CorMedix Inc.

Good morning, ladies and gentlemen, and welcome to the CoreMedics, Inc. 4th Quarter and 4-Year 2023 Earnings Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star 0 for the operator. This call is being recorded on March 12, 2024. I would now like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

Good morning, and welcome to the CoreMedics Full Year 2023 Earnings Conference Call. Leading the call today is Joe Tedisco, Chief Executive Officer of CoreMedics. He is joined by Dr. Matt David, Executive Vice President and CFO, Beth Zelnick-Kaufman, EVP and Chief Legal Officer, Liz Hurlburt, EVP of Chief Clinical Strategy and Operations Officer, and Erin 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 meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following. Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its commercial launch prospects for DefendCast, its clinical development programs for expanded uses of DefendCast, manufacturing activities, and marketing approvals for other product candidates, future financial position, future revenues and projected costs, and reimbursement and potential market acceptance of DefendCast or other product candidates. Action results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in CoreMedix filings with the SEC, including the latest quarterly report on Form 10-Q and annual report on Form 10-K, copies of which are available free of charge at the SEC's website at www.sec.gov 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. Please note that CoreMedix does not intend to update these forward-looking statements, except as required by law. 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.

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. Since we last presented earnings in November, the company has achieved a number of key milestones, Most notably, the final NDA approval of DefendCAS by the U.S. FDA, as well as confirmation from CMS that DefendCAS will be eligible to receive a transition drug add-on payment or to DAPA for outpatient reimbursement as CMS has classified DefendCAS as a renal dialysis service under the end-stage renal disease prospective payment system. As we previously announced, we submitted our HCPS J-code application to CMS in December and our Tdap application in January, following receipt of that reimbursement guidance from CMS. Those applications remain under review at CMS, and CMS has confirmed in writing that they are actively reviewing our JCODE and Tdap applications and are working toward a July 1, 2024, effective implementation for a DefendCAS Tdap payment. That said, CMS reserves the right to request additional information for any application, which may impact the review timing and or approvability of a J-code or Tdapa. Both a J-code and an approved and effective Tdapa application are gating items for the outpatient commercial launch of DefendCAS, which is currently slated for July 1st. The company remains on schedule to commence our commercial launch for the inpatient setting on April 15th. We have staffed and trained our field sales and medical affairs organizations, and held a successful internal team launch meeting during the last week of February. The team we have built is deeply experienced and specialized with backgrounds in both infectious disease and nephrology, spanning both the inpatient and outpatient settings of care. We are also ramping up inventory production in accordance with our internal plan, which is heavily weighted toward the back part of the year. As part of our supply chain strategy, the company is on track to submit a supplement to our NDA in April. qualifying Siegfried's site in Hamel, Germany as an alternative manufacturing site for DefendCath. Assuming a favorable FDA review of the supplement, additional production from that site would come online by the end of 2024. As we think about the inpatient launch trajectory in April, we do expect the ramp for inpatient utilization to be fairly modest over the first two launch quarters, as inpatient health systems and hospitals are working through their respective P&T formulary review processes. On average, the P&T process for a particular system or hospital can range from three to nine months. That said, we have received significant interest over the last few months and are actively working through the P&T process with several large and mid-sized health systems. We expect this activity to intensify in the coming months as our field-based key account managers have just begun calling on hospitals and health systems to effectuate pre-launch contracting discussions. On the outpatient side, we continue to have productive discussions with large and mid-sized dialysis operators, and we look forward to providing additional updates over the coming months as these discussions advance. Based upon our current base case forecast for 2024, we continue to believe that the company can achieve breakeven profitability on a run rate basis by the end of December 2024 assuming we are able to achieve our internal base case assumptions for DefendCath demand, uptake, net pricing, and reimbursement. We believe we have sufficient cash resources on hand to achieve this objective. However, should the launch and uptake of DefendCath be slower than our internal projections, requiring more capital, we believe we have several financing alternatives available to the company, including non-dilutive sources of financing. CoreMedix has grown in size with the addition of new hires in field sales and medical affairs, as well as other additions across the organization. I am thankful for all of those involved in the latest expansion, our new team members, and all the work that has gone into preparing the company for our anticipated commercial launch. I am proud of what we have accomplished over these recent months and excited to bring DefendCast to patients. I would now like to turn over the call to Matt to discuss the company's fourth quarter and year-end financial results and financial position. Matt?