5/8/2025

speaker
Operator
Conference Call Operator

Good day, and thank you for standing by. Welcome to the medical first quarter 2025 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker for today, Jessica Eckberg. Please go ahead.

speaker
Jessica Eckberg
Investor Relations Representative

Thank you, operator. Welcome to Aveda Medical's first quarter 2025 earnings call. Joining me on today's call are Jim Corbett, Chief Executive Officer, and David O'Toole, Chief Financial Officer. Today's earnings release and presentation are available on our website, www.avedamedical.com, under the investor relations section. Before we begin, I'd like to remind you that this call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward-looking statements. Please review our most recent filings with the SEC for comprehensive descriptions of the risk factors. Any forward-looking statements provided during this call are based on management's expectations as of today. I will now turn the call over to Jim for his comments.

speaker
Jim Corbett
Chief Executive Officer

Thank you, Jessica. Good afternoon to those joining us here in the U.S., and good morning to our colleagues and investors in Australia. We entered 2025 stronger, sharper, and more strategically prepared than ever before. There's more to do, but the foundation we've built gives us the opportunity to accelerate and deliver against the full potential of our expanded platform. Let's turn to slide three. We are no longer a single product, burn-only company. Today, we are a fully integrated, multi-product platform positioned to lead in therapeutic acute wound care. With this transformation, our U.S. addressable market has expanded from roughly $500 million to more than $3.5 billion annually. That's a seven-fold increase that materially reshapes our long-term growth trajectory. Revenue for the first quarter increased 67% over the first quarter of the prior year. It's a strong indicator of the traction we're gaining. We see the quarter as a launch readiness phase, gearing up to fully reignite our growth in Q2 and beyond. powered by a portfolio that is now fully ready to scale. Let me walk you through how our expanded portfolio has come together and how we're positioning the organization to capitalize on it effectively. In February, we launched Resell Go Mini, a targeted innovation designed specifically for trauma centers treating smaller wounds. Let me step back for a moment and explain why we created it. Our original resale system was developed to treat large burns covering up to 10% total body surface area or about 1920 square centimeters. However, data from our pivotal trial to support our pre-market approval of full thickness skin defects for trauma and early market observations made it clear most traumatic wounds are significantly smaller. Typically, well under 480 square centimeters or less than 2.5% total body surface area that is treated by ResubGo Mini. In fact, during our PMA trial for non-thermal skin defects, the wound area treated was less than 2.5% total body surface area. What that told us is that outside of burn centers, in trauma and surgical settings, Wounds requiring grafting are predominantly smaller, yet our standard resell kit was optimized for much larger wounds. Enter ResellGo Mini. Same ResellGo multi-use processing device, same procedural consistency, same clinical benefits, but with a disposable cartridge optimized for trauma cases covering wounds up to 480 square centimeters. It is a purpose-built solution informed directly by real-world clinical needs and designed for optimal integration into trauma workflows. ResellGo Mini unlocks the trauma market of approximately 270,000 cases annually in the United States. The early feedback has been encouraging, and we're already seeing adoption. We also launched CoHelix, our collagen-based dermal matrix nationwide on April 1st, 2025 in all sizes following a successful limited release during Q1. For those new to the story, last quarter we shared a standout case that took place at the Ohio State University Wexner Medical Center. In that case, a 67-year-old woman with a third degree burn was treated under physician direction using Cohelix as part of the treatment protocol. By day seven, her wound had progressed to a point the physician deemed ready for grafting. She was discharged within 10 days. According to one of her clinicians, had she been treated with an alternative dermal matrix, her hospital stay would likely have extended to a month. Her treating physician also noted that Cohelix not only reduced the time the patient spent in the hospital, but he believes it could allow physicians to treat more patients due to how easy it was to use in the operating room. In fact, the surgical team described CoHelix as a welcome addition to their toolkit and emphasized its compatibility with their existing protocols. These initial experiences reflect the kind of clinical feedback we're hearing as adoption expands. the type of outcome other centers are looking for as they evaluate integration into their protocols. CoHelix is now available in multiple sheet sizes, including a large format 700 square centimeter sheet. Importantly, three large format sheets cover the treatment area of a typical resell burn case of 1920 square centimeters, enabling full coverage of the wound. To facilitate adoption and stocking, we are deploying CoHelix through an RFID-enabled consignment model that streamlines hospital inventory management and ensures traceability to address important financial and regulatory considerations. In parallel, we have fully implemented the manufacturing of Permuter, our biosynthetic dressing, under our roof at our state-of-the-art facility in Ventura, California. Alongside this, we have amended our distribution agreement with Statical Scientific. This strategic move delivers cost efficiencies, scale, and a larger revenue share of the average selling price. 60% of the revenue goes to Aveda, up from 50%. With these additions, our commercial lineup now includes Resell Ease of Use, Resell Go, Resell Go Mini, CoHelix, and PermiDerm. This is the first time we've had such a broad spectrum of products available to support both burn and trauma centers. One broad integrated portfolio targeted at the same hospital, same doctor, the same patient, and the same wound. This matters because hospitals are looking for integrated, scalable wound care solutions that solve more and more of their wound care needs. Aveda Medical provides that now. Slide four shows what that means in terms of potential revenue per case. As hospitals adopt across our portfolio, we expect the realized average selling price per case to rise meaningfully. Now, to support our portfolio transformation, we needed to evolve our commercial model to match. This required a significant shift in our commercial approach. Historically, Our reps provided heavy service-oriented case-based procedural support, meaning our clinical special staff or sales reps would be physically present for many resale cases. That model served us well during the initial introduction of this first-in-category product when we were a burn-only single-product company. With the launch of multiple products and a more complex call point, we need to evolve our sales model. Robin Vandenberg, who joined us last August, led a full evaluation of our commercial organization. Under her leadership, we've redesigned the model, shifting from a service-oriented case-based support structure to a more focused selling-oriented approach. Our reps still cover cases, but within a standard two-stage workflow for a full thickness case, typically around 10% total body surface area, They're now actively selling at multiple points throughout the two procedures. In stage one, they're introducing and selling the dermal matrix. Then in stage two, they're selling resell with split-thickness skin graft and closing the graft with PermiDerm. Here's an overview of the changes we've made. We consolidated from 12 regions to nine regions. We reduced our total field headcount from 108 to 82. We have transitioned most clinical specialists into commercial roles, preserving critical product knowledge while expanding our commercial reach. We didn't lose expertise. We redeployed our expertise. Now our sales reps are spending more time on conversations that drive adoption across the entire portfolio while still covering cases. We've realigned incentives accordingly. We will continue to have a small single digit number of clinical specialists generally assigned to our largest customers. As part of this evolution, we evaluated every program in the company, created meaningful efficiencies. Overall, we expect to save $2.5 million per quarter in operating expenses and improve operating margin, all while increasing our selling capacity. Of that, Approximately $1.3 million comes from the commercial transformation with the remainder from G&A and R&D savings. We also strengthened leadership in the process. Laura Ackerman has stepped into one of our two area vice presidents of sales roles, reporting directly to Robin. It's the right team at the right time to meet the moment. Meanwhile, we're seeing reimbursement support continue to build. Earlier this month, CMS proposed a new technology add-on payment known as NTEP for resale. If approved, the policy could take effect on October 1st. We're optimistic and we're actively engaged in the public comment process. As for vitiligo, our clinical studies were accepted for publication in March, and the results met our expectations. That said, the reimbursement landscape remains highly uncertain. As a consequence, we are stepping back from further commercial investment in the vitiligo indication at this time. Our focus remains squarely on acute wound care, where we see the greatest and clearest opportunity. Let me end by looking ahead. We've come a long way. Two years ago, we were focused solely on burns addressing a $500 million market opportunity. Today, with a broad acute wound care portfolio, Our addressable market is in excess of 3.5 billion in the U.S. alone, backed by a scalable commercial model, integrated operations, and expanding reimbursement support. Our future is bright. On May 13th, we'll bring this story to life at the Aveda Medical Acute Wound Care Showcase 2025. We'll share clinical results by some of our treating physicians, economic insights, and we will hear how our products have changed patients' lives. You'll be hearing directly from the physicians and patients whose lives they've helped heal. I hope you'll join us. You can register by visiting our website, clicking the investor relations tab, and selecting the events section. With that, I'll turn it over to David to walk through our financial results.

Disclaimer

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