CorMedix (CRMD) Q1 2023 Earnings Call Transcript

CorMedix (CRMD -0.37%)
Q1 2023 Earnings Call
May 15, 2023, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to the CorMedix first quarter 2023 earnings conference call. All participants will be in a listen-only mode. [Operator instructions] Please note this event is being recorded. I would now like to turn the conference over to Monique Kosse.

Please go ahead.

Monique Kosse -- Investor Relations

Thank you. Good afternoon, everyone, and welcome to the CorMedix first 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 and include, but are not limited to, any of the following.

Any statements other than statements of historical fact regarding management's expectations; beliefs; goals; and plans about the company's prospects, including its clinical development program, manufacturing activities, and NDA approval for DefenCath in the U.S. or other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DefenCath or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans, the timing, cost, progress, results, estimates, and interpretations thereof; projections as to the company's future capital raising and spending and cash position; expectations 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's filing with the SEC, including the latest quarterly report on Form 10-Q and 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 these 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.

Joe Todisco -- Chief Executive Officer

Thank you, Monique. Good afternoon, everyone, and thank you for joining us on this call. Since our last earnings call in March, the company has achieved a number of key milestones, most importantly, today's announcement that the NDA for DefenCath is being resubmitted to the FDA. I'm incredibly proud of the team that has worked so hard to ensure the company would achieve this important objective.

Phoebe will provide more color around the substance of our Type A meeting with FDA in April. And as we announced a few weeks ago, we do expect the resubmission to be classified as Class 2 with a six-month review and an anticipated target action date in November. We will update investors once we have confirmation from FDA regarding the submission status of the NDA. In addition to our resubmission, we also announced two key business updates that can be important value drivers for DefenCath.

The first was that following our submission of a duplicate new technology add-on payment, or NTAP, application in the fourth quarter of 2022 to the Centers for Medicare and Medicaid Services, CMS has now issued the inpatient prospective payment system 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefenCath. This is a meaningful increase above the previously approved NTAP and represents reimbursement to inpatient facilities at 75% of the anticipated WAC price of $1,170 per three milliliter vial, with an average utilization of 19.5 vials per hospital stay. As we mentioned in our recent update, CorMedix will be migrating DefenCath from a five milliliter to a three milliliter vial volume based upon market preferences. This NTAP application was submitted with that migration in mind.

The final IPPS rule will be published in late summer, and we expect this payment amount to be issued in that final rule. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1st of 2024. The company also recently announced that the U.S. Patent and Trademark Office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduce blood flow in central venous catheters.

This newly allowed U.S. patent application reflects the unique and proprietary nature of DefenCath and will extend our current intellectual property protection to anticipated expiration date in 2042, which is beyond the 10.5 years of marketing exclusivity available upon an FDA approval of the DefenCath NDA, Once this patent is granted, we plan to seek listing in FDA's publication of approved drug products with therapeutic equivalence evaluations, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity information as part of the NDA approval process. While our technical and regulatory teams have been working diligently toward our resubmission and preparing the supply chain for potential commercialization, our commercial and medical affairs teams have been engaging with key stakeholders across settings of care to ensure CorMedix is in positioned to maximize the value of DefenCath. As the initial phase of our launch will focus on inpatient utilization, we have begun engaging with leadership members of pharmacy and technology committees at multiple health systems, hospitals, and integrated delivery networks to better prepare for the formulary process.

We expect to work with health institutions during the upcoming months to establish baseline infection rates at their respective institutions, such that the impact of defense utilization in the system can be quantified. On the outpatient side, we have also intensified engagements with potential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursement. Catheter-related bloodstream infections remain one of the most severe complications associated with receiving hemodialysis through a central venous catheter. And adequate reimbursement to dialysis providers for infection prevention is essential to improving patient outcomes.

A formal application for outpatient reimbursement cannot be submitted until after an NDA receives FDA approval. However, we do expect to begin a dialog with CMS, providing the agency with documentation supporting our reimbursement position over the upcoming months. I will now turn the call over to Phoebe to discuss our Type A meeting with FDA and potential timelines for FDA approval. Phoebe?

Phoebe Mounts -- Executive Vice President, General Counsel

Thanks, Joe. Good afternoon, everyone. First, I would like to start by expressing my gratitude to the technical and regulatory team that have worked diligently to prepare to resubmit the DefenCath NDA as soon as possible. As you know, CorMedix received a complete response letter in August of 2022 due solely to deficiencies cited at contract manufacturers of active pharmaceutical ingredient and finished product, but citing no DefenCath- or clinical-related deficiencies.

Since August, our technical and regulatory teams have been developing three different pathways, utilizing alternative CMO, and API suppliers to ensure resubmission as quickly as possible, which we have discussed during the last two earnings calls. In March, we submitted a Type A meeting request to FDA to discuss plans for resubmission, and we were gratified that FDA granted the request for a meeting in April. We provided FDA with significant documentation and compelling justification for pathway 1 that would utilize our existing CMO and existing API supplier to support a Class 1 resubmission with a 60-day review period. The discussion with FDA related to pathway 1 was very positive and productive.

However, based upon FDA's feedback, it was apparent that CorMedix would be better served by resubmitting the NDA, not only with our existing CMO, but incorporating multiple sources of heparin API. The inclusion of multiple sources of heparin API necessitated the inclusion of new manufacturing information in the submission, which we expect to result in a Class 2 resubmission with a six-month review period. We view the discussion with FDA is highly valuable. And following our receipt of the formal meeting minutes from this discussion, CorMedix is now resubmitting the DefenCath NDA in accordance with agency guidance.

We believe that when the NDA is accepted for filing, it will be deemed a Class 2 resubmission with a six-month review and receive a PDUFA target action date in November. As Joe mentioned, CorMedix will provide additional updates if and when these milestones are achieved. I would now like to turn the call over to Matt, who will provide a financial update. Matt?

Matt David -- Executive Vice President, Chief Financial Officer

Thanks, Phoebe, and good afternoon, everyone. I am pleased to be here today to provide an overview of our first quarter 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 March 31st, 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 first quarter of 2023 financial results, our net loss was approximately 10.6 million, or $0.24 per share, compared with the loss of 7.0 million, or $0.18 per share in the first quarter of 2022. The higher net loss recognized in 2023 compared with 2022 included an increase in R&D expenses and SG&A expenses versus the first quarter of 2022. Operating expenses in the first quarter of 2023 increased approximately 57% to 11 million compared with 7 million in the first quarter of 2022. R&D expense increased by approximately 49% to 3.4 million, driven primarily by an increase in personnel expenses and noncash charges for stock-based compensation, and increases in costs related to medical affairs, activities, and costs related to the manufacturing of defensive prior to its potential marketing approval.

These increases were partially offset by a decrease in consulting fees for the period. SG&A expense increased approximately 50% to 7.6 million in the first quarter of 2023 compared with 4.8 million in the first 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, an increase in personnel expenses due to additional hires, and an increase in noncash charges for stock-based compensation. These increases were partially offset by decreases in legal fees for the period.

We recorded net cash used in operations during the first quarter of 2023 of 10.4 million compared with net cash used in operations of 6.7 million for the first quarter of 2022. CorMedix remains in a good position from a balance sheet perspective. The company has cash and cash equivalents of 55.6 million as of March 31, 2023. This includes approximately 7.2 million raised during the first quarter of 2023 through our ATM program.

Including approximately 3.7 million in net proceeds from our ATM program following the end of first quarter 2023, CorMedix has March 31, 2023 pro forma cash and equivalents of approximately 59.3 million. We believe our cash and cash equivalents gives the company flexibility to fund its operations, at least through the first half of 2024, after taking into consideration costs related to manufacturing activities and costs related to commercial launch preparation in anticipation of the potential FDA approval of DefenCath. I will now turn the call back over to Joe for closing remarks. Joe?

Joe Todisco -- Chief Executive Officer

Thanks, Matt. As I mentioned earlier, I believe the company is executing well on our key objectives, and we're now increasing focus on commercial readiness. Over the last few months, we have made a number of key leadership hires in both commercial operations and medical affairs, most notably new heads of market access, government affairs, strategic partnerships, and trade. We will continue to add additional resources as we progress through milestone events during the year.

As we said earlier, we anticipate a target action date in the middle of November, and we'll plan for commercial launch as early as the beginning of 2024. In the upcoming quarters, we will provide more clarity around market opportunities, launch expectations, and timing. Thank you for your continued support of and interest in CorMedix.

Questions & Answers:

Operator

[Operator instructions] And the first question will be from Joon Lee from Truist Securities. Please go ahead.

Les Sulewski -- Truist Securities -- Analyst

Good evening. This is Les on for Joon. Thank you for taking my questions. First, what would be the protocol with the FDA for when you are ready to add in the CMO 2?

Joe Todisco -- Chief Executive Officer

Thanks, Les. I think our current plan for the additional CMO would be presumably post-approval of the NDA, submitting it as a supplement. And that's the current plan.

Les Sulewski -- Truist Securities -- Analyst

Got it. Can you talk a little bit more about the reasoning behind the -- the vial fill rate change? And why now that it's being proposed and not earlier? Thank you.

Joe Todisco -- Chief Executive Officer

Well, you know, as we, you know, began doing additional market research, engaging the inpatient and outpatient side, we saw a preference for a smaller vial fill that they would tap only one time as opposed to the 5 mL that they would have twice. If we had pursued the original heparin APIs player only, we would have probably gotten approval with the 5 mL and then submitted the 3 mL as a supplement. But given that the agency wanted multiple sources of heparin, it made sense to include it in this submission.

Les Sulewski -- Truist Securities -- Analyst

Got it, that's helpful. Just one more for me. Can you talk a little bit more about the strengths of the newly issued patent and, perhaps, handicap the exclusivity timeline that you expect? And then, also, as a follow-up to that, what would be your strategy to deal with any potential NDA filers?

Joe Todisco -- Chief Executive Officer

OK, thanks, Les. Yeah, actually we do think the newly allowed claims are very meaningful. We think that once the patents issued, it's going to be eligible to be listed in the Orange Book, right, which means that generic filers would have to certify against it if it's Orange Book-listed. And post-expiration of the 10 and a half years of marketing exclusivity, this could be a material barrier to generic competition.

So, generic versions of injectable solutions have to demonstrate that they're quantitatively and qualitatively the same in terms of inactive ingredients in order to obtain a designation from the FDA as substitutable. In our view, it's going to be very difficult for a generic to design around these patent claims while also demonstrating substitute ability of the FDA. So, we feel good about the patent claims. In terms of -- the second question was you were asking about the NDA process, can you clarify that question?

Les Sulewski -- Truist Securities -- Analyst

Yeah, I guess your strategy, your legal defense strategy to deal with any potential NDA filers that you, you know, might come across, I think we've seen that recently in an industry happened at an early stage of launch. So, I just wanted to see if you have anything for us.

Joe Todisco -- Chief Executive Officer

Well, Les, it can't really happen at the early stage, so let's clarify a couple of things because we have NCE exclusivity on -- related to taurolidine, the taurolidine component of DefenCath. That NCE exclusivity means that a generic filer who's not challenging our patent can't even submit an application for five years. One that is challenging the patent can submit it in four years. So, we've got quite a lot of time before someone can even submit.

And the 10.5 years that we do have means, regardless of patents, an NDA can't be approved for 10.5 years. So, there's quite a lot of time between now and when I think we do need to comment on IP litigation strategy, let's say.

Les Sulewski -- Truist Securities -- Analyst

Got it. Very helpful. Thank you.

Joe Todisco -- Chief Executive Officer

Thanks, Les.

Operator

[Operator instructions] The next question will be from Serge Belanger from Needham and Company. Please go ahead.

Serge Belanger -- Needham and Company -- Analyst

Hi, good afternoon. A couple questions for us. I guess, first on the NTAP reimbursement, I think the most recent approval included a 20% bump on the prior total that was approved. So, just curious what drove that pretty significant bump.

And how does that price level for -- how does that reimbursement level kind of inform your pricing for the outpatient segment?

Joe Todisco -- Chief Executive Officer

OK, thanks, Serge. So, in terms of the NTAP reapplication, migrating from the 5 mL to the 3 mL essentially meant that we -- for each patient, you're getting two three milliliter vials, which is six milliliters of liquid. So, the amount of liquid dispensed increases. So, that's a large portion of the increase in the 19.5 vials as opposed to 9.5 that were in the original NTAP application.

So, that drives most of the change in the NTAP. The second part of your question was around outpatient pricing?

Serge Belanger -- Needham and Company -- Analyst

Yeah. Is the NTAP reimbursement inform the --

Joe Todisco -- Chief Executive Officer

OK, how does it -- so, yeah.

Serge Belanger -- Needham and Company -- Analyst

Pricing, yeah.

Joe Todisco -- Chief Executive Officer

Yeah, I'd say that they're not necessarily related. We're still working on what the outpatient and inpatient pricing strategy is going to be. So, we have an NTAP, which is reimbursement to the healthcare institution, but it may not necessarily be reflective of what the true net price is going to be, right, to the institutions. I mean, we've said on the outpatient side, net pricing is going to be materially lower, right? So, we're not going to guide today as to just how much lower and where we see that going.

But we understand there are different therapeutic segments, different patient, you know, size, patient populations. So, the pricing is going to have to be different in those two settings.

Serge Belanger -- Needham and Company -- Analyst

OK, and just thinking ahead of a product launch early next year, especially in the inpatient setting, how should we think about kind of the trajectory? Do you expect each facility will do pilot studies and economic studies before they implement or incorporate the product that's part of the practice?

Joe Todisco -- Chief Executive Officer

Look, I think, you know, right now, we're having a lot of conversations with institutions of what's going to be required to work through the P&T process. You know, I think with the initial phase of the launch, it's going to take some time to work through the P&T process for each system. Some are going to be faster than others. And obviously, the conversations with partnerships we're pursuing right now are going to lay the groundwork for a better launch.

You know, I think, Erin, do you want to provide any more color?

Erin Mistry -- Executive Vice President, Chief Commercial Officer

Sure. Thanks, Joe. Yeah, to that point, we've -- we have had -- we're running in parallel strategic partnership discussions, as well as, obviously, a full commercial launch. It's dependent on the institution, right? Some are heavier lifts than others, and that's part of the segmentation and analytics that we're running right now to understand who will do -- who will want to do pilots, who will take this for face value, what's the ease of getting on formulary, and frankly, where are the relationships, right, the physician champions that can help shepherd that process through.

So, to your -- to answer your question, it's institution-dependent.

Serge Belanger -- Needham and Company -- Analyst

OK, thank you.

Joe Todisco -- Chief Executive Officer

Thanks, Serge.

Operator

And, ladies and gentlemen, at this time, I'd like to turn the call back over to Monique Kosse for additional questions from our audience.

Monique Kosse -- Investor Relations

Thank you, operator. We'll now go -- we did get some questions in, written questions, and I will read those questions here. OK, the first question, there's a couple parts to it, when would you expect FDA to inspect your CMO 1 and why do you think the outcome will be different this time? What's changed? And does the CMO have any other NDAs pending?

Joe Todisco -- Chief Executive Officer

OK, thanks, Monique. That's a good question. I think in terms of what might be different this time, you know, the last eight months we've seen significant increase in engagement of the CMO with external consultants, and those consultants have deep FDA experience. So, we're encouraged by what we've seen in terms of corrective action implementation and, you know, those corrective actions that came out of the original inspection, and we're optimistic that they're ready for potential PAI reinspection now.

So, that said, we don't own the CMO, so all we can do is provide support. And once we do have a PAI date, we can also use our best efforts to do final prep for inspection and, you know, post any inspection, help them address any new observations that could arise. But I think we're, you know, optimistic with what we've seen from the site in terms of implementing corrective actions. In terms of other filings, we've been told that they have other NDAs pending from different sites in Western Europe that could potentially get a PAI before we do.

So, you know, we're certainly going to be in close contact with them to understand any FDA observations in other facilities, or anything that could impact our application.

Monique Kosse -- Investor Relations

OK, thank you. All right. Another question here from the audience. Can you provide more color on why the FDA wanted two sources of heparin in the application? And what will happen if the initial supplier of heparin has not resolved its warning letter before your target action date?

Joe Todisco -- Chief Executive Officer

OK, thanks. I think the first part of that question, I think Phoebe did a good job addressing in the script. But, you know, it's pretty straightforward. We were hoping to get a Class 1 submission with the original heparin source, given that the CMO and the API supplier had rectified the compliance concerns, or in our view, had rectified the compliance concerns.

But during the FDA meeting, I think the agency, you know, strongly encouraged us to submit data from our new source of heparin, but also include the existing heparin data to give them more time to evaluate that site's compliance. I think, you know, should we get to our target action date and the FDA has not yet resolved that that warning letter, you know, we're free to withdraw that heparin supplier and only go with the new source if that's what's needed to pursue approval.

Monique Kosse -- Investor Relations

OK, thank you, Joe. And the last question here from the audience. How are you thinking about the timing of ramp-up of field-based personnel? And is there a scenario where you hire the field team ahead of NDA approval? And how about on the medical side?

Joe Todisco -- Chief Executive Officer

OK, yeah, I guess we think about commercial medical a little bit differently. So, let's assume that we get a PDUFA date that's in mid-November. There's going to be milestone events that happen along the course of the summer and early fall that could give us confidence, right, to hire more commercial personnel at risk. I think most importantly, any PAI inspection the FDA could do at our CMO, right, that bolsters our confidence.

As I mentioned in the script, we're already adding key leader positions across functions. But when it comes to the, call it the key -- the field-based key account managers, ideally, what we would want to do is have those personnel identified with offer letters in hand around the time of a potential approval and then onboard them immediately after. And that's certainly what we're going to try to do. On the medical side, it's a bit different.

We really need to have the full team staffed up ahead of any potential approval we have. Four MSLs are on board right now. Those are medical science liaisons. We'll probably seek to have around eight at the time of launch.

So, these roles are critical as they can have medical professional to medical professional types of conversations with physicians around disease state awareness, where commercial personnel are much more limited in what they can discuss and who are not permitted to do any pre-approval marketing on the product. Regardless, to be successful, we're going to need to recruit qualified capable people on both sides of the business, chief formulary access, you know, contract appropriately, and then get channel pull-through, so --

Monique Kosse -- Investor Relations

OK, thank you. And that does conclude that there are no further questions here written online here. I'll turn it back over to the operator now to close the call.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Monique Kosse -- Investor Relations

Joe Todisco -- Chief Executive Officer

Phoebe Mounts -- Executive Vice President, General Counsel

Matt David -- Executive Vice President, Chief Financial Officer

Les Sulewski -- Truist Securities -- Analyst

Serge Belanger -- Needham and Company -- Analyst

Erin Mistry -- Executive Vice President, Chief Commercial Officer

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