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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 8, 2022
AXOGEN, INC.
(Exact Name of Registrant as Specified in Charter)


Minnesota
(State or Other Jurisdiction of
Incorporation or Organization)
001-36046
(Commission File Number)

41-1301878
(I.R.S. Employer Identification No.)

13631 Progress Boulevard, Suite 400 Alachua, Florida
(Address of principal executive offices)

32615
(Zip Code)
(386) 462-6800
(Registrant's telephone number, including area code)

N/A
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of exchange on which registered
Common Stock, $0.01 par value AXGN The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐



Item 2.02 Results of Operations and Financial Condition

On November 8, 2022, Axogen, Inc. (the “Company”) issued a press release announcing its third quarter 2022 financial results. A copy of the press release is furnished as Exhibit 99.1.

The information furnished pursuant to Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or under the Exchange Act, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.

Item 7.01 Regulation FD Disclosure

On November 8, 2022, the Company also posted an updated corporate presentation to its website at https://ir.axogeninc.com/news-events. The Company may use the corporate presentation from time to time in conversation with analysts, investors, and others. A copy of the corporate presentation is furnished as Exhibit 99.2.

The information in this Item 7.01, including Exhibit 99.2, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference into any filing under the Securities Act or Exchange Act, except as shall be expressly set forth by specific reference in such filing.


Item 9.01. Financial Statements and Exhibits

(d) Exhibits

Exhibit No.
Description
99.1
99.2
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)



SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AXOGEN, INC.
Dated: November 8, 2022 By: Bradley L. Ottinger
Bradley L. Ottinger
General Counsel and Chief Compliance Officer

EX-99.1 2 a991axgnreleasedatednovemb.htm EX-99.1 Document

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Axogen, Inc Reports 2022 Third Quarter Financial Results

ALACHUA and TAMPA, FL – November 8, 2022 – Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today reported financial results and business highlights for the third quarter ended September 30, 2022.
Third Quarter Financial Results 2022 and Business Highlights
•Net revenue was $37.0 million during the third quarter, an increase of 18% over the third quarter of 2021.*
•Gross margin was 83.3% for the quarter compared to 83.2% in the third quarter of 2021.
•Net loss for the quarter was $4.3 million, or $0.10 per share, compared to net loss of $7.1 million, or $0.17 per share in the third quarter of 2021.
•Adjusted net loss for the quarter was $0.4 million, or $0.01 per share, compared to adjusted net loss of $3.6 million, or $0.08 per share, in the third quarter of 2021.
•Adjusted EBITDA was $0.4 million for the quarter, compared to an adjusted EBITDA loss of $2.5 million in the third quarter of 2021.
•The balance of all cash and cash equivalents and investments on September 30, 2022 was $59.4 million, as compared to a balance of $64.3 million on June 30, 2022. The net change includes capital expenditures of $3.9 million related to the construction of the company's new processing facility in Dayton, OH, and approximately $1.0 million net operating cash burn.
•Appointed William Burke to the Axogen Board of Directors, and Chair of the Audit Committee.
•As previously announced, Adrian Tyndall, M.D. MPH, FACEP will join the Axogen Board of Directors effective December 13, 2022, filling a vacancy with the simultaneous retirement of founding director, Mark Gold M.D.

“We are pleased with our performance this quarter, as solid execution drove revenue growth in each of our products and across our applications," commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “We are encouraged with our year-to-date progress including surgeons reception of our RECON study results, and are confident in our ability to achieve sustainable long-term growth as we continue our mission to restore nerve function and quality of life to patients with peripheral nerve injuries.”



Additional Operational and Business Highlights
•Core Accounts totaled 331, an increase of 11% sequentially, and 17% over an adjusted* prior year level of 283. Revenue from Core Accounts continued to represent approximately 60% of total revenue.
•Active Accounts totaled 952, up 1% sequentially, and 2% over an adjusted* prior year level of 930. Revenue from the top 10% of Active Accounts represents approximately 35% of total revenue.
•Ended the quarter with a total of 207 new peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio, up from 196 the previous quarter.
•Ended the quarter with 111 direct sales representatives, compared to 116 at the end of the second quarter of 2022, and compared to 109 one year ago.
•Axogen’s peripheral nerve repair portfolio was featured throughout the clinical and scientific sessions of the 77th Annual Meeting of the American Society for Surgery of the Hand (ASSH).

Updating 2022 Financial Guidance
Management is narrowing the range of our annual revenue guidance and expects full-year 2022 revenue to be in the range of $137.5 million to $140.0 million versus the prior range of $135.0 million to $142.0 million. Full-year 2022 gross margin is expected to be above 80%.
*The Company voluntarily suspended market availability of Avive® Soft Tissue Membrane on June 1, 2021, and therefore no Avive revenue was recorded in either the third quarter of 2021 or 2022.

Conference Call
The Company will host a conference call and webcast for the investment community today at 8:00 a.m. ET. Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or use the direct dial-in number at (201) 689-8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the Company's website at www.axogeninc.com and clicking on the webcast link.
Following the conference call, a replay will be available in the Investors section of the Company's website at www.axogeninc.com under Investors.

About Axogen
Axogen (AXGN) is the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care 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.




Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector®, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; and Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Cautionary Statements Concerning Forward-Looking Statements
This press release 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 estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the impact of COVID-19 on our business, including but not limited to global supply chain issues, hospital staffing challenges and its impact on our business, statements regarding our growth, our financial guidance and performance, product development, product potential, regulatory process and approvals, APC renovation timing and expense, sales growth, product adoption, market awareness of our products, anticipated capital requirements, including the potential of future financings, data validation, expected clinical study enrollment, timing and outcomes, our visibility at and sponsorship of conferences and our educational events, regulatory process and approvals and other factors, including legislative, regulatory, political, geopolitical, and economic developments, including global business disruption caused by Russia’s invasion of Ukraine and related sanctions, not within our control. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many risks and uncertainties that affect our business and our market, particularly those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.




About Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense and litigation and related expenses. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share - basic and diluted which excludes non-cash stock compensation expense and litigation and related expenses from Net Loss and Net Loss Per Common Share - basic and diluted, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of Axogen’s GAAP financial measures to the corresponding non-GAAP measures should be carefully evaluated.

We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by our institutional investors and the analyst community to help them analyze the performance of our business.


Contact:
Axogen, Inc.
Ed Joyce, Director, Investor Relations
ejoyce@axogeninc.com





Axogen, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(In Thousands, Except Share and Per Share Amounts)
September 30,
2022
December 31,
2021
Assets
Current assets:
Cash and cash equivalents $ 14,318  $ 32,756 
Restricted cash 6,251  6,251 
Investments 38,792  51,330 
Accounts receivable, net of allowance for doubtful accounts of $606 and $276, respectively 21,363  18,158 
Inventory 19,116  16,693 
Prepaid expenses and other 2,614  1,861 
Total current assets 102,454  127,049 
Property and equipment, net 74,867  62,923 
Operating lease right-of-use assets 14,751  15,193 
Intangible assets, net 3,448  2,859 
Total assets $ 195,520  $ 208,024 
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued expenses $ 22,017  $ 22,459 
Current maturities of long-term lease obligations 1,530  1,834 
Total current liabilities 23,547  24,293 
Long-term debt, net of debt discount and financing fees 45,487  44,821 
Long-term lease obligations 20,634  20,798 
Debt derivative liabilities 4,407  5,562 
Total liabilities 94,075  95,474 
Commitments and contingencies - see Note 12
Shareholders’ equity:
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 42,272,223 and 41,736,950 shares issued and outstanding 423  417 
Additional paid-in capital 355,187  342,765 
Accumulated deficit (254,165) (230,632)
Total shareholders’ equity 101,445  112,550 
Total liabilities and shareholders’ equity $ 195,520  $ 208,024 




Axogen, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(In Thousands, Except Per Share Amounts)
Three Months Ended Nine Months Ended
September 30,
2022
September 30,
2021
September 30,
2022
September 30,
2021
Revenues $ 36,959  $ 31,204  $ 102,420  $ 95,821 
Cost of goods sold 6,176  5,239  18,006  17,503 
Gross profit 30,783  25,965  84,414  78,318 
Costs and expenses:
Sales and marketing 19,792  18,370  60,349  55,594 
Research and development 7,050  6,404  20,347  17,875 
General and administrative 8,796  7,880  27,817  24,912 
Total costs and expenses 35,638  32,654  108,513  98,381 
Loss from operations (4,855) (6,689) (24,099) (20,063)
Other (expense) income:
Investment income 186  17  172  80 
Interest expense (61) (417) (664) (1,427)
Change in fair value of derivatives 469  (46) 1,155  (152)
Other expense (57) (6) (97) (137)
Total other expense, net 537  (452) 566  (1,636)
Net loss $ (4,318) $ (7,141) $ (23,533) $ (21,699)
Weighted average common shares outstanding — basic and diluted 42,220,519  41,467,596  42,008,013  41,087,568 
Loss per common share — basic and diluted $ (0.10) $ (0.17) $ (0.56) $ (0.53)







Axogen, Inc.
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES
Three and Nine Months ended September 30, 2022 and 2021
(unaudited)
(In Thousands, Except Per Share Amounts)

Three Months Ended Nine Months Ended
September 30,
2022
September 30,
2021
September 30,
2022
September 30,
2021
Net loss $ (4,318) $ (7,141) $ (23,533) $ (21,699)
Depreciation and amortization expense 830  706  2,380  2,207 
Investment income (186) (17) (172) (80)
Income tax expense 31  20  64  47 
Interest expense 61  417  664  1,009 
EBITDA - non GAAP $ (3,582) $ (6,015) $ (20,597) $ (18,516)
Non cash stock-based compensation expense 3,849  2,911  11,437  9,410 
Litigation and related costs 101  628  584  1,236 
Adjusted EBITDA - non GAAP $ 368  $ (2,476) $ (8,576) $ (7,870)
Net loss $ (4,318) $ (7,141) $ (23,533) $ (21,699)
Non cash stock-based compensation expense 3,849  2,911  11,437  9,410 
Litigation and related costs 101  628  584  1,236 
Adjusted net loss - non GAAP $ (368) $ (3,602) $ (11,512) $ (11,053)
Weighted average common shares outstanding basic and diluted 42,220,519  41,467,596  42,008,013  41,087,568 
Loss per common share — basic and diluted $ (0.10) $ (0.17) $ (0.56) $ (0.53)
Non cash stock-based compensation expense $ 0.09  $ 0.07  $ 0.27  $ 0.23 
Litigation and related costs $ —  $ 0.02  $ 0.01  $ 0.03 
Adjusted net loss per common share - basis and diluted - non GAAP $ (0.01) $ (0.08) $ (0.28) $ (0.27)




Axogen, Inc.
Condensed Consolidated Statements of Changes in Shareholders’ Equity
(unaudited)
(In Thousands, Except Share Amounts)
Common Stock Additional Paid-in
Capital
Accumulated
Deficit
Total Shareholders'
Equity
Shares Amount
Three Months Ended September 30, 2022
Balance at June 30, 2022 42,134,504  $ 420  $ 351,117  $ (249,847) $ 101,690 
Net loss —  —  —  (4,318) (4,318)
Stock-based compensation —  —  3,849  —  3,849 
Issuance of restricted and performance stock units 55,934  (1) —  — 
Exercise of stock options and employee stock purchase plan 81,785  222  —  224 
Balance at September 30, 2022 42,272,223  $ 423  $ 355,187  $ (254,165) $ 101,445 
Nine Months Ended September 30, 2022
Balance at December 31, 2021 41,736,950  $ 417  $ 342,765  $ (230,632) $ 112,550 
Net loss —  —  —  (23,533) (23,533)
Stock-based compensation —  —  11,437  —  11,437 
Issuance of restricted and performance stock units 315,275  (3) —  — 
Exercise of stock options and employee stock purchase plan 219,998  988  —  991 
Balance at September 30, 2022 42,272,223  $ 423  $ 355,187  $ (254,165) $ 101,445 
Three Months Ended September 30, 2021
Balance at June 30, 2021 41,337,108  $ 413  $ 336,495  $ (218,205) $ 118,703 
Net loss —  —  —  (7,141) (7,141)
Stock-based compensation —  —  $ 2,911  —  2,911 
Issuance of restricted and performance stock units 67,249  (1) —  — 
Exercise of stock options and employee stock purchase plan 154,572  807  —  808 
Balance at September 30, 2021 41,558,929  $ 415  $ 340,212  $ (225,346) $ 115,281 
Nine Months Ended September 30, 2021
Balance at December 31, 2020 40,618,766  $ 406  $ 326,390  $ (203,647) $ 123,149 
Net loss —  —  —  (21,699) (21,699)
Stock-based compensation —  —  9,410  —  9,410 
Issuance of restricted and performance stock units 206,193  (2) —  — 
Exercise of stock options and employee stock purchase plan 733,970  4,414  —  4,421 
Balance at September 30, 2021 41,558,929  $ 415  $ 340,212  $ (225,346) $ 115,281 





Axogen, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(InThousands)
Nine Months Ended
September 30,
2022
September 30,
2021
Cash flows from operating activities:
Net loss $ (23,533) $ (21,699)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation 2,182  2,059 
Amortization of right-of-use assets 1,303  1,418 
Amortization of intangible assets 198  148 
Amortization of debt discount and deferred financing fees 667  384 
Provision for bad debt 566  (145)
Provision for inventory write-down 1,381  2,850 
Change in fair value of derivatives (1,155) 152 
Investment losses 44  49 
Stock-based compensation 11,437  9,410 
Change in operating assets and liabilities:
Accounts receivable (3,695) (804)
Inventory (3,804) (5,774)
Prepaid expenses and other (828) 1,146 
Accounts payable and accrued expenses (870) (927)
Operating lease obligations (1,320) (154)
Cash paid for interest portion of finance leases (1) (1)
Contract and other liabilities —  (3)
Net cash used in operating activities (17,428) (11,891)
Cash flows from investing activities:
Purchase of property and equipment (13,456) (20,641)
Economic development grant proceeds —  950 
Purchase of investments (24,607) (39,139)
Proceeds from sale of investments 37,100  49,300 
Cash payments for intangible assets (1,028) (534)
Net cash used in investing activities (1,991) (10,064)
Cash flows from financing activities:
Payments for debt issuance costs (9) — 
Proceeds from the issuance of long-term debt —  15,000 
Cash paid for debt portion of finance leases —  (12)
Proceeds from exercise of stock options and ESPP stock purchases 990  4,421 
Net cash provided by financing activities 981  19,409 
Net decrease in cash, cash equivalents, and restricted cash (18,438) (2,546)
Cash, cash equivalents, and restricted cash, beginning of period 39,007  55,609 
Cash, cash equivalents, and restricted cash, end of period $ 20,569  $ 53,063 
Supplemental disclosures of cash flow activity:
Cash paid for interest, net of capitalized interest $ —  $ 646 
Supplemental disclosure of non-cash investing and financing activities:
Acquisition of fixed assets in accounts payable and accrued expenses $ 2,090  $ 1,460 
Obtaining a right-of-use asset in exchange for a lease liability $ 920  $ 1,375 
Obtaining of property and equipment in exchange for a lease liability $ 22  $ — 
Embedded derivative associated with the long-term debt $ —  $ 1,173 
Acquisition of intangible assets in accounts payable and accrued expenses $ 177  $ 261 


EX-99.2 3 a992axgncorppresentation.htm EX-99.2 a992axgncorppresentation
November 8, 2022 nasdaq: axgn Corporate presentation


 
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 estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Actual results or event could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, statements related to the impact of COVID-19 on our business, hospital staffing challenges and its impact on our business, statements regarding our growth, our financial guidance and performance, product development, product potential, regulatory process and approvals, APC renovation timing and expense, sales growth, product adoption, market awareness of our products, anticipated capital requirements, including the potential of future financings, data validation, expected clinical study enrollment, timing and outcomes, , our visibility at and sponsorship of conferences and our educational events, regulatory process and approvals and other factors, including legislative, regulatory, political, geopolitical, and economic developments, including global business disruption caused by Russia’s invasion of Ukraine and related sanctions, not within our control. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this presentation should be evaluated together with the many risks and uncertainties that affect our business and our market, particularly those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward- looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise. Safe harbor statement revolutionizing the science of nerve repair™


 
3 The Axogen platform for nerve repair revolutionizing the science of nerve repair™


 
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 Nerves can be injured in three ways: 1. Transection Traumatic nerve injuries e.g., motor vehicle accidents, power tool accidents, battlefield injuries, gunshot wounds, surgical injuries, neuroma-in- continuity 2. Compression Carpal, cubital, tarsal tunnel revisions, blunt trauma, previous surgeries 3. Stump Neuroma Amputations, mastectomies, previous surgeries revolutionizing the science of nerve repair™


 
Connection Protection Termination 5 A comprehensive platform for addressing nerve injuries revolutionizing the science of nerve repair™


 
Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth 6 • Exclusively focused on peripheral nerve repair with a differentiated platform • 10+ years of demonstrated clinical outcome consistency • Featured in 207 peer-reviewed clinical publications • Over 50,000 Avance® Nerve Grafts implanted • Significant barriers to competitive entry • FDA granted Avance Regenerative Medicine Advanced Therapy (RMAT) designation • Commercial and surgeon education capabilities • Solid balance sheet provides resources to execute business plan • Experienced management team with strong track record of success revolutionizing the science of nerve repair™


 
Targeted nerve markets (U.S.) 7 Trauma $1.9B Breast $250M OMF $300M Carpal & Cubital Tunnel $270M U.S. potential procedural estimates >900,000** • Trauma: > 700,000 • Carpal Tunnel Revisions & Cubital Tunnel: 130,000 • Oral Maxillofacial (OMF): 56,000 • Breast Neurotization Procedures: 15,000 *$2.7B estimate does not include pain market **Referenced papers were used to derive specific assumptions in the procedure potential estimates. Papers used include both U.S. and OUS databases and studies. See Appendix for data sources. >$2.7 Billion* revolutionizing the science of nerve repair™


 
8 Delivering strong, consistent revenue growth & gross margins Operational Highlights • Q3 revenue growth of 18%.* • Procedure volumes improved as hospitals continued to address staffing challenges. • Total Core Accounts of 331 increased 11% sequentially, and 17% increase over an adjusted* prior year level of 283. • Total Active Accounts of 952 increased 1% sequentially, and 2% increase over an adjusted* prior year level of 930. 83.3% Gross Margin for the quarter ended September 30, 2022 U.S. $ in millions * Axogen voluntarily suspended market availability of Avive® Soft Tissue Membrane on June 1, 2021, and therefore there was no Avive revenue recorded in either the third quarter of 2021 or 2022. Avive revenue totaled approximately $4.1 million and $5.5 million for the years ended 2021 and 2020 respectively. $27.3 $41.1 $60.4 $83.9 $106.7 $112.3 $127.4 2015 2016 2017 2018 2019 2020 2021 Annual Revenue 29% CAGR revolutionizing the science of nerve repair™ $31.2 $37.0 Q3 2021 Q3 2022 Q3 Revenue 18% Increase over Q3 2021


 
Guidance 9 2022 Annual Financial Guidance – Updated 11/8/2022 • Full-year 2022 revenue is expected to be between $137.5 million and $140 million, compared to prior range of $135 million to $142 million. – Represents approximately 12% to 14% growth over 2021 revenue excluding the impact of $4.1 million of Avive revenue in 2021. • Full-year 2022 gross margin is expected to remain above 80%. revolutionizing the science of nerve repair™


 
Traditional TRANSECTION repair options are suboptimal 10 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 • Secondary surgery • Loss of function and sensation at harvest site • 27% complication rate including infection, wound healing and chronic pain 19 • Limited availability of graft length and diameter SYNTHETIC CONDUITS Convenient off the shelf option; limited efficacy & use • Provides only gross direction for regrowth • Limited to small gaps • 34%-57% failure rate >5mm gaps20, 21 • Semi-rigid and opaque material limits use and visualization • Repair reliant on fibrin clot formation revolutionizing the science of nerve repair™


 
11 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 • Eliminates need for an additional surgical site and risks of donor nerve harvest22 • May reduce OR time Structural support for regenerating axons • Cleansed and decellularized extracellular matrix (ECM) • Offers the benefits of human peripheral nerve micro-architecture and handling Revascularizes and remodels into patient’s own tissue similar to autologous nerve23 16 size options in a variety of lengths (up to 70mm) and diameters (up to 5mm) Only minimally processed porcine ECM for connector-assisted coaptation Alternative to direct suture repair • Reduces the risk of forced fascicular mismatch24, 25 Alleviates tension at critical zone of regeneration • Disperses tension across repair site26 • Moves suture inflammation away from coaptation face27, 28 Remodels into vascularized patient tissue28, 29, 30, 31, 32 14 size options in lengths of 10mm and 15mm, and diameters up to 7mm Axogen solutions for TRANSECTION repair revolutionizing the science of nerve repair™


 
Traditional COMPRESSION repair options are suboptimal 12 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 surrounding tissue • Only wraps part of the nerve circumference • Increases procedure time COLLAGEN WRAPS Off-the-shelf • Semi-rigid material limits use • Degrades over time and does not provide a lasting barrier to soft tissue attachment revolutionizing the science of nerve repair™


 
13 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 attachments34 Allows nerve gliding • Minimizes risk of entrapment34 • Creates a barrier between repair and surrounding tissue bed34 • ECM revascularizes and remodels into patient’s own tissue29,35 revolutionizing the science of nerve repair™


 
Traditional STUMP NEUROMA options are suboptimal 14 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 36 BURYING IN MUSCLE/BONE Traditional method of neurectomy and neuromyodesis • Simply resecting the nerve results in subsequent neuroma formation and risk of secondary surgery • Pain due to muscular contraction or localized pressure • Larger surgical dissection • Only 33-40% of patients were satisfied with treatment after burial into bone or muscle 37, 38, 39 INJECTIONS Pharmacologic intervention, typically alcohol or steroids40, 41, 42, 43, 44, 45 • Chemical injections are only successful 40% of the time 43, 44 • Temporary solution that has a reduced benefit over time • May cause considerable side effects revolutionizing the science of nerve repair™


 
15 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 or painful neuroma formation • Provides a barrier from neurotrophic factors and mechanical stimulation SIS Material allows for vascularization and gradual remodeling (as shown in animal studies)46, 47 • Material gradually incorporates into patient’s own tissue, creating a physical barrier to surrounding soft tissue Intra-operative versatility • Ideal for anatomic areas with limited or no musculature • Alternative to historical techniques such as burying in muscle or bone • Available in a variety of diameters revolutionizing the science of nerve repair™


 
16 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 Axogen has Enforcement Discretion from FDA allowing continued sales under controls applicable to HCT/Ps with agreed transition plan to regulation as a Biological Product under a Biologic License Application (BLA) if approved. A new (non-biosimilar) competitive processed nerve allograft, we believe, would need to complete clinical testing and obtain BLA approval prior to clinical release. Avance expected to be the reference product for the category of processed nerve allograft Avance nerve graft IP protection to 2023 and beyond New (non-biosimilar) competitive BLA product estimated 8 years Protection from potential biosimilars –12 years data exclusivity from BLA approval revolutionizing the science of nerve repair™ 6,972,168 9,690,975 7,402,319 9,996,729 7,732,200 10,311,281 7,851,447 10,441,681 8,758,794 10,783,349 8,986,733 10,813,643 9,402,868 11,147,558 9,572,911 11,156,595 9,597,429


 
RECONSM: A Multicenter, Prospective, Randomized, Subject & Evaluator Blinded Comparative Study of Nerve Cuffs & Avance Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities revolutionizing the science of nerve repair™ 17 Safety & efficacy non- inferiority comparison of Avance vs conduit Evaluated upper extremity digital nerve repair for nerve gaps 5-25mm 220 subjects from up to 25 U.S. centers stratified into gap lengths with two-thirds in the 5-14mm group and one- third in the 15-25mm group 17


 
RECON Study Demographics: Balanced across both groups revolutionizing the science of nerve repair™ 18 Conduit Avance Overall Subjects, n 108 112 220 Female (%) 28.7% 30.4% 29.5% Male (%) 71.3% 69.6% 70.5% Age, years Median 39.5 36.0 37.0 Min, Max 18, 69 18, 68 18, 69 Nerve Injury Gap Length, mm 12.9 13.4 13.1 18


 
RECON Study Topline Results 19revolutionizing the science of nerve repair™ 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 greater than 12 mm (p-value 0.021). ✓ Avance demonstrated statistical superiority for time to recovery of static two-point discrimination as compared to conduits, returning normal sensation* up to 3 months earlier in gaps greater than 10 mm (p-value 0.037). The safety profile was consistent with previously published data ✓ Conduit repairs were observed to have an increased likelihood of persistent and unresolved nerve pain with an incidence of 9 (8%) conduit subjects as compared to 2 (2%) Avance subjects. * Normal Sensation is defined by the Medical Research Council Classification (MRCC) score as S4 or return of static two-point discrimination outcomes of ≤ 6mm. Primary Endpoint Achieved • This phase three pivotal study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data. • The data will support the company’s Biologics License Application (BLA) submission in the second half of 2023


 
20 Market development strategy B u il d M a rk e t A w a re n e s s E d u c a te S u rg e o n s , D e v e lo p A d v o c a te s G ro w B o d y o f C li n ic a l E v id e n c e E x e c u te S a le s P la n E x p a n d P ro d u c t P ip e li n e + A p p li c a ti o n s revolutionizing the science of nerve repair™


 
21 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 social media presenceB u il d M a rk e t A w a re n e s s revolutionizing the science of nerve repair™ resensation.com rethink-pain.com


 
22 P IL L A R 2 Emphasis on education • In-person and virtual national education programs • Providing customized multimodal learning programs to specific surgeon cohorts for advanced learning • Ongoing interactive webinar series covering the principles of nerve repair • Train more than three-quarters of all hand and micro-surgery fellows annuallyE d u c a te S u rg e o n s , D e v e lo p A d v o c a te s revolutionizing the science of nerve repair™


 
Outcomes from RANGER® Registry 48,49 23 P IL L A R 3 Strong commitment to developing clinical evidence RANGER® Registry Study: Enrollment Ongoing • Multi-center clinical study in PNR with >2,700 enrolled to date • Overall meaningful recovery rates of 82-84%; comparable to autograft MATCH® Registry Study: Enrollment Ongoing • Avance compared to matched cohort of autograft and synthetic conduits RECONSM Study: Primary Endpoint Achieved • Prospective, randomized, controlled study of Avance Nerve Graft vs synthetic conduits in digital injuries 5 to 25mm, to support BLA submission in 2023 Sensation-NOW ® Registry Study: Enrollment Ongoing • Multi-center clinical study in breast neurotization REPOSESM: Enrollment Complete • Prospective, randomized, controlled study of Axoguard Nerve Cap® vs neurectomy REPOSE-XLSM: Pilot Study Initiated • Pilot study evaluating the feasibility of large-diameter Axoguard Nerve Cap® for protecting and preserving terminated nerve ends after trauma or amputation. RETHINK PAINTM Registry Study: Enrollment Ongoing • Designed to capture the patient’s pain journey, from onset of chronic pain to nerve repair G ro w B o d y o f C li n ic a l E v id e n c e Peer Reviewed Clinical Papers* Extremity Trauma Breast Oral and Maxillofacial Pain Other Applications revolutionizing the science of nerve repair™ 116 13 35 49 30 207 *Certain publications contain data on multiple applications.


 
24 P IL L A R 4 Focused sales execution, increasing market penetration P IL L A R 3 E x e c u te S a le s P la n Sales execution focused on driving results • Continue driving penetration in Active and Core Accounts • 5,100 potential U.S. accounts perform nerve repair • 952 Active Accounts as of September 30, 2022 o Active Accounts represent approximately 85% of total revenue o Top 10% of Active Accounts represent approximately 35% of total revenue • 331 Core Accounts as of September 30, 2022 o Core Accounts represent approximately 60% of total revenue Expanded sales reach • U.S. direct sales team o 111 direct sales professionals at end of Q3 2022 • Supplemented by independent agencies • Revenue from direct sales channel represented approximately 90% of total revenue revolutionizing the science of nerve repair™


 
25 P IL L A R 5 Expand the opportunity in nerve repair P IL L A R 4 P IL L A R 3 E x p a n d P ro d u c t P ip e li n e & A p p li c a ti o n s Breast Neurotization Loss of breast sensation affects Quality of Life Urology Prostatectomy OMF Iatrogenic nerve injuries, mandible tumor resections affects eating, speaking, intimacy Extremities (Trauma and Compression) Acute trauma, revision carpal tunnel and cubital tunnel Head & Neck OB/GYN General Surgery Cardio Thoracic Orthopedic Podiatry Vascular Pain Iatrogenic injuries, post-traumatic, migraine, joint pain, amputations, symptomatic neuromas, and nerve compressions Ophthalmology Expanding Core Business: Market Expansion & Development; Product Pipeline; International revolutionizing the science of nerve repair™


 
26 Balance Sheet Highlights September 30, 2022 Cash, Cash Equivalents, and Investments $59.4 million Total Long-term Debt $50.0 million* Capital Structure (shares) September 30, 2022 Common Stock 42,272,223 Common Stock Options, RSUs, PSUs 6,998,426 Common Stock and Common Stock Equivalents 49,270,649 Balance sheet and capital structure * Total long-term debt includes debt proceeds under the terms of the agreement with Oberland Capital, inclusive of unamortized debt discount and deferred financing fees. revolutionizing the science of nerve repair™


 
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 - Quality Management System, Regulatory, and Good Manufacturing Practices Governance - Framework for Ethics Codes and Accountability Environment – Responsible, Sustainable Operations People Sustainability Business


 
Executive team 28 Erick DeVinney VP, Peripheral Nerve Science and Clinical Innovation Angiotech, PRA Intl Mike Donovan VP, Operations Zimmer Ivica Ducic, M.D., Ph.D. Medical Director Washington Nerve Institute Angelo Scopelianos, Ph.D. Chief Research & Development Officer J&J Peter J. Mariani Executive Vice President and Chief Financial Officer Guidant, Lensar, Hansen Isabelle Billet Chief Strategy & Business Development Officer J&J, C.R. Bard, Cardinal Karen Zaderej Chairman, CEO, & President J&J (Ethicon) Maria Martinez Chief Human Resources Officer HSNi, Bausch + Lomb revolutionizing the science of nerve repair™ Brad Ottinger General Counsel, Chief Compliance Officer MicroPort Orthopedics Doris Quackenbush Vice President of Sales Convatec


 
Axogen is the preeminent nerve repair company with a foundation for long-term sustainable growth 29 • Exclusively focused on peripheral nerve repair with a differentiated platform • 10+ years of demonstrated clinical outcome consistency • Featured in 207 peer-reviewed clinical publications • Over 50,000 Avance® Nerve Grafts implanted • Significant barriers to competitive entry • FDA granted Avance Regenerative Medicine Advanced Therapy (RMAT) designation • Commercial and surgeon education capabilities • Solid balance sheet provides resources to execute business plan • Experienced management team with strong track record of success revolutionizing the science of nerve repair™


 
Appendix • Key Clinical Data • Historical Core and Active Accounts • CMS outpatient and ASC reimbursement rates • Total Addressable Market • Axogen product portfolio and indications for use 30revolutionizing the science of nerve repair™


 
Avance Nerve Graft repairs found to be significantly better than conduit repairs 31 • 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 conduit • Findings show overall meaningful recovery rate was 88% for Avance Nerve Graft and 61% for conduit (p=0.001) for gaps up to 25mm • Average static two-point discrimination improved to 9.7mm for Avance Nerve Graft as compared to 12.2mm for conduit (p=0.018) • Note: lower measurement is reflective of improved discrimination and a better outcome • As gap length increased, Avance Nerve Graft outcome rates remained consistent while conduit rates declined significantly “Leversedge et al., A Multicenter Matched Cohort Study of Processed Nerve Allograft and Conduit in Digital Nerve Reconstruction” – Journal of Hand Surgery, September 202048 0% 20% 40% 60% 80% 100% ⱡMeaningful Recovery Rate by Gap Length Conduit Allograft <15mm 15-25mm ⱡMeaningful Recovery = ≥S3 on the MRCC Scale *p=0.008, **p=0.001 67% 92% 45% 85% * ** revolutionizing the science of nerve repair™


 
Study finds Avance Nerve Graft (allograft) clinical outcomes recovery rates comparable to nerve autograft 32 “Safa et al., A Propensity Matched Cohort Study on Outcomes from Processed Nerve Allograft and Nerve Autograft in Upper Extremity Nerve Repairs”49 Presented at American Society for Surgery of the Hand (ASSH), Oct 2020 • Study of 156 nerve repairs found meaningful recovery rates for Avance Nerve Graft were comparable to autograft for both sensory and motor function Defined as MRCC Score ≥ S3/M3 Historical data on Nerve Autograft50,51,52,53,54,55, Mixed Nerve: 57-80%; Digital Nerve: 60-88% 68% 80% 70% 78% 72% 73% 0% 20% 40% 60% 80% 100% Sensory Mixed Sensory Mixed Motor ⱡMeaningful Recovery Outcomes by Nerve Function Autograft Allograft revolutionizing the science of nerve repair™


 
Studies find Avance Nerve Graft performed comparably to nerve autograft for both clinical outcomes and facility procedure costs 33 “Styron et al., Nerve Repair Hospital Index Procedure Costs – Allograft vs. Autograft Repair Type” Presented at the American Society for Surgery of the Hand (ASSH), October 202056 • Data from the 2018 Medicare Standard Analytic File57 • 340 claims reviewed for autograft and allograft, included inpatient and outpatient procedures • Found hospital facility procedure cost for Avance Nerve Graft was comparable to that of traditional nerve autograft • Did not evaluate the potential additional costs associated with managing the autograft donor site and subsequent morbidities “Styron et al., Comparative Effectiveness Evaluating Allograft, Autograft and Conduit Nerve Repairs: A Systematic Review” Presented at the American Association for Hand Surgery (AAHS), January 202158 • Systematic review of recovery outcomes from over 35 clinical studies and 1,500 nerve repairs with autograft, allograft and conduit repairs • Evaluated short and long gaps for both sensory and motor outcomes • Autograft and allograft outcome rates were found to be statistically better than conduit repairs* • Autograft and allograft outcome rates were found to be similar, regardless of gap length or nerve function • Cost comparison conducted with Medicare data on Hospital Index Procedure Costs for autograft and allograft were found to be similar *Conduits only had available data for short gap sensory nerve group revolutionizing the science of nerve repair™


 
First publication on breast neurotization outcomes with Avance Nerve Graft demonstrated greater return of protective sensation 34 • Early outcomes from a single center study, as part of the Sensation-NOW registry • 36 breast reconstructions that included: 22 breast reconstructions with Resensation® 14 standard non-neurotized breast reconstructions • Return of Protective Sensation (p=0.04) 73% of the Resensation group 36% of the non-neurotized group • Neurotization with Avance Nerve Graft resulted in greater return of sensation and return of sensation in more of the breast as compared to standard reconstruction without nerve repair. “Momeni et al., Flap Neurotization in Breast Reconstruction with Nerve Allografts: 1-year Clinical Outcomes” – Plastic and Reconstructive Microsurgery Global Open, January 202159 36% 73% 0 20 40 60 80 100 Non-Neurotized Neurotized Subjects Reporting Return of Protective Sensation in Reconstructed Breast p = 0.04 revolutionizing the science of nerve repair™


 
Axogen sponsored REPOSESM pilot study analysis demonstrates clinically significant improvement for subjects with chronic neuropathic pain when using Axoguard Nerve Cap® following neurectomy60 35 15-subject, single arm pilot phase evaluating reduction in pain from baseline following surgical excision of the neuroma and placement of the Axoguard Nerve Cap • Significant & clinically meaningful reduction in pain • Significant and clinically meaningful improvements in Fatigue, Physical Function, Sleep Disturbance, Pain Interference, Pain Intensity, and Pain Behavior as measured by the validated PROMIS® measures • Positive indicators for reduction in pain medication burden, including opioids • No recurrence of neuroma 0 20 40 60 80 100 Baseline 2 Weeks 1 month 3 month 6 month 9 month 12 Month 1 0 0 -p o in t V is u a l A n a lo g S c a le ( V A S ) Clinically meaningful reduction in pain sustained through 12 months Minimal Clinically Important Difference (MCID): 17mm Δ 3 months: -69 ± 23; p < 0.0001 Δ 12 months: -80 ± 13; p < 0.0001 revolutionizing the science of nerve repair™


 
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 in the last 12 months 36revolutionizing the science of nerve repair™ 232 216 237 256 265 294 283 282 285 298 331 243 228 248 269 274 306 292 294 288 299 331 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Core Ex-Avive Total Core 791 760 845 859 875 921 930 941 923 940 952825 789 875 893 919 959 954 951 926 941 952 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Active Ex-Avive Total Active Active


 
CPT Code Descriptor C-APC Hospital Outpatient (HOPD) Ambulatory Surgery Center (ASC) 2022 2023 % Change 2022 2023 % Change 64912 Nerve allograft repair2 5432 $ 5,824 $6,179 6.10% $3,868 $4,125 6.64% 64910 Conduit or vein allograft repair2 5432 $ 5,824 $6,179 6.10% $3,881 $3,905 0.62% 64886 Autograft repair (head and neck >4cm)2 5432 $ 5,824 $6,179 6.10% $4,245 $4,375 3.06% 64890 Autograft repair (hand and foot≤4cm) 6 5432 $ 5,824 $6,179 6.10% $3,249 $2,602 -19.91% 64891 Autograft repair (hand and foot>4cm) 2 5432 $ 5,824 $6,179 6.10% $3,249 $3,383 4.12% 64892 Autograft repair (arm and leg ≤4cm)2 5432 $5,824 $6,179 6.10% $3,718 $3,383 -9.01% 64893 Autograft repair (arm and leg >4cm)3 5432 $5,824 $6,179 6.10% $2,496 $3,383 35.54% 64897 Autograft repair (arm and leg ≤4cm multiple strands)3 5432 $5,824 $6,179 6.10% $2,496 $3,660 46.63% 64885 and 64895-96,98 Autograft repair (all other nerve type) 5 5432 $5,824 $6,179 6.10% $2,496 $2,632 5.45% 64834-36, 40, 56, 57, 62-64 Direct Repair (other hand/foot, arm/leg, repair/transpose, facial, low back,)5 5432 $5,824 $6,179 6.10% $2,496 $2,632 5.45% 64865 Direct Repair of facial nerve7 5432 $5,824 $6,179 6.10% $2,496 $3,383 35.54% 64831, 61 Direct Repair (digital, brachial plexus/arm) 4 5431 $1,793 $ 1,798 0.28% $825 $854 3.52% 64858 Direct Repair (sciatic)2 5431 $1,793 $ 1,798 0.28% $1,465 $1,481 1.09% 2023 CMS Final outpatient reimbursement rates - hospital and ASC 37 Although CMS rates1 only apply to Medicare cases, which represents a small percentage of traumatic injuries, private payors are often influenced by the analysis and decisions made by CMS 1. National average payment rates. Commercial payments are traditionally 1.5-2x higher than Medicare. 2. Nerve allograft repair CPT 64912, conduit repair CPT 64910, autograft repairs hand/foot >4cm CPT 64891, arm/leg≤4cm CPT code 64892, and head/neck >4cm CPT 64886 remain in C-APC 5432 and direct repair sciatic CPT 64858 remains in C-APC 5431 and all continue to meet ASC device intensive criteria 3. Autograft repair arm and leg >4cm CPT 64893, Autograft repair arm/leg ≤4cm multiple strands CPT 64897, remains in C-APC 5432 and meets ASC device intensive criteria in 2023 4. Direct repair digital and brachial plexus/arm CPT codes 64831 and 64861 remain in C-APC 5431 and do not meet ASC device intensive criteria. 5. Autograft repair all other nerve type CPT 64885 and 64895-96,98 and Direct repair other hand/foot CPT 64834-36, leg CPT 64840, repair/transpose CPT 64856, arm/leg CPT 64857, low back CPT 64862-64 remain in C-APC 5432 and do not meet ASC device intensive criteria 6. Autograft repair hand/foot ≤4cm CPT 64890 remains in C-APC 5432 no longer meets ASC device intensive criteria in 2023 7. Direct repair of facial nerve CPT 64865 meets ASC device intensive criteria in 2023 Note: Hospital inpatient rates for nerve repair align to DRGs 040, 041, 042 and range from $11.5k to $23.7k in the 2023 IPPS Proposed Rule


 
2023 Center for Medicare and Medicaid Services (CMS): Final Physician Fee Schedule (PFS) revolutionizing the science of nerve repair™ 38November 7, 2022 CPT Codes to Descriptor Physician Fee Schedule (PFS) 2022 2023 % Change 64912 Nerve allograft repair $910 $886 -2.7% 64910 Conduit or vein allograft repair $790 $753 -4.7% 64885 to 64898* Autograft repair $1,031 to $1,462 $1,038 to $1,408 -3.7% to 0.8% 64831 to 64861* Direct Repair $712 to $1,567 $690 to $1,522 -2.9% to -3.0% *excludes add-on procedure codes


 
Projected Incidence(a) Weighted Average Procedure Value Estimated Total Addressable Market Trauma Transection injuries >5mm (b) Other trauma injuries (c) 700,000 100% 203,000 29% 497,000 71% $2,715 $5,515 $1,570 $1,900M 100% $1,120M 59% $780M 41% 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 Totals >900,000 (potent ia l ) >$2.7B a) Estimated Annual incidence of PNI surgery are figures rounded to the nearest thousandth except for Breast Reconstruction Neurotization (rounded to nearest hundredth). b) Transection injuries > 5mm assumes a factor of 1.22 nerve repairs per procedures, and utilization of the Axogen portfolio of products, based upon data observed in the RANGER® registry c) Other trauma injuries include transections < 5mm and crush injuries utilizing the Axoguard product line based upon literature and data observed in the RANGER® registry 39 Estimated $2.7B value of market opportunity in existing applications revolutionizing the science of nerve repair™


 
40 Estimated Trauma total addressable market revolutionizing the science of nerve repair™


 
Trauma total addressable market (continued) 41revolutionizing the science of nerve repair™


 
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 regulations, U.S. State regulations and the guidelines of the American Association of Tissue Banks (AATB). Additionally, international regulations are followed as appropriate. • Indication for Use: Avance Nerve Graft is processed nerve allograft (human) intended for the surgical repair of peripheral nerve discontinuities to support regeneration across the defect. • Contraindications: Avance Nerve Graft is contraindicated for use in any patient in whom soft tissue implants are contraindicated. This includes any pathology that would limit the blood supply and compromise healing or evidence of a current infection. Axoguard Nerve Connector ® • Regulatory Classifications: Class II Medical Devices - 510(k) cleared, CE Marked • Indications for Use (EU and UK): The Axoguard Nerve Connector is indicated for the repair of peripheral nerve discontinuities with gaps up to 5 mm. The Axoguard Nerve Connector is supplied sterile and is intended for single use. • Indications for Use (ROW): Axoguard Nerve Connector is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The Axoguard Nerve Connector is supplied sterile and is intended for single use. • Contraindications: This device is derived from a porcine source and should not be used for patients with known sensitivity to porcine material. Axoguard Nerve Protector ® • Regulatory Classifications: Class II Medical Devices - 510(k) cleared, CE Marked • Indication for Use: Axoguard Nerve Protector is indicated for the repair of peripheral nerve injuries in which there is no gap. The Axoguard Nerve Connector is supplied sterile and is intended for single use. • Contraindications: This device is derived from a porcine source and should not be used for patients with known sensitivity to porcine material. 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 nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. • Contraindications: Axoguard Nerve Cap is derived from a porcine source and should not be used for patients with known sensitivity to porcine derived materials. Axoguard Nerve Cap is contraindicated for use in any patient for whom soft tissue implants are contraindicated; this includes any pathology that would limit the blood supply and compromise healing, or evidence of a current infection. Axoguard Nerve Cap should not be implanted directly under the skin. Note: This device is not intended for use in vascular applications. 42revolutionizing the science of nerve repair™


 
nasdaq: axgn 43revolutionizing the science of nerve repair™


 
44 Footnotes Trauma Market Data: 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 with Multiple Injuries. J Trauma. 1998; 45(1): 116-122. 3. Uzun, et al., Traumatic peripheral nerve injuries: demographic and electrophysiologic findings of 802 patients from a developing country. J Clin Neuromusc Dis. 2006; 7(3): 97–103. 4. Portincasa, et al. Microsurgical treatment of injury to peripheral nerves in upper and lower limbs: a critical review of the last 8 years. Microsurgery. 2007; 27(5): 455–462. Carpal Tunnel Revisions & Cubital Tunnel Market Data 5. Medicare National HCPS Aggregate Summary Table CY2016. https://data.cms.gov/Medicare-Physician-Supplier/Medicare-National-HCPCS-Aggregate-Summary-Table-CY/jtra-d83c/data 6. Sotereanos, et al. Vein wrapping for the treatment of recurrent carpal tunnel syndrome. Tech Hand Up Extrem Surg.1997; 1(1):35-40. 7. Seradge, et al. Cubital tunnel release with medial epicondylectomy factors influencing the outcome. J Hand Surg Am. 1998; 23(3): 483-491. 8. Papatheodorou, et al. Preliminary results of recurrent cubital tunnel syndrome treated with neurolysis and porcine extracellular matrix nerve wrap. J Hand Surg Am. 2015; 40(5): 987-992 OMF Market Data 9. Lin, et al. Systematic Review and Meta-Analysis on Incidence of Altered Sensation of Mandibular Implant Surgery - PLoS One. 2016; 11(4): e0154082. 10. Hussaini. Procedure frequency in the jaws related to implant location. Dent Oral Craniofac Res. 2016; 2(2): 230-233. 11. Nguyen, et al. Risk factors for permanent injury of inferior alveolar and lingual nerves during third molar surgery. J Oral Maxillofac Surg. 2014; 72(12): 2394-2401. 12. Cheung, et al. Incidence of neurosensory deficits and recovery after lower third molar surgery: a prospective clinical study of 4338 cases. Int J Oral Maxillofac Surg. 2010; 39(4): 320–326. 13. Dental Implants Market (Product - Endosteal Implants, Subperiosteal Implants, Transosteal Implants, Intramucosal Implants; Material - Titanium Implants, Zirconium Implants; End User - Hospitals, Dental Clinics, and Academic & Research Institutes) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2017 – 2025. https://www.transparencymarketresearch.com/dental-implants-market.html 14. Cha, et al. Frequency of bone graft in implant surgery. Maxillofac Plast and Reconstr Surg. 2016; 38(1): 19. 15. Miloro, M (ed). Trigeminal Nerve Injuries. Springer; 2013. 16. Pogrel et al. Permanent nerve involvement resulting: From inferior alveolar nerve blocks. J Am Dent Assoc. 2000; 131(7): 901-907. 17. Agbaje, et al. Systematic review of the incidence of inferior alveolar nerve injury in bilateral sagittal split osteotomy and the assessment of neurosensory disturbances. Int. J Oral Maxillofac. Surg. 2015; 44(4): 447-451. Breast Neurotization Market Data, and Other Clinical References 18. ASPS 2017– Plastic Surgery Statistics Report. www.plasticsurgery.org/documents/News/Statistics/2017/plastic-surgery-statistics-full-report-2017.pdf 19. Rappaport, et al. Clinical utilization and complications of sural nerve biopsy. Am J Surg. 1993; 166(3): 252-256. 20. Weber, et al. A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans. Plast Reconstr Surg. 2000; 106(5): 1036-1045. 21. Wangensteen, et al. Collagen tube conduits in peripheral nerve repair: A retrospective analysis. Hand. 2010; 5(3): 273-277. 22. Data on file at Axogen 23. Karabekmez, et al. Early clinical outcomes with the use of decellularized nerve allograft for repair of sensory defects within the hand. Hand. 2009; 4(3): 245-249. 24. Boeckstyns, et al. Collagen conduit versus microsurgical neurorrhaphy: 2-year follow-up of a prospective, blinded clinical and electrophysiological multicenter randomized, controlled trial. J hand Surg Am. 2013; 38(12): 2405-2411. 25. Brushart, et al. Selective reinnervation of distal motor stumps by peripheral motor axons. Exp Neurol. 1987; 97(2): 289-300. 26. Schmidhammer, et al. Alleviated tension at the repair site enhances functional regeneration: The effect of full range of motion mobilization on the regeneration of peripheral nerves--histologic, electrophysiologic, and functional results in a rat model. J Trauma. 2004; 56(3): 571-584 27. Tang, et al. The optimal number and location of sutures in conduit-assisted primary digital nerve repair. J Hand Surg Eur Vol. 2018; 43(6): 621-625. 28. Data on file at Axogen 29. Badylak, et al. Small intestinal submucosa: A substrate for in vitro cell growth. J Biomater Sci Polym Ed. 1998; 9(8): 863-878. 30. Hodde, et al. Effects of sterilization on an extracellular matrix scaffold: Part II. Bioactivity and matrix interaction. J Mater Sci Mater Med. 2007; 18(4): 545-550. 31. Nihsen, et al. Bioactivity of small intestinal submucosa and oxidized regenerated cellulose/collagen. Adv Skin Wound Care. 2008; 21(10): 479-486. 32. Zhukauskas et al., Comparative Study of Porcine Small Intestine Submucosa and Cross-Linked Bovine Type I Collagen as a Nerve Conduit. JHS GO 3(5), 282-288 Sep 2021 33. Hodde, et al. Vascular endothelial growth factor in porcine-derived extracellular matrix. Endothelium. 2001; 8(1): 11-24. 34. Data on file at Axogen 35. Kokkalis, et al. Assessment of processed porcine extracellular matrix as a protective barrier in a rabbit nerve wrap model. J Recon MicroSurg. 2011; 27(1): 19-28. 36. Pet MA, Ko JH, Friedly JL, Smith DG. Traction Neurectomy for Treatment of Painful Residual Limb Neuroma in Lower Extremity Amputees J Orthop Trauma. 29 (9), e321-5 Sep 2015. 37. Laborde K, et al. Results of surgical treatment of painful neuromas of the hand. The Journal of Hand Surgery. March 1981;7(2):190-193. revolutionizing the science of nerve repair™


 
45 Footnotes 38. Galeano M, et al. A free vein graft cap influences neuroma formation after nerve transection. Microsurgery. 2009;29(7):568-572. 39. Stokvis A. Surgical management of painful neuromas. Rotterdam, The Netherlands: Optima Grafische Communicatie; 2010. 40. Lin E, et al. Local administration of norephinephrine in the stump evokes dose-dependent pain in amputees. Clin J Pain. 2006;22(5):482-486. 41. O’Reilly MA, et al. Neuromas as the cause of pain in the residual limbs of amputees. An ultrasound study. Clin Radiology. May 1-6, 2016. 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. Fallat L. Cryosurgery or sclerosing injections: which is better for neuromas. Podiatry Today. 2004;17(6):58-66. 45. Bradley MD. Plantar neuroma: analysis of results following surgical excision in 145 patients. South Med J. 1976;69:853-845. 46. Kehoe S, et al. FDA-approved guidance conduits and wraps for peripheral nerve injury: A review of materials and efficacy. Injury. 2012;43:553-572. 47. Record RD, Hillegonds D, Simmons C, Tullius R, Rickey FA, Elmore D, Badylak SF. In vivo degradation of 14C-labeled small intestinal submucosa (SIS) when used for urinary bladder repair. Biomaterials. 2001 Oct;22(19):2653-9. 48. Leversedge FJ, Zoldos J, Nydick J, Kao DS, Thayer W, MacKay B, McKee D, Hoyen H, Safa B, Buncke GM. A Multicenter Matched Cohort Study of Processed Nerve Allograft and Conduit in Digital Nerve Reconstruction. J Hand Surg Am. 2020 Dec;45(12):1148-1156. 49. Safa B, Power D, Liu A, Thayer WP, et al. A Propensity Matched Cohort Study on Outcomes from Processed Nerve Allograft and Nerve Autograft in Upper Extremity Nerve Repairs. In: The 75th Annual Meeting of the ASSH. Virtual Annual Meeting, October 1-2, 2020. 50. Safa B, Jain S, Desai MJ, Greenberg JA, Niacaris TR, Nydick JA, Leversedge FJ, Megee DM, Zoldos J, Rinker BD, McKee DM, MacKay BJ, Ingari JV, Nesti LJ, Cho M, Valerio IL, Kao DS, El-Sheikh Y, Weber RV, Shores JT, Styron JF, Thayer WP, Przylecki WH, Hoyen HA, Buncke GM. Peripheral nerve repair throughout the body with processed nerve allografts: Results from a large multicenter study. Microsurgery. 2020 Jul;40(5):527-537. 51. Sallam AA, El-Deeb MS, Imam MA. Nerve Transfer Versus Nerve Graft for Reconstruction of High Ulnar Nerve Injuries. J Hand Surg Am. 2017 Apr;42(4):265-273 52. Roganovic Z, Pavlicevic G. Difference in recovery potential of peripheral nerves after graft repairs. Neurosurgery. 2006 Sep;59(3):621-33; discussion 621-33. 53. Frykman G, Gramyk K. Results of nerve grafting. In: Gelberman R, ed. Operative nerve repair and reconstruction. Philadelphia: JB Lippincott, 1991:553–567 54. Vastamäki M, Kallio PK, Solonen KA. The results of secondary microsurgical repair of ulnar nerve injury. J Hand Surg Br. 1993 Jun;18(3):323-6. 55. Kallio PK, Vastamäki M, Solonen KA. The results of secondary microsurgical repair of radial nerve in 33 patients. J Hand Surg Br. 1993 Jun;18(3):320-2. 56. Styron JF, Thompson AK, Park LI, Watson GJ. Nerve Repair Hospital Index Procedure Costs – Allograft vs. Autograft Repair Type. In: The 75th Annual Meeting of the ASSH. Virtual Annual Meeting, October 1-2, 2020. 57. U.S. Centers for Medicare and Medicaid Services, Medicare Claims standard analytic file. 2018. 58. Styron JF, Lans-Valera J. Comparative Effectiveness Evaluating Allograft, Autograft and Conduit Nerve Repairs: A Systematic Review. American Association for Hand Surgery. Virtual Annual Meeting, January 2021 59. Momeni A, Meyer S, Shefren K, Januszyk M. Flap Neurotization in Breast Reconstruction with Nerve Allografts: 1-year Clinical Outcomes. Plast Reconstr Surg Glob Open. 2021 Jan 12;9(1):e3328 60. to Pereira R, Dauphinee D, Frania S, Garrett A, Martin C, Van Gils C, Thomajan C. Clinical evaluation of an innovative nerve termination cap for treatment and prevention of stump neuroma pain: Results from a prospective pilot clinical study. Fastrac. 2022; 2(2): 100179. © 2022 Axogen Corporation. The stylized “a” logo and Avance Nerve Graft are trademarks of Axogen Corporation. Axoguard is a registered trademark of Axogen Corporation. Axoguard Nerve Connector and Axoguard Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, West Lafayette, Indiana, and are distributed exclusively by Axogen Corporation. LB-0588 revolutionizing the science of nerve repair™