CorMedix Inc.

Greetings. Welcome to the CoreMedix fourth quarter and fiscal year 2020 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Instructions will be given at that time. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the call over to your host, Dan Ferry. Please go ahead.

Good afternoon, and welcome to the CoreMedix fourth quarter and fiscal year 2020 earnings conference call. Leading the call today is Kosa Blosch, Chief Executive Officer of CoreMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel, and Dr. Matt David, Executive Vice President and 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 and marketing approval for DefendCath in the U.S. and other product candidates. Future Financial Position, Future Revenues and Projected Costs, and 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 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, 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 CoreMedix's 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 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 Baloch, 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 earnings call, we will discuss fourth quarter and fiscal year 2020 financial information and the overall progress CoreMedix is making in bringing defend caps to the U.S. market for its first indication for use as a catheter-lock solution for hemodialysis patients to reduce catheter-related bloodstream infections. Joining me on this call are Phoebe and Matt. 2020 was a year where CoreMedix continued to make significant strides. CoreMedix added to the team, including our appointment of Matt David, MD, as the company Executive Vice President and Chief Financial Officer, and other senior-level hires on the market access and medical affairs side to help prepare the company for our anticipated commercial launch of DefendCal. In July, CoreMedix announced a 23 million equity financing that brought in capital, new institutional holders, and broadened our Wall Street relationship with banks and research analysts. Late in the summer, CoreMedix announced the acceptance by the FDA of our new drug application, the NDA, for DefendCat. Our product candidate to be used as a catalog solution in hemodialysis patients for the prevention of catheter-related bloodstream infections, CRBSI. The FDA also granted priority review and set a prescription drug user fee act, which is called PDUFA, date of February 28, 2021, for the completion of its review for approval of the NDA. In the fall, CoreMedix added two new board members, Paulo Costa and Greg Duncan. Paulo brings decades of leadership experience in the pharmaceutical sector as President and CEO of Novartis U.S. Corporation. He has also demonstrated his strategic insight as Chairman of Amblin Pharmaceutical through its successful fail to BMS and AstraZeneca. Greg also brings decades of commercial leadership experience across a range of therapeutic areas, as well as experience in strategic transactions during his time at both Pfizer and UCB. As we rolled into 2021, CoreMedix announced in January that we plan to transition to the NASDAQ platform, which we have said is a better fit with more of our biopharma peers, as well as more high-growth companies. Just a few weeks ago, we announced that the U.S. Food and Drug Administration, the FDA, cannot approve the new drug application for Defencath in its present form. FDA noted concerns at the third-party manufacturing facilities after a review of records requested by the FDA and provided by the manufacturing facility. All of the above took place during the pandemic, and while we were not pleased with the recent news, we were pleased that the FDA did not have any further questions about the efficacy and safety of DefendCab. We outlined during our March 9 call with investors that we will work with both the FDA and the Contract Manufacturing Organization, or CMO, to resolve the deficiencies identified by the FDA. Our plan, as we outlined, is to have a meeting mid-April with the FDA and discuss the resolution plans with the FDA. Once we have the meeting with the FDA, we will provide further updates. Now, in the meantime, we continue to use our time to focus our efforts on three fronts. First, working with the CMO to resolve the third-party manufacturing deficiencies and meeting with the FDA. Second, continue to connect with the hemodialysis community and prepare core medics to successfully launch DEFENCAT when approved by the FDA. And thirdly, preparing the clinical study protocols for DEFENCAT label expansions so that in a post-approval setting we will be able to start those studies in a timely manner. We are proceeding with these plans while conserving cash so that financially we have the resources required to successfully bring DependCast to patients in the U.S. market. Now let's move to the first topic. Follow up to the March 9th regulatory update we provided. Phoebe?