CorMedix Inc.

Good day and welcome to the Corps Medics, Inc. Third Quarter 2024 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 of LifeSci Advisors. Please go ahead.

Thanks, operator. Good morning, and welcome to the CoreMedics Third Quarter 2024 Earnings Conference Call. Leading the call today is Joe Tedisco, Chief Executive Officer of CoreMedics. And he is joined by Dr. Matt David, Executive Vice President and CFO, Beth Zelnick-Kaufman, EVP and Chief Legal 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 position. Action 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 CoreMedics' filings with the SEC, which are available free of charge at the SEC's website or upon request from CoreMedics. CoreMedics may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Corps Medics does not intend to update these forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of Corps Medics. Joe, please go ahead.

Thanks, Dan. Good morning, everyone, and thank you for joining the call. As we approach the end of our first calendar year of commercial launch at DefendCat, I'm incredibly proud of the team's efforts and pleased with the commercial results thus far. The third quarter marks the first full quarter of product shipment for DefendCast, as well as the first quarter of outpatient product utilization. Our net revenue for the third quarter of $11.5 million exceeded street consensus and was largely driven by our initial anchor customer, U.S. Renal, which has done an exceptional job with DefendCast implementation within its clinics. We recently announced new agreements with two mid-sized dialysis operators and one large-scale operator, which combined with our existing customers will provide patients access to Fencast at roughly 60% of dialysis clinics in the U.S. We are currently working diligently with our new partners to operationalize those agreements and currently expect purchases to commence for all three before the end of the fourth quarter. While we have not issued revenue guidance for the fourth quarter, based upon our current forecast, we do expect to be EBITDA positive for the fourth quarter. With respect to guidance, wide potential variability for fourth quarter revenue, driven by the timing and scale of purchases by our LDO customer, as well as the scale of purchases by our newly announced midsize customers. DefendCat, for the most part, is being protocolized by the outpatient customers that adopt the product, meaning they are establishing criteria for patients in their system for which DefendCat is appropriate, and then implementing protocols based on those criteria. This requires a significant pre-implementation effort with each customer to establish protocols, order sets, and conduct training on an enterprise level. In the case of our LDO customer, it requires implementation on a much larger scale to allow a rollout at over 2,000 clinics. The upside of having our drug protocolized in this manner is that once a customer goes live, we expect the patient conversion ramp to move fairly quickly. The downside is that setup can take anywhere from several weeks to a few months. Currently, we are expecting our LDO customer to begin ordering in December, but a couple of weeks' movement in either direction from a customer of this scale would obviously have a material impact on our fourth quarter revenue. For our new MDO customers, we expect orders to begin in November. With respect to our inpatient launch activities, we have made significant progress in terms of building DefendCast champions within hospitals and health systems and scheduling P&T meetings with those institutions. A large number of P&T meetings occurred in the third quarter, and we are in the process of fielding questions and providing additional information required for a formal decision. These P&T committee discussions require both a comprehensive review and collaboration across multiple stakeholders, including clinical and financial, within the health system. To that extent, we expect the inpatient uptake process to be longer and the ramp to be more consistent with traditional inpatient launches in comparison to the more rapid uptake we have seen on the outpatient side. We have started to see some utilization in the handful of hospitals that have completed P&T review early and added the PhenCath to formulary, and we are optimistic to build on that progress in 2025 as we continue our field efforts with the PhenCath advocates. Focusing now on our clinical developments, we announced in the second quarter that we received supportive feedback from FDA related to our proposed clinical pathway for adult total parental nutrition, or TPM. Since then, we've received FDA feedback and conducted extensive market research and clinical feasibility studies. And accordingly, we are refining the clinical protocol and anticipate submitting it to FDA by mid-November to align with our plans to operationalize the study in the first half of 2025. 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 2028 timeframe and we estimate annual peak sales potential in this indication to be in the range of $150 million to $200 million. We will provide investors with updates on progress as we move forward. From a clinical budget standpoint, we anticipate the study to cost between $10 and $12 million, with the majority of expense spanning the 2025 and 2026 calendar years. During our previous earnings call, we also announced three additional clinical initiatives. all expected to commence in the 2024 or early 2025 timeframe. The most meaningful of the three from a data value standpoint is our real-world evidence study that we will run in cooperation with our study partner, U.S. Renal Care. Our hope with this study, in which we expect to evaluate outcomes of roughly 2,000 patients over 24 months at a cost of less than $1 million a year, would be to generate real-world evidence around the impact of the FENCAS utilization on cost of patient care, infection rates, hospitalizations, mortality, and multiple other metrics such as lost chair time and antibiotic use. Ultimately, we would intend to utilize this data in our post-DADAPA period to negotiate future sustainable reimbursement from Medicare Advantage plans and other value-based care contracting entities. Data collection for this study has already commenced. adult TPN and real-world evidence studies, we will also be commencing a study in pediatric hemodialysis. This will be a relatively small study spread over several years, as we expect patient enrollment to be a challenge given an extremely small patient population and the need for very personalized protocols for these ultra-vulnerable patients. This pediatric study is a post-marketing requirement under the Pediatric Research Equity Act by the FDA, and we have FDA's concurrence on a final study protocol. We had planned to begin patient enrollment in early 2025, and we expect the study to cost between $4 and $6 million, spread over five years. Lastly, in addition to our other clinical initiatives, we plan to commence an expanded access program for high-risk populations, including but not limited to pediatric TPM, peritoneal dialysis patients with refractory peritonitis, and neutropenic oncology patients utilizing a CDC. These high-risk patients are those that have exhausted other infection prevention methods and unfortunately remain at significant risk for comorbidities and mortality. The cost for the expanded access program is expected to be less than $750,000 a year, primarily in the form of free product and distribution costs. And we expect to generate data that supports further label expansion and complements our adult TPM program. I would now like to turn the call over to Matt to discuss the company's third quarter financial results and financial position. Matt?