Axogen, Inc.

Ladies and gentlemen, thank you for your patience. Please remain on the line. Your conference call will begin momentarily. Again, we do appreciate your patience. Please remain on the line. Your conference call will begin momentarily. Thank you. Good day, ladies and gentlemen, and welcome to the Accident, Inc. Report's first quarter earnings call. All lines have been placed on a listen-only mode. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Ed Joyce. Sir, the floor is yours.

Thank you, Dagma, and good afternoon, everyone. Joining me on today's call is Karen Zadare, Accident's Chairman, Chief Executive Officer and President, Eric Deviney, Vice President of Peripheral Nerve Science and Clinical Innovation, and Pete Mariani, Executive Vice President and Chief Financial Officer. Karen will discuss the quarter and our outlook for the year. Eric will discuss the recon study and top-line results, and Pete will provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session. Today's call is being broadcast live via webcast, which is available on the investor section of the Axigen website. Within an hour following the end of the live call, a replay will be available in the investor sections of the company's website at www.axigeninc.com. Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation, The company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements related to the expected impact of COVID-19 and hospital staffing on our business, statements regarding our growth, our financial guidance, product development, product potential, expected clinical enrollment timing and outcomes, regulatory processes and approval, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events, global business disruptions caused by Russia's invasion of Ukraine and related sanctions, and other matters not within our control. And with that, I'd like to turn the call over to Karen. Karen?

Thank you, Ed, and good afternoon, everyone. It's a pleasure to be talking to you today. I'm pleased with our first quarter revenue of $31 million, matching last year's first quarter, and an increase of 6%, excluding the impact of revenue from a five soft tissue membrane. We're also thrilled to have announced today that our RECON study successfully achieved its primary endpoint, which is a critical milestone towards transitioning advanced nerve graft to a licensed biologic and further supports the expanded adoption of AVANCE. Before providing comments on our operational results, we'd like to discuss the RECOM Topline Data Readout. The study achieved its primary endpoint of non-inferiority as compared to conduits. The safety profile of the study was consistent with previously published data, and we remain on track to complete the work necessary to submit our BLA in the second half of 2023. I would like to remind you that this study was the culmination of many years of effort and one of the most significant undertakings in our company's history. We're extremely pleased with today's outcome, which is consistent with the results we have seen in our registry data collected over the last decade. Achieving RECON's top-line endpoint provides clinical confirmation of the performance of advanced nerve grafts. The results of this study provide level one clinical evidence, the highest quality possible, which significantly bolsters our growing arsenal of data and peer-reviewed papers, and provides robust data to support surgeon adoption of Avance as the optimal treatment option for many patients with peripheral nerve injuries. We believe the current standard of treatment using Autograft is suboptimal. and can lead to complications with a second surgical site. Use of advanced nerve graft has an established track record and continues to gain traction with surgeons as they adopt the oxygen algorithm. We still have much work to be done prior to filing the actual BLA submission, which we anticipate will occur in the second half of 2023. We're in the process of compiling the appropriate documentation on this clinical study, our facilities, operations, quality systems, and much more, all of which are required for a successful application. I'd like to now turn the call over to Eric Deviney, our VP of Peripheral Nurse Science and Clinical Innovation, who will go over the Recon trial and top-line results. Eric has been with Axigen for 15 years and has been instrumental in the design and execution of the Recon study, and we're happy to have him on the call today.