Organogenesis Holdings Inc.

Welcome, ladies and gentlemen, to the fourth quarter and fiscal year 2023 earnings conference call for Organogenesis Holding, Inc. At this time, all participants are being placed in listen-only mode. Please note that this conference call is being recorded, and 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 could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filing with the Securities and Exchange Commission, including item A, excuse me, including item 1A risk factors of the company's most recent annual report and its sequential filing quarterly reports. You are cautioned not to place undue reliance upon any forward-looking statement, 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 statement, whether a result of new information, future events, or otherwise, except it's required by applicable security law. This call also includes references to certain financial measures that are not calculated in accordance with general accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliation of those 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 Escohaney, 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' fourth quarter in fiscal year 2023. 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 will begin with an overview of the fourth quarter revenue results and an update on our key operating and strategic 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 year end, as well as our financial guidance for 2024, which we introduced in our press release this afternoon. Then I will share some closing thoughts before we open the call for your questions. Our sales results came in at the low end of our guidance range outlined on our third quarter conference call and reflect the expected challenging operating environment as a result of the local coverage determinations having been announced and subsequently withdrawn last fall. More specifically, our fourth quarter guidance range is assumed continued significant business disruption driven by customer confusion and uncertainty. As outlined on our last quarter's earnings call, we expected our sales reps to be spending more time servicing existing customers and regaining lost customers versus cultivating new customer adoption, thus impacting our year-over-year growth trends in the quarter. Additionally, the higher end of our guidance range assumed improvement in the operating environment as we moved through Q4, which ultimately did not materialize. Despite the challenging quarter, we're pleased to see the positive momentum in the business trends we experienced towards the end of December continue into early 2024, and our commercial team continues to see progress in their broad-based efforts to re-engage with our customers to bring our products back to the healing algorithms and formularies. We're encouraged by the evidence that the commercial support programs we implemented to enhance existing customer relationships and to regain lost accounts are proving effective. Importantly, we've dedicated a majority of our time and share of voice during the fourth quarter towards clarifying the misinformation in the market. We have refocused our commercial resources to drive growth in our customer base by emphasizing our differentiated products and their clinical values. Turning to an update on our operational progress in recent months, our ongoing phase three clinical trials evaluating the use of Renu for the management of symptoms associated with knee osteoarthritis continue to progress as planned. As a reminder, Renu is a unique cryopreserved amniotic suspension allograft, or ASA, containing viable cells, extracellular matrix, and importantly, is rich in anti-inflammatory and regenerative growth factors. We achieved the last patient last visit milestone in January for the first phase three clinical trial to evaluate the efficacy of Renu for the treatment of symptomatic knee osteoarthritis and preparations for the database lock and analysis are currently underway. We are currently targeting the completion of top line data analysis by the end of April, which we intend to share publicly via press release. In 2021, Renu received the FDA's Regenerative Medicine Advanced Therapy, or RMAT, designation for osteoarthritis of the knee, which underscores the strength of our existing clinical evidence and its potential to address a largely unmet medical need. And as previously discussed, we expect to have a subsequent discussion with the FDA regarding the clinical data requirements for the BLA, and we intend to propose the first Phase III clinical trial combined with a published 200-patient RCT as valid scientific evidence and sufficient for BLA approval. We are also pleased with the progress we're seeing in our second Phase III clinical trial for Renu. We now have 40 clinical sites up and running and have enrolled more than 200 patients to date. While it's difficult to predict the pace of enrollment with precision, our current timeline has us achieving full enrollment in the first quarter of 2025 ahead of our original expectations when we started enrollment in the second Phase III clinical trial last September. Additionally, consistent with our first Phase III clinical trial, we're on track to enroll between 25 and 30 percent of the most severe knee OA patient population, also known as KL4s. While there is no known treatment that completely cures knee OA, it is possible to treat the disease symptoms with the goal of avoiding or delaying costly invasive knee replacement surgery. If successful, Renu would be the only FDA-approved biologic intra-articular injection to improve the symptoms of the most severe cases of OA.

With that, let me turn it over to Dave. Dave?