CorMedix Inc.

Good afternoon and welcome to the CoreMedix first quarter 2023 earnings conference call. All participants will be in a 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 Monique Cossie. Please go ahead.

Thank you. Good afternoon, everyone, and welcome to the CoreMedics First Quarter 2023 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 of Dr. Phoebe Mounts, EVP and General Counsel, 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 clinical development program, manufacturing activities, and NDA approval for DFINCAP in the U.S. or other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DFINCAP or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans, the timing, cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash position, expectations to the timing and nature of anticipated regulatory actions, possible product licensing, business development or other transactions, any commercial plans and expectations, market projections for product candidates, and expectations as to manufacturing and product component costs. Actual 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 Corps Medics' filing 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 Corps Medics. Corps Medics may not actually achieve these 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 is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of CoreMedix. Joe, please go ahead.

Thank you, Monique. Good afternoon, everyone, and thank you for joining us on this call. Since our last earnings call in March, the company has achieved a number of key milestones. Most importantly, today's announcement that the NDA for DefendCat is being resubmitted to the FDA. I'm incredibly proud of the team that has worked so hard to ensure the company would achieve this important objective. CVE will provide more color around the substance of our Type A meeting with FDA in April. And as we announced a few weeks ago, we do expect the resubmission to be classified as a Class 2 with a six-month review and anticipate a target action date in November. We will update investors once we have confirmation from FDA regarding the submission status of the NDA. In addition to our resubmission, we also announced two key business updates that can be important value drivers for DefendCast. The first was that following our submission of a duplicate new technology add-on payment, or NTAP, application in the fourth quarter of 2022 to the Centers for Medicare and Medicaid Services, CMS has now issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefendCat. This is a meaningful increase above the previously approved NTAP and represents reimbursement to inpatient facilities at 75% of the anticipated WAC price of $1,170 per 3-milliliter vial, with an average utilization of 19.5 vials per hospital stay. As we mentioned in our recent update, CoreMedix will be migrating DefendCath from a 5 milliliter to a 3 milliliter vial volume based upon market preferences. This NTAP application was submitted with that migration in mind. The final IPPS rule will be published in late summer, and we expect this payment amount to be issued in that final rule. This NTAP is conditioned upon the DefendCath NDA obtaining final FDA approval prior to July 1st of 2024. The company also recently announced that the U.S. Patent and Trademark Office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. patent application reflects the unique and proprietary nature of DefendCath and will extend our current intellectual property protection to anticipated expiration date in 2042, which is beyond the 10 and a half years of marketing exclusivity available upon an FDA approval of the DefendCat NDA. Once this patent is granted, we plan to seek listing in FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity information as part of the NDA approval process. While our technical and regulatory teams have been working diligently toward our resubmission and preparing the supply chain for potential commercialization, our commercial and medical affairs teams have been engaging with key stakeholders across settings of care to ensure CoreMedix is in position to maximize the value of Defencas. As the initial phase of our launch will focus on inpatient utilization, we have begun engaging with leadership members of pharmacy and technology committees at multiple health systems, hospitals, and integrated delivery networks to better prepare for the formulary process. We expect to work with health institutions during the upcoming months to establish baseline infection rates at their respective institutions, such that the impact of the PhenCas utilization in the system can be quantified. On the outpatient side, we have also intensified engagements with potential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursement. Catheter-related bloodstream infections remain one of the most severe complications associated with receiving hemodialysis through a central venous catheter. and adequate reimbursement to dialysis providers for infection prevention is essential to improving patient outcome. A formal application for outpatient reimbursement cannot be submitted until after an MDA receives FDA approval. However, we do expect to begin a dialogue with CMS, providing the agency with documentation supporting our reimbursement position over the upcoming months. I will now turn the call over to Phoebe to discuss our Type A meeting with FDA and potential timelines for FDA approval. Phoebe?