CorMedix Inc.

Good day, and welcome to the Core Medics Third Quarter 2025 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Daniel Ferry of LifeSci Advisors. Please go ahead.

Thank you, Operator. Good morning, and welcome to the Corps Medics Third Quarter 2025 Earnings and Corporate Update Conference Call. Leading the call today is Joe Tedisco, 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, and Dr. Matt David, EVP and Chief Business Officer, are 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 Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact 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 core medics filings with the SEC, which are available free of charge at the SEC's website or upon request from core medics. CoreMedix may not actually achieve the goals or plans described in these forward-looking statements, and 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 and the current report on Form 8K filed with the SEC. This information is available on the investor relations section of CoreMedix's website. At this time, it's now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of CoreMedix. Joe, please go ahead.

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. This has been an exciting quarter in the evolution of CoreMedix as we announced and closed the acquisition of Moenta Therapeutics in a combination cash and stock transactions. This deal is transformational for CoreMedix, creating a diversified specialty pharmaceutical company with a broad portfolio of commercial and late-stage pipeline products. Integration of the legacy CoreMedix and Lenta operations has progressed faster than originally expected. And as we announced in October, we expect to capture approximately 30 million of the projected 35 to 45 million of total synergies on a run rate basis before the end of 2025. I'm excited to announce today that as part of our integration, CoreMedix, Inc. will be rebranding as CoreMedix Therapeutics, and all employees will unify under this company name. We're also adopting a new logo to signify the go-forward organizational commitment to develop and commercialize novel therapies for the prevention and treatment of life-threatening conditions. This past quarter marks the most successful quarter from a financial perspective in company history, registering record levels for revenue, of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million. Our revenue performance was largely driven by faster-than-expected adoption by our DefendCast LDO customer, utilization growth from our existing customer base, as well as partial quarter contribution from the Malenta portfolio assets. Based on the recent momentum, Today, we are raising our pro forma combined full year revenue guidance from a minimum of $375 million to a range of 390 to 410 million. In addition, we are increasing our previous guidance for pro forma fully synergized adjusted EBITDA for 2025 from a range of 165 to 185 million to a new range of 220 to $240 million. On the business development front, we also successfully closed our strategic minority investment in Telfera, Inc. This small strategic investment gives us a foothold in a late-stage critical care product that is highly complementary to CoreMedix's acute care portfolio. As part of the transaction, CoreMedix is granted a right of first negotiation to acquire Telfera following the announcement of phase three results, which we anticipate to be available in the first half of 2026. We will continue to evaluate Telferra in the coming months as their clinical trial progresses toward completion. With respect to DefendCAS, we are very pleased overall with the utilization of DefendCAS in the outpatient hemodialysis segment during our initial phase of TdapA, and we have now begun planning with customers for the post-TdapA add-on periods, which we expect will begin in July of 2026. with our strategy to increase patient utilization of DefendCath during our post-HDAPA add-on periods. We'll be working over the coming months to finalize supply pricing with customers under existing contracts based upon the final post-HDAPA add-on framework, as well as engaging in conversations with Medicare Advantage payers following the publication of our real-world evidence data later this year. Lastly, as CoreMedix evolves, I think it's important for investors to begin focusing on important near- and medium-term catalysts and value drivers for the company beyond the hemodialysis sector. First and most importantly, the second quarter of 2026 is expected to bring top-line data for the use of Roseo as prophylaxis of invasive fungal infections. We believe the total addressable market for immune-compromised patients that are currently undergoing antifungal prophylaxis is more than $2 billion. Phase III RESPECT study is running head-to-head against the current standard of care, which is a combination of posiconazole and antifungal and Bactrim, an antibiotic that also has antifungal activity. Posiconazole demonstrates severe drug-to-drug interactions with many medications the target patient population is currently taking, including immunosuppressive drugs like tacrolimus and cyclosporine, as well as numerous therapeutics used in treating hematological malignancies such as leukemia, multiple myeloma, or non-Hodgkin's lymphoma, all patient populations that may undergo bone and marrow transplantation as part of their therapy. For these patients, Roseo, used as prophylaxis against these invasive fungal infections, could represent a new standard of care that may allow patients to experience less drug-to-drug interactions, less frequent dosing, and more flexibility in their setting of care for treatment. Our second near-term catalyst outside of hemodialysis is the expected expansion of Defencas into the prevention of CLABSI for adult patients receiving total parenteral nutrition, or TPN. Our most recent market research continues to highlight the critical unmet medical need and pervasively high bloodstream infection rates in this patient population. Prophylactic intervention is urgently needed for these vulnerable patients. We have previously guided to a total addressable market in this indication of up to $750 million and anticipate Phase III completion as early as the end of 2026 or beginning of 2027. I believe that CoreMedix has done an exceptional job of maximizing the value of the initial TdapA period afforded to DefendCAS, has a long-term strategy in hemodialysis for post-TdapA periods, and has redeployed cash flow into a pipeline that can position the company for long-term, sustainable growth. I am excited about the future. I would now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities, operations, and integration. Liz, please go ahead.