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Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.
Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual
results to differ materially from those indicated by such forward-looking statements include the risks that the Company may be unable to transition to a
biopharmaceutical company at an accelerated pace; the Company may be unable successfully to develop anticipated new products; the timing of
anticipated regulatory clearances and approvals may be delayed or denied; adverse regulatory actions against the Company; the markets for the
Companys current and future products may not be as large as the Company projects or grow as anticipated; the Company may not be able to achieve the
market share it anticipates; the Company may face more and more effective competition, the Company may not continue to achieve significant process
improvements and efficiencies; the Company may be unable to achieve the milestones and financial projections in the 3 and 1 in 20 plan; market
demand for the Companys products may not grow or could decline; unexpected concerns may arise from additional data or analysis from our clinical
trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional
information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be
unable to hire the expected number of sales representatives on a timely basis. For additional risks that might affect the Company, please review the Risk
Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements
speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
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INVESTMENT HIGHLIGHTS
3
COMPANY HIGHLIGHTS
4
EXPERIENCED MANAGEMENT TEAM
Parker H. Pete Petit William C. Taylor Michael J. Senken Alexandra O. Haden
Chairman & CEO President & COO Chief Financial Officer General Counsel
Dr. Rebeccah Brown Dr. Donald E. Fetterolf Dr. Thomas J. Koob Dr. I. Mark Landy
Vice President, Chief Medical Officer Chief Scientific Officer Vice President,
Global Regulatory Affairs Strategic Initiatives
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DELIVERING CONSISTENT SUSTAINABLE GROWTH
60
50
$s - Millions
40
30
20
10
6
2017 GROWTH DRIVERS
7
5-YEAR STRATEGIC PLAN: 3 AND 1 IN 20
2020 Assumptions
Organic Rev Growth
107.5M FDSO
*EBITDA 30%
Tax 36%
$187M $560M
* Adjusted
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U.S. WOUND BIOLOGICS MARKET IN 2020
10%
21% 17.5%
39%
2015 SDS Segment 2016 SDS Segment 44.7% 2020 SDS Segment
27%
31.9%
34% 5%
6%
5.9%
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WOUND CARE GROWTH TARGET: 5YR 20% CAGR
3. International Expansion
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EPIFIX VLU MULTICENTER TRIAL INTERIM ANALYSIS
VLU: EpiFix vs. Control % Subjects Complete VLU: Apligraf vs. Control % Subjects Complete
Wound Closure Wound Closure
100% 100%
0% 0%
Week 4 Week 8 Week 12 Week 16 Week 4 Week 8 Week 12 Week 24
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VLU COMMERCIAL COVERAGE IMPACT MODEL
1. Increase Footprint
Continue to Hire Direct Surgical Reps,
Currently at 30
Deeper Penetration of GPO and IDN
Contracts
3. Grow Demand
Publish Clinical Trials Showing
Improved Surgical Outcomes and Wound Care Operating Room Pain Management
Reduced Complications
Increase Number of VAC Approvals
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TARGET HIGH VALUE SURGICAL PROCEDURES
Orthopedics
Spine, Trauma, Extremities , 2,821
1,528 Sports Medicine
GYN
Hysterectomy, Endometriosis,
$2.9B
1,154 Myomectomy, C-Section, Episiotomy 1,000
PLASTICS
Hand-Tendon and Nerves, Mohs,
652 Scar Revision, Skin Grafting, Surgical 990
Site Dehiscence, Burn
GENERAL COLORECTAL
Bariatric, Fistula Repair,
GI Anastomosis
714 714
UROLOGY
Prostatectomy, Partial Nephrectomy,
237 Cystectomy 200
Source: Millenium Research Group, MRG Lap 2014, ASPS Statistics, MiMedx 2015 Annual Plan, MiMedx internal coding data, Management Estimates
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MUSCULOSKELETAL PAIN IS A LARGE OPPORTUNITY
Wound Care
Operating Room
Pain Management
Knee OA Pain Out of pocket pay 361 Reimbursement opportunity BLA Launch
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2015 U.S. JOINT PAIN INJECTION MARKET
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PLANTAR FASCIITIS PHASE 2B STUDY OUTLINE
80
70
Average VAS Score (SE)
60
50
40
30
20
10
0
Baseline 1 Month 2 Months 3 Months 6 Months
AmnioFix Saline
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REPORTED INTERIM PHASE 2B DATA
Note that at the 3 month time point, subjects within the placebo group were
allowed to undergo alternative therapy.
80
70
Average VAS Score (SE)
60
50
40
30
20
10
0
Baseline 1 Month 2 Months 3 Months 6 Months
AmnioFix Saline
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REPORTED INTERIM PHASE 2B DATA
The average reduction in pain from baseline over the first 3 months of the study for patients
treated with AmnioFix Injectable was 77.5% (vs. 45.7% for placebo)
Through 6 months post-injection, the average reduction in pain from baseline was 85.9% for
AmnioFix Injectable (vs. 57.1% for placebo). These results unquestionably demonstrate that
AmnioFix Injectable provides a robust pain relief signal
0%
-10%
Percent Reduction from Baseline
-20%
-30%
-40%
-50%
-60%
-70%
-80%
-90%
-100%
Baseline 1 Month 2 Months 3 Months 6 Months
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AmnioFix Saline
AI REDUCED THE USE OF OPIOIDS IN PILOT PF STUDY
100%
73.30%
57.10%
50%
26.70%
20%
2424* Tramadol post injection; week 1 and 2 boot ; week 3 and 4 tennis shoe and limited activity; week 5+ normal activity as tolerated
PLANTAR FASCIITIS PHASE 3 STUDY OUTLINE
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
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ACHILLES TENDONITIS PHASE 3 STUDY OUTLINE
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
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A SAFER MORE EFFECTIVE PRODUCT IS NEEDED
*
*
* **
*
*
*
**
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RESPIRATORY AND CARDIOVASCULAR UPDATE
Cardiovascular System
Published Small Animal Study Particle size
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FINANCIAL HIGHLIGHTS
Cash from $13.5M $7.3M +85% Cash from $24.1M $6.3M +283%
Ops Ops
*(non-GAAP)
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FINANCIAL HIGHLIGHTS
Revenue
350
300
250
200
150
100
50
0
2014 2015 2016 2017 (Est.)
Wound SSO
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KEY 2017 MILESTONES
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REFERENCES
1. http://www.apligraf.com/professional/pdf/FDAApprovalLetter.pdf
2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p000036
3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm
4. http://www.prnewswire.com/news-releases/derma-sciences-expands-access-of-its-amniotic-tissue-product-line-with-new-premier-inc-agreement-
300024252.html
5. http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083440.pdf
6. http://ir.alliqua.com/press-releases/detail/544/alliqua-to-launch-biovancer-human-amniotic-membrane
7. http://investor.osiris.com/annuals-proxies.cfm; 2011.
8. www.clinicaltrials.gov. Accessed 03/01/17.
9. Zelen CM, Serena TE, Denozire 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: 891900. 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 356362. 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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