Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026CANTON, Mass., Dec. 23, 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 and Sports Medicine markets, today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Admini ...

Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 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 and Sports Medicine markets, today announced the successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in co ...

Core Insights - Investing is viewed as a learning process where failures serve as tuition and successes contribute to lessons learned [1] Company and Industry Summary - The focus of recent research has been primarily on healthcare stocks, indicating a strategic emphasis in investment analysis [1] - The analyst holds a beneficial long position in ORGO, suggesting confidence in the company's future performance [2] - The article expresses personal opinions and experiences, highlighting the importance of sharing insights and anecdotes within the investment community [1][2]

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Financial Data and Key Metrics Changes - Net product revenue for Q3 2025 was $150.5 million, up 31% year-over-year and up 49% sequentially, exceeding previous guidance [12][13] - Gross profit for Q3 was $114.2 million, or 76% of net product revenue, compared to 77% last year [13] - GAAP net income for Q3 was $21.6 million, compared to $12.3 million last year, an increase of $9.2 million [15] - Adjusted EBITDA for Q3 was $30.1 million, compared to $13.4 million last year [15] Business Line Data and Key Metrics Changes - Advanced wound care net product revenue for Q3 was $141.5 million, up 31% year-over-year [12] - Net product revenue from surgical and sports medicine products for Q3 was $9 million, up 25% [13] Market Data and Key Metrics Changes - The final Medicare physician fee schedule for 2026 was announced, which is expected to significantly impact the industry [4][5] - The new policy is anticipated to address rapid escalation in Medicare spending while ensuring consistent payment across care sites [5][10] Company Strategy and Development Direction - The company aims to leverage its strong brand equity and deep customer relationships to enhance market presence [10] - There is a commitment to work with CMS and other stakeholders to expand access to innovative technologies [5][10] - The company plans to advance its competitive position by focusing on clinical evidence and product efficacy [10][30] Management's Comments on Operating Environment and Future Outlook - Management noted that they are starting to see changes in clinician behavior regarding product utilization following the new fee schedule [23] - The company expects to regain market share lost in previous years and anticipates growth drivers in 2026 [30] - There is confidence in the potential approval of the Renew product based on combined efficacy data from trials [9][36] Other Important Information - The company amended its credit agreement to provide access to up to $75 million of future borrowings [16] - The updated revenue guidance for 2025 is between $500 million and $525 million, representing a year-over-year increase of 4% to 9% [17] Q&A Session Summary Question: How are conversations with the clinical community regarding physician behavior changes following the PFS? - Management indicated that changes in clinician behavior are starting to be observed, with contracts being processed for approved products [23] Question: What can the company do to generate awareness regarding products as volume opens up? - The company plans to leverage strong brand equity and focus on clinical efficacy to raise awareness [24] Question: How might the new rates impact margins for next year? - Management noted that while ASPs are expected to decline, the company is well-positioned with covered products that will be reimbursed at higher rates [30] Question: Are initial approval timelines for Renew still on the table? - Management believes there is still an opportunity to file for approval, with a potential two-month delay being reasonable [36]

Market Focus and Product Development - Organogenesis reported a significant focus on advanced wound care and surgical markets, addressing chronic and acute wounds with a comprehensive product portfolio[100] - The company plans to transition Dermagraft manufacturing to a new facility in Smithfield, Rhode Island, expected to begin in 2027, which will lead to substantial long-term cost savings[104] - A Phase 3 clinical trial for ReNu showed a statistically significant reduction in knee pain (p=0.0177) and maintenance of function (p<0.0001) at six months[107] - The second Phase 3 trial of ReNu did not achieve statistical significance for its primary endpoint, despite showing a numerical improvement in pain reduction[108] Financial Performance - Net product revenue increased by $35.3 million, or 31%, to $150.5 million for the three months ended September 30, 2025, compared to $115.2 million for the same period in 2024[131] - Advanced Wound Care net product revenue increased by $33.5 million, or 31%, to $141.5 million in Q3 2025, while it decreased by $21.0 million, or 6%, to $314.1 million for the nine months ended September 30, 2025[138] - Surgical & Sports Medicine net product revenue increased by $1.8 million, or 25%, to $9.0 million in Q3 2025, and by $3.6 million, or 17%, to $23.9 million for the nine months ended September 30, 2025[139] - Gross profit increased by $25.9 million, or 29%, to $114.2 million in Q3 2025, but decreased by $20.3 million, or 8%, to $250.4 million for the nine months ended September 30, 2025[141] - Adjusted EBITDA for Q3 2025 was $30.1 million, compared to $13.4 million in Q3 2024, reflecting a significant improvement in operational performance[134] - The company recorded a net income of $21.6 million for Q3 2025, compared to a net income of $12.3 million for the same period in 2024[131] - The total revenue for the nine months ended September 30, 2025, was $338.6 million, compared to $355.4 million for the same period in 2024, indicating a slight decline[131] Expenses and Investments - Selling, general and administrative expenses are expected to increase due to investments in market development and geographic expansion[123] - Research and development expenses include costs for clinical trials and enhancements to existing products, which are expensed as incurred[124] - Research and development expenses increased by $2.9 million, or 28%, to $13.2 million in Q3 2025 from $10.3 million in Q3 2024[143] - Selling, general and administrative expenses rose by $7.9 million, or 11%, to $79.7 million in Q3 2025 from $71.8 million in Q3 2024, primarily due to increased commissions and headcount-related expenses[144] - For the nine months ended September 30, 2025, selling, general and administrative expenses increased by $5.4 million, or 2%, to $226.1 million from $220.7 million in the same period of 2024[145] Cash Flow and Working Capital - As of September 30, 2025, the company had working capital of $205.1 million, including $63.7 million in cash and cash equivalents[150] - Net cash used in operating activities was $49.7 million for the nine months ended September 30, 2025, compared to net cash provided of $3.3 million in the same period of 2024[153] - During the nine months ended September 30, 2025, net cash used in investing activities was $9.5 million, up from $6.7 million in the same period of 2024[156] Tax and Compliance - Income tax benefit decreased by $6.1 million, or 94%, to $0.4 million in Q3 2025 from $6.5 million in Q3 2024, mainly due to changes in estimated effective tax rates[148] - Income tax benefit increased by $3.5 million, or 57%, to $9.8 million for the nine months ended September 30, 2025, compared to $6.2 million in the same period of 2024[149] - As of September 30, 2025, the company did not require a valuation allowance for its net U.S. deferred tax assets[128] - As of September 30, 2025, the company was in compliance with the covenants under the 2021 Credit Agreement, with no outstanding borrowings under the Term Loan Facility or the Revolving Facility[163] Market Risks and Accounting Standards - Medicare's proposed local coverage determinations could classify over 200 products as "non-covered," potentially impacting revenue from products like PuraPly and Novachor[111] - For calendar year 2026, CMS will pay approximately $127.28 per square centimeter for certain skin substitute products, which may affect product utilization and revenue[112] - There were no material changes to market risk disclosures for the nine months ended September 30, 2025[167] - Recently issued accounting standards were reviewed as disclosed in the financial statements[166] - No off-balance sheet arrangements were reported during the periods presented[165]

Revenue Performance - Net product revenue for Q3 2025 was $150.5 million, an increase of $35.3 million or 31% compared to Q3 2024 revenue of $115.2 million[4] - Advanced Wound Care products generated $141.5 million in revenue, a 31% increase from $107.9 million in Q3 2024[4] - Surgical & Sports Medicine products revenue reached $9.0 million, reflecting a 25% increase from $7.2 million in Q3 2024[4] - Total revenue for the three months ended September 30, 2025, was $150,864, a 30.9% increase from $115,177 in the same period of 2024[25] - Net product revenue for the nine months ended September 30, 2025, was $337,959, compared to $355,387 for the same period in 2024, reflecting a decrease of 4.9%[25] Income and Earnings - Net income for Q3 2025 was $21.6 million, up from $12.3 million in Q3 2024, representing an increase of $9.2 million[9] - The company reported a net income of $21,567 for the three months ended September 30, 2025, compared to $12,331 for the same period in 2024, marking a 75.1% increase[25] - The company reported a basic net income per share of $0.11 for the three months ended September 30, 2025, compared to $0.09 for the same period in 2024[25] - Adjusted net income for Q3 2025 was $23,231,000, compared to $12,940,000 in Q3 2024, representing an increase of 80%[32] - Projected net income for 2025 is expected to be between $8,600,000 and $25,400,000[39] EBITDA and Financial Metrics - Adjusted EBITDA for Q3 2025 was $30.1 million, an increase of $16.7 million compared to $13.4 million in Q3 2024[10] - Adjusted EBITDA for Q3 2025 was $30,119,000, compared to $13,410,000 in Q3 2024, reflecting a significant increase[29] - Projected Adjusted EBITDA for the year ending December 31, 2025, ranges from $45,500,000 to $68,300,000[37] - Non-GAAP operating income for Q3 2025 was $23,007,000, compared to $7,076,000 in Q3 2024, showing a substantial improvement[34] Guidance and Projections - The company expects net product revenue for FY 2025 to be between $500.0 million and $525.0 million, a year-over-year increase of 4% to 9%[21] - Advanced Wound Care revenue guidance for FY 2025 is projected between $470.0 million and $490.0 million, an increase of 4% to 8% year-over-year[21] - Surgical & Sports Medicine revenue guidance for FY 2025 is estimated between $30.0 million and $35.0 million, reflecting a year-over-year increase of 6% to 23%[21] Expenses and Cash Flow - Operating expenses for Q3 2025 were $130.1 million, an increase of $21.2 million or 19% compared to Q3 2024[7] - Operating expenses for the three months ended September 30, 2025, totaled $130,137, up from $108,935 in the same period of 2024, representing an increase of 19.5%[25] - The company experienced a net cash used in operating activities of $49,729 for the nine months ended September 30, 2025, compared to a net cash provided of $3,271 for the same period in 2024[27] - Cash and cash equivalents decreased to $63,745 as of September 30, 2025, from $135,571 as of December 31, 2024, a decline of 53%[23] - As of September 30, 2025, the company had $64.4 million in cash and cash equivalents, down from $136.2 million at the end of 2024[19] Assets and Liabilities - Total assets increased to $509,827 as of September 30, 2025, compared to $497,886 as of December 31, 2024, an increase of 2.3%[23] - Total liabilities rose to $123,848 as of September 30, 2025, from $112,570 as of December 31, 2024, an increase of 10%[23] Restructuring and Fair Value - The company incurred a restructuring charge of $516,000 in Q3 2025, consistent with ongoing restructuring activities[30] - The fair value write-down for an asset held for sale was $922,000 in Q3 2025[32] Market and Competition - The company anticipates significant competition and rapid technological changes that may impact future performance[41] - The company is focused on expanding its product offerings in advanced wound care and surgical & sports medicine markets[42]

Core Insights - Organogenesis Holdings Inc. reported record revenue performance in Q3 2025, driven by strong execution and customer relationships, positioning the company well for future growth opportunities [3][4]. Financial Performance - Net product revenue for Q3 2025 was $150.5 million, a 31% increase from $115.2 million in Q3 2024, with Advanced Wound Care products contributing $141.5 million (up 31%) and Surgical & Sports Medicine products contributing $9.0 million (up 25%) [4][7]. - Gross profit for Q3 2025 was $114.2 million, representing 76% of net product revenue, compared to $88.4 million (77%) in Q3 2024, marking a 29% increase [5]. - Operating expenses for Q3 2025 were $130.1 million, up 19% from $108.9 million in Q3 2024, with significant increases in cost of goods sold and selling, general, and administrative expenses [6]. - Net income for Q3 2025 was $21.6 million ($0.11 per share), compared to $12.3 million ($0.09 per share) in Q3 2024, reflecting a $9.2 million increase [9]. - Adjusted EBITDA for Q3 2025 was $30.1 million, up from $13.4 million in Q3 2024, indicating strong operational performance [10]. Year-to-Date Results - For the nine months ended September 30, 2025, net product revenue was $338.0 million, down 5% from $355.4 million in the same period of 2024, primarily due to a 6% decrease in Advanced Wound Care products [11]. - Gross profit for the nine months was $250.4 million (74% of net product revenue), down from $270.7 million (76%) in the prior year [12]. - Operating expenses for the nine months decreased by 3% to $357.2 million compared to $366.9 million in 2024 [13]. - The company recorded a net loss of $6.7 million for the nine months, slightly improved from a loss of $6.8 million in the same period of 2024 [15]. Guidance and Future Outlook - The company updated its revenue guidance for the fiscal year 2025, expecting net product revenue between $500.0 million and $525.0 million, representing a year-over-year increase of 4% to 9% [20]. - The guidance includes expectations for Advanced Wound Care products to generate between $470.0 million and $490.0 million, and Surgical & Sports Medicine products to generate between $30.0 million and $35.0 million [20].

Core Insights - Organogenesis Holdings Inc. commends the Centers for Medicare & Medicaid Services (CMS) for its payment reform for skin substitutes and cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule [1][2] Group 1: Payment Reform - The new payment methodology includes FDA classifications and a per centimeter square payment approach for both physician offices and hospital outpatient settings [2] - This reform is expected to enhance access to PMA products and address issues of abuse in the current payment system [2] Group 2: Company Positioning - Organogenesis believes it is well-positioned in the skin substitutes market for 2026 and beyond, leveraging over forty years of leadership in regenerative medicine [2] - The company has a diverse, evidence-based portfolio with technologies across all FDA categories, which supports its competitive stance in the market [2]

Core Insights - Organogenesis Holdings Inc. has granted inducement awards to its newly hired Chief Technology Officer, Michael Catarina, consisting of non-statutory stock options and restricted stock units [1][2][3] Summary by Sections Inducement Awards - The inducement awards include non-statutory stock options to purchase 82,542 shares and restricted stock units for 47,962 shares of Class A common stock [1] - The stock options have an exercise price of $4.17 per share, which is the closing price on October 29, 2025 [2] - Both the stock options and restricted stock units will vest annually in substantially equal installments over four years, contingent on Mr. Catarina's continued employment [2] Compliance and Regulations - The awards were granted as an inducement material to Mr. Catarina's acceptance of employment, in accordance with Nasdaq Listing Rule 5635(c)(4) [3] Company Overview - Organogenesis Holdings Inc. specializes in regenerative medicine, focusing on advanced wound care and surgical & sports medicine markets [4] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [4]