Jaguar Health Q4 2025 Earnings Call - Future Pak Deal Funds a Pivot to Rare Intestinal Failure Program, Targeting NDA in 2027

Melissa, Webcast Moderator, Jaguar Health: Greetings, and welcome to Jaguar Health Investor Webcast. Before I turn the call over to management, I’d like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on current available information and management’s current assumptions, expectations, and projections about future events.

While management believes its assumptions, expectations, and projections are reasonable in the view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company’s actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the Forward-Looking Statements and Risk Factor sections of the company’s Form 10-K for the year 2025, which was filed with the SEC on April 7th, 2026, and its other filings with the SEC, which are available in the Investor Relations section of Jaguar’s website. Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise.

Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today’s conference is being recorded. At this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health’s Founder, President, and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte, Founder, President, and Chief Executive Officer, Jaguar Health / Napo Pharmaceuticals / Napo Therapeutics: Thanks very much, Melissa, and thank you, everybody. Hello. Thank you for joining the investor webcast today. As you heard, my name’s Lisa Conte. I’m the Founder, President, and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I am the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably to refer to the company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the fourth quarter of 2025 last year.

I am once again pleased to steal Carol’s thunder, and I am further pleased to report that our combined net fourth quarter 2025 revenue of approximately $3.2 million for both our prescription and non-prescription products, including license revenue, increased approximately 5% versus the net Q3 2025 of approximately $3.1 million. Our strategy for 2026 is business development, and I’m pleased to add the description continued business development. Our theme is what’s different now. Let me start by addressing our achievement of bringing about a transformative business platform at Jaguar. The key event was the closing of a U.S. out-license agreement with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer, Mytesi. An agreement that is fully aligned with our strategy to sharply focus our crofelemer development efforts on rare disease intestinal failure indications.

The out-license agreement also covers Canalevia-CA1 crofelemer for the treatment of chemotherapy-induced diarrhea in dogs as conditionally approved. The key transformative points of this deal are straightforward. First, there’s non-dilutive dollars that provide the fuel for the development of our rare disease pipeline. The deal had $18 million up front, of which $16 million we have already received. We received when we signed the deal in January, $2 million coming based on certain conditions, and an additional $20 million in milestone payments and other future payments. These are non-dilutive dollars, and we’ve already received close to $4 million of additional payments above and beyond the $16 million. This is, again, non-dilutive dollars. This has been our vision. This has been our mission. This has been our objective for several years now. Jaguar continues to be the manufacturer of crofelemer, and we are selling it to Future Pak at a profit.

It now has become a profit center. We have really breakthrough data in the rare disease area, which I’m going to be talking about in a moment, and near-term development catalysts, clinical catalysts, regulatory catalysts for disease with a lethal natural history, and with endpoints that we’re looking at to potentially extend life for this situation. We’re in late-stage clinical development in our rare disease intestinal failure program, and that includes something called MVID, microvillus inclusion disease, which is an ultra-rare congenital diarrheal disorder, and short bowel syndrome with intestinal failure. MVID, we are targeting a New Drug Application for 2027, and that would be coincident with completing a phase II trial, a placebo-controlled trial for short bowel syndrome. For short bowel syndrome, third parties put the market opportunity at about $8 billion by 2023. That’s about 100 times the size of the Mytesi HIV estimated market size.

In that deal, we got an $18 million upfront payment. So that’s the enormity and of the blockbuster opportunity in terms of impact on patients, impact on the mortality, the morbidity, the cost to the healthcare system, and as we are looking to bring in additional partnerships, the type of non-dilutive dollars that we are targeting to bring into this company. We have really meaningful catalysts in the next six to 12 months, as you’ll hear as I continue to go through this presentation, and a goal to bring in a license deal for rare disease. That is the key objective of the company, and as I mentioned, that is our strategy for 2026. We do have a slide that summarizes these points. Carol, I’m not sure if you are able to put that slide up. Our-

Carol Lizak, Chief Financial Officer, Jaguar Health: Yes.

Lisa Conte, Founder, President, and Chief Executive Officer, Jaguar Health / Napo Pharmaceuticals / Napo Therapeutics: Oh, terrific. As I mentioned, the intestinal failure program is a blockbuster market, and it’s catastrophic for the patients. What is intestinal failure? Intestinal failure is a situation where the patient can’t absorb their nutrients of life, their proteins, their carbs, vitamins, et cetera. They end up on parenteral nutrition, parenteral support, that’s IV support, up to 20 hours a day, seven days a week. Obviously, hugely catastrophic for quality of life, but also for other health issues. It’s TPN, parenteral support, but total parenteral nutrition is considered oftentimes as toxic as chemotherapy for a patient, yet necessary for them to live. Otherwise, as I mentioned, it’s a lethal natural history for these patients.

For an MVID patient, if they are not diagnosed immediately when they’re born, they die. If they are diagnosed, they do go on total parenteral nutrition from the moment that they’re born, and they typically don’t last beyond their teenage years, first of all, because of the IV interventions. There’s infections, there’s other problems. TPN is remarkably toxic to kidneys, to liver, to cognitive function. Patients often are on a much slower growth curve. What is the endpoint that we’re looking for in our clinical trials? What’s the endpoint that we’re looking for with crofelemer intervention? It’s reduction of TPN and parenteral support by even 5% will be meaningful. Now, I was talking with a patient advocate just a couple of weeks ago. Why is that?

Because if you can reduce even 5%, 10%, 15% the amount of time that the patient is on parenteral support, it can, for example, allow a child to go off their IV nutrition and be able to attend school. They can get most, if not all, of their parenteral support when they’re asleep. It makes a very big difference in the opportunity for the patient and the patient’s entire community, which includes their physician, often nurses, nutritionists, and the family all working together. Remember, every single day, these patients require parenteral nutrition. The groundbreaking results that we have already achieved in the intestinal failure area were the results of an independent proof of concept study that was conducted with crofelemer in pediatric patients in UAE with intestinal failure due to microvillus inclusion disease for one patient and short bowel syndrome in two patients.

These were presented November 8th last year, 2025, at NASPGHAN, which is the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. This was presented by the study’s primary investigator, Dr. Mohammed Daghdi, who has been a colleague and collaborator with the company for many years, over about eight years now. The initial results present and demonstrate disease progression modification with crofelemer through reduction of parenteral support, the key endpoint that I mentioned, in pediatric intestinal failure patients, and that reduction ranged from 12%-37%. Remember I said even 5% would be considered meaningful, and what does meaningful mean in terms of the vision, the viewpoint from regulatory agencies, FDA? Very specifically, the two pediatric short bowel syndrome intestinal failure patients who completed the treatment, the results show crofelemer reduced parenteral support between 12.5% and 15.6%.

For the MVID patient, the parenteral support needs were reduced by up to 37%. There have been no safety issues, which is consistent with the safety profile of crofelemer as demonstrated in thousands of patients in published clinical trials and in other disorders and years of commercial availability of the drug as the FDA approved Mytesi for the HIV indication. We expect the patients participating in the ongoing trial in the UAE to be provided with crofelemer for the rest of their lives. Now, at this point, these patients have been treated for over a year. Initially, in the investigator-initiated trial protocol, they were treated for about three months with increasing doses, and then, again, no safety issues, they were taken off the drug and very, very quickly, in a matter of literally days.

Both the treating community, the parents, and the physicians immediately needed to put the patients back on as there was a relapse situation, which is a very important indication of benefit when you’re in a non-placebo-controlled situation. So based on FDA support for a recently submitted protocol amendment for our placebo-controlled trial, which is fully enrolled for MVID, we will continue to evaluate the safety and the efficacy of crofelimer. Now this is crofelimer, but it’s not Mitek in terms of formulation. It’s a highly concentrated liquid formulation that is appropriate for intestinal failure patients. As you can imagine, a pill would go right through them, and we’re also talking about pediatric, in some cases, infants, to be administered this product.

In this trial, which as I mentioned is fully enrolled, the placebo-controlled trial, we filed amendment to allow the opportunity for patients to then go into a treatment-only extension phase. Again, it’s expected that we would provide product for the rest of their lives. This trial is taking place, as often happens with rare diseases, globally, so you can access the patients in the U.S., in Italy, and in the UAE. We’re talking about an opportunity to complete our regulatory program and potentially file with the continued response, as we’re seeing, for a New Drug Application based on a single-digit number of patients.

We also expect to be able to file for a Breakthrough designation with the FDA, which is an opportunity to accelerate the U.S. regulatory path and potentially qualify for the European Medicines Agency, which is like the FDA of Europe, PRIME, Priority Medicines, which can accelerate the regulatory path to approval and to market and commercialize and provide patient access in all 27 E.U. countries. As I mentioned, the target for the NDA with the FDA, the new drug application, is in the first half of 2027. MVID, again, is a devastating, catastrophic, ultra-rare pediatric disorder. The estimated worldwide prevalence is about 200 patients. This trial of crofelemer in just a small number of patients is expected to be both statistically meaningful and remarkably meaningful, huge impact for the individual patients and be supportive of registration.

There’s no therapies available or even in clinical development for MVID other than life-saving parenteral support. Again, lethal natural history and underscores the need for new therapies. We do have orphan designation in the U.S. and Europe for both MVID and short bowel syndrome. Not only does that provide the opportunity and the efficiency for a smaller number of patients, by the way, significantly lower cost, smaller number of patients in clinical trials, but also for a great deal of regulatory impact and communication as we’re progressing through the program, and we absolutely have been taking advantage of that. As I mentioned, coincidentally, in time, we also have the intestinal failure program enhanced by clinical proof of concept data in pediatric patients with intestinal failure due to short bowel syndrome.

We have an ongoing randomized double-blind placebo-controlled phase II study, again, of this highly concentrated liquid formulation of crofelemer in adult short bowel syndrome intestinal failure patients. Short bowel syndrome and the intestinal failure affects a significantly larger patient population, though, than MVID, although still an orphan indication. That arises from congenital anomalies, surgical resection due to Crohn’s disease, cancer, accidents. Adult and pediatric patients with intestinal failure face chronic dependence on parenteral support due to the insufficient absorbent surface area of their intestines. Unlike MVID, where the patient’s intestine is completely intact but not functioning, the intestinal failure situation in short bowel syndrome patients is due to their short bowel. Our intestines, a normal one is typically 20-25 feet. These could be five feet or less, so there’s simply not enough geography to absorb the nutrients of life.

Patient population is estimated at about 12,000 patients in the United States in 2021, and this was from a third-party epidemiology study. We expect approval of crofelemer for MVID would support the development program for SBS-IF because the approval of MVID would likely help attract further partnering interests since it’s the same product. It’s a different indication, but it would be the same product. Safety, manufacturing, we get to benefit from the approval that we already have out there for Mytesi, for crofelemer, although in a different formulation, and then the efficacy. Very specifically, we’re interested in a partner to assist in the funding for the final development and commercialization of crofelemer for MVID and short bowel syndrome IF with commercialization efforts from the partner outside the United States, addressing the global need of this population. Drugs are, of course, approved based on manufacturing and safety, which I mentioned.

Again, we get to leverage what we already have in place. The efficacy, safety, the benefit/risk ratio, with a risk of zero, the benefit, any benefit that we can show and continue to show based on our proof-of-concept data can be infinity and beyond. We established our ability to perform and close on important non-dilutive business dollar deals from where I started this presentation in January with the Future Pak deal. Again, $16 million non-diluted dollars received upfront in January, another $2 million coming, $20 potential million dollars throughout the course of the deal, over $3 million of which other dollars we have already received. In this market, the IF market is considered to be 100x larger than the HIV market.

With the clinical proof-of-concept data that we already have in hand and near-term clinical and regulatory milestones ongoing from investigator-initiated trials, from presentations, publications, from the ongoing placebo-controlled trials that we have, patients going into treatment-only extension phase, we are confident in our ability and our focus to execute upon our business development goals and strategy with our IF program and the opportunity to further bring in non-dilutive dollars. I’ll now hand the discussion over to Carol for her recap of the financial highlights that we released earlier this week for the third quarter of 2025. Over to you, Carol.

Carol Lizak, Chief Financial Officer, Jaguar Health: Well, good morning, Lisa, and thank you all for joining our webcast today. I’ll begin my review of our financials for the fourth quarter of 2025. The total net revenue for the company’s prescription products, Mytesi, Gelclair, and Canalevia-CA1, non-prescription products, and license revenue, was approximately $3.2 million in the fourth quarter of 2025, representing an increase of 5% over the total net revenue in the third quarter of 2025, which totaled approximately $3.1 million, and a decrease of approximately 8% over the total net revenue in the fourth quarter of 2024, which totaled approximately $three and a half million. In 2025, approximately $11.2 million out of the company’s total net revenue of $eleven and a half million dollars was generated by sales of Mytesi and Canalevia-CA1.

Under the terms of the license agreement Jaguar entered with Future Pak in January 2026, Future Pak will be responsible for all commercial efforts and will receive all proceeds from the U.S. sales of Mytesi and Canalevia-CA1 as of January 12, 2026. Jaguar will be responsible for supply of product at a premium price and will recognize manufacturing revenue. Future Pak has already purchased product from Jaguar, in addition to paying $16 million to Jaguar of the upfront license fee and a $3 million payment. As we announced last month, the $3 million payment followed by Jaguar’s termination of the buyback provision of the licensing agreement we entered in January with Future Pak.

This allows Future Pak to continue to commercialize Mytesi beyond five years. As Lisa mentioned, Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak, and the license agreement is in alignment with Jaguar’s strategy to concentrate on crofelemer late-stage development efforts for human rare disease intestinal failure indications. Mytesi prescription volume decreased approximately 3.7% in the year 2025 over 2024, by approximately 5.8% in the fourth quarter of 2025 over the third quarter of 2025, and by approximately 12.2% in the fourth quarter of 2025 over the same period last year. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

Loss from operations increased by $15.1 million from $30.8 million in the year ended December 31, 2024 to $45.9 million in 2025. Non-GAAP recurring EBITDA for 2025 and 2024 were a net loss of $48.1 million and $35.9 million respectively. Net loss attributable to common shareholders increased by approximately $15.1 million from $thirty-eight and a half million in the year ended December 31, 2024 to $53.6 million in 2025.

In addition to the loss from operations, the fair value of financial and hybrid instrument designation at fair value option decreased by $3.2 million from a loss of $9 and a half million in the year ended December 31, 2024 to a loss of $6.3 million in 2025, primarily due to fair value adjustments in notes payable designated as FVO, or fair value option. Loss on extinguishment of debt increased by $3 million from a gain of $1.2 million in the year ended December 31, 2024 to a loss of $1.8 million in 2025, primarily due to substantial modifications to the expected payments of one royalty interest agreement, which triggered extinguishment accounting. That concludes my recap of high-level financials to the fourth quarter of 2025. I will now hand the discussion back to Lisa.

Lisa Conte, Founder, President, and Chief Executive Officer, Jaguar Health / Napo Pharmaceuticals / Napo Therapeutics: Thanks very much, Carol. Thanks, everyone, for listening. I do want to mention that while the Future Pak deal, as it brings in, as I said, non-dilutive dollars and value to fuel our rare disease program, the value to Future Pak is very important in the HIV area, the addition of Mytesi to their portfolio. Last year, Future Pak bought Theratechnologies, which has two HIV products with a remarkable overlap in the targets of physicians that are treating patients that would be expected to be experiencing GI disorder and HIV-related diarrhea. These are typically older patients. About 50% of patients living with HIV now in the United States are over the age of 50, have had the virus in their gut for over 10 years, often experiencing enteropathy and the inflammation that can lead to leaky gut and diarrhea.

They have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. Mytesi is in good hands in terms of getting to those patients with the unmet medical need and allowing us to focus on our next indications with important unmet medical need and disease, again, with a lethal natural history. The opportunity to benefit immediate symptom management, disease progression, modification, and potentially extension of the patient’s life. Okay. We expect to provide clinical proof of concept milestones and business development discussions throughout the rest of this year and into 2027 with a very clear goal and focus to bring in non-dilutive funds from potential licensee partner or partners.

We at Jaguar, Napo, and Napo Therapeutics remain fully energized and excited about the multiple expected near-term catalysts for crofelemer in the company, all of which we view as significant, value-enhancing, and potentially transformative for patients and for the company and all the stakeholders in the company. Have a good day. This concludes our webcast for today, and we’ll see you with the next quarter.

Melissa, Webcast Moderator, Jaguar Health: Thank you. Ladies and gentlemen, this concludes today’s conference call. You may disconnect your lines at this time. Thank you for your participation.