.For compliancewith the IFRS7 rule, theCompanydisclosesa sensitivity analysis of an increase/decrease of exchangerate on operations in U.S. Dollars of 10%. The exposure ofoperationstothecurrencyriskislimitedtothenetamountof $3.3million ($1.3million revenue and $4.6million costs),giving a potential loss of EUR278 thousand in case of anincreaseof theU.S.Dollar/EURexchangerateby10%,andapotentialgainofEUR227thousandincaseofandecreaseoftheexchangerateby10%.
Liquidityrisk:TheGroupmanages liquidity riskbymaintainingadequatereservesandbycontinuouslymonitoringforecastandactualcash flows andmatching thematurity profiles of financialassets and liabilities. The Company has no borrowingarrangements at December 31, 2010 and has no derivativeinstruments.
Otherrisks:TheGroupsubscribes to certain insurancepolicies to covermatterssuchas(i)fire,theft,andotherdamagetoitsassets,(ii)productliabilityinsuranceandclinicaltrialinsurance,and(iii)D&Oinsurance.Todate,noclaimshavebeenmadeunderthese insurancepoliciesandthere isnoguarantee that theinsuranceswillcoveralldamagesiftheyshouldeveroccur.
Todate,theCompanyhasreceivedseveralgovernmentgrantsforvariousR&Dprojects.Someofthesegrantamountscanbere-claimediftheCompanydoesnotfulfillalltheconditionsofthegrantagreements.
5.1.5.15 Sharecapitalandreserves
AtDecember31,theCompany’ssharecapitalwasrepresentedbythefollowingnumberofshares(units).Onlyoneclassofshares(commonshares)existsandtheyhavenoparvalue.
YearsendedDecember312010 2009 2008
Commonshares 13,185,614 13,185,614 13,161,074Totaloutstandingshares
13,185,614 13,185,614 13,161,074
5.1.5.14 FinancialRiskManagement
Capitalmanagement:TheCompanymanagesitscapitalwiththeaimofensuringthattheCompanycancontinuetooperateincontinuity.
Creditrisk:The limited number of the group’s customers subjects theCompany to concentrations of credit risk. In 2008, eightcustomersgeneratedmorethan90%oftheturnoverandthesituationwassimilarin2009.In2010,theCompanygenerated90% of its turnover with sixteen customers, reducing theconcentrationofcreditrisk.
Customer’scompliancewithagreedcredittermsismonitoredregularly and closely. No major overdue trade accountsreceivableareidentifiedandtheyear-end2010balancewasEUR1,058thousand.
Receivables related to research grants from the Dutch andBelgian government (EUR1,254 thousand at December31,2010)arerecognizedwhenthereisareasonableassurancethattheCompanywillcomplywiththeconditionsattachedtothemandthegrantwillbereceived.TheCompanyconsidersthe overall recognition criteria being met when an awardletterhasbeenreceived,therelatedprojectcostshavebeenincurred,andgrantspecificmilestoneshavebeenachievedorareassumedtobereliablyachievedinthefuture;
Thecreditriskoncashandcashequivalents(EUR10,593thousand)islimitedgiventhatthecounterpartiesarebankswithhighcreditscoresattributedbyinternationalratingagencies
Interestrisk:Thegroup isnot subject tomaterial interest risk.All leaseshavefixedinterestrates.
Currencyrisk:Thegroupisnotcurrentlyexposedtomaterialcurrencyrisk,butinthefuturethisriskmayincreasewithanexpansionoftheCompany’sU.S.activities.ThegrouphascashoutflowsinU.S.DollarsfortheoperationsofitsU.S.wholly-ownedsubsidiaryand for numerous external research and developmentprojects it carries outwith U.S.-basedmedical centers. TheCompany has material commercial revenues denominatedin U.S. Dollars.. The Company has not engaged in hedgingof the foreign currency risk via derivative instruments.TheCompanyannouncedin2010thatitintendstosellproductsdirectly to treating physicians in the United States via acommercial laboratory.Thisnewactivityhasnotstartedyetin2010,butislikelytoincreasethedollar-denominatedcosts
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ThecapitalstockandtheissuancepremiumatDecember31amountedtothefollowing:
YearsendedDecember31ThousandsofEuro(EUR) 2009 2008 2007ShareCapitalasperstatutoryaccounts
10,518 54,001 53,901
IPOCosts&CapitalIncreasecosts
0 (2,912) (2,912)
SharecapitalunderIFRS 10,518 51,089 50,989Issuancepremium 10,882 10,882 10,872Sharecapitalandissuancepremium
21,400 61,971 61,861
Nonewshareswereissuedin2010.TheExtraordinaryGeneralShareholders’meetingof June21,2010approved theformalreductionofthesharecapitalinaccordancewitharticle614
ThetablebelowprovidesanoverviewofthehistoryoftheCompany’ssharecapitalsinceitsincorporationin2003.Theoverviewshouldbereadtogetherwiththenotessetoutbelowthetable.
Date TransactionNumber
(andclass)ofsharesissued
Issuepricepershare(EUR)
Issuepricepershare(EUR)
post-stocksplit
Capitalincrease
(‘000EUR)
Sharecapitalaftertransaction
INCORPORATIONJan10,2003 Incorporation 202,975 0.30 0.06 62 62
PHASEIFINANCINGROUNDDECEMBER20,2002(PREFERREDASHARES)Feb7,2003 Capitalincrease
incash197,025
(preferredA)20.00 4.00 3,941 4,002
June30,2003 Capitalincreaseincash
33,333(preferredA)
20.00 4.00 667 4,669
Sept30,2003 Capitalincreaseincash
218,139(preferredA)
22.31 4.46 4,867 9,535
June30,2004 Capitalincreaseincash
195,504(preferredA)
23.87 4.77 4,667 14,202
PHASEIIFINANCINGROUNDOCTOBER19,2005(PREFERREDBSHARES)Oct28,2005 Capitalincrease
incash375,000
(preferredB)24.00 4.80 9,000 23,202
Mar31,2006 Capitalincreaseincash
193,548(preferredB)
31.00 6.20 6,000 29,202
STOCKSPLITANDCONVERSIONOFALLSHARESTOCOMMONSHARESMay23,2006 7,077,620 - - - - 29,202
IPOJune30,2006 Capitalincrease
incash2,933,334(ordinary)
7.50 7.50 22,000 51,202
ABSORPTIONOFLOSSESJune30,2006 Absorption
oflosses- - - (10,218) 40,984
of the Belgian Company Code through the incorporation(and neutralization) of (accumulated) sustained losses asdemonstrated from the approved annual accounts as perDecember 31, 2009, without reducing the total numberof issued and outstanding shares, in order to improve theratioof theCompany’snetassets vis-à-vis its share capital.Therefore,thesharecapitalwasreducedbyEUR43,483,535.37,bringing the share capital per the statutory accounts fromEUR54,001,197.27 to EUR10,517,661.90. This transactioncaused the share capital under IFRS to be reduced fromEUR51,089thousandtoEUR10,518thousand.
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Date TransactionNumber
(andclass)ofsharesissued
Issuepricepershare(EUR)
Issuepricepershare(EUR)
post-stocksplit
Capitalincrease
(‘000EUR)
Sharecapitalaftertransaction
EXERCISEOFOVER-ALLOTMENTWARRANTSJune30,2006 Capitalincrease
throughexerciseof
over-allotmentwarrants
440,000(ordinary)
7.50 7.50 1,817 42,801(asperstatutory
accounts)
DEDUCTIONOFIPOCOSTS(UnderIFRS)June30,2006 Deductionof
IPOcosts- - - (2,174) 40,627
(underIFRS)
EXERCISEOFWARRANTSApril18,2007 Capitalincrease
incash182,560
(ordinary)4.70 4.70 748 41,375
SECONDARYOFFERINGOFSHARESOctober19,
2007Capitalincrease
incash1,063,510(ordinary)
10.00 10.00 4,355 45,730
EXERCISEOFWARRANTSOctober25,
2007Capitalincrease
incash50,837
(ordinary)4.73 4.73 208 45,938
DEDUCTIONOFSecondaryOfferingFees(UnderIFRS)December31,
2007DeductionofSPOcosts
- - - (457) 45,481(underIFRS)
EXERCISEOFWARRANTSApril24,2008 Capitalincrease
incash61,120
(ordinary)4.59 4.59 250 45,731
EXERCISEOFWARRANTSNovember5,
2008Capitalincrease
incash19,375
(ordinary)4.73 4.73 80 45,811
SECONDARYOFFERINGOFSHARESDecember18,
2008Capitalincrease
incash1,332,877(ordinary)
6.29 6.29 5,459 51,270
DEDUCTIONOFSecondaryOfferingFees(UnderIFRS)December31,
2008DeductionofSPOcosts
- - - (281) 50,989(underIFRS)
EXERCISEOFWARRANTSApril17,2009 Capitalincrease
incash24,540
(ordinary)4.49 4.49 100 51,089
REDUCTIONOFSHARECAPITAL(withnochangetonumberofshares)June21,2010 Reductionof
ShareCapital- - - - 10,518
Atincorporation,onJanuary10,2003,theCompanyissued202,975commonsharesinconsiderationforacontributionincashofEUR61,500.OnJanuary30,2003,200,000ofthesesharesweretransferredtotheCompany’smanagementandconsultants.
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Theextraordinaryshareholders’meetingofOctober28,2005approvedtheissuanceof375,000newseriesBpreferredsharesinconsiderationforacontributionincashofEUR9,000,000.At the same time, the 120 existing series A anti-dilutionwarrantswerecancelledand160newseriesAanti-dilutionwarrantswereissuedtotheownersoftheseriesAandseriesBpreferredshares.
The extraordinary shareholders’meeting ofMarch 31, 2006approvedtheissuanceof193,548newseriesBpreferredsharesinconsiderationforacontributionincashofEUR5,999,988.
The annual general shareholders’meeting ofMay 23, 2006approvedthesplitofalloutstandingsharesataconversionrateof5-for-1andtheconversionofalltypesofsharesintoasingleclassofcommonshares.
OnMay 23, 2006, the general shareholders’meeting of theCompany decided to increase the Company’s share capitalthrough issuance of new shares in connection with aninitialpublicoffering.The capital increasewithanamountofEUR 22,000,005wascompletedon June30,2006.At thesametime,allexistingsharesoftheCompanywereconvertedintoordinaryshares.
OnMay23,2006, thegeneralshareholders’meetingpasseda resolution tomake a formal capital reduction, upon thelisting of the Company’s shares on Euronext, through theincorporation of the Company’s Belgian statutory accountlosses through the period ended December 31, 2005 (for atotalamountofEUR10,217,809)withoutcancellationofanyshares.ThecapitaldecreasewascompletedonJune30,2006.
OnMay 23, 2006, the general shareholders’meeting of theCompanydecided to create an over-allotmentwarrant.Theover-allotmentwarrantwasgranted to INGBelgiumNV/SAandFortisBankNV/SAtocoverover-allotmentsinconnectionwiththeinitialpublicofferingbytheCompany.OnJune30,2006, the share capital was increased with an amount ofEUR 1,817,200 through exercise of 440,000 over-allotmentwarrantsandthe issuanceof440,000newordinaryshares.AnamountofEUR1,482,800wasallocatedtotheCompany’sissuancepremiumaccount.
Theextraordinaryshareholders’meetingofFebruary7,2003approvedtheissuanceof197,025newseriesApreferredsharesinconsiderationforacontributionincashofEUR3,940,500.At the same occasion, two different classes of shareswerecreated, i.e., the ordinary or common shares and the seriesA preferred shares. All shares issued at this occasion and2,975ofthesharesissuedatincorporationwerere-classifiedas seriesApreferred shares.The remaining200,000sharesare ordinary or common shares. At the same shareholders’meeting100seriesAanti-dilutionwarrantswerealsoissuedtotheownersoftheexistingseriesApreferredshares.
The extraordinary shareholders’ meeting of June 30, 2003approvedtheissuanceof33,333newseriesApreferredsharesinconsiderationforacontributionincashofEUR666,660.Atthesametime,20newseriesAanti-dilutionwarrantswereissuedtothesubscribertothenewlyissuedseriesApreferredshares.
The extraordinary shareholders’ meeting of September30, 2003 approved the issuance of 218,139 new series Apreferredshares inconsideration foracontribution incashofEUR4,866,681.
The extraordinary shareholders’ meeting of May 12, 2004approved the issuance of 30,000 warrants and authorizedtheissuanceofanadditional15,000warrantsbytheBoardofDirectorsintheframeworkoftheauthorizedcapitalpursuanttothetermsoftheapprovedstockoptionplanforemployees,consultantsanddirectors.InMay2004,29,750warrantsweregrantedtobeneficiariesunderthestockoptionplanand250warrantswerenevergrantedandbecamenull andvoidonJune30,2004inaccordancewiththetermsandconditionsofthestockoptionplan.
The extraordinary shareholders’ meeting of June 30, 2004approvedtheissuanceof195,504newseriesApreferredsharesinconsiderationforacontributionincashofEUR4,666,680.
OnJuly12,2005,theBoardofDirectorsapprovedtheissuanceof15,000warrantsintheframeworkoftheauthorizedcapitalpursuanttothetermsof thestockoptionplanapprovedin2004.Allthesewarrantsweregrantedtobeneficiariesunderthestockoptionplan.
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In accordance with IFRS and general industry practice, theCompanydecidedin2006torecordthecostsassociatedwiththeIPOin2006asdirectreductionofthesharecapitalintheequityaccountofthebalancesheetratherthanasanexpenseintheincomestatement.
On April 18, 2007, the share capital was increased throughexercise of (i) 9,937 warrants issued by the extraordinarygeneral shareholders’ meeting of May 12, 2004 (Warrants2004)atanexercisepriceofEUR22.31perwarrant,(ii)6,900warrants issued by the Board of Directors on July 12, 2005(Warrants2005)atanexercisepriceofEUR23.87perwarrant,and(iii)19,675warrantsissuedbytheextraordinarygeneralshareholders’meetingofMarch22,2006(Warrants2006)atanexercisepriceofEUR24.00perwarrant.The issue sharepricesintheabovetableindicatetheweightedaveragepriceoftheexercisedwarrants.Pursuanttothestocksplitdecideduponbythegeneralshareholders’meetingofMay23,2006,eachWarrant2004,Warrant2005andWarrant2006entitlestheholderthereoftofivesharesoftheCompany.
OnOctober15,2007,theBoardofDirectorsdecidedtoincreasethe Company’s share capital in connection with a privateplacementwithqualifiedinstitutionalinvestors.ThecapitalincreasewithanamountofEUR4,354,954.02wascompletedonOctober19,2007.
OnOctober25,2007,thesharecapitalwasincreasedthroughexercise of (i) 2,680 warrants issued by the extraordinarygeneral shareholders’ meeting of May 12, 2004 (Warrants2004) at an exercise price of EUR22.31 per warrant, (ii)3,000warrants issued by the Board ofDirectors on July 12,2005 (Warrants 2005) at an exercise price of EUR23.87 perwarrant, (iii) 4,425 warrants issued by the extraordinarygeneral shareholders’meetingofMarch22,2006 (WarrantsMarch2006)atanexercisepriceofEUR24perwarrant, (iv)187warrants issuedby theBoardofDirectorsonNovember8, 2006 (Warrants November 2006) at an exercise price ofEUR7.72perwarrantand(v)125warrantsissuedbytheBoardofDirectorsonApril18,2007(WarrantsJanuary2007)atanexercisepriceofEUR10.87perwarrant.Theissuesharepricesintheabovetableindicatetheweightedaveragepriceoftheexercisedwarrants.Pursuanttothestocksplitdecideduponby thegeneralshareholders’meetingofMay23,2006,eachWarrant2004,Warrant2005andWarrant2006entitlestheholderthereoftofivesharesoftheCompany.
OnApril 25, 2008, the share capitalwas increased throughexercise of (i) 7,500 warrants issued by the extraordinarygeneral shareholders’ meeting of May 12, 2004 (Warrants2004) at an exercise price of EUR22.31 per warrant, and(ii) 4,724 warrants issued by the extraordinary generalshareholders’meetingofMarch22,2006(Warrants2006)atanexercisepriceofEUR24.00perwarrant.The issue sharepricesintheabovetableindicatetheweightedaveragepriceoftheexercisedwarrants.Pursuanttothestocksplitdecideduponbythegeneralshareholders’meetingofMay23,2006,eachWarrant2004,Warrant2005andWarrant2006entitlestheholderthereoftofivesharesoftheCompany.
OnNovember5,2008,thesharecapitalwasincreasedthroughexercise of (i) 625 warrants issued by the extraordinarygeneral shareholders’ meeting of May 12, 2004 (Warrants2004)atanexercisepriceofEUR22.31perwarrant,(ii)2,500warrants issued by the Board of Directors on July 12, 2005(Warrants2005)atanexercisepriceofEUR23.87perwarrant,and (iii) 750 warrants issued by the extraordinary generalshareholders’meetingofMarch22,2006(Warrants2006)atanexercisepriceofEUR24.00perwarrant.The issue sharepricesintheabovetableindicatetheweightedaveragepriceoftheexercisedwarrants.Pursuanttothestocksplitdecideduponbythegeneralshareholders’meetingofMay23,2006,eachWarrant2004,Warrant2005andWarrant2006entitlestheholderthereoftofivesharesoftheCompany.
On December 18, 2008, the Board of Directors decided toincrease the Company’s share capital in connectionwith aprivateplacementwithqualifiedinstitutionalinvestors.Thecapital increase foranamountofEUR 5,458,797.75and theissuanceof1,332,877newcommonshareswascompletedonDecember18,2008.
On April 17, 2009, the share capital was increased throughexercise of (i) 4,508 warrants issued by the extraordinarygeneral shareholders’ meeting of May 12, 2004 (Warrants2004)atanexercisepriceofEUR22.31perwarrant,and(ii)400warrants issued by the extraordinary general shareholders’meeting ofMarch 22, 2006 (Warrants 2006) at an exerciseprice of EUR24.00 per warrant. The issue share prices inthe above table indicate theweighted average price of theexercisedwarrants.Pursuanttothestocksplitdecideduponby thegeneralshareholders’meetingofMay23,2006,eachWarrant2004andWarrant2006entitlestheholderthereoftofivesharesoftheCompany.
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modalities thatare tobedecidedby theBoardofDirectors,includingbymeansofcontributionincashorinkind,withinthelimitsaspermittedbytheBelgianCompanyCode,throughconversion of reserves and issuance premiums, with orwithoutissuanceofnewshares,withorwithoutvotingrights,throughissuanceofconvertiblebonds,subordinatedornot,throughissuanceofwarrantsorbondstowhichwarrantsorothertangiblevaluesareattached,and/orthroughissuanceofothersecurities,suchassharesintheframeworkofastockoptionplan.
Intheframeworkoftheuseofitspowerswithintheframeworkoftheauthorizedcapital,theBoardofDirectorscanlimitorcancelthepreferentialsubscriptionrightoftheshareholdersin the interest of the Company, subject to the limitationsand in accordancewith the conditions provided for by theBelgian Company Code. This limitation or cancellation canalsooccur to thebenefitof theemployeesof theCompanyand its subsidiaries, and, to the extent permitted by law,to thebenefit of oneormore specificpersons thatarenotemployeesoftheCompanyoritssubsidiaries.
ThepoweroftheBoardofDirectorstoincreasetheshareissubjecttothefollowingspecialrestrictionsandconditions:
a)TheBoardofDirectorsisauthorizedtoincreasethesharecapitalforwhateverpurposeorwhatevertransactionthatthe Board of Directors deems appropriate or necessaryprovidedandtotheextentthatthetotalamountoffundsraised (consisting of capital contribution and issuancepremium)doesnotexceedEUR18,000,000.
b)Assoonas theBoardofDirectorswillhave increased thesharecapital, inoneormoretransactions,foranamountequaltothemaximumamountprovidedabove,thentheBoardofDirectorscanonly,totheextentpossible,furtherincrease the share capital in one or more transactionsbeyondthisinitialmaximumamount,providedthatsuchincreaseisapprovedbyatleasttwothirdsofthemembersof the Board of Directors, and provided further that theincrease takes placewithin the framework of any of thefollowing transactions: (i) the issuance of stock basedremuneration or incentive plans, such as stock optionplans, stock purchase plans or other plans, for directors,management and personnel of the Company or itssubsidiaries or (ii) the issuance of financial instrumentsin consideration of the acquisition of shares, assets andliabilitiesorcombinationsofshares,assetsandliabilitiesofcompanies,undertakings,businessandassociationsor(iii)the issuanceof financial instruments inconsiderationof
On June 21, 2010, the Extraordinary General Shareholders’meetingapprovedtheformalreductionofthesharecapitalin accordance with article 614 of the Belgian CompanyCode through the incorporation (and neutralization) of(accumulated) sustained losses as demonstrated from theapprovedannualaccountsasperDecember31,2009,withoutreducingthetotalnumberofissuedandoutstandingshares,inordertoimprovetheratiooftheCompany’snetassetsvis-à-visitssharecapital.Therefore,thesharecapitalwasreducedbyEUR43,483,535.37,bringingthesharecapitalperthestatutoryaccounts from EUR54,001,197.27 to EUR10,517,661.90. ThistransactioncausedthesharecapitalunderIFRStobereducedfromEUR51,089thousandtoEUR10,518thousand.
Votingrights–Eachshareisentitledtoonevote.
Dividends – The Company has never declared or paid anydividendson its sharesanddoesnotanticipatepayinganydividends in the foreseeable future. Under Belgian law,the Company is required to allocate at least 5% of its netprofits during each financial year to the legal reserveuntilsuch reserve has reached an amount equal to 10% of theCompany’ssharecapital.AtDecember31,2010,therewerenoprofitsavailablefordistributionunderBelgianlaw.
Preferentialsubscriptionrights–Ontheoccasionofanycapitalincrease or issue of warrants, the Company’s shareholdershave a preferential subscription right. Such preferentialsubscription right is proportionate to the shareholder’sparticipation in the Company’s capital at the time of thecapitalincreaseorissueofwarrants.
Authorized capital – By virtue of the resolution of theextraordinary general shareholders’ meeting held onFebruary 18, 2011, theBoardofDirectorshasbeenexpresslyauthorized to increase the share capital in one or moretransactionswithanamountofuptoEUR10,517,661.90(the“AuthorizedCapitalAmount”),subjecttocertainlimitationsand conditionsdescribedbelow.TheBoardofDirectors canexercise thispower foraperiodstartingon thedateof thepublication of the relevant resolution of the extraordinarygeneralshareholders'meetingintheAnnexestotheBelgianOfficialGazetteandendingonthedateoftheannualgeneralshareholders'meetingtobeheldin2012whichshallresolveontheannualaccountsrelatingtotheaccountingyearendingonDecember31,2011.Thisauthorizationmayberenewedinaccordancewiththerelevantlegalprovisions.
The capital increases towhich canbedecidedaccording tothis authorization, can take place in accordance with the
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theacquisitionoflicensesorrightsonintellectualproperty(whether registered or unregistered intellectual propertyrights,orapplicationsthereof),suchaspatents,copyrights,data base rights and design rights, and know-how ortradesecretsor(iv) theissuanceoffinancial instrumentsin consideration of entering into partnerships or otherbusinessassociations.
By virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the BoardofDirectors has also been expressly authorized to increasethe share capital in one or more transactions following anotificationby theBelgianBanking, Finance and InsuranceCommission that ithasbeen informedofapublic takeoverbid on the Company’s financial instruments, throughcontributions in cashwith cancellationor limitationof thepreferentialsubscriptionrightsoftheshareholders(includingforthebenefitofoneormorewelldefinedpersonswhoarenotemployeesoftheCompany)orthroughcontributionsinkind,withissuanceofshares,warrantsorconvertiblebonds,subject to the terms and conditions provided for in theBelgianCompanyCode.TheBoardofDirectors canexercisethispowerforthesameperiodasmentionedabove.
At the date of this document, the Board of Directors hasnot used the above described (renewed) powers under theauthorizedcapital.
Externallyimposedcapitalrequirements–Noneofthecurrentcontractsof theCompany imposeanycapital requirementson the Company. Article 633 of the Belgian Company CoderequiresthatifinthestatutoryBelgian-GAAPaccountsthenetassetsofalimitedliabilitycompany(sociétéanonyme)havefallenbelow50%ofitssharecapitalasaresultofsustainedlosses, a shareholders’ meeting must be convened withintwomonthsasfromthedeterminationofsuchsituationinordertodeliberateandtoresolveuponthedissolutionoftheCompanyorthecontinuationofitsactivitiesoftheCompany(andanyotherproposedmeasurestoaddressthesituation)upon proposal of the Board of Directors of the Company.Article634oftheBelgianCompanyCodestatesthatifinthestatutoryBelgian-GAAPaccountsthenetassetsofalimitedliability company (société anonyme) have fallen below EUR61,500,anyinterestedpartycanaskthecourtstodissolvetheCompany.ThecourtsmaygranttheCompanytimetorectifythe situation.At thedateof thisdocument, theCompany’sfinancialsituation issuch thatnoactionneeds tobe takenpursuanttoeitherArticle633or634oftheBelgianCompanyCode.
5.1.5.16 FinanceleaseobligationsandotherleaseobligationsYearsendedDecember31
ThousandsofEuro(EUR) 2010 2009 2008AmountspayableunderfinanceleaseWithinoneyear 2 0 1Inthesecondtofifthyear 2 0 0Afterfiveyears 0 0 0Total 0 0 1Lessfuturefinancecharges 0 0 0Presentvalueofleaseobligations 0 0 1
Outstandingcommitmentsforfutureminimumrentpayments,whichfalldueasfollows:Withinoneyear 399 1,317 858Inthesecondtofifthyear 418 541 778Afterfiveyears 0 0 0ThefairvalueoftheCompany’sleaseobligationsapproximatedtheir carrying value. Outstanding commitments for futureminimumrentpaymentsincluderentalfeesrelatedtoleasedfacilitiesandvehicles.Theseleasecontractscanbeterminatedearlywithcertainindemnityfees.Allfiguresshownassumethattheleasecontractswillnotbeterminatedearly.
5.1.5.17 Accountspayable
a.Tradeaccountspayable
YearsendedDecember31
ThousandsofEuro(EUR) 2010 2009 2008Tradeaccountspayable 656 1,085 1,585Accrualsforinvoicestobereceived 900 1,596 939Totaltradeaccountspayable 1,556 2,681 2,524
b.Othercurrentliabilities
YearsendedDecember31
ThousandsofEuro(EUR) 2010 2009 2008Payroll 375 774 530Otheraccruals 351 778 149Totalothercurrentliabilities 726 1,552 679
The trade accounts payable and other current liabilitiesbalanceshavebeenreducedin2010followingthereductionofcostsinitiatedatend-2009andthechangeinstrategywhichhasledtoafocusonasmallersetofprojectsandproducts.
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5.1.5.19 StockOptionplans(warrants)
The Company has created several pools of warrants understockoptionplansforgranttoeligibleemployees,directors,andconsultants.
When theannualgeneral shareholders’meetingofMay23,2006decidedtohavea5-for-1stocksplitforalloutstandingshares, it also decided to modify all warrants outstandingprior to that date. The exercise price of the warrants wasleftunchangedbuteachwarrantbecameconvertibleinto5commonsharesupontheirexercise,ratherthanjust1share.
The table below provides an overview as per December 31,2010 of the warrants that have been created, granted andthatarestillexercisable.
5.1.5.18 Retirementbenefitschemes
TheCompanyoperatesdefinedcontributionsystems forallitsqualifyingemployees.TheassetsoftheschemesareheldseparatelyfromthoseoftheCompanyindesignatedfunds.
A total cost of EUR170 in 2010 (EUR185,000 in 2009 andEUR149,000 in 2008) represents contributions payable totheseschemesbytheCompanyatratesspecifiedintherulesoftheplans.
Theemployeesof theCompanyinBelgiumaremembersofastate-managedretirementbenefitschemeoperatedbythegovernment(i.e.,legalpension)andaremembersofabank-operatedprivatepensionscheme.TheCompany is requiredto contribute a specified percentage of payroll costs to theretirement benefit scheme to fund the benefits. The onlyobligation of the Company with respect to the retirementbenefitschemeistomakethespecifiedcontributions.
WarrantdataasofDecember31,2010
Plandate Totalnumbercreated
Totalnumbergranted
Totalterminated
Totalexercised
Totaloutstanding
Totalexercisable
Exerciseprice
May12,2004
30,000 29,750 4,500 25,250 0 0 EUR22.31
July12,2005
15,000 15,000 2,600 12,400 0 0 EUR23.87
March22,2006
66,700 66,700 4,438 29,974 32,288 32,288 EUR24.00
November8,2006
47,500 47,500 3,656 187 43,657 43,647 EUR7.72
April18,2007
55,100 55,100 10,864 125 44,111 42,594 EUR10.87
May25,2007
50,000 50,000 10,313 0 39,687 37,187 EUR11.42
May30,2008
61,000 49,000 16,688 0 32,312 21,812 EUR9.10
January2,2009
120,500 116,600 22,657 0 93,943 48,661 EUR6,32
June21,2010
145,000 145,000 0 0 145,000 0 EUR2.07
590,800 574,650 75,716 67,936 430,998 226,199
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Thetablebelowpresentsthesamedataastheabovetable,exceptitprovidesthenumberofcommonsharesandtheexercisepriceofthewarrantsinordertoobtainasinglecommonshare.
WarrantdataasofDecember31,2010reflectingpotentialnumberofcommonsharesunderlyingthewarrants
Plandate
Totalpotential
sharesfromwarrants
created
Totalpotential
sharesfromwarrants
granted
Totalpotential
sharesfromwarrants
terminated
Totalsharesissuedfrom
exercisedwarrants
Totalpotential
sharesfromoutstanding
warrants
Totalpotential
sharesfromexercisable
warrants
Exercisepriceperpotential
share
May12,2004
150,000 148,750 22,500 126,250 0 0 EUR4.46
July12,2005
75,000 75,000 13,000 62,000 0 0 EUR4.77
March22,2006
333,500 333,500 22,190 149,870 161,440 161,440 EUR4.80
November8,2006
47,500 47,500 3,656 187 43,657 43,647 EUR7.72
April18,2007
55,100 55,100 10,864 125 44,111 42,594 EUR10.87
May25,2007
50,000 50,000 10,313 0 39,687 37,187 EUR11.42
May30,2008
61,000 49,000 16,688 0 32,312 21,812 EUR9.10
January2,2009
120,500 116,600 22,657 0 93,943 48,661 EUR6.32
June21,2010
145,000 145,000 0 0 145,000 0 EUR2.07
1,037,600 1,020,450 121,868 338,432 560,150 355,351
ThetablebelowpresentstheoutstandingwarrantsandtheirexercisepriceattheendofDecemberofeachyear:
Warrants
Weightedaverageexerciseprice
(EUR)
Potentialsharesfromexerciseof
warrants
Weightedaverageexercisepriceper
potentialshare(EUR)Outstanding31December2004 29,750 22.31 148,750 4.46 Grantedin2005 15,000 23.87 75,000 4.77Outstanding31December2005 44,750 22.83 223,750 4.57 Grantedin2006 114,200 17.23 381,000 5.16Outstanding31December2006 158,450 18.80 602,250 4.94 Grantedin2007 105,100 11.13 105,100 11.13Outstanding31December2007 213,683 14.01 463,015 6.47 Grantedin2008 49,000 9.10 49,000 9.10Outstanding31December2008 240,560 12.41 420,148 7.11 Grantedin2009 116,600 6.32 116,600 6.32Outstanding31December2009 337,788 10.10 477,340 7.14 Grantedin2010 145,000 2.07 145,000 2.07Outstanding31December2010 430,998 7.50 560,150 5.77Exercisableat31December2010 226,199 11.08 355,351 7.05
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During the course of 2010, the Company agreed to issuenew warrants under a new warrant plan. However thisnewwarrantplanwasnot created in 2010norhas it beencreatedyetasofthedateofthisdocument.In2010,pertheemploymentcontractandjobofferlettersgivento2newhires,theCompanyagreed to issue these individuals85,000newwarrants. Furthermore, the Board of Directors meeting ofDecember 2010 decided to award 110,000 newwarrants tocertainemployeesandconsultantsoftheCompany.Thistotalof195,000newwarrantshasnotbeencreatednorissuedyetandisnot includedintheabovetable.Theexercisepriceofthesenewwarrantshasnotbeendeterminedyetastheywillbebasedon the 30-dayaveragemarketpriceprior to theirissuanceandcreationbeforeanotary.TheCompanyexpectsto issue these 195,000 newwarrants in the course of 2011.Thesenewwarrantsstilltobeissuedarenotreflectedintheabovetables.
Furthermore, the Board agreed in 2010 to award 30,000additionalnewwarrants to theCEOasavariablebonusforhis 2010 performance.These 30,000warrants have not yetbeen creatednor issuedandarenot included in theabovetable.Theexercisepriceofthesenewwarrantshasnotbeendeterminedyetastheywillbebasedonthe30-dayaveragemarket price prior to their issuance and creation before anotary. The Company expects to issue these 30,000 newwarrantsinthecourseof2011.These30,000newwarrantsareexpectedtobeimmediatelyvesteduponthedateofcreationandissuance,howevertheycannotbeexercisedpriortotheirthirdyearanniversary.
A.Warrant Pool of 2004 for employees, directors,andconsultants
Byadecisionof theextraordinary shareholders’meetingofMay 12, 2004, the Company issued 30,000warrants givingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequal to the fair market price of the underlying commonsharesatthedateofgrant.
The warrants were granted to selected beneficiaries bydecision of the nomination and remuneration committeeand the Board of Directors. Under this plan, 25% of thewarrants become exercisable during each year followingthedateof thegrant, itbeingunderstoodhowever thatnowarrantsareexercisableunlessthebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Theduration
ofthewarrantsis5yearsfromthedateofthecreationofthewarrants.Warrants that have not been exercised within 5yearsoftheircreationbecomenullandvoid.
29,750ofthe30,000warrantsinthiswarrantpoolhavebeengranted. The 250 non-granted warrants were cancelled. Afurther500ofthegrantedwarrantswereterminatedin2006and4,000in2009.Theannualgeneralshareholders’meetingofMay23, 2006modified thewarrantsof thispool so thattheybecomeconvertibleinto5commonsharesuponexerciserather thanjust1share.Thiswasdoneat thesametimeasalloutstandingsharesweresplit5-for-1.Nowarrantsremainoutstandingor exercisableunder thisplanatDecember 31,2009andDecember31,2010.
B.WarrantPoolof2005foremployeesanddirectors
Byadecisionof theextraordinary shareholders’meetingofJuly12,2005,theCompanyissued15,000additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequaltothefairmarketpriceoftheunderlyingcommonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthis plan, 25% of the warrants become exercisable duringeachyearfollowingthedateofthegrant,itbeingunderstoodhowever that no warrants are exercisable unless thebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany. Non-exercisable warrants become exercisable incaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationofthewarrantsis5yearsfromthedateofthecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin 5 yearsof their creationbecomenullandvoid.
Allwarrantsinthiswarrantpoolhavebeengranted.Theannualgeneralshareholders’meetingofMay23,2006modifiedthewarrantsofthispoolsothattheybecomeconvertibleinto5commonsharesuponexerciserather thanjust1share.Thiswasdoneat the same timeasall outstanding sharesweresplit5-for-1.Nowarrants remainoutstandingorexercisableunderthisplanatDecember31,2010.
C.Warrant pool of March 2006 for employees, directors, andconsultants
By a decision of the extraordinary shareholders’ meetingof March 22, 2006, the Company issued 66,700 additionalwarrants giving the beneficiaries the right to purchasecommonsharesoftheCompany.Thewarrantsweregranted
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withanexercisepriceequal to the fairmarketpriceof theunderlyingcommonsharesatthedateofgrant.Thewarrantswere granted to selected beneficiaries by decision of thenomination and remuneration committee and the Boardof Directors. Under this plan, 25% of the warrants becomeexercisableduringeachyearfollowingthedateofthegrant,itbeingunderstoodhoweverthatnowarrantsareexercisableunless the beneficiary has provided as least 1 full year ofservices to theCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationofthewarrantsis 10 years from the date of the creation of the warrants.Warrants that have not been exercised within 10 years oftheircreationbecomenullandvoid.
Allwarrantsinthiswarrantpoolhavebeengranted.In2007,2,000ofthesewarrantswerecancelledduetothefactthatthe warrant beneficiaries ceased providing services to theCompany, a further 1,337 warrants were cancelled in 2008,and additional 1,101 warrants were also cancelled in 2009.The annual general shareholders’meeting ofMay 23, 2006modified the warrants of this pool so that they becomeconvertibleinto5commonsharesuponexerciseratherthanjust1share.Thiswasdoneatthesametimeasalloutstandingshares were split 5-for-1. The number of outstanding andexercisable warrants under this Plan remains the same atDecember31,2010asatDecember31,2009.
D.WarrantpoolofNovember2006foremployees
ByadecisionoftheBoardofDirectors’meetingofNovember8,2006,theCompanyissued47,500additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequal to the fair market price of the underlying commonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthisplan,25%ofthewarrantsbecomeexercisableduringeachyearfollowingthedateofthegrant(onastraight-linebasis,or6.25%perquarter) itbeingunderstoodhowever thatnowarrantsareexercisableunlessthebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationof thewarrants is 10years from thedateof thecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin10yearsoftheircreationbecomenullandvoid.Allwarrantsinthiswarrantpoolhavebeengranted.In2007,938ofthesewarrants were cancelled due to the fact that the warrant
beneficiaries ceased providing services to the Company. Afurther2,718warrantswerecancelledin2010.
E. WarrantpoolofApril2007foremployees
Byadecisionof theBoardofDirectors’meetingofApril 18,2007,theCompanyissued55,100additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequal to the fair market price of the underlying commonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthisplan,25%ofthewarrantsbecomeexercisableduringeachyearfollowingthedateofthegrant(onastraight-linebasis,or6.25%perquarter) itbeingunderstoodhowever thatnowarrantsareexercisableunlessthebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationof thewarrants is 10years from thedateof thecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin10yearsoftheircreationbecomenullandvoid.Allwarrantsin this warrant pool have been granted. Respectively 3,812and738ofthesewarrantswerecancelledduetothefactthatthe warrant beneficiaries ceased providing services to theCompany in 2008and 2009.A further6,314warrantswerecancelledin2010.
F. WarrantpoolofMay2007fordirectorsandconsultants
Byadecisionof theextraordinary shareholders’meetingofMay25,2007,theCompanyissued50,000additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequaltothefairmarketpriceoftheunderlyingcommonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthis plan, 25% of the warrants become exercisable duringeachyearfollowingthedateofthegrant(onastraight-linebasis, or 6.25% per quarter) it being understood howeverthatnowarrantsareexercisableunless thebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeof control of the Company. All warrants were granted forfree.The duration of thewarrants is 5 years from the dateofthecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin 5 years of their creation become null andvoid.In2010,10,313warrantsunderthisPlanwerecancelled
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I. WarrantpoolofMay2010forcertaindirectors
By a decision of the extraordinary general shareholders’meeting of June 21, 2010, the Company issued145,000additionalwarrantsgivingthebeneficiariestherighttopurchase common sharesof theCompany.Thewarrantsweregrantedwithanexercisepriceequaltothefairmarketpriceoftheunderlyingcommonsharesatthedateofgrant.Under this plan, 25% of the warrants become exercisableduringeachyearfollowingthedateofthegrant(onastraight-linebasis,or6.25%perquarter)itbeingunderstoodhoweverthatnowarrantsareexercisableunless thebeneficiaryhasprovided as least 1 full year of service (as director) to theCompany. Non-exercisable warrants become exercisable incaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationofthewarrantsis5yearsfromthedateofthecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin 5 yearsof their creationbecomenullandvoid.All145,000warrantsweregrantedtoagroupoffournewdirectorsoftheCompany,includingtheCEO.The145,000warrantsremainoutstandingattheendof2010.
ThefollowingtableprovidesanoverviewoftheoutstandingwarrantsperpersonnelcategoryatDecember31,2010:
Category Numberofwarrants
Executivedirectors 130,000Non-executivedirectors 30,000
ManagementTeam 42,190Otheremployeesandconsultants 357,960
TotaloutstandingatDecember31,2010 560,150
J. Accountingforshare-basedpayment
The warrants have been accounted for in accordance withInternational Financial Reporting Standard 2 Share-basedpayment.IFRS2takeseffectforallwarrants.
The share-based compensation expense recognized in theincomestatementsassuchisgivenbelowasisthecumulatedbalancesheetamount:
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Share-basedcompensation
170 348 281
CumulatedShare-basedcompensation
2,151 1,981 1,633
The Cumulated Share-based compensation amount is partof theTotal Shareholders’ Equity on thebalance sheet.Thisamountispresentedonthebalancesheetforbothexercisedandnon-exercisedwarrants.
G.WarrantpoolofMay2008foremployees
Byadecisionof theBoardofDirectors’meetingofMay 30,2008,theCompanyissued61,000additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequal to the fair market price of the underlying commonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthisplan,25%ofthewarrantsbecomeexercisableduringeachyearfollowingthedateofthegrant(onastraight-linebasis,or6.25%perquarter) itbeingunderstoodhowever thatnowarrantsareexercisableunlessthebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationof thewarrants is 10years from thedateof thecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin10yearsoftheircreationbecomenullandvoid.Allwarrantsinthiswarrantpoolhavebeengranted.In2008,875ofthesewarrants were cancelled due to the fact that the warrantbeneficiariesceasedprovidingservicestotheCompany,8,625warrants were cancelled in 2009, and 7,188 warrants werecancelledin2010.
H.WarrantpoolofJanuary2009foremployees
ByadecisionoftheBoardofDirectors’meetingofJanuary27,2009,theCompanyissued120,500additionalwarrantsgivingthebeneficiariestherighttopurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequal to the fair market price of the underlying commonshares at the date of grant. The warrants were granted toselected beneficiaries by decision of the nomination andremunerationcommitteeandtheBoardofDirectors.Underthisplan,25%ofthewarrantsbecomeexercisableduringeachyearfollowingthedateofthegrant(onastraight-linebasis,or6.25%perquarter) itbeingunderstoodhowever thatnowarrantsareexercisableunlessthebeneficiaryhasprovidedasleast1fullyearofservicestotheCompany.Non-exercisablewarrantsbecomeexercisableincaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationof thewarrants is 10years from thedateof thecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin10 years of their creation become null and void. The 3,900non-grantedwarrantswerecancelledin2009.In2010,22,657warrantswerecancelledunderthisPlan.
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Theweightedaverageexercisepriceofalloutstandingwarrants(vested and non-vested warrants; assuming 1 warrant = 1share)isEUR5.77.Theweightedaverageexercisepriceofalloutstandingvestedwarrants(assuming1warrant=1share)isEUR7.05.Theweightedaverageremainingcontractuallifeofalloutstandingwarrantsattheendof2010is5.2years.
The fair value of eachwarrant is estimated on the date ofgrantusingtheBlack-Scholesmethodologywiththefollowingassumptions:
Afterstocksplit5:1
Warrants2004granted
12May2004toBelgian
beneficiaries
Warrants2004granted
12May2004toother
beneficiaries
Warrants2005granted
12July2005toBelgian
beneficiaries
Warrants2005granted
12July2005toother
beneficiaries
Warrants2006granted
21March2006toBelgian
beneficiaries
Warrants2006granted
21March2006toother
beneficiariesNumberofwarrantsgranted 28,750 120,000 50,000 25,000 201,250 132,250
Exerciseprice(EUR) 4.46 4.46 4.77 4.77 4.80 4.80Expecteddividendyield 0% 0% 0% 0% 0% 0%
Expectedstockpricevolatility 51% 51% 51% 51% 51% 51%Risk-freeinterestrate 3.25% 3.25% 3.25% 3.25% 3.25% 3.25%
Expectedduration(months) 51.7 48.1 43.7 40.7 88.4 54.4
Afterstocksplit5:1
Warrants2006granted
2October2006toBelgian
beneficiaries
Warrants2006granted
2October2006toother
beneficiaries
Warrants2007granted
4January2007toBelgian
beneficiaries
Warrants2007granted
4January2007toother
beneficiaries
Warrants2007granted
25May2007toBelgian
beneficiaries
Warrants2007granted
25May2007toother
beneficiariesNumberofwarrantsgranted 19,500 28,000 22,100 23,000 15,000 35,000
Exerciseprice(EUR) 7.72 7.72 10.87 10.87 11.42 11.42Expecteddividendyield 0% 0% 0% 0% 0% 0%
Expectedstockpricevolatility 65% 65% 65% 65% 65% 65%Risk-freeinterestrate 4.41% 4.41% 4.41% 4.41% 4.41% 4.41%
Expectedduration(months) 84.0 72.0 87.0 68.9 55.3 37.2
Afterstocksplit5:1
Warrants2008granted
30May2008toBelgian
beneficiaries
Warrants2008granted
30May2008toother
beneficiaries
Warrants2009granted
2January2009toBelgian
beneficiaries
Warrants2009granted
2January2009toother
beneficiaries
Warrants2010granted
21June2010toBelgian
beneficiaries
Warrants2010granted
21June2010toBelgian
beneficiariesNumberofwarrantsgranted 12,000 37,000 63,400 53,200 135,000 10,000
Exerciseprice(EUR) 9.10 9.10 6.32 6.32 2.07 2.07Expecteddividendyield 0% 0% 0% 0% 0% 0%
Expectedstockpricevolatility 52.30% 52.30% 57.24% 57.24% 76.17% 76.17%Risk-freeinterestrate 4.92% 4.92% 3.98% 3.98% 3.40% 3.40%
Expectedduration(months) 82.1 61.1 74.08 62.88 51.35 33.34
Theweightedaveragerisk-freeinterestratesusedarebasedonBelgianSovereignStripsatthedateofgrantwithatermequaltotheexpectedlifeofthewarrants.
Theexpectedvolatilitywasdeterminedusingtheaveragevolatilityofthestockoverthelasttwoyearsatthedateofthegrantdatewhensufficientdatawereavailableorusingtheaveragevolatilityofthesectorwhenthesedatawerenotavailable.
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5.1.5.20Relatedparties
Transactions between MDxHealth SA, MDxHealth Inc.,MDxHealth PharmacoDx BVBA and OncoMethylomeSciencesBV,whicharerelatedparties,havebeeneliminatedin consolidation and are not disclosed in this note. Theintercompany services between the fourMDxHealth groupentitiesrelatetoR&Dandadministrativeservicescarriedoutbythesubsidiarycompaniesonbehalfoftheparentcompanyand to administrative services carried out by the parentcompany for the subsidiaries. In 2010, the services chargedby the subsidiaries to the parent company amounted toEUR5million(EUR1.2millionfromOncoMethylomeSciencesBV, EUR2 million from MDxHealth PharmacoDx BVBA andEUR1.8millionfromMDxHealthInc.).
Transactions between the Company and its employees,consultantsordirectorsaredisclosedbelow.
Therewerenootherrelatedpartytransactions.
Remunerationofkeymanagementpersonnel
At December 31, 2010, the Executive Management Teamcomprised5members:1.ChiefExecutiveOfficerandexecutivedirector,Dr.JanGroen2.VPofCorporateandLegalAffairs,Mr.JosephSollee3.ChiefFinancialOfficer,Decofisprl(representedbyMr.PhilipDevine)4.Vice-PresidentofCommercialOperations,Mr.ChristopherThibodeau
5.VPofR&D,Dr.JamesClark
At December 31, 2010, the broader Management Teamcomprisedthefollowingadditionalmember:6.VP of Regulatory Affairs and Quality Systems,Dr.MelissaThompson
Their combined remunerationpackage, including employertaxes,amountedtothefollowing(allwarrantandsharedatafor all years reflect theMay 23, 2006 5-for-1 stock split andrelatedchangetothewarrantplans):
YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008Numberofmanagementmembersandexecutivedirectors
6 11 10
Short-termemployeebenefits EUR742 EUR1,798 EUR1,697Post-employmentbenefits EUR19 EUR60 EUR39Otheremploymentcosts EUR115 EUR329 EUR237Totalbenefits EUR876 EUR2,187 EUR1,973Numberofwarrantsoffered 130,000 60,000 25,000Cumulativeoutstandingwarrants
172,190 263,690 221,690
Exercisablewarrants 29,822 179,503 121,068Exercisedwarrants 0 10,000 27,935IFRSshare-basedcompensationexpense
EUR63 EUR156 EUR140
Outstandingreceivablesfrompersons
0 0 0
Outstandingpayablestopersons
EUR8 0 0
Sharesowned 10,000 535,966 648,450
In 2010, as an aggregate for the group comprised by the 5executivemanagers,nostockoptionswereexercised,130,000newstockoptionsweregrantedandacceptedbytheCEO(foranannualized IFRScostofEUR9),andnosharesweresold.TheBoardandtheCompanyhavecommittedin2010tograntanadditional30,000warrants to theCEOand135,000newwarrantstothe4remainingexecutivemanagers.Thesestockoptionshavenotbeencreatednorissuedyet,donotyethaveafixedexerciseprice,andarenotincludedintheabovetable.
In 2009, as an aggregate for the group comprised by the5 executivemanagers, 10,000 stock optionswere exercised,30,000newstockoptionsweregrantedandaccepted(foranannualized IFRS cost ofEUR25,626), and 4,280 sharesweresold.
No loans, quasi-loans or other guarantees are outstandingwithmembersoftheExecutiveManagementTeam.
Transactionswithnon-executivedirectors
The non-executive and non-independent directors receivea fee for attending and preparing for Board meetings,for assisting the Company with Board matters, and theyreceive reimbursement for expenses directly related tothe Board meetings. In 2010, 2009 and 2008, respectivelyEUR34,000, EUR69,000 and EUR33,000 were paid as feesand reimbursement for expenses to these non-executivenon-independentmembersoftheBoardofDirectors.
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eventuallyusedinacommercializedproduct.Inaddition,theCompanymustprovidethelicensorwithperiodicreports.
C.Commercial and intellectual property sub-licensingagreements
TheCompanyhasenteredintonumerouspartneringandsub-licensingagreements.
PharmacoDxPartners
MDxHealth collaborates with a range of pharmaceuticalcompanies in the identification and development ofbiomarkers for potential use as companion diagnostics fortheirtherapeuticdrugsorvaccines.MDxHealthusuallyderivesrevenuesfromprovidingR&Dandclinicaltestingservicestothesepartners.The identityof thesepartners isnotalwaysdisclosed. In addition to the pharmaceutical collaborationsdescribed in detail below, MDxHealth has entered intocollaborations in this manner with other pharmaceuticalcompaniessuchasAbbottLaboratories,F.Hoffmann-LaRocheLtd.,andPfizer.
MerckSeronoIn 2008, MDxHealth entered into a licensing and testingagreementwithMerck KGaA of Darmstadt, Germany (nowMerckSerono).Underthetermsoftheagreement,MDxHealthprovidesMGMTgenepromotermethylationtestingservicesforMerck'sclinicaltrialprogramofCilengitide.TheMDxHealthMGMTtestisbeingusedintwoMerckclinicaltrialswithitsdrug Cilengitide for patients with newly diagnosed braintumors (glioblastomas), including a Phase III clinical trial(CENTRIC)andPhaseIIclinicaltrial(CORE).PatientselectionfortheseMercktrialsisbasedontheMGMTgenepromotermethylationstatusoftheirtumortissue.
Aspartoftheagreement,Merckobtainedarightofreferenceto the MDxHealth MGMT test in its packaging insert (i.e.drug label) for Cilengitide, andMDxHealth agreed to granttoMerckaworldwide,indefiniteduration,andnon-exclusivelicense to use the results of the MDxHealth MGMT genepromoter methylation assay for optimizing glioblastomamultiforme (GBM) treatmentwithCilengitide. In return forsuchcommitment,Merckagreed toassistMDxHealth in itsdevelopmenteffortsfortheMGMTAssay,aswellastocertainlabelingobligationsinfavorofMDxHealth.Underthetermsoftheagreement,therightstotheMGMTassayareretainedexclusivelybyMDxHealth.
The independent directors receive a fee for attending andpreparingmeetingsoftheBoardofDirectors,forassistingtheCompanywithBoardmatters,andtheyreceivereimbursementforexpensesdirectlyrelatedtotheBoardmeetings. In2010,2009 and 2008, respectively EUR128,000, EUR87,000 andEUR100,000werepaidasfeesandexpensereimbursementtoindependentmembersoftheBoardofDirectors.
5,000 warrants were granted to each of the 3 new non-executive directors who joined the Board of Directors in2010.Byadecisionoftheextraordinarygeneralshareholders’meetingofJune21,2010,theCompanyissued15,000warrantsto non-executive directors in 2010 giving them right topurchasecommonsharesoftheCompany.Thewarrantsweregrantedwithanexercisepriceequaltothefairmarketpriceoftheunderlyingcommonsharesatthedateofgrant.Underthis plan, 25% of the warrants become exercisable duringeachyearfollowingthedateofthegrant(onastraight-linebasis, or 6.25% per quarter) it being understood howeverthatnowarrantsareexercisableunless thebeneficiaryhasprovided as least 1 full year of service (as director) to theCompany. Non-exercisable warrants become exercisable incaseofachangeofcontroloftheCompany.Allwarrantsweregrantedforfree.Thedurationofthewarrantsis5yearsfromthedateofthecreationofthewarrants.Warrantsthathavenotbeenexercisedwithin 5 yearsof their creationbecomenullandvoid.
5.1.5.21 Significantagreements,commitmentsandcontingencies
A.Collaborative research agreements and clinical researchagreements
TheCompanyhasentered intonumerousagreementswithuniversities, medical centers and external researchers forresearch and development work and for the validation oftheCompany’s technologyandproducts.Theseagreementstypicallyhavedurationsofonetothreeyears.TheCompanymust pay fixed fees to the collaborators and in exchangereceivesaccessandrightstotheresultsofthework.
B. Intellectualpropertyin-licensingagreements
TheCompanyhasentered intonumerousagreementswithuniversities and companies for in-licensing intellectualproperty. These agreements typically require the Companyto pay an up-front fee, annual maintenance fees and/orminimumannualroyaltyfees,legalfeesrelatedtothepatents,and certain milestone and royalty fees if the patents are
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with MDxHealth to assess the potential use of one ofMDxHealth’s DNA methylation specific PCR biomarkers inGSK’simmunotherapydevelopmentprogram.
MolecularDiagnosticsPartners
ExactSciencesIn2010,MDxHealthenteredintoanexclusivelicenseagreementwithExactSciencesCorporationforstool-basedscreeningofcolorectal cancer. Under the terms of the agreement, ExactSciences obtained exclusive, worldwide rights to use up totwo ofMDxHealth’s DNAmethylation biomarkers in stool-baseddetectionofcolorectalcancer,aswellasnon-exclusiveaccesstoMDxHealth’sMSPplatformtechnologyforusewiththosebiomarkers.Inreturn,MDxHealthreceivedanupfrontlicensepaymentandisentitledtoreceive,subjecttocertainconditions,milestonepaymentsandroyaltiesonnetsales.
In January 2011, following Exact Sciences’ completion ofpreliminary studies, MDxHealth announced the electionby Exact Sciences to include an MDxHealth methylationbiomarker, together with MDxHealth’s MSP platformtechnology, in Exact Sciences’ ColoGuard stool-based DNAcolon cancer screening test. This confirmation triggered amilestonepaymenttoMDxHealthfromExactSciences.
VeridexIn December 2010, MDxHealth entered into two non-exclusive licenses with Veridex LLC (a Johnson & JohnsonCompany)for theuseofcertainofMDxHealth’sproprietaryDNAmethylationproductsincolorectalandprostatecancerscreening. Under the agreements, Veridex licensed non-exclusive rights for the performance of service testing atits own laboratories worldwide using MDxHealth’s DNAmethylationbiomarkersforuseinblood-baseddetectionofcolorectalcancer,aswellastissue-andurine-baseddetectionofprostatecancer.Inreturn,MDxHealthisentitledtoreceive,subject to certain conditions, milestone payments androyalties on net sales. The new license agreements replaceprioragreementsfirstenteredintowithVeridexLLCin2004granting exclusive worldwide rights to prostate cancertestingservicesandkits.TheselicensegrantstoVeridexweretheresultofanagreementbetweenMDxHealthandOrtho-ClinicalDiagnostics,Inc.(OCD,aJohnson&JohnsonCompany)that was entered into in 2003, whenMDxHealth acquiredcertainmethylationmarkers and technology fromTibotec-Virco (a Johnson& JohnsonCompany).Under the terms ofthis2003agreement,MDxHealthagreedtofirstoffertoOCDthe exclusive right to license, at commercially reasonableterms, any product in the human in vitro diagnostics fieldthatcontainsthosetechnologycomponentsthatwereonceownedbyTibotec-Virco. Since 2003,MDxHealthhasoffered
Pfizer,Inc.In2010,MDxHealthentered intoacollaborationagreementwithPfizertopursuetheidentificationanddevelopmentofaMDxHealthbiomarkerpredictingresponsetoPfizer’scancerdrug candidate for PARP inhibition, PF-01367338. NewcastleUniversity (UK) is also participating in the collaboration.The collaboration is assessing the potential to develop anMDxHealth test as a companion diagnostic test to guidetreatment decisions in treatment of ovarian and breastcancerswiththePfizerdrugcandidate.
Under the termsof theagreement,MDxHealth isprovidingmarker discovery, assay development and clinical trialtesting services to Pfizer, and will retain rights to theeventualcommercialcompaniondiagnostictest.Inaddition,the partners have announced their mutual intentionto ultimately set up a high throughput platform that isclinicallyvalidatedtorapidlytestforepigeneticdefectsinkeyDNAdamagerepair (DDR)genestosupport thedesignandimplementationofclinicaltrialstoenablethedevelopmentofoptimized,targetedtherapies.
Schering-PloughIn2005,MDxHealthenteredintoacollaborationandlicenseagreement with Schering-Plough Corporation. Under thelicense, Schering-Plough received a worldwide, indefiniteduration, and non-exclusive right from MDxHealth to usethe results of theMDxHealthMGMT assay to evaluate themethylationstatusoftheMGMTgeneinpatientstreatedorto be treatedwith temozolomide or other Schering-Ploughproducts. Under the terms of the agreement, the rights tothe MGMT assay are retained exclusively by MDxHealth.MDxHealthreceivedanupfrontlicensepayment,amilestonepayment and is entitled, subject to certain conditions, tofurther milestone payments and sample processing feesfromSchering-Plough.
Underthecollaboration,MDxHealthprovidesMGMTtestingservicesforcertainofSchering-Plough’sclinicaltrialsinvolvingtemozolomide,includingamulti-center,international,phaseIIIclinicaltrialforbraincancer,aswellasotherclinicaltrialsoutsideofbraincancer.
GlaxoSmithKlineBiologicals(GSK)In2010,MDxHealthexpanded itsexistingrelationshipwithGlaxoSmithKlineBiologicals(GSK)topursuethedevelopmentand testing of new companion diagnostic tests that canpotentiallybeusedwithGSK’simmunotherapeuticoncologyprogram.MDxHealth’scollaborationwithGSKwas initiatedin 2007underaWallonia-BioWingrant concerningmutualresearch in the immunotherapeutic oncology field. Undertheexpandedagreementsignedin2010,GSKiscollaborating
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based bladder cancer tests. In return,MDxHealth received anupfront licensepayment and is entitled to receive, subject tocertain conditions, milestone payments and royalties on netsales.
D.Litigation
Since the incorporation of the Company, the Companyhas not incurred any claims by third parties nor filed anyclaimsagainstthirdparties.Asaresult,theCompanyhasnoprovisionsforlitigationatthistime.
E. Grants
Since its incorporation, MDxHealth has been awardedmultiplegrantsfromtheBelgianregionalgovernments,fromtheEuropeanUnion,andfromtheDutchgovernment.
To date, MDxHealth has been approved for a total ofEUR9.2millioningrantsandhasreceivedgrantpaymentsforatotalofEUR7.5million.AtotalofEUR7.5millionhasalreadybeenrecognizedasrevenuesintheperiod2004-2010. If theCompany respects the conditions of the already approvedgrants, the Company stands to receive a further EUR1.2million in grant payments.The total revenue generated bythegrantswasEUR568thousandin2010.
Themainactivegrantsarethefollowing:
productsunderthisfirstrighttolicenseoptioninthefieldsofprostate,lung,colon,cervical,brainandbladdercancer,ofwhichVeridexhasexerciseditslicenserightsonlyforProstateand blood-based colon, each on a non-exclusive basis forservicetesting.
LabCorpIn 2008, MDxHealth granted to Laboratory Corporation ofAmerica(LabCorp)aroyaltybearingsublicensetotheMGMTtest(exclusivelicensefortheNorthAmericanmarketonly,ofindefiniteduration,andforservice testingonly)andenteredinto an agreement to supply reagents to LabCorp for itscolorectal cancer screening test (ColoSure). In 2007, LabCorpobtainedanon-exclusivelicensetoperformlaboratory-baseddiagnostic testing services in North America on prostatetissuesamplesusingselectedMDxHealth’sDNAmethylationbiomarkers.In2008,LabCorpbegantocommercializethethreeafore-mentionedtestsinNorthAmerica.
PredictiveBiosciencesIn2010,MDxHealthenteredintoanexclusivelicenseagreementwithPredictiveBiosciencesfordiagnosticapplicationsinbladdercancer.Underthetermsoftheagreement,PredictiveBiosciencesobtainedexclusiverights in theUnitedStatesfor theuseofanumberofMDxHealth’sDNAmethylationbiomarkersinbladdercancertestingofurine,bloodandotherbodilyfluids.MDxHealthretainedexclusiveworldwiderightstothesemarkersintissue-
(1)Name(2)Source(3)Description(4)Applicability
StartDate
EndDate
EURAmountApproved
EURAmountReceived MainConditions
(1)BIOWINproject(2)Belgiangovernment–MarshallPlan(3)researchintoearlycancerdetectiontest(4)coverspartofpersonnel/labcosts,collaboratorcosts,andsamplecollectioncosts
1/7/2007 30/6/2011(extendedcomparedtooriginalenddateof31/12/10)
EUR2,179,378 EUR1,858,471 Respectplansandbudget.311Ktobepaidduringinitialperiod,restatendofeachsemi-annualperiod,except
last15%paidatend
(1)CTMMDecode(2)Dutchgovernment–SenterNovem(3)researchanddevelopmentintocoloncancerdetectiontest(4)coverspartofpersonnel/labcosts,equipmentcosts,andsamplecollectioncosts
1/9/2008 31/08/2013 EUR189,016 EUR89,691 Respectplansandbudget.Comments:Projectwas
modifiedin2010tomeetneedsofCompany
(1)CTMMAirforce(2)Dutchgovernment–SenterNovem(3)researchanddevelopmentintolungcancerandhead&neckcancerdetectiontest(4)coverspartofpersonnel/labcosts,equipmentcosts,andsamplecollectioncosts
1/10/2008 30/09/2013 EUR100,000 EUR42,184 Respectplansandbudget.Comments:Projectwill
continuetonormalend-datebutcompanyexpensedallremainingcostsofproject
in2010(1)Eurotransbio(2)Belgiangovernment(Wallonia),(3)R&Dforbiomarkersusedforassessingaggressivenessofbladdercancer(4)coversmainlypersonnelandsamplecollectioncosts
1/9/2010 1/9/2012 EUR770,000 EUR0 Respectplansandbudget.Comments:Projectfull
start-uponlyoccurredinQ12011,thusnorevenuefrom
projectrecognizedin2010
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bytheamount.Whenthegrantisrecognizedasincome,thepayableisreducedbytheamount.Thegrantisonlyrecordedasapayable/receivablewhen(i)thegranthasbeenapprovedbythegrantingparty,(ii)theamountsaremeasurable,and(iii)theCompanybelievesitwillmeettheconditionsnecessarytobeabletoreceive/usethegrant.
5.1.5.22 Subsequentevents
OnJanuary10,2011,MDxHealthannouncedthatitspartner,•Exact Sciences Inc., has confirmed that it is pursuing thedevelopmentofitsstool-basedcolorectalcancerscreeningtestusingabio-markerand theMSP-technologywhich itin-licensedfromMDxHealthOnJanuary21,2011MDxHealthannouncedtheconvocation•ofanextraordinaryshareholdersmeetingtobeheldFebruary14, 2011. At this meeting, the shareholders renewed theauthorizedsharecapitalandallowedtheBoardofDirectorstousethecapitalforstandardcorporatetransactionssuchascapitalincreases,M&A,andnewwarrants.On January 26, 2011, MDxHealth announced that the•CompanyPredictiveBioSciencesInchadpublisheditsfirstsetofclinicaldataforabladdercancerscreeningtestusingtheMSPtechnologyandmarkerswhichithadin-licensedfromMDxHealthin2010.On January 31, 2011, MDxHealth announced a new•partnership with Pfizer Inc. and Newcastle Universityfor the development of potential companion diagnostictests for the cancer PARP-inhibitor drugwhich Pfizer hasin development.MDxHealthmay receive service fees andmilestonefeesfromthisdeal.Thegoalistodevelopatestthat could eventually be commercialized with the drug,if the drug and the test are eventually successful andapproved.
5.1.5.23 Reconciliation between the consolidated financialstatementsunderlocalGAAPandIFRS
TheCompanypresents the financial statementsunder IFRSfor the previous three years. The date of transition for theCompany is as such January 1, 2003.TheBoardofDirectorsdecided to start preparing and filing the Company’sconsolidatedfinancialstatementsunderIFRSasofDecember31,2005andthereafter.
The statutory annual accounts presented under section 6are prepared on a non-consolidated basis and under local(Belgian)GAAP.
In 2008, the subsidiary of MDxHealth based in theNetherlands was approved for a 2-year grant project forcolorectal cancer research.This projectwas in coordinationwith the EuroTransBio and SenterNovem organizations.As part of the project,MDxHealthwas approved for up toEUR499,540 in grant payments, of which EUR124,878 waspaidasanup-frontadvance.Theprojectwasneverperformeddue to changes in the project and the eventual change instrategy of theCompany.None of the grant amountswererecognizedasrevenue,theprojectgrantamountshavenowexpired, and MDxHealth expects in 2011 to reimburse theup-frontadvancepayment it received.Assuch,a liabilityofEUR124,878 is recorded in the accounts of the Company atDecember31,2010.
In October 2008, the subsidiary of MDxHealth based inthe Netherlands was approved for a 5-year project calledCTMM AirForce for R&D into lung and head&neck cancerapplications.MDxHealthneedstomakecertaincontributionsto the project and receives certain grant payments. Sincethe project cannot be interrupted by request of the Dutchgovernment and since MDxHealth does not believe theprojectwillgenerateanypositiveresults,MDxHealthdecidedin2010toexpensein2010all thecontributionsMDxHealthmustmaketotheprojectoveritsremainingterm.AnygrantsMDxHealthmayreceiveintheremainingtermoftheprojectwillberecognizedasincomeinthecorrespondingremainingtermoftheproject.
MDxHealth in 2010 received a proposal from theWalloongovernment to extend the subsidy for the lung cancerproject.ThispossibleextensionisstillunderdiscussionandassuchtheCompanyhasnotrecognizedin2010anysubsidyrevenues from this project nor recorded any receivables/payables related to the potential grant extension. TheCompany continued to perform work on the lung cancerprojectin2010.
Thegrantsaresubjecttoperiodicreportingonthestatusoftheprojectsandonthecostsincurredtodatebytheproject.The approved amounts are the maximum amounts theCompanystandstoreceive.IftheCompanyspendslessontheprojectsthantheoriginalbudgetordeviatesfromtheplanswithoutconsent,thenitrisksreceivinglowergrantpaymentsthantheamountsthatwereinitiallyapproved.
Whenagovernmentgrant isallocated, theCompanybooksthefullamountasbothareceivableandapayable.Noincomeisrecognizedwhenthegrantisapproved,butisfullydeferredat thatpoint.When it is received, the receivable is reduced
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Equityreconciliationandprofit&lossreconciliationbetweenlocalGAAPandIFRS(onaconsolidatedbasis)
YearsendedDecember31in‘000Euro 2010 2009 2008
Equity Lossoftheyear
Equity Lossoftheyear
Equity Lossoftheyear
UnderBelgianGAAP 10,761 (8,100) 18,855 (15,964) 34,709 (10,463)Purchaseofintangibleassets (7,035) (7,035) (590) (6,445) (530)Depreciationofintangibleassets 6,997 17 6,980 2,586 4,394 850DeferredtaxesassetseliminationNL 0 0 15 (15) (11)Governmentgrant 0 0 0 (38)Share-basedcompensation (170) (348) (281)Deductionofcapitalincreasecosts 281Totalrestatements (38) (153) (55) 1,663 (2,066) 271UnderIFRS 10,723 (8,253) 18,800 (14,301) 32,643 (10,192)
In the statutory accounts the costs related to certain•researchanddevelopmenthadbeenpreviouslycapitalizedand amortized on a straight-line basis over a period of 5years, starting at January 1, 2003. In the IFRS statementsdevelopment costs are capitalized to the extent that allconditions for capitalization have been satisfied (to dateandcurrentlynoR&DiscapitalizedintheCompany’sIFRSaccounts).ToalignthestatutoryaccountswiththoseintheconsolidatedIFRSaccounts,in2009,theCompanydecidedtofullyexpense theresearchanddevelopmentcosts thatwerepreviouslycapitalizedinthestatutoryaccounts.ThischangehasnoimpactontheconsolidatedIFRSaccounts.The Dutch subsidiary of the Company (OncoMethylome•SciencesBV)hasrecordedinthepastadeferredtaxassetonitstaxlosscarryforward.Itisnotprobablethatsufficienttaxableprofitswouldexistinthefutureagainstwhichtheunusedtaxlossescanbeutilized.IntheIFRSstatements,nodeferredtaxassetsarerecorded.
Under Belgian GAAP no employee benefit expense is•recognized for stock offered to employees and otherbeneficiaries.UnderIFRS2Share-basedPayment,theentityshallmeasureacompensationexpenseforthefairvalueoftheservicesreceivedfromemployeesandothersprovidingsimilarservicesbyreferencetothefairvalueoftheequityinstruments granted. There is no net impact on equityas for equity-settled share-based payment transactionsunder IFRS 2, the compensation expense is recordedby acorrespondingincreaseinequity.
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5.1.5.24DisclosureunderArticle114oftheRoyalDecreedatedJanuary30,2001implementingtheBelgianCompanyCode
Subsidiaries
The Company has three wholly-owned subsidiaries,asfollows:
MDxHealthInc.Address 2505MeridianParkway,suite310,
Durham,NC27713,USAIncorporationDate April14,2003Numberofemployees
6atDecember31,2010:2employeesengagedinresearchanddevelopmentand4employeesengagedinsales,generalandadministrativefunctions.10atDecember31,2009:5employeesengagedinresearchanddevelopmentand5employeesengagedinsales,generalandadministrativefunctions.10atDecember31,2008:5employeesengagedinresearchanddevelopmentand5employeesengagedinsales,generalandadministrativefunctions.
OncoMethylomeSciencesBVAddress Tour5GIGA,Avenuedel’Hôpital11,
4000LiègeIncorporationDate March16,2004Numberofemployees
1atDecember31,2010:1employeeengagedinsales,generalandadministrativefunctions.15atDecember31,2009:12employeesengagedinresearchanddevelopmentand3employeesengagedinsales,generalandadministrativefunctions.15atDecember31,2008:13employeesengagedinresearchanddevelopmentand2employeesengagedinsales,generalandadministrativefunctions.
MDxHealthPharmacoDxBVBAAddress Technologiepark4,
VIBBio-Incubator,9052Zwijnaarde/Ghent,Belgium
IncorporationDate May25,2007(RegisterofLegalPersonsnumberBE0889.683.703)
Numberofemployees
7atDecember31,2010:5employeesengagedinresearchanddevelopmentand2employeesengagedinsales,generalandadministrativefunctions.16atDecember31,2009:13employeesengagedinresearchanddevelopmentand3employeesengagedinsales,generalandadministrativefunctions.16atDecember31,2008:13employeesengagedinresearchanddevelopmentand3employeesengagedinsales,generalandadministrativefunctions.
RemunerationoftheBoard
ThetotalremunerationoftheBoardofDirectors(includingtheexecutivedirector)in2010,2009and2008wasEUR436,000,EUR519,000 and EUR518,000 respectively (excluding VAT,stock-based compensation and expenses reimbursement).No advances or credits have been granted to anymemberoftheBoardofDirectors.NoneofthemembersoftheBoardofDirectorshave receivedanynon-monetary remunerationotherthanwarrantsasdisclosedabove.
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than in 2009, as a result of an increase in themixof totalrevenuesderivedfromcommercialsales,particularlyservicetestingforthepharmaceuticalindustrywhichisperformedintheCompany’sISO-certifiedlab.
Researchanddevelopmentexpenses
ResearchanddevelopmentexpenseswereEUR6,812,000 in2010comparedtoEUR13,089,000in2009,adecreaseof48%.ThemainreasonsforthedecreaseintheR&Dexpendituresin 2010 are the following: (i) the large clinical trials for acolorectal cancer test which were occurring in 2009 werediscontinuedin2010astheCompanydecidedtoout-licensescreening applications rather than develop such test in-house, (ii) several projects and outside collaborations werediscontinuedin2010whentheydidnotfitthenewstrategy,(iii)severalcostcuttingandre-focusingeffortswerelaunchedat the end of 2009, which included the closure of the labfacilitiesintheNetherlands,and(iv)theCompanyperformedacceleratedamortizationoncertainintangibleassetsin2009whichwerenot required in2010.Thedetailof the researchanddevelopmentexpensesisasfollows.
YearsendedDecember31ThousandsofEuro 2010 2009Personnelcosts 3,619 3,714Labconsumables 306 945Externalresearchanddevelopmentcollaborators
1,667 3,912
Patentsandlicenses 347 331Depreciation&amortization 338 2,281
Otherexpenses 535 1,906Total 6,812 13,089
Selling,generalandadministrativeexpenses
In 2010, selling, general and administrative expensesamounted to EUR3,745,000 compared to EUR4,011,000 in2009,adecreaseof 7%.Thedecrease incosts is largelydueto less general management personnel and less businessdevelopment personnel in relation to the cost-cuttinglaunchedattheendof2009.
5.2. Management discussion andanalysis of financial conditionandresultsofoperations
Thefollowingdiscussionpertainstotheconsolidatedfinancialstatements of the Company which have been prepared inaccordancewithInternationalFinancialReportingStandards(IFRS) as developed and published by the InternationalAccountingStandardsBoard(IASB).Thefinancialstatementscanbefoundinsection5.1ofthisdocument.
ResultsofOperationsfortheYearEndedDecember31,2010comparedtoYearEndedDecember31,2009
Revenues
TotalrevenuesslightlydecreasedfromEUR2,548,000in2009to EUR2,536,000 in 2010, a decrease of 0.5%. Revenues arederivedfrom(i)commercialproductsales,services,orroyaltiesandfrom(ii)grants.Commercialrevenuesin2010increasedby91%,fromEUR1,031,000in2009toEUR1,968,000in2010asaresultmainlyofextratestingservicesandvolumeperformedfor the pharmaceutical industry. Grant revenue decreasedby63% in 2010, fromEUR1,517,000 in 2009 toEUR568,000in 2010, as the Company discontinued subsidized projectsinnon-coreearly-stageresearchprojectsthatdidnotfitthenewstrategydefinedfortheCompanyin2010.
SubstantiallyalloftheCompany’srevenueshavebeenderivedfromcommerciallicenseagreements,frompharmacogenomiccontracts and from government grants. The commercialrevenuesincludeup-frontfeesandmilestonefees(whichareirregular in termsof the timing and amounts) and testingfees,contractresearchfees,androyaltiesonsalesofproductslicensedtothirdparties.
The Company has been awarded EUR9.2million in grantsandsubsidiessinceitsinceptionofwhichEUR568,000havebeenrecordedas revenues in2010.Grants recorded in2010represent22%oftotalrevenuesandwerereceivedfromtheBelgianandDutchgovernmentsprimarily fordevelopmentwork on women’s cancers and colon cancer diagnosticproducts.Grantsawardedgenerallytaketheformofrefundsof specific expenses incurred in connection with approvedscientificresearchactivities.
Costofgoodsandservicessold
ThecostsofgoodsincluderoyaltiesMDxHealthmustpaytothirdpartiesandthecostsassociatedwithprovidingtestingservicestothirdparties.Thecostofgoodswashigherin2010
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The detail of the administrative and selling expenses is asfollows:
YearsendedDecember31ThousandsofEuro 2010 2009Personnelcosts 1,847 2,063Depreciation 37 17Professionalfees 1,211 878Otherexpenses 650 1,053Total 3,745 4,011
Financialresults
In2010,theCompanyendedtheyearwithanetfinancialgainofEUR137whileitrecordedanetfinancialgainofEUR430,000in2009.Thenet“financialincome”decreasedin2010duetoaloweraveragecashbalanceandtolowerinterestratesondeposits. MDxHealth earned EUR222 thousand of interestincomeandfinancialgainsin2010,andthiswasdecreasedbyforeignexchangedifferencesofEUR85thousandduetothefluctuationofthedollarthroughout2010.In2010,MDxHealthrecognizedaone-timegainofEUR135thousandonthesaleofFinancialAssets(sharesboughtin2008thatwerere-soldforagainin2010).
Netloss
The net loss was EUR8,253,000 in 2010 compared toEUR14,301,000in2009,andecreaseof42%.Thisdecreaseisdueprimarilytoadecreaseinoperatingcostsfollowingthecost-cuttingandre-focuseffortslaunchedinQ42009.
ResultsofOperationsfortheYearEndedDecember31,2009comparedtoYearEndedDecember31,2008
Revenues
Total revenues decreased from EUR3,024,000 in 2008 toEUR2,548,200in2009,adecreaseof15%.
SubstantiallyalloftheCompany’srevenueshavebeenderivedfromcommerciallicenseagreements,frompharmacogenomiccontracts and from government grants. The commercialrevenuesincludeup-frontfeesandmilestonefees(whichareirregular in termsof the timing and amounts) and testingfees,contractresearchfees,androyaltiesonsalesofproductslicensed to third parties. No up-front feeswere received in2009unlikein2008wheresuchfeeswerereceivedonsomenewcommercialagreements.
The Company has been awarded EUR8.5 million in grantsandsubsidiessinceitsinceptionofwhichEUR1,517,000havebeenrecordedasrevenuesin2009.Grantsrecordedin2009represent60%oftotalrevenuesandwerereceivedfromtheBelgianandDutchgovernmentsprimarily fordevelopmentworkon lungandcoloncancerdiagnosticproducts.Grantsawarded generally take the form of refunds of specificexpenses incurred in connection with approved scientificresearch activities. The Company expects to receive all ormostof theEUR3million remaining fundsavailableunderapprovedgrantsandsubsidiesin2010through2013.
Costofgoodsandservicessold
ThecostsofgoodsincluderoyaltiesMDxHealthmustpaytothirdpartiesandthecostsassociatedwithprovidingtestingservicestothirdparties.Thecostofgoodswaslowerin2009than in 2008, following the trend of the revenues they areassociatedwith.
Researchanddevelopmentexpenses
ResearchanddevelopmentexpenseswereEUR10,999,000in2008comparedtoEUR13,091,000in2009,anincreaseof19%.Themainoverall increase inR&Dexpenses isdue to (i) thecostsofthesamplesforvalidatingtheCompany’scolorectalblood-based test forwhich the trialwasexpanded in2009,and (ii) the decision to fully amortize certain intangibleassets associated with in-licensed intellectual property.External research and development collaboration expensesdecreasedsignificantly,andisexplainedbytheendofsomelarge collaborationswith external parties. In January 2008,theCompanyin-licensedsometechnologyfromEpigenomicsAGwhich it has been amortizing over 5 years, but in 2009itwas recognized that this intangibleasset shouldbe fullywritten off since the Company no longer had plans to usethe technology. Other research and development expensesincreasedprimarily as a result of extra costs related to theconcentrationofinternalresearchactivitiesbytheCompanyinEurope.FollowingtheannouncementonNovember5,2009tore-focustheCompany’sactivitiesoncertaincoreprojectsandareas,therewereextracostsrelatedtothereductionofsomepersonnelwhowereworkingonnon-coreactivitiesandcostsassociatedwitheliminatingtheduplicationofcertainlabprocessesacrossthe3labsitesinEurope.
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Liquidity,workingcapital,andcapitalresourcesfortheyearsendedDecember31,2010,2009,and2008
YearendedDecember31,2010
At December 31, 2010, the cash and cash equivalents ofMDxHealthamountedtoEUR10.6millioncomparedtoEUR18millionattheendof2009.
In 2010, net cash used in operating activities amounted toEUR8.1millionandnetcashprovidedbyinvestingactivitieswasEUR0.7million.The totalnet cashconsumptionof theCompany was reduced from EUR12.6 million in 2009 toEUR7.4millionin2010.Thiscashconsumptionimprovementof41%isdueprimarilytothecostcutsinitiatedinQ42009,animprovementinworkingcapital,andthesaleoffinancialassetsin2010.
The operating cash flow was mainly impacted by the netresultandanimprovementinworkingcapital.
YearendedDecember31,2009
At December 31, 2009, the cash and cash equivalents ofMDxHealthamountedtoEUR18millioncomparedtoEUR30.6millionattheendof2008.
In 2009,net cashused inoperatingactivitiesamounted toEUR12.8millionandnetcashprovidedbyinvestingactivitieswasEUR0.1million.Netcashprovidedbyfinancingactivitiesamounted to EUR0.1 million. Overall, the cash position ofMDxHealthdecreasedbyEUR12.6millionin2009.
The operating cash flow was mainly impacted by the netresult.Theincreaseinaccountreceivablewasmainlyduetolonger collection times on subsidies and reimbursableVATfromtheDutchandBelgianauthorities.
The2009 investingcash flowsweremainly impactedby (i)a decrease in the purchase of intangible assets in 2009 ascomparedto2008and(ii)byadecreaseinfinancialrevenuesin2009.
The cash flows from financing activities were mainlyimpactedby the exercise of stockoptionswhichgeneratedEUR0.1millionofnetproceedsforMDxHealth.
The detail of the research anddevelopment expenses is asfollows.
Selling,generalandadministrativeexpenses
In 2009, selling, general and administrative expensesamounted to EUR4,011,000 compared to EUR3,107,000 in2008,anincreaseof29%.Theincreaseincostsislargelyduetomoregeneralmanagementpersonnelandmorebusinessdevelopmentpersonnel(whowerehiredmainlyattheendof2008).Thedetailoftheadministrativeandsellingexpensesisasfollows:
YearsendedDecember31ThousandsofEuro 2009 2008Personnelcosts 2,063 1,599Depreciation 17 4Professionalfees 878 891Otherexpenses 1,053 613Total 4,011 3,107
Financialresults
In 2009, the Company ended the yearwith a net financialgain of EUR430,000 while it recorded a net financialgain of EUR1,134,000 in 2008. The net “financial income”decreased in 2009 due to a lower average cash balanceand to lower interest rates ondeposits.MDxHealth earnedEUR450thousandofinterestincomeandfinancialgainsin2009,andthiswasdecreasedbyforeignexchangedifferencesof EUR20 thousand due to the fluctuation of the dollarthroughout2009.
Netloss
Net loss was EUR14,301,000 in 2009 compared toEUR10,192,000 in 2008, an increase of 40%. This increaseis due to a decrease in revenues and an increase in costs.Approximatelytwo-thirdsofthe2009increaseinoperatingcosts is due to one-time costs associatedwith the re-focusinitiativeannouncedonNovember5,2009.TheCompanyhasmadeaccrualsofapproximatelyEUR1millionin2009tocovercostsassociatedwith focusing theR&Dona smaller setofcoreproducts,reducingthenumberofpersonnelin2010,andconcentratingtheR&Dactivitiesinfewersites.Furthermore,the Company has recognized EUR1.3million in accelerateddepreciationandamortizationonfixedassetsandintangibleassetsthatarenolongerdeemedofvalue.
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The2008investingcashflowsweremainlyimpactedby(i)adecreaseinthepurchaseoftangibleassetsforthepurchaseofequipmentcompared to2007and (ii) an increase in thepurchaseofintangibleassetswiththelicenseacquiredfromEpigenomicsinJanuary2008.
The cash flows from financing activities were mainlyimpacted by the SecondaryOffering of shares on Euronextandtheissuanceofnewsharesin2008relatedtotheexerciseofstockoptionswhichtogethergeneratedEUR8.5millionofnetproceedsforMDxHealth.
YearendedDecember31,2008
At December 31, 2008, the cash and cash equivalents ofMDxHealth amounted to EUR30.6 million compared toEUR33.1millionattheendof2007.
In 2008,net cashused inoperatingactivities amounted toEUR9.3millionandnetcashusedbyinvestingactivitieswereEUR1.6 million. Net cash provided by financing activitiesamounted to EUR8.5 million. Overall, the cash position ofMDxHealthdecreasedbyEUR2.5millionin2008.
The operating cash flow was mainly impacted by the netresult. The decrease in account receivable wasmainly dueto the large collection of subsidies amounts and to VATreimbursementfromtheDutchauthorities.
5.3. ReportoftheBoardofDirectorsontheconsolidatedfinancialstatementsThefollowingreporthasbeenestablishedby theBoardofDirectorsonFebruary18,2011forsubmissionto theAnnualGeneralShareholders’MeetingofMay27th,2011.
DearMDxHealthShareholder,
WearepleasedtopresenttoyoutheconsolidatedfinancialstatementsfortheyearendedDecember31,2010.TheBoardofDirectors,representedbyitsdirectors,declaresthat,tothebestofitsknowledge,(i)theconsolidatedfinancialstatementsfortheyearendedDecember31,2010giveafairviewoftheassets,liabilities,financialpositionandresultsofMDxHealthandoftheentitiesincludedintheconsolidation,and(ii)theconsolidatedBoardreportofMDxHealthincludesafairviewofthedevelopmentandperformanceofthebusinessandthepositionoftheCompanyandoftheundertakingsincludedintheconsolidation,aswellasadescriptionofthemainrisksanduncertaintiesthattheyface.
5.3.1. Discussion and analysis of the consolidatedfinancialstatementsof2010,2009,and2008
TheconsolidatedfinancialstatementshavebeenpreparedinaccordancewithIFRSandhavebeenapprovedforissuebytheBoardofDirectorsonFebruary18,2011.
Revenues
Substantially all of the Company’s revenues have beenderived frompharmaceutical company service agreements,commerciallicenseagreementsandfromgovernmentgrants.
Thecommercialrevenuesaremainlyup-frontfees,milestonefeesand service testing revenues, and thusare irregular intermsofthetimingandamounts.Totalrevenuesin2010,2009,and 2008wereEUR2.5millionEUR2.5million, andEUR3.0million,respectively.ThecommercialrevenueswereprimarilygeneratedfromdealswithMerckCorporation,VeridexLLC(aJohnson&Johnsoncompany),Abbott,GSKBiologicals,Pfizer,Exact Sciences andMerck Serono. The government grantsincludeprimarilyBelgianandDutchgovernmentgrantsforcolonandwomen’scancerR&Dprojects.
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Thetotalnetcashconsumptionimprovedin2010primarilyduetothefollowingreasons:
Areductionofoperatingcostsduetothecost-cuttingand•re-focusprogramlaunchedinQ42009Animprovementofworkingcapital,particularlyareduction•inaccountsreceivableThesaleofthefinancialassetsin2010•
BalanceSheet
ThebalancesheetatDecember31,2010remainedsimilarintermsofcompositiontopreviousyearsasevidencedby thefollowingkeyratios:
FortheyearendedDec31 2010 2009 2008
Cash&cashequivalentsasa%oftotalassets
73% 73% 78%
Workingcapitalasa%oftotalassets
70% 70% 75%
Solvencyratio(equity/totalassets)
74% 76% 84%
Gearingratio(Financialdebt/equity)
0% 0% 0%
CashandcashequivalentsofEUR10.6millionaccountfor73%oftotalassetsatDecember31,2010.Theothermajorassetsareproperty,plantandequipment(EUR0.6millionor4%oftotalassets)whichisprimarilycomposedofequipmentpurchasedin2006and2007,andgrantsawardedtotheCompanyandreceivableovertheperiod2011-2013(EUR1.3millionor9%oftotalassets).
TotalequityofEUR10.7millionaccountsfor74%ofthetotalbalancesheetatDecember31,2010.Theothermajorliabilitiesaretradepayables(EUR1.6millionor11%oftotalassets),anddeferred revenues related to thegrantsalreadyawarded totheCompanyandwhich cover theperiod2011-2013 (EUR1.3millionor9%oftotalassets).
Taxation
ThelossesoftheCompanyinthelastthreeyearsimplythatnoincometaxesarepayablefortheseyears.OnDecember31,2010,theCompanyhadnettaxlossescarriedforwardamountingto EUR74 million, implying a potential deferred tax assetof EUR25million. Due to the uncertainty surrounding theCompany’sabilitytorealizetaxableprofitsinthenearfuture,theCompanydidnotrecognizeanydeferredtaxassetsonitsbalancesheet.
Operatingcharges
‘000EURforyearendedDec31 2010 2009 2008
Research&developmentexpenses
6,812 13,089 10,999
Selling,generalandadministrativeexpenses
3,745 4,011 3,107
Otheroperatingexpenses (25) 0 1TotalOperatingCharges 10,532 17,100 14,107
Totaloperatingchargesdecreasedby38%fromEUR17.1millionin2009toEUR10.5millionin2010,mainlyduetothefollowing:(i)thelargeclinicaltrialsforacolorectalcancertestwhichwereoccurringin2009werediscontinuedin2010astheCompanydecided to out-license screening applications rather thandevelop such tests in-house, (ii) several projects and outsidecollaborationswerediscontinued in2010when theydidnotfit thenewstrategy, (iii) several cost cuttingand re-focusingefforts were launched at the end of 2009, which includedthe closure of the lab facilities in the Netherlands, and (iv)theCompanyperformedacceleratedamortizationoncertainintangibleassetsin2009whichwerenotrequiredin2010.
As a consequence, R&D expenses decreased by 48% fromEUR13.1 million in 2009 to EUR6.9 million in 2010. SG&Aexpenses decreased by 7% from EUR4 million in 2009 toEUR3.7millionin2010,mainlyduetothecost-cuttingandre-focuseffortslaunchedinQ42009.
Netresults
EBITandnetlosswereEUR-14.7million,andEUR-14.3millionin2009comparedtoEUR-8.4million,andEUR-8.3millionin2010.Thedecreasedlossisdueprimarilytothecost-cutsandthe re-focusprogram launched inQ4 2009.These includedthe closure or the Netherlands facility, the discontinuanceof several projects in-house (such as the colorectal cancerscreeningtest),andthereductionofseveraloperatingcosts(suchasthereductionofthenumberofpersonnel).
CashFlow
ThenetcashbalancedecreasedbyEUR7.4millionin2010duetothecontinuinglossesof theCompany.Howeverthetotalnetcashconsumptionin2010was41%lowerthanin2009.
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5.3.2. Capital increases and issuance of financialinstruments
No shares were issued in 2010. However, following theapprovalofthegeneralshareholders’meetingofJune21,2010,thesharecapitaloftheCompanywasreduced,howevertherewasnochangetothenumberofoutstandingshares.
OnJune21,2010,thegeneralshareholders’meetingapprovedthe creation and grant of 145,000 newwarrants to 4 newdirectorsoftheCompany,includingthenewCEO.Thewarrantsveststraight-lineover4years(inquarterlyinstallments),haveadurationof5years,andhaveanexercisepriceofEUR2.07.
5.3.3. Risks
In 2010, the Company was potentially subjected to thefollowingrisks:
ThebusinessmodelofMDxHealthhasrecentlyconsiderably•changed and the Company may not be successful inaccomplishinganyofitsnewobjectives.The Company is at an early stage of development and•may encounter difficulties in its growth and expansionofactivitiesLosses have been incurred since the inception of the•Company, further losses are expected in the foreseeablefuture,andfurtherfundingwillbeneededTheCompanyisdependentonintellectualpropertyrights•which could be challenged and the Company could beaffectedbynewpatentsofthirdpartiesThe Company must comply with many conditions in•ordertomaintaintheintellectualpropertyrightswhichitin-licensesfromthirdpartiesThe enforcement of the Company’s intellectual property•rightscouldinvolvesignificantcostsandcouldimpactthecommercialfreedomoftheCompanyincertainareasTheCompany’sperformancecouldbehinderedbytheway•itscommercialpartnersutilizecertainofitstechnologiesThe Company’s success is dependent upon factors such•as its ability to access samples, work with or obtain thesupport of certain scientific or medical partners, recruitand retain key personnel, generate positive clinical studyresults, obtain regulatory approval of its products andcomplywithongoingregulations,partnerwiththirdpartiesforthemanufactureandsaleofitsproducts,getthemarkettoacceptanduseitsproducts,andobtainreimbursementofitsproductsforpatientsTheCompanyoperatesinmarketsinwhichthecompetition•andregulatoryenvironmentmaychangeandthusimpacttheCompany’sproductsandstrategy
TheCompanyissubjecttoproductliabilityrisks•Foreignexchangeratefluctuationscouldimpacttheresults•oftheCompany
In 2010, financial risk management involved primarilythefollowing:
Credit risk:• the small number of customers exposes theCompany to credit risk. In 2010, 90% of revenues weregenerated by 16 customers whereas in 2009 90% ofrevenues were generated by 8 customers. The credit riskwas reduced by the fact that all customers are leadinginternationalcompanieswithstrongcreditratings.Interest risk:• The Company is not currently subject tomaterialinterestrisksinceithasalmostnofinancialdebtCurrency risk:• The Company is not currently subject tomaterial currency risk. The Company reports in euros,butgenerates themajorityof its commercial revenues indollars. No hedging instruments have been used so far.WiththenewstrategicfocusontheU.S.market,infutureyearsthecurrencyriskoftheCompanymayincrease.Liquidity and investment risk:• The Company has investedall of its cash and cash equivalents in highly-rated andhighly-liquidbanksavingsormoneymarketaccounts.TheCompanyhasnotinvestedinanyderivativeinstrumentsorCDOs.
5.3.4. Servicesperformedbytheauditor
TheCompanypaidEUR62thousandinfeestotheauditorin2010.Thefeesarebrokendownasfollows:
statutoryof• EUR31thousandaudit fee for consolidated and stand-alone financials•ofEUR25thousandothermissionsfor• EUR6thousand
5.3.5. Subsequentevents
OnJanuary10,2011,MDxHealthannouncedthatitspartner,•Exact Sciences Inc., has confirmed that it is pursuing thedevelopmentofitsstool-basedcolorectalcancerscreeningtestusingabio-markerand theMSP-technologywhich itin-licensedfromMDxHealthOn January 26, 2011, MDxHealth announced that the•CompanyPredictiveBioSciencesInchadpublisheditsfirstsetofclinicaldataforabladdercancerscreeningtestusingtheMSPtechnologyandmarkerswhichithadin-licensedfromMDxHealthin2010.On January 31, 2011, MDxHealth announced a new•partnership with Pfizer Inc. and Newcastle University
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for the development of potential companion diagnostictests for the cancer Parp-inhibitor drug which Pfizer hasin development.MDxHealthmay receive service fees andmilestonefeesfromthisdeal.Thegoalistodevelopatestthatcouldeventuallybecommercializedwiththedrug,ifthedrugandthetestareeventuallysuccessfulandapproved.On February 18, 2011 MDxHealth held an extraordinary•general shareholders’ meeting. At this meeting, theshareholders renewedandmodified theauthorizedsharecapitalforaperioduntiltheannualgeneralshareholders’meetingofMay2012.
5.3.6. Research&Development
Prior to 2010, the Company primarily performed discoveryR&D projects for a wide range of cancer applicationsso as to out-license biomarkers to 3rd party companieswhich would develop the products and eventuallycommercialize them. This strategy did not generatesufficient revenues for theCompanyand left theCompanyexcessively dependent on external parties for its future.At the end of 2009, MDxHealth announced that it wouldchangeitsstrategyin2010andfocusitsR&Dactivitiesonasmaller set of coreproducts.Thisnewstrategywas furtherclarified throughout 2010 by adding a number of newexperiencedindustrymanagersanddirectorstotheCompany.Today,theR&Dactivitiesarefocusedonthedevelopmentof(i)ClinicalDiagnosticproducts(ClinicalDx)toassistphysiciansin the diagnosis of cancer, and (ii) Pharmaco Diagnosticproducts(PharmacoDx)toassistpharmaceuticalcompaniesandphysiciansingettingthecorrectcancertreatmenttotherightpatient.MDxHealthisnowdevelopingproductswhichit intends to commercialize itself, primarily via a CLIA labwhichtheCompanyintendstoestablishintheUnitedStates.With this new strategy the R&D is thus focused on“development”ofproductsforitsowncommercialization.
ResearchandDiscovery
MDxHealth maintains an internal R&D team specializedin new biomarker discovery and optimization. In addition,MDxHealthcollaborateswithseveraluniversitiesandmedicalcenters throughout the world in new biomarker discovery.For example, MDxHealth collaborates with the JohnsHopkins University and the University of Gent in the areaof methylation biomarker discovery using next generationsequencing.Thisapproachhasoptimizedourcurrentassaydevelopment process by focusing on the DNA regions ofinterest,ensuringan“intelligent”andacceleratedbiomarker
discoveryprocess.Wealsocontinueourdiscoveryprogramsforbothlungandcoloncancer.
ProductDevelopment
On October 2010, MDxHealth announced a re-focusing ofits diagnostics business on three clinical areas: prostate,colorectal, and lung cancer. Further, the Company has orintends toout-licensenon-tissuebasedscreeningproducts.The pharmacogenomics activity continues as evidenced bytherecentagreementswithGSKandPfizer.
Theproductsonwhichthemostspendingwasdonein2010arethefollowing:
Colorectal cancer:• TheCompanyperformedR&Dona testfor the screening of colon cancer. As screening tests arenot part of the companies new strategy, this test wasout-licensed in July. After this time no further work wasperformedonthistest.Bladder cancer:• TheCompanyperformedR&Donaurine-basedtestfor thedetectionofbladdercancerandfor themonitoring of recurrence. As non-tissue based tests arenotpartoftheCompany’snewstrategy,thistestwasout-licensedinNovember2010.Afterthistimenofurtherworkwas performed on this urine test, however the Companycontinues to perform research on a tissue-based test forbladdercancer.Lungcancer:• TheCompanyperformedsomeR&Donabloodandasputum-basedtestforthescreeningoflungcancer.This development work will form the basis of the LungConfirmtest.Prostatecancer:• TheCompanyisfurthervalidatingaProstateConfirmMDxdiagnostictest.
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Themostadvancedproductsincludethefollowing:
Prostate cancer ConfirmMDx and InformMDx tests:•Prostate tests are now being developed “in-house “ andwe intend to commercialize them as LDT’s through aU.S.CLIA-certifiedlaboratory.BrainCancerPredict(MGMTforGlioblastoma):• TheCompanyisdevelopingatesttopredictbraincancerpatientresponseto alkylating agentmedication (MGMT).The test is beingusedbyMerckSeronoandotherpharmaceuticalcompaniesinclinical trials forbraincancerdrugs.TheMGMT tissue-based test is currently being commercialized in NorthAmericaviaLaboratoryCorporationofAmerica(LabCorp).
TheCompany’sotherdevelopmentprojectsare:
Lung cancer Inform test:• This test will provide a riskassessment of Stage I lung cancer patients withconfirmationofwhetherthepatientiseitheratlowriskorhighriskofrecurrence.Companiondiagnostics:• TheCompanyisworkingonseveraltests,includingacolonpredictivetest,todeterminewhichpatientswillrespondtocertaindrugsforparticularcancers.Thisworkisoftendoneinpartnershipwithpharmaceuticalcompanieswhichhaveadrugindevelopment.
TheCompany’sre-focusingonacoresetofclinicalareaswillallowMDxHealthtoreduceexternalfundingofbasicresearchin non-core clinical areas and will allow the Company toincreaseeffortsondevelopmentoftheexistingproducts.
5.3.7. Disclosures within the framework of thetakeover directive (see also section 4.5 and4.6oftheRegistrationDocument)
JustificationtoContinueusingtheaccountingrulesonthebasisofgoingconcern
Despitecumulatedlosses,theBoardhasdecidedtocontinuetoapplytheaccountingrulesonthebasisofgoingconcern.Thisdecisionisjustifiedby(i)thesuccessofthetechnologyoftheCompanyinvariouscancerapplicationsandscientificpublications, (ii) continued interest in the Company’stechnology, (iii) the continued industry growth in the fieldof molecular diagnostics and personalized medicine, (iv)the fact that sufficient cash is available to support furtherdevelopment of the Company’s products over the next12monthsperiodinfunctionofthecurrentbusinessplan,and(v)TheBoardofDirectorsisconfidentthatadditionalfinancing
can be obtained. As announced November 4, 2010, theCompanyisevaluatingalternativestoraiseadditionalfunds.Considering the situation, there is enough cash to sustainthecurrentprojectsof theCompanyat leastuntil thedateof the annual general shareholders’ meeting scheduledforMay2012.
Capitalstructure
At the end of 2010, the issued capital of MDxHealth SAamounted to EUR10,517,661.90 represented by 13,185,614shares without nominal value. All shares have the samerightsandobligationsandparticipateequally intheprofitsofMDxHealthSA.
Restrictionsconcerningthetransferofsecurities
The Company’s articles of association do not impose anyrestrictions on the transfer of securities in addition to therestrictionsprovidedforintheBelgianCompanyCode.
Holdersofsecuritieswithspecialcontrolrights
TheCompanyhasnotgrantedany special control rights totheholdersofitssecurities.
Mechanismforcontrolofshareplansforemployees
There are no shares or similar plans for employees inadditiontothestockoptionplansdisclosedelsewhereinthisdocument.
Restrictionsconcerningtheexerciseofthevotingright
EachshareholderofMDxHealthSAisentitledtoonevotepershare.Therearenodifferentcategoriesofshares.Votingrightscanbesuspended,amongstothers,inrelationtoshares:
whichwerenotfullypaidup,notwithstandingtherequest•theretooftheBoardofDirectorsoftheCompany;towhichmore than oneperson is entitled, except in the•eventasinglerepresentativeisappointedfortheexerciseofthevotingright;which entitle their holder to voting rights above the•threshold of 3%, 5%, or any multiple of 5% of the totalnumber of voting rights attached to the outstandingfinancial instrumentsof theCompanyon thedateof therelevantgeneralshareholders’meeting,exceptintheeventwheretherelevantshareholderhasnotifiedtheCompany
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andtheCBFAatleast20dayspriortothedateofthegeneralshareholders’meetingonwhichheorshewishestovoteofitsshareholdingexceedingthethresholdsabove;andofwhich thevotingrightwassuspendedbyacompetent•courtortheCBFA.
Agreements between shareholders which are known tothe issuer and may result in restrictions on the transfer ofsecuritiesand/orexerciseofvotingrights
There are no declared or known agreements betweenshareholders.
RulesfortheappointmentandthereplacementofDirectorsandtheamendmentofthearticlesofassociation
PursuanttotheCompany’sarticlesofassociation,theBoardof Directors of the Company is to be composed of at least3 directors. The Company’s corporate governance charterrequiresthattheBoardofDirectorsis,totheextentpossible,composedofatleastfivedirectors,ofwhichatleast3directorsareindependentdirectors,andtotheextentpossible,atleasthalfofthedirectorsarenon-executivedirectors.Thedirectorsof theCompanyareappointedby thegeneralshareholders’meeting.However,inaccordancewiththeBelgianCompanyCode,ifthemandateofadirectorbecomesvacantduetohisdeathorresignation,theremainingdirectorshavetherighttoappointtemporarilyanewdirectortofillthevacancyuntilthe first general shareholders’ meeting after the mandatebecame vacant. The new director completes the term ofthe directorwhosemandate became vacant.The corporategovernancecharterprovidesthatdirectorscanbeappointedforamaximum(renewable) termof fouryears.At thedateof this document, the Board of Directors is composed of 7members,3ofwhomareindependentdirectors.
Amendments to the articles of association (other than anamendmentofthecorporatepurpose)requirethepresenceorrepresentationofatleast50%ofthesharecapitaloftheCompanyandtheapprovalofatleast75%ofthevotescast.AnamendmentoftheCompany’scorporatepurpose,requiresthe approval of at least 80%of the votes cast at a generalshareholders’ meeting, which in principle can only validlypass such resolution if at least 50%of the share capital oftheCompanyandatleast50%oftheprofitcertificates,ifany,arepresentorrepresented. In theeventwhere therequiredquorum is not present or represented at the firstmeeting,a second meeting needs to be convened through a new
notice.Thesecondgeneralshareholders’meetingcanvalidlydeliberate and decide regardless of the number of sharespresentorrepresented.
Powers of Directors, in particular the power to issue orbuybackshares
The Board of Directors of MDxHealth SA has the broadestpowerstomanageandrepresenttheCompany,excepttotheextentprovidedotherwisebyapplicablelawortheCompany’sarticlesofassociation.
By virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the Boardof Directors has been expressly authorized to increase theshare capital in one ormore transactionswith an amountofuptoEUR10,517,661.90(the“AuthorizedCapitalAmount”),subject to certain limitations and conditions describedbelow.TheBoard ofDirectors can exercise this power for aperiodstartingonthedateofthepublicationoftherelevantresolutionoftheextraordinarygeneralshareholders'meetingintheAnnexestotheBelgianOfficialGazetteandendingonthe date of the annual general shareholders' meeting tobeheld in2012which shall resolveon theannualaccountsrelatingtotheaccountingyearendingonDecember31,2011.Thisauthorizationmaybe renewed inaccordancewith therelevantlegalprovisions.
The capital increases towhich canbedecidedaccording tothis authorization, can take place in accordance with themodalities thatare tobedecidedby theBoardofDirectors,includingbymeansofcontributionincashorinkind,withinthelimitsaspermittedbytheBelgianCompanyCode,throughconversion of reserves and issuance premiums, with orwithoutissuanceofnewshares,withorwithoutvotingrights,throughissuanceofconvertiblebonds,subordinatedornot,throughissuanceofwarrantsorbondstowhichwarrantsorothertangiblevaluesareattached,and/orthroughissuanceofothersecurities,suchassharesintheframeworkofastockoptionplan.
Intheframeworkoftheuseofitspowerswithintheframeworkof theauthorizedcapital, theBoardofDirectors can limitorcancelthepreferentialsubscriptionrightoftheshareholdersintheinterestoftheCompany,subjecttothelimitationsandinaccordancewiththeconditionsprovidedforbytheBelgianCompanyCode.Thislimitationorcancellationcanalsooccurto the benefit of the employees of the Company and itssubsidiaries,and,totheextentpermittedbylaw,tothebenefit
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ofoneormorespecificpersonsthatarenotemployeesoftheCompanyoritssubsidiaries.
ThepoweroftheBoardofDirectorstoincreasetheshareissubjecttothefollowingspecialrestrictionsandconditions:
a)TheBoardofDirectorsisauthorizedtoincreasethesharecapitalforwhateverpurposeorwhatevertransactionthatthe Board of Directors deems appropriate or necessaryprovidedandtotheextentthatthetotalamountoffundsraised (consisting of capital contribution and issuancepremium)doesnotexceedEUR18,000,000.
b)Assoonas theBoardofDirectorswillhave increased thesharecapital, inoneormoretransactions,foranamountequaltothemaximumamountprovidedabove,thentheBoardofDirectorscanonly,totheextentpossible,furtherincrease the share capital in one or more transactionsbeyondthisinitialmaximumamount,providedthatsuchincreaseisapprovedbyatleasttwothirdsofthemembersof the Board of Directors, and provided further that theincrease takes placewithin the framework of any of thefollowing transactions: (i) the issuance of stock basedremuneration or incentive plans, such as stock optionplans, stock purchase plans or other plans, for directors,management and personnel of the Company or itssubsidiaries or (ii) the issuance of financial instrumentsin consideration of the acquisition of shares, assets andliabilitiesorcombinationsofshares,assetsandliabilitiesofcompanies,undertakings,businessandassociationsor(iii)the issuanceof financial instruments inconsiderationoftheacquisitionoflicensesorrightsonintellectualproperty(whether registered or unregistered intellectual propertyrights,orapplicationsthereof),suchaspatents,copyrights,data base rights and design rights, and know-how ortradesecretsor(iv) theissuanceoffinancial instrumentsin consideration of entering into partnerships or otherbusinessassociations.
By virtue of the resolution of the Extraordinary GeneralShareholders’ Meeting held on February 18, 2011, the Boardof Directors has also been expressly authorized to increasethe share capital in one or more transactions following anotification by the Belgian Banking, Finance and InsuranceCommission that it has been informed of a public takeoverbid on the Company’s financial instruments, throughcontributions in cash with cancellation or limitation of the
preferentialsubscriptionrightsoftheshareholders(includingfor thebenefitofoneormorewelldefinedpersonswhoarenotemployeesof theCompany)or throughcontributions inkind,with issuanceof shares,warrantsor convertiblebonds,subjecttothetermsandconditionsprovidedforintheBelgianCompanyCode.TheBoardofDirectorscanexercisethispowerforthesameperiodasmentionedabove.
At the date of this document, the Board of Directors hasnot used the above described (renewed) powers under theauthorizedcapital.
Significant agreements which take effect, alter orterminateuponachangeofcontroloftheissuerfollowingatakeoverbid
AccordingtothetermsandconditionsofthewarrantsissuedbyMDxHealth, non-vested warrants become exercisable incaseofachangeofcontroloftheCompany(seealsoSection5.1.5.19 of the RegistrationDocument). In addition,materialagreements with EXACT Sciences (as further described inSection5.1.5.21oftheRegistrationDocument)includechangeofcontrolclauses.
Agreements with Directors or employees providing forcompensationiftheyresignoraremaderedundantwithoutvalid reason or if their employment ceases because of apublictakeoverbid
There are individual agreements between the Companyand certainMembers of theManagementCommittee thatprovideaseverancepaymentofupto12months,shouldthisagreementbe terminateddue to theCompany’s changeofcontrol.
DoneonFebruary18,2011OnbehalfoftheBoardofDirectors
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5.4. Statutoryauditor’sreport5.4.1. Statutory auditor’s report to the general
meetingofshareholdersofMDxHealthSAontheconsolidatedfinancialstatementsfortheyearendedDecember31,2010
In accordance with the legal requirements, we report toyouontheperformanceofthemandateofstatutoryauditor,which has been entrusted to us. This report contains ouropiniononthetrueandfairviewoftheconsolidatedfinancialstatementsaswellastherequiredadditionalstatements.
Unqualified audit opinion on the consolidated financialstatements
Wehave audited the consolidated financial statements forthe year ended 31 December 2010, prepared in accordancewithInternationalFinancialReportingStandardsasadoptedby the European Union, which show a balance sheettotal of EUR14,419 thousand and a consolidated loss ofEUR8,253thousand.
Managementisresponsibleforthepreparationandthefairpresentation of these consolidated financial statements.This responsibility includes: designing, implementing andmaintaining internal control relevant to the preparationof consolidated financial statements that are free frommaterial misstatement, whether due to fraud or error;selectingandapplyingappropriateaccountingpoliciesandmaking accounting estimates that are reasonable in thecircumstances.
Our responsibility is to express an opinion on theseconsolidated financial statements based on our audit.We conducted our audit in accordance with the legalrequirements and the Auditing Standards applicable inBelgium,asissuedbytheInstitutdesRéviseursd’Entreprises.Thosestandardsrequirethatweplanandperformtheaudittoobtainreasonableassuranceastowhethertheconsolidatedfinancialstatementsarefreefrommaterialmisstatement,astowhetherduetofraudorerror.
Inaccordancewiththeabove-mentionedauditingstandards,we considered the group’s accounting system, as well asits internal control procedures. We have obtained frommanagementand theCompany'sofficials, theexplanationsand information necessary for executing our audit
procedures.Wehaveexamined,onatestbasis,theevidencesupporting the amounts included in the consolidatedfinancialstatements.Wehaveassessedtheappropriatenessof theaccountingpolicies and consolidationprinciples, thereasonableness of the significant accounting estimatesmadebytheCompany,aswellastheoverallpresentationoftheconsolidatedfinancialstatements.Webelievethattheseproceduresprovideareasonablebasisforouropinion.
In our opinion the consolidated financial statements forthe year ended 31December 2010givea trueand fair viewof the group’s assets and liabilities, its financial positionand the results of its operations in accordance withInternational Financial Reporting Standards as adopted bytheEuropeanUnion.
Additionalstatements
The preparation of the consolidated Directors’ report anditscontentaretheresponsibilityofmanagement.
Our responsibility is to supplement our report with thefollowing additional statements, which do not modify ourauditopinionontheconsolidatedfinancialstatements:
TheconsolidatedDirectors’ report includes the informationrequired by law and is consistent with the consolidatedfinancialstatements.Weare,however,unabletocommentonthedescriptionoftheprincipalrisksanduncertaintieswhichtheconsolidatedgroupisfacing,andofitsfinancialsituation,its foreseeable evolution or the significant influence ofcertainfactsonitsfuturedevelopment.Wecanneverthelessconfirmthatthemattersdiscloseddonotpresentanyobviousinconsistencieswiththeinformationthatwebecameawareofduringtheperformanceofourmandate.
Zaventem,18February2011
BDORéviseursd'EntreprisesSoc.Civ.SCRLStatutoryAuditorRepresentedbyBertKegels
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5.4.2. Statutory auditor’s report to the generalmeeting of shareholders of MDxHealth ontheconsolidatedfinancialstatementsfortheyearendedDecember31,2009
Inaccordancewiththelegalrequirements,wereporttoyouon the performance of the mandate of statutory auditor,which has been entrusted to us. This report contains ouropiniononthetrueandfairviewoftheconsolidatedfinancialstatementsaswellastherequiredadditionalstatements.
Unqualified audit opinion on the consolidated financialstatements,withanemphasisofmatterparagraph.
Wehave audited the consolidated financial statements forthe year ended 31 December 2009, prepared in accordancewith International Financial ReportingStandardsas agreedby the European Union, which show a balance sheettotal of EUR24,752 thousand and a consolidated loss ofEUR14,301thousand.
Managementisresponsibleforthepreparationandthefairpresentation of these consolidated financial statements.This responsibility includes: designing, implementing andmaintaining internal control relevant to the preparationof consolidated financial statements that are free frommaterial misstatement, whether due to fraud or error;selecting and applying appropriate accounting policiesand making accounting estimates that are reasonable inthecircumstances.
Our responsibility is to express an opinion on theseconsolidated financial statements based on our audit.We conducted our audit in accordance with the legalrequirements and the Auditing Standards applicable inBelgium,asissuedbytheInstitutdesRéviseursd’Entreprises.Thosestandardsrequirethatweplanandperformtheaudittoobtainreasonableassuranceastowhethertheconsolidatedfinancialstatementsarefreefrommaterialmisstatement,astowhetherduetofraudorerror.
Inaccordancewiththeabove-mentionedauditingstandards,we considered the group’s accounting system, as well asits internal control procedures. We have obtained frommanagementand theCompany'sofficials, theexplanationsand information necessary for executing our auditprocedures.Wehaveexamined,onatestbasis,theevidencesupporting the amounts included in the consolidatedfinancialstatements.Wehaveassessedtheappropriatenessof theaccountingpolicies and consolidationprinciples, thereasonableness of the significant accounting estimates
madebytheCompany,aswellastheoverallpresentationoftheconsolidatedfinancialstatements.Webelievethattheseproceduresprovideareasonablebasisforouropinion.
In our opinion the consolidated financial statements fortheyearended31December2009givea trueandfairviewof the group’s assets and liabilities, its financial positionand the results of its operations in accordance withInternational Financial Reporting Standards as agreed bytheEuropeanUnion.
Although the Company has incurred considerable losseswhich affect the financial position of the Company, thefinancial statements are prepared in going concern. ThisassumptionisonlyjustifiedtotheextentthattheCompanyfurthercanrelyonthefinancialsupportoftheshareholdersor other financial sources.Without prejudice to the aboveunqualifiedopinion,wedrawyour attention to theannualreport inwhichtheBoardofDirectors,accordingtoBelgianlegalrequirements,justifiestheapplicationofthevaluationrules in going concern. No adjustments were made withrespect tovaluationorclassificationofbalancesheet itemsthat would be required in case the Company discontinuesitsactivities
Additionalstatements
ThepreparationoftheconsolidatedDirectors’reportanditscontentaretheresponsibilityofmanagement.
Our responsibility is to supplement our report with thefollowing additional statements, which do not modify ourauditopinionontheconsolidatedfinancialstatements:
TheconsolidatedDirectors’ report includes the informationrequired by law and is consistent with the consolidatedfinancialstatements.Weare,however,unabletocommentonthedescriptionoftheprincipalrisksanduncertaintieswhichtheconsolidatedgroupisfacing,andofitsfinancialsituation,its foreseeable evolution or the significant influence ofcertainfactsonitsfuturedevelopment.Wecanneverthelessconfirmthatthemattersdiscloseddonotpresentanyobviousinconsistencieswiththeinformationthatwebecameawareofduringtheperformanceofourmandate.
Zaventem,March10,2010BDORéviseursd'EntreprisesSoc.Civ.SCRLStatutoryAuditorRepresentedbyBertKegels
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5.4.3. Statutory auditor’s report to the generalmeeting of shareholders of MDxHealth ontheconsolidatedfinancialstatementsfortheyearendedDecember31,2008
Inaccordancewiththelegalrequirements,wereporttoyouon the performance of the mandate of statutory auditor,which has been entrusted to us. This report contains ouropiniononthetrueandfairviewoftheconsolidatedfinancialstatementsaswellastherequiredadditionalstatements.
Unqualified audit opinion on the consolidated financialstatements
Wehave audited the consolidated financial statements fortheendedasatDecember31,2008,prepared inaccordancewith International Financial Reporting Standards asadopted by the European Union, which show a balancesheet total of EUR39,052 thousand and a loss for the yearofEUR10,192thousand.
Managementisresponsibleforthepreparationandthefairpresentation of these consolidated financial statements.This responsibility includes: designing, implementing andmaintaining internal control relevant to the preparationof consolidated financial statements that are free frommaterial misstatement, whether due to fraud or error;selecting and applying appropriate accounting principlesand making accounting estimates that are reasonable inthecircumstances.
Our responsibility is to express an opinion on theseconsolidated financial statements based on our audit.WeconductedourauditinaccordancewiththelegalrequirementsandtheAuditingStandardsapplicableinBelgium,asissuedbytheInstituteofRegisteredAuditors(InstitutdesReviseursd’Entreprises / Instituut der Bedrijfsrevisoren). Thosestandards require that we plan and perform the audit toobtainreasonableassuranceastowhethertheconsolidatedfinancialstatementsarefreefrommaterialmisstatement,astowhetherduetofraudorerror.
Inaccordancewiththeabove-mentionedauditingstandards,we considered the group’s accounting system, as well asits internal control procedures. We have obtained frommanagementand theCompany'sofficials, theexplanationsand information necessary for executing our auditprocedures.Wehaveexamined,onatestbasis,theevidencesupporting the amounts included in the consolidatedfinancialstatements.Wehaveassessedtheappropriatenessof the accounting principles and consolidation principles,the reasonablenessof the significant accounting estimatesmadebytheCompany,aswellastheoverallpresentationoftheconsolidatedfinancialstatements.Webelievethattheseproceduresprovideareasonablebasisforouropinion.
Zaventem,March12,2009BDOAtrioBedrijfsrevisoren/Réviseursd’EntreprisesSoc.Civ.SCRLRepresentedbyLucAnnick
StatutoryAuditor
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6.StatutoryFinancialStatements
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ThestatutoryfinancialstatementsasfiledwiththeBelgianNationalBankarebaseduponBelgianGAAP.Anunqualifiedauditopinionwillbeissuedbythestatutoryauditor.
TheinformationincludedinthissectionisanextractfromthestatutoryaccountsthatwillbefiledwiththeBelgianNationalBankanddonotincludeallinformationasrequiredbyarticles98and100oftheCompanylaws.ThefullstatutoryaccountshavenotyetbeenfiledwiththeBelgianNationalBankasofthedateofthisdocument.OncefiledwiththeBelgianNationalBank, thefullstatutoryaccountswillalsobemadeavailable in theinvestorssectionofMDxHealth’swebsite(www.MDxHealth.com).
6.1. StatutoryincomestatementSTATUTORYINCOMESTATEMENT YearsendedDecember31ThousandsofEuro(EUR) 2010 2009 2008I.Operatingincome 2,827 2,787 2,819A.Turnover 1,931 1,227 1,401D.Otheroperatingincome 896 1,560 1,418II.Operatingcharges 11,854 16,469 12,825A.Purchaseofgoodsandmaterials 537 665 399B.Servicesandothergoods 8,455 12,475 9,072C.Remuneration,socialsecuritycosts,pensions 2,200 1,641 1,677D.Depreciation&amountswrittenofffixedassets 660 1,685 1,672G.Otheroperatingcharges 2 3 5III.Operatingprofit/(loss) (9,027) (13,682) (10,006)IV.Financialincome 297 608 1,161A.Incomefromfinancialassets 0 0 18B.Incomefromcurrentassets 76 339 790C.Other 221 269 353V.Financialcharges 143 198 60A.Debtcharges 0 0 11C.Other 143 198 49VI.Currentprofit/(loss)beforetaxes (8,873) (13,272) (8,905)VII.Extraordinaryincome 0 0 0Extraordinary“reprise”depreciationsonintangibleandtangibleassets
0 0 0
VIII.Extraordinarycharges 2 2,872 2A.Extraordinarydepreciations&amountswrittenofffixedassets 2 2,872 2IX.Profit/(loss)beforetaxes (8,875) (16,144) (8,907)X.Incometaxes 0 0 0XI.Profit/(loss)fortheyearaftertaxes (8,875) (16,144) (8,907)
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APPROPRIATIONACCOUNT YearendedDecember31ThousandsofEuro(EUR) 2010 2009 2008A.LosstobeappropriatedA1.Lossfortheperiodavailableforappropriation (8,875) (16,144) (8,907)A2.Lossbroughtforward (43,483) (27,339) (18,432)B.TransferfromcapitalandreservesB1.Fromcapitalandsharepremiumaccount 43,483C.TransfertoequityC1.TocapitalD.ResulttobecarriedforwardD2.Losstobecarriedforward 8,875 43,483 27,339
6.2. StatutorybalancesheetSTATUTORYBALANCESHEETAFTERAPPROPRIATIONS YearendedDecember31ThousandsofEuro(EUR) 2010 2009 2008ASSETS 4,699 5,286 8,064I.Formationexpenses 0 1 2II.Intangibleassets 85 98 3,691III.Tangiblefixedassets 544 620 797B.Plant,machineryandequipment 457 516 747C.Furnitureandvehicles 87 104 50IV.Financialassets 4,070 4,567 3,574A.Affiliatedenterprises 4,065 4,065 3,065A1.Investments 4,065 4,065 3,065A2.Amountsreceivable 0 0 0C.Otherfinancialassets 5 502 509C1.Investments 0 500 500C2.Amountsreceivedandcashguarantee 5 2 9CURRENTASSETS 13,349 21,272 34,005V.AmountsreceivableafteroneyearVI.Stocksandcontractsinprogress 108 82 99VII.Amountsreceivablewithinoneyear 2,521 3,613 4,107A.Tradedebtors 941 459 1,172B.Otheramountsreceivable 1,580 3,154 2,935VIII.Investments 9,678 16,305 28,497B.Otherinvestmentsanddeposits 9,678 16,305 28,497IX.Cashatbankandinhand 834 1,099 1,172X.Deferredchargesandaccruedincome 208 172 132TOTALASSETS 18,048 26,557 42,070
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ThousandsofEuro(EUR) YearendedDecember31STATUTORYBALANCESHEETAFTERAPPROPRIATIONS 2010 2009 2008CAPITALANDRESERVES 12,525 21,400 37,440I.Capital 10,518 54,001 53,901A.Issuedcapital 10,518 54,001 53,901II.Sharepremiumaccount 10,882 10,882 10,872III.RevaluationsurplusesIV.ReservesV.Accumulatedprofit/(loss) (8,875) (43,483) (27,339)VI.Investmentgrants 0 0 6VII.ProvisionsandpostponedtaxesA.ProvisionsforliabilitiesandchargesA4.Otherliabilities&chargesAMOUNTSPAYABLE 5,523 5,157 4,631VIII.Debtspayableafter1yearA.FinancialdebtsA3.LeasingandothersimilarrightsA4.CreditinstitutionsIX.Debtspayablewithin1year 4,499 4,332 2,465A.CurrentportionofdebtsafteroneyearB.FinancialdebtsB1.CreditinstitutionsC.Tradedebts 4,196 3,992 2,111C1.Suppliers 4,196 3,992 2,111D.Advancesreceivedoncontractsinprogress 141 151 164E.Taxes,remuneration&socialsecurity 162 189 190E1.TaxesE2.Remuneration&socialsecurity 162 189 190F.OtheramountspayablesX.Accruedchargesanddeferredincome 1,024 825 2,166TOTALLIABILITIES 18,048 26,557 42,070
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6.3. Accountingpolicies(BelgianGAAP)
Thevaluationruleshavebeenpreparedinaccordancewiththeprovisions of Chapter II of the Royal Decree of January 30,2001relatingtotheimplementationoftheBelgianCompanyCode.
Formationexpensesandcostsrelatingtocapitalincreases
These are recognized as assets and are amortized 20%annually.Duringthefinancialyear,thecostsrelatedtocapitalincreases are recognized as expenses in theprofit and lossstatement.
Intangibleassets
Researchanddevelopmentcosts
The Company applies the same recognition criteriafor Research and Development costs for Belgian GAAPthanforIFRS.
CertainexternalResearchcostsarecapitalizedanddepreciatedin the same financial year. These assets are capitalized atpurchasepriceoratactualcostsincurredor,iflower,attheirusefulvalue.
Certain external Development costs are capitalized if theproject is already likely to generate a profitable product.These assets are capitalized at purchase price or at actualcostsincurredor,iflower,attheirusefulvalue.
These assets are amortized on a straight-line basis over aperiod of 5 years. In the event that Development costs areexceptionally depreciated over a period exceeding 5 years,thiswillbejustified.
Patents,licensesandsimilarrights
These assets are capitalized at purchase price or, if lower,at their useful value. These assets are depreciated on astraight-linebasisoveraperiodof5years.
Tangiblefixedassets
Theseassets(whicharedetailedbelowonaline-by-linebasis)arecapitalizedasfollows:
Atpurchaseprice•
Depreciation MethodL/D*Other BasisNR/R**
DepreciationRatePrincipal
Min–MaxAccessoryCosts
Min–Max1. Industrial,administrativeor
commercialbuildings(a)L NR
2. Otherbuildings L NR3. Installationsandequipment(a) L NR 20%–33.33% 20%–33.33%4. Vehicles(a) L NR 20%–20% 20%–20%5. Officeequipmentandfurniture(a) L NR 10%–20% 10%–20%
*L: Linear D:Degressive**NR: Notrevalued R: revalued(a): includingleasedassets
Intheeventwheretheaccountingvalueexceedstheusefulvalue(ortherealizedvaluefortheassetsthatarenolongerused),theCompanyshouldperformadditionalorexceptionaldepreciations.
The Company applies an accelerated depreciation plan inagreementwiththerelevanttaxauthorities. Insuchacase,theamountofthetaxdeductibleandexcessiveaccelerated
depreciation compared to the economically justifiabledepreciationsistobementioned.
Excessiveamountofthefinancialyear;•Excessivecumulatedamount.•
Thetangiblefixedassets,ofwhichthelife-timeisnotlimitedintime,arereducedinvalueincaseofdepreciationorlastingvaluereduction.
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Provisionsforrisksandcharges
Theprovisionsforrisksandchargesareindividualizedtakinginto account the corresponding risks and charges they areintendedtocover.
Theprovisionsforrisksandchargescanonlybemaintainedprovided that theyexceed,asper thedateof theclosingofthe financial year, an actual appreciation of depreciations,chargesandrisksforwhichtheyhavebeenestablished.
Debts(payableafteroneyear–payablewithinoneyear)
Alldebtsarecapitalizedattheirnominalvalueatthedateoftheclosingofthefinancialyear.
Thevaluationrulesapplicabletoamountsreceivablearealsoapplicable for debts, with the difference however that theimplicitproratainterestsarerecordedintheregularizationaccountsontheassetsside.
Atthedateoftheclosingofthefinancialyear,allchargestobepaid in relation to the financial year concernedand thepreviousfinancialyearsaretakenintoaccount.
Regularizationaccounts
Regularizationaccountsontheassetsside
Theseaccountsinclude:
The• pro rata parts of the charges incurred during thefinancialyearorduringapreviousfinancialyearbutthatarerelatedtooneormoresubsequentfinancialyears.The• proratapartsoftheproceedsthatwillonlybereceivedduring a subsequent financial year but that relate to apreviousfinancialyear.
Regularizationaccountsontheliabilitiesside
Theseaccountsinclude:
The• pro rata parts of the charges that will only be paidduring a subsequent financial year but that relate to apreviousfinancialyear.The• pro rata parts of the proceeds received during thefinancial year or a previous financial year but that relatetooneormoresubsequentfinancialyears.
Financialassets
Theseassetsarecapitalizedatpurchasepriceexcludinganymiscellaneousfees.
Thesharesandparticipationsarereducedinvalueincaseofdepreciationor lastingreductioninvalue,asaresultof thesituation, theprofitabilityorperspectiveof theCompanyinwhichthesharesortheparticipationsareheld.
Reductions in value of amounts receivable included in thefinancialfixedassetsarerecordedwhenthepaymentthereoforpartthereofattheirduedateisuncertainorhasbecomecompromised.
Amountsreceivable(afteroneyear–withinoneyear)
Theamountsreceivablethatarerepresentedbyfixedrevenueinstrumentsarecapitalizedatpurchasepriceexcludinganymiscellaneousfees.
Other amounts receivable (commercial and other amountsreceivable that are not represented by fixed revenueinstruments)arecapitalizedattheirnominalvalue.
Thiscapitalizationisaccompaniedbytherecordingthereofintheregularizationaccountsontheliabilitiessideandoftheproratatemporisbookingoftheresultsof:
Theinterestscontractuallyincludedinthenominalvalueof•theamountsreceivable;Thedifferencebetweenthepurchasecostandthenominal•valueoftheamountsreceivable;The advances of payable amounts receivable at a date of•more than 1 year, that are not subject to interest or thataresubjecttoaninterestratethatisabnormallylow.Theseadvancesare calculatedat theapplicablemarket rate forsuch amounts receivable at the time they enter into theCompany’sestate.
Treasuryplacementsandavailablecash
Placementswithfinancialinstitutionsarecapitalizedattheirnominalvalue.The titles are capitalized at purchase cost excludingmiscellaneousfees.
Reductions in value are recorded in the event where therealization value at the date of the closing of the financialyearisbelowthepurchasecost.
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Thislossresultsmainlyfromthecostsrelatedtotheresearchand development of new products which have not yetgenerated significant revenues. On November 5, 2009, theCompany announced a re-focus on fewer products and acost reductionprogram.OnOctober 19, 2010, theCompanyannounceditsnewstrategy.Costsdecreasedin2010mainlyduetotheclosureoftheAmsterdamlabfacility,areductioninthenumberofprojectsandpersonnel,andtheout-licensingofcancerscreeningapplicationstothirdparties.
2Statutoryandnon-distributablereserves
TheCompanyhasacorporatecapitalofEUR10,517,661.90.TheCompanyhasnostatutoryreserve.
AstheCompanyhascloseditsannualaccountswithrespecttothepastfiscalyearwithaloss,theCompanyisnotlegallyobligedtoreserveadditionalamounts.
3Allocationoftheresults
Weproposetocarryforwardthelosstothenextfiscalyear.
Material events that took place since the end of thefiscalyear
OnJanuary10,2011,MDxHealthannouncedthatitspartner,•Exact Sciences Inc., has confirmed that it is pursuing thedevelopmentofitsstool-basedcolorectalcancerscreeningtestusingabio-markerand theMSP-technologywhich itin-licensedfromMDxHealth.On January 26, 2011, MDxHealth announced that the•CompanyPredictiveBioSciencesInchadpublisheditsfirstsetofclinicaldataforabladdercancerscreeningtestusingtheMSPtechnologyandmarkerswhichithadin-licensedfromMDxHealthin2010.On January 31, 2011, MDxHealth announced a new•partnership with Pfizer Inc. and Newcastle Universityfor the development of potential companion diagnostictests for the cancer Parp-inhibitor drug which Pfizer hasin development.MDxHealthmay receive service fees andmilestonefeesfromthisdeal.Thegoalistodevelopatestthatcouldeventuallybecommercializedwiththedrug,ifthedrugandthetestareeventuallysuccessfulandapproved.On February 18, 2011 MDxHealth held an extraordinary•general shareholders’ meeting. At this meeting, theshareholders renewedandmodified theauthorizedsharecapitalforaperioduntiltheannualgeneralshareholders’meetingofMay2012.
The commercial contract revenue feeswhich are not linkedtoacompletedoruniqueeventarespreadovertheremainingtermoftheagreement.
Currencies
Theamountsreceivableanddebtsincurrenciesareconvertedattheapplicableexchangerateatthedateoftheclosingofthefinancialyear.
Currencylossesarerecordedinthestatementofresults.
Unrealized currency gains are reported as proceeds to berecordedontheregularizationaccountsontheliabilitiesside.
6.4. ReportoftheBoardofDirectorsonthestatutoryfinancialstatements
The following report has been established by the Board ofDirectors on February 18, 2011 for submission to theAnnualGeneralShareholders’MeetingofMay27,2011.
DearMDxHealthShareholder,
We are pleased to present to you the statutory financialstatementsfortheyearendedDecember31,2010.
PursuanttotheprovisionsoftheBelgianCompanyCode(C.C.)and the articles of association of the Company, we reporton the situation of your company for the fiscal year of theCompanyclosedon31December2010.
Commentsontheannualaccounts
Wesubmitforyourapprovaltheannualaccountsforthefiscalyear closed on 31December 2010.The annual accounts givea trueandfairviewof thecourseofaffairsof theCompanyduringthepastfiscalyear.Fromtheannualaccountsyoucanderivethefollowing:
1Resultsofthefiscalyear
TheCompanyhascloseditsannualaccountswithrespecttothepastfiscalyearwithalossofEUR8,875,494.20
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development process by focusing on the DNA regions ofinterest,ensuringan“intelligent”andacceleratedbiomarkerdiscoveryprocess.Wealsocontinueourdiscoveryprogramsforbothlungandcoloncancer.
ProductDevelopment
On October 2010, MDxHealth announced a re-focusing ofits diagnostics business on three clinical areas: prostate,colorectal, and lung cancer. Further, the Company has orintends toout-licensenon-tissuebasedscreeningproducts.The pharmacogenomics activity continues as evidenced bytherecentagreementswithGSKandPfizer.
Theproductsonwhichthemostspendingwasdonein2010arethefollowing:
Colorectal cancer:• TheCompanyperformedR&Dona testfor the screening of colon cancer. As screening tests arenot part of the companies new strategy, this test wasout-licensed in July. After this time no further work wasperformedonthistest.Bladder cancer:• TheCompanyperformedR&Donaurine-basedtestfor thedetectionofbladdercancerandfor themonitoring of recurrence. As non-tissue based tests arenotpartoftheCompany’snewstrategy,thistestwasout-licensedinNovember2010.Afterthistimenofurtherworkwas performed on this urine test, however the Companycontinues to perform research on a tissue-based test forbladdercancer.Lungcancer:• TheCompanyperformedsomeR&Donabloodandasputum-basedtestforthescreeningoflungcancer.This development work will form the basis of the LungConfirmtest.Prostate cancer:• The Company is further validating aProstateConfirmMDxdiagnostictest.
Themostadvancedproductsincludethefollowing:
Prostate cancer ConfirmMDx and InformMDx tests:• Prostate tests are now being developed “in-house “ andwe intend to commercialize them as LDT’s through aU.S.CLIA-certifiedlaboratory.BrainCancerPredict(MGMTforGlioblastoma):• TheCompanyisdevelopingatesttopredictbraincancerpatientresponse
Circumstances which could significantly affect thedevelopmentoftheCompany
The Company has more than 12 months of cash on hand,howeveritdoesnothaveenoughfundstobringtheCompanytoasituationofprofitability.AsannouncedNovember4,2010,theCompanyisevaluatingalternativestoraiseadditionalfunds.To carry out the Company’s new strategy announced onOctober19,2010,theCompanywillneedaU.S.-basedservicelaboratory(CLIAlab).Suchalabisneededtoperformdirectsales of laboratory-developed-tests (LDTs) toU.S. physicians.TheCompanycurrentlydoesnotownnoroperatesuchalabandisevaluatingalternativestoestablishandoperatesuchafacilityintheUnitedStates.
Activitiesinthefieldofresearchanddevelopment
Prior to 2010, the Company primarily performed discoveryR&D projects for a wide range of cancer applicationsso as to out-license biomarkers to 3rd party companieswhich would develop the products and eventuallycommercialize them. This strategy did not generatesufficient revenues for theCompanyand left theCompanyexcessively dependent on external parties for its future.At the end of 2009, MDxHealth announced that it wouldchangeitsstrategyin2010andfocusitsR&Dactivitiesonasmaller set of coreproducts.Thisnewstrategywas furtherclarified throughout 2010 by adding a number of newexperiencedindustrymanagersanddirectorstotheCompany.Today,theR&Dactivitiesarefocusedonthedevelopmentof(i)ClinicalDiagnosticproducts(ClinicalDx)toassistphysiciansin the diagnosis of cancer, and (ii) Pharmaco Diagnosticproducts(PharmacoDx)toassistpharmaceuticalcompaniesandphysiciansingettingthecorrectcancertreatmenttotherightpatient.MDxHealthisnowdevelopingproductswhichit intends to commercialize itself, primarily via a CLIA labwhichtheCompanyintendstoestablishintheUnitedStates.With this new strategy the R&D is thus focused on“development”ofproductsforitsowncommercialization.
ResearchandDiscovery
MDxHealth maintains an internal R&D team specializedin new biomarker discovery and optimization. In addition,MDxHealthcollaborateswithseveraluniversitiesandmedicalcenters throughout the world in new biomarker discovery.For example, MDxHealth collaborates with the JohnsHopkins University and the University of Gent in the areaof methylation biomarker discovery using next generationsequencing.Thisapproachhasoptimizedourcurrentassay
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determinedyetastheywillbebasedonthe30-dayaveragemarket price prior to their issuance and creation before anotary. The Company expects to issue these 30,000 newwarrantsinthecourseof2011.These30,000newwarrantsareexpectedtobeimmediatelyvesteduponthedateofcreationandissuance,howevertheycannotbeexercisedpriortotheirthirdyearanniversary.
BranchesoftheCompany
TheCompanyhasnobranch.
Justification to Continue using the accounting rules onthebasisofgoingconcernDespitecumulatedlosses,theBoardhasdecidedtocontinuetoapplytheaccountingrulesonthebasisofgoingconcern.Thisdecisionisjustifiedby(i)thesuccessofthetechnologyoftheCompanyinvariouscancerapplicationsandscientificpublications, (ii) continued interest in the Company’stechnology, (iii) the continued industry growth in the fieldof molecular diagnostics and personalized medicine, (iv)the fact that sufficient cash is available to support furtherdevelopment of the Company’s products over the next12monthsperiodinfunctionofthecurrentbusinessplan,and(v)TheBoardofDirectorsisconfidentthatadditionalfinancingcan be obtained. As announced November 4, 2010, theCompanyisevaluatingalternativestoraiseadditionalfunds.Considering the situation, there is enough cash to sustainthecurrentprojectsoftheCompanyatleastuntilthedateoftheannualgeneralshareholders’meetingscheduledforMay2012.
Financialrisks(article968°C.C.)VirtuallyalloftheCompany’scurrencyriskcurrentlyrelatestoU.S.Dollars.Mostoftherevenues,exceptforgovernmentgrants,havebeen inU.S.Dollars.At this time, theCompanydoesnotusehedginginstrumentstocovertheexchangeraterisk.
Riskfactors(article961°C.C.)In 2010, the Company was potentially subjected to thefollowingrisks:
ThebusinessmodelofMDxHealthhasrecentlyconsiderably•changed and the Company may not be successful inaccomplishinganyofitsnewobjectives.
to alkylating agentmedication (MGMT).The test is beingusedbyMerckSeronoandotherpharmaceuticalcompaniesinclinical trials forbraincancerdrugs.TheMGMT tissue-based test is currently being commercialized in NorthAmericaviaLaboratoryCorporationofAmerica(LabCorp).
TheCompany’sotherdevelopmentprojectsare:
Lung cancer Inform test:• This test will provide a riskassessmentofStageIlungcancerpatientswithconfirmationofwhether thepatient iseitherat lowriskorhighriskofrecurrence.Companiondiagnostics:• TheCompanyisworkingonseveraltests,includingaColonpredictivetest,todeterminewhichpatientswillrespondtocertaindrugsforparticularcancers.Thisworkisoftendoneinpartnershipwithpharmaceuticalcompanieswhichhaveadrugindevelopment.
TheCompany’sre-focusingonacoresetofclinicalareaswillallowMDxHealthtoreduceexternalfundingofbasicresearchin non-core clinical areas and will allow the Company toincreaseeffortsondevelopmentoftheexistingproducts.
Obligationsnotreflectedinthe2010financialstatements
During the course of 2010, the Company agreed to issuenew warrants under a new warrant plan. However thisnewwarrantplanwasnot created in 2010norhas it beencreatedyetasofthedateofthisdocument.In2010,pertheemployment contract and job offer letters given to 2 newhires,theCompanyagreedtoissuetheseindividuals85,000newwarrants.Furthermore, theBoardofDirectorsmeetingofDecember2010decidedtoaward110,000newwarrantstocertainemployeesandconsultantsoftheCompany.Thistotalof195,000newwarrantshasnotbeencreatednorissuedyetandisnot includedintheabovetable.Theexercisepriceofthesenewwarrantshasnotbeendeterminedyetastheywillbebasedon the 30-dayaveragemarketpriceprior to theirissuanceandcreationbeforeanotary.TheCompanyexpectsto issue these 195,000 newwarrants in the course of 2011.Thesenewwarrantsstilltobeissuedarenotreflectedintheabovetables.
Furthermore, the Board agreed in 2010 to award 30,000additionalnewwarrants to theCEOasavariablebonusforhis 2010 performance.These 30,000warrants have not yetbeen creatednor issuedandarenot included in theabovetable.Theexercisepriceofthesenewwarrantshasnotbeen
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In 2010, financial risk management involved primarily thefollowing:
Credit risk:• the small number of customers exposes theCompany to credit risk. In 2010, 90% of revenues weregenerated by 16 customers whereas in 2009 90% ofrevenues were generated by 8 customers. The credit riskwas reduced by the fact that all customers are leadinginternationalcompanieswithstrongcreditratings.Interest risk:• The Company is not currently subject tomaterialinterestrisksinceithasalmostnofinancialdebtCurrency risk:• The Company is not currently subject tomaterialcurrencyrisk.TheCompanyreports ineuros,butgeneratesthemajorityofitscommercialrevenuesindollars.To date, the Company’s operating costs in dollars haveexceeded its revenues indollars.Nohedging instrumentshavebeenusedsofar.WiththenewstrategicfocusontheU.S.market,infutureyearsthecurrencyriskoftheCompanymayincrease.Liquidity and investment risk:The Company has invested•all of its cash and cash equivalents in highly-rated andhighly-liquidbanksavingsormoneymarketaccounts.TheCompanyhasnotinvestedinanyderivativeinstrumentsorCDOs.
Performancebythestatutoryauditorofexceptionalactivitiesorexecutionofspecialinstructions(Article134C.C.)Duringthepastfiscalyear,inadditiontotheirusualactivity,the statutory auditor performed additional activities onbehalf of the Company mainly for the issuance of specialreports related to warrant plans, grant report certificationand for participation to the audit committees. The totalamountpaidfortheseadditionalactivitiesisEUR2,000.
The Company is at an early stage of development and•mayencounterdifficultiesinitsgrowthandexpansionofactivitiesLosses have been incurred since the inception of the•Company, further losses are expected in the foreseeablefuture,andfurtherfundingwillbeneededTheCompanyisdependentonintellectualpropertyrights•which could be challenged and the Company could beaffectedbynewpatentsofthirdpartiesTheCompanymustcomplywithmanyconditionsinorder•to maintain the intellectual property rights which it in-licensesfromthirdpartiesThe enforcement of the Company’s intellectual property•rightscouldinvolvesignificantcostsandcouldimpactthecommercialfreedomoftheCompanyincertainareasTheCompany’sperformancecouldbehinderedbytheway•itscommercialpartnersutilizecertainofitstechnologiesThe Company’s success is dependent upon factors such•as its ability to access samples, work with or obtain thesupport of certain scientific or medical partners, recruitand retain key personnel, generate positive clinical studyresults, obtain regulatory approval of its products andcomplywithongoingregulations,partnerwiththirdpartiesforthemanufactureandsaleofitsproducts,getthemarkettoacceptanduseitsproducts,andobtainreimbursementofitsproductsforpatientsTheCompanyoperatesinmarketsinwhichthecompetition•andregulatoryenvironmentmaychangeandthusimpacttheCompany’sproductsandstrategyTheCompanyissubjecttoproductliabilityrisks•Foreignexchangeratefluctuationscouldimpacttheresults•oftheCompany
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hasafinancialinterestthatconflictswiththecontemplateddecision by the Board of Directors to approve theminutesof the Nomination and Remuneration Committee held onDecember 6, 2010 as said minutes contain inter alia theapprovalofthedeterminationofDr.JanGroen’sbonusaswellasthegrantofoptionstopurchasesharesoftheCompanytoDr.JanGroen.
Dr. JanGroen stated that hewill also inform the statutoryauditor of the Company about the aforementioned inaccordancewithArticle523oftheBelgianCompanyCode.
The Board of Directors took note of the aforementionedstatement and started with the deliberation on theCommitteeMatters.
Attheinvitationofthechairman,Mr.Myslinski,chairoftheNomination and Remuneration Committee, provided anoverviewofremunerationandpersonnelmattersregardingtheManagementTeamandotherCompanystaffmembers,including the need to align the Company’s remunerationpolicies and terms following the strategic restart of theCompany.
The Board of Directors considered that the financialconsequencesoftheapprovaloftheminutesoftheNominationandRemunerationCommitteeheldonDecember6,2010,asfarasDr.JanGroen’sremunerationisconcerned,werelimited,astheyapprove(i)aprorataportionofanannualizedbonusamountofEUR22,000(basedontheportionoftheportionof the calendar year 2010 employed with the Company)and (ii) the grant of options to purchase 30,000 shares ofthe Company, subject to necessary shareholder action. ThebonuswillhaveaverylimitedimpactontheprofitandlossstatementoftheCompany,whilethegrantoftheoptionswillhavealimiteddilutiveeffectfortheCompany’sshareholders,dependingontheexerciseprice.
Afterfulldiscussions,uponamotiondulymade,secondedandunanimouslycarried,theBoardapprovedtheminutesoftheNominationandRemunerationCommitteeheldDecember6,2010inLiège,intheformpresentedtotheBoard,andadoptedandratifiedtheresolutionssetforththerein.
Indendence and competence of an auditcommitteememberTherulesforpublicly-listedcompaniesrequirethattheauditcommitteebecomposedofatleastoneindependentdirectorwiththenecessarycompetenceinauditingandaccounting,whichisandhasalwaysbeenthecaseforMDxHealth’sauditcommittee.
Mrs. HildeWindels, chairperson of the committee,meets•thecriteriaofindependence:She is inher firstmandateon theBoardofMDxHealth•andhasneverheldanyExecutiveManagementpositionwiththeCompany.SheownsnosharesintheCompanyandisthebeneficiary•ofsomecompanywarrantsasdisclosedinsection3.3.Shefulfillstheothercriteriaofindependenceaslistedin•section3.1.3.Mrs. Hilde Windels meets the criteria of necessary•competenceinauditingandaccounting:She has been the CFO of Devgen NV, a publicly-listed•company,forwhichshehandleditsIPOanditsfinancialreportingShe is currently the CFO of 2 privately-held healthcare•companies.Shehasbeenacommercialbanker.•Sheholdsadegreeineconomics.•
Conflictsofinterest(Article523C.C.)In accordance with Article 523 of the Belgian CompanyCode, the Board of Directors clearly stated each time theyexperiencedan interestofapatrimonialnaturepotentiallydepartingfromtheinterestsof theCompany.Thefollowingconflictofinteresthasbeenreportedin2010:
Minutes of the Meeting of the Board of Directors held onDecember7,2010
In anticipation of the commencement of discussions onNominationandRemunerationCommitteematters,allnon-director attendees at the meeting were asked to and didexcusethemselvesfromthemeeting.
Furthermore, prior to the deliberation on this item, Dr. JanGroen,directoroftheCompany,gavethefollowingstatementtotheBoardofDirectors,asfarasnecessaryandapplicableinaccordancewithArticle523oftheBelgianCompanyCode.Dr. JanGroen informed themeetingabout the fact thathe
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StatutoryFinancialStatements
number of voting rights attached to the outstandingfinancial instrumentsof theCompanyon thedateof therelevantgeneralshareholders’meeting,exceptintheeventwheretherelevantshareholderhasnotifiedtheCompanyandtheCBFAatleast20dayspriortothedateofthegeneralshareholders’meetingonwhichheorshewishestovoteofitsshareholdingexceedingthethresholdsabove;andofwhich thevotingrightwassuspendedbyacompetent•courtortheCBFA.
Agreements between shareholders which are known tothe issuer and may result in restrictions on the transfer ofsecuritiesand/orexerciseofvotingrightsThere are no declared or known agreements betweenshareholders.
RulesfortheappointmentandthereplacementofDirectorsandtheamendmentofthearticlesofassociationPursuanttotheCompany’sarticlesofassociation,theBoardof Directors of the Company is to be composed of at least3 directors. The Company’s corporate governance charterrequiresthattheBoardofDirectorsis,totheextentpossible,composedofatleastfivedirectors,ofwhichatleast3directorsareindependentdirectors,andtotheextentpossible,atleasthalfofthedirectorsarenon-executivedirectors.Thedirectorsof theCompanyareappointedby thegeneralshareholders’meeting.However,inaccordancewiththeBelgianCompanyCode,ifthemandateofadirectorbecomesvacantduetohisdeathorresignation,theremainingdirectorshavetherighttoappointtemporarilyanewdirectortofillthevacancyuntilthe first general shareholders’ meeting after the mandatebecame vacant. The new director completes the term ofthe directorwhosemandate became vacant.The corporategovernancecharterprovidesthatdirectorscanbeappointedforamaximum(renewable) termof fouryears.At thedateof this document, the Board of Directors is composed of 7members,3ofwhomareindependentdirectors.
Amendments to the articles of association (other than anamendmentofthecorporatepurpose)requirethepresenceorrepresentationofatleast50%ofthesharecapitaloftheCompanyandtheapprovalofatleast75%ofthevotescast.
Further, among other items, Dr. Groen re-confirmed to thefullBoardhisdecisiontoacceptoptionsinlieuofadditionalcash bonus as set forth in theminutes of theNominationand Remuneration Committee, and the Board instructedthe chair, Mr. Erickson, to undertake in early 2011 a reviewandevaluationof theBoard, its committeesand individualdirectorsinaccordancewithandasprescribedbySection2.5oftheCompany’sCorporateGovernanceCharter.
Disclosures within the framework of the takeover directive(seealsosection4.5and4.6oftheRegistrationDocument)
CapitalstructureAt the end of 2010, the issued capital of MDxHealth SAamounted to EUR10,517,661.90 represented by 13,185,614shares without nominal value. All shares have the samerightsandobligationsandparticipateequally intheprofitsofMDxHealthSA.
RestrictionsconcerningthetransferofsecuritiesThe Company’s articles of association do not impose anyrestrictions on the transfer of securities in addition to therestrictionsprovidedforintheBelgianCompanyCode.
HoldersofsecuritieswithspecialcontrolrightsTheCompanyhasnotgrantedany special control rights totheholdersofitssecurities.
MechanismforcontrolofshareplansforemployeesThere are no shares or similar plans for employees inadditiontothestockoptionplansdisclosedelsewhereinthisdocument.
RestrictionsconcerningtheexerciseofthevotingrightEachshareholderofMDxHealthSAisentitledtoonevotepershare.Therearenodifferentcategoriesofshares.Votingrightscanbesuspended,amongstothers,inrelationtoshares:
whichwerenotfullypaidup,notwithstandingtherequest•theretooftheBoardofDirectorsoftheCompany;towhichmore than oneperson is entitled, except in the•eventasinglerepresentativeisappointedfortheexerciseofthevotingright;which entitle their holder to voting rights above the•threshold of 3%, 5%, or any multiple of 5% of the total
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cancelthepreferentialsubscriptionrightoftheshareholdersin the interest of the Company, subject to the limitationsand in accordancewith the conditions provided for by theBelgian Company Code. This limitation or cancellation canalsooccur to thebenefitof theemployeesof theCompanyand its subsidiaries, and, to the extent permitted by law,to thebenefit of oneormore specificpersons thatarenotemployeesoftheCompanyoritssubsidiaries.
ThepoweroftheBoardofDirectorstoincreasetheshareissubjecttothefollowingspecialrestrictionsandconditions:
a)TheBoardofDirectorsisauthorizedtoincreasethesharecapitalforwhateverpurposeorwhatevertransactionthatthe Board of Directors deems appropriate or necessaryprovidedandtotheextentthatthetotalamountoffundsraised (consisting of capital contribution and issuancepremium)doesnotexceedEUR18,000,000.
b)Assoonas theBoardofDirectorswillhave increased thesharecapital, inoneormoretransactions,foranamountequaltothemaximumamountprovidedabove,thentheBoardofDirectorscanonly,totheextentpossible,furtherincrease the share capital in one or more transactionsbeyondthisinitialmaximumamount,providedthatsuchincreaseisapprovedbyatleasttwothirdsofthemembersof the Board of Directors, and provided further that theincrease takes placewithin the framework of any of thefollowing transactions: (i) the issuance of stock basedremuneration or incentive plans, such as stock optionplans, stock purchase plans or other plans, for directors,management and personnel of the Company or itssubsidiaries or (ii) the issuance of financial instrumentsin consideration of the acquisition of shares, assets andliabilitiesorcombinationsofshares,assetsandliabilitiesofcompanies,undertakings,businessandassociationsor(iii)the issuanceof financial instruments inconsiderationoftheacquisitionoflicensesorrightsonintellectualproperty(whether registered or unregistered intellectual propertyrights,orapplicationsthereof),suchaspatents,copyrights,data base rights and design rights, and know-how ortradesecretsor(iv) theissuanceoffinancial instrumentsin consideration of entering into partnerships or otherbusinessassociations.
By virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the BoardofDirectors has also been expressly authorized to increasethe share capital in one or more transactions following anotificationby theBelgianBanking, Finance and Insurance
AnamendmentoftheCompany’scorporatepurpose,requiresthe approval of at least 80%of the votes cast at a generalshareholders’ meeting, which in principle can only validlypass such resolution if at least 50%of the share capital oftheCompanyandatleast50%oftheprofitcertificates,ifany,arepresentorrepresented. In theeventwhere therequiredquorum is not present or represented at the firstmeeting,a second meeting needs to be convened through a newnotice.Thesecondgeneralshareholders’meetingcanvalidlydeliberate and decide regardless of the number of sharespresentorrepresented.
Powers of Directors, in particular the power to issue orbuybacksharesThe Board of Directors of MDxHealth SA has the broadestpowerstomanageandrepresenttheCompany,excepttotheextentprovidedotherwisebyapplicablelawortheCompany’sarticlesofassociation.
By virtue of the resolution of the extraordinary generalshareholders’meeting held on February 18, 2011, the Boardof Directors has been expressly authorized to increase theshare capital in one ormore transactionswith an amountofuptoEUR10,517,661.90(the“AuthorizedCapitalAmount”),subject to certain limitations and conditions describedbelow.TheBoard ofDirectors can exercise this power for aperiodstartingonthedateofthepublicationoftherelevantresolutionoftheextraordinarygeneralshareholders'meetingintheAnnexestotheBelgianOfficialGazetteandendingonthe date of the annual general shareholders' meeting tobeheld in2012which shall resolveon theannualaccountsrelatingtotheaccountingyearendingonDecember31,2011.Thisauthorizationmaybe renewed inaccordancewith therelevantlegalprovisions.
The capital increases towhich canbedecidedaccording tothis authorization, can take place in accordance with themodalities thatare tobedecidedby theBoardofDirectors,includingbymeansofcontributionincashorinkind,withinthelimitsaspermittedbytheBelgianCompanyCode,throughconversion of reserves and issuance premiums, with orwithoutissuanceofnewshares,withorwithoutvotingrights,throughissuanceofconvertiblebonds,subordinatedornot,throughissuanceofwarrantsorbondstowhichwarrantsorothertangiblevaluesareattached,and/orthroughissuanceofothersecurities,suchassharesintheframeworkofastockoptionplan.
Intheframeworkoftheuseofitspowerswithintheframeworkoftheauthorizedcapital,theBoardofDirectorscanlimitor
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Commission that ithasbeen informedofapublic takeoverbid on the Company’s financial instruments, throughcontributions in cashwith cancellationor limitationof thepreferentialsubscriptionrightsoftheshareholders(includingforthebenefitofoneormorewelldefinedpersonswhoarenotemployeesoftheCompany)orthroughcontributionsinkind,withissuanceofshares,warrantsorconvertiblebonds,subject to the terms and conditions provided for in theBelgianCompanyCode.TheBoardofDirectors canexercisethispowerforthesameperiodasmentionedabove.
Onthedateofthisdocument,theBoardofDirectorshasnotused theabovedescribed (renewed)powers to increase thecapitalwithintheframeworkoftheauthorizedcapital.
Significant agreements which take effect alter orterminateuponachangeofcontroloftheissuerfollowingatakeoverbidAccordingtothetermsandconditionsofthewarrantsissuedbyMDxHealth, non-vested warrants become exercisable incaseofachangeofcontroloftheCompany(seealsoSection5.1.5.19 of the RegistrationDocument). In addition,materialagreements with EXACT Sciences (as further described inSection5.1.5.21oftheRegistrationDocument)includechangeofcontrolclauses.
Agreements with Directors or employees providing forcompensationiftheyresignoraremaderedundantwithoutvalid reason or if their employment ceases because of apublictakeoverbidThere are individual agreements between the Companyand certainMembers of theManagementCommittee thatprovideaseverancepaymentofupto12months,shouldthis
agreement be terminated due to the Company’s changeofcontrol.
After deliberation and decision upon the annual accounts,theshareholders'meetingshallberequested torelease thedirectors and the statutory auditor from liability for theexecutionoftheirmandateduringthepastfiscalyear.
DoneonFebruary18,2011
OnbehalfoftheBoardofDirectors
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7. BusinessGlossary
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BusinessGlossary
Alkylatingagents Aclassofoncology therapeuticdrugs.Alkylatingagents stop tumorgrowthbymakingDNAstrandsunabletouncoilandseparate,anecessarystepinDNAreplicationandtumorgrowth.
Assay Atermforasingleexperimentoradiagnostictestincorporatingtherequiredmarkerstoanalyzeaclinicalspecimen.
Bioinformatics Theuseoftechniquesfromappliedmathematics,informatics,statistics,andcomputersciencetosolvebiologicalproblemsandidentifysignificantcorrelations.
Biopsy Aprocedurewhereatumortissuesampleisremovedfromthebodyforlaboratoryexaminationtodeterminewhetherornotcancerorsomeotherdiseaseispresent.Abiopsycanbeperformedusinganeedletoextractasmallamountofcellsorasasurgicalproceduretoremovealargerpieceoftissue.
Biotechnology Biotechnology is a technology based on or influencing biological processes, especiallywhenusedinagriculture,foodscience,andmedicine.
Cancer Cancer is a type of disease caused by genetic instability and characterized by uncontrolleddivisionofcellsandtheabilityofthesecellstoinvadeotherorgans.
Cell Thebasicunitofalivingorganism.Eachcellissurroundedbyamembraneandhasanucleuscontainingasetofgenesthatprovideitwiththeinformationnecessarytooperateanddivide.
cGMPcertification CurrentGoodManufacturingPractices-qualitysystemsrequirementsformanufacture,testinganddevelopmentofmedicalproductstoensuremanufacturingpractices,designsandcontrolsprovidesafe,accurate,reliableandrepeatableresults.cGMP’sareenforcedbytheFDAFoodandDrugAdministration.GMPcomplianceisrecognizedworldwideasaninternationalstandardofmanufacture.
Chemotherapy Drugtreatmentthatdestroyscancercells.Chemotherapymaybeusedinadditiontosurgeryandissometimesusedincombinationwithothertherapiessuchasradiation.
CLIA TheU.S.ClinicalLaboratoryImprovementAmendments(CLIA)establishesqualitystandardsforalllaboratorytestingtoensuretheaccuracy,reliabilityandtimelinessofpatienttestresults.
Clinicalsample Asampletakenfromthebody(ex.blood,urine,tissue)andanalyzedinordertogaininformationaboutaperson’smedicalstate.
Clinicaltrial Aresearchstudy,usuallyindiseasedpatients,totestdrugs,procedures,ortestingtechnologiestodetermine how well they work compared to other practices or the natural course of thedisease.
Clinicalverification A product development stage that consists of testing a product prototype on a set ofclinicalsamples.
CommercialImplementationTrial(productpipelinestep)
Aphasewithin theproductdevelopmentprocess thatsupports theacceptanceof thenewlydevelopedassayinthemarket.
CommercialPivotalTrial(productpipelinestep)
Aphasewithintheproductdevelopmentprocesstoevaluatetheclinicalvalidationoftheassayincollaborationwithaclinicalfacility.
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CPTcodes Current Procedural Terminology Codes- numbers assigned to every medical task used byphysiciansandor laboratories todetermineamountofreimbursementthatpractitionerwillreceivefrominsurer.CPTcodesareassignedbyAMAAmericanMedicalAssociationtoprovideuniformdefinitionforservicesandreimbursement.
Cytosine Cytosine isoneof the5mainnucleotidesofDNAandRNAused instoringand transportinggeneticinformation.
DevelopmentValidation(productpipelinestep)
Aphasewithin theproductdevelopmentprocess to evaluate theperformanceof thenewlydevelopedassayusingadefinedsampleset.
DevelopmentVerification(productpipelinestep)
Aphase within theproductdevelopmentprocess todefinetheperformancecharacteristicsoftheassay
Diagnosis Identificationofaconditionordisease(ex.breastcancer),byitssigns,symptoms,andtheresultsoflaboratoryorhistopathologicaltests.
DNA(DeoxyribonucleicAcid) DNAisanucleicacidpolymer,usuallyintheformofadoublehelix,ofwhichthegenesaremadeandcodeforlifeprocesses.
Freedomtooperate(FTO) FTO,withinanintellectualpropertysetting,referstotheabilityofacompanytocommerciallyproduce,marketanduseanewproduct,processorservicewithoutinfringingtheintellectualpropertyrightsofothers.
Gene Aunitofgeneticinformation.Genesareencodedinacell’sDNAandtheproteinstheyexpresscontrolthephysicaldevelopmentandbehaviorofthecellorthewholeorganism.
Geneexpression Gene expression is amulti-step process bywhich a gene's DNA sequence is converted intoproteins.
In-VitroDiagnostics(IVD) IVDsaretestsperformedoutsidethehumanbodyonclinicalsamplessuchasblood,urine,orbiopsytissue.
Kit(diagnostickit) In-vitro diagnostic test that is packaged in a box which that can be shipped to end-userlaboratories.
LDT LaboratoryDevelopedTest-refertoassaysdevelopedinalaboratoryforusewithinthatlaboratory.While these testsarenot currently regulatedby FDAFoodandDrugAdministration, the labmustvalidateallaspectsofthetesttoensurepatientsafety,reliability,repeatability,accuracyaswellasvalidatingallinstruments,reagentsandorsuppliesusedinthetest.
Marker A substance native to the organism, whose presence is indicative of a particular medicalcondition.
MarkerID Aproductdevelopmentstagethatconsistsofidentifyingandprioritizingpromisingmarkers.
Marker&AssayDevelopment Aproductdevelopmentstage thatconsistsof testingpromisingmarkersonclinicalsamples(toestablishinitialsensitivityandspecificityforadefinedclinicalindication),andconsequentlydevelopingarobustandreproducibleassayforthemarkerinquestion.
Methylation Control mechanism that regulates gene expression in DNA without causing a permanentgeneticalteration.
Methylation-SpecificPCR(MSP)
Atechnologyfordetectinggenemethylation.
MGMT The O6-methylguanine DNA-methyltransferase (MGMT) gene has been widely studied andshowntobeabletopredictglioblastomacancerpatientresponsetoalkylatingagents
PCR The polymerase chain reaction is a technique for the in vitro amplification of specific DNAsequencesbythesimultaneousprimerextensionofcomplementarystrandsofDNA.
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BusinessGlossary
Pharmacogenomics ThestudyandapplicationofDNAandRNAbasedbiomarkers topredicthowan individual'sgenesaffectthebody'sresponsetoatherapeuticdrug.
PSA Prostate-Specific-Antigen, awidely used butwidely criticized blood-based screening test forprostatecancer.
Recurrence Areturnofcanceraftertreatment.
ResearchDiscovery(productpipelinestep)
Researchphaseoftheproductdevelopmentprocessthatconsistsprimarilyofdiscoveringnewbiomarkers in clinical samples from patientswithandwithout cancer or between samplesfrompatientsrespondingornotrespondingtoacertaindrug.
ResearchFeasibility(productpipelinestep)
Aphasewithintheproductdevelopmentprocesstooptimizethebiomarkerperformanceforthedevelopmentofthediagnosticassay.
Screening Thetestingofapopulationfordisease.
Sensitivity Ameasureofadiagnostictest’saccuracy.Sensitivitymeasuresthepercentageofpeoplewitha certainmedical condition that produces a positive test result. Tests with good sensitivityproducefewfalsenegativeresults.
Servicelaboratory Laboratorythatprovidesmedicaltestingservices.
Servicelabandkitdevelopment
Thefinalstagesofproductdevelopmentthatarespecifictotheunderlyingproduct’sintendeddistributionchannel(servicelaboratoriesordiagnostickitcompanies).
Specificity A measure of a diagnostic test’s accuracy. Specificity measures what percentage of peoplewithoutamedicalconditionthetestresultisnegative.Testswithgoodspecificityproducefewfalsepositiveresults.
Temozolomide AnapprovedalkylatingchemotherapeuticdrugmarketedbySchering-Ploughcorporation.
Tumor Tissuegrowthwherethecellsthatmakeupthetissuehavemultiplieduncontrollably.Atumorcanbebenign(non-cancerous)ormalignant(cancerous).
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MDxHealthSA
Tour5GIGAniveau+3Av.del’Hôpital114000LiègeBelgiumT:+32(0)43642070F:+32(0)43642071
MDxHealth,Inc.
2505MeridianParkwaySuite310Durham,NC27713USAT:+19192810980F:+19192810981
MDxHealthSA
Tour5GIGANiveau+3Avenuedel’Hôpital11
4000LiègeBelgium
T:+32(0)43642070F:+32(0)43642071
VAT:BE0479.292.440
Email:[email protected]