CANTON, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2025.

Third Quarter 2025 Financial Results Summary:

• Net product revenue of $150.5 million for the third quarter of 2025, an increase of $35.3 million compared to net product revenue of $115.2 million for the third quarter of 2024. Net product revenue for the third quarter of 2025 consists of:
  • Net product revenue from Advanced Wound Care products of $141.5 million, an increase of 31% from the third quarter of 2024.
  • Net product revenue from Surgical & Sports Medicine products of $9.0 million, an increase of 25% from the third quarter of 2024.
• Net income of $21.6 million for the third quarter of 2025, compared to net income of $12.3 million for the third quarter of 2024, an increase in net income of $9.2 million.
• Adjusted net income of $23.2 million for the third quarter of 2025, compared to adjusted net income of $12.9 million for the third quarter of 2024, an increase in adjusted net income of $10.3 million.
• Adjusted EBITDA of $30.1 million for the third quarter of 2025, compared to Adjusted EBITDA of $13.4 million for the third quarter of 2024, an increase in Adjusted EBITDA of $16.7 million.

“Our record revenue performance in the third quarter reflects the team’s strong execution and commitment to our strategy, leveraging our deep customer relationships to promote access to new and existing products despite the continued challenging environment,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. “In light of the recently announced CMS payment rule, I believe we are well-positioned in 2026 and beyond propelled by the strength of our evidence-based portfolio of regenerative technologies combined with the transformative potential of ReNu in a significant new and addressable market opportunity.”

Third Quarter 2025 Financial Results:

Net product revenue for the third quarter of 2025 was $150.5 million, compared to $115.2 million for the third quarter of 2024, an increase of $35.3 million, or 31%. The increase in net product revenue was driven by an increase of $33.5 million, or 31%, in net product revenue for Advanced Wound Care products and an increase of $1.8 million, or 25%, in net product revenue for Surgical & Sports Medicine products.

The Company recorded $0.4 million in grant income during the third quarter of 2025 related to a government grant the Company received in 2025.

Gross profit for the third quarter of 2025 was $114.2 million, or 76% of net product revenue, compared to $88.4 million, or 77% of net product revenue for the third quarter of 2024, an increase of $25.9 million, or 29%.

Operating expenses for the third quarter of 2025 were $130.1 million compared to $108.9 million for the third quarter of 2024, an increase of $21.2 million, or 19%. Cost of goods sold was $36.3 million for the third quarter of 2025, compared to $26.8 million for the third quarter of 2024, an increase of $9.5 million, or 35%. Selling, general and administrative expenses were $79.7 million for the third quarter of 2025, compared to $71.8 million for the third quarter of 2024, an increase of $7.9 million, or 11%. R&D expense was $13.2 million for the third quarter of 2025, compared to $10.3 million for the third quarter of 2024, an increase of $2.9 million, or 28%. For the three months ended September 30, 2025, the Company recorded impairment and write-down expenses of $0.9 million.

Operating income for the third quarter of 2025 was $20.7 million, compared to an operating income of $6.2 million for the third quarter of 2024, an increase in operating income of $14.5 million.

Total other income (expense), net, for the third quarter of 2025 was $0.4 million income, compared to $(0.4) million expense for the third quarter of 2024, a change of $0.9 million.

Net income for the third quarter of 2025 was $21.6 million, or $0.11 per share, compared to a net income of $12.3 million, or $0.09 per share, for the third quarter of 2024, an increase in net income of $9.2 million, or $0.02 per share.

Adjusted net income was $23.2 million for the third quarter of 2025, compared to adjusted net income of $12.9 million for the third quarter of 2024, an increase of $10.3 million.

Adjusted EBITDA was $30.1 million for the third quarter of 2025, compared to Adjusted EBITDA of $13.4 million for the third quarter of 2024, an increase of $16.7 million.

Non-GAAP operating income was $23.0 million for the third quarter of 2025, compared to non-GAAP operating income of $7.1 million for the third quarter of 2024, an increase of $15.9 million.

Nine Months ended September 30, 2025, Financial Results:

Net product revenue for the nine months ended September 30, 2025 was $338.0 million, compared to $355.4 million for the nine months ended September 30, 2024, a decrease of $17.4 million, or 5%. The decrease in net product revenue was driven by a decrease of $21.0 million, or 6%, in net product revenue for Advanced Wound Care products partially offset by an increase of $3.6 million, or 17%, in net product revenue for Surgical & Sports Medicine products.

Gross profit for the nine months ended September 30, 2025 was $250.4 million, or 74% of net product revenue, compared to $270.7 million, or 76% of net product revenue for nine months ended September 30, 2024, a decrease of $20.3 million, or 8%.

Operating expenses for the nine months ended September 30, 2025 were $357.2 million compared to $366.9 million for the nine months ended September 30, 2024, a decrease of $9.7 million, or 3%. Cost of goods sold was $87.6 million for the nine months ended September 30, 2025, compared to $84.7 million for the nine months ended September 30, 2024, an increase of $2.9 million, or 3%. Selling, general and administrative expenses were $226.1 million for the nine months ended September 30, 2025, compared to $220.7 million for the nine months ended September 30, 2024, an increase of $5.4 million, or 2%. R&D expense was $34.3 million for the nine months ended September 30, 2025, compared to $38.7 million for the nine months ended September 30, 2024, a decrease of $4.5 million, or 12%. For the nine months ended September 30, 2025 and 2024, the Company recorded impairment and write down expenses of $9.2 million and $22.8 million, respectively.

Operating loss for the nine months ended September 30, 2025 was $18.6 million, compared to an operating loss of $11.5 million for the nine months ended September 30, 2024, an increase in operating loss of $7.1 million.

Other income (expense), net, for the nine months ended September 30, 2025 was $2.1 million income, compared to $(1.6) million expense for the nine months ended September 30, 2024, a change of $3.7 million.

Net loss for the nine months ended September 30, 2025 was $6.7 million, or $(0.12) per share, compared to a net loss of $6.8 million, or $(0.05) per share, for the nine months ended September 30, 2024, a decrease in net loss of $0.1 million, or an increase in net loss per share of $(0.07).

Adjusted net income was $2.3 million for the nine months ended September 30, 2025, compared to adjusted net income of $11.7 million for the nine months ended September 30, 2024, a decrease in adjusted net income of $9.4 million.

Adjusted EBITDA was $14.0 million for the nine months ended September 30, 2025, compared to Adjusted EBITDA of $31.6 million for the nine months ended September 30, 2024, a decrease in Adjusted EBITDA of $17.7 million.

Non-GAAP operating loss was $(6.3) million for the nine months ended September 30, 2025, compared to non-GAAP operating income of $13.9 million for the nine months ended September 30, 2024, a change of $20.2 million.

As of September 30, 2025, the Company had $64.4 million in cash, cash equivalents and restricted cash and no outstanding debt obligations, compared to $136.2 million in cash, cash equivalents and restricted cash and no outstanding debt obligations as of December 31, 2024.

Fiscal Year 2025 Guidance:

For the year ending December 31, 2025 the Company is updating its prior revenue guidance and updating its profitability guidance and expects:

• Net product revenue between $500.0 million and $525.0 million, representing an increase of 4% to 9% year-over-year as compared to net product revenue of $482.0 million for the year ended December 31, 2024.
  • The 2025 net product revenue guidance range assumes:
    • Net product revenue from Advanced Wound Care products between $470.0 million and $490.0 million, an increase of 4% to 8% year-over-year as compared to net product revenue of $453.6 million for the year ended December 31, 2024.
    • Net product revenue from Surgical & Sports Medicine products between $30.0 million and $35.0 million, an increase of 6% to 23% year-over-year as compared to net product revenue of $28.4 million for the year ended December 31, 2024.
• Net income between $8.6 million and $25.4 million and adjusted net income between $21.5 million and $38.4 million.
• EBITDA between $19.1 million and $41.9 million and Adjusted EBITDA between $45.5 million and $68.3 million.

Third Quarter Earnings Conference Call:

Management will host a conference call at 5:00 p.m. Eastern Time on November 6th to discuss the results of the quarter, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference by dialing 800-715-9871 (646-307-1963 for international callers) and providing access code: 9073428. The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year.

Non-GAAP Financial Measures

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, adjusted net income, and non-GAAP operating income (loss) to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA, adjusted net income and non-GAAP operating income (loss) help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA, adjusted net income and non-GAAP operating income (loss) provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

Adjusted EBITDA

Adjusted EBITDA consists of GAAP net income (loss) excluding: (i) interest income (expense), net, (ii) income tax benefit, (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, and (vi) additional infrequently occurring adjustments described in more detail below.

The following table presents a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented:

(1) Amount reflects the fair value adjustment of a purchased building classified as held for sale.
(2) Amount reflects employee severance and benefits as well as other exit costs associated with the Company’s restructuring activities.
(3) Amount reflects the impairment of a purchased building and associated unfinished construction work.
(4) Amount reflects the write-down of costs previously capitalized in the development of internal-use software, that the Company determined have no future value.

Adjusted Net Income

Adjusted net income is defined as GAAP net income (loss) plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below, less the estimated tax on these adjustments.

The following table presents a reconciliation of GAAP income (loss) to non-GAAP adjusted net income, for the periods presented:

(1) Amount reflects the fair value adjustment of a purchased building classified as held for sale.
(2) Amount reflects employee severance and benefits as well as other exit costs associated with the Company’s restructuring activities.
(3) Amount reflects the impairment of a purchased building and associated unfinished construction work.
(4) Amount reflects the write-down of costs previously capitalized in the development of internal-use software, that the Company determined have no future value.

Non-GAAP Operating Income (Loss)

Non-GAAP operating income (loss) is defined as GAAP income (loss) from operations plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below.

The following table presents a reconciliation of GAAP income (loss) from operations to non-GAAP operating income (loss), for the periods presented:

(1) Amount reflects the fair value adjustment of a purchased building classified as held for sale
(2) Amount reflects employee severance and benefits as well as other exit costs associated with the Company’s restructuring activities
(3) Amount reflects the impairment of a purchased building and associated unfinished construction work.
(4) Amount reflects the write-down of costs previously capitalized in the development of internal-use software, that the Company determined have no future value.

Amounts reported within the following tables are presented and calculated based on underlying unrounded amounts. As a result, the sum of components may not equal corresponding totals due to rounding.

Projected EBITDA and Adjusted EBITDA

The following table presents a reconciliation of projected GAAP net income to projected non-GAAP EBITDA and projected non-GAAP Adjusted EBITDA included in our guidance for the year ending December 31, 2025:

(1) Amount reflects the fair value adjustment of a purchased building classified as held for sale.
(2) Amounts reflect employee severance and benefits as well as other exit costs associated with the Company’s restructuring activities.

Projected Adjusted Net Income

The following table presents a reconciliation of projected GAAP net income to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2025:

(1) Amount reflects the fair value adjustment of a purchased building classified as held for sale.
(2) Amounts reflect employee severance and benefits as well as other exit costs associated with the Company’s restructuring activities.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, net income, adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2025 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact and uncertainty of any changes to the coverage and reimbursement levels for the Company’s products (including as a result of the proposed LCDs and the finalized CMS rules related to reimbursement for skin substitute products that could each take effect as soon as January 1, 2026); (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the current period and prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) any resurgence of the COVID-19 pandemic or the occurrence of another public health emergency and its impact, if any, on the Company’s fiscal condition and results of operations; (11) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; (12) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (13) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

About Organogenesis Holdings Inc.

Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.