CorMedix Inc.

Please stand by. We're about to begin. Good day, everyone, and welcome to the CoreMedix Incorporated First Quarter 2020 Earnings Conference Call. Today's call is being recorded. 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 CoreMedix First Quarter 2020 Earnings Conference Call. Leading the call today is Kosa Belush. Chief Executive Officer of CoreMedix. He is joined by Phoebe Mounts, Executive Vice President and General Counsel, Paul Chu, Chief Medical Officer, and Matt David, Chief Financial 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 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 for Neutrolin in the U.S. and other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of Neutrolin and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost results 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 or other business development 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 CoreMedix filings with the SEC. and more, 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 is now my pleasure to turn the call over to Mr. Koso Baluch. Chief Executive Officer of CoreMedix. Koso, please go ahead.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's call, we will cover several topics with you on the overall progress CoreMedix is making in bringing nutrition to the U.S. market for the first indication for use as a capital loss solution for human dialysis patients. with subsequent expansion into other indications, plus an update on the number of topics pertinent to call medics. Joining me in this call are C.B., Paul, and our new Chief Financial Officer, Matt David. We will cover five topics. First, I'm pleased to inform you that our first-year CFO to take the potential job has been completed. I'd like to introduce our new CFO, Matt David. Matt brings a wealth of capital markets and advisory experience, having spent the majority of his career in the healthcare investment banking world, with a variety of financial institutions, including the Bank of America, Merrill Lynch, and previously, Fergan Partners, Thomas Riles, and Piper Jeffrey, as well as experience on the research side at Lehman Brothers. In addition, Matt trained as a physician at NYU, which has helped him effectively communicate the strategy, positioning of the company, while he's played a key role, including most recently at Ovis Therapeutics. We're pleased to have Matt join us at this critical stage in co-medics development. We're also fortunate that Bob Cook is available to assist Matt to ensure a seamless transition. Although today is Matt's first day, we have already started the process of bringing Matt up to speed on ongoing activities and strategic priorities for the company. Secondly, as we've previously stated, our next public communication regarding the new drug application for Nutrilite will occur once we have received a response from the FDA regarding the acceptance to file of our rolling submission. As we've previously stated, Nutrient is the first product to have successfully completed a phase three study for the prevention of CRBSIs in human dialysis and has done so in spectacular fashion with a reduction of over 70% in CRBSIs with a p-value of 30,0006. CRBSIs are a leading cause of death for patients with catheters and impose enormous costs to our healthcare system. As a result, mutual address is both a critical unmet medical need and will also significantly reduce costs to the healthcare system. This is why we're so excited about the opportunity to bring our data to the Center for Medical Care and Medicaid Services, CMS, which pays the healthcare costs for around 90% of the patients who are receiving hemodialysis. CMS pays for a significant amount of the cost of hemodialysis under the program for end-stage renal disease patients referred to as the bundle, a fixed reimbursement arrangement which has historically been an impediment to the adoption of new technology and better care for patients undergoing hemodialysis. However, in recognition of this issue, CMS now has a program to accelerate the adoption of new treatments that can both improve patient care and or reduce costs. This program is called TDAPA, which stands for Transitional Drug Add-on Payment Adjustment, which allows for reimbursement of new technologies outside the bundle while the necessary utilization data is collected to determine how to incorporate the cost of these products. In principle, T-WAPA designation lasts for two years. However, other products already in T-WAPA have been included in this program for beyond a two-year period. We believe, and so do external experts, that Nutrient is qualified for reimbursement under T-WAPA, and CoreMedix is preparing its T-WAPA application, which will be submitted under FDA approval of Nutrient NDA. We believe that a T-DAP approval will dramatically speed the acceptance of nutrients as a standard of care for the prevention of CRDSI in hemodialysis. Now I would like to address the market opportunity for nutrients in hemodialysis and other indications for use. As previously stated, we believe the U.S. market opportunity in human dialysis to be approximately 80 million vials per year by 2025. While we have not yet discussed our pricing plans for Nutri, we believe that the product can garner significant market share based on the support of clinical data regarding the reduction of CRDSI infections. The potential cost savings to the healthcare system The lack of alternatives and for these patients to reimburse with coverage under the GWAPA program. Our current value-based pricing model demonstrates that there is a substantial opportunity in the hemodialysis setting alone. Please also keep in mind that this does not include or take into account other indications such as oncology and TPM. which effectively more than doubles the market opportunity once CoreMedix is able to secure FDA approval for those indications. We are excited as we continue through the regulatory process and begin preparing for the commercial launch of Nutrient. Our goal is to do it as quickly and efficiently as possible while maximizing value to our shareholders. Matt David, as well as other recent hires are all necessary and welcome additions to our management team, and they will help us achieve our goals. I'd also like to turn our attention to two other topics, namely the new brand name in the U.S. and selected international markets for our capital loss solution and a parallel event that we have just scheduled. When we begin with the brand name, As Phoebe will discuss, FDA regulates the brand name that any company uses for its drug product, and the agency must review and approve the brand name prior to use. I'm pleased to inform you that we have received conditional approval from the FDA for the name of DefendCat, spelled as D-E-S-E-N-C-A-T-H, DefendCat, for our catalog solutions. This is very exciting and provides us the opportunity to build the brand equity going forward. Over time, you will see that the name Defeat Camp will be used for the U.S., Canada, and other markets where we have not yet launched. In existing markets, such as the European and Middle East markets, the brand name Defeat Camp will continue to be used as a catalog solution. Now moving on to the KOL event. I'm pleased to inform you that CoreMedix will be hosting a KOL event for investors on May 19, 2020, beginning at noon. The title of the event will be Antimicrobial Resistance, Catheter-Related Blood Screen Infection, CRBSI, and the Potential for Neutrin. Paul will be providing you further details during this call. Please review the 10Q that we are filing today. As we previously announced, CoreMedix was approved to sell 5.5 million of our new Jersey net operating losses through the state tax certificate program and raise approximately 5.2 million net of commissions. We will also note that in April 2020, CoreMedix was awarded a small business waiver of the MDA filing fee by the FDA. We paid that filing fee in Q1, which we reported on our March 31, 2020 balance sheet, as a refundable deposit, and which was reimbursed by the FDA in April. The filing fee amount was $2.9 million. We were pleased to be given the waiver and a refund very quickly. As a result of the New Jersey NRL sale and the reimbursement of the FDA filing fee, Our pro forma cash position as of March 31st, 2020 was $31.3 million. Now, let's start with our newly appointed Chief Financial Officer, Matt Raven. Matt?