Organogenesis Holdings Inc.

Please stand by. Welcome, ladies and gentlemen, to the fourth quarter and full year 2025 earnings conference call for OrganiGenesis Holding Inc. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risk and uncertainties that it could cause actual results to differ materially from those indicated, including the risk and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly report. 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, further events, or otherwise, except as required by applicable security laws. This call will also include references to certain financial measures that are not calculated in accordance with the generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliation of these non-GAAP financial measures to the most comparable measures calculated in accordance with GAAP are available in the company's earnings release on the investor relations portion of our website. I would now like to turn the call over to Mr. Gary S. Goheni, Sr.,

organogenesis holdings president chief executive officer and chair of the board please go ahead thank you operator and welcome everyone to organogenesis holdings fourth quarter 2025 earnings conference call i'm joined on the call today by dave francisco our chief financial officer Let me start with a brief agenda of what we're going to cover during our prepared remarks. I will begin with an overview of our fourth quarter revenue results and provide an update on key developments in recent months. Dave will then provide you with an in-depth review of our fourth quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial outlook for 2026, which we introduced in our press release this afternoon. And I'll provide some closing comments before we open up the call for questions. Let's begin with the review of our revenue results in Q4. We delivered record sales results, which exceeded the high end of the guidance range outlined on our third quarter conference call, driven primarily by better than expected growth in sales of our advanced wound care products, which increased 83% year over year. Sales of our surgical and sports medicine products declined 2% year over year, which was within the range of our guidance assumptions. The record revenue performance we delivered in the fourth quarter reflects our team's strong execution and commitment to our strategy to build upon our deep customer relationships and promoting access to existing and recently launched products. I want to acknowledge and thank our team for continuing to show up every day for our patients amidst a very challenging environment in 2025. 2025 was a significant year for the industry, with CMS enacting the most meaningful health policy changes in decades. We continue to believe these changes are favorable to our portfolio and to our mission. CMS shifted reimbursement to support high-quality, evidence-backed PMA products while reducing payment for non-PMA products that have not undergone the most rigorous type of review so that more patients have access to products that go beyond simple wound coverings. CMS has cited the clinical differentiation of PMA products and supports higher payment for the category to encourage innovation in the space. Their comments indicate that PMA products were never part of the problem and understand the higher development and manufacturing costs require sufficient reimbursement. not only to sustain the market availability of Applegraph and other high-value PMA products, but also to introduce new PMA products in the future. As discussed on our earnings calls last year, Organogenesis has actively participated bringing about these changes, and we remain committed to working with CMS and other stakeholders to further expand access to lifesaving technologies, as well as incentivize investment in innovation in the space and achieve long-term stability in the market. Unfortunately, withdrawal of LCD coverage policies for skin substitutes announced on December 24th in comments regarding discarded product on December 30th have resulted in clinical confusion and material disruption in the market. We do not believe these actions by CMS signal any step back from the original goals outlined to reform coverage and payment of skin substitutes. We believe the comments on December 30th regarding discarded product were intended to proactively address activity from certain competitors in the market that were attempting to exploit the new payment policies by focusing on larger size skin substitute products, specifically amniotic products. Unfortunately, these comments have resulted in significant clinical confusion impacting utilization of our PMA approved product in the first two months of 2026. We do not believe the agency's commentary on discarded products should apply to PMA products. CMS's commentary and actions in recent years have indicated that PMA products were never part of the fraud and abuse. Further, CMS expressly stated in the final Medicare physician fee schedule for calendar year 2026 announced on October 31st of 2025 that PMA products are clinically differentiated and deserve payment at a higher rate. We believe the significant clinician confusion, which is impacting utilization of our PMA approved product, is a result of the agency's comments on December 30th and will be resolved in a way that's consistent with the policy CMS set by grouping products based on their FDA classification. As discussed on our earnings call last year, this was a key focus of our feedback and policy recommendations to the agency. CMS has consistently indicated one of their goals in policy reform was to increase access to PMA products. While 2026 is off to a difficult start, I want to make it clear that I'm very optimistic about our future. We believe CMS's efforts to overhaul coverage and payment for our market represent a watershed moment for the industry in the final Medicare Physician Fee Schedule for calendar year 2026, announced on October 31st, 2025, represents the most meaningful step forward towards payment reform in more than a decade. I believe our overall position is very strong, and it is from this strong position that we are making capital investments that will support our company's future growth and continued leadership in the space. Our new manufacturing and R&D center in Smithfield, Rhode Island, is advancing well. This state-of-the-art facility, once completed, will allow us to scale manufacturing of Applegraph and PureApply AM. We commercialized Dermagraph, strengthening our portfolio with another clinically proven PMA product and gives us the capacity to expand our product portfolio to treat burns with FortiShield and Transite, which is another PMA product. We are increasing our focus on clinical evidence by investing in trials and published studies because science and evidence have always been core to our foundation. And as coverage policies evolve, evidence will be the currency of credibility, and we intend to remain in the lead. Looking beyond wound care, we are closer than ever to expanding our mission into entirely new markets with our Renew program. Late last year, we initiated our rolling BLA submission, which we expect to complete in the first half of 2026. And if approved by the FDA, Renu represents a transformational opportunity, not just for organogenesis, but for the millions of Americans living with knee osteoarthritis pain, particularly those whose only alternative today is a total knee replacement. We can change the treatment paradigm and improve the lives of these patients as part of our vision to be a force for meaningful change and set a higher expectation in healing and recovery. With more than 40 years in regenerative medicine and a diverse evidence-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitute market and will continue to be a leader in the space with highly innovative, highly efficacious products that deliver on our mission of advancing healing and recovery beyond our customers' expectations. With that, I'll turn it over to Dave.

Thanks, Gary.