CorMedix Inc. (NASDAQ:CRMD) Q3 2023 Earnings Call Transcript

CorMedix Inc. (NASDAQ:CRMD) Q3 2023 Earnings Call Transcript November 14, 2023

CorMedix Inc. beats earnings expectations. Reported EPS is $-0.17, expectations were $-0.21.

Operator: Good afternoon, and welcome to CorMedix Third Quarter 2023 Earnings Conference Call. Today’s call is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

Daniel Ferry: Good afternoon, and welcome to the CorMedix third quarter 2023 earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix; and he is joined by Dr. Matt David, Executive Vice President and CFO; Dr. Phoebe Mounts, EVP and General Counsel; and Erin Mistry, EVP and Chief Commercial 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 that 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. or for other product candidates; future financial position; future revenues and projected costs; and reimbursement and potential market acceptance of DefenCath or other product candidates.

More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, progress, results, estimates and interpretations thereof; projections as to the company’s future capital raising and spending in cash position, including projections regarding the sufficiency of the company’s current cash resources to potentially bring the company through to breakeven profitability, expectations as to the timing and nature of anticipated regulatory actions, reimbursement decisions, possible product licensing, business development or other transactions; any commercial plans and expectations, intellectual property protections for our product candidates, 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, including the latest quarterly report on Form 10-Q and the annual report on Form 10-K, 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 Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

Joseph Todisco: Thanks, Dan. Good afternoon, everyone, and thank you for joining us. As we approach tomorrow’s target action date for DefenCath, I am very pleased with the progress that the company has made toward pursuing final NDA approval from FDA, as well as preparations for commercialization. I’m happy to announce that the FDA completed a preapproval inspection for our finished dosage CDMO site in September, we are very pleased with the outcome. And an Establishment Inspection Report or EIR is expected to be issued imminently. I’d like to thank and congratulate all of the CorMedix employees, who have worked diligently with our CDMO and external consultants in preparation for the inspection, as well as thank our CDMO, ROVI Pharma Industrial Services, for their commitment to CorMedix and DefenCath.

Phoebe will provide additional clarity around preapproval inspections and the status of the NDA review process. Certainly, it’s frustrating for us to host this call today, a day ahead of our PDUFA date, but this was the last day we could conduct this call under SEC requirements, and we were hopeful that FDA could potentially take action earlier than our target action date. FDA has communicated to CorMedix that they are working towards taking action on our application tomorrow. And at present time, the company is not aware of any outstanding review items or deficiencies that would lead to a negative outcome. In that regard, in advance of our target action date, we have intensified our preparations for commercial launch with a number of key new hires in market access, sales training, pricing and contracting, commercial operations, field medical and drug safety and pharmacovigilance.

We are building a significant number of capabilities in-house, as well as relying on external vendors for certain activities that require larger scale. Our inpatient field team will consist of a combination of in-house market access key account managers, as well as external expert advisers with deep relationships at specific high-value target institutions and health systems. In the event we do receive final FDA approval over the coming days, we are targeting a commercial launch before the end of the first quarter of 2024, likely initially focused on the inpatient segment only. Our assumptions around commercial launch and sales ramp may be impacted by external factors, most notably the timing of reimbursement guidance from the Center for Medicare and Medicaid Services, or CMS, around outpatient reimbursement for DefenCath.

Over the past two months, we have been engaged in an active back-and-forth discussion with CMS, making our case that the DefenCath should be properly reimbursed as an outpatient drug product under Medicare Part B. We have provided the government with significant legal, commercial and health economic rationale in support of DefenCath obtaining separate payment. The alternative to separate payment under Medicare Part B would be a CMS determination that DefenCath is a renal dialysis service, ineligible for a transitional drug add-on payment or TDAPA. While we maintain our guidance to analysts and investors to consider TDAPA as our base case from a financial modeling standpoint, the company feels strongly that the DefenCath does not fall within the current statutory definition of a renal dialysis service and therefore, should properly be separately reimbursed under Medicare Part B.

CorMedix is preparing to submit an application to CMS for a unique product J-code on January 1, 2024, for Part B reimbursement, provided our NDA receives FDA approval. The deadline from CMS to submit an application for TDAPA is also on January 1. Absent direct feedback from CMS advising the company to submit an application for TDAPA prior to that January deadline, CorMedix does not intend to submit an application at this time as we do not believe that the product is a renal dialysis service. As TDAPA is a quarterly application process with a full quarter to implement, should CMS deemed DefenCath to be a renal dialysis service, our TDAPA application will, therefore, lag any such determination and may impact the timing of outpatient product launched by a quarter.

It is also worth noting that a prolonged government shutdown could adversely impact the timing of any guidance from CMS around reimbursement and the submission review of either a J-code or TDAPA application. With respect to a potential inpatient launch in the first quarter of 2024, we contemplate this would be a soft launch as we can only begin the process of seeking P&T formulary approval at various health systems, once the NDA for DefenCath has final FDA approval. Over the past several months, we have accelerated the process of building relationships with key target health systems, identifying key opinion leaders and engaging external advisers that have existing relationships with those targeted systems. The P&T process varies looking to get anywhere from three to nine months depending on the health system.

We are hopeful to be able to land some quick early formulary positions. However, the ramp on the inpatient side is expected to be slow over the first three to nine months of launch. At present time, due to the inpatient formulary lag and the expected timing to implement any outpatient reimbursement, we would not expect meaningful revenue contributions until the second half of 2024. Provided we obtain timely NDA approval, we anticipate discussing more granularity around inpatient launch ramp and the timing of outpatient launch during our year-end earnings call. I will now turn the call over to Phoebe for a regulatory update and discuss progress toward potential FDA approval. Phoebe?

Phoebe Mounts: Thanks, Joe. Good afternoon, everyone. I would like to thank and congratulate everyone on the teams who have worked so hard towards preparation of the CDMO site for a preapproval inspection, as well as in responding to all other requests by FDA for information on the DefenCath NDA resubmission. In addition to a preapproval inspection of our primary finished dosage manufacturing site, the FDA has also conducted preapproval inspections for DefenCath, as suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities. We are not aware of any outstanding review issues at this time. Over the past several months, we have received multiple requests for information from FDA, related to the content of the DefenCath including draft prescribing information, which is consistent with the normal NDA review process.

Most recently, we received a request for updated secondary packaging labels as well as a request for information related to our postapproval pediatric study commitment. You may recall that CorMedix and FDA agreed to a postmarketing commitment to conduct a study in pediatric hemodialysis patients, pursuant to PREA or Pediatric Research Equity Act and BPCA or Best Pharmaceuticals for Children Act. When this study is completed, it will have the potential to extend 6 months of marketing exclusivity to the five years of marketing exclusivity for potential approval of DefenCath as a new chemical entity or NCE and the additional five years for the designation of DefenCath as a qualified infectious disease product. We view these requests as positive indicators that our NDA review is progressing in line with our expectations.

We have also received written notification from FDA that the proprietary name DefenCath remains conditionally acceptable, pending final approval of the NDA by FDA. Lastly, we made the decision to proactively retail to FDA and withdraw from our application our original supplier of heparin API. You may recall from our prior communications that during our Type A meeting in April, the FDA had advised us to resubmit the NDA with two suppliers of heparin API, as our initial supplier had an ongoing warning letter unrelated to heparin. FDA advised during our Type A meeting that should the warning letter remain unresolved as we approach our target action date, we would have the ability to withdraw that source as a supplier from the application. As of late September, the warning letter remained unresolved.

And though our supplier has implemented corrective actions, no closeout inspection has yet been scheduled by FDA. To that extent, we made the decision to withdraw that supplier of heparin API from our NDA application so as not to unnecessarily delay our eligibility for final NDA approval. We will reevaluate resubmitting the heparin supplier following clearance of the warning letter and the potential FDA approval of the DefenCath NDA. We now optimistically anticipate FDA action with tomorrow’s target action date. It is worth emphasizing that the PDUFA date is a target action date and not a statutory requirement. FDA is not required to take action by the action date and there are recent instances of FDA taking action on days preceding or following a specific target date.

As noted by Joe, FDA has communicated that the NDA remains under review and the agency is working towards taking action by the PDUFA date. We are unaware of any outstanding information that is required. I would now like to turn the call over to Matt, who will provide a financial update. Matt?

Matt David: Thanks, Phoebe, and good afternoon, everyone. I am pleased to be here today to provide an overview of our third quarter and year-to-date 2023 financial results as well as an update on CorMedix’ cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2023. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our third quarter of 2023 financial results, our net loss was approximately $9.7 million or $0.17 per share, compared with a loss of $6.9 million or $0.17 per share in the third quarter of 2022. The higher net loss recognized in 2023, compared with 2022 included an increase in operating expenses, driven by prelaunch activities for DefenCath versus the third quarter of 2022.

Operating expenses in the third quarter of 2023, increased approximately 50% to $10.5 million, compared with $7 million in the third quarter of 2022. R&D expense increased by approximately 14% to $2.7 million, driven primarily by an increase in costs related to medical affairs activities and an increase in personnel expenses. SG&A expense increased approximately 69% to $7.8 million in the third quarter of 2023, compared with $4.6 million in the third quarter of 2022. This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath and an increase in personnel expenses due to additional hires, partially offset by a decrease in legal fees for the period.

With respect to our 9-month year-to-date 2023 financial results, total operating expenses during the nine months year-to-date of 2023, amounted to $33.3 million, compared with $22.3 million in the first nine months of 2022, an increase of 49%. R&D expense increased 39% to $10.9 million, driven primarily by an increase in personnel expenses and increase in costs related to medical affairs activities and an increase in costs related to the technical and quality operations for the manufacturing of DefenCath, prior to its potential marketing approval. SG&A expense increased approximately 55% to $22.4 million compared with the first nine months of 2022, primarily driven by an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, an increase in personnel expenses and an increase in noncash charges for stock-based compensation.

These increases were partially offset by a decrease in legal fees for the period. We recorded net cash used in operations during the nine months year-to-date of 2023 of $27.7 million, compared with net cash used in operations of $18.2 million in the same period in 2022. The increase is primarily driven by an increase in net loss primarily attributable to an increase in operating expenses as compared to the same period in 2022. With the closing of our announced equity offering earlier in the third quarter, CorMedix is in a strong position from a balance sheet perspective as we prepare the company for a potential commercial launch in the first quarter of 2024. The company has cash and cash equivalents of $86.6 million as of September 30, 2023.

We believe our cash, cash equivalents, short-term investments and other available resources gives the company the capability to fund the commercial launch of DefenCath through to anticipated profitability, assuming we are able to obtain timely approval of the DefenCath NDA on our action date and commenced commercial launch in the first quarter of 2024 as well as achieve other internal base case assumptions. I will now turn the call back over to Joe for closing remarks. Joe?

Joseph Todisco: Thanks, Matt. CorMedix is keenly focused on our upcoming target action date and hoping for a positive outcome from FDA. We are firing on all cylinders, preparing for a potential commercial launch. We have the inventory manufactured and ready to be labeled once we have a final label from FDA. And we have new batches scheduled from our CDMO. We are actively in communications with CMS. And once the determination is made regarding our reimbursement structure, we will pivot our launch strategy accordingly. As I mentioned earlier, I do expect to be able to provide more granularity around launch assumptions on our next earnings call. I appreciate everyone’s continued support in CorMedix. I’m happy to take questions.

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Q&A Session

Operator: [Operator Instructions] And your first question comes from the line of Jason Butler from JMP Securities. Your line is open.

Jason Butler: Thanks for taking the questions and congrats on all of the progress to date, and obviously, we’re excitedly waiting for the decision from FDA. Couple of questions. You mentioned that you’ve had some label discussions or negotiations with FDA. Is the label or the draft label that you’re aware of today, consistent with your expectations? And do you think it gives you an optimal launch opportunity? And then understanding that a full commercial launch will happen in 1Q, how soon will the product be commercially available? And can you give us any color on, a, the steps that you’ll take from now until commercial — full commercial launch and how we should think about capacity, especially from the API supplier during the first parts of the launch?

Joseph Todisco: All right. Thank you, Jason. I think the first question is easy to address on the label. There were no surprises in anything that we’ve seen in our communications from FDA, so we’re certainly happy with the feedback that we’ve seen on the label. And as you point out, we’re not guiding toward a full commercial launch in the first quarter. And certainly, there are some decision points we might have to make that could cause us to want to maybe push out a couple of weeks around reimbursement, right? We want to maximize the value of whatever reimbursement structure that we get, and we’re very conscious of ASP management. But we’re targeting right now, having the product available for inpatient launch by the end of the first quarter of 2024.

Capacity, we — as I said, we have CDMO capacity reserved for batches early in the year. We can certainly scale that up toward the back part of the year as we get toward our outpatient — kicking off our outpatient launch, but we’ve also already placed purchase orders for API, so API capacity should not be a constraint on launch in the back part of the year.

Jason Butler: Great. And then just last one on the outpatient reimbursement. Any insights into the dialogue with CMS at this point? Do you feel like — have you got any responses from them that indicate that you’re making progress towards securing approval under Medicare Part D?

Joseph Todisco: It’s Part B not Part D. But look, I think it’s been a productive back-and-forth discussion. I think we continue to guide that our base case for investors should be TDAPA. We think TDAPA is perfectly adequate reimbursement structure for end-stage renal disease or renal dialysis services. We just don’t think that DefenCath falls within the scope of renal dialysis service. So all I’ll say is that we think it’s been productive. We think we’ve provided the government with compelling HEOR and patient market data. And we’re hopeful that CMS would make a determination or give us guidance before the end of the year. There’s certainly no timing that they’re bound by. But they are aware that there’s a deadline for a J-code and a TDAPA application on Jan 1 as we are. And we’re hopeful that barring a long-term government shutdown that we could get some direction from them before the end of the year.

Jason Butler: Great. Thanks for taking the questions.

Joseph Todisco: Thanks.

Operator: And your next question comes from the line of Joon Lee from Truist Securities. Your line is open.

Leszek Sulewski: Hi, guys. This is Les on for Joon. I just want to echo that — congrats on the progress, looking forward to tomorrow. Just to clear up, you’ll be submitting the application for the outpatient side for J-code, assuming Jan 1. Is there a possibility for you to resubmit if not approved for the first time? And what’s the time line look like on that? And I have a follow-up.

Joseph Todisco: Both. I think what you’re asking, though, Les, is if we submit the application and we don’t have a determination from CMS on the reimbursement structure, is that what you’re asking?

Leszek Sulewski: Yes.

Joseph Todisco: Well, certainly, look, if we submit the application and then subsequently, CMS guides us that they believe TDAPA is the appropriate structure, we’d have to reevaluate what discussions we would have with them around continuing to pursue separate payment, but I likely would not forgo the opportunity to submit TDAPA application and start that process.

Leszek Sulewski: Okay. Thanks for that. And you did mention that there’s a lingering potential government shutdown. I mean we — very unknown, but in the unlikely scenario that does happen, how does that impact any of your commercial launch if at all? And then also, where are you standing in engagement with P&T meetings and what have been your prelaunch activities thus far? Thank you.

Joseph Todisco: All right. Well, look, as I mentioned in the script, to the extent there was a long-term shutdown that prevented CMS from giving us reimbursement guidance or reviewing either a TDAPA or J-code application, certainly, that could impact the timing of commercial launch. In order for products to get utilization, they need adequate reimbursement and that needs to be established whether it’s for inpatient health systems or outpatient dialysis facilities. In terms of prelaunch activities, we’ve been quite active, right? We’ve had a number of discussions with various health systems with the LDOs around how potentially different reimbursement structures could fit into their system, so we’re preparing for various ultimate scenarios and getting ready for commercialization. Les, did we lose you? Operator, can we move to the next question, please?