Jaguar Health, Inc.

Greetings and welcome to Jaguar Health Investor Webcast. At this time, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 risk 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 7, 2026, and its other filings with the SEC, which are available in the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements. except as required by law. 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. 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.

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, Napa 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 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. 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. outlicense agreement with FuturePAC for Mitessi, our FDA-approved tablet formulation of profilamer, Mitessi. an agreement that is fully aligned with our strategy to sharply focus our profilamer development efforts, our profilamer development efforts on rare disease intestinal failure indications. The out-license agreement also covers canalevia CA1, profilamer 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-diluted 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-diluted dollars. And we've already received close to $4 million of additional payments above and beyond the 16. 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 Cofelimer, and we are selling it to FuturePak 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, microvirus 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 two 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 Mitessi HIV estimated market size. In that deal, we got an $18 million upfront payment. So that's the enormity 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-diluted 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. 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 were able to put that slide up. Our intestinal failure program... Oh, terrific, terrific. As I mentioned, the intestinal failure program is a blockbuster market, and it's catastrophic for the patients. what is intestinal failure? So 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, seven days a week. So obviously, hugely catastrophic for quality of life but also for other health issues. It's TPN, parental 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 TBN is remarkably toxic to kidneys, to liver, to cognitive function. Patients often are on a much lower 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 crofilomer intervention? its reduction of TPN and parental support by even 5% will be meaningful. 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 parental 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 parental 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 parental nutrition. So the groundbreaking results that we have already achieved in the intestinal failure area with the results of an independent proof-of-concept study that was conducted with profilamer in pediatric patients in UAE with intestinal failure due to microvirus inclusion disease for one patient and short bowel syndrome in two patients. And these were presented November 8th, last year, 2025. at NASSCAM, which is the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. This was presented by the study's primary investigator, Dr. Mohammed Mugdadi, 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 profilamer through reduction of parental support, the key endpoint that I mentioned, in pediatric intestinal failure patients, and that reduction ranged from 12 to 37%. 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 two pediatric short bowel syndrome intestinal failure patients who completed the treatment, the results show profilamer reduced parental support between 12.5 and 15.6%. For the MVID patient, the parental support needs were reduced by up to 37%. And there have been no safety issues, which is consistent with the safety profile that profilamer has demonstrated in thousands of patients in published clinical trials and in other disorders and years of commercial availability of the drug at the FDA, as the FDA approved Mitessi for the HIV indication. We expect the patients participating in the ongoing trial in the UAV to be provided with cofellumar 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 community, 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 profilamer Now this is Crofilamer, but it's not Mitessi 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 an 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 patient. 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 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's 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. MVAD, again, it's devastating, catastrophic, ultra-rare pediatric disorder. The estimated worldwide prevalence is about 200 patients. So this trial of profilamer 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 parental support, again, lethal natural history and underscores the need for new therapies. We do have orphan designation in the US 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 control phase two study, again, of this highly concentrated liquid formulation of crofilomer 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 parental support due to the insufficient absorbent surface area of their intestines. So unlike MVID, where the patient's intestine is completely intact but not functioning, the intestinal failure situation in short bowels in your patients is due to their short bowel. Our intestines, 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 Cofelimer for MVID would support the development program for SBSIS because the approval of MVID would likely help attract further partnering interest since it's the same product. 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 Mitessi for profilamer, 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 profilamer 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 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-diluted business dollar deals from where I started this presentation in January with the Future Back deal. Again, 16 million non-diluted dollars received up front 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 100 times 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 IAF 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.

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, Mitessi, GelClear, and Canolevia 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 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 Mitessi and Canalivia CA1. Under the terms of the license agreement, Jaguar entered with FuturePAC in January 2026. FuturePAC will be responsible for all commercial efforts and will receive all proceeds from the U.S. sales of Mitessi and can only receive one as of January 12, 2026. Jaguar will be responsible for supply of product at a premium price and will recognize manufacturing revenue. Future Pac 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 FuturePAC. This allows FuturePAC to continue to commercialize Mitessi beyond five years. As Lisa mentioned, Jaguar will continue to manufacture Mitessi and Canolevia CA1 for future pack. And the license agreement is in alignment with Jaguar's strategy to concentrate on Crefellumar late stage development efforts for human rare disease intestinal failure indications. My TESI 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 invoice 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 38.5 million in the year and then 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 nine 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 FBO or fair value option. Loss and 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.

Thanks very much, Carol. Thanks, everyone, for listening. I do want to mention that while the future PAC deal as it brings in, as I said, non-dilutive dollars and value to fuel our rare disease program. The value to FuturePak is very important in the HIV area. The addition of Mitessi to their portfolio. Last year, FuturePak bought Thera Technologies, which has two HIV programs, two HIV products, excuse me, 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. And they, so they have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. So Mitessi 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 licensee partner or partners. We at Jaguar, NAPO, and NAPO Therapeutics remain fully energized and excited about the multiple expected near-term catalysts for profilamer 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.

Thank you. Ladies and gentlemen, this concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.