Axogen
27 named things its latest annual report says its results depend on, each in the company's own words. 9 of them are also named by other companies we've read.
Customers
Commercial health insurers
earns from · approximately 65% of commercially insured patientsnamed as a riskToday, approximately 65% of commercially insured patients in the U.S. have coverage for procedures utilizing our products, and we continue to collaborate with payers to close remaining gaps.Business (Item 1)
Suppliers
Single-source raw material suppliers
depends onnamed as a riskHowever, there are materials within the manufacturing and production process that come from single suppliers, some of which are outside of the U.S., or certain supplies which may be difficult to procure due to supply chain shortages or changes in global trade regulations.Risk factors (Item 1A)
Also named by BIIB
Evergen (formerly Cook Biotech Incorporated)
depends onnamed as a riskAlthough we believe we could develop or obtain products that would replace the Axoguard products obtained through the Evergen agreements, the loss of the ability to sell the Axoguard products could have a material adverse effect on our business, results of operations, financial condition, and prospects.Risk factors (Item 1A)
Third-party contract sterilization provider
depends onnamed as a riskAny disruptions or planned shutdowns of our third-party contractor’s qualified site could cause temporary disruptions in our ability to supply Avance finished product, which could have an adverse effect on our business.Risk factors (Item 1A)
Partners and platforms
Independent sales agencies
earns from · approximately 8% of global product revenuenamed as a riskIn 2025, approximately 8% of global product revenue was generated through independent agencies.Risk factors (Item 1A)
Competitors
Autograft and hollow-tube nerve conduits
competes withnamed as a riskFor the foreseeable future, we believe a significant number of surgeons will continue to choose to perform autograft procedures when feasible, despite the necessity of performing a second operation and its drawbacks.Risk factors (Item 1A)
Places
Germany
subject tonamed as a riskWe are in the process of updating our registration status with the German Health Authorities for product manufactured at our APC Facility and will be unable to ship the Avance Nerve Graft to Germany until we receive approval from The German Health Authorities.Risk factors (Item 1A)
Also named by APO, BF/B, CPRT, DASH, EBAY, GD, GDDY, KRYS and 12 more
Dayton, Ohio
operates innamed as a riskWe expect to continue to rely on the Dayton Facility for the processing of Avive+ Soft Tissue Matrix.Business (Item 1)
Also named by TRMB
Vandalia, Ohio
concentrated innamed as a riskFor example, Avance is supplied by a single Axogen owned and operated manufacturing facility and our ability to continue manufacturing Avance at this facility under the terms of our BLA is dependent on the successful implementation of certain updates to our previous environmental monitoring program.Risk factors (Item 1A)
Burleson, Texas
operates innamed as a riskAny failure in the physical infrastructure of our facilities, including the APC Facility, the Dayton Facility, and our distribution facility in Burleson, Texas could lead to significant costs and disruptions that could reduce our revenue and harm both our business reputation and financial results.Risk factors (Item 1A)
United States
concentrated inRevenue from the distribution of our Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector, Axoguard Nerve Cap and Avive+ Soft Tissue Matrix in the U.S. is the main contributor to our total reported sales and have been the key component of our growth to date.Business (Item 1)
Also named by ABBV, ADP, AJG, AMGN, APA, AXP, BALL, BAM and 139 more
Commodities and inputs
Donated human peripheral nerve tissue
depends onnamed as a riskWe are highly dependent on our ability to recover human peripheral nerve tissue from tissue donors for our Avance Products.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject to · Approximately 60% of our total revenuesnamed as a riskApproximately 60% of our total revenues are from sales of Avance Products and any adverse decision from the FDA would negatively impact our operations and financial condition.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, BAX and 112 more
Centers for Medicare & Medicaid Services (CMS)
subject to · 96% in hospital outpatient centers and 221% in ambulatory surgery centers since 2019With the new 2026 CMS reimbursement rates for nerve repair in the outpatient setting that became effective January 1st, reimbursement for procedures using Avance Nerve Graft have increased 96% in hospital outpatient centers and 221% in ambulatory surgery centers since 2019.Risk factors (Item 1A)
Also named by A, ABT, AMGN, BAX, BWIN, CNC, COO, COR and 23 more
American Association of Tissue Banks (AATB)
subject tonamed as a riskThe loss of accreditation or registration could keep us from selling and distributing our products, which may have negative effects on our business, results of operations, financial condition, and prospects.Risk factors (Item 1A)
Laws and programs
Ohio economic development grants
approximately $950 thousandnamed as a riskIf we are unable to maintain minimum requirements under our grant agreements, we could be obligated to pay back up to approximately $950 thousand as of December 31, 2025 related to these grants.Business (Item 1)
Medicare
earns fromnamed as a riskTherefore, adequate coverage and reimbursement from third-party payors, including government payors such as Medicare and Medicaid, are important for obtaining product acceptance and widespread adoption in the marketplace.Risk factors (Item 1A)
Also named by ABT, ARWR, BAX, BDX, BMY, BSX, CAH, CDNA and 48 more
U.S.-China tariffs
subject tonamed as a riskRising threats of international tariffs, including tariffs applied to goods traded between the U.S. and China, could materially and adversely affect our business, results of operations, financial condition, and prospects.Risk factors (Item 1A)
Federal Anti-Kickback Statute
subject tonamed as a riskOur practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor.Business (Item 1)
FDA Accelerated Approval Program
subject tonamed as a riskPortions of the FDA-approved indication for Avance were granted under the FDA’s accelerated approval program, and continued approval for these indications is contingent upon our timely completion of required post-marketing confirmatory studies.Risk factors (Item 1A)
CPT code 64912
subject tonamed as a riskEffective January 1, 2026, CMS created a new Ambulatory Payment Category 5433 for level 3 nerve repair.Risk factors (Item 1A)
21 CFR Part 1271
subject tonamed as a riskIn addition to the FDA requirements for biological products, our Avance Products will continue to be subject to various requirements for human tissue under 21 CFR Part 1271.Risk factors (Item 1A)
PHS Act Section 361
subject tonamed as a riskProducts regulated solely under Section 361 of the PHS Act are a product category under close scrutiny by the FDA for compliance with the regulatory requirements and potentially subject to regulatory change in the future.Business (Item 1)
National Organ Transplant Act (NOTA)
subject tonamed as a riskIf NOTA is interpreted or enforced in a manner that prevents us from receiving payment for services we render or prevents us from paying tissue banks or certain of our clients for the services they render for us, our business, results of operations, financial condition, and prospects could be materially and adversely affected.Risk factors (Item 1A)
European Medical Device Regulation 2017/745 (E.U. MDR)
subject tonamed as a riskGiven the significant additional pre-market and post-market requirements imposed by the E.U. MDR, the overall impact of these new rules could have a material, adverse effect on our international revenue and expenses.Business (Item 1)
Florida, New York, California and Maryland tissue banking regulations
subject tonamed as a riskRegulations issued by Florida, New York, California, and Maryland, among other states, are particularly relevant to our business.Risk factors (Item 1A)
Technology
Axoguard Product Line patents (Evergen)
named as a riskFor example, the material U.S. patents covering the formulations used in our Axoguard Product Line, which are held by Evergen, have expired.Risk factors (Item 1A)