2017 06 07 mimedx investor presentation final...source: millenium research group, mrg lap 2014, asps...
TRANSCRIPT
June 2017
FORWARD LOOKING STATEMENT
This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Suchstatements are forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statementsinclude, but are not limited to, the strategic benefit of the Company's placenta donation network and the difficulty that a competitor wouldface in establishing a competitive network, the Company’s ability to transition to a biopharmaceutical company at an accelerated pace, thestrength of the Company’s patent portfolio overall, the timing of the adjudication of the Company’s currently pending patent cases and theoutcome of those cases, the expansion of the Company’s sales force, the Company’s ability successfully to develop new products and thetiming and receipt of pending and anticipated regulatory clearances and approvals, that the Company’s ongoing investment in clinical trialswill continue to propel its success in gaining reimbursement coverage and regulatory approvals, that the Company will receive favorablecoverage decisions from Aetna and other payers and will increase penetration in its GPO/IDN contracts, the growth in the markets for theCompany’s current and future products and the share of such markets that the Company will be able to garner, the Company’s ability tocontinue to outpace its competitors, the Company’s ability to continue to make and benefit from process improvements and efficiencies, andthe Company’s ability to achieve the milestones and financial projections in the “3 in 1 and 20” plan. Among the risks and uncertainties thatcould cause actual results to differ materially from those indicated‐by such forward‐looking statements include that the Company may notrealize the strategic benefit of the Company's placenta donation network and a competitor may succeed in establishing a sizable competitivenetwork, the Company may be unable to transition to a biopharmaceutical company at an accelerated pace, the adjudication of theCompany’s current patent cases may be delayed or the outcomes may be unfavorable, there may be new challenges to the validity of theCompany’s patents or new incidences of infringement, the Company may not be able to expand its sales force as planned or the expansionmay be delayed, the Company may be unable to increase penetration of its GPO/IDN contracts, the Company may be unable successfully todevelop anticipated new products or the timing of such development may be delayed, the timing of anticipated regulatory clearances andapprovals may be delayed or denied, adverse regulatory actions against the Company, the Company’s ongoing investment in clinical trialsmay not have the expected impact on the Company’s ability to gain reimbursement coverage and regulatory approvals, the markets for theCompany’s current and future products may not be as large as the Company projects or grow as anticipated, the Company may not be able toachieve the market share it anticipates, including in the international market, the Company may face more and more effective competition,the Company may not continue to achieve significant process improvements and efficiencies, and the Company may be unable to achieve themilestones and financial projections in the “3 in 1 and 20” plan, market demand for the Company’s products may not grow or could decline,and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, withoutlimitation, its 10‐K filing for the fiscal year ended December 31, 2016. By making these forward‐looking statements, the Company does notundertake to update, them in any manner except as may be required by the Company's disclosure obligations in filings it makes with theSecurities and Exchange Commission under the federal securities laws.
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INVESTMENT HIGHLIGHTS
• Global Company Delivering Innovative Placental Tissue Based Regenerative Therapies and Therapeutic Biologics that Restore Function and Improve Quality of Life
• Opportunity to use a Product Under the 361 Regulations before Conducting a BLA Trial Provides Unique Clinical Trial and Revenue Benefits
• “3 and 1 in 20” Strategic Plan Triples 2015 Revenues to $560M and Delivers $1.00 of Adjusted Earnings in 2020
• Sustain 20%+ Revenue Growth Over the Long Term
• 86% Gross Margins and Strong Balance Sheet
• Deliver P&L Leverage in 2017 and Beyond
• Since May 2014, Executed $69M of a $86M Share Repurchase Program
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COMPANY HIGHLIGHTS
• 5 Innovative Technology Platforms
• Over 100* Issued and Allowed Patents
• Proprietary Purion Processed Placental Tissue Allograft Contains a Milieu of 220 Proteins (Growth Factors, Chemokines and Cytokines)
• Industry Leader in the Amniotic and Placental Tissue Market
• Emerging Leader in the Surgical and Ortho‐Biologics Market
• In 2020 Complete Transition to a Biopharmaceutical Company– Existing Products Remain Regulated through Section 361 of PHSA– New Products Regulated through Section 351 of PHSA under IND/BLA– Pain Management, Respiratory Disease and Cardiovascular Disease are Large
Biopharmaceutical Opportunities
*owned and licensed
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EXPERIENCED MANAGEMENT TEAM
Thornton A. KuntzSenior Vice President,HR & Administration
Deborah L. DeanExecutive Vice President
Christopher M. CashmanExecutive Vice President &
Chief Commercialization Officer
Mark E. DiazSenior Vice President, Commercial Operations
Dr. Rebeccah Brown Vice President,
Global Regulatory Affairs
Dr. Donald E. FetterolfChief Medical Officer
Dr. Thomas J. Koob Chief Scientific Officer
Dr. I. Mark LandyVice President,
Strategic Initiatives
Scott M. TurnerSenior Vice President,
Operations & Procurement
Michael W. CarltonSenior Vice President,
Global Sales
Kevin D. LillySenior Vice President,
Sales
Marlene M. DeSimoneSenior Vice President,
Marketing
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Parker H. “Pete” PetitChairman & CEO
William C. TaylorPresident & COO
Michael J. SenkenChief Financial Officer
Alexandra O. Haden General Counsel
0
10
20
30
40
50
60
70
$’s ‐
Millions
DELIVERING CONSISTENT SUSTAINABLE GROWTH
• 25 Consecutive Quarters of Sequential Revenue Growth• Met or Exceeded Revenue Guidance in 24 of Last 25 Quarters
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2017 GROWTH DRIVERS
• 2016 New Product Launches: EpiCord, AmnioFill, OrthoFlo Lyo
• Continued Sales Force Expansion
• Clinical Trial Results and Publications
• Incremental Commercial Reimbursement Coverage for DFU and VLU
• International Expansion
• Continued Leverage of GPO/IDN Contracts 5 Group Purchasing Organizations (GPO) contracts in place
‐ 4 have 80% or sole commitment tiers for Amniotic Tissue/Skin Substitute‐ Covers approximately 4,000 hospitals
40 Integrated Delivery Networks (IDN) Contracts‐ Covers approximately 1,300 hospitals‐ Many have committed Amniotic Tissue Contracts
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5‐YEAR STRATEGIC PLAN: “3 AND 1 IN 20”
In 2020: Triple 2015 Revenue, Deliver $1.00 of adjusted EPS and Complete Transition to a Biopharmaceutical Company
$560M$187M
Wound Care Operating Room Pain Management
* Adjusted
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2020 AssumptionsOrganic Rev Growth
107.5M FDSO*EBITDA 30%
Tax 36%
U.S. WOUND BIOLOGICS MARKET IN 2020
2020 Skin/Dermal Substitute (SDS) Segment Sales Estimate $1.1B 2020 Amniotic Tissue Share Estimate 58% vs. 29% in 2014
2016 SDS Sales Estimate $681M up 15% vs. 20152016 MiMedx Amniotic Tissue Share 63%
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SmartTRAK Business Intelligence and Company Estimates
39%
6%34%
21%
44.7%
5.9%
31.9%
17.5%
58%
5%
27%
10%
Amniotic Tissue Allografts Xenografts Cell‐Based Bioengineering
2015 SDS Segment
$587M2016 SDS Segment
$681M2020 SDS Segment
$1.1B
2016 WOUND SKIN SUBSTITUTE MARKET UPDATE
• FY 2016 Total Spend Estimated at $680.7M– +15% Growth Over 2015*
• MiMedx:– 31.0% Share for 4Q16; 24.9% Share in FY 2015
• Integra– 21.1% Share for 4Q16; 19.4% Share in FY 2015
• 3Q16 Share was 21.6% and 1Q16 was 21.7%• Does not include Derma Sciences Acquisition• AmnioMatrix and AmnioExcel 2016 Product Revenue Totaled ~$3.3M
– Integra Burn Revenue Estimated at $40M• 15% Market Share Excluding Burn Product
– Omnigraft IDRT CMS Hospital Outpatient Spend was $41K in 3Q16 and $68K for 9 Months (2016)
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CHRONIC WOUND MARKET IS UNDERPENETRATED
2015 6.5M US Patients have
Chronic Wounds
3M are non‐healing wounds
2016 U.S. Market Facts• Annual Cost of Treating Chronic Wounds
in the U.S. is $25 Billion• Skin/Dermal Substitutes is the Largest
Segment at $681 Million
MiMedx is the Market Leader at 30%
• Sales of Placenta Derived / Amniotic Tissue Products Grew 33% to $305M MiMedx is the Market Share Leader at 63%
1.4M Chronic DFU/VLU Wounds ‐ $3B Mkt Opportunity Alone
SmartTRAK Business Intelligence
Under 200K Are Treated With A Skin or Dermal Substitute
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Wound Care Operating Room Pain Management
Wound Care Growth Drivers
1. Continue To Take Market Share • Leverage Safety Advantage of Terminal Sterilization • Expand Scientific and Clinical Body of Evidence • Increase Lives Under Coverage• Broaden Reach In IDN / GPO Contracts• New Products• New Settings, Long‐term Care (LTAC)
2. Expand The Market• Secondary City Expansion• Convert Physicians that do not
use AWC Products• Influence and Improve Referral
Patterns
3. International Expansion
WOUND CARE GROWTH TARGET: 5YR 20% CAGR
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EPIFIX VLU MULTICENTER TRIAL INTERIM ANALYSIS
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Note: The MiMedx control was more efficacious than the Apligraf control
17%
33%
58%
72%
11%
24%
41%46%
0%
20%
40%
60%
80%
100%
Week 4 Week 8 Week 12 Week 16
VLU: EpiFix vs. Control % Subjects Complete Wound Closure
EpiFix (N=36) Control (N=37)
9%
29%37%
57%
5%
19%24%
40%
0%
20%
40%
60%
80%
100%
Week 4 Week 8 Week 12 Week 24
VLU: Apligraf vs. Control % Subjects Complete Wound Closure
Apligraf (N=130) Control (N=110)
17%
33%
58%
72%
9%
29%37%
57%
0%10%20%30%40%50%60%70%80%90%100%
Week 4 Week 8 Week 12 Week 16 Week 24
EpiFix vs. Apligraf VLU Study Results
EpiFix (N=36) Apligraf (N=130)
Controls: Multi‐Layer Compression Therapy withEpiFix – NuDerm AlginateApligraf – Moist Gauze with Zinc Paste
Please note: Apligraf and EpiFix studies are independent of one anotherApligraf Reference: PMA Supplement (P950032) approval dated 05/22/1998EpiFix Reference: Interim Data Report, report dated 11/04/2016
VLU COMMERCIAL COVERAGE IMPACT MODEL
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2015 6.5M US Patients have
Chronic Wounds
3M are non‐healing wounds
Market Penetration
# of Applications 5% 10.0% 15.0% 20.0% 25.0% 30.0%
1 $ 12,184,780 $ 24,369,560 $ 36,554,340 $ 48,739,119 $ 60,923,899 $ 73,108,679
2 $ 24,369,560 $ 48,739,119 $ 73,108,679 $ 97,478,239 $ 121,847,799 $ 146,217,358
3 $ 36,554,340 $ 73,108,679 $ 109,663,019 $ 146,217,358 $ 182,771,698 $ 219,326,038
4 $ 48,739,119 $ 97,478,239 $ 146,217,358 $ 194,956,478 $ 243,695,597 $ 292,434,717
5 $ 60,923,899 $ 121,847,799 $ 182,771,698 $ 243,695,597 $ 304,619,497 $ 365,543,396
Total EpiFix® Commercial Lives DFU/VLU 198,000,000
Currently Uncovered VLU (67%) 132,955,205
VLU Prevalence Rate 0.183%*
Additional VLU Patients when covered 243,696
EpiFix® Average Price $1,000
*Under 65 Truven Data
SDS COMPETITIVE PRODUCT COMPARISON
Apligraf and Dermagraft are registered trademarks of Organogenesis, Inc.Omnigraft and PriMatrix are registered trademarks of Integra Life Sciences Corporation. AMNIOEXCEL is registered trademark of BioD, LLC, an Integra Life Sciences company.BIOVANCE is a registered trademark of Alliqua Biomedical, Inc.Grafix is registered trademark of Osiris Therapeutics, Inc.References provided at end of presentation.
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Operating Room Growth Drivers
1. Increase Footprint• Continue to Hire Direct Surgical Reps,
Currently at 30• Deeper Penetration of GPO and IDN
Contracts
2. Expand Product Line• New Product Launches:
AmnioFill, OrthoFlo LYO• Synergistic Acquisitions
3. Grow Demand• Publish Clinical Trials Showing
Improved Surgical Outcomes and Reduced Complications
• Increase Number of VAC Approvals
OPERATING ROOM GROWTH TARGET: 5YR 20% CAGR
Wound Care Operating Room Pain Management
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TARGET HIGH VALUE SURGICAL PROCEDURES
Source: Millenium Research Group, MRG Lap 2014, ASPS Statistics, MiMedx 2015 Annual Plan, MiMedx internal coding data, Management Estimates
$2.9B
UROLOGYProstatectomy, Partial Nephrectomy,
Cystectomy
GENERAL COLORECTALBariatric, Fistula Repair,
GI Anastomosis
PLASTICSHand‐Tendon and Nerves, Mohs,
Scar Revision, Skin Grafting, Surgical Site Dehiscence, Burn
GYNHysterectomy, Endometriosis,
Myomectomy, C‐Section, Episiotomy
4.3MNumber of Procedures (000)
$5.7BAddressable Market Value ($M)
1,154
652
714
237
1,000
990
200
714
OrthopedicsSpine, Trauma, Extremities ,
Sports Medicine1,528 2,821
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TRANSITION TO A BIOPHARMACEUTICAL COMPANY
• Lead Product contains a Milieu of 220+ Proteins with a Unified Mechanism of Action and Proven Safety Profile
• Extensive Placental Tissue Technology Patent Family covers BLA Indications
• Opportunity to use a Product Under the 361 Regulations before conducting a BLA Trial Provides Unique Clinical Trial and Revenue Benefits
• Release Interim Phase 2b Data from Lead BLA Program in 3Q17 and Initiate Phase 3 Trial in 4Q17 or Early 2018
• File IND for Second Indication and Initiate Phase 2 Trial in 3Q17
• Exiting 2020 Biopharma Sales Approximately 20% of Total Revenue
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INITIAL BLA FOCUS IS PAIN MANAGEMENT
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Wound Care
Operating Room
Pain Management
2017 2018 2019 2020 2021
Knee OA Pain
Plantar Fasciitis Pain
BLA Launch361 Reimbursement opportunityOut of pocket pay
Everyday use Under 361 Regulations Provides the Opportunity to Generate Pain Revenue while the BLA Process is Ongoing
Out of pocket pay BLA Launch
SmartTRAK Business Intelligence and Company Estimates
2015 U.S. JOINT PAIN INJECTION MARKET
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A SAFER MORE EFFECTIVE PRODUCT IS NEEDED
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*
* Toxic side effects and limited efficacy ** Limited efficacy
**
*
****
**
AMNIOFIX INJECTABLE POSITIONING OPTIONS
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PAIN MANAGEMENT CLINICAL TRIAL MILESTONES
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RESPIRATORY AND CARDIOVASCULAR UPDATE
• Respiratory System– Completing Drug Discovery and
Design Process– Initiating Pre‐Clinical Development
Program – Current Goal is to Begin Human
Testing in 4Q 2018
• Cardiovascular System– Published Small Animal Study– Refining Development Program– Optimizing Delivery System
Scanning Electron Microscope Slides of Respirable Particles
Particle size distribution
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FINANCIAL HIGHLIGHTS
Q1 2017 Q1 2016 Change
Revenue $72.6M $53.4M +36%
Gross Margin % 88.0% 85.1% +290 bps
Adj. GM* 88.1% 86.5% +160 bps
R&D % 5.8% 4.7% +110 bps
S,G&A 72.9% 76.2% ‐330 bps
Net Inc. $4.3M $1.2M +261%
Adj. NI* $7.4M $4.9M +51%
Adj. EBITDA* $12.4M $9.1M +37%
Cash from Ops $10.6M ($1.0M) +$11.6M
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*(non‐GAAP)
FINANCIAL HIGHLIGHTS
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0
50
100
150
200
250
300
350
2014 2015 2016 2017 (Est.)
Revenue
Wound SSO
2017 Revenue Guidance = $303.5M ‐ $307M
KEY 2017 MILESTONES
Positive Aetna and KaiserCoverage Decisions
• First Half 2017– First Patent Infringement Trial– Report VLU Multicenter Data– Report DFU Multicenter Data
• Mid‐2017– Plantar Fasciitis llb Interim Data– Publish GI Anastomosis Data
• Second Half 2017– Publication VLU Multicenter Trial– Publication DFU Multicenter Trial– Report Prostatectomy Data– Knee OA Data
• 2017– Additional “Reimbursement Wins”
• 2018– Plantar Fasciitis Phase llb Data– Knee OA Data
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REFERENCES
1. http://www.apligraf.com/professional/pdf/FDAApprovalLetter.pdf2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p0000363. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm4. http://www.prnewswire.com/news‐releases/derma‐sciences‐expands‐access‐of‐its‐amniotic‐tissue‐product‐line‐with‐new‐premier‐inc‐agreement‐
300024252.html5. http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083440.pdf6. http://ir.alliqua.com/press‐releases/detail/544/alliqua‐to‐launch‐biovancer‐human‐amniotic‐membrane7. http://investor.osiris.com/annuals‐proxies.cfm; 2011.8. www.clinicaltrials.gov. Accessed 03/01/17.9. Zelen CM, Serena TE, Denozière G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of
diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502‐7.10. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion
membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr;11(2):122‐8.11. Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi‐centre comparative effectiveness study of healing using
dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015 Dec;12(6):724‐32.
12. Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi‐centre comparative study examining clinical efficacy and cost. Int Wound J. 2016 Apr;13(2):272‐82.
13. Veves A, Falanga V, Armstrong DG, Sabolinski ML. “Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial.” Diabetes Care. (24)2. 2001. pp 290‐5.
14. Marston W, Hanft J, Norwood P, Pollak R. “The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers.” Diabetes Care, Vol 26 #6, June 2000.
15. Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M. and Chung, K. C. (2015), A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Rep and Reg, 23: 891–900. doi:10.1111/wrr.12357.
16. Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70‐7.
17. Kavros, S; Dutra, T; Gonzalez‐Cruz, R; Liden, B; Marcus, B; McGuire, J; Nazario‐Guirau, L. The Use of PriMatrix, a Fetal Bovine Acellular Dermal Matrix, in Healing Chronic Diabetic Foot Ulcers: A Prospective Multicenter Study. Advances in Skin & Wound Care: August 2014 ‐ Volume 27 ‐ Issue 8 ‐ p 356–362. doi: 10.1097/01.ASW.0000451891.87020.69.
18. Lavery A, et al. “The efficacy and safety of Grafix for treatment of chronic diabetes foot ulcers: results of a multi‐centre, controlled, randomized, blinded, clinical trial.” Int Wound J 2014; doi: 10.1111/iwj.12329.
19. Public domain
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