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CorMedix Inc.
3/5/2026
Good morning and welcome to the Corps Medics fourth quarter and full year 2025 earnings and corporate update conference call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.
Good morning. And welcome to the Corps Medics fourth quarter and full year 2025 earnings and corporate update conference call. Leading the call today is Joe Tedisco, Chairman and Chief Executive Officer of Corps Medics. And he is joined by Liz Hurlburt, EVP and Chief Operating Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick-Kaufman, EVP and Chief Legal and Compliance Officer, Mike Seckler, EVP and Chief Commercial Officer, and Dr. Matt David, EVP and Chief Business Officer, are also on the line and will be available during the Q&A session. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Security Litigation Reform Act of 1995. These statements are statements other than statements of historical facts regarding management's expectations, beliefs, goals, and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CoreMedix filings with the SEC, which are available free of charge at the SEC's website or upon request from CoreMedix. CoreMedix may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. CoreMedix does not intend to update these forward-looking statements except as required by law. During this call, the company will discuss certain non-GAAP measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CoreMedix earnings release in the current report on Form 8K filed with the SEC. This information is also available on the Investor Relations section of CoreMedix's website. At this time, it is now my pleasure to turn the call over to Joe Tedisco, Chairman and Chief Executive Officer of CoreMedix. Joe, please go ahead.
Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. 2025 was truly a transformational year for CoreMedix. While the FinCAS achieved peak sales of just under $260 million, we are excited to have both announced and closed the acquisition of Moenta Therapeutics in the third quarter of the year. In addition, the team worked expeditiously to facilitate integration and achieve our target synergy of $35 million during the fourth quarter of 2025. This was a monumental achievement and truly a testament to the operational execution capabilities of the CourtMedics leadership team. As we turn our attention to the year ahead, there is much focus on our post-TDAPA add-on period strategy for maintaining patient utilization rates for DefendCast in outpatient hemodialysis. As a reminder, on July 1st of this year, the TDAPA reimbursement for DefendCast We'll transition from a buy-and-bill format to a bundled add-on mechanism. We've had multiple conversations with our top customers and are in the process of finalizing supply pricing for Q3 and Q4 of 2026, as well as for 2027. At this time, we are affirming our 2026 DefendCast guidance of $150 to $170 million and 2027 DefendCast guidance of $100 to $125 million. With respect to 2026, we expect much of the revenue concentration to be front-loaded in the first half of the year as price erosion related to the post-TDAPA add-on occurs in the third and fourth quarter. Assuming CMS utilizes the same methodology to calculate the 2027 bundle addition, we do expect a meaningful increase in traditional Medicare provider reimbursement 2027, which we expect to translate into a higher net selling price in 2027 compared to Q3 and Q4 of 2026. To that extent, we took the extra step of issuing 2027 DefendCast guidance, which is based on existing patient utilization rates, as well as our current estimates for the range of net selling prices, and does not include potential upside from new customers or managed care contracting. In addition to DefendCast guidance, the company is also affirming its full year 2026 financial guidance of revenue of 300 to 320 million and adjusted EBITDA of $100 to $125 million. That said, we are actively in discussions with multiple Medicare Advantage providers, as well as new potential customers for DefendCat in both the inpatient and outpatient settings of care, focused on execution of sales and marketing efforts for Rosio, Minison, and Vabomir, and will evaluate appropriate updates to financial guidance as we progress throughout 2026. This past month, we completed our first Analyst R&D Day, in which we focused on educating our analysts and investor community on the market opportunity for our antifungal product, Roseo, in its current approved indication in the treatment of invasive fungal infections, as well as our key pipeline assets of Roseo in development for prophylaxis of invasive fungal infections and DefendCast in development for prevention of CLABSI in adult patients receiving total parental nutrition. Liz will provide an update on the status of these development programs shortly. During the Analyst Day event, stakeholders were given the opportunity to engage with multiple panels of physician thought leaders around key aspects for each of these three growth opportunities for core medics. The webcast of the event and associated materials remains available on our website, and I encourage all investors to review those materials. The feedback from thought leaders was excellent and underscores our view for the large potential market opportunity for Rizeo, which we estimate at approximately $2.5 billion across both potential indications, and for DefendCat and Tipien, which we estimate between $500 and $750 million. 2026 is expected to be a transitional year for CoreMedix, with a heightened investor focus on new catalysts and value drivers. Most notably, our phase three respect data for Roseo and prophylaxis, which is on track for the second quarter of this year. With the acquisition of Malenta, not only did we acquire what we believe will be an exceptional growth asset in Roseo, but also added highly durable institutionally administered products like Minison and Vabomir, which we expect to provide a stable base of revenue while the company builds toward future growth. I believe CoreMedix has done an exceptional job of maximizing the value of the initial to DAPA period afforded to defend cats in outpatient hemodialysis and parlayed that success into building a pipeline that positions the company for long-term sustainable growth. I'd now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities. Liz, please go ahead.
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