Slide 1: Corporate presentation
August 8, 2024 nasdaq: axgn Corporate presentation
Slide 2: Safe harbor statement
2 Safe harbor statement revolutionizing the science of nerve repair® 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
Slide 3: The Axogen platform for nerve repair
3 The Axogen platform for nerve repair revolutionizing the science of nerve repair® • Exclusively focused on peripheral nerve repair with a differentiated platform • 15+ years of demonstrated clinical outcome consistency • 275 peer-reviewed clinical publications • Over 100,000 Avance® nerve grafts i
Slide 4: The function of nerves and injury types
4 The function of nerves and injury types 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
Slide 5: Comprehensive platform for addressing nerve injuries
August 7, 2024revolutionizing the science of nerve repair 5 Comprehensive platform for addressing nerve injuries TerminationProtectionConnection
Slide 6: Targeted nerve markets (U.S.)
Targeted nerve markets (U.S.) 6 Trauma $1.9B Breast $250M OMF $300M Carpal & Cubital Tunnel $270M U.S. potential procedural estimates >900,000** • Trauma1-4: > 700,000 • Carpal and Cubital Tunnel Revisions5-8: 130,000 • Oral Maxillofacial (OMF)9-17: 56,000 • Breast Neurotization Procedures18: 15,000
Slide 7: Opportunities in nerve repair
7 P IL L A R 5 Opportunities in nerve repair P IL L A R 4 P IL L A R 3 Pain Post-traumatic, TKA and TKH pain, amputations, symptomatic neuromas, and nerve compressions, revision carpal tunnel and cubital tunnel Core business anchored in Trauma and Upper Extremity, and expanded to Breast, OMF and Pai
Slide 8: Delivering strong revenue growth and gross margins
$41.1 $60.4 $83.9 $106.7 $112.3 $127.4 $138.6 $159.0 2016 2017 2018 2019 2020 2021 2022 2023 Annual Revenue 21% CAGR 8 Delivering strong revenue growth and gross margins U.S. $ in millions revolutionizing the science of nerve repair® Management expects: • Full-year 2024 revenue to be in the range of
Slide 9: Growth drivers
Growth drivers revolutionizing the science of nerve repair® 9 Clinical Data • Clinical data published supports increased adoption particularly with middle adopters – RECONSM 19 – Meta Analysis of clinical outcomes and Medicare Economic Data20 – Premier Economic Data21 – Cost–effectiveness analysis o
Slide 10: Axogen Processing Center (APC)
10 Axogen Processing Center (APC) • Fully transferred all Avance processing to APC in December 2023 • Supports BLA requirements for Avance Nerve Graft® • Provides 3x previous capacity, designed for long-term growth and expansion revolutionizing the science of nerve repair®
Slide 11: Product Portfolio
Product Portfolio revolutionizing the science of nerve repair® 11
Slide 12: Traditional transection repair options are suboptimal
Traditional Transection repair options are suboptimal 12 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 13: Transection repair solutions: Avance Nerve Graft and Axoguard Nerve Connector
13 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 study26
Slide 14: Traditional compression repair options are suboptimal
Traditional Compression repair options are suboptimal 14 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 vascularized flap • Barrier to attachment to s
Slide 15: Axogen solutions for compression repair
15 Axogen solutions 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 process38 • Minimizes soft tissu
Slide 16: Avive+ Soft Tissue Matrix
revolutionizing the science of nerve repair® 16 Avive+ Soft Tissue Matrix Resorbable Avive+ Soft Tissue Matrix is a temporary resorbable soft tissue barrier for the prevention of soft tissue attachment in an acute wound bed. Made from human birth tissue that will resorb after the critical stage of h
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 recurrence 39 BURYING IN MUSCLE/
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
Slide 19: Avance patents and regulatory landscape
19 Avance Patents and Regulatory Landscape Avance nerve graft is processed and distributed in accordance with US FDA requirements for Human Cellular and Tissue-based Products (HCT/P) Issued U.S. Patents (additional patents pending) Axogen has Enforcement Discretion from FDA allowing continued sales
Slide 20: Market development strategy
20 Market development strategy B u ild M a rk e t A w a re n e s s G ro w B o d y o f C lin ic al E vi d e n c e E x ec u te S a le s P la n E x p an d P ro d u c t P ip e li n e + A p p li ca ti o n s revolutionizing the science of nerve repair® E d u ca te S u rg e o n s, D ev e lo p A d vo c a te
Slide 21: Strong commitment to developing clinical evidence
Outcomes from RANGER Registry 44,45 21 P IL L A R 3 Strong commitment to developing clinical evidence RANGER® Registry Study: Enrollment Complete • Multi-center clinical study in PNR with >2,700 enrolled to date • Overall meaningful recovery rates of 82-84%; comparable to autograft MATCH® Registry S
Slide 22: RECON study design
RECON : A Multicenter, Prospective, Randomized, Subject & Evaluator Blinded Comparative Study of Nerve Cuffs & Avance Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities 22 Safety & efficacy non- inferiority comparison of Avance vs conduit Evaluated upper extremity digit
Slide 23: RECON Study Topline Results
revolutionizing the science of nerve repair® RECON Study Topline Results 23 Statistical superiority demonstrated at increasing gap lengths Avance demonstrated statistical superiority for return of sensory function (measured by static two-point discrimination) as compared to conduits in gaps greate
Slide 24: REPOSE Study Top Line Results
REPOSE Study Top Line Results revolutionizing the science of nerve repair 24August 7, 2024 Statistical superiority demonstrated in Reduction of Total Pain Axoguard Nerve Cap demonstrated statistical superiority vs. standard-of-care neurectomy in the Reduction of Total Pain reported by participants
Slide 25: Independent publication of nerve meta-analysis
Independent Publication of Nerve Meta-Analysis Provides the Strongest Clinical and Economic Evidence To-Date of the Performance of Avance® Nerve Graft Across All Gap Lengths and Nerve Types 25 • Analyzed 35 peer-reviewed studies with 711 allograft, 670 autograft, and 178 conduit repairs, over four d
Slide 26: Procedure costs of peripheral nerve graft reconstruction
Procedure Costs of Peripheral Nerve Graft Reconstruction Raizman et al. PRS Global Open21 26revolutionizing the science of nerve repair® • Retrospective study of U.S. all-payer data on facility procedure costs from 2018 to 2020. Included over 1,300 nerve repairs. Conclusions: • No significant differ
Slide 27: Focus on building awareness among clinicians and patients
27 Focus on building awareness among clinicians and patients • Increasing omnichannel engagement with clinicians and patients • Continuing clinical conference participation both virtually and in-person as appropriate • Ongoing patient ambassador program • Garnering positive media attention • Growing
Slide 28: Education and advocacy efforts
Knowledge is power: continued education and advocacy efforts with patients, clinicians and key legislators elevates the problems associated with numbness.
Slide 29: Emphasis on education
29 P IL L A R 2 Emphasis on education • In-person and virtual national education programs • Customized multimodal learning programs to specific surgeon groups for advanced learning • Ongoing interactive webinar series covering the principles of nerve repair • Emphasis on training hand and micro- sur
Slide 30: Focused sales execution, increasing market penetration
30 P IL L A R 4 Focused sales execution, increasing market penetration P IL L A R 3 E xe c u te S a le s P la n Sales execution focused on driving results • Continue driving penetration in Core Accounts • Approximately 5,100 potential U.S. accounts perform nerve repair • 412 Core Accounts as of June
Slide 31: Committed to our patients and communities
Committed to our patients, the communities we serve, and our pursuit of advancing the science of nerve repair in ethical and sustainable ways Diversity, Equity, and Inclusion - Being the Company where exceptional people want to work Cybersecurity – Data Privacy, Training, and Policies Compliance – Q
Slide 32: Executive team
Executive team 32 Doris Quackenbush VP, Sales Convatec revolutionizing the science of nerve repair® Erick DeVinney Chief Innovation Officer Angiotech, PRA Intl Todd Puckett VP, Operations NuVasive, Zimmer Ivica Ducic, M.D., Ph.D. Chief Medical Officer Washington Nerve Institute Jens Schroeder Kemp C
Slide 33: Appendix
Appendix • Key clinical data • Historical core and active accounts • CMS outpatient and ASC reimbursement rates • Total addressable market • Cash, debt, and capital structure • Axogen product portfolio and indications for use 33revolutionizing the science of nerve repair®
Slide 34: Avance nerve graft repairs significantly better than conduit repairs
Avance nerve graft repairs found to be significantly better than conduit repairs 34 • 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 graft and 49 were repaired with manufactured
Slide 35: Breast neurotization outcomes with Avance Nerve Graft
First publication on breast neurotization outcomes with Avance Nerve Graft demonstrated greater return of protective sensation 35 • Early outcomes from a single center study, as part of the Sensation-NOW® registry • 36 breast reconstructions that included: 22 breast reconstructions with Resensation®
Slide 36: REPOSE pilot study analysis
Axogen sponsored REPOSESM pilot study analysis demonstrates clinically significant improvement for subjects with chronic neuropathic pain when using Axoguard Nerve Cap® following neurectomy47 36 15-subject, single arm pilot phase evaluating reduction in pain from baseline following surgical excision
Slide 37: Historical Core and Active Accounts
Historical Core and Active Accounts 37revolutionizing the science of nerve repair® * Axogen voluntarily suspended market availability of Avive® Soft Tissue Membrane on June 1, 2021. Active and Core Account metrics are Adjusted for past Avive revenue. Core Accounts represents ~65% of revenue and grew
Slide 38: CMS outpatient and ASC reimbursement rates
Ambulatory Surgery Center (ASC)Hospital Outpatient (HOPD) C-APCDescriptorCPT Code % ChangeProposed 20252024% ChangeProposed 20252024 1.41%$4,644$4,579 1.30%$6,437$6,3545432Nerve allograft repair264912 4.82%$4,495 $4,288 1.30%$6,437$6,3545432Conduit or vein allograft repair264910 -30.25%$3,136 $4,496
Slide 39: 2024-25 CMS Proposed Physician Fee Schedule
2024-25 YoY Center for Medicare and Medicaid Services (CMS): Proposed Physician Fee Schedule (PFS) revolutionizing the science of nerve repair 39August 7, 2024 Physician Fee Schedule (PFS) DescriptorCPT Codes to f % Change2025 Proposed2024 -1.95%$880$897Nerve allograft repair64912 -1.65%$752$765Cond
Slide 40: CMS outpatient and ASC rates 2019-25
Ambulatory Surgery Center (ASC)Hospital Outpatient (HOPD) C-APCDescriptorCPT Code 6Y % Change2025 Proposed202420196Y % Change2025 Proposed20242019 141.88%$4,644$4,579 $1,92040.98%$6,437$6,354$4,5665432Nerve allograft repair264912 72.02%$4,495 $4,288 $2,61340.98%$6,437$6,354$4,5665432Conduit or vein
Slide 41: 2019-25 CMS Proposed Physician Fee Schedule
2019-25 Center for Medicare and Medicaid Services (CMS): Proposed Physician Fee Schedule (PFS) revolutionizing the science of nerve repair 41August 7, 2024 Physician Fee Schedule (PFS) DescriptorCPT Codes3 6Y % Change2025 Proposed20242019 9.40%$880$897$804Nerve allograft repair64912 -8.80%$752$765$8
Slide 42: Estimated Trauma total addressable market
42 Estimated Trauma total addressable market revolutionizing the science of nerve repair® 1 1 2 2
Slide 43: Trauma total addressable market (continued)
Trauma total addressable market (continued) 43revolutionizing the science of nerve repair® 4
Slide 44: Estimated Total Addressable Market
Projected Incidence(a) Weighted Average Procedure Value Estimated Total Addressable Market $1,900M 100% $1,120M 59% $238M 12% $535M 28% $2,715 $5,515 $1,200 $1,825 700,000 100% 203,000 29% 198,000 29% 293,000 42% Trauma Transection injuries >5mm (b) Transection injuries <5mm Non-Transected Injuries
Slide 45: US Nerve Repair Trauma Categories
$238 $1,901 $453 $675 $535 <5mm nerve injuries Digital & other sensory nerves >5mm Mix/Motor >5mm Protection Total Trauma Market US Nerve Repair Trauma Categories ($M) We continue to see a significant growth opportunity in the trauma market as we leverage new clinical & health economic data and prod
Slide 46: Balance sheet and capital structure
46 June 30, 2024Balance Sheet Highlights $27.1 millionCash, Cash Equivalents, and Investments $50.0 million*Total Long-term Debt June 30, 2024Capital Structure (shares) 43,824,738Common Stock 9,402,510Common Stock Options, RSUs, PSUs 53,227,248Common Stock and Common Stock Equivalents Balance sheet
Slide 47: 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 US Food and Drug (FDA) requirements for Human Cellular and Tissue- based Products (HCT/P) under 21 CFR Part 1271 regulations, US State regula
Slide 48: Axogen comprehensive portfolio of products (Cont'd)
Axogen comprehensive portfolio of products (Cont’d) revolutionizing the science of nerve repair® 48 Axoguard Nerve Cap® • Regulatory Classification: Class II Medical Device – 510(k) cleared • Indications for Use: Axoguard Nerve Cap is indicated to protect a peripheral nerve end and to separate the n
Slide 49: Axogen comprehensive portfolio of products (Cont'd)
Axogen comprehensive portfolio of products (Cont’d) revolutionizing the science of nerve repair 49 Avive+ Soft Tissue MatrixTM • Regulatory Classification: Avive+ Soft Tissue Matrix is processed and distributed in accordance with US Food and Drug (FDA) requirements for Human Cellular and Tissue-base
Slide 50: Footnotes
50 Footnotes revolutionizing the science of nerve repair® 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 periphera
Slide 51: Footnotes
51 Footnotes 37. Nihsen, et al. Bioactivity of small intestinal submucosa and oxidized regenerated cellulose/collagen. Adv Skin Wound Care. 2008; 21(10): 479-486. 38. Hodde, et al. Vascular endothelial growth factor in porcine-derived extracellular matrix. Endothelium. 2001; 8(1): 11-24. 39. Pet MA,
Slide 52: 52revolutionizing
nasdaq: axgn 52revolutionizing the science of nerve repair®