Jaguar (JAGX) Q4 2025 Earnings Transcript

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Date

Friday, April 10, 2026 at 7 a.m. ET

Call participants

• Founder, President, and Chief Executive Officer — Lisa Conte
• Chief Financial Officer — Carol Lizak

Takeaways

• Net revenue -- $3.2 million for the fourth quarter, a five percent sequential increase from $3.1 million in the prior quarter and an eight percent decline from $3.5 million in the prior year’s fourth quarter.
• Full-year revenue concentration -- $11.2 million of the $11.5 million total revenue in 2025 was generated by Mytesi and Canalevia-CA1 sales.
• Out-license transaction -- An out-license agreement with Future Pak for Mytesi and Canalevia-CA1 closed with $18 million upfront (of which $16 million was already received by January); $2 million is contingent, and an additional $20 million may be earned via milestones and other payments.
• Additional upfront payments -- Close to $4 million in addition to the initial $16 million upfront payment has been received from Future Pak.
• Licensing structure -- As of January 12, 2026, Future Pak assumes all U.S. commercialization for Mytesi and Canalevia-CA1; Jaguar remains manufacturer, selling at a premium and recognizing manufacturing revenue.
• Mytesi prescription volume -- Decreased by three point seven percent for full-year 2025, dropped five point eight percent sequentially from the third quarter, and fell twelve point two percent relative to the fourth quarter of 2024.
• Loss from operations -- $45.9 million in 2025, an increase of $15.1 million compared to $30.8 million in 2024.
• Net loss attributable to common shareholders -- $53.6 million in 2025, up $15.1 million from $38.5 million in 2024.
• Non-GAAP recurring EBITDA -- Net losses of $48.1 million in 2025 and $35.9 million in 2024.
• Clinical catalyst data -- Crofelemer reduced parenteral support in pediatric intestinal failure patients by twelve percent to thirty-seven percent, as reported from a proof-of-concept UAE study (twelve point five percent to fifteen point six percent in short bowel syndrome; thirty-seven percent in MVID).
• U.S. and EU orphan designation -- Crofelemer granted orphan designation in both markets for MVID and short bowel syndrome.
• Next regulatory milestones -- A New Drug Application for MVID is targeted in the first half of 2027, alongside completion of a Phase II short bowel syndrome trial.
• Addressable market estimate -- The short bowel syndrome market was cited as $8 billion, which management characterized as "about 100x the size of the Mytesi HIV estimated market size."
• Business development focus -- Management said, "[Our] key objective...and...strategy for 2026" is to secure additional partnerships and non-dilutive funding through further licensing deals in rare-disease indications.
• Proof-of-concept outcomes -- Jaguar reported that all patients in the UAE proof-of-concept trial relapsed quickly after stopping crofelemer, requiring re-initiation of therapy, and noted "no safety issues" to date.
• Deal structure changes -- A $3 million payment followed Jaguar’s termination of the buy-back provision in the Future Pak license, allowing commercialization beyond five years.
• Manufacturing revenue -- Jaguar expects to generate profit by supplying crofelemer to Future Pak at a premium price under the licensing agreement.
• Regulatory acceleration -- Jaguar intends to seek U.S. FDA Breakthrough designation and EMA PRIME status for crofelemer in these rare indications.
• Fair value of financial instruments -- Loss decreased by $3.2 million to $6.3 million in 2025, reflecting fair value adjustments in notes-payable designated at Fair Value Option.
• Debt extinguishment -- Loss increased by $3 million to $1.8 million, primarily from modification of a royalty-interest agreement.

Risks

• Mytesi prescription volumes declined five point eight percent sequentially and twelve point two percent year over year in the fourth quarter, signaling ongoing weakness in core HIV-related sales.
• Net loss attributable to common shareholders increased by $15.1 million to $53.6 million in 2025, with higher losses from operations and negative non-GAAP EBITDA.
• CEO Conte stated, "it's a lethal natural history for these patients," emphasizing that clinical success remains essential for market viability.
• Future U.S. sales of Mytesi and Canalevia-CA1 are fully dependent on partner Future Pak's commercialization efforts, as Jaguar no longer directly controls that revenue stream.

Summary

Jaguar Health (NASDAQ:JAGX) delivered a sequential revenue uptick following the out-license of Mytesi and Canalevia-CA1, which generated immediate non-dilutive cash inflows and shifted the company’s revenue mix. Significant losses persisted, with broader year-over-year declines in Mytesi prescription volume and escalating operational losses. Management reported meaningful parenteral support reductions in rare pediatric indications for crofelemer, advancing late-stage trials and asserting strategy alignment around licensing and business development. The company highlighted a sizable addressable rare-disease market and outlined explicit near-term regulatory and partnering milestones as primary value drivers.

• The shift to a manufacturing-focused model for Mytesi and Canalevia-CA1 is expected to generate premium-priced, partner-driven revenue rather than direct U.S. pharmaceutical sales.
• Jaguar is targeting regulatory submissions for MVID in the first half of 2027 and aiming for simultaneous progress in short bowel syndrome trials.
• Accelerated regulatory designations such as FDA Breakthrough and EMA PRIME are pursued to expedite rare-disease indication approvals, potentially expanding patient access and commercialization opportunities.
• Termination of the Future Pak buy-back provision secures long-term licensing revenue but eliminates Jaguar’s option to reclaim direct commercialization rights for Mytesi and Canalevia-CA1.

Industry glossary

• MVID (Microvillus Inclusion Disease): An ultra-rare congenital diarrheal disorder resulting in intestinal failure, typically requiring lifelong parenteral nutrition.
• Short bowel syndrome with intestinal failure (SBS-IF): A condition where insufficient functional intestine leads to chronic dependence on intravenous nutritional support.
• TPN (Total Parenteral Nutrition): Intravenous administration of nutrients used when the digestive tract is non-functional, mentioned as both life-saving and potentially toxic.
• Canalevia-CA1: Jaguar’s crofelemer formulation for treating chemotherapy-induced diarrhea in dogs, conditionally approved and partnered with Future Pak.
• EMA PRIME: Priority Medicines status by the European Medicines Agency to accelerate regulatory pathways for therapies addressing unmet medical needs.

Full Conference Call Transcript

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. And 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: Thanks very much, Melissa, and thank you, everybody. Hello. Thank you for joining the Investor Webcast today. As you heard, my name is Lisa Conte. I'm the Founder, President, and CEO of Jaguar Health and our wholly-owned subsidiary, Napo Pharmaceuticals, and I am the Chairman of our Italian subsidiary, Napo Therapeutics. So as usual, I may use the words Jaguar and Napo interchangeably to refer to the Company. And after I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the fourth quarter of 2025 last year.

And, 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 nonprescription 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. And 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 upfront, 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. So, 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 natural -- 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, 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 100x 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 health care 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 6 to 12 months, as you'll hear as I continue to go through this presentation and a goal to license -- 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. Terrific. Terrific. As I mentioned, the intestinal-failure program is a blockbuster market, and it's catastrophic for the patients. What is intestinal failure? The intestinal failure is a situation where the patient can't absorb their nutrients of life. Their proteins, their carbs, vitamins, et cetera.

So they end up on parenteral nutrition, parenteral support, that's IV support up to 20 hours a day, 7 days a week. So, 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.

And 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. But TPN is remarkably toxic to kidneys, to liver, to cognitive function, patients often are on a much slower growth-curve. So, 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. And, I was talking with a patient advocate just a couple of weeks ago. And 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. So, it makes a very, very big difference in the opportunity for the patient and the patient's entire community, which includes the physician, often nurses, nutritionists, and the family, all working together. Remember, every single day, these patients require parenteral nutrition.

So, 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, and these were presented November 8 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 Miqdady, who has been a colleague and collaborator with the Company for many years, over about 8 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% to 37%. And remember, I said even 5% would be considered meaningful and what is meaningful means in terms of the vision, the viewpoint from regulatory agencies, FDA. Very specifically, the 2 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%, and 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 in other disorders and years of commercial availability of the drug at the FDA -- 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 3 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 community, and 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 efficacy of crofelemer. Now, this is crofelemer, but it's not Mytesi 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. And again, it's expected that we would provide product for the rest of their lives. And this trial is taking place as often happens with rare diseases globally, so you can access the patients.

So, in the United States, in Italy, and in the UAE, we're talking about an opportunity to complete our regulatory program and potentially file with 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 from -- 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 EU countries.

As I mentioned, the target for the NDA with the FDA, the New Drug Application is in the first half of 2027, MVID against devastating, catastrophic, ultra-rare pediatric disorder; the estimated worldwide prevalence is about 200 patients. So, 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.

And 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 than MVID, although still an orphan indication. And 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 absorptive surface area of their intestine. So, 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 intestine, the normal one is typically 20, 25 feet. These could be 5 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 interest, 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, 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 and the efficacy, safety, the benefit-risk ratio, with a risk of 0, 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 deals from where I started this presentation in January with the Future Pak deal. Again, $16 million non-dilutive dollars received upfront in January, another $2 million coming, $20 potential million 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 further bring in 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: 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 nonprescription 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 $3.5 million. In 2025, approximately $11.2 million out of the Company's total net revenue of $11.5 million 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 the 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 buy-back provision of the Licensing Agreement we entered in January with Future Pak.

This allows Future Pak to continue to commercialize Mytesi beyond 5 years. As Lisa mentioned, Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak, and the Licensing 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 net loss of $48.1 million and $35.9 million, respectively. Net loss attributable to common shareholders increased by approximately $15.1 million, from $38.5 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 $9.5 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 at 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: Thanks very much, Carol. Thanks, everyone, for listening. I do want to mention that while the Future Pak deal 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 2 HIV programs -- 2 HIV products, excuse me, with a remarkable overlap in the targets, the 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. And they -- so they have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. So 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.

So 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 licensing partner or partners. We, at Jaguar, Napo, and Napo Therapeutics remain fully energized and excited about the multiple expected near-term catalysts for crofelemer and 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.

Operator: Thank you. Ladies and gentlemen, this concludes today's Conference Call. You may disconnect your lines at this time. Thank you for your participation.

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