ALACHUA, Fla. and TAMPA, Fla., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today reported financial results and business highlights for the third quarter ended September 30, 2025.

Third Quarter Financial Results

Third quarter revenue was $60.1 million, a 23.5% increase compared to the third quarter of 2024, and a 6.0% increase over the second quarter of 2025.
For the third quarter of 2025, gross margin was 76.6%, up from 74.9% for the third quarter of 2024, and up from 74.2% in the second quarter of 2025.
Net income for the quarter was $0.7 million, or $0.01 per share, compared to a Net loss of $1.9 million, or $0.04 per share for the third quarter of 2024.
Adjusted net income for the quarter was $6.1 million, or $0.12 per share, compared to $3.1 million, or $0.07 per share, for the third quarter of 2024.
Adjusted EBITDA was $9.2 million for the quarter, compared to $6.5 million for the third quarter of 2024.
The balance of cash and cash equivalents, restricted cash, and investments at September 30, 2025, was $39.8 million, as compared to a balance of $39.5 million at December 31, 2024, an increase of $0.3 million. Cash and cash equivalents, restricted cash, and investments increased $3.9 million during the third quarter of 2025.

"Our third quarter performance reflects the continued maturation of the peripheral nerve repair market, with revenue growing 23.5% to $60.1 million and adjusted EBITDA of $9.2 million as we scale our commercial operations," commented Michael Dale, CEO and Director of Axogen, Inc. "New position statements from AAHS and ASRM, together with AAOMS guidelines recognizing nerve allografts as standard medical practice, and the addition of 1.1 million additional covered lives, validate our ongoing market development strategy. With double-digit growth across all markets and the expected completion of our Avance^® Nerve Graft BLA in December, we're advancing our mission to make peripheral nerve repair an expected standard of care."

Summary of Business Highlights

Third quarter 2025 revenue growth was broad-based, including double-digit growth from third quarter 2024 in all markets, which includes Extremities, Oral Maxillofacial & Head and Neck, and Breast.

The American Association of Hand Surgery ("AAHS") and the American Society for Reconstructive Microsurgery ("ASRM") released official position statements recognizing nerve allograft as a standard medical practice option for the treatment of peripheral nerve defects during the third quarter 2025. Including the previously released clinical practice guidelines from the American Association of Oral and Maxillofacial Surgeons ("AAOMS"), the number of societies with positional statements or clinical practice guidelines increased to three.

Expanded coverage and reimbursement for nerve repair for peripheral nerve injuries using synthetic conduits or allografts, increasing the total number of new lives covered in 2025 to approximately 18.1 million and bringing coverage amongst commercial payers to more than 64%.
The U.S. Food and Drug Administration ("FDA") accepted the filing of the Company's Biologics License Application ("BLA") for Avance^® Nerve Graft on November 1, 2024, and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of September 5, 2025, and on August 22, 2025 extended the PDUFA goal date to December 5, 2025. FDA approval of the BLA for Avance^® Nerve Graft is now anticipated by December 5, 2025.

2025 Financial Guidance

We are raising our revenue guidance to at least 19% growth, or $222.8 million for the full year. We continue to expect gross margin for the year to be in the range of 73% to 75%. This range reflects one-time costs, mainly related to an anticipated Avance^® Nerve Graft BLA approval, which we expect will negatively impact gross margin by approximately 1%, or $2 million. Lastly, we reiterate that we expect to be net cash flow positive for the full year.

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 providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Axogen's product portfolio includes 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 (pig) 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 minimizing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; 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; and Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue healing. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea and several other countries.

For more information, visit www.axogeninc.com.

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," "priorities," "objectives," "targets," "intends," "plan(s)," "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. Forward-looking statements include, but are not limited to, statements regarding our business model optimization plans; market development strategies and objectives; our expectations around the potential positive impact on our business of the AAHS and ASRM releasing official position statements recognizing nerve allograft as a standard medical practice options for the treatment of nerve defects, as well as clinical practice guidelines from the 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 beliefs around the strengths and discipline of our commercial execution; our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care; and our expectation of BLA approval in December 2025, as well as statements under the subheading "2025 Financial Guidance." Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions from leadership transitions, global supply chain issues, record inflation, hospital staffing challenges, product development timelines, product potential, expected clinical enrollment timing and outcomes, regulatory processes and approvals, financial performance, sales growth, surgeon and product adoption rates, market awareness of our products, data validation processes, our visibility at and sponsorship of conferences and educational events, global business disruption from Russia's invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, the evolving macroeconomic environment (including financial market volatility), escalating geopolitical tensions and trade disputes with U.S. trading partners, potential impact of recent government actions and policies, including the One Big Beautiful Bill Act and the October 2025 U.S. government shutdown, on our business, tax position, and regulatory processes, as well as those risk factors described under Part I, Item 1A., "Risk Factors," in our Annual Report on Form 10-K for the year ended December 31, 2024 and other risks and uncertainties, which may be detailed from time to time in reports filed by the Company with the SEC. 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.

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, EBITDA margin, and Adjusted EBITDA, which further exclude noncash stock compensation expense, and Adjusted EBITDA margin. We also use the non-GAAP financial measures of Adjusted Net Income (Loss) and Adjusted Net Income (Loss) Per Common Share - diluted which excludes noncash stock compensation expense from Net Income (Loss) and Net Income (Loss) Per Common Share - diluted. 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 the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP 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 (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (ii) they are used by our institutional investors and the analyst community to help them analyze the performance of our business.

Contact:

Axogen, Inc.

InvestorRelations@axogeninc.com

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

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

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	)

Axogen, Inc. Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures (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
Net income (loss)	$	708		$	(1,858	)	$	(2,547	)	$	(10,414	)
Depreciation and amortization expense		1,730			1,719			5,248			5,034
Investment income		(319	)		(296	)		(816	)		(816	)
Income tax (benefit) expense		(62	)		26			4			76
Interest expense		1,757			1,893			5,984			6,405
EBITDA - non-GAAP	$	3,814		$	1,484		$	7,873		$	285
EBITDA margin - non-GAAP		6.3	%		3.1	%		4.8	%		0.2	%

Noncash stock-based compensation expense		5,424			5,004			13,501			12,830
Adjusted EBITDA - non-GAAP	$	9,238		$	6,488		$	21,374		$	13,115
Adjusted EBITDA margin - non-GAAP		15.4	%		13.3	%		12.9	%		9.5	%

Net income (loss)	$	708		$	(1,858	)	$	(2,547	)	$	(10,414	)
Noncash stock-based compensation expense		5,424			5,004			13,501			12,830
Adjusted net income - non-GAAP	$	6,132		$	3,146		$	10,954		$	2,416

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

Net income (loss) per common share - diluted	$	0.01		$	(0.04	)	$	(0.06	)	$	(0.24	)
Noncash stock-based compensation expense		0.11			0.11			0.29			0.29
Adjusted net income per common share - diluted - non-GAAP	$	0.12		$	0.07		$	0.24		$	0.05

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		Additional Paid-in Capital			Accumulated Deficit			Total Shareholders' Equity
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
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

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

Axogen, Inc. Reports Third Quarter 2025 Financial Results