axgn-20250930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to______________

Commission file number: 001-36046

Axogen, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Minnesota

(State or other jurisdiction of

incorporation or organization)

13631 Progress Blvd., Suite 400 Alachua, FL

(Address of principal executive offices)

41-1301878

(I.R.S. Employer

Identification No.)

32615

(Zip Code)

386-462-6800

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)


Securities registered pursuant to Section 12(b) of the Act:
Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, $0.01 par value	AXGN	The Nasdaq Stock Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☒

Non-accelerated filer	☐	Smaller reporting company	☐

		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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 27, 2025, the registrant had 46,122,289 shares of common stock outstanding.

Table of Contents

Axogen, Inc.


Table of Contents

Part I - Financial Information
Item 1.	Financial Statements	2
	Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 (Unaudited)	2
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024 (Unaudited)	3
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 (Unaudited)	4
	Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three and nine months ended September 30, 2025 and 2024 (Unaudited)	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27

Item 4.	Controls and Procedures	27

Part II - Other Information

Item 1.	Legal Proceedings	28

Item 1A.	Risk Factors	28

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28

Item 3.	Defaults Upon Senior Securities	28

Item 4.	Mine Safety Disclosures	28

Item 5.	Other Information	28

Item 6.	Exhibits	29

	Signatures	30

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Axogen, Inc.

Forward-Looking Statements

From time to time, in reports filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) (including this Quarterly Report on Form 10-Q), in press releases, and in other communications to shareholders or the investment community, Axogen, Inc. (including Axogen, Inc.’s wholly owned subsidiaries, Axogen Corporation, Axogen Processing Corporation, Axogen Germany GmbH and Axogen Europe GmbH, the “Company,” “Axogen,” “we,” “our,” or “us”) may provide forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, concerning possible or anticipated future results of operations or business developments. 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 the Company is active, as well as its 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.

The forward-looking statements in this Form 10-Q include, but are not limited to, the following:

•Our belief that we will continue to drive growth in the nerve protection category;

•Our expectations around our targeted strategy relating to the expansion of nerve repair indications with a focus on deepening our presence in high-potential accounts;

•Our expectations regarding the potential impact of recent government actions and policies, including the One Big Beautiful Bill Act (“OBBBA”) and the October 2025 U.S. government shutdown, on our business, tax position, and regulatory processes, including the U.S. Food and Drug Administration (“FDA”) review of our Biologics License Application for Avance® Nerve Graft;

•Our expectations around the potential positive impact on our business of the American Association for Hand Surgery (“AAHS”) and the American Society for Reconstructive Microsurgery (“ASRM”) releasing official position statements recognizing allograft as a standard medical practice option for the treatment of peripheral nerve defects, as well as prior clinical guidelines released by the American Association of Oral and Maxillofacial Surgeons (“AAOMS”);

•Our expectations around the potential positive impact on our business of expanded coverage and reimbursement for peripheral nerve injuries using synthetic conduits or allografts;

•Our expectations around the anticipated approval of Avance® Nerve Graft by the FDA in December 2025; and

•Our belief that our existing cash and cash equivalents and investments, as well as cash provided by sales of our products will allow us to fund our operations through at least the next twelve months.

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 Quarterly Report on Form 10-Q should be evaluated together with the many risks and uncertainties that affect the Company’s business and its market, particularly those discussed in the risk factors and cautionary statements set forth in the Company’s filings with the SEC, including as described in “Risk Factors” included in Item 1A and “Risk Factor Summary” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Forward-looking statements are not guarantees 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, the Company assumes no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or otherwise.

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PART 1 — FINANCIAL INFORMATION

ITEM 1 — FINANCIAL STATEMENTS

Axogen, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)


	September 30, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	23,902	$	27,554
Restricted cash	4,000		6,000
Investments	11,889		5,928
Accounts receivable, net of allowance for doubtful accounts of $1,075 and $788, respectively	30,775		24,105
Inventory	40,581		33,183
Prepaid expenses and other assets	3,309		2,447
Total current assets	114,456		99,217
Property and equipment, net	82,374		84,667
Operating lease right-of-use assets	13,137		14,265
Intangible assets, net	6,433		5,579
Total assets	$	216,400	$	203,728

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	25,672	$	28,641
Current maturities of long-term lease obligations	2,336		1,969
Total current liabilities	28,008		30,610

Long-term debt, net of debt discount and financing fees	48,162		47,496
Long-term lease obligations	17,416		19,221
Debt derivative liabilities	1,868		2,400
Other long-term liabilities	141		94
Total liabilities	95,595		99,821

Commitments and contingencies - see Note 13

Shareholders’ equity:
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 46,117,283 and 44,148,836 shares issued and outstanding, respectively	461		441
Additional paid-in capital	414,151		394,726
Accumulated deficit	(293,807)		(291,260)
Total shareholders’ equity	120,805		103,907
Total liabilities and shareholders’ equity	$	216,400	$	203,728

See Notes to Condensed Consolidated Financial Statements.

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Axogen, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended				Nine Months Ended
	September 30, 2025		September 30, 2024		September 30, 2025		September 30, 2024
Revenues	$	60,082	$	48,644	$	165,304	$	137,933
Cost of goods sold	14,089		12,206		42,360		33,531
Gross profit	45,993		36,438		122,944		104,402
Costs and expenses:
Sales and marketing	25,680		18,924		70,529		58,437
Research and development	7,565		6,996		20,509		21,063
General and administrative	10,836		10,834		29,983		30,206
Total costs and expenses	44,081		36,754		121,021		109,706
Income (loss) from operations	1,912		(316)		1,923		(5,304)
Other income (expense):
Investment income	319		296		816		816
Rental income	—		90		—		90
Interest expense	(1,757)		(1,893)		(5,984)		(6,405)
Change in fair value of debt derivative liabilities	209		13		531		542
Other income (expense), net	25		(48)		167		(153)
Total other expense, net	(1,204)		(1,542)		(4,470)		(5,110)
Net income (loss)	$	708	$	(1,858)	$	(2,547)	$	(10,414)

Weighted average common shares outstanding - basic	46,494,598		43,882,110		45,905,069		43,610,481
Weighted average common shares outstanding - diluted	49,088,436		43,882,110		45,905,069		43,610,481

Net income (loss) per common share - basic	$	0.02	$	(0.04)	$	(0.06)	$	(0.24)
Net income (loss) per common share - diluted	$	0.01	$	(0.04)	$	(0.06)	$	(0.24)

See Notes to Condensed Consolidated Financial Statements.

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Axogen, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)


	Nine Months Ended
	September 30, 2025		September 30, 2024
Cash flows from operating activities:
Net loss	$	(2,547)	$	(10,414)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	5,027		4,831
Amortization of right-of-use assets	294		889
Amortization of intangible assets	221		202
Amortization of debt discount and deferred financing fees	666		669
Provision for bad debts	358		604

Change in fair value of debt derivative liabilities	(531)		(542)
Investment gains	(238)		(95)
Stock-based compensation	13,501		12,830
Change in operating assets and liabilities:
Accounts receivable	(7,028)		(85)
Inventory	(7,398)		(6,343)
Prepaid expenses and other assets	(619)		1,189
Accounts payable and accrued expenses	(2,985)		(7,125)
Operating lease obligations	(833)		(1,303)
Cash paid for interest portion of financing lease obligations	(3)		(2)
Other long-term liabilities	(111)		495
Net cash used in operating activities	(2,226)		(4,200)

Cash flows from investing activities:
Purchase of property and equipment	(2,498)		(2,431)

Purchase of investments	(13,723)		(5,773)
Proceeds from sale of investments	8,000		—
Cash payments for intangible assets	(1,138)		(1,280)
Net cash used in investing activities	(9,359)		(9,484)

Cash flows from financing activities:





Cash paid for debt portion of financing lease obligations	(11)		(6)
Proceeds from exercise of stock options and ESPP stock purchases	5,944		1,326
Net cash provided by financing activities	5,933		1,320
Net decrease in cash and cash equivalents, and restricted cash	(5,652)		(12,364)
Cash and cash equivalents, and restricted cash, beginning of period	33,554		37,026
Cash and cash equivalents, and restricted cash, end of period	$	27,902	$	24,662

Supplemental disclosures of cash flow activity:
Cash paid for interest	$	5,089	$	5,736
Supplemental disclosure of noncash investing and financing activities:
Acquisition of property and equipment change in accounts payable and accrued expenses	$	236	$	114



Acquisition of intangible assets change in accounts payable and accrued expenses	$	(63)	$	14

See Notes to Condensed Consolidated Financial Statements.

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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, 2025
Balance at June 30, 2025	45,765,290	$	457	$	406,334	$	(294,515)	$	112,276
Net income	—	—		—		708		708
Stock-based compensation	—	—		5,424		—		5,424
Issuance of restricted and performance stock units	81,925	1		(1)		—		—
Exercise of stock options	270,068	3		2,394		—		2,397
Balance at September 30, 2025	46,117,283	$	461	$	414,151	$	(293,807)	$	120,805

Nine Months Ended September 30, 2025
Balance at December 31, 2024	44,148,836	$	441	$	394,726	$	(291,260)	$	103,907
Net loss	—	—		—		(2,547)		(2,547)
Stock-based compensation	—	—		13,501		—		13,501
Issuance of restricted and performance stock units	1,301,062	13		(13)		—		—
Exercise of stock options and employee stock purchases under the ESPP	667,385	7		5,937		—		5,944
Balance at September 30, 2025	46,117,283	$	461	$	414,151	$	(293,807)	$	120,805

Three Months Ended September 30, 2024
Balance at June 30, 2024	43,824,738	$	438	$	385,101	$	(289,852)	$	95,687
Net loss	—	—		—		(1,858)		(1,858)
Stock-based compensation	—	—		5,004		—		5,004
Issuance of restricted and performance stock units	112,185	1		(1)		—		—
Exercise of stock options	65,400	1		573		—		574
Balance at September 30, 2024	44,002,323	$	440	$	390,677	$	(291,710)	$	99,407

Nine Months Ended September 30, 2024
Balance at December 31, 2023	43,124,496	$	431	$	376,530	$	(281,296)	$	95,665
Net loss	—	—		—		(10,414)		(10,414)
Stock-based compensation	—	—		12,830		—		12,830
Issuance of restricted and performance stock units	695,571	7		(7)		—		—
Exercise of stock options and employee stock purchases under the ESPP	182,256	2		1,324		—		1,326
Balance at September 30, 2024	44,002,323	$	440	$	390,677	$	(291,710)	$	99,407

See Notes to Condensed Consolidated Financial Statements.

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Axogen, Inc.

Notes to Condensed Consolidated Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

1.Nature of Business

Axogen, Inc. (together with its wholly-owned subsidiaries, the “Company”) was incorporated in Minnesota. The Company’s business is focused on the science, development and commercialization of the technologies used for peripheral nerve regeneration and repair. The Company’s products include Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap® and Avive+ Soft Tissue Matrix™. The Company is headquartered in Florida. The Company has processing, warehousing and distribution facilities in Ohio and Texas.

The Company manages its operations as a single operating segment. Substantially all of the Company’s assets are maintained in the United States (“U.S.”). The Company derives substantially all of its revenues from sales to customers in the U.S.

2.Summary of Significant Accounting Policies

Please see Note 2 - Summary of Significant Accounting Policies to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), filed with the SEC on February 26, 2025, for a description of all significant accounting policies.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of September 30, 2025 and December 31, 2024 and for the three and nine months ended September 30, 2025 and 2024. The Company’s condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and therefore do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the U.S. (“U.S. GAAP”) and should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2024, which are included in the 2024 Annual Report on Form 10-K.

The interim condensed consolidated financial statements are unaudited, and in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments necessary for a fair presentation of results for the periods presented. The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the full year due primarily to the impact of the continued uncertainty of general economic conditions that may impact the Company’s markets for the remainder of fiscal year 2025. All intercompany accounts and transactions have been eliminated in consolidation.

Cash and Cash Equivalents and Concentration

Cash and cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of acquisition. Certain of the Company’s cash and cash equivalents balances exceed Federal Deposit Insurance Corporation (“FDIC”) insured limits or are invested in money market accounts with investment banks that are not FDIC-insured. The Company places its cash and cash equivalents in what it believes to be credit-worthy financial institutions. As of September 30, 2025, $23,402 of the cash and cash equivalents balance were not FDIC-insured or were in excess of FDIC limits.

Restricted Cash

Amounts included in restricted cash represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. See Note 8 - Long-Term Debt, Net of Debt Discount and Financing Fees - Other Credit Facilities.

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Axogen, Inc.

Notes to Condensed Consolidated Financial Statements - Continued

(unaudited)

(in thousands, except share and per share amounts)

The following table provides a reconciliation of Cash and cash equivalents, and Restricted cash reported on the Condensed Consolidated Balance Sheets that sum to the total of the same amounts shown on the Condensed Consolidated Statements of Cash Flows as of the periods presented:


(in thousands)	September 30, 2025		December 31, 2024
Cash and cash equivalents	$	23,902	$	27,554
Restricted cash	4,000		6,000
Total Cash and cash equivalents, and Restricted cash shown on the Condensed Consolidated Statements of Cash Flows	$	27,902	$	33,554

Recent Accounting Pronouncements

In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03 — Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) — Disaggregation of Income Statement Expenses (“ASU 2024-03”), and in January 2025, the FASB issued ASU 2025-01 — Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date (“ASU 2025-01”). ASU 2024-03 requires additional disclosure of the nature of expenses included in the statement of operations as well as disclosures about specific types of expenses included in the expense captions presented in the statement of operations. ASU 2024-03, as clarified by ASU 2025-01, is effective for annual periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Both early adoption and retrospective application are permitted. The Company expects to enhance annual expense disclosures based on the new requirements.

In December 2023, the FASB issued ASU 2023-09 — Income Taxes (Topic 740) — Improvements to Income Tax Disclosures (“ASU 2023-09”). The new guidance provides for disclosure on an annual basis of the following: (i) specific categories in the rate reconciliation and (ii) additional information for reconciling items that meet a quantitative threshold of greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 and early adoption is permitted. The Company expects to enhance annual income tax reporting disclosures based on the new requirements.

All other ASUs issued and not yet effective as of September 30, 2025 and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s current or future financial position or results of operations.

3. Inventory

Inventory consists of the following as of the periods presented:


(in thousands)	September 30, 2025		December 31, 2024
Finished goods	$	35,159	$	27,054
Work in process	1,454		1,325
Raw materials	3,968		4,804
Inventory	$	40,581	$	33,183

As of September 30, 2025 and December 31, 2024, the Company reserved $3,444 and $1,630, respectively, for potential losses relating to inventory.

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Axogen, Inc.

Notes to Condensed Consolidated Financial Statements - Continued

(unaudited)

(in thousands, except share and per share amounts)

4. Property and Equipment, Net

Property and equipment, net consist of the following as of the periods presented:


(in thousands)	September 30, 2025		December 31, 2024
Land	$	731	$

SEC Form 10-Q filed by Axogen Inc.