CorMedix Inc.

Hello, and welcome to the Corps Medics, Inc. First Quarter 2022 Earnings Call-In Webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Daniel Ferry with Lifestyle Advisors. Please go ahead.

Good afternoon, and welcome to the Corps Medics First Quarter 2022 2022 Earnings Conference Call. Leading the call today is Joe Tedesco, newly appointed Chief Executive Officer of Corps Medics, and Dr. Matt David, Executive Vice President and CFO. They are joined by Dr. Phoebe Mounts, EVP, General Counsel and Head of Technical Operations, and Aaron Mistry, SVP and Head of Payer Strategy, Government Affairs and Trade. 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 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 marketing approval for DefendCath in the U.S. and other product candidates, future financial position, future revenues and projected costs, potential market acceptance of DefendCath, NeutralIn, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the submission and timing, cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash position, expectations as 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 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, 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. An investor should not place undue reliance on these statements. Please note that 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 afternoon, everyone, and thank you for joining us on this call. I'm excited to begin my tenure this week as the Chief Executive Officer of Corps Medics. I'd like to start by thanking Dr. Matt David for his continued leadership while I fulfilled my contractual obligations to my previous employer. I look forward to working with Matt more closely as our growth and commercial strategy must be aligned with our financial strategy. In addition, I would like to thank the broader CoreMedix team who have worked tirelessly over the last year to complete the DefendCAS NDA resubmission. These past two months during my transition, I've had the opportunity to meet with each CoreMedix employee individually and have been incredibly impressed with the knowledge, skill, and commitment of the current team. I've also developed a deeper understanding of the operational, commercial, financial, and regulatory hurdles the company and our lead product, DefendCast, face in the near to medium term. While my first 100 days will include continued evaluation and understanding, the company must make several key operating and commercial decisions over the next several months in order to be ready to commercialize DefendCast as soon as possible after securing anticipated FDA approval of the NDA. To that extent, I will not have the luxury of delaying many key decisions related to supply chain planning, distribution, commercial strategy, or personnel. As such, this morning we announced certain key management and reporting changes within the leadership team of CoreMedix and operational changes with our international business. Liz Hurlburt, EVP of Clinical Operations, will take on an expanded role as EVP of Clinical and Medical Affairs assuming oversight of medical affairs, drug safety, and pharmacovigilance, in addition to her existing clinical operations responsibilities. Donna Ucci has been appointed to the role of SVP and Head of Global Quality, reporting directly to me. Donna joined us after most recently serving as VP Global Quality Management at Amule Pharmaceuticals, and with more than 20 years quality leadership experience in previous roles, at Impax, Allergan, and Pfizer. Frank Raffael has been appointed to the role of VP of Supply Chain, joining the company with more than 30 years of supply chain experience, including previous roles at Teva and Quotient Sciences. I'm excited to have Don and Frank join the organization as they together add meaningful quality, manufacturing, supply chain expertise, and I look forward to bolstering the organization with other key additions as we aim to transition from a development stage company to a commercial organization. Lastly, the company and Tom Nussbickel, EVP and Chief Commercial Officer, have mutually agreed to part ways. I want to thank Tom for his commitment and dedication to CoreMedix and wish him success in his future endeavors. Until such time as a permanent Chief Commercial Officer is appointed, I will be taking a more active role in the day-to-day activities of the commercial team as we build out our commercial strategy. We've also made the decision to wind down our operations in Europe. The company had previously made Neutralin available for sale in France, Germany, and some Middle Eastern countries as a medical device. Going forward, the company will focus on our U.S. commercialization and launch strategy, and after securing FDA approval, may pursue an international expansion via a larger regional partnership. During our year-end earnings call in March, Matt and Phoebe communicated that FDA has accepted for review our DefendCast NDA resubmission and informed Corps Medics that the resubmission is complete and considered a Class II response to the action letter with a six-month review cycle from the date of submission and an action date in the third quarter. It is important to keep in mind that the PDUFA goal of six months is merely an internal FDA target for the review of 90% of this type of resubmission, and FDA is not compelled or obligated to act on the application within the six-month timeframe. As Phoebe mentioned on the prior earnings call, we expect FDA to conduct a pre-approval inspection of the company's CMO as part of the review cycle. We have been notified by our CMO that FDA has provided a date for that inspection, and that scheduled date is prior to our goal date. It is important to note that any FDA inspection of our CMO will assess the commercial readiness of the facility and manufacturing operations beyond those specific to DeventCAS, and CoreMedix will only have visibility to FDA observations related to our product. It is also worth noting that any planned inspection from FDA could always be delayed or rescheduled as a result of the ongoing COVID-19 pandemic. We also disclosed in our March earnings call an ongoing work stream to identify U.S.-based CMOs that could be utilized for expanded manufacturing capacity to support commercial launch and for development of a pre-filled syringe format. That work stream is progressing on schedule, and we will provide updates later in the year. Lastly, from a supply chain standpoint, we're also continuing initiatives to dual source key components and active ingredients in order to de-risk potential global supply chain disruptions as well as potential governmental regulatory actions at any key supplier. Over the next few months, I will be working closely with the commercial team as we build out our launch strategy for DefendCast, including critical decisions around pricing, reimbursement, messaging, staffing, and sales deployment. Certain roles will need to be filled and decisions made prior to securing FDA approval of the DefendCast NDA. However, it is not my intention to hire or train field-based sales personnel, until we have our FDA approval firmly in hand. A core part of our market access strategy will be working to secure favorable reimbursement for DefendCAS in both the inpatient and outpatient dialysis settings. Based on our expanded understanding of the market opportunity for DefendCAS gleaned from our discussions with key stakeholders, such as dialysis providers, hospitals, CMS, and patient advocacy groups, We see market potential for DefendCast beyond the outpatient dialysis clinics with a meaningful market opportunity for utilization in the hospital inpatient setting. This past Tuesday, May 10th, the Center for Medicare and Medicaid Services, CMS, published in the Federal Register the Fiscal Year 2023 Hospital Inpatient Prospective Payment System, or IPPS for short, a proposed rule to update IPPS hospital policies, which includes the agency's thoughts on new technology add-on payment, or NTAP applications. An NTAP provides a hospital with additional reimbursement for novel therapeutics beyond the bundled payment associated with a DRG for inpatient care in a particular diagnosis code. CoreMedix has submitted its application for DefendCast to receive NTAP designation. It has been reviewed favorably by CMS. against eligibility criteria, and a final rule will be published by CMS in the Federal Register no later than August 1st. Typically, in order for an NTAP to be effective October 1st of a current year, the product NDA must be approved by July 1st of that year. However, because the FENCAS has received Qualified Infectious Disease Product Designation, or QIDP, from FDA, we are eligible for a more flexible start date. Specifically, we expect our NTAP to take effect the first quarter following the anticipated FDA approval of the NDA, provided such approval occurs before July 1st of 2023. In the NTAP application, which was submitted in October of 2021 to ensure a start date as early as possible, we stated that the DefendCath NDA had received a complete response letter and was pending resubmission without being able to provide CMS with information on the anticipated approval timeline. In a Federal Register notice published this week, CMS has incorrectly stated that CoreMedix expects the FDA to approve the DefendCast NDA prior to July 1st of this year. We've advised CMS of this error and requested the agency publish a correction. On the outpatient side, we remain committed to exploring all avenues for product reimbursement, including our efforts to secure a transitional drug add-on payment adjustment, or TdapA, as soon as practicable after securing our anticipated FDA approval. That said, we are also employing a dual strategy with CMS to simultaneously petition the agency to exclude DefendCAS from the ESRD payment bundle entirely, We believe there are compelling arguments that the FENCAS does not fall within the scope of products and services calculated as part of the dialysis bundle under the current statute, and therefore should be reimbursed separately by CMS as an outpatient drug product with a unique J-code. To be clear, any decision to separately reimburse the FENCAS or to grant the FENCAS to DAPA is ultimately at the sole discretion of CMS. but we will be working diligently over these next few months along with other key stakeholders such as hospital systems, dialysis clinics, and patient advocacy groups to make these arguments to CMS. We will disclose more about our market access reimbursement and pricing strategy once we receive anticipated FDA approval and we get closer to our potential commercial launch date. While the company has been focused on obtaining FDA approval of and commercializing to FENCAF, I believe it will be equally important to establish a medium to long-term strategic growth plan that involves not only pursuing new indications for Defend-Cas, but potentially new uses of Tirolavine, as well as potential product in-licensing and acquisitions of products, both commercial and pre-commercial, that will be synergistic with our expected sales deployment in hospitals or dialysis centers. To bolster these efforts, the company recently announced the formation of a new scientific advisory board, or SAB, comprised of experts in nephrology, infectious disease, medical nutrition, and oncology. The SAB's mission is to provide strategic and scientific advice to core medics as we advance toward a potential commercial launch, as well as evaluate lifecycle expansion and business development opportunities for the company. I'll now turn the call over to Matt to cover financial results and cash guidance. Matt?