Organogenesis Holdings Inc.

Reconciliations of these non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the investor relations portion of our website. I would now like to turn the call over to Mr. Gary S. Gilheny, Sr., Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board.

Please go ahead, sir.

Thank you, Operator, and welcome everyone to Organogenesis Holdings' third 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'll cover during our prepared remarks. I'll begin with an overview of our third quarter revenue results and provide an update on key operating and strategic developments in recent months. Dave will then provide you with an in-depth review of our third quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial guidance for 2025, which we updated in our press release this afternoon. Then we'll open up the call for questions. Let me begin with a review of our revenue results for Q3. We delivered sales results which exceeded the high end of our guidance range outlined in our second quarter call. driven primarily by better than expected growth in sales of our advanced wound care products, which increased 31% year over year. Sales of our surgical and sports medicine products also performed well, increasing 25% year over year in the third quarter. The record revenue performance we delivered in the third 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 despite continued aggressive pricing strategies from our competitors. On October 31st, CMS announced the final Medicare physician fee schedule for the calendar year 2026. As mentioned in our last Boarders Earnings Call, this is a watershed moment for the industry in the most impactful development in more than a decade. And we congratulate CMS on taking this significant step in payment reform and are pleased CMS finalized skin substitute classifications based on FDA regulatory status and a per square centimeter payment methodology in both the physician office and hospital outpatient settings. We are pleased that CMS has recognized the clinical differentiation of PMA products and has taken steps toward higher payment and expanded access for PMA products. We remain committed to working with CMS and other stakeholders to further expand access to these lifesaving technologies, as well as incentivize investment and innovation in the space and achieve long-term market stability. We believe this new policy will address abuse under the current system and the resulting rapid escalation in Medicare spending, while ensuring a much-needed consistent payment approach across sites of care. 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 for 2026 and beyond 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. Before turning the call over to David, I wanted to provide some updates on key clinical and regulatory developments in recent months. Beginning with an update on our RENEW program. On September 25th, we announced that the second phase three trial of RENEW did not achieve statistical significance for its primary endpoint, despite demonstrating a numerical improvement in baseline pain reduction that exceeded the results of the first phase three trial. Baseline pain reduction at six months for Renu was negative 6.9 for the second Phase III study compared to negative 6.0 in the first Phase III study. Additionally, Renu results from the second Phase III study continued to demonstrate a favorable safety profile. Given the first Phase III trial achieved statistically significant reduction in pain compared to saline, and the second Phase III trial demonstrated a numerical improvement in baseline pain reduction that exceeded the results of the first Phase III trial. We believe these combined results support the potential approval of RENEW for pain symptoms associated with knee osteoarthritis, included in those patients classified as the most severe. RENEW has been studied in three large RCTs of more than 1,300 patients combined. Organogenesis believes the totality of this data is compelling evidence for the FDA to review in a biologic license application. Additionally, FDA granted Renu Regenerative Medicine Advanced Therapy, or RMAT, designation based on Renu demonstrating the potential to treat an unmet need in symptomatic knee osteoarthritis, a serious condition affecting more than 30 million Americans. We have a meeting scheduled for December 12th with the FDA to discuss our submission, including using the combined efficacy analysis from both Phase III studies to support a BLA approval. We believe gathering robust and comprehensive clinical and real-world evidence is an essential component of developing a competitive product portfolio and driving further penetration in the markets where we compete. While we did not meet the November 1st submission deadline for new data for LCD coverage consideration in 2026 for PurePly AM for DFU and Affinity for VLU, these studies and analyses continue, and we intend to submit for coverage once they're published. We remain confident in our strong competitive position in the skin substitute market heading into next year. We have substantial advantages, including strong brand equity, deep customer relationships, and importantly, three highly innovative, highly efficacious commercialized products on the covered list, if the LCDs take effect as scheduled on January 1st, 2026. Specifically, our Applegraph product for DFU and VLU, and our Affinity and Nuccio products for DFU. We have strongly advocated for CMS to implement an integrated coverage and payment policy for the skin substitute market. We believe they have taken the right steps to address rapidly escalating Medicare costs while ensuring patient access to the most appropriate clinically effective technologies. We believe these changes present an enormous opportunity for organogenesis to serve more patients and, importantly, will be positive for the long-term health of the wound care market. Beyond 2026, we expect to advance our competitive position as we leverage our development engine fueling new innovation, capacity to launch and reintroduce products, including our Dermagraph product, which is already covered for DFU and VLU under the LCDs. Strategic investments in expanding the body of clinical evidence supporting our technologies and a transformational opportunity with Renew. With that, I'd like to turn the call over to Dave.