Slide 1: Corporate presentation
As of September 30, 2021 nasdaq: axgn Corporate presentation
Slide 2: Safe harbor statement
2 This presentation contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimate
Slide 3: The Axogen platform for nerve repair
3 The Axogen platform for nerve repair revolutionizing the science of nerve repair™
Slide 4: The function of nerves
4 The function of nerves Nerves are like wires • Transfer signals across a network • If cut, data cannot be transferred • If crushed, short circuits and data corruption may occur The peripheral nervous system is a vast network from every organ to and from the brain • Sensory • Motor • Autonomic revo
Slide 5: Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth
Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth 5 Exclusively focused on peripheral nerve repair across an expanding set of applications addressing a large market opportunity Differentiated platform for nerve repair, anchored by Avance® Nerve Graf
Slide 6: Delivering strong, consistent revenue growth & gross margins
6 Delivering strong, consistent revenue growth & gross margins revolutionizing the science of nerve repair™ Q3 Operational Highlights • 9%* growth excluding the impact of Avive and deferred procedures in Q3 of 2020 • Revenue was negatively impacted by lower procedure volumes due to impact of the Del
Slide 7: Guidance Update
Guidance Update revolutionizing the science of nerve repair™ 7November 3, 2021 November 2021 Updating annual financial guidance • Full-year 2021 revenue will be in the range of $127.0M to $129.0M • Full-year 2021 gross margin is expected to remain above 80% As we look forward to 2022 and beyond, we
Slide 8: How are nerves injured?
revolutionizing the science of nerve repair™ 8 How are nerves injured? Transection Traumatic nerve injuries e.g., motor vehicle accidents, power tool accidents, battlefield injuries, gunshot wounds, surgical injuries, neuromas in continuity Connect Compression Carpal, cubital, tarsal tunnel revision
Slide 9: Current targeted nerve markets (U.S.)
Current targeted nerve markets (U.S.) 9 Trauma $1.9B Breast $250M OMF $300M Carpal & Cubital Tunnel $270M U.S. potential procedural estimates >900,000** • Trauma: > 700,000(1,2,3,4) • Carpal Tunnel Revisions & Cubital Tunnel: 130,000(5,6,7,8) • OMF: 56,000(9,10,11,12,13,14,15,16,17) • Breast Neuroti
Slide 10: Estimated $2.7B value of market opportunity in existing applications
Annual Incidence(a) Weighted Average Procedure Value Total Addressable Market Trauma 700,000 (b) $2,725 (C) $1,900M Carpal and Cubital Tunnel 130,000 $2,100 $270M Oral and Maxillo-Facial (OMF) 56,000 $5,400 $300M Breast Reconstruction Neurotization 24,500 f laps (15,000 pat ients ) $10,200 $250M Tot
Slide 11: Trauma total addressable market
11 Trauma total addressable market revolutionizing the science of nerve repair™
Slide 12: Trauma total addressable market (continued)
Trauma total addressable market (continued) 12revolutionizing the science of nerve repair™
Slide 13: Traditional transection repair options are suboptimal
Traditional TRANSECTION repair options are suboptimal 13 SUTURE Direct suture repair of no-gap injuries • Common repair method • May result in tension to the repair leading to ischemia • Concentrates sutures at the coaptation site AUTOGRAFT Traditional method despite several disadvantages • Secondar
Slide 14: Axogen solution for transection repair
14 25 µm Processed human nerve allograft for bridging nerve gaps Clinically studied off-the-shelf alternative • A biologically active nerve therapy with more than ten years of comprehensive clinical evidence • 82-84% meaningful recovery in sensory, mixed and motor nerve gaps in multi-center study22
Slide 15: Traditional compression repair options are suboptimal
Traditional COMPRESSION repair options are suboptimal 15 VEIN WRAPPING Autologous vein • Barrier to attachment to surrounding tissue • Requires extra time and skill to perform spiral wrapping technique • Second surgery site HYPOTHENAR FAT PAD Autologous vascularization flap • Barrier to attachment t
Slide 16: Axogen solution for compression repair
16 Axogen solution for COMPRESSION repair Minimally processed porcine extracellular matrix for wrapping and protecting injured peripheral nerve Protects repair site from surrounding tissue • Processing results in an implant that works with the body’s natural healing process33 • Minimizes soft tissue
Slide 17: Traditional stump neuroma options are suboptimal
Traditional STUMP NEUROMA options are suboptimal 17 TRACTION NEURECTOMY Nerve placed in traction and cut to allow for retraction • Simply resecting the nerve results in subsequent neuroma formation and risk of secondary surgery • Causes traction injury • High risk of recurrence36 BURYING IN MUSCLE/B
Slide 18: Axogen solution for stump neuroma
18 Axogen solution for STUMP NEUROMA Proprietary small intestine submucosa (SIS) matrix designed to separate the nerve end from the surrounding environment to protect it from mechanical stimulation and reduce painful neuroma formation. Protects and isolates • Reduces the development of symptomatic o
Slide 19: Axogen's comprehensive platform for addressing nerve injuries
Axogen’s comprehensive platform for addressing nerve injuries revolutionizing the science of nerve repair™ Connection Protection Termination 19
Slide 20: Avance IP and regulatory barriers to competitive entry
20 Avance IP and regulatory barriers to competitive entry Avance nerve graft is processed and distributed in accordance with US FDA requirements for Human Cellular and Tissue-based Products (HCT/P) Avance nerve graft Issued U.S. Patents 6,696,575 9,597,429 6,972,168 9,690,975 7,402,319 9,996,729 7,7
Slide 21: Unique Avance technology creates barriers to competitive entry
Unique Avance technology creates barriers to competitive entry revolutionizing the science of nerve repair™ 21 Progress toward Biologics License Application (BLA) for Avance Nerve Graft • Received Regenerative Medicine Advanced Therapy (RMAT) designation for Avance Nerve Graft in September 2018 • Hi
Slide 22: Market development strategy
22 Market development strategy B ui ld M ar ke t Aw ar en es s Ed uc at e Su rg eo ns , D ev el op A dv oc at es G ro w B od y of C lin ic al E vi de nc e Ex ec ut e Sa le s Pl an Ex pa nd P ro du ct P ip el in e + Ap pl ic at io ns revolutionizing the science of nerve repair™
Slide 23: Focus on building awareness among clinicians and patients
23 Focus on building awareness among clinicians and patients B ui ld M ar ke t Aw ar en es s • Increasing omnichannel engagement with clinicians and patients • Continuing clinical conference participation both virtually and in person as appropriate • Ongoing patient ambassador program • Garnering po
Slide 24: Emphasis on education
24 P IL L A R 2 Emphasis on education B ui ld M ar ke t Aw ar en es s Ed uc at e Su rg eo ns , D ev el op A dv oc at es • Returned to in-person national education programs in September • Providing customized multimodal learning programs to specific surgeon cohorts for advanced learning • Ongoing int
Slide 25: Strong commitment to developing clinical evidence
25 P IL L A R 3 Strong commitment to developing clinical evidence B ui ld M ar ke t Aw ar en es s Ed uc at e Su rg eo ns , D ev el op A dv oc at es G ro w B od y of C lin ic al E vi de nc e RANGER® Registry Study: Enrollment Ongoing • The largest multi-center clinical study in peripheral nerve repai
Slide 26: Growing body of clinical evidence
26 P IL L A R 3 *Total number as of September 30, 2021 for the Axogen portfolio of surgical implant products. Certain publications contain data on multiple applications. A full set of clinical references can be found at: https://www.axogeninc.com/wp- content/uploads/2021/09/Axogen-Clinical-Bibliogra
Slide 27: Avance Nerve Graft repairs found to be significantly better than conduit repairs
Avance Nerve Graft repairs found to be significantly better than conduit repairs revolutionizing the science of nerve repair™ 27 • Peer-reviewed publication from the MATCH cohort of the RANGER Registry • Includes outcomes from 110 subjects with 162 nerve injuries; 113 were repaired with Avance Nerve
Slide 28: Recent study finds Avance Nerve Graft recovery rates comparable to nerve autograft
Recent study finds Avance Nerve Graft (allograft) clinical outcomes recovery rates comparable to nerve autograft revolutionizing the science of nerve repair™ 28 “Safa et al., A Propensity Matched Cohort Study on Outcomes from Processed Nerve Allograft and Nerve Autograft in Upper Extremity Nerve Rep
Slide 29: Avance performed comparably to autograft for clinical outcomes and facility procedure costs
Recent studies find Avance Nerve Graft performed comparably to nerve autograft for both clinical outcomes and facility procedure costs revolutionizing the science of nerve repair™ 29 “Styron et al., Nerve Repair Hospital Index Procedure Costs – Allograft vs. Autograft Repair Type” Presented at the A
Slide 30: First publication on breast neurotization outcomes with Avance Nerve Graft
First publication on breast neurotization outcomes with Avance Nerve Graft demonstrated greater return of protective sensation revolutionizing the science of nerve repair™ 30 • Early outcomes from a single center study, as part of the Sensation-NOW registry • 36 breast reconstructions that included:
Slide 31: REPOSE pilot study analysis for chronic neuropathic pain with Axoguard Nerve Cap
Axogen sponsored REPOSESM pilot study analysis demonstrates clinically significant improvement for subjects with chronic neuropathic pain when using Axoguard Nerve Cap® following neurectomy60 revolutionizing the science of nerve repair™ 31November 3, 2021 15-subject, single arm pilot phase evaluatin
Slide 32: Focused sales execution, increasing market penetration
32 P IL L A R 4 Focused sales execution, increasing market penetration B ui ld M ar ke t Aw ar en es s Ed uc at e Su rg eo ns , D ev el op A dv oc at es G ro w B od y of C lin ic al E vi de nc e Ex ec ut e Sa le s Pl an Sales execution focused on driving results • Continue driving penetration in Act
Slide 33: CMS reimbursement by CPT code: HOPD and ASC
CPT Code Descriptor C-APC Hospital Outpatient (HOPD) Ambulatory Surgery Center (ASC) 2019 2020 2021 2022 3Y % Change 2019 2020 2021 2022 3Y % Change 64912 Nerve allograft repair2 5432 $4,566 $5,508 $5,700 $5,824 27.6% $1,920 $3,422 $3,788 $3,868 101.5% 64910 Conduit or vein allograft repair2 5432 $4
Slide 34: 2022 CMS Physician Fee Schedule
2022 Center for Medicare and Medicaid Services (CMS): Physician Fee Schedule (PFS) revolutionizing the science of nerve repair™ 34November 3, 2021 • 2022 physician fees declined for all services (not just nerve repair). In 2021 congress passed legislation in late December to override the proposed de
Slide 35: Expand the opportunity in nerve repair
35 P IL L A R 5 Expand the opportunity in nerve repair B ui ld M ar ke t Aw ar en es s Ed uc at e Su rg eo ns , D ev el op A dv oc at es G ro w B od y of C lin ic al E vi de nc e Ex ec ut e Sa le s P la n Ex pa nd P ro du ct Pi pe lin e + Ap pl ic at io ns International Expansion Product Pipeline Fu
Slide 36: Platform for nerve repair across multiple applications
36 Platform for nerve repair across multiple applications Breast Neurotization Loss of breast sensation affects QOL Urology Prostatectomy OMF Iatrogenic nerve injuries, mandible tumor resections affects eating, speaking, intimacy Extremities (Trauma and Compression) Acute trauma, revision carpal tun
Slide 37: Balance sheet and capital structure
37 Balance Sheet Highlights September 30, 2021 Cash, Cash Equivalents, and Investments $98.1 million Total Long-term Debt $50.0 million* Capital Structure (shares) September 30, 2021 Common Stock 41,558,929 Common Stock Options, RSUs, PSUs 5,463697 Common Stock and Common Stock Equivalents 47,022,62
Slide 38: Executive team
Executive team 38 Karen Zaderej Chairman, CEO, & President J&J (Ethicon) Peter J. Mariani Executive Vice President and Chief Financial Officer Guidant, Lensar, Hansen Erick DeVinney VP, Peripheral Nerve Science and Clinical Innovation Angiotech, PRA Intl Mike Donovan VP, Operations Zimmer Brad Ottin
Slide 39: Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth
Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth 39 Exclusively focused on peripheral nerve repair across an expanding set of applications addressing a large market opportunity Differentiated platform for nerve repair, anchored by Avance® Nerve Gra
Slide 40: nasdaq: axgn 40revolutionizing the science of nerve repair™
nasdaq: axgn 40revolutionizing the science of nerve repair™
Slide 41: Historical Active and Core Accounts
Historical Active and Core Accounts Active Accounts typically contribute ≈85% of total revenue Top 10% of Active Accounts typically contribute ≈35% of total revenue Active Accounts 6 orders in the last 12 months Core Accounts typically contribute ≈60% of total revenue Core Accounts ≥$100,000 revenue
Slide 42: Footnotes
42 Footnotes 1. National Hospital Ambulatory Medical Care Survey: 2015 Emergency Department Summary Tables – Table 18. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2015_ed_web_tables.pdf 2. Noble, et al.. Analysis of Upper and Lower Extremity Peripheral Nerve Injuries in a Population of Patients
Slide 43: Footnotes
43 Footnotes 42. Rajput K, et al. Painful neuromas. The Clinical Journal of Pain. 2012;28(7):639-645 43. Gruber H, et al. Practical experience with sonographically guided phenol instillation of stump neuroma: predictors of effects, success, and outcome. Am J Roentgenol. 2008;190(5):1263-1269. 44. Fa
Slide 44: Axogen comprehensive portfolio of products
Axogen comprehensive portfolio of products • Avance® Nerve Graft – Regulatory Classification: Avance Nerve Graft is processed and distributed in accordance with U.S. Food and Drug Administration (FDA) requirements for Human Cellular and Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulation