CorMedix Inc.

Good afternoon and welcome to CoreMedx Third Quarter 2023 Earnings Conference Call. Today's call is being recorded. There will be a question and answer session at the end of today's presentation and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

Good afternoon and welcome to the CoreMedx Third Quarter 2023 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, Dr. Phoebe Mount, EVP and General Counsel, and Aaron Mystery, 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 subject to certain risks and uncertainties that 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 marketing approval for DefendCast in the U.S. or for other product candidates, future financial position, future revenues and projected costs, and reimbursement and potential market acceptance of DefendCast or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, progress, results, estimates, and interpretations thereof. Projections as to the company's future capital raising and spending and cash position, including projections regarding the sufficiency of the company's current cash resources to potentially bring the company through to break-even profitability, expectations as to the timing and nature of anticipated regulatory actions, reimbursement decisions, possible product licensing, business development, or other transactions, any commercial plans and expectations, intellectual property protections for our product candidates, market projections for our 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 core medics filings with the SEC, including the latest quarterly report on Form 10-Q and the 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 core medics. Core medics 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 Corematics 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 Corematics. Joe, please go ahead.

Thanks, Dan. Good afternoon, everyone, and thank you for joining us. As we approach tomorrow's target action date for DefendCast, I am very pleased with the progress that the company has made toward pursuing final NDA approval from FDA, as well as preparations for commercialization. I'm happy to announce that the FDA completed a pre-approval inspection for our finished-dose CDMO site in September. We are very pleased with the outcome. And an establishment inspection report, or EIR, is expected to be issued imminently. I'd like to thank and congratulate all of the CoreMedix employees who have worked diligently with our CDMO and external consultants in preparation for the inspection, as well as thank our CDMO, Roe v. Pharma Industrial Services, for their commitment to CoreMedix and DefendCast. Phoebe will provide additional clarity around pre-approval inspections and the status of the NDA review process. Certainly, it's frustrating for us to host this call today, a day ahead of our PDUFA date, but this was the last day we could conduct this call under SEC requirements, and we were hopeful that FDA could potentially take action earlier than our target action date. FDA has communicated to CoreMedix that they are working towards taking action on our application tomorrow, and at present time, the company is not aware of any outstanding review items or deficiencies that would lead to a negative outcome. In that regard, in advance of our target action date, we have intensified our preparations for commercial launch with a number of key new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance. we are building a significant number of capabilities in-house, as well as relying on external vendors for certain activities that require larger scale. Our inpatient field team will consist of a combination of in-house market access key account managers, as well as external expert advisors with deep relationships at specific high-value target institutions and health systems. In the event we do receive final FDA approval over the coming days, we are targeting a commercial launch before the end of the first quarter of 2024, likely initially focused on the inpatient segment only. Our assumptions around commercial launch and sales ramp may be impacted by external factors, most notably the timing of reimbursement guidance from the Center for Medicare and Medicaid Services, or CMS, around outpatient reimbursement for DefendCAS. Over the past two months, we have been engaged in an active back and forth discussion with CMS making our case that DefendCath should be properly reimbursed as an outpatient drug product under Medicare Part B. We have provided the government with significant legal, commercial, and health economic rationale in support of DefendCath obtaining separate payment. The alternative to separate payment under Medicare Part B would be a CMS determination that DefendCath is a renal dialysis service and eligible for a transitional drug add-on payment or Tdapa. While we maintain our guidance to analysts and investors to consider Tdapa as our base case from a financial modeling standpoint, the company feels strongly that the FENCAS does not fall within the current statutory definition of a renal dialysis service and therefore should properly be separately reimbursed under Medicare Part B. CoreMedix is preparing to submit an application to CMS for a unique product J-code on January 1, 2024 for Part B reimbursement provided our NDA receives FDA approval. The deadline from CMS to submit an application for Tdapa is also on January 1st. Absent direct feedback from CMS advising the company to submit an application for Tdapa prior to that January deadline, CoreMedix does not intend to submit an application at this time as we do not believe that the product is a renal dialysis service. As Tdap is a quarterly application process with a full quarter to implement, should CMS deem DefendCast to be a renal dialysis service, our Tdap application will therefore lag any such determination and may impact the timing of outpatient product launch by a quarter. It is also worth noting that a prolonged government shutdown could adversely impact the timing of any guidance from CMS around reimbursement and the submission or review of either a J-code or Tdap application. With respect to a potential inpatient launch in the first quarter of 2024, we contemplate this would be a soft launch as we could only begin the process of seeking P&T formulary approval at various health systems once the NDA for DefendCath has final FDA approval. Over the past several months, we have accelerated the process of building relationships with key target health systems, identifying key opinion leaders, and engaging external advisors who have existing relationships with those targeted systems. The P&T process varies, but can take anywhere from three to nine months, depending on the health system. We are hopeful to be able to land some quick early formulary positions. However, the ramp on the inpatient side is expected to be slow over the first three to nine months of launch. At present time, due to the inpatient formulary lag and the expected timing to implement any outpatient reimbursement, we would not expect meaningful revenue contributions until the second half of 2024. Provided we obtain timely NDA approval, we anticipate discussing more granularity around inpatient launch ramp and the timing of outpatient launch during our year-end earnings call. I will now turn the call over to Phoebe for a regulatory update and discuss progress toward potential FDA approval. Phoebe?