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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.
2
INVESTMENT HIGHLIGHTS
3
COMPANY HIGHLIGHTS
5
DELIVERING CONSISTENT SUSTAINABLE GROWTH
90
80
70
60
$s - Millions
50
40
30
20
10
6
2017 GROWTH DRIVERS
7
5-YEAR STRATEGIC PLAN: 3 AND 1 IN 20
2020 Assumptions
Organic Rev Growth
*EBITDA 30%
Tax 36%
$187M $560M**
* Adjusted
8
U.S. WOUND BIOLOGICS MARKET IN 2020
10%
21% 18%
39%
2015 SDS Segment 2016 SDS Segment 45% 2020 SDS Segment
27%
32%
34% 5%
6%
6%
3. International Expansion
10
CHRONIC WOUND MARKET IS UNDERPENETRATED
35% 37%
40% 29%
Please note: Apligraf and EpiFix studies are 17%
20% 9%
independent of one another
Controls: Multi-Layer Compression
Apligraf Reference: PMA Supplement
0% Therapy with EpiFix NuDerm Alginate
(P950032) approval dated 05/22/1998
Week 4 Week 8 Week 12 Week 16 Week 24 Apligraf Moist Gauze with Zinc Paste
EpiFix Reference: Published Final Data
Report, Reported Press Release 08/31/2017
EpiFix (N=52) Apligraf (N=130)
12
VLU COMMERCIAL INSURANCE
COVERAGE IMPACT MODEL
ONLY 33% of Commercial Payers Cover EpiFix For Both DFU and VLU
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
15
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
Dehiscence, Breast Recon, 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
16
MUSCULOSKELETAL PAIN IS A LARGE OPPORTUNITY
Wound Care
Operating Room
Pain Management
Knee OA Pain Out of Pocket Pay 361 Reimbursement Opportunity BLA Launch
17
2015 U.S. JOINT PAIN INJECTION MARKET
Number of Procedures
19
PLANTAR FASCIITIS:
REPORTED INTERIM PHASE 2B DATA
Primary Efficacy Endpoint, Pain Relief at 3 Months: AmnioFix Injectable Demonstrated
Clinically Meaningful and Statistically Significant Separation from Placebo (p-value = 0.0001)
Statistically Significant Results Were Seen at 6 Months (p-value = 0.0005)
Average Reduction in Pain from Baseline at 3 Months was 77.5% vs. 45.7% for Placebo
Average Reduction in Pain from Baseline at 6 Months was 85.9% vs. 57.1% for Placebo
0%
At 3 Months Subjects in the Placebo
-10% Group Were Allowed to Undergo
Alternative Therapy
-20%
Percent Reduction from Baseline
-30%
-40%
-50%
-60%
-70%
-80%
-90%
-100%
Baseline 1 Month 2 Months 3 Months 6 Months
AmnioFix Saline
20
OSTEOARTHRITIS (OA) IS A BOOMING EPIDEMIC
*
*
* **
*
*
*
**
23
PAIN MANAGEMENT CLINICAL TRIAL MILESTONES
Cardiovascular System
Published Small Animal Study Particle size
distribution
Refining Development Program
Optimizing Delivery System
25
FINANCIAL HIGHLIGHTS
Cash from $18.0M $2.8M +531% Cash from $42.1M $9.1M +360%
Ops Ops
*Reconciliation of non-GAAP financial measures included in supplemental slides section of the slide deck
26
FINANCIAL HIGHLIGHTS
Revenue
350
300
250
200
150
100
50
0
2014 2015 2016 2017 (Est.)
Wound SSO
27
KEY 2017 MILESTONES
28
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
30
PLANTAR FASCIITIS PHASE 2B STUDY OUTLINE
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
32
ACHILLES TENDONITIS PHASE 3 STUDY OUTLINE
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
33
OSTEOARTHRITIS PHASE 2B STUDY OUTLINE
Non-GAAP Adjustments:
35
SUPPLEMENTAL SLIDE
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
NET INCOME
Three Months Ended Nine Months Ended
September 30, 2017 September 30, 2017
2017 2016 2017 2016
Net Income (Per GAAP) $17.5M $3.3M $29.9M $6.5M
Non-GAAP Adjustments:
Tax Rate Normalization* (7.4M) (.5M) (11.4M) (0.9M)
Gain on Divestiture (4.3M) -- (4.3M)
One Time Costs Incurred in Connection -- 0.2M -- 1.1M
with Acquisition
One Time Inventory Costs Incurred in -- 0.3M 0.2M 1.6M
Connection with Acquisition
Amortization of Intangible Assets 0.4M 0.6M 1.5M 1.9M
Share-based Compensation 5.3M 4.7M 15.2M 13.8M
Estimated Income Tax Impact from (2.0M) (2.4M) (5.9M) (7.7M)
Adjustments
Adjusted Net Income $9.5M $6.2M $25.2M $16.3M
*Assumes a normalized tax rate of 42% for 2016 and 35% for 2017.
36
SUPPLEMENTAL SLIDE
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
EBITDA
Three Months Ended Nine Months Ended
September 30, 2017 September 30, 2017
2017 2016 2017 2016
Net Income (Per GAAP) $17.5M $3.3M $29.9M $6.5M
Add Back:
Gain on Divestiture (4.2M) -- (4.3M) --