mark j. levin - corporate-ir.net€¦ · this presentation contains “forward-looking...
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© 2002 Millennium Pharmaceuticals, Inc.
Mark J. LevinChairperson and Chief Executive Officer
JPMorgan H&Q 20th AnnualHealthcare ConferenceSan Francisco, CAJanuary 9, 2002
This presentation contains “forward-looking statements,” includingstatements about our growth and future operating results, discovery anddevelopment of products, potential acquisitions, strategic alliances andintellectual property. Various risks may cause Millennium’s actual resultsto differ materially, including: adverse results in our drug discovery andclinical development processes; failure to obtain patent protection for ourdiscoveries; commercial limitations imposed by patents owned orcontrolled by third parties; our dependence upon strategic alliance partnersto develop and commercialize products and services based on our work;difficulties or delays in obtaining regulatory approvals to market productsand services resulting from our development efforts; and the requirementfor substantial funding to conduct research and development and to expandcommercialization activities. For a further list and description of the risksand uncertainties we face, see the reports we have filed with the Securitiesand Exchange Commission. We disclaim any intention or obligation toupdate or revise any forward-looking statements, whether as a resultof new information, future events or otherwise.
IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SECMillennium has filed with the SEC a Registration Statement on Form S-4 in connection with thetransaction and Millennium and COR plan to file with the SEC and mail to their respectivestockholders a Joint Proxy Statement/Prospectus in connection with the transaction. TheRegistration Statement and the Joint Proxy Statement/Prospectus will contain important informationabout Millennium, COR, the transaction and related matters. Investors and security holders areurged to read the Registration Statement and the Joint Proxy Statement/Prospectus carefully whenthey are available.Investors and security holders will be able to obtain free copies of the Registration Statement andthe Joint Proxy Statement/ Prospectus and other documents filed with the SEC by Millennium andCOR through the web site maintained by the SEC at www.sec.gov.In addition, investors and security holders will be able to obtain free copies of the RegistrationStatement and the Joint Proxy Statement/Prospectus from Millennium by contacting the InvestorRelations group at each company.Millennium and COR, and their respective directors and executive officers, may be soliciting proxiesfrom Millennium's or COR's stockholders in connection with the planned merger. A list of the namesof Millennium's directors and executive officers and descriptions of their interests in Millennium iscontained in Millennium's proxy statement dated March 26, 2001, and its Annual Report on Form 10-Kfor the year ended December 31, 2000, and its Current Report on Form 8-K dated December 6, 2001,which documents are filed with the SEC. A list of the names of COR's directors and executive officersand descriptions of their interests in COR is contained in COR's proxy statement dated April 26, 2001,its Annual Report on Form 10-K for the year ended December 31, 2000 and its Current Report on Form8-K dated December 7, 2001, which documents are filed with the SEC. A more complete descriptionwill be available in the Registration Statement and the Joint Proxy Statement/Prospectus.
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Millennium / COR Therapeutics Merger
❚ Leadership in 4 key franchise areas❚ Commercial capabilities to support oncology franchise❚ INTEGRILIN® – #1 injectable antiplatelet drug❚ Discovery synergies to build sustainable pipeline
Creating the Leading Biopharmaceutical Company:
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Agenda
❚ Vision – Mission – Strategy❙ Creating the Leading Biopharmaceutical Company
❚ Franchise and Pipeline Highlights
❚ 2001 Accomplishments
❚ 2002 Goals
❚ Delivering on Our Promise
Vision – Mission – Strategy:Creating the LeadingBiopharmaceutical Company
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Millennium Pharmaceuticals, Inc.
VisionTranscending the Limits of MedicineSM
MissionCreate the Leading Biopharmaceutical Company
Strategy❚ Breakthrough Products:
Sustainable Pipeline – Franchise Businesses
❚ Personalized Medicine and Productivity
❚ Value Creation
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Breakthrough Products: SustainablePipeline – Franchise Businesses
❚ Four major franchises
❚ Two therapeutic products on market❙ INTEGRILIN®
❙ Campath®
❚ 10 molecules in clinical trials
❚ Discovery engine to deliver a sustainable pipeline
Sustainable Pipeline
2002 3-4
2005➔ 5+
NMEs toClinic / Year
NMEs toMarket / Year
GenomeTranscriptomeProteomeMolecular PathwaysBiologic Systems
75+
HTS /Year
2003 / 4 1
2005 ➔ 1-2
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Personalized Medicine ➔ Productivity
GenomicTechnologiesThe Right Gene
Oncology Inflammation Metabolic
Cell CycleProteosomeApoptosis
ChemokinesCardsApoptosis
CNS MetabolismLeptin PathwayGut Biochemistry
Franchise Areas
Tissues / Transcriptional Profiling /Proteomics / Informatics
Tissue / Patients /Imaging / Outcome Data
Cardiovascular
ThrombosisAngiogenesisMyocyte
IntegrinsIon ChannelsGPCRs
MolecularPathwaysThe Right Target
Classes ofMoleculesThe Right Drug
DiseaseMarkersThe Right Patients
KinasesProteasesAntibodies
KinasesGPCRsAntibodies
GPCRsTransportersProteases
Bottlenecks
Process Development / Manufacturing
Gene/TargetIdentification
TargetValidation
LeadIdentification
Lead OPPreclinical Clinical Trials
Commercialand PatientManagement
Process
Integrated G2P Platform
Chips Proteomics Imaging Structure PredictiveADMET
CDU SNPFluidics
Biology Markers Computational Biology
Chemistry Chemical GeneticsComputational
Chemistry
Patho-pharmacology
Pharmaco-genomics
PatientManagement
Platform KnowledgeManagement
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Product Development Pipeline
Phase II Marketed /Phase IVPhase IIIPhase I
ClinicalCandidates
2002
MLN4760
INTEGRILIN® – STEMI
INTEGRILIN® – ACS/PCI
INTEGRILIN® – CABG
MLN341 – SolidMLN591RLMLN576
MLN341 – MMMLN341 – CLL
CT53518MLN591DM1MLN944CT53608
MLN02 – Crohn’s
MLN02 – UC
MLN977 (Oral)
CCR2CCR1CCR5MLN273
Cardiovascular
Oncology
Inflammation
Metabolic
XaCAB2
MLN519MLN01
STG-A-MD
Campath® — CLL
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Commercial Capabilities
Today The Future❙ Cardiovascular❙ Oncology
BreakthroughProducts
❙ US cardiologyand hospitalpresence
❙ Global presence in70% worldwide marketGeographic
Presence
❙ Commercialinfrastructure❙ Medical affairs❙ Business analysis
❙ Customer management❙ Web / internet commerce❙ Knowledge management
StrategicMarketing
❙ Integrated knowledge❙ Critical mass /
market leadership❙ Personalized medicine
products
❙ Inflammation❙ Metabolic
❙ >$100 B markets❙ Access new products
❙ Expand US presence❙ Initiate European effort❙ Partner Japan
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Leading Biopharmaceutical Company$100 Billion, 20% CAGR
Business OrganizationPersonalized
Medicine /Productivity
Pipeline
2 Rx products10 Clinicals3-4 New NMEs inclinic ’025+ New NMEs / yearclinic ’05 �1-2 Products /year ’05
Discovery leadership
Discovery � Clinic❙ Structure❙ ADMET❙ CDU❙ PGx
KnowledgeManagement
1200 R&D$500 M+ R&D ’02Business LeadershipCommercial Leadersin ACS / PCIPeople Focus
4 FranchisesAventis, Abbott,Schering, Bayer4 M&A (’97-’01)3 Inlicensing (’01)Strong balancesheet
Value Creation
Franchise andPipeline Highlights
Franchise Leadership – Building Businesses
Worldwide Market
Indication
Commercialization
R&D Investment
Cardiovascular Oncology Inflammation Metabolic
$40 B >$20 B $25 B $10 B
ACS, CABG,CHF 1°/2°prevention
Hematologicand solidtumors
RA, Asthma,COPD, IBD,MS, HIV
Obesity,Type IIdiabetes
MillenniumUS & Europe
MillenniumUS & Europe
MillenniumAventis
MillenniumAbbott
160 FTEs,$60 M
560 FTEs,$200 M
530* FTEs,$130 M
300* FTEs,$60 M
*FTEs include partner efforts© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Cardiovascular Franchise
PlaqueRupture
ThrombusVessel Wall
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Products
Franchise: Cardiovascular
❚ INTEGRILIN® – Unstable angina / NSTEMI / PCI
Clinical ❚ INTEGRILIN® – STEMI, CABG❚ MLN01 – Reperfusion injury❚ MLN519 – Reperfusion injury
Expertise ❚ Thrombosis and atherosclerosis❚ Cardiac myocyte biology❚ Growth factor receptors and endothelial
cell biology
2002 Clinical Candidates ❚ Factor Xa Inhibitor
Market Opportunity ❚ Largest therapeutic category – $40 B market
❚ CAB2
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
INTEGRILIN®
Breakthrough Drug for AcuteCoronary Syndromes and PCI❙ Glycoprotein IIb / IIIa inhibitor❙ Small molecule
#1 Intravenous Antiplatelet Agent❙ $230 M in 2001 sales
❙ 34% growth vs. 2000❙ Market leader with >50% patient market share❙ >30% annual growth with >$500 M peak sales❙ Partnership with Schering Plough
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
INTEGRILIN: Driving 30% Growth
Seizing market share❚ Aggressive conversion effort with top 100 hospitals
Growing the market❚ CRUSADE in 60,000 unstable angina patients
Adding new indications❚ ADVANCE MI in 6,000 patients presenting with heart attack
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Factor Xa Inhibitor Program
Opportunity❚ Oral anticoagulant therapy❚ Replacement for Coumadin❚ Novel treatment for DVT; atrial
fibrillation (3-4 M patients / year)
Key Features❚ Long half-life, high oral availability❚ Predictable PK / PD, minimal food
effect (no need for monitoring)❚ Favorable safety
Status Preclinical❚ Proof-of-concept
in animal models❚ Broad series of
potent and selectiveinhibitors
❚ 2002 clinicalcandidate selected:CT54004
Cardiovascular Franchise: Additional Programs
Program Status Lead IndicationsMechanisms
MLN01 Phase I Reperfusion injuryAnti-CD18
PDGF receptor Lead OptimizationVascularproliferativedisease
CAB2 PreclinicalCABGcomplications
Complementinhibitor
Platelet ADPreceptor
Lead OptimizationPrimary andsecondary MIprevention, stroke
Plateletaggregationinhibitor
MLN519 Phase I Reperfusion injuryProteasome
RTK inhibitor
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Cardiovascular Franchise:Personalized Medicine Initiatives
Major marker study with Eric Topol, M.D.,Cleveland Clinic❚ 500 CVD patients / 500 patients❚ 300 SNPs genotyped❚ 27 SNPs / Haplotypes with association
Pharmacogenomics in ADVANCE MI
Oncology Franchise
Normal Cell Cancer Cell Angiogenesis
CancerSpread
Lymphatic
BloodVessel
GrowthFactors
GrowthSignalingEnzymes
Metastatic
New Blood Vessel Growth
EnvironmentalDamage
GrowthFactor
Receptors
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Products
Franchise: Oncology
❚ Campath® – Refractory CLL❚Melastatin® – Malignant melanoma
diagnostic
Clinical ❚MLN341 – Multiple cancers❚MLN591RL – Prostate cancer❚MLN576 – Solid tumors
Expertise ❚ Proteasome❚ Kinases
2002 Clinical Candidates ❚MLN591DM1❚MLN944
❚ Antibodies❚ Pharmacogenomics
❚ CT53518❚ CT53608
Market Opportunity ❚ The leading area of unmet medical need
❚ Bayerprograms
MLN341: Proteasome Inhibition
Major point of intervention in oncology
❚ New mechanism
❚ Novel pathway
❚ Broad applications
❚ Broad IP estate
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
MLN341 in Refractory Multiple Myeloma:Preliminary Phase II DataStudy Population❚ Heavily pretreated and
refractory❚ Progressing at study entry❚ Median survival 6-12 months❚ Uniformly fatal
Efficacy❚ 85% stable or improved❚ 52% response rate — 2 cycles❚ 11% showed >90% reduction
in M protein level
Safety❚ MLN341 well tolerated❚ Side effects are
manageable (nausea,diarrhea, fatigueand thrombocytopenia)
❚ Grade 3 peripheralneuropathy occurredin 3 patients (3%)
❚ <10% patientsdiscontinued due toany adverse events
MLN341: Complete Responsein Multiple Myeloma
Prior Therapies (14):❚MP, VAD, Mel/PBSC x 3, dexamethasone❚Gemcitabine, DCEP, dendritic vaccine❚ Thalidomide, DCEAP, Doxil/Navelbine
10/1/00 12/1/00 2/1/01 4/1/01 6/1/01 8/1/01 10/1/010.0
0.5
1.0
1.5
2.0
2.5
M protein
MLN341
CR
g/dL
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
MLN341: Clinical Program
Ongoing Phase I studies:❚ Gemcitabine (pancreas and lung) — 50 patients,
accrual ongoing❚ Irinotecan (gastrointestinal) — 56 patients, accrual ongoing
New Phase I studies❚ Taxotere® (lung, prostate, breast) — 214 patients,
accrual started❚ Doxil® (advanced malignancies)
Planned clinical studies❚ Phase III multiple myeloma — 1H ’02❚ Multiple solid tumor pivotal trials — ’02 – ’03
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Anti-PSMA Antibody (MLN591)Prostate Specific Membrane Antigen
Opportunity❚ No effective therapies
for hormone refractorydisease
Key Features❚ PSMA expressed in
most prostate tumors❚ Expression increases
with tumor progression
Status Phase I❚ RL clinical trials in advanced
prostate and non-prostate cancers❚ Initiate Phase I DM1 and
Phase II RL studies — ’02Results to date❚ Radiolabeled anti-PSMA
❚ >60 patients treated to date❚ Antibody is well-tolerated❚ PSA levels and tumor
mass reduction
MLN591RL in Refractory Prostate Cancer
Patient had >50% decrease in PSA level
MLN591RL Dose
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Oncology Franchise: Additional Programs
Program Status Lead IndicationsMechanisms
MLN576 Phase I Solid tumorsDual Topo I / IIinhibitor
MLN591DM1 Preclinical Prostate cancerAnti-PSMA
CT53518 IND filed AMLRTK inhibitor
MLN944 Preclinical Solid tumorsDual Topo I / IIinhibitor
CT53608 RTK inhibitor Late Lead Glioblastoma
Pharmacogenomics: ❚ MLN341 ❚ MLN591 ❚ CT53518© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Inflammation Franchise
Leukocyte Activation/
Differentiation Migration
Tissue Damage/Repair
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Franchise: Inflammation
Clinical ❚ MLN02 – Crohn’s, UC❚ MLN977 (Oral) – Asthma
Expertise ❚ Leukocyte activation/differentiation:kinases, co-stimulation❚ Leukocyte migration: chemokines, integrins❚ Tissue damage and repair: leukotrienes, TNF, fibrosis
Partnerships ❚ 50-50 with Aventis
❚ CCR2❚ CCR1 (Aventis)
2002 Clinical Candidates
Market Opportunity ❚ Major markets in asthma, fibrosis (e.g. cirrhosis),RA, IBD and MS
❚ CCR5❚ MLN273
❚ MLN977 (Inhalation)❚ CT54141
Preclinical
Metabolic Franchise
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Franchise: Metabolic
Clinical ❚ MLN4760 – Obesity, first genomically-derivedtarget in clinic
Expertise ❚ Key pathways in metabolic / diabetes research❚ Hunger / Satiety❚ Thermogenesis
Partnerships ❚ Worldwide 50-50 with Abbott
❚ STG-A-MD – obesity2002 Clinical Candidates
❚ Insulin Resistance / Secretion❚ Absorption
❚ MC4 agonist❚ MC4 antagonist
Preclinical ❚ FATP4
Market Opportunity ❚ Obesity – largest future market
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
MLN4760 — Obesity
Opportunity❚ First genomics program
to clinic from Millennium-Abbott alliance
❚ Potential new therapeuticapproach
Key Features❚ Inhibits novel
carboxypeptidase❚ Non-appetite suppressant
mechanism
Status Phase I❚ Clinical trial for
PK / PD and safety❚ 56 subjects, accrual
ongoing
Results to date❚ Preclinical data support
favorable change inmetabolic profile
2001 Accomplishments
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Products❚ INTEGRILIN®
❙ >50% patient share❙ 34% growth vs. 2000
❚ Campath® on market❙ US, Europe
Pipeline❚ >80 High Throughput Screens❚ >12 late lead preclinical
candidates
2001 Accomplishments
Clinic 10 molecules in clinic(and 1 IND filed)❚ MLN341 – Phase II trials,
Phase I trials❚ MLN977 (Oral) – Phase II❚ MLN02 – Phase II❚ MLN591RL – Phase I❚ MLN576 – Phase I
1-2 molecules from genomics❚ MLN4760 – Phase I
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Productivity
❚ Leading discovery effort
❚ Alliances: Affymetrics,SGX, Caliper, Pharsight,Abbott
❚ Knowledge management,CDU initiative underway
2001 Accomplishments
Value Creation❚ COR Merger❚ Metabolic Disease:
50-50 worldwide Abbott❚ In/Out-licensing – PSMA,
TOPO I / II, GC-C,CAB2, MLN01, Campath®
❚ 200+ issued patents,2000+ patent applications
❚ On track to hit guidance
2002 Goals
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
2002 Goals: Creating a MajorBiopharmaceutical Company
Breakthrough Products / Sustainable Pipeline❚ INTEGRILIN® WW sales $300 M❚ MLN341 to start Phase III myeloma trial —
1H ’02❚ 3-4 new NMEs in clinic❚ >75 HTS❚ >$500 M R&D investment❚ Continue to build our 4 major franchise
businesses
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
2002 Goals: Creating a MajorBiopharmaceutical Company
Personalized Medicine / Productivity❚ Pharmacogenomics in 6 clinical programs
Value Creation❚ Financial guidance
❚ Revenue >$400 M❚ R&D expense >$500 M
❚ Target breakeven 2004❚ Continued M&A and transforming alliances
❚ $175-200 M NOL❚ >$1.7 B in cash with
~$250 M debt
© 2002 Millennium Pharmaceuticals, Inc. ML H&Q 011002
Millennium: Creating the LeadingBiopharmaceutical Company
Delivering on our promise of molecularmedicine to create the next era of therapeuticbreakthroughs that make a difference inpeople’s lives
Sustainable product pipeline❚ Critical mass ➔ capabilities❚ Strong financial position❚ Business leader in transforming relationships❚ Transforming commercial marketplace❚ Personalized medicine and productivity
Creating the LeadingBiopharmaceutical Company