CANTON, Mass., Nov. 15, 2024 (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, commends today’s decision by the U.S. Centers for Medicare & Medicaid Services (CMS) on local coverage determination (LCD) based on peer-reviewed and evidence-based data of clinical efficacy. The LCD covers skin substitute g ...

Financial Data and Key Metrics Changes - Net revenue for Q3 2024 was $115.2 million, up 6% year-over-year, exceeding previous guidance [25] - Gross profit for Q3 was $88 million, representing 76.7% of net revenue, compared to 76.2% last year [26] - Operating income decreased to $6.2 million from $8.1 million year-over-year, a decline of 22% [27] - Adjusted net income increased to $12.9 million from $5.3 million year-over-year, primarily due to a change in income tax [28] - Adjusted EBITDA for Q3 was $13.4 million, or 12% of net revenue, down from 14.7% last year [29] Business Line Data and Key Metrics Changes - Advanced wound care net revenue was $108 million, up 7% year-over-year [26] - Net revenue from surgical and sports medicine products was $7 million, up 1% [26] Market Data and Key Metrics Changes - The company expects net revenue for 2024 to be between $455 million and $480 million, representing a year-over-year increase of 5% to 11% [32] - Advanced wound care products are expected to generate revenue between $429 million and $452 million, a year-over-year increase of 6% to 11% [33] Company Strategy and Development Direction - The company is focused on leveraging clinical data to secure coverage for additional products and is actively engaging with CMS for payment reform [22][37] - The RENEW program is on track for a BLA submission by the end of Q4 2025, which could transform pain management for knee osteoarthritis [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the challenging operating environment and highlighted strong execution from the commercial team [7][35] - The company anticipates potential near-term disruptions in Q4 due to LCDs but remains optimistic about long-term growth opportunities [32][49] Other Important Information - The company completed a private placement of Series A convertible preferred stock, raising $100 million to fund strategic growth initiatives [30][31] - CMS has not proposed changes to payment policies for skin substitutes for 2025, but the company is advocating for a value-based payment methodology [16][19] Q&A Session Summary Question: Update on broadening the salesforce and focus on sports medicine - The company increased its rep count in the quarter, with good performance noted, particularly in wound care [42] Question: Insights on operating expenses and R&D spending - R&D expenses were lower than expected, with a return to Q2 spending levels anticipated in Q4 [43][44] Question: Guidance for Q4 and impacts from LCDs - The company expects limited impact in Q3 but maintains a wide range for Q4 guidance due to potential customer spending pullback [46][49] Question: Timeline for RENEW program and interim analysis - The last patient visit was completed in June, with an interim analysis expected by Q4, keeping the BLA submission on track for Q4 2025 [50][51]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of I ...

ORGANOGENESIS Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports Third Quarter 2024 Financial Results CANTON, Mass., (November 12, 2024) -- 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, 2024. Third Quarter 2024 Financial Result ...

CANTON, Mass., Nov. 12, 2024 (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 announced that it has entered into a Subscription Agreement with affiliates of Avista Healthcare Partners (“Investors”) for the sale of its Series A Convertible Preferred Stock (“Preferred Stock”) in a private placement f ...

CANTON, Mass., Nov. 11, 2024 (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 favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee os ...

CANTON, Mass., Oct. 16, 2024 (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 that third quarter of fiscal year 2024 financial results will be reported after the market closes on Tuesday, November 12th. Management will host a conference call at 5:00 p.m. Eastern Time on November 12th to ...

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Robust 218-patient RCT demonstrates statistically superior frequency of wound closure at 12 weeks compared to standard of care (p=.04) Organogenesis believes published study satisfies requirements for Medicare coverage under proposed Local Coverage Determination (LCDs) CANTON, Mass., Oct. 01, 2024 (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 Ca ...

CANTON, Mass., Sept. 04, 2024 (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 announced that management will participate in the following upcoming investor conferences: The Morgan Stanley Global Healthcare Conference at the New York Marriott Marquis in New York, NY Management will participate in i ...