CorMedix Inc.

Good day and welcome to the Corematics Inc. First Quarter 2025 Financial Results 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 your telephone keypad. 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 Dan Ferry, LifeSci Advisors. Please go ahead.

Good morning, and welcome to the Corps of Medics first quarter 2025 earnings conference call. Leading the call today is Joe Tedisco, Chief Executive Officer of Corps of Medics. He is joined by Dr. Matt David, Executive Vice President and CFO. That's Zelnick Kaufman, EVP and Chief Legal and Compliance Officer, Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer, and Aaron Mistry, EVP and Chief Commercial Officer. 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 meeting 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 positions. 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's findings 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, 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 8-K filed with the SEC. This information is available on the investor relations section of CoreMedix's website. At this time, is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of CoreMedix. Joe, please go ahead.

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. CoreMedix continues to have solid momentum with the launch of DefendCast, highlighted by strong first quarter net sales of $39.1 million, in line with our earlier pre-announced results, adjusted EBITDA for the first quarter of $23.6 million, was slightly above our earlier preannouncement. We continue to see steady utilization growth with existing anchor customer U.S. Renal Care, IRC and DCI, as well as new utilization with smaller outpatient dialysis operators and inpatient hospitals and health systems. For the month of April, as an example, inpatient hospital ordering accounted for more than 6% of shipments, up more than double from the first quarter. In early April, we updated our net revenue guidance for DefendCast sales to existing customers for the first half of the year, and we guided to a range of $62 million to $70 million, which implied second quarter 2025 net revenue guidance of $23 million to $31 million based upon first quarter results. I'm happy to say that based on order trends and inventory tracking, we're able to further narrow our guidance toward the upper end of that range, and currently project net revenue of approximately $70 million from existing purchasing customers over the first half of the year. As we stated on our previous call, the moderate sequential decline in revenue anticipated between Q1 and Q2 of this year is largely due to the timing of shipments to U.S. Renal Care, in which they purchased a few additional weeks of inventory in both the fourth quarter of 2024 and first quarter of 2025, respectively. We expect that beginning in the third quarter of this year for order volumes from U.S. Renal Care to normalize and more closely track patient utilization. To that extent, we do anticipate utilization growth in the back half of 2025 as new patients initiate therapy at existing customers and as we add new customers in both the inpatient and outpatient settings. A large variable for our potential full-year financial outlook is the timing and scale of uptake by our previously announced large dialysis operator customer. Over the last few weeks, we have seen increased levels of communication and planning-related activities with medical and operations staff at the customer, and to that extent, we are optimistic of achieving our target for a mid-year 2025 implementation start. We intend to update investors once we have more definitive timeline from the customers. Turning back to the inpatient market, our dedicated inpatient sales team is now fully staffed, trained, and operational in the field, and we are hopeful to increase penetration as we move throughout 2025. Our partnership with WSI for promotion to federal facilities is also fully operational, and we received and shipped our first orders to VA facilities in the first quarter. Focusing now on our clinical developments, We've begun our phase three clinical study for the reduction of central line associated bloodstream infections, or CLABSIs, in adult patients receiving total parental nutrition, or TPN, through a central venous catheter. Site selection began in February, and I'm happy to report that our first site is operational and actively screening patients, and we expect our first patient to be dosed over the next few days. As a reminder, this is a 12-month study in less than 150 patients. and we are targeting completion of the study and submission of a new drug application to FDA by the end of 2026 or beginning of 2027. We recently submitted to FDA an application for orphan drug status for this indication and are awaiting FDA's determination of eligibility. The company's goal for TPN is to obtain FDA approval for an expanded use of our tyrolidine and heparin catheter lock solution in the late 2027 to early 2028 timeframe. And we estimate annual peak sales potential in the syndication to be in the range of $150 million to $200 million, based off a total addressable market size of $500 million to $750 million. We will provide investors with updates on progress in this important area of unmet need as we move forward. Our other clinical initiatives also continue to make solid progress. excuse me, our real world evidence study that is being run in cooperation with our study partner, US Renal Care, has eclipsed 2000 patients and will hit its midpoint in July. Our hope with this study, in which we expect to evaluate patient outcomes over a 24 month period, is to generate real-world evidence around the impact of DefendCath utilization on the cost of patient care, infection rates, hospitalizations, mortality, and multiple other metrics such as lost chair time and CRBSI-related antibiotic use. Data from this study will be critical to our objective of making DefendCath a standard of care catheter lock in the outpatient hemodialysis setting. In addition to our adult TPN and real-world evidence studies, our study of DefendCath in the pediatric Hemodialysis population is on target to begin in the third quarter of this year. And our expanded access program for high-risk populations, including but not limited to pediatric TPN, peritoneal dialysis patients with refractory peritonitis, and neutropenic oncology patients utilizing a CVC, is now live. I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position. Matt?