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]

Core Viewpoint - Organogenesis Holdings Inc. is currently under investigation for potential securities fraud violations, which raises concerns regarding the company's compliance and governance practices [1] Group 1 - The investigation is being conducted by the DJS Law Group, indicating a formal inquiry into the company's financial practices [1] - Stakeholders are encouraged to discuss their rights in light of the ongoing investigation, suggesting potential implications for investors and shareholders [1]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Organogenesis Holdings Inc. following the failure of a key clinical trial for its product ReNu, which has led to a significant drop in the company's stock price [1][2]. Group 1: Company Performance - On September 25, 2025, Organogenesis announced that its second phase 3 trial for the cryopreserved amniotic suspension allograft ReNu did not meet its primary endpoint, failing to show a significant change in pain reduction [1]. - Following this announcement, Organogenesis's stock price decreased by $0.58 per share, or 12.39%, closing at $4.10 per share on September 26, 2025 [2]. Group 2: Legal Investigation - Pomerantz LLP is representing investors in investigating claims against Organogenesis and its officers/directors regarding possible securities fraud or other illegal business practices [1]. - The firm has a long history in corporate and securities class litigation, having recovered substantial damages for victims of securities fraud and corporate misconduct [3].

Core Viewpoint - Organogenesis Holdings Inc. will report its third quarter fiscal year 2025 financial results on November 6, 2025, after market close [1] Group 1: Financial Reporting - The financial results for the third quarter will be announced after the market closes on November 6, 2025 [1] - A conference call will be held at 5:00 p.m. Eastern Time on the same day to discuss the results and provide a corporate update [2] Group 2: Company Overview - Organogenesis Holdings Inc. specializes in regenerative medicine, focusing on advanced wound care and surgical and sports medicine markets [3] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3]

Company Overview - Organogenesis Holdings Inc. (NASDAQ: ORGO) is a healthcare company focused on developing regenerative therapies for advanced wound care (AWC), surgery, and sports medicine [1] - The AWC segment represents over 90% of the company's revenue [1] Financial Performance - The AWC segment has experienced a contraction of approximately 25% year-over-year [1]

Core Insights - Organogenesis Holdings Inc. announced topline data from the second Phase 3 randomized controlled trial of ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis management [1][6] Study Results - The trial did not achieve statistical significance for its primary endpoint, although ReNu showed a numerical improvement in baseline pain reduction compared to the first Phase 3 trial [3][5] - Baseline pain reduction at six months for ReNu was -6.9 in the second Phase 3 study, compared to -6.0 in the first Phase 3 study [3] - The primary endpoint assessed the difference in knee pain reduction between ReNu and saline groups using the WOMAC pain scale [4] Statistical Analysis - The study demonstrated a numerical improvement of -0.51 favoring ReNu with a one-sided p-value of 0.0393, compared to the target threshold of 0.023 [5] - The first Phase 3 trial achieved a statistically significant improvement of -0.72 with a p-value of 0.0177 [5] Future Steps - The company plans to request a pre-BLA meeting with the FDA to discuss the submission pathway, including a combined efficacy analysis from both Phase 3 studies to support a BLA approval [6] Market Reaction - Following the announcement, Organogenesis Holdings shares fell by 15.49% to $3.95, trading within a 52-week range of $2.61 to $6.71 [7]

Core Insights - The second Phase 3 trial of ReNu did not achieve statistical significance for its primary endpoint, but showed a numerical improvement in pain reduction compared to the first Phase 3 trial [1][2][3] - The company plans to request a pre-BLA meeting with the FDA to discuss the submission pathway for ReNu, leveraging data from both Phase 3 trials [3][6] - ReNu has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating its potential to address an unmet medical need in knee osteoarthritis [3][7] Study Results - The second Phase 3 trial involved 594 patients and demonstrated a baseline pain reduction of -6.9 for ReNu compared to -6.0 in the first Phase 3 trial [1][10] - The primary endpoint assessed the difference in knee pain reduction at six months using the WOMAC pain scale, with a numerical improvement of -0.5 favoring ReNu in the second trial [2][10] - The first Phase 3 trial achieved a statistically significant improvement of -0.7 favoring ReNu [2] Market Context - Knee osteoarthritis affects over 30 million Americans and is a leading cause of disability and poor quality of life [4] - The company believes that if approved, ReNu will meet a significant unmet medical need for patients suffering from symptomatic knee osteoarthritis [4][6]

Summary of Organogenesis Holdings Conference Call Company Overview - **Company**: Organogenesis Holdings (ORGO) - **Industry**: Biotechnology, specifically in wound care and surgical products - **Background**: Established in 1985 as a spin-off from MIT, with a focus on innovative wound care solutions. The company has evolved from a single product to a comprehensive portfolio addressing various wound care needs [1][2] Key Points Discussed Industry Changes and Regulatory Environment - **Physician Fee Schedule (PFS)**: A significant change in the reimbursement model is anticipated, which is viewed as a watershed moment for the industry. The proposed rule aims to standardize reimbursement across various care settings, enhancing patient access to products [4][5] - **Market Expansion**: The market volume has doubled from 2021 to 2024, indicating growth despite a tenfold increase in costs. This shift is expected to stabilize the market and reduce financial incentives based on product choice, focusing instead on clinical efficacy [6][7][8] Product Portfolio and Growth Areas - **Current Products**: The company highlighted the importance of PMA products, including the relaunch of Dermograph and the burn portfolio featuring Transite. These products are expected to gain value with the new reimbursement model [9][10] - **New Product Launches**: Two new dehydrated products were launched, which are gaining traction and are expected to contribute to stronger performance in the second half of the year [14][15] - **Surgical and Sports Medicine Growth**: The surgical segment grew by 16% in Q2 and 13% for the half-year, driven by the PuraPly brand and the introduction of Cygnus Matrix [16][17] Future Outlook and Strategic Initiatives - **Renew Product Update**: The second phase three trial has been completed, with top-line data expected soon. If successful, a BLA application will be filed by the end of the year, with commercialization anticipated in 2027 [20][21] - **Sales Strategy**: The company plans to build a direct sales force of 150 to 200 reps for the new product, focusing on the pain management market, particularly targeting the hyaluronic acid segment [22][23] Financial Health - **Balance Sheet**: The company reported a strong balance sheet with approximately $70 million in cash, positioning it well for future growth and profitability [25] Market Positioning - **Competitive Landscape**: The company aims to differentiate itself by offering a broad portfolio that addresses all stages of wound healing, utilizing both dehydrated and living technologies [26][27] Research and Development - **RCT Progress**: Ongoing research is expected to yield a publication by November 1, with plans to have PuraPly available on the LCD by January 1 [29] Additional Insights - **Hybrid Sales Model**: The introduction of hybrid representatives who can operate in both operating rooms and advanced wound care centers is seen as a valuable strategy to enhance customer relationships and sales [19] This summary encapsulates the key discussions and insights from the Organogenesis Holdings conference call, highlighting the company's strategic direction, product innovations, and market dynamics.

Financial Data and Key Metrics Changes - Net product revenue for Q2 was $100.8 million, down 23% year over year, within the guidance range of $100 million to $110 million [16] - Advanced Wound Care net product revenue was $92.7 million, down 25%, while Surgical and Sports Medicine products revenue increased by 16% to $8.1 million [16][20] - Gross profit for Q2 was $73.1 million, representing 73% of net product revenue, down from 78% the previous year [17] - Operating expenses decreased to $113.6 million from $144.1 million, a reduction of 21% year over year [17] - GAAP net loss for Q2 was $9.4 million, compared to a net loss of $17 million last year, showing improvement [18] Business Line Data and Key Metrics Changes - Advanced Wound Care products saw a revenue decline of 25%, attributed to customer demand disruptions and competitive pricing strategies [5][16] - Surgical and Sports Medicine products experienced a revenue increase of 16%, indicating strong performance in this segment [16] Market Data and Key Metrics Changes - The proposed Medicare payment reform for skin substitutes is expected to significantly impact the market, with a proposed rate of approximately $125 per square centimeter [30] - The current market for Aplograft is only 3% of units sold, indicating substantial growth potential with the new payment structure [31] Company Strategy and Development Direction - The company is focused on gathering clinical and real-world evidence to enhance its product portfolio and market penetration [10] - Expansion of biomanufacturing capabilities is underway, with a new facility in Smithfield, Rhode Island, aimed at supporting product reintroduction and new launches [11] - The RENEW program is on track for submission by the end of the year, targeting a significant market of over 30 million Americans suffering from knee osteoarthritis [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the proposed CMS payment reforms, viewing them as a transformational opportunity for the company and the industry [30] - The company anticipates aggressive pricing strategies from competitors in the latter half of 2025 but remains confident in its product momentum [33] - The guidance for 2025 has been updated, expecting net revenue between $480 million and $510 million, reflecting a year-over-year change of flat to a 6% increase [19][20] Other Important Information - The company has no outstanding debt obligations and reported cash and equivalents of $73.7 million as of June 30, 2025, down from $136.2 million at the end of 2024 [19] - Adjusted EBITDA loss for Q2 was $3.6 million, compared to adjusted EBITDA income of $15.6 million last year, indicating a significant shift in profitability [18] Q&A Session Summary Question: How does the CMS proposal for 2026 impact the company? - Management views the CMS proposal as a transformational event, providing a significant opportunity for their products and leveling the playing field in reimbursement [30][31] Question: Has the guidance reduction accounted for aggressive market behavior? - Management believes the guidance reduction reflects the current market conditions and anticipates strong performance from recently launched products in the second half of the year [34][35] Question: What is the timing for the reintroduction of Dermagraft? - Management indicated that Dermagraft is expected to be launched by 2027 [37] Question: How does RENEW position itself in the knee OA treatment landscape? - Management highlighted the strength of RENEW's data, indicating it will compete well against existing injectable options [41] Question: What drove the strength in the Surgical and Sports Medicine segment? - The segment's growth was attributed to strong performance and the implementation of hybrid sales strategies, with a 16% increase in Q2 [42]