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Edited Transcript of CRMD earnings conference call or presentation 11-May-20 8:30pm GMT

Q1 2020 CorMedix Inc Earnings Call

Summit Jun 9, 2020 (Thomson StreetEvents) -- Edited Transcript of CorMedix Inc earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Khoso Baluch

CorMedix Inc. - CEO & Director

* Matthew T. David

CorMedix Inc. - Executive VP & CFO

* Paul Chew

CorMedix Inc. - Acting Chief Medical Officer

* Phoebe Mounts

CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal

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Conference Call Participants

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* Andrew Jacob D'Silva

B. Riley FBR, Inc., Research Division - Senior Analyst

* Daniel Ferry

LifeSci Advisors, LLC - MD & Relationship Manager

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Presentation

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Operator [1]

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Good day, everyone, and welcome to the CorMedix Inc. 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.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [2]

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Good afternoon, and welcome to the CorMedix First Quarter 2020 Earnings Conference Call. Leading the call today is Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Phoebe Mounts, Executive Vice President and General Counsel; Paul Chew, 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 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 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 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 Mr. Khoso Baluch, Chief Executive Officer of CorMedix. Khoso, please go ahead.

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Khoso Baluch, CorMedix Inc. - CEO & Director [3]

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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 CorMedix is making in bringing Neutrolin to the U.S. market for the first indication for use as a catheter lock solution for hemodialysis patients with subsequent expansion into other indications, plus an update on a number of topics pertinent to CorMedix.

Joining me on this call are Phoebe, Paul and our new Chief Financial Officer, Matt David. We will cover 4 topics. First, I'm pleased to inform you that our search for CFO to take the position of Bob 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 health care investment banking roles with a variety of financial institutions, including the Bank of America Merrill Lynch and previously Ferghana Partners, Thomas Weisel and Piper Jaffray, as well as experience on the research side at Lehman Brothers. In addition, Matt trained as a physician at NYU, which is helping effectively communicate the strategy positioning of the company where he played a key role, including most recently at Ovid Therapeutics.

We are pleased to have Matt join us at this critical stage in CorMedix's development. We are 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 project communication regarding the new drug application for Neutrolin will occur once we will receive a response from the FDA regarding the acceptance to file of our rolling submission. At this time, we are maintaining our guidance for an anticipated decision on approval of the NDA in the second half of 2020.

Now I want to address the commercial opportunity for Neutrolin. As we've previously stated, Neutrolin is the first product to have successfully completed a Phase III study for the prevention of CRBSI in hemodialysis and has done so in spectacular fashion with a reduction of over 70% in CRBSI with a p-value of 0.0006. CRBSI are a leading cost of death for patients with catheters and impose an enormous cost to our health care system. As a result, Neutrolin addresses both the critical unmet medical need and also significantly reduced cost to the health care system. This is why we are so excited about the opportunity to bring our data to the Center for Medical Care and Medicaid Services [sic] (Centers for Medicare & Medicaid Services), CMS, which pays the health care costs for around 90% of the patients who are receiving hemodialysis. CMS seek 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 technology outside the bundle while the necessary utilization data is collected to determine how to incorporate the cost of these products. In principle, TDAPA designation lasts for 2 years. However, other products already in TDAPA have been included in these programs but beyond the 2-year period. We believe and serving full line experts that Neutrolin is qualified for reimbursement under TDAPA and CorMedix is preparing its TDAPA application, which will be submitted on FDA approval of Neutrolin NDA. We believe that a TDAPA approval will dramatically speed the acceptance of Neutrolin as the standard of care for the prevention of CRBSI in hemodialysis.

Now I would like to address the market opportunity for Neutrolin in hemodialysis and other indications for use. As previously stated, we believe the U.S. market opportunity in hemodialysis to be approximately 80 million vials per year by 2025. While we have not yet discussed our pricing plans for Neutrolin, we believe that the product can garner significant market share based on the support of clinical data regarding the reduction of CRBSI infections, the potential cost savings to the health care system, the lack of alternatives and for these patients with reimbursement coverage under the TDAPA program.

Our current value-based pricing model demonstrates that there is a substantial opportunity to hemodialysis setting alone. Please also keep in mind that this does not include or take into account other indications such as oncology and TPN, which effectively more than doubles the market opportunity once CorMedix 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 Neutrolin. 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 on 2 other topics, namely the new brand win in the U.S. and selected international markets for our catheter lock solution and a KOL event that we have just scheduled when we begin with the branding.

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-new product to use. I'm pleased to inform you that we have received conditional approval from the FDA for the name of DEFENCATH, spelled as D-E-F-E-N-C-A-T-H, DEFENCATH, for our catheter lock solution. This is very exciting and provides us the opportunity to build the brand equity going forward. Over time, you would see that the name DEFENCATH will be used for the U.S., Canada and other markets where we had not yet launched. In existing markets, such as the European and Middle East markets, the brand name Neutrolin will continue to be used as catheter lock solution.

Now moving on to the KOL event. I'm pleased to inform you that CorMedix will be hosting a KOL event for investors on May 19, 2020, beginning at noon. The cycle of the events will be antimicrobial resistance; catheter-related bloodstream infections, CRBSI; and the potential for Neutrolin. Paul will be providing with further details during this call.

Finally, please review the 10-Q that we are filing today. As we previously announced, CorMedix was approved to sell $5.5 million of our New Jersey net operating losses through the same tax certificate program and use approximately $5.2 million net of commissions. We will also note that in April 2020, CorMedix was awarded a small business waiver of the NDA filing fee by the FDA. We think that filing fee in quarter 1, which we reported on our March 31, 2020 balance sheet, is 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 the refund very quickly. As a result of the New Jersey NOL sales and the reimbursement of the FDA filing fee, our pro forma cash position as of March 31, 2020, was $21.3 million.

Now let's start with our newly appointed Chief Financial Officer, Matt David. Matt?

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Matthew T. David, CorMedix Inc. - Executive VP & CFO [4]

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Thank you, Khoso, for the warm welcome and kind introduction. I'm thrilled to be joining CorMedix at such an exciting time for the company. As DEFENCATH approaches the potential regulatory approval later this year, the company will face a range of strategic decisions, all aimed at bringing DEFENCATH to patients who could benefit from it as expeditiously as possible.

As I have been coming up to speed on CorMedix and the various strategic priorities, I gained a particular appreciation for the accomplishments of the company to date and the prospects of this novel product in the substantial hemodialysis market.

As Khoso mentioned in the introduction, I have spent the majority of my career as an investment banker focused on advising small therapeutics companies on everything from various forms of capital raising to strategic initiatives. I'm eager to bring my experience in finance, capital markets and strategy to the broader CorMedix team as we move closer to the company's first approval and subsequent launch into the hemodialysis market. As both a physician and a biopharma executive, I am enthusiastic about the prospects of DEFENCATH for the targeted patient population and the health care system broadly.

While we are living in unprecedented times with the COVID-19 pandemic, I am a firm believer that the biopharma industry will triumph in the long run. Companies like CorMedix are solving clinical problems, aiming to fill unmet needs and have the potential to generate substantial value for patients and stakeholders alike in the long run.

Let me hand back to Khoso.

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Khoso Baluch, CorMedix Inc. - CEO & Director [5]

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Thank you, Matt. Now let's move to the regulatory update with Phoebe. Phoebe?

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Phoebe Mounts, CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal [6]

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Thank you, Khoso. It is a pleasure to be here again, and let me start with the granting by FDA of our request for the small business waiver and the prompt refund of NDA filing fees. We appreciate FDA's continuing efforts to work with us during the coronavirus pandemic, which has resulted in challenges and work adjustments for all of us. We are grateful for their continuing effort as we work through the NDA submission process.

Next, as Khoso mentioned, we are very happy to announce the new name of DEFENCATH for the CorMedix catheter lock solution that is intended for the U.S. market. As you know, Neutrolin is regulated as a medical device in Europe and has been CE marked for commercial distribution in several markets outside of the U.S. In the U.S., where FDA is regulating the catheter lock solution as a new drug, part of the premarket review of a product that is the subject of an NDA requires that FDA approve the proprietary name for the new product prior to launch. CorMedix saw it as an opportunity to identify a strong brand name to distinguish Neutrolin as a drug in the U.S.

CorMedix went through a rigorous process to select potential names that it believed would meet FDA's requirements. As part of the premarket review process, FDA evaluates both safety and promotional aspects of the product's proposed proprietary name. The evaluations are intended to minimize medication errors and to ensure compliance with promotional requirements by avoiding implied claims. For example, FDA conducts look-alike and sound-alike analyses to prevent medication errors in the prescribing, dispensing and administration of the drug product to the patient. We look forward to a final approval by the FDA of DEFENCATH as the proprietary name when the NDA is approved.

Next, as you know from previous updates, our primary focus has been on submitting modules for the new drug application for DEFENCATH to secure marketing authorization in the U.S. for the initial indication for use in hemodialysis patients. As Khoso stated, our next public communication regarding our NDA filing will occur once we have received a response from the FDA regarding the acceptance to file of a rolling submission. At this time, we are maintaining our guidance for an anticipated decision of approval of the NDA in the second half of 2020.

Finally, in addition to continuing with the submission of the NDA for preventing catheter-related bloodstream infections in adult hemodialysis patients, we are working on developing the regulatory pathway for additional indications for use in oncology patients and for patients requiring total parenteral nutrition, or TPN. While we focus on securing the first indication for use in adult hemodialysis patients with the data from LOCK-IT-100, we are developing protocols for expanding the indications for use in the pediatric hemodialysis patients and other patients with central venous catheters.

With that summary, let me pass the floor to Paul, to cover the KOL event. Paul?

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Paul Chew, CorMedix Inc. - Acting Chief Medical Officer [7]

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Thanks, Phoebe. Good afternoon, everyone. I'm pleased to be back and share with you the exciting event we have planned on May 19, a webinar on preventable infection in hemodialysis patients with central venous catheters.

The webinar is designed for new and existing investors. Why now? Today's COVID-19 pandemic threatens the world and shows historically the importance of preventing infection. But the constant threat of life-threatening infection is nothing new in the hemodialysis patients with catheters. In fact, COVID-19 was reported early in the pandemic in hemodialysis clinics for immunocompromised patients are closely seated together for hours at a time. Every day, they face the threat of life-threatening infection, especially from organisms resistant to last-resort antibiotics.

Now is the time to highlight the importance of infection prevention in the hemodialysis catheter patients who is the most vulnerable type of hemodialysis patients. CorMedix will broadcast a 1-hour webinar on May 19 at 12 noon Eastern, with 3 experienced key opinion leaders. This webinar will focus on the threat of antimicrobial resistance to the hemodialysis catheter patients, the daily challenges and unmet medical needs of infection prevention keenly in the hemodialysis clinic and the potential for DEFENCATH to address both of these challenges.

The call will feature Dr. Bruce Polsky from the Long Island School of Medicine and NYU Winthrop Hospital; Dr. Bruce Reidenberg from Weill Cornell Medicine; and Dr. Nelson Kopyt from the Lehigh Valley Health Network. They'll be available to answer questions following the webinar. The invitation and press release for the webinar are available on the CorMedix website, and I hope many of you will be able to attend.

With that, let me turn the floor back to Khoso.

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Khoso Baluch, CorMedix Inc. - CEO & Director [8]

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Thank you, Paul. And as stated, our goal is to maximize shareholders' value. Because hemodialysis is a very concentrated payer provider market, we continue our preparations to commercialize DEFENCATH in the U.S. whether on our own or with a strategic or commercial partner. All options are on the table and will be evaluated with this one goal in mind. We began building material functions by hiring individuals to fill senior roles in the commercial area. This gradual build-up with health path to move forward in preparing and refining our launch plans as we move closer to an anticipated decision for DEFENCATH NDA.

Over the last several weeks, we have expanded the team with additional market access payer experts. We intend to incrementally build out the team over the course of the year, followed at the end by the hiring of the field sales force, facing up in a goal-to-roll scenario message with a strategic or commercial partner.

We are now in position to step up and focus a great deal of our energy in engaging specifically with the various stakeholders within the dialysis market through direct contact, both with a large dialysis provider and with the payers, including CMS. This will provide CorMedix the strong foundation required to launch as soon as possible after the NDA approval.

Once again, let me remind you that the huge market represents a very large unmet medical need, as today there are no pharmacological agents approved in the U.S. for the prevention of CRBSI in central venous catheters. I therefore believe should DEFENCATH be approved by the FDA, it will rapidly become the standard of care in the U.S.

Now let me provide you with a top line review of the first quarter 2020. As I previously mentioned, I urge you to read the information containing report for a more complete discussion on our financial results. Total cash on hand and short-term investments, as of March 31, 2020, is $23.2 million, excluding restricted cash of $0.2 million. During the quarter, the company made selective use of facility on program, raising approximately $2.5 million net of commissions by selling approximately 268,000 shares at an average price of about $6.92 per share. Additionally, we received approximately $0.4 million in proceeding from the exercise of certain warrants. We also announced that we were approved to sell $5.5 million of our New Jersey net operating losses through the state's tax certificate program and raised approximately $5.2 million net of commissions.

These funds were received in April. With these funds, plus the $2.9 million refunded from the FDA that we received in April in connection with the small business waiver of the NDA filing fee, we have a pro forma cash position as of March 31, 2020, of $31.3 million. We believe that we have sufficient resources to fund operations into the second quarter of 2021, including initial preparation for commercial launch of DEFENCATH after approval by the FDA.

For complete cash spend, defined as cash used in operations, was $8 million during the first quarter 2020. While this was substantially higher than the previous quarter, a large portion of that bond was represented by the refundable filing fees, plus approximately $0.7 million of incremental June expense, primarily to support pre-launch activities.

Excluding the impact of the refunded NDA filing fee, our going rate is likely to modestly increase over the next 2 quarters as we continue preparation for commercialization and commence manufacturing of DEFENCATH for the sale after approval.

So let me turn now into key takeaways from this call. What Matt, Phoebe and Paul covered with you hopefully provides you with insight into the work efforts on which we are focused and that have occurred over the last 2 months. I'm pleased about the progress we are making despite challenges imposed by the coronavirus pandemic. I want to re-emphasize: First, I'm delighted that Matt has joined CorMedix as we prepared for approval of DEFENCATH; two, we are extremely pleased that the effort to make the regulatory process forward with the FDA is on track; we are maintaining our guidance for an anticipated decision on approval of the NDA in the second half of 2020; we are pleased with the conditional approval from the FDA of DEFENCATH brand name, this provides us with a tremendous opportunity to start the process to grow equity around this name; and finally, we're continuing our financial strategy, which is to explore available alternatives to ensure the company is appropriately funded to execute on our plans.

Our current cash is sufficient to fund a portion of [entity] required for loan and to build some of the commercial leadership infrastructure.

Finally, a reminder that while we are initially focused on the hemodialysis market, we are beginning to seek additional indications for DEFENCATH used in catheter, oncology and TPN patients. We have had previous discussions with the FDA on clinical trial design for use of the catheter lock solution in oncology and TPN and are working to develop the protocol with a goal of finalizing the regulatory pathway for these patient groups.

Our goal is to maximize shareholders' value. I continue to believe that once DEFENCATH is approved, it will become the standard of care for preventing catheter-related bloodstream infections in hemodialysis patients.

As Phoebe discussed, the last year has been very productive in moving DEFENCATH through the required regulatory process with a diligent focus on securing U.S. margin approval. I'm very pleased with the strength of our management team. Each of the team members bring a unique mix of skills and experience. The team will continue to evolve over the coming quarters in area of strategic needs.

The strategy we embarked on a few years ago will continue to move forward at an ever-increasing pace. I look forward to providing you with material development updates via the CorMedix website, press release and conference call. Thank you for your continued support of CorMedix. And let me hand the call back to the operator. Thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll take our first question from Andrew D'Silva with B. Riley FBR.

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Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [2]

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Just a couple of quick ones for me. I think you mentioned your 10-Q might be out later today, but just so I have it. Could you let me know what depreciation and amortization and stock-based comp was for the quarter? And then while you're pulling that, could you give just a little bit of color on COVID-19's impact, if any, on just your ability to acquire talent? Have you been able to continue to identify appropriate members that you would expect to onboard closer to an approval? Or has there been a substantial disruption due to COVID-19? And I'm specifically interested as it relates to sales and marketing.

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Khoso Baluch, CorMedix Inc. - CEO & Director [3]

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Yes. Thank you, Andy, for your question. The first part of your question, I would suggest if you look in our 10-Q that we have submitted, and we will then do a follow up with you post this call to answer if you still have any questions there.

As it relates to the COVID-19, let me give you some further background. In the interest of our employees and their families, we closed our Berkeley Heights, New Jersey office in the middle of March and we also report to work remotely from home, and we are continuing to work very collaboratively in a remote setting. And as you can see, we have been hiring individuals that I've outlined. Matt is one of them, but there are other individuals we have been hiring during this period. So it did not -- impacted our ability to continue to move our programs forward and, specifically, in terms of hiring at the moment. There's a lot of video conferencing capabilities, and we've moved our face-to-face meetings to video conferencing, and that has done a pretty good job.

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Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [4]

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Okay. Great. Great. And just as it relates to TDAPA, you had a lot of commentary on that during the prepared remarks. Did anything new evolve related to TDAPA? Or were you just effectively reiterating your belief that you should be able to qualify under it?

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Khoso Baluch, CorMedix Inc. - CEO & Director [5]

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Number one, we are reiterating our firm belief from where we stand on TDAPA. And as we have brought on board individuals moving in the market access payer environment, coding and reimbursement aspects, they have also had an opportunity to continue to kick the tires and begin to have daily discussions not just internally but externally to the company with experts in that space. And the belief continues to be very firm that we will be eligible to TDAPA and expect to get TDAPA once we have the NDA approval.

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Andrew Jacob D'Silva, B. Riley FBR, Inc., Research Division - Senior Analyst [6]

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That would be great to see. Absolutely. And just kind of lumping 2 COVID-19 questions together. The discussion around infectious diseases has to be extremely relevant right now. Has that changed anything with just your discussions with regulators or potential partners, the likes of DaVita or Fresenius?

And then as it relates to COVID-19 and your NDA, has the FDA released any of the earlier restrictions just related to ex-U.S. facility inspections? And that's everything for me.

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Khoso Baluch, CorMedix Inc. - CEO & Director [7]

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Okay. Phoebe, I will ask you to please respond as far as the FDA and regulatory comments are concerned. And then I'll come back to cover the other discussion. So Phoebe?

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Phoebe Mounts, CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal [8]

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Yes. Thank you for the question, Andy. We have not had any follow-up from FDA to suggest that there will or will not be any delays in the ex-U.S. facility inspection. So I think everyone is still hoping very much that we can turn things around quickly. But at the moment, as you know, FDA is under travel restrictions.

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Khoso Baluch, CorMedix Inc. - CEO & Director [9]

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And Andy, to your question about discussions with dialysis providers, we are always having discussions with a whole range of individuals, including the large dialysis providers. Obviously, the substance of those discussions are not for prime time at present. As I said during the prepared remarks, we will continue to have deeper and more specific discussions with individuals in the dialysis provider setting, but also with CMS as we go forward and we prepare ourselves for the approval, or once we get approval of DEFENCATH here in the U.S.

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Operator [10]

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And with no further questions in the queue, at this time, I would like to turn the call back over to Dan Ferry for some additional questions.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [11]

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Thank you, operator. I have some questions that we have received from the audience, from investors, leading up to today's earnings call.

The first one is for Paul. Paul, is there going to be any new information shared during this KOL event that you referenced?

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Paul Chew, CorMedix Inc. - Acting Chief Medical Officer [12]

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Thanks, Dan. The KOL event next week will provide information to investors and analysts from the perspective of clinical experts. We're moving through uncharted territory with COVID-19, and this has impacted our hemodialysis patients, and our KOLs will share the challenges these very vulnerable patients are facing going through this as well as CRBSI. This is an opportunity for investors to talk to KOLs who have their own thoughts on their patients and the market for current medical need.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [13]

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Great. Thanks, Paul. The second question is for Matt. Matt, as you have not been a CFO in the past, why do you think you can do this role?

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Matthew T. David, CorMedix Inc. - Executive VP & CFO [14]

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Sure. No problem. Happy to take your question. Sure. As part of my experience as a health care investment banker for many years, I worked closely with many CFOs, and I'm familiar with the role and responsibilities that go with it.

Given where CorMedix is now as a company, the capital markets and strategic adviser experience may be particularly relevant here. I've said the last couple of years working within companies, including most recently as Head of Strategy at Ovid Therapeutics, a public company, where I was responsible for financing strategy and investor relations. Lastly, I'm grateful to have the support of a talented team and Bob's experience close at hand during this transition. Hope that helps.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [15]

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Thanks, Matt. Okay. And Phoebe, I have a couple for you. So Phoebe, with the rolling submission, is the FDA reviewing each section as it is submitted? And if not, what is the value of the rolling submission?

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Phoebe Mounts, CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal [16]

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Those are good questions, Dan. Thank you. FDA's program provides both for the rolling submission and rolling review of modules. So we're very grateful that the FDA granted us the opportunity to use the rolling submission and review program and appreciate the agency's efforts to help us address as quickly as possible the unmet medical need of reducing CRBSI for hemodialysis patients.

For the second question on the value of the rolling submission and review, it is intended to provide efficiency and time-saving to both the sponsor and the FDA. The sponsor can submit sections or modules of related information as it is completed, and the FDA can begin reviewing information as it is received. FDA can then request additional information as it's needed for the submitted module while respond to works on the preparation and submission of additional modules and responses to the request for additional information from the agency in real time. Thank you.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [17]

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Thanks, Phoebe. And as you can imagine, I have a few more here. What percentage of the NDA modules has been submitted? And why not tell us when you have completed the filing?

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Phoebe Mounts, CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal [18]

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Well, as I'm sure everyone knows, we're -- as I said in the past on the calls, there is a significant amount of information that needs to be submitted for an NDA, and there is ongoing dialogue with the FDA during the process, as I just noted. We appreciate your interest in our progress on submission of the modules. But the clinical information is really one the FDA has accepted the NDA for filing, because it has deemed that the NDA is sufficiently complete for FDA to review it. So I can assure you that preparation of the NDA is a priority for CorMedix, and we are all aware of the imperatives to work diligently to prepare and submit the information. Thank you.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [19]

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Great. And Phoebe, one last one. Thank you again for your time. Do you still believe that you can potentially get approval in the second half of 2020?

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Phoebe Mounts, CorMedix Inc. - Executive VP, General Counsel, Secretary & Head of Regulatory, Compliance and Legal [20]

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At this time, we are maintaining our guidance for an anticipated decision on approval of the NDA in the second half of 2020. We are all very cognizant of preparing an NDA that is complete and provides all of the information in the agency's required format to ensure an efficient review. We focused on discussions with FDA in 2019 to make sure that we understood the FDA's expectations to evaluate the manufacturing as well as safety and effectiveness of DEFENCATH. We also believe that by being attentive to the quality and completeness of the submission that we are assisting the FDA to achieve an efficient review process to enable approval in the second half of 2020.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [21]

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Okay. Thanks, Phoebe. Matt, I have another one for you. The question is, you do not have cash to cover your burn rate. And therefore, you're going to need to do a financing in the near term? What are your plans? Are you guys going to dilute us?

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Matthew T. David, CorMedix Inc. - Executive VP & CFO [22]

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Sure. Happy to take that one. This is Matt David. We have stated that we have sufficient cash into 2Q of '21. As any biopharma company, we have multiple routes towards funding the company and we'll evaluate these alternatives while maintaining shareholder value in mind. Beyond that, we are not going to discuss timing or other specifics related to potential financing or strategic activities.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [23]

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Great. Thanks, Matt. And Khoso, one final question for you. Have you talked or spoken to any strategic partners?

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Khoso Baluch, CorMedix Inc. - CEO & Director [24]

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Pleased to answer your question, Dan. I have previously stated publicly that we will actively pursue whatever part is in the best interest of our shareholders, and that includes looking at strategic partners. Clearly, we will not provide any information of such matters, discussions or any of that until and when disclosure is required. Thank you.

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Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [25]

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Okay. Thank you, Khoso. Those are the questions that I have prepared based on the activity leading up to this call. I'd like to turn it back over to you, Khoso, for closing remarks.

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Khoso Baluch, CorMedix Inc. - CEO & Director [26]

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Thanks, Dan. So CorMedix remains committed to bringing DEFENCATH to the U.S. market, whether on its own or with a strategic or commercial partner to help patients in need of protection from life-threatening infections. The importance of preventing infection is even more apparent during this coronavirus pandemic.

Thank you all for your time and your attention, and have a good evening. Goodbye.

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Operator [27]

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And again, this does conclude today's conference. We thank you for your participation. You may now disconnect.