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AXGN on Nasdaq

Axogen, Inc.

In its 2026 annual report the company says: “We are the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries. We provide innovative, clinically proven, and economically effective repair solutions for surgeons and healthcare providers.”3 It is headquartered in Alachua, Florida.1 Its shares trade on Nasdaq under the symbol AXGN.1

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Last updated Oct 21, 2026.

Overview

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  • TickerAXGN on Nasdaq1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersAlachua, Florida1
  • Incorporated inMN2
  • Business address13631 Progress Blvd., Suite 400, Alachua, Fl 326152
  • Filer categoryLarge accelerated filer2

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We are the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries. We provide innovative, clinically proven, and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

74.3%Gross margin4
-3.5%Operating margin4
-7.0%Net margin4
20.2%Revenue growth, 20254
-12.2%Return on equity4
0.38×Debt to equity4
-$2.9MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 99% of the revenue Axogen, Inc. broke down this way in fiscal 2025.

  1. United States$222.4M499%up 21% from 2024
  2. Outside the United States$2.8M41%down 10% from 2024
Regions by year
Regions202320242025
United States$156.2M$184.2M$222.4M
Outside the United States$2.8M$3.1M$2.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue26¢$57.9M
  • Research and development15¢$32.9M
  • Other costs60¢$134.5M

Out of $225.2M in revenue.4 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending100¢$3.7M

Out of $812.0K of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.4

Financial statements

Revenue56784$225.2M in 2025+111% since 2019
0$100.0M$200.0M$300.0M2019: $106.7M$106.7M20192020: $112.3M$112.3M2020+5%2021: $127.4M$127.4M2021+13%2022: $138.6M$138.6M2022+9%2023: $159.0M$159.0M2023+15%2024: $187.3M$187.3M2024+18%2025: $225.2M$225.2M2025+20%
Gross profit56784$167.4M in 2025+87% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $89.4M$89.4M20192020: $90.7M$90.7M2020+2%2021: $104.4M$104.4M2021+15%2022: $108.8M$108.8M2022+4%2023: $121.9M$121.9M2023+12%2024: $142.0M$142.0M2024+16%2025: $167.4M$167.4M2025+18%
Operating income56784-$7.8M in 2025−75% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$31.4M-$31.4M20192020: -$23.2M-$23.2M2020−26%2021: -$25.4M-$25.4M2021+10%2022: -$29.7M-$29.7M2022+17%2023: -$21.5M-$21.5M2023−28%2024: -$3.3M-$3.3M2024−85%2025: -$7.8M-$7.8M2025+139%
Net income56784-$15.7M in 2025−46% since 2019
-$30.0M-$20.0M-$10.0M02019: -$29.1M-$29.1M20192020: -$23.8M-$23.8M2020−18%2021: -$27.0M-$27.0M2021+13%2022: -$28.9M-$28.9M2022+7%2023: -$21.7M-$21.7M2023−25%2024: -$10.0M-$10.0M2024−54%2025: -$15.7M-$15.7M2025+58%

Every line of the income statement as filed: the last 3 fiscal years, latest first.4

Period ending2025-12-312024-12-312023-12-31
Revenues$225.2M$187.3M$159.0M
Cost of goods sold$57.9M$45.4M$37.1M
Gross profit$167.4M$142.0M$121.9M
Sales and marketing$97.7M$78.5M$77.6M
Research and development$32.9M$27.8M$27.3M
General and administrative$44.6M$39.0M$38.4M
Total costs and expenses$175.2M$145.3M$143.3M
Loss from operations-$7.8M-$3.3M-$21.5M
Investment income$1.2M$1.1M$1.5M
Interest expense-$7.7M-$8.2M-$2.8M
Change in fair value of debt derivative liabilities-$1.5M$587.0K$1.5M
Other income (expense), net$167.0K-$199.0K-$437.0K
Total other expense, net-$7.9M-$6.7M-$254.0K
Net loss-$15.7M-$10.0M-$21.7M
Weighted average common shares outstanding - basic (in shares)46.1M shares44.3M shares42.9M shares
Weighted average common shares outstanding - diluted (in shares)46.1M shares44.3M shares42.9M shares
Net loss per common share - basic (in USD per share)-$0.34-$0.23-$0.51
Net loss per common share - diluted (in USD per share)-$0.34-$0.23-$0.51

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Corporate structure

Axogen, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Axogen, Inc.

  • Axogen, Inc. Alachua, Florida

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Axogen, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Finance-lease assets$44.0K4 Dec 31, 2025$37.0K4 Dec 31, 2024+18.9%
Operating-lease assets (leased space)$12.7M4 Dec 31, 2025$14.3M4 Dec 31, 2024−10.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.5M4 Dec 31, 2025$27.6M4 Dec 31, 2024+29.0%
Marketable securities, current$6.0M4 Dec 31, 2025$5.9M4 Dec 31, 2024+0.9%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$6.8M4 Dec 31, 2025$5.6M4 Dec 31, 2024+21.0%
Finite-lived intangibles, gross$6.1M8 Dec 31, 2024$6.0M8 Dec 31, 2023+1.4%
Accumulated amortization$1.4M4 Dec 31, 2025$1.1M4 Dec 31, 2024+32.2%
Finite-lived intangibles, net$5.0M8 Dec 31, 2024$4.1M8 Dec 31, 2023+22.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$42.4M4 Dec 31, 2025$33.2M4 Dec 31, 2024+27.7%
Raw materials$5.2M4 Dec 31, 2025$4.8M4 Dec 31, 2024+7.9%
Work in process$1.2M4 Dec 31, 2025$1.3M4 Dec 31, 2024−8.3%
Finished goods$36.0M4 Dec 31, 2025$27.1M4 Dec 31, 2024+33.0%

Properties, in its own words

Our material physical properties consisted of the following as of December 31, 2025:

Location · General Character · Total Square Feet · Square Feet Utilized · Expiration

The rest of Item 2

Alachua, Florida (1) · Headquarters - General office, warehousing and distribution · 19,000 · 19,000 · October 31, 2026

Tampa, Florida (1)(2) · Headquarters - General office, medical laboratory and meeting space · 75,000 · 50,000 · October 31, 2034

Burleson, Texas (1) · Facility - Raw material and finished goods warehousing and distribution · 15,000 · 15,000 · April 30, 2027

10,000 · 5,000 · September 30, 2027

Vandalia, Ohio · Facility - Clean-room, manufacturing, warehousing and office space · 107,000 · 84,000 · N/A

Dayton, Ohio (3) · Facility - Clean-room, manufacturing, warehousing and office space · Varies · Varies · December 31, 2026

___________

(1)Property is encumbered by a lease agreement.

(2)Portions of this property are subleased under two sublease agreements with different sublessees.

(3)Property is encumbered by our License and Services Agreement as an embedded lease. Total square feet and utilization varies each month for the use of clean room, manufacturing, warehousing, and office space in accordance with the License and Services Agreement. See Note 15 - Commitments and Contingencies in the Notes to the Consolidated Financial Statements in Part II, Item 8 of this Form 10-K for details regarding the License and Services Agreement.

We believe that our facilities will be sufficient to operate our business for the next 12 months and that current lease obligations will not change materially.

Item 2 of the 10-K filed Feb 24, 2026.3

Leadership

Who has led Axogen, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Gregory Gene Freitag2010
  2. Karen L. Zaderej2011–2024
  3. Michael D. Dale2024–now

President

  1. Karen L. Zaderej2011
  2. Michael D. Dale2024

Chief financial officer

  1. Gregory Gene Freitag2010–2015
  2. Lee Robert Johnston Jr.2014
  3. Peter J. Mariani2016–2023
  4. Jamie Mark Grooms2018
  5. Nir Naor2024–2025
  6. Lindsey Marie Hartley2025–now
2010201520202025
Board members and other officers (39)

Former names

  • LECTEC CORP /MN/Nov 14, 1995 to Sep 29, 20112

Timeline

  1. Oct 1, 20268-K Regulation FD disclosure56
  2. Sep 10, 20268-K Entered a material agreement; Regulation FD disclosure; Other events57
  3. Sep 10, 20268-K Entered a material agreement; Regulation FD disclosure58
  4. Jul 29, 20268-K Results of operations; Regulation FD disclosure59
  5. Jun 23, 20268-K Shareholder vote60
  6. Apr 28, 20268-K Results of operations; Regulation FD disclosure61
  7. Feb 24, 20268-K Results of operations; Regulation FD disclosure62
  8. Jan 23, 20268-K Entered a material agreement; Other events63
  9. Jan 12, 20268-K Results of operations; Regulation FD disclosure64
  10. Dec 5, 20258-K Executive or director change65
  11. Dec 4, 20258-K Regulation FD disclosure; Other events66
  12. Oct 29, 20258-K Results of operations; Regulation FD disclosure67
  13. Aug 9, 2024New chief executive Michael D. Dale becomes CEO12
  14. Oct 11, 2011New chief executive Karen L. Zaderej becomes CEO13
  15. Jun 1, 2010New chief executive Gregory Gene Freitag becomes CEO14

Calendar

Coming up

  1. Oct 28, 2026 · Before the openReports results for the quarter ending Sep/2026 A year earlier it reported $0.01 a share, on Oct 29, 2025.68

When it reported results

  1. Jul 29, 2026Reported quarterly or annual results59
  2. Apr 28, 2026Reported quarterly or annual results61
  3. Feb 24, 2026Reported quarterly or annual results62
  4. Jan 12, 2026Reported quarterly or annual results64
  5. Oct 29, 2025Reported quarterly or annual results67
  6. Aug 5, 2025Reported quarterly or annual results69
  7. May 8, 2025Reported quarterly or annual results70
  8. Feb 25, 2025Reported quarterly or annual results71

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

421 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 58 major events, 233 insider forms, 29 large holders, 80 other. The latest 20:

  1. Oct 2, 2026SCHEDULE 13G EDGAR
  2. Oct 1, 20268-K EDGAR
  3. Sep 10, 2026424B5 EDGAR
  4. Sep 10, 20268-K/A EDGAR
  5. Sep 10, 20268-K EDGAR
  6. Sep 4, 20264 EDGAR
  7. Sep 2, 2026144 EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 12, 20264 EDGAR
  10. Aug 12, 20264 EDGAR
  11. Aug 11, 2026144 EDGAR
  12. Aug 11, 20264 EDGAR
  13. Aug 10, 2026144 EDGAR
  14. Aug 7, 2026144 EDGAR
  15. Jul 31, 2026SCHEDULE 13G/A EDGAR
  16. Jul 29, 202610-Q EDGAR
  17. Jul 29, 20268-K EDGAR
  18. Jun 26, 20264 EDGAR
  19. Jun 26, 20264 EDGAR
  20. Jun 26, 20264 EDGAR

The 421 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

72 open-market trades by officers, directors and large owners since October 2021: 4 buys and 68 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 2, 2026TYNDALL JOSEPH A.DirectorSale3,500$49.70$173.9KForm 4
Aug 11, 2026Wendell Amy McBrideDirectorSale13,353$48.42$646.6KForm 4
Aug 10, 2026Began Marc AEVP & General CounselSale67,500$47.35$3.2MForm 4
Aug 7, 2026Weiler Kathy JohnsonDirectorSale14,150$45.30$641.0KForm 4
May 8, 2026Wendell Amy McBrideDirectorSale1,647$42.60$70.2KForm 4
May 7, 2026JOHNSON JOHNDirectorSale11,050$43.26$478.0KForm 4
May 7, 2026Weiler Kathy JohnsonDirectorSale16,344$44.09$720.6KForm 4
May 7, 2026Kemp JensChief Marketing OfficerSale4,000$43.44$173.8KForm 4
May 7, 2026Hartley Lindsey MarieCFOSale1,051$43.67$45.9KForm 4
May 7, 2026Quackenbush DorisSales VPSale3,878$43.51$168.7KForm 4
Mar 16, 2026DeVinney Erick WayneChief Innovation OfficerSale5,221$32.84$171.5KForm 4
Dec 16, 2025Wendell Amy McBrideDirectorSale43,684$29.31$1.3MForm 4
Dec 16, 2025Weiler Kathy JohnsonDirectorSale46,653$29.55$1.4MForm 4
Dec 15, 2025Hartley Lindsey MarieCFOSale14,812$29.86$442.3KForm 4
Dec 11, 2025Began Marc AEVP & General CounselSale13,222$30.00$396.7KForm 4
Dec 10, 2025DALE MICHAEL DChief Executive OfficerSale25,000$30.00$750.0KForm 4
Dec 9, 2025JOHNSON JOHNDirectorSale21,686$29.98$650.1KForm 4
Dec 9, 2025DALE MICHAEL DChief Executive OfficerSale61,463$31.21$1.9MForm 4
Dec 9, 2025TYNDALL JOSEPH A.DirectorSale25,108$30.98$777.8KForm 4
Dec 9, 2025DeVinney Erick WayneChief Innovation OfficerSale19,517$31.21$609.1KForm 4

All 72 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Michael Dale66$775.9K$9.0M81
2025Marc Began59$439.1K$3.1M81
2025Jens Kemp49$395.2K$2.3M81
2025Erick DeVinney51$414.6K$2.3M81
2025Lindsey Hartley42$395.1K$1.9M81
2025Nir Naor51$228.2K$271.5K81
2024CEO and President$303.2K$8.8M81
2024Former CFO$475.1K$3.0M81
2024Chief Innovation Officer$400.3K$2.3M81
2024Executive VicePresident and GC$423.9K$1.8M81
2024Chief Marketing Officer$374.4K$1.7M81
2023Chief Innovation Officer$348.0K$1.5M81
2023Former CFO$36.4K$60.3K81

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.4,419,208$204.1M0.0%+548,357
First Light Asset Management, LLC2,748,361$126.9M7.7%−1,254,407
Morgan Stanley2,747,924$126.9M0.0%−375,058
Vanguard Capital Management LLC2,257,948$104.3M0.0%−33,615
Assenagon Asset Management S.A.2,087,300$96.4M0.1%+706,037
Polar Capital Holdings Plc1,500,822$69.3M0.2%No change
Artemis Investment Management LLP1,396,792$64.5M0.6%+1,046,904
Wellington Management Group Llp1,391,654$64.3M0.0%+427,089
Geode Capital Management, LLC1,375,240$63.5M0.0%+155,099
Citadel Advisors LLC1,360,831$62.9M0.0%+1,115,777
Wasatch Advisors LP1,295,949$59.9M0.4%−561,401
Goldman Sachs Group Inc1,261,519$58.3M0.0%+678,556
State Street Corp1,246,821$57.6M0.0%+100,318
Fmr LLC1,222,864$56.5M0.0%−91,156
Hood River Capital Management LLC1,067,072$49.3M0.4%New
Rtw Investments, LP1,011,576$46.7M0.4%New
Next Century Growth Investors LLC872,546$40.3M2.1%+6,583
UBS Group AG836,209$38.6M0.0%+721,989
Armistice Capital, LLC775,000$35.8M1.0%−161,000
Bamco Inc /ny/740,210$34.2M0.1%+96,467
ArrowMark Colorado Holdings LLC711,795$32.9M1.4%−1,203,644
Driehaus Capital Management LLC707,234$32.7M0.2%+478,797
TimesSquare Capital Management, LLC689,833$31.9M0.5%+114,469
First Eagle Investment Management, LLC682,154$31.5M0.0%+327,564
Deutsche Bank Ag\651,784$30.1M0.0%+17,387

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Axogen, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAxogen, Inc.1
  • CIK0000805928
  • Employer ID (EIN)41-13018783
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company3
  • Incorporated inMinnesota3
  • Fiscal year endsDecember 311
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address13631 Progress Blvd., Suite 400, Alachua, FL 326151
  • Phone(386) 462-68171
  • Shares outstanding53,761,513 as of Jul 27, 202610
  • Public float$430.7M as of Jun 30, 20253
  • AuditorDeloitte & Touche LLP, Tampa, Florida PCAOB ID 34; it also attests to the company’s internal control over financial reporting3
  • On EDGAR sinceMay 12, 19951
  • Filings1,366 in all: 4 (609), 8-K (207), 10-Q (81), 3 (56), 144 (48), SC 13G/A (40), 4/A (30), 10-K (26)1
    All 56 form types

    DEF 14A (26), SC 13G (21), S-8 (20), CORRESP (17), 424B5 (15), 10QSB (13), S-8 POS (13), CT ORDER (12), UPLOAD (10), EFFECT (9), SCHEDULE 13G/A (9), 8-K/A (8), 10-K/A (7), 3/A (7), S-1/A (6), SC 13D (6), 10KSB (5), ARS (5), PRE 14A (5), PRER14A (5), S-3 (5), DEFA14A (4), NT 10-K (4), NT 10-Q (3), POS AM (3), S-3ASR (3), 10-Q/A (2), 424B3 (2), 5 (2), S-4/A (2), SC 13D/A (2), SCHEDULE 13G (2), 10-KT (1), 10KSB/A (1), 424B2 (1), 424B4 (1), 425 (1), 5/A (1), 8-A12B (1), CERTNAS (1), D (1), DEFR14A (1), POS EX (1), POSASR (1), S-1 (1), S-3/A (1), S-3MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Jul 29, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par valueAXGNThe Nasdaq Stock Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Axogen, Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 58 risks under these headings, as written.3

  • Risks Related to Our Business and Strategy
  • Approximately 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.
  • The manufacturing process for Avance is complex and we or our third-party contractors may encounter difficulties in production. If we or our third-party contractors encounter such difficulties, our ability to supply Avance for commercial sale could be delayed or halted entirely, which would have a material adverse effect on our business.
  • Our revenue growth depends on our ability to increase distribution and sales to existing customers and develop new customers, domestically and internationally, and there can be no assurance that these efforts will result in significant increases in sales.
  • We are highly dependent on the continued availability of our facilities and could be harmed if we continue to experience operating challenges with our APC Facility or if any of our facilities are unavailable for any prolonged period of time.
  • If our estimates of the TAM for peripheral nerve repair and reconstruction are inaccurate, our growth prospects and financial performance could be materially adversely affected.
  • Our revenue depends on a limited number of products.
  • Our revenue depends upon prompt and adequate reimbursement from public and private insurers and national health systems.
  • Our operating results could be adversely impacted if we are unable to effectively manage and sustain our future growth or scale our operations.
  • Our success will be dependent on continued acceptance of our products by the medical community.
  • If we do not manage product inventory in an effective and efficient manner, it could adversely affect profitability.
  • There may be significant fluctuations in our operating results.
The other 47 risks
  • We have a history of net losses and have not consistently experienced positive cash flow from operations, and our ability to achieve consistent positive cash flow will depend on increasing revenue from distribution of our products, which may not be achievable.
  • Loss of key members of management, who we need to succeed, could adversely affect our business.
  • Delays, interruptions, or the cessation of production by our third-party suppliers, including products supplied by single suppliers, of important materials may prevent or delay our ability to manufacture or process the final products.
  • Technological change and competition for newly developed products could reduce demand for our products.
  • We may not be successful in our efforts to build a pipeline of additional product candidates.
  • Negative publicity concerning methods of donating human tissue and screening of donated tissue may reduce demand for our products and negatively impact the supply of available donor tissue.
  • The failure of third parties to perform many necessary services for the commercialization of our products, including services related to recovery/acquisition, sterilization, distribution, and transportation, would impair our ability to meet commercial demand.
  • We are dependent on our relationships with independent agencies to generate a material portion of our revenue.
  • We may be unsuccessful in commercializing our products outside the U.S.
  • We may seek to expand our business in ways that could result in diversion of resources and extra expenses.
  • We may be subject to future product liability litigation, which could be expensive, and our insurance coverage may not be adequate.
  • We are currently operating in a period of economic uncertainty and capital markets volatility driven in part by growing geopolitical tensions and evolving global security risks, any of which could materially and adversely affect our business, financial condition and results of operations.
  • Changes in U.S. trade policy, threats of international tariffs, and changes to the U.S. political landscape may adversely affect our business, results of operations, financial condition, and prospects.
  • Our failure to protect our technology systems and comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our business, results of operations, financial condition, and prospects.
  • We are dependent on internal information and telecommunications systems, and any failure of these systems, including system security breaches, data protection breaches or other cybersecurity attacks, may negatively impact our business and results of operations.
  • Our business and financial performance could be adversely affected, directly or indirectly, by natural or man-made disasters or other similar events.
  • Changes in the tax code could have a material adverse effect on our results of operations, financial condition, liquidity, and capital investments.
  • We may have exposure to additional tax liabilities as a result of our foreign operations.
  • Risks Related to the Regulatory Environment in which We Operate
  • We obtained regulatory approval for certain uses of Avance through the FDA’s accelerated approval pathway and traditional approval will be contingent on successful completion of a confirmatory post-approval trial. Failure to successfully complete our confirmatory post-approval trial or obtain traditional approval would have a material adverse effect on our business.
  • If the FDA were to withdraw or suspend our BLA approval, narrow the approved indication, or otherwise limit the use of our Avance Products, our revenues would be significantly impacted and thus would have a material adverse effect on us.
  • Failure to obtain regulatory and pricing approvals in foreign jurisdictions after BLA approval for Avance or our other products could delay or prevent commercialization of our products abroad.
  • The use, misuse or off-label use of our products may harm our reputation and the reputation of our products, which could result in injuries leading to product liability suits, and could be costly to our business, and/or result in FDA sanctions.
  • U.S. governmental regulation could restrict the use of our Avance Products, restrict our procurement of tissue or increase costs.
  • Failure to obtain regulatory or other approvals from certain states in which we operate after BLA approval for Avance could delay, hinder, or prevent commercialization of our products.
  • BLA approval for Avance could result in different protocols for hospitals’ access to the product, as well as different coverage and reimbursement protocols, both of which may negatively affect surgeons’ access to, revenues derived from, and profitability of, Avance Products.
  • Our Axoguard products are subject to FDA and international regulatory requirements.
  • Our operations must comply with FDA and other governmental requirements.
  • Defective products could lead to recall or other negative business conditions.
  • Clinical trials can be long and expensive, and results are ultimately uncertain.
  • We rely on third parties to conduct our clinical trials, and they may not perform as contractually required or expected.
  • Healthcare law and policy changes may have a material adverse effect on us.
  • We could be subject to civil or criminal penalties if we are found to have violated laws protecting the confidentiality of health information, which could increase our liabilities and harm our reputation or our business.
  • Risks Related to Our Intellectual Property
  • Failure to protect or maintain our IP rights could result in costly and time-consuming litigation and our loss of any potential competitive advantage.
  • Future protection for our proprietary rights is uncertain and may impact our ability to successfully compete in our industry.
  • The patent protection for our products may expire before we are able to maximize their commercial value, which may subject us to increased competition and reduce or eliminate our opportunity to generate product revenue.
  • Others may claim an ownership interest in our IP or claim that we infringe on their IP rights, which could expose us to litigation and have a significant adverse effect on our prospects.
  • Our trademarks are valuable, and our business may be adversely affected if trademarks are not adequately protected.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Risks Related to Financing Our Business
  • We may need to raise additional funds to finance our future capital or operating needs, which could have adverse impacts on our business, results of operations and the interests of our shareholders.
  • Risks Related to Our Common Stock
  • An active trading market in our common stock may not be maintained.
  • The price of our common stock could be volatile due to a number of factors, which could lead to losses by investors and costly securities litigation.
  • We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price.
  • We do not anticipate paying any cash dividends in the foreseeable future.
  • Anti-takeover provisions in Minnesota law may deter acquisition bids for us that you might consider favorable.
  • Our management has broad discretion in the use and placement of our cash and cash equivalents and, despite management’s efforts, cash and cash equivalents may be used in a manner that does not increase the value of shareholders’ investments or placed in otherwise reputable financial institutions that fail.
  • General Risks
  • Our business and stock price may be adversely affected if our internal controls are not effective.
  • We incur costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.

Legal proceedings

Information required by this item is set forth in Note 15 - Commitments and Contingencies of the Notes to Consolidated Financial Statements in this Annual Report on Form 10-K and is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.3

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