CorMedix Inc. (CRMD) Q4 2020 Earnings Report, Transcript and Summary

Greetings. Welcome to the CorMedix 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. [Operator Instructions] As a reminder, 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 CorMedix fourth quarter and fiscal year 2020 earnings conference call. Leading the call today is Khoso Baluch, Chief Executive Officer of CorMedix. 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 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 and marketing approval for DEFENCATH in the US 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 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 CorMedix 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.

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 CorMedix is making in bringing DEFENCATH to the US 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 CorMedix continued to make significant strides. CorMedix 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 DEFENCATH. In July, CorMedix 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, CorMedix announced the acceptance by the FDA of our new drug application, the NDA, for DEFENCATH. Our product candidates to be used as a catheter lock 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, CorMedix 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 Amylin Pharmaceuticals through its successful sale 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, CorMedix 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 facility 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 DEFENCATH. 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 CorMedix to successfully launch DEFENCATH when approved by the FDA; and thirdly, preparing the clinical study protocols for DEFENCATH 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 preserving cash, so that financially we have the resources required to successfully bring DEFENCATH to patients in the U.S. market. Now, let's move to the first topic. Follow-up to the March 9 regulatory update we provided. Phoebe?

Thank you, Khoso. Good afternoon, everyone. I will start with the all-important timeline. The timeline we outlined on March 1 and reiterated on March 9 for a planned meeting with the FDA in mid-April remains on track based on the progress we have made. We have been working intensely with our third-party manufacturing facility to develop the proposed resolutions to the deficiencies. There has been a strong collaborative effort to develop responses for each of the six deficiencies identified by FDA for the manufacturing facility. In addition, we have developed the protocol for the manual extraction study being required by FDA to demonstrate that the labeled volume of the drug product can be consistently withdrawn from vials. I am pleased to announce that FDA has granted our request to meet with them to begin resolving the outstanding deficiencies. As we have previously stated, the purpose of the meeting with FDA is to obtain agreement with the agency on the adequacy of our proposed plans for resolution of the deficiencies. Our contract manufacturing organization will join us in the meeting with FDA. As we planned, the meeting will occur in mid-April, and we will provide an update on our progress and timeline for resolution of the deficiencies after the meeting with FDA. Our goal is to ensure that FDA can conclude that the manufacturing facility is ready to support commercial operation for DEFENCATH without the need for an on-site inspection. As I have explained on previous calls, FDA identified the deficiencies based on a review of records that it had requested from the CMO. There was no on-site inspection due to travel restrictions in place because of the ongoing COVID-19 pandemic. The travel restrictions have resulted in an ever-increasing backlog of inspections at the agency. We are hopeful that FDA will continue to recognize the potential for DEFENCATH to address an unmet medical need of reducing life-threatening, catheter-related bloodstream infections, and complete the review of the manufacturing facility using the records review approach to approve the NDA as quickly as possible. Thank you. And I will now turn the call back to Matt, to cover financial results and cash guidance. Matt?

Thanks, Phoebe. I am pleased to be here today to provide an overview of our fourth quarter and full year 2020 financial results, as well as an update on recent financing activity. The company has just filed its report on Form 10-K for the fourth quarter and year ended December 31, 2020. 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 of 2020 financial results, our net loss was approximately $6.1 million or $0.19 per share compared with a loss of $5.3 million or $0.21 per share in the fourth quarter of 2019. The higher net loss recognized in 2020 compared with 2019 was due to increased expenses related to our preparations for DEFENCATH's commercial launch. We recorded increases in both SG&A, as well as R&D expenses. Operating expenses in the fourth quarter of 2020 increased approximately 13% to $6.1 million compared with $5.4 million in the fourth quarter of 2019. R&D expense decreased by approximately 14% to $2.3 million, driven primarily by decreased spend on clinical trial costs and to a lesser extent by fewer manufacturing-related costs for the quarter. SG&A expense increased approximately 41% to $3.8 million compared with $2.7 million in the fourth quarter of 2019. This increase was driven by increased costs related to market research in preparation for the potential approval of DEFENCATH and higher staffing costs due to additional hires. We recorded net cash used in operations during the fourth quarter of 2020 of $5.9, primarily driven by increases in operating expenses due to higher SG&A expenses related to market research and preparation for the potential approval. This compares with net cash used in operations of $3.9 million, we recorded in the fourth quarter of 2019. results. With respect to our full year 2020 financial results. Our net loss for 2020 was approximately $22 million or $0.77 per share compared with a net loss of $16.4 million, before recognition of deemed dividends or $0.68 per share in 2019. The higher net loss recognized in 2020 compared with 2019 was due compared with 2019 was due to higher G&A costs as well as R&D costs. Operating to higher expenses in 2020 increased approximately 30% to $27.3 million compared with $20.9 million in 2019. R&D expense increased by approximately 21% to $13.4 million, driven primarily by increased costs related to raw material purchases that had to be expensed, increased personnel costs, offset by a reduction in clinical trial expenses related to the closing of the LOCK-IT-100 clinical trial. SG&A expense increased approximately 41% to $13.9 million compared with $9.9 million in 2019. This increase was driven by higher staffing costs due to additional hires, as well as increased costs related to market research in preparation for the potential approval of DEFENCATH. As we have discussed on our March 9 investor call, CorMedix is in a strong position from a balance sheet perspective. Inclusive of our year-end cash and equivalents of $46.3 million and proceeds of $41.5 million from ATM issuance following the end of 2020, the company has December 31, 2020, pro forma cash and equivalents of $87.8 million. We believe this gives the company flexibility to work through the manufacturing issues that have been described, continue to prepare for bringing defend cat to market and take CorMedix at least into the second half of 2022. While, we are continuing to work through the identified manufacturing issues, we also intend to be active participants in several upcoming investor conferences as we continue to look to diversify the shareholder base and raise awareness among the investor community regarding CorMedix and DEFENCATH potential value proposition. With that, I would like to pass the floor back to Khoso.

Thank you, Matt. Let me remind you that Hemodialysis segment represents a significant market with a very large unmet medical need. Today, there is no pharmacological agent approved in the US where patients urgently need an antimicrobial catheter rock solution for preventing of CRBSI in central venous catheters. DefenCath would be the first anti-microbial catheter lock solution approved by the FDA in the U.S., where deaths occur in as many as 35% of hemodialysis patients experiencing a CRBSI. I believe that should DefenCath be approved by the FDA, it can rapidly become the standard of care in the U.S. To summarize, we continue to use the time to focus our efforts on three fronts. Working with the CMO to resolve the third-party manufacturing deficiencies and meeting with the FDA; second, continuing to connect with the hemodialysis community and prepare CorMedix to successfully launch DefenCath when approved by the FDA; and thirdly, preparing the clinical study protocol for DefenCath label expansion so that in post-approval setting, we will be able to start those studies in a timely manner. A reminder that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for DefenCath use in central venous catheters, oncology and total parental nutrition patients. We have had previous discussions with the FDA on the clinical trial design for use of DefenCath as a catheter lock solution in oncology and total parental nutrition patients and are working to develop the protocols with the goal of finalizing the regulatory pathway for reducing catheter related bloodstream infections in this additional patient groups and executing all these plans on a post-approval basis. In conclusion, we remain confident that we have the right team and appropriate resources in place to resolve the third-party manufacturing deficiencies that have been identified and bring DefenCath to the hemodialysis patients in the U.S. We expect to provide an update post the FDA meeting over the coming weeks. Thank you for your continued support of CorMedix. And with this, I will pass the floor back to the operator to open it up for questions. Stacy?

At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Please go ahead.

Hi. Thanks for taking the questions. First one on the FDA meeting. Obviously, you said the goal of the meeting is to gain alignment with FDA on the resolution plans. But just wondering if you will actually have any of the work requested by FDA completed by the meeting, either in terms of documentation protocols, or the vial fill volume study or airflow visualization studies that they asked for, will you've actually completed any, or have any new data to take to the meeting?

Thank you, Jason. Let me pass the floor to Phoebe.

Thank you for the question, Jason. As you know, when you request a meeting with FDA, you have to put a background package together and justify to the agency that it's appropriate for them to grant the request based on time and information available. They don't want to meet with you if it's premature. So yes, we obviously were involved in developing the proposed responses. Some of those proposed responses involve existing documentation. And we make sure that we -- where we could, we provided information that was responsive to the deficiency. So, there is new information there for them to review for some of the responses.

Great. And then just one more clarification question on that -- on the complete response letter there. You mentioned that there was a couple of questions related to equipment that was not relevant to DEFENCATH. Is it still your view that those parts of the CRL are for equipment not relevant to DEFENCATH?

Maybe, yes. Yes, Jason, the issue was planned expansion at the manufacturing facility, which involved installation of new equipment. That is new equipment non-intended for manufacturer of DEFENCATH. So, the information that has been used and is in place is the appropriate equipment for DEFENCATH manufacture.

Okay, great. And then just last one for me in terms of the development plans for additional indications or use settings. Any color you can provide at this point on the scope of those development programs, specifically do you think you need Phase 3 efficacy and safety studies, or could there be other potentially more rapid strategies to get these additional indications added to the label?

Phoebe?

As you can imagine, those are issues that need to be discussed with FDA before anyone starts to trial. You want to make sure that the agency is on board with the way you intend to conduct the study and gather the data. So, we will obviously meet with FDA at the appropriate time and talk to them. Our plan is to do it in a post-approval setting after the NDA has been approved for use in hemodialysis patients. So, the expectation would be that we're doing it in post-approval setting, and we would not be doing a Phase 3 trial but the effectiveness of DEFENCATH for reducing catheter-related bloodstream infections in a catheter in hemodialysis patients should be relatable to use of a central venous catheter and other patient populations, and we would argue that the proper focus should be on safety.

Okay, great. Very helpful. Thanks for taking the questions.

You're welcome. Thank you.

Next question, Joon Lee with Truist Securities. Please go ahead.

Hi. Thanks for taking our question. I have a few. Has anyone reached out to discuss a potential acquisition of the company? I mean if DEFENCATH is as good as it looks on paper and if the CMC issues are as remediable as you say they are, wouldn't some obvious players make an offer for the company? Just curious if you can make any comments there? And I have a follow-up.

Thanks Joon. This is, at the moment, not the right forum or time to discuss that topic. Should there be any information that is material, we would clearly update the market where -- when and where appropriate.

Okay, fair enough. And then you mentioned that you are working closely with the CMO to address the deficiency of the third-party manufacturer. So, the impression is that it was their deficiencies, so what are you -- why do you need to be involved in addressing their issues? What is it that you can contribute to the CMO's deficiencies?

Thanks Joon. Phoebe?

Thanks Joon. That's a good question. I think folks don't understand that there's a parallel process here. As you noted, we have direct control over documentation and information on manufacturing, that's submitted directly to the new drug application. As part of that process, FDA inspects the manufacturing facility and reviews documentation and the facility for its ability to manufacture that product in a commercial setting. So the inspection by FDA, whether it's by records assessment or an on-site inspection, involves reviewing manufacturing records for the product in the NDA, but it also goes broader than that. It goes to the actual facility and the equipment to the maintenance and the training and the personnel. So, it's a parallel process, but obviously they are intertwined and can't be separated, because FDA is there to look at the potential for that facility to manufacture the product that’s the subject of the NDA.

Got it. Thanks for that clarification. And the last question is, at the meeting with the FDA in mid-April, will there be a determination as to whether a site visit will be needed or not? And is this still the case that site visits are unlikely to occur within the next 12 months due to various restrictions? And if that determination is made during the meeting, how quickly would you be able to share that with the Street? Thank you.

Phoebe?

So, obviously, that's one of the topics for discussion with the FDA. Obviously, as I said in my comments, we'd like the FDA to continue its records assessment and determine that it doesn't need to do an on-site inspection. We’ll know after the meeting, I doubt that FDA will give us a definitive answer, but we’ll certainly know if that remains a possibility. And as you noted there again, as I said, there is a backlog of companies waiting for on-site inspections because of the travel restrictions, and it's not clear without a discussion with FDA and having more information available as to the timing of when that inspection would take place. But again, that line of communication is between FDA and manufacturing facility. And I think implicit in this discussion is, that this is not a unique issue for CorMedix, that this is an industry-wide problem. And I think it's clear that then the GAO has stepped in and asked FDA for a plan for resolving the backlog. And so, I think it’s incumbent upon the industry and the FDA to figure out how to get through this backlog as fast as possible, so that patients aren't denied products that can save with their lives.

Got it. So just to clarify, if I understood this correctly. Is it the case that you will be able to share the update with the Street right after the meeting, or will you be waiting for the minutes, which could take several weeks, or is it the case that you won't be able to disclose the contents of the meeting that because that is actually a communication between the FDA and the CMO? Which one is it? I wasn't clear what the --

It's a simple answer, Joon. We'll be providing an update after we meet with FDA.

Okay. Thank you. Looking forward to the update.

Next question, Chad Messer with Needham & Company. Please, go ahead.

Great. Thanks for taking my question. We’ve covered a lot of ground on this in previous calls. But just wondering, what additional details you may be able to share with us in terms of expectations for timing, assuming we do have a positive outcome here. And we are looking at potential label expansion into the oncology and parenteral nutrition indications, what might that look like in an ideal situation in terms of getting information back to us?

So Chad, I think you got two parts to your question. The first part is what are the color will we be able to provide in terms of timing of our current situation? And then about label expansion. So let me start, and Phoebe, then you can add into what I add any other components to it. But like we said, after we've met with the FDA mid-April, we will provide an update to the Street, the best update we can provide based on the meeting that we have with the FDA and the clarity we've got as to the plan we've got for our resolution. And as Phoebe outlined, once we have the NDA approved for hemodialysis, we will be sitting down with the FDA to finalize the protocol that we are working on right now, and assuming we've got alignment with the FDA on that protocol. We will then provide another update to the market in terms of what the timing and what the study will look like. But it's too early right now to speculate, because it can be a variety of different outcomes. So I wouldn't want at the moment to speculate. Phoebe?

I think you covered it. Thank you.

Okay. Great. Thank you.

Next question, Andrew D'Silva, B. Riley & Company. Please go ahead.

Hi, there. Good afternoon. Thanks for taking my questions. I got a few quick ones. Phoebe, just you noticed – or you noted actually that a lot of the CRLs or CRL related activity in the market is maybe more of a factor related to macro pandemic related issues with the FDA and their ability to travel. I was curious, does that also relate to the manual extraction study in the airflow visualization study? Are those items that don't really fall under the aspect of them meeting to travel to actually look at stuff?

Well, you've mixed the two issues there, Andy. The first one, the airflow dynamics comes from information provided from the manufacturing facility to FDA as part of the records assessment. And so, the added information they would ordinarily include in an on-site inspection. The manual extraction study came in the CRL to us. So remember, very early on March 1st, we said that we were not aware of what the deficiencies were in the records assessment for the manufacturing facility because that was information that went directly to the manufacturing facility. But the manual extraction study came to us in the CRL letter – in the quick response letter, sorry. So that is something that was not involved in the assessment of the manufacturing facility.

So would -- theoretically, even if the pandemic wasn’t going on that, that deficiency still would have warranted a CRO? Am I understanding that correctly?

That's something you have to ask FDA. I can't answer that question for you.

Okay. And then I remember last time when you had your call, we were talking about Class I or Class II submissions. And I was curious if the majority of this is actually non-efficacy related, I remember reading something about at least with supplements that, if it's not efficacy related in following the Class I or Class II, do you know if that's applicable in this situation, or is this definitely because it's an NDA going to be a Class I or Class II resubmission distinction?

The timing is clearly a critical issue in this process and that's a topic for discussion with FDA. So hopefully, we'll have more insight after the meeting in mid-April.

Okay. So but procedurally, you don't know if this outside of – outside a Class I or Class II and just have kind of its own category for non-efficacy?

It's worthy of discussion with FDA.

Okay. And just last question for me. A couple of quick bookkeeping. Can you let us know since you're not really working on any commercialization activity, how we should think about OpEx in the first quarter? Is the fourth quarter a good representation what the first quarter would look like? And then with the tax credit, I think over the last couple of years, it's been split between the first and the second quarter. Should we model that in for the first quarter or the second quarter? Thank you.

Thanks, Andy. Matt, would you take those two questions?

Sure. I'm happy to. Thanks, Andy, for the question. I think for your first question about some guidance we're not giving a guidance, but I think that you can look to the fourth quarter, as you indicated as reasonable for going forward, at least for the near term. Likely come in below that as a target, but I think it's a reasonable assumption. Okay, in terms of operating expenses. I think moving on to your second question about the tax credit. I think we stated in the press release that we expect that to close in the second quarter.

Okay. Perfect. Thank you for the color. Best of luck going forward and good luck in the meeting as well.

Thank you.

Thanks, Andy.

Thank you.

Thank you. I will now turn the call over to Dan Ferry for additional questions received from the audience.

Thanks, Khoso. Thanks, operator. Khoso, we have some or at least we have one additional question from the audience here. It is directed to you, Khoso. Are you expecting any changes to the management team? Any additional hires needed to fix the current situation?

Thanks, Dan. I do not see any need for additions or changes to the management team to address the current situation. The management team is very experienced. And as I've said during the prepared remarks, CorMedix in conjunction with our CMO is working to develop the information needed to be submitted to the FDA. So, we're very confident with the team and the experience that they have got. So, no additions are planned or expected.

Okay. Thank you, Khoso. I'll turn it back over to you for closing remarks.

Thank you, Dan. That question, which we just had sort of touches on some of my closing remarks, and that is CorMedix has an experienced team of executives, who are taking pharmaceuticals through the various phases of clinical studies, registration and successfully launched products in the U.S. market. As we've stated previously, CorMedix remains committed to bring in DefenCath to the U.S. market, whether on our own or with a strategic or commercial partner to help patients in need of protecting from life treating infections. The importance of reducing the incidence of infections and keeping patients out of hospitals even more apparent during this ongoing coronavirus pandemic. So, thank you once again for your time and attention, and have a good evening.

This concludes today's conference. You may disconnect your lines at this time and thank you for your participation.