Earnings Call Transcript - NRXP Q4 2024

Operator, Operator

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and Full Year 2024 Earnings Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. This call is being recorded on Monday, March 17, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

Matthew Duffy, Chief Business Officer

Thank you, Joelle, and good morning, everyone. Welcome to our call. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. Federal Securities Laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made during this call speak only as of the day hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued this morning and the company's Form 10-K, which was filed on Friday and may be accessed from the Investor page of the NRx Pharmaceuticals, Inc. website. Joining me today on the call are Jonathan Javitt, our Founder, Chairman, and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in the 10-K and in the press release, following which Mike will review the company's financial results. Following our prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan?

Jonathan Javitt, Founder, Chairman, and CEO

Thank you, Matt. Good morning, everyone. I appreciate you being here. As many of you are aware, the Board appointed me to lead NRx five months ago to navigate a challenging capital market landscape for pre-revenue biotech companies. During this period, we've secured new funding, eliminated harmful debt, and transitioned our focus from just research and development to becoming a healthcare company capable of generating revenue and aiming for profitability by the end of 2025. This is uncommon for small-cap biotech firms. At NRx, our commitment to treating and preventing suicidality, depression, PTSD, and related disorders remains strong. Our revenue strategy has progressed, and with the increased commitment from the U.S. government, especially under the new administration, the treatment options for these critical conditions align closely with our business model. NRx is now operating with two entities: the original NeuroRx and the newly established HOPE Therapeutics. NRx owns all drugs in development and HOPE focuses on providing clinical care. Under NeuroRx, we have started the process to file a New Drug Application for NRX-100, a preservative-free intravenous ketamine, which has shown over two years of room temperature stability. We are equipped to produce over 1 million doses monthly if approved by the FDA. An agreement for the acquisition of this product, valued at over $300 million in milestones plus royalties, reinforces our drug development strategy. NeuroRx is also working on an expedited NDA for NRX-101, combining D-cycloserine and lurasidone, expecting to file within the next quarter under accelerated approval guidelines. Our HOPE Therapeutics subsidiary aims to operate clinics to care for patients with mental health conditions using a range of therapies, including drugs, medical devices, and digital health. The transformation in treating these conditions has shifted from reliance on outdated methods to more effective therapies and clinical successes, which are increasingly documented in reputable trials. Nevertheless, our findings suggest that a single treatment often isn't sufficient for long-term recovery, indicating a need for combinations of therapies. To that end, we've signed letters of intent to acquire three profitable interventional psychiatry clinics, with additional negotiations for more clinics underway. We aim to navigate the complexities of these acquisitions while adhering to state regulations to create a company that provides essential treatments to patients and returns for investors. Suicidality affects millions, with about 3.8 million Americans planning to take their lives annually. Ketamine is often out of reach for many who need it, available mostly for those able to pay out-of-pocket until we secure FDA approval. We're moving forward with the NDA for NRX-100, targeting suicidal depression, supported by robust efficacy data. We've received offers for potential licensing and distribution of NRX-100, valued at over $300 million in milestones and royalties. Safety concerns related to ketamine's use must be addressed as its use expands, particularly regarding the potential brain toxicity from prolonged use. Current ketamine formulations were not designed for repeated doses, and the preservatives used pose their own risks. We are petitioning the FDA to remove those preparations until they can be proven safe for long-term use. We are also filing an abbreviated NDA for preservative-free ketamine across approved human and veterinary uses. This may broaden the market for NRX-100 significantly. Our capacity can scale up to produce 1 million vials monthly. The old formulation of ketamine presents challenges for administration; thus, we've developed a stable, pH-neutral version expected to enter human bioequivalence studies this year. If we gain FDA approval, we could vastly expand access to patients in need. With NRX-101, we focus on biploar depression, which affects around 7 million people in the U.S. Its treatments often involve suicide risk. NRX-101 could revolutionize care, showing promising results in clinical trials compared to existing options. Notably, it reduces symptoms of akathisia, a harmful side effect of antidepressants. This could change how bipolar depression is treated. Our plans to file for accelerated approval for NRX-101 are underway. The market for this indication is projected to exceed $2 billion, with the broader bipolar market over $5 billion. We have advanced significantly with HOPE Therapeutics, establishing a clear plan for a nationwide network of clinics, similar to successful models in other medical fields. We've recognized that ketamine requires complementary therapies to maintain its effect in many patients. We're pursuing an acquisition of Kadima, an interventional psychiatry clinic, with plans for additional clinics in Florida. Our growth strategy involves acquiring revenue-generating centers and expanding services. We anticipate acquiring 20 clinics with an average revenue of $5 million each to meet our growth goals by 2025. Financially, these top clinics yield around 30% operating margins, offering room for growth. Funding for HOPE will be separate from NRx's finances, though earnings will support NRx's profitability and potential spin-off. We've recently closed the third tranche of funding from Anson Funds, totaling nearly $20 million. We plan to finance HOPE clinics through traditional loans and private equity. We are also working with a TMS technology manufacturer for additional support. Our focus on reducing operational expenses positions us well to achieve profitability by 2025, driven by revenue from HOPE and sales of our medications. As I stepped into NRx's leadership, I invited Michael Abrams as our first full-time CFO, whose experience has already proven beneficial. Now I hand it over to Mike to discuss our financial results for 2024.

Michael Abrams, Chief Financial Officer

Thank you, Jonathan. For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million, from $27.8 million for the year ended December 31, 2023. This change was primarily driven by a decrease in research and development expense. For the year ended December 31, 2024, research and development expense decreased by approximately $7.2 million or 53.6% to $6.2 million, as compared to $13.4 million for the year ended December 31, 2023. This change is primarily driven by a decrease in clinical trial and development expense due to the conclusion of the Phase 2b/3 study for NRX-101. Finally, general administrative expense for the year ended December 31, 2024 decreased by approximately $7.7 million to $13.5 million as compared to $14.2 million for the year ended December 31, 2023. This change was primarily driven by a reduction in insurance and employee costs, partially offset by the increase in consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics. As of December 31, 2024, we had approximately $1.4 million in cash and cash equivalents. As noted above, in January 2025, the company completed two financings with aggregate gross proceeds of approximately $8.5 million. Management believes the current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path of generating revenue and value for our shareholders. Please see detailed financials on our Form 10-K filed with the Securities and Exchange Commission, which will also be available on our website. With that, I turn the call back to Jonathan.

Jonathan Javitt, Founder, Chairman, and CEO

Thank you, Michael. The mission of NRx to prevent and treat suicidality in patients with depression and PTSD has continued to move forward. Over the last year, we've streamlined operations, we've retired toxic debt, and we've capitalized the company to move forward. Planned 2025 PDUFA dates for our two NDAs and continuing the development of HOPE Therapeutics' national network for care delivery are transformative steps for the company and for the treatment of mental health in the United States. I'd like to thank the NRx team, our investors, and most importantly the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. Operator, we're ready to take questions from the audience.

Operator, Operator

Thank you. Ladies and gentlemen, we will begin the question-and-answer session. Your first question comes from Jason Kolbert with D. Boral Capital. Your line is now open.

Jason Kolbert, Analyst

Good morning, guys. Congratulations on all the progress. A couple of questions. Jonathan, you made a good argument for removing the preservative from ketamine. If you remove the preservative for ketamine, how does that change the formulation? And for example, what do you do in its place?

Jonathan Javitt, Founder, Chairman, and CEO

When you say what do you do in its place, why do you need to do anything in its place?

Jason Kolbert, Analyst

Why is it there in the first place? Does ketamine degrade?

Jonathan Javitt, Founder, Chairman, and CEO

Great question. So the preservative was included in ketamine way back when because an anesthesiologist would put it on the cart in the hospital and would draw out of the vial multiple times. So any time you stick more than one needle into a sterile vial, it's considered to be contaminated and to require a germicidal preservative in the bottle.

Jason Kolbert, Analyst

Got you. Okay. Great.

Jonathan Javitt, Founder, Chairman, and CEO

So as long as you have a single-use vial, by law you don't need a preservative. Now when we started this, people said, oh yes, but that preservative is critical to the stability and sterility of ketamine. Well, it turns out not to be true. That turns out to be a novel and surprising finding. That's why we've pointed out that we've now got the ability to file for two-year shelf stability at room temperature for preservative-free ketamine. And you've seen this happen in the ophthalmology industry, where it was assumed that glaucoma eyedrops and other eyedrops that people use on a long-term basis would always be in a big bottle with a preservative in it. The same was true for artificial tears that people were used to buying in the drugstore. And 15 or more years ago, I was involved in research that showed that those preservatives are actually quite toxic to the cornea and the conjunctiva. And that's why more often than not, people are buying artificial tears in single-dose preservative-free vials. And more and more of the prescription eye drops have been moved to single-dose preservative-free vials. If you read the material data sheet on benzethonium chloride, it's pretty frightening. The material data sheet says this product is caustic, it's toxic, and it may cause severe burns. Clinical evidence shows that it's anything but safe.

Jason Kolbert, Analyst

Thank you. I didn’t connect the dots during the call, but I understand now, and it all makes sense. Can you discuss the acquisition strategy for adding more clinics this year? Without providing specific guidance, give us a general idea of how that acquisition is progressing, the level of interest, the number of clinics available, and any particular regions you want to target. Share your expectations for this time next year.

Jonathan Javitt, Founder, Chairman, and CEO

Well, Florida has become a geography of focus for us, partly because we've identified a group of clinics that, in our view, are already doing it right. Not to paint with too broader brush, but you can find a ketamine clinic on every other street corner in the United States today. However, many of them are clinics that do ketamine on Mondays and vitamin drips on Tuesdays, and who knows what on Wednesdays. Organizations that know how to combine ketamine and in the future other psychedelic drugs with neuromodulatory technology like TMS are few and far between. These are tough patients to treat on a comprehensive basis, and anybody who says, come on in for your ketamine shot and go elsewhere for the rest of your care is not doing any patient any favors. That's why we retained BTIG and have partnered with BTIG to cast a broad net for clinics that we believe are doing it right, and to use that platform of acquiring clinics as a basis for building out a nationwide network. When we talk about the kinds of financing that's available, you're talking about tiered risk financing. Our conversation so far suggests that commercial banks are prepared to finance up to 50% loan to value on fairly attractive commercial terms. Our conversation so far suggests that clinic owners are willing to take some piece of the acquisition in the form of HOPE Therapeutic shares. And that leaves financing in the middle, perhaps 20% to 30% of each acquisition that will come from investors who expect a higher rate of return, but a rate of return that HOPE can certainly afford to pay. So the capital stack from our perspective is not a major impediment to getting our initial acquisitions done. The hard work is the pile of legal documents that are required to acquire any healthcare facility in the United States, especially in states that have corporate practice of medicine laws, and the due diligence that we have to do, both on the financial front and on the regulatory front on each acquisition to make sure that these are acquisitions we can put on the balance sheet and offer to our shareholders.

Jason Kolbert, Analyst

Perfect. I completely understand. Thank you. One last question. In the press release, you talk a little bit about the potential for a ketamine deal, $300 million in milestones and tiered royalties, and the fact that you've received interest, non-binding term sheets. Can you expand a little bit about that, because that certainly changes the company's future and creates a very significant inflection point for investors?

Jonathan Javitt, Founder, Chairman, and CEO

Yes, a deal is never done until it's done. But as we've moved closer to having a marketable drug, there's a real desire out there on the part of already commercial organizations to be able to offer such a drug to patients. I don't think anybody questions the size of the available market, and having a partner that already has a sales force in the field could be more attractive than raising the money to launch the drug ourselves. So we're gratified that commercial partners have started showing up. We've told our investors what we can say today about what that might look like.

Operator, Operator

Your next question comes from Tom Shrader with BTIG. Your line is now open.

Thomas Shrader, Analyst

Good morning. Thanks for taking the question. Good luck on the busy year. A follow-up on the last line of questioning. The ketamine clinic landscape in Florida, is it chunky? So when you say you have nine facilities, is that one deal or is that nine independent negotiations? Should we look for this target to happen in big chunks? And then maybe if you could give us a little bit of color on having an ANDA and an NDA in front of the FDA at the same time. How unusual is that? Is it the same people that deal with it? Is your manufacturing packet enough for both? Just it's unusual to me, and I thought you could talk a little bit about what it would look like at the FDA. Thank you.

Jonathan Javitt, Founder, Chairman, and CEO

So on the ketamine front, I think you should expect acquisitions to be chunky, your word, to represent more than one clinic at a time. In the case of Kadima, which is a one-site facility, we started there because we've been unable to identify another clinic that's doing so many things right all at the same time. But in general, the clinics that are doing it well are doing it at multiple locations, and we would expect that to be part of our acquisition path. With regard to an ANDA and an NDA, the NDA is specifically to ask the Division of Psychiatry products to add the depression and suicidality indications to the ketamine label. Quite frankly, somebody could have come along and said, well, let's do that with the original formulation that has the preservative in it. But it's really a scientific exercise in attempting to prove safety and efficacy to the satisfaction of the review division while also satisfying the manufacturing side of the FDA. Well, that same manufacturing package, that same Module 3 that we've already submitted, while it's necessary for the new drug approval application, is largely sufficient for an ANDA because under the ANDA, we're not seeking to change the label of ketamine. We're seeking to offer a preservative-free version of a drug that's already generic.

Thomas Shrader, Analyst

So the ANDA would be for analgesia?

Jonathan Javitt, Founder, Chairman, and CEO

The ANDA would have the same indications as the currently marketed forms of ketamine, but it wouldn't have the toxic preservative in it.

Operator, Operator

Your next question comes from Vernon Bernardino with H.C. Wainwright. Your line is now open.

Vernon Bernardino, Analyst

Hi, good morning, everyone. Thanks for taking my question and congrats on the progress. Looks like it will be a busy second quarter. Regarding the terms with the commercial pharmaceutical company for NRX-100, do you anticipate that will be a second quarter announcement as far as the finalization of the deal?

Jonathan Javitt, Founder, Chairman, and CEO

Well, we hope it may be. And the deal is never done until it's done. On the other hand, we see the expression of interest as one that may even become broader. We have the resources to continue to move these applications forward. We don't need a commercial deal right now, but we would certainly welcome the right partner.

Vernon Bernardino, Analyst

Great. Regarding the ketamine intended for intravenous use and the removal of benzethonium chloride, the idea is for it to be single-use. How feasible would it be for a competitor to create their own single-use presentations of intravenous ketamine?

Jonathan Javitt, Founder, Chairman, and CEO

Well, there are a couple of challenges that anybody who wants to enter the market will have today. Certainly, the sponsor of ketamine, who owns the label, could certainly do it if they wanted to. But if they don't already have a preservative-free formulation for stability, they've got a couple of years of work before they can enter the market and file their ANDA. Do we expect that we'll long-term have the ketamine market to ourselves? I think that's too much for anybody to expect for a market that's quite that large. But for a period of time, we may well have it. And if some of the advice we've received suggests that the preservative-free formulation we've engineered is surprising and ultimately stands up to patent review, we could have that market to ourselves for longer than anticipated.

Vernon Bernardino, Analyst

Thanks for that additional information. Then regarding the persistent psychiatry centers you intend to acquire, those are still projected to be ones you think will have run rates of about $5 million a year in revenue?

Jonathan Javitt, Founder, Chairman, and CEO

Or larger.

Vernon Bernardino, Analyst

Okay. And one of those you intend to acquire, you say three positions, one of those includes Kadima or these are in addition to Kadima?

Jonathan Javitt, Founder, Chairman, and CEO

That includes Kadima.

Vernon Bernardino, Analyst

Okay. And then lastly for me, the term sheet with the publicly traded strategic investor that manufactures TMS devices, they manufacture their own or several devices or…

Jonathan Javitt, Founder, Chairman, and CEO

Probably wouldn't be appropriate to say anything more at this time.

Vernon Bernardino, Analyst

Okay. Great. Thanks for taking my question.

Jonathan Javitt, Founder, Chairman, and CEO

Thank you.

Vernon Bernardino, Analyst

Yes, and congrats on the progress.

Operator, Operator

Your next question comes from Ed Woo with Ascendiant Capital. Your line is now open.

Ed Woo, Analyst

Yes, congratulations on the progress. As you may potentially have NRX-100 and NRX-101 approval this year with the FDA, have you thought about what you might do internationally with both of them?

Jonathan Javitt, Founder, Chairman, and CEO

Well, we've talked in previous calls and filings about relationships that we've developed in France, a European country that is highly focused on this disease. The French estimate that someone commits suicide in France every 45 seconds. And as you know, one of the clinical trials that we're citing to the FDA is a French government-funded study conducted at seven French hospitals. It could be the largest study ever attempted in patients with suicidal depression. So were that to continue to evolve and our relationship with Foundation FundaMental result in a European filing, that would certainly have resonance throughout Europe. We've not considered going beyond the U.S. and Europe by ourselves. As you know, we've had relationships with Asia-Pacific entities. And as we gain momentum, we expect that interest to increase at the same time.

Ed Woo, Analyst

Great. Well, thanks for answering my questions. I wish you guys good luck.

Operator, Operator

Ladies and gentlemen, I will now turn the call over to Matt for other questions.

Matthew Duffy, Chief Business Officer

Thank you, Joelle. Jonathan, we received another question electronically regarding HOPE. The question is that HOPE seems very interesting, but how does it directly benefit NRx shareholders that NRx owns the equity in HOPE at this point?

Jonathan Javitt, Founder, Chairman, and CEO

Currently, HOPE is an asset on the NRx balance sheet. If NRx retains its shares in HOPE Therapeutics and HOPE becomes profitable, those profits will benefit NRx. As more investors join HOPE, the profits will also benefit all HOPE investors. However, NRx is expected to remain a key investor. We have expressed our intention to distribute HOPE shares to those who hold NRx stocks at the time of the distribution. This was disclosed last year but was delayed due to a challenging lender situation, which was ultimately resolved by a court ruling that allowed the HOPE distribution to proceed. We are committed to moving forward with this spinout while ensuring it is tax-free for NRx shareholders. As long as HOPE remains on the NRx balance sheet, any developments involving HOPE will ultimately benefit NRx shareholders.

Matthew Duffy, Chief Business Officer

Okay, thank you very much. Everyone, that's all the time we have for questions today. Thank you, everyone, for joining us this morning. We're extremely excited about the year ahead and with our two potential drug approvals and a subsidiary targeting multiple profitable mental health clinics. This concludes the NRx Pharmaceuticals fourth quarter 2024 results conference call. Thank you all for participating and have a great day.

Operator, Operator

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.