Good afternoon, and welcome to the CorMedix's Fourth Quarter 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. I would now like to turn the conference over to Daniel Ferry from LifeSci Advisors. Please go ahead.

Good afternoon, and welcome to the CorMedix's fourth quarter and year-end 2021 earnings conference call. Leading the call today is Dr. Matt David, Interim Chief Executive Officer and Executive Vice President, and Chief Financial Officer of CorMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel. 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 marketing approval for DefenCath in the U.S. and other product candidates; future financial position; future revenues and projected costs; and potential market acceptance of DefenCath, Neutrolin, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the 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 the 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 the clinical development, regulatory approvals and commercialization. These risks are described in greater detail in CorMedix'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 CorMedix. CorMedix 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 CorMedix 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 Dr. Matt David, Interim Chief Executive Officer and Chief Financial Officer of CorMedix. Matt, please go ahead.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. While it has been an incredibly busy time, we are excited to be here this afternoon to discuss CorMedix updates as well as reflect on our priorities as a company over the coming months. On today's earnings call, we will discuss the fourth quarter and full-year 2021 financial information and the overall progress CorMedix is making in bringing DefenCath to the U.S. market for its first indication for use as a catheter lock solution for the hemodialysis patients to reduce catheter-related bloodstream infections. Let's begin with the topics for discussion today. On February 28, we announced that CorMedix had resubmitted the DefenCath NDA to the FDA in parallel with our third-party contract manufacturer or CMO, submitting responses to the deficiencies identified at the manufacturing facility in the post-application action letter issued by the FDA concurrently with the CRL in 2021. The CorMedix team, led by Phoebe, worked tirelessly in conjunction with our CMO in order to reach that important milestone for CorMedix. Yesterday, we were very pleased to share that the FDA has accepted the NDA resubmission for filing and begun the review process. Phoebe is here to provide details on our progress on the regulatory and manufacturing front since our last update. As we continue to chart a course towards the potential DefenCath approval and launch, CorMedix announced recently that the Board has appointed Joe Todisco as Chief Executive Officer. Joe brings significant experience in commercial operations, leadership and business strategy to our organization and has spent the last 10 years building and leading commercial organizations globally across multiple therapeutic areas. Most recently, Joe served as Chief Commercial Officer of Amneal's Specialty business, where he was responsible for managing and growing a $400 million…

Thank you, Matt, and good afternoon, everyone. I am very pleased to be able to report that FDA has accepted the DefenCath NDA resubmission for filings. I would like to start with my gratitude to the resubmission team of [Ray Osterio], Amaru Sanchez, Jessica Vaughn and Sibu Varghese and express my appreciation for being able to work with dedicated individuals whose hard work and expertise have enabled CorMedix to move DefenCath a step closer to FDA approval and reducing life-threatening catheter-related bloodstream infections in patients. As we had announced late last month, we believe the resubmitted NDA for DefenCath provided the data requested by FDA in the Complete Response Letter, or CRL. In parallel, we worked collaboratively with the company's third-party contract manufacturer and believe it address the deficiencies identified at the manufacturing facility in the post-application action letter issued by FDA to the manufacturer concurrently with the CRL. FDA reviews the NDA resubmission for completeness and made a filing decision. In accepting the resubmission for filing, FDA informed CorMedix that the resubmission is complete and considered a Class II response to the action letter. FDA's policies and procedures defined Class II resubmission essentially as a resubmission that includes any item not specified as a Class I item, which is an explicit list of nine items, such as minor reanalysis of data previously submitted. The DefenCath resubmission has new manufacturing data that has not been previously submitted to FDA and is therefore considered Class II with a six-month review cycle. As we had previously discussed, FDA had stated that resolution of the deficiencies may require a pre-approval inspection of the manufacturing facility. We have learned from our manufacturing partner that it has been notified by FDA already that the FDA will conduct an inspection. We believe that CorMedix and the…

Thanks, Phoebe. Next, I will provide an overview of our fourth quarter and full-year 2021 financial results as well as an update on CorMedix's cash position. The company has filed its report on Form 10-K for the full-year ended December 31, 2021. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our fourth quarter 2021 financial results, the company has cash and equivalents and short-term investments of $65.5 million as of December 31, 2021, including approximately $3 million in net proceeds from our ATM program in the first quarter of 2022, CorMedix has December 31, pro forma cash and equivalents of $68.5 million. Our net loss was approximately $7.8 million or $0.20 per share compared with a net loss of $6.1 million or $0.19 per share in the fourth quarter of 2020. The higher net loss recognized in the fourth quarter of 2021 compared with the same period in 2020 was driven by increases in costs related to the manufacturing of DefenCath prior to its potential marketing approval and non-cash charges for stock-based compensation. We recorded an increase in SG&A and an increase in R&D expenses. Operating expenses in the fourth quarter of 2021 increased approximately 28% to $7.8 million compared with $6.1 million in the fourth quarter of 2020. R&D expense increased by approximately 41% to $3.2 million, driven primarily by an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval and to a lesser extent, by an increase in consulting fees and an increase in non-cash charges for stock-based compensation. SG&A expense increased approximately 21% to $4.6 million compared with $3.8 million in the fourth quarter of 2020. This increase was driven by an increase in non-cash charges…

Thank you. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Please proceed.

Hi. Thanks for taking the questions and congrats on the progress, great to see. First one, Matt, have you received a PDUFA date from the FDA yet? And can you share that with us? And then on the reimbursement side of things, are you still planning to pursue reimbursement under the TDAPA program? And what would the timelines be based on your PDUFA date? Thanks.

Thanks, Jason. First on the PDUFA side, I'll pass things to Phoebe to start. Thanks.

Thanks, Jason. Thanks, Matt. As I'm sure most folks know the Prescription Drug User Fee Act, or PDUFA, sets performance goals for FDA for completion of agency review. And those are goals, performance goals and not statutory timelines imposed on FDA. So everyone is cognizant of issues that can develop during the review process that may impact the timeline. And given the COVID-19 pandemic, everyone is acutely aware of unforeseen disruptions of travel and planned activities. So given the potential for changes, we are prepared to work within the six-month review cycle, and we're hoping for the best. So we will provide updates to investors if there are significant delays that occur in the review timeline, but we're hopeful that the six months of review will be sufficient.

Thanks, Phoebe. And I'll just jump in, on your other part of your question, Jason, which was about TDAPA, I think. Yes, as you know, we're evaluating all the alternatives, but continue to believe TDAPA route is an important one for products in the renal space. We've talked about the timing before, which is that you apply following an approval. And so it takes, depending on the timing of the quarterly cycle, it takes one to two quarters.

Got it. Great. And then just a second one for me, you said that you were – forgive me if I'm not quoting you exactly, but confident that the planned inspection, manufacturing inspection can happen within the six-month window. Is that inspection already scheduled? Or what gives you the confidence that FDA can get that done within the six-month period?

Phoebe?

We’ve learned from the manufacturers that FDA has reached out to them about scheduling the inspection. So based on the discussions that are ongoing, I'm confident that we'll get it done in the six months.

Okay. Great. And then just last one for me. As you work through the commercial preparations, are you having any direct interactions with the leading dialysis providers? Or can you just give us any more color there about how you're building awareness of the products and the data set?

Yes. No, absolutely. Thanks, Jason. Yes, as we touched on, there's a number of things that the CorMedix team is doing to prepare for commercial launch. The team has been expanding our understanding of the DefenCath opportunity through market research, payer research and really continuing that work on the pharmacoeconomic side. We have broadened our understanding of the patient journey for a renal failure patient. That includes all the components from placement of a central venous catheter to initiation of hemodialysis to inpatient visits and beyond. And so we will begin to recruit. I think some of the key commercial roles as we prepare for a potential launch, but we're just really continuing on that work and laying some of the groundwork at this point. I think once Joe gets up to speed and really begins on the CorMedix side, we'll talk a little bit more about the commercial strategy. So you'll get some of that detail in the future.

Okay, great. Thanks again for taking the questions and again congrats on all the progress.

Thanks, Jason.

Thanks, Jason.

Our next question is from Joon Lee with Truist. Please proceed.

Hey, thanks for taking our question as well. I believe the wording in the prior press release was that the onsite inspection has been scheduled. If and when that happens, would you consider that to be a disclosable item, given the deficiencies related to the CMO?

Phoebe?

That's the conversations that occur between FDA and the manufacturer. That's not information that CorMedix is that we're willing to disclose.

Got it. And when Mr. Todisco joins the company, what will be his first order of business? And in fact, when is he actually going to be joining the company? I know that he has some obligations to his current employer, but just curious what the timing could be?

Yes. No problem. Thanks for the question. Thanks for joining today, Joon. Yes. So as we've said before, I think in our press release and today, Joe is expecting to join on or around May 16. And really, in terms of priorities, I'll certainly let him go through that with you, but I believe some of the very first orders of business is to kind of get in there and start setting the tone from a commercial strategy perspective. As Phoebe, walked you through today, we have a timeline, right. We've got some great news that we received this week that we were so excited to share as it relates to the acceptance of the submission and our six-month review cycle. So I think it really is going to be figuring out step one, two, three, four and beyond, making sure that we are prepared upon that anticipated approval to bring DefenCath to patients.

Great. And then last question. What's assumed in your cash burn guidance through first half of 2023?

Sure. No, it's a great question. So as we said, the cash guidance includes items such as commercial supply for launch and the initial stages of the commercial launch. And so that factors in that. I think what you'll see, as you think about the rest of the year, is that things will – less so in the beginning of the year, but really as you get towards the second half of the year begin to dial up from a spend perspective as we need to ramp up each of those components to ready the company for a commercial launch.

All right. Thanks for the questions and looking forward to the updates.

Thanks, Joon.

Our next question is from Rohit Bhasin with Needham & Company. Please proceed.

Hi. This is Rohit on for Serge. Thanks for taking my question. Is there anything you can tell us in terms of pricing of DefenCath? And have you had any recent discussions with payers?

Sure. No, thanks, Rohit, and thanks for joining us today. Yes, on – for pricing, I think I mentioned during the call, we have discussions with payers, including CMS, obviously, a very significant payer for the renal space often and all the time. So that's ongoing. In terms of specific pricing as it relates to DefenCath, we continue to work through the pharmacoeconomic data that we described before, and hopefully, we'll share more this year and continue the dialogue with payers in the space. So we really would plan to discuss pricing around the time of a potential approval.

Great. Thank you.

Ladies and gentlemen, there are no further questions at this time. I will now hand the call back to Daniel Ferry for questions from the audience.

Thank you, operator. Matt, our first question is regarding Joe's joining in mid-May. Matt, does that mean you will stay on at CorMedix and focus on CFO responsibilities?

Thanks for the question. Yes, I am planning on continuing to serve as CorMedix' CFO, as I have since May 2020. I am proud of what we have accomplished as a team over these past six months and look forward to working with Joe as we guide the company strategy going forward. Thanks.

Thanks, Matt. Okay. And another one here on the commercial side of things. Can you comment on plans for additional indications like pediatrics, TPN, oncology?

Sure. We have discussed in the past that CorMedix plans to pursue opportunities to broaden the use of DefenCath following an approval. And we've continued to expand our understanding of the various patient groups that use central venous catheters. We'll aim to discuss these in more detail during subsequent calls.

Excellent. And on the balance sheet, Matt, will CorMedix need to raise money in order to launch DefenCath? And what options are available to the company?

Thanks, Dan, and thanks for whoever submitted the question. It has always been a priority to make sure that CorMedix has adequate funding to accomplish our strategic goals. As we mentioned, our cash guidance through the first half of 2023 includes costs related to the initial stages of a commercial launch. Despite the turbulence in the markets, I think that we will have access to a similar range of alternatives as other commercial stage companies. So equity, convertible debt, royalty financing, et cetera.

Understood. Thanks, Matt. I'd like to turn the floor back over to you for closing remarks.

Thanks, Dan, and thanks, everyone, for the questions and your continued support of CorMedix. We are pleased to be able to share these updates with you today. CorMedix remains committed to bringing DefenCath to the U.S. market to help patients in need of protection from life-threatening infections. The importance of reducing the incidence of infections and keeping patients out of the hospital had been even more apparent during the ongoing COVID-19 pandemic. Thank you for your time and attention and have a good evening.

This concludes today's conference. Thank you very much for your participation. You may now disconnect.