CorMedix Inc.

Good day and welcome to the CoreMedicSync second quarter 2024 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal conference specialists for 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 try your question, please press star then two. Please note, this event is being recorded. I'd now like to turn the conference over to your host today, Daniel Ferry. Please go ahead.

Good morning, and welcome to the Corps Medics Second Quarter 2024 Earnings Conference Call. Leading the call today is Joe Tedisco, Chief Executive Officer of Corps Medics, and he is joined by Dr. Matt David, Executive Vice President and CFO, Beth Zelnick-Kaufman, EVP and Chief Legal Officer, Liz Frobert, 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. 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. At this time, it 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. As we reach the midpoint in the financial year, I'm incredibly pleased with the progress the company has made related to the launch of DefendCath, and I'm optimistic about the sales trajectory we have seen through only the first few weeks of the outpatient launch. CoreMedix commenced the inpatient launch of DefendCath on April 15th and commenced the outpatient launch during the first week of July, just after the close of the second quarter. The commercial launch milestone marks the culmination of the efforts of countless individuals, including CoreMedix employees, contractors, and consultants, who worked tirelessly over the last decade to bring this innovative drug product to patients in need. I'm extremely proud of this achievement, and I'm excited about the potential for DefendCast utilization and the resulting impact DefendCast can have on patient infection rates. Though the inpatient launch of DefendCast commenced on April 15th, As we communicated earlier, the inpatient sales cycle is relatively long, and our initial efforts have been focused on engaging customers to champion DefendCAT for P&T formulary review with hospitals and health systems. In this regard, we have seen significant progress in terms of meetings scheduled over the upcoming months, and from the handful of meetings that have already occurred, we are pleased with the majority of outcomes. We do expect a lag between P&T formulary approval and facility ordering, and we may have more and we have many more P&T meetings scheduled between now and the end of this calendar year. In light of this long sales cycle, second quarter sales were expectedly modest, consisting primarily of trade stocking for inpatient facilities. We expect inpatient sales to begin to ramp in the fourth quarter as the FENCAS is reviewed, added to formulary, and adopted into hospital workflows for patient use. We have seen some inventory begin to flow to those inpatient institutions that have completed formulary reviews, and we are optimistic of increased order flow as more hospitals and systems hopefully approve DefendCath and add it to their respective formularies throughout the year. The outpatient launch of DefendCath officially commenced on July 1st with initial orders placed in June and material product shipments beginning the week of July 8th. As we announced earlier this morning, we have recorded unaudited quarter-to-date sales of 5.2 million as of August 13th. Our third quarter sales have been exclusively to small and mid-sized dialysis operators, and we have verified pull-through to the clinic level for more than 95% of those shipments. To that extent, there is very little, if any, trade stocking in these third quarter net sales figures. In terms of onboarding new outpatient dialysis providers, the company believes we're in late stages of negotiations with one of the top dialysis providers in the country for the implementation of the FENCAV, as well as multiple smaller and mid-sized providers. and we are optimistic we will be operationalizing new commercial supply agreements shortly. As I stated at the opening of these remarks, we have seen a positive sales trend throughout our first five weeks of outpatient shipments coming entirely from small and mid-sized dialysis operators, and we expect that growth trend to continue throughout the year as existing customers expand to PhenCAS to newly identified patients. In addition, we are hopeful to see the commencement of sales to new accounts before the end of the third quarter. From a market access standpoint, outpatient reimbursement under DADAPA commenced on July 1st and applies to all Medicare fee-for-service patients, which comprises roughly 45% of all ESRD patients in the United States. Medicare Advantage, comprising an additional 45% of ESRD patients, remains an opportunity for growth and expansion for the DefendCAS reimbursement. We have been engaged with all major Medicare Advantage organizations across the country, and we are happy to report that UnitedHealthcare, The largest MA plan in the country in terms of covered lives, which accounts for roughly 30% of Medicare Advantage enrollment, has confirmed that they will provide comparable to DAPA reimbursement for DefendCab beginning on September 1st. Humana, which comprises roughly 20% of Medicare Advantage population, has also confirmed that they will provide to DAPA reimbursement, which may vary depending on provider contracts. As we progress through our first year of launch, the company intends to remain engaged with Medicare Advantage plans to ensure adequate reimbursement to operators. From a long-term perspective, the company believes that ESRD Medicare patients in general will continue to migrate from Medicare fee-for-service into Medicare Advantage plans and that the value-based care proposition for DefendCast will resonate with MA plans and hopefully result in long-term sustainable separate reimbursement in this patient segment. Shifting gears to 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 TPN, subject to the agency's review of our final study protocol. I'm happy to announce that this past week we have submitted our final protocol to FDA, and subject to FDA's concurrence, we expect to begin patient enrollment in the first quarter of 2025. We have posted on the company's website an updated corporate presentation that now includes market research information related to TPN. There remains a significant unmet medical need in this patient population, with up to 26% of TPN patients having a catheter-related infection and those patients having increased morbidity and mortality rates. Market research estimates that the addressable market opportunity in TPN is approximately 4.7 million TPN infusions per year. The company's goal is to obtain FDA approval for an expanded use of our tyrolidine and heparin catheter lock solution in TPN in the 2027 to 2028 timeframe, as we estimate annual peak sales potential in this indication to be in the range of $150 to $200 million, incrementally beyond hemodialysis. 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 million and $12 million, with the majority of expense spanning the 2025 and 2026 calendar years. Simultaneously with our adult TPN study, we will also be commencing a few additional clinical initiatives. The first is 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've submitted to FDA a final study protocol. Subject to FDA's concurrence, we have plans to begin patient enrollment in early 2025. We expect this study to cost between $4 million and $6 million, spread over four to five years. In addition to our adult TPN and pediatric HD studies, we plan to commence two other clinical initiatives in 2025. The first is an 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 central venous catheter. 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 expanded access 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 TPN program. The other clinical initiative, which is perhaps most meaningful from a potential data value standpoint, is a real-world evidence study of DefendCath in adult hemodialysis patients that we will run in cooperation with one of our existing commercial partners. Our hope with this study, which we expect to take approximately 24 months and cost less than $1 million per year, would be to generate real-world evidence around the impact of DefendCath utilization on cost of patient care, infection rate, hospitalizations, mortality, and multiple other metrics such as lost chair time and antibiotic use. Ultimately, we would look to utilize this data in our post-ADAPTA period to negotiate future sustainable reimbursement for Medicare Advantage plans and other value-based care contracting entities. I'd now like to turn the call over to Matt to discuss the company's second quarter financial results and financial position. Matt?