axgn-20250630

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 June 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 July 31, 2025, the registrant had 46,012,574 shares of common stock outstanding.

Table of Contents


Part I - Financial Information
Item 1.	Financial Statements	3
	Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 (Unaudited)	3
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024 (Unaudited)	4
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (Unaudited)	5
	Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three and six months ended June 30, 2025 and 2024 (Unaudited)	6
	Notes to Unaudited Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26

Item 4.	Controls and Procedures	26

Part II - Other Information

Item 1.	Legal Proceedings	27

Item 1A.	Risk Factors	27

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27

Item 3.	Defaults Upon Senior Securities	27

Item 4.	Mine Safety Disclosures	27

Item 5.	Other Information	27

Item 6.	Exhibits	28

	Signatures	29

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 around the anticipated approval of Avance® Nerve Graft by the U.S. Food and Drug Administration (“FDA”) in September 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 (the “2024 Annual Report on Form 10-K”). 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.

PART 1 — FINANCIAL INFORMATION

ITEM 1 — FINANCIAL STATEMENTS

Axogen, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share amounts)


	June 30, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	20,036	$	27,554
Restricted cash	6,000		6,000
Investments	9,886		5,928
Accounts receivable, net of allowance for doubtful accounts of $1,144 and $788, respectively	28,029		24,105
Inventory	36,774		33,183
Prepaid expenses and other assets	2,694		2,447
Total current assets	103,419		99,217
Property and equipment, net	82,392		84,667
Operating lease right-of-use assets	13,527		14,265

Intangible assets, net	6,115		5,579

Total assets	$	205,453	$	203,728

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	22,770	$	28,641
Current maturities of long-term lease obligations	2,210		1,969
Total current liabilities	24,980		30,610

Long-term debt, net of debt discount and financing fees	47,938		47,496
Long-term lease obligations	18,040		19,221
Debt derivative liabilities	2,078		2,400
Other long-term liabilities	141		94
Total liabilities	93,177		99,821

Commitments and contingencies - see Note 13

Shareholders’ equity:
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 45,765,290 and 44,148,836 shares issued and outstanding, respectively	457		441
Additional paid-in capital	406,334		394,726
Accumulated deficit	(294,515)		(291,260)
Total shareholders’ equity	112,276		103,907
Total liabilities and shareholders’ equity	$	205,453	$	203,728

See Notes to Condensed Consolidated Financial Statements.

Axogen, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(In thousands, except share and per share amounts)


	Three Months Ended				Six Months Ended
	June 30, 2025		June 30, 2024		June 30, 2025		June 30, 2024
Revenues	$	56,662	$	47,912	$	105,222	$	89,289
Cost of goods sold	14,644		12,567		28,271		21,325
Gross profit	42,018		35,345		76,951		67,964
Costs and expenses:
Sales and marketing	23,804		19,698		44,849		39,513
Research and development	6,853		6,658		12,944		14,066
General and administrative	9,689		9,417		19,147		19,373
Total costs and expenses	40,346		35,773		76,940		72,952
Income (loss) from operations	1,672		(428)		11		(4,988)
Other income (expense):
Investment income	225		227		497		520

Interest expense	(1,977)		(2,185)		(4,227)		(4,512)
Change in fair value of debt derivative liabilities	480		464		322		529
Other income (expense), net	179		1		142		(105)
Total other expense, net	(1,093)		(1,493)		(3,266)		(3,568)
Net income (loss)	$	579	$	(1,921)	$	(3,255)	$	(8,556)

Weighted average common shares outstanding - basic	46,063,092		43,713,313		45,605,419		43,473,541
Weighted average common shares outstanding - diluted	47,980,830		43,713,313		45,605,419		43,473,541

Net income (loss) per common share - basic	$	0.01	$	(0.04)	$	(0.07)	$	(0.20)
Net income (loss) per common share - diluted	$	0.01	$	(0.04)	$	(0.07)	$	(0.20)

See Notes to Condensed Consolidated Financial Statements.

Axogen, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(In thousands)


	Six Months Ended
	June 30, 2025		June 30, 2024
Cash flows from operating activities:
Net loss	$	(3,255)	$	(8,556)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	3,385		3,177
Amortization of right-of-use assets	184		642
Amortization of intangible assets	133		138
Amortization of debt discount and deferred financing fees	442		444
Provision for bad debts	386		528

Change in fair value of debt derivative liabilities	(322)		(529)
Investment gains	(121)		(33)
Stock-based compensation	8,077		7,826
Change in operating assets and liabilities:
Accounts receivable	(4,310)		(533)
Inventory	(3,591)		(4,995)
Prepaid expenses and other	(81)		957
Accounts payable and accrued expenses	(5,755)		(6,577)
Operating lease obligations	(542)		(731)
Cash paid for interest portion of financing lease obligations	(2)		(2)
Other long-term liabilities	(77)		143
Net cash used in operating activities	(5,449)		(8,101)

Cash flows from investing activities:
Purchase of property and equipment	(978)		(1,834)

Purchase of investments	(7,837)		(1,911)
Proceeds from sale of investments	4,000		—
Cash payments for intangible assets	(793)		(739)
Net cash used in investing activities	(5,608)		(4,484)

Cash flows from financing activities:





Cash paid for debt portion of financing lease obligations	(8)		(4)
Proceeds from exercise of stock options and ESPP stock purchases	3,547		752
Net cash provided by financing activities	3,539		748
Net decrease in cash and cash equivalents, and restricted cash	(7,518)		(11,837)
Cash and cash equivalents, and restricted cash, beginning of period	33,554		37,026
Cash and cash equivalents, and restricted cash, end of period	$	26,036	$	25,189

Supplemental disclosures of cash flow activity:
Cash paid for interest	$	3,559	$	3,758
Supplemental disclosure of noncash investing and financing activities:
Acquisition of property and equipment change in accounts payable and accrued expenses	$	132	$	178



Acquisition of intangible assets change in accounts payable and accrued expenses	$	(124)	$	242

See Notes to Condensed Consolidated Financial Statements.

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 June 30, 2025
Balance at March 31, 2025	45,512,623	$	455	$	400,004	$	(295,094)	$	105,365
Net income	—	—		—		579		579
Stock-based compensation	—	—		5,168		—		5,168
Issuance of restricted and performance stock units	113,923	1		(1)		—		—
Exercise of stock options and employee stock purchases under the ESPP	138,744	1		1,163		—		1,164
Balance at June 30, 2025	45,765,290	$	457	$	406,334	$	(294,515)	$	112,276

Six Months Ended June 30, 2025
Balance at December 31, 2024	44,148,836	$	441	$	394,726	$	(291,260)	$	103,907
Net loss	—	—		—		(3,255)		(3,255)
Stock-based compensation	—	—		8,077		—		8,077
Issuance of restricted and performance stock units	1,219,137	12		(12)		—		—
Exercise of stock options and employee stock purchases under the ESPP	397,317	4		3,543		—		3,547
Balance at June 30, 2025	45,765,290	$	457	$	406,334	$	(294,515)	$	112,276

Three Months Ended June 30, 2024
Balance at March 31, 2024	43,687,729	$	437	$	380,650	$	(287,931)	$	93,156
Net loss	—	—		—		(1,921)		(1,921)
Stock-based compensation	—	—		3,907		—		3,907
Issuance of restricted and performance stock units	44,153	—		—		—		—
Exercise of stock options and employee stock purchases under the ESPP	92,856	1		544		—		545
Balance at June 30, 2024	43,824,738	$	438	$	385,101	$	(289,852)	$	95,687

Six Months Ended June 30, 2024
Balance at December 31, 2023	43,124,496	$	431	$	376,530	$	(281,296)	$	95,665
Net loss	—	—		—		(8,556)		(8,556)
Stock-based compensation	—	—		7,826		—		7,826
Issuance of restricted and performance stock units	583,386	6		(6)		—		—
Exercise of stock options and employee stock purchases under the ESPP	116,856	1		751		—		752
Balance at June 30, 2024	43,824,738	$	438	$	385,101	$	(289,852)	$	95,687

See Notes to Condensed Consolidated Financial Statements.

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 2024 Annual Report on Form 10-K for the year ended December 31, 2024, 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 June 30, 2025 and December 31, 2024 and for the three and six months ended June 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 for the year ended December 31, 2024.

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 six months ended June 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 June 30, 2025, $19,536 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.

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)	June 30, 2025		December 31, 2024
Cash and cash equivalents	$	20,036	$	27,554
Restricted cash	6,000		6,000
Total Cash and cash equivalents, and Restricted cash shown on the Condensed Consolidated Statements of Cash Flows	$	26,036	$	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 June 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)	June 30, 2025		December 31, 2024
Finished goods	$	31,266	$	27,054
Work in process	1,485		1,325
Raw materials	4,023		4,804
Inventory	$	36,774	$	33,183

As of June 30, 2025 and December 31, 2024, the Company reserved $3,679 and $1,630, respectively, for potential losses relating to inventory.

4. Property and Equipment, Net

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


(in thousands)	June 30, 2025		December 31, 2024
Land	$	731	$	731
Building	60,679		60,679
Leasehold improvements	17,977		17,977
Processing equipment	14,457		13,950
Furniture and equipment	10,798		9,583
Projects in process	857		1,499
Finance lease right-of-use assets	159		159
Property and equipment, at cost	105,658		104,578
Less: accumulated depreciation	(23,266)		(19,911)
Property and equipment, net	$	82,392	$	84,667

Depreciation expense is as follows for the periods presented:


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Depreciation expense	$	1,657	$	1,657	$	3,385	$	3,177

5. Intangible Assets, Net

Intangible assets, net consist of the following as of the periods presented:


	June 30, 2025						December 31, 2024
(in thousands)	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
Amortizable intangible assets:
Patents	$	6,728	$	(1,239)	$	5,489	$	6,090	$	(1,073)	$	5,017



Unamortized intangible assets:
Trademarks	626		—		626		562		—		562
Total intangible assets	$	7,354	$	(1,239)	$	6,115	$	6,652	$	(1,073)	$	5,579

Amortization expense is as follows for the periods presented:


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Amortization expense	$	66	$	76	$	133	$	138

As of June 30, 2025, future amortization of patents is as follows:


Year Ending December 31,	(in thousands)
2025 (excluding the six months ended June 30, 2025)	$	167
2026	334
2027	334
2028	334
2029	334
Thereafter	3,986
Total	$	5,489

6. Fair Value Measurements

The following tables present the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of the periods presented:

June 30, 2025

(in thousands)

(Level 1)

(Level 2)

(Level 3)

Total

Assets:

Money market funds (1)

10,869

—

SEC Form 10-Q filed by Axogen Inc.