Jaguar Health - Earnings Call - Q3 2025

Transcript

Speaker 1

Greetings and welcome to the 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. As a reminder, this conference is being recorded. Before I turn the call over to management, I'd like to remind you that management makes 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, product initiatives including products in the development stage which may 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 currently available information and management's current assumptions, expectations, and projections about future events.

While management believes its assumptions, expectations, and projections are reasonable in 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 year 2024, which was filed March 31, 2025, and its other filings with the SEC, which are available on the investor relations section of Jaguar's webcast. 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 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's my pleasure to turn the call over to Lisa Conte, Jaguar Health's founder, president, and chief officer. Lisa, the floor is yours.

Speaker 0

Thank you very much. Appreciate that introduction. Hello to everybody. Good morning. My name is Lisa Conte, and I am Founder, President, and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I am also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably as I refer to our company. After I speak this morning, our CFO, Carol Lizak, will provide a recap of the financial highlights for the third quarter of 2025. I am going to kick off by once again stealing Carol's thunder as we are pleased to report that our combined net third quarter 2025 revenue of approximately $3.1 million for prescription and non-prescription products, including license revenue, increased approximately 4% versus the net Q2 2025 of approximately $3 million.

I'm also happy to report that 2025 continues to be the year of convergence of key clinical and regulatory catalysts for Jaguar, catalysts that we feel will be transformative in terms of the value that they bring to all stakeholders in the company, from patients, very importantly, from patients to shareholders, also very important. Simply put, with the recent achievements of these catalysts, our strategy continues to be to negotiate business development partnerships for licensed rights to the development and commercialization of our human and animal late-stage health products, with the goal of generating non-dilutive funding for Jaguar. We have three key late-stage initiatives that are the subject of business development negotiations. The first is our orphan indications of crofelemer for intestinal failure associated with a congenital diarrheal disease referred to as MVID, microvillus inclusion disease.

I'm going to refer to it as MVID, in short, bowel syndrome, which I'm going to refer to as SBS. And this program refers to crofelemer, though not our commercialized Mytesi formulation of crofelemer. Crofelemer in a distinct, novel, highly concentrated liquid formulation, which is appropriate for the patient condition, into a liquid formulation from a lyophilized cake. So what is intestinal failure? It's a debilitating lifelong condition that requires patients to receive life-sustaining fluids, electrolytes, and nutrients through intravenous administration, which consists of something referred to as TPN, total parenteral nutrition, with supplemental intravenous fluids, which together constitute parenteral support. As you can imagine already, this sounds terrible. These are patients who can't absorb their nutrients of life, their protein, carbs, etc. So they are living on IV nutrition.

Most intestinal failure patients require parenteral support up to seven days a week and sometimes for 20 hours or more a day, hooked up to IV nutrition. Clearly, this is a catastrophic healthcare situation, quality of life situation. Short bowel syndrome is a rare disease of approximately 40,000 patients globally. For this indication, Jaguar has received orphan drug designation in the United States and in Europe. MVID, intestinal failure, MVID patients, this is an ultra-rare disease of approximately 100-200 patients globally. We have also received orphan drug designation in the U.S. and Europe. Infants that are born with this genetic defect have a lethal natural history. They do not become adults. They only survive as immediately receiving TPN, total parenteral nutrition, as I mentioned, parenteral support, which has many toxicities associated with it, including liver and kidney toxicity, neurodevelopment delay, many more, which often become life-threatening.

Crofelemer has been shown to have a groundbreaking reduction of parenteral support of up to 37%. This is important, as you can imagine, for reducing the amount of time on toxic TPN and parenteral support. This result was presented last week at the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, referred to as NASPGHAN. It is an annual meeting in Chicago, and the results were presented by the study's primary investigator in the investigator-initiated trial, Dr. Mohammed Mighdadi. This is important because the reduction of parenteral nutrition, parenteral support is both potentially life-extending, life-saving, and disease progression-modifying, and provides an opportunity for improved quality of life in this otherwise catastrophic medical and disease situation for the patient and, quite frankly, the entire family of the child and his or her caregiving team.

This unprecedented result is especially compelling given that no approved treatments exist for MVID, and we're not aware of any approach, even in development, for MVID. Additionally, as presented at NAFSCAM, were two short bowel syndrome patients surviving on parenteral support, parenteral nutrition, parenteral support, which similarly had reductions of approximately 12% in their parenteral support. This result is equally important for the same reason, for the opportunity to reduce the toxicity associated with the parenteral support. Also, while some short bowel syndrome patients do have an opportunity to be treated with a growth hormone approach to potentially grow their short bowel. As an aside, by the way, growth hormone is not a standard of care, has many side effects itself, and additionally, is not even possible in an MVID patient, as MVID patients have fully intact guts. They're simply not functioning, so there's nothing to grow.

Anyway, back to short bowel syndrome. Approximately one-third of the short bowel syndrome population are patients with surgical reasons for their short bowel and have adaptation issues during which they cannot receive a growth hormone and/or may have a hyperproliferative circumstance such as cancer, and therefore are definitely not candidates for a growth hormone approach. Once again, crofelemer is demonstrating proof of concept in an orphan population with no treatment alternative, nothing in development. Once again, this is a distinct product from Mytesi, the same active ingredient, crofelemer, and will be commercialized globally under a business model associated and appropriate for the incentives for rare diseases. I'll now discuss our other core crofelemer development program, cancer therapy-related diarrhea, CTD, a planned label extension of supplemental NDA for the already FDA-approved Mytesi product.

This program, and again, it's a distinct product from the IF, highly concentrated liquid formulation, is also the subject of ongoing business development negotiations. The key clarifying and coordinating event was, again, a separate type C meeting with the FDA in May of 2025 discussing an expedited pathway for approval in metastatic breast cancer patients based on supportive data of prophylaxis of cancer therapy-related diarrhea in breast cancer patients from the completed phase 3 on-target trial, which was presented at San Antonio Breast Cancer Symposium in December of 2024. We're going to combine this with anticipated data from a pivotal randomized withdrawal treatment trial in metastatic breast cancer patients to be initiated in early 2026. In our experience, a randomized withdrawal trial is the optimal design for a product that works.

It's a clinical trial design where participants first receive an active treatment and then, if they respond, are randomly assigned to either continue the active treatment or receive placebo. As a reminder, this trial is with the same formulation and dose as the approved Mytesi for HIV-related diarrhea, for which, of course, chronic safety and manufacturing regulatory hurdles have already been approved. Chronic safety or any safety in manufacturing are the two most common reasons why NDAs fail. Those have already been achieved with Mytesi. The efficacy endpoint potentially expands the indication of Mytesi to cancer therapy-related diarrhea under a supplemental NDA, and cancer therapy-related diarrhea is a blockbuster opportunity for the patients, of course, and the market opportunity.

There are approximately 160,000 metastatic breast cancer patients in the United States, many of whom are on diarrhea-causing targeted therapies for the rest of their lives, which thankfully are becoming 5, 10, 15 years of survival sometimes. We have filed for orphan drug designation for metastatic breast cancer indication. Approximately 40% of patients go off their life-saving targeted therapies specifically because of diarrhea. Now crofelemer has the opportunity to benefit not only patient quality of life, dignity, and comfort, as important as those supportive care impacts are, though also impact the outcome of the successful outcome of their cancer therapy. Moving along now to the animal health side of our business, our primary activity for Canalivia is our prescription drug candidate of crofelemer. Canalivia is an animal formulation indication that is FDA conditionally approved under the name Canalivia CA1 for the treatment of chemotherapy-induced diarrhea in dogs.

Our primary activity is negotiating with potential partners with which to collaborate to achieve three parallel goals for the drug: expand the US indication for chemotherapy-induced diarrhea in dogs to the treatment of general diarrhea in dogs, obtain approval in the European Union for Canalivia for general diarrhea in dogs, and, based on an existing Jaguar study that already exists, maintain continuity of availability in the United States of Canalivia for the treatment of chemotherapy-induced diarrhea in dogs, for which it is already approved again. Remarkably, a cancer patient in the United States experiencing diarrhea can have crofelemer promoted and prescribed if that patient is a dog; a human, not yet. I'm pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalivia to regulatory approval and commercialization for general diarrhea globally.

This is our third ongoing business development negotiation with the goal of bringing non-dilutive dollars to recognize the contribution to late-stage drug development and risk reduction Jaguar has achieved with crofelemer for various indications. Timeline associated with these activities for intestinal failure, based on a type C meeting, a distinct meeting from the cancer meeting that we had with the FDA on October 2nd, we laid out a pathway for potential expedited review based on continued results like we're seeing in the MVID patient for having data that's viable by potentially the end of 2026, literally based on a single-digit number of patients because of the ultra-rare nature of the disease and the lethal natural history of the disease. Also looking next year for breakthrough designation in the United States and prime in Europe programs that help get products approved in an expedited way for an ultra-rare disease situation.

For cancer therapy-related diarrhea, we would look to complete the trial for the randomized withdrawal by the end of 2026 as well in support of a supplemental NDA filing. That would be two potential NDA filings from date at the end of 2026 on the human side. On the animal health side, we're looking to close an animal health partnership in the very near future. I'll now hand the discussion over to Carol, our CFO, for a recap of the financial highlights for the third quarter of 2026. Take it away, Carol. Good morning, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the third quarter of 2025.

The combined net third quarter 2025 revenue of approximately $3.1 million for prescription and non-prescription products, including license revenue, increased approximately 4% versus net second quarter 2025 revenue of approximately $3 million and equaled net third quarter 2024 revenue of approximately $3.1 million. Mytesi prescription volume increased by approximately 0.9% in the third quarter of 2025 over the second quarter of this year. Mytesi prescription volume in the third quarter of 2025 decreased by 3.6% compared to the volume in the third quarter 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 decreased by $24,000 from $7.2 million in the third quarter ended September 30, 2024, to $7.3 million during the same period this year.

Non-GAAP recurring EBITDA for the third quarters of 2025 and 2024 were a net loss of $8.9 million and $9.2 million, respectively. Net loss attributable to common shareholders decreased by $352,000 from $9.9 million in the quarter ended September 30, 2024, to $9.5 million in the same period in 2025. That concludes my recap of high-level financials for the third quarter of 2025. I will now hand this discussion back to Lisa. Thanks, Carol. Okay, to all members of the Jaguar, Napo, and Napo Therapeutics family, we 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, as I mentioned, all stakeholders, including our shareholders.

Pharmaceutical development is a long-term outcome, and these catalysts represent the convergence of key potential inflection points in our major programs that we've worked on for years. We expect these catalysts to lead to significant collaborations, business development, and licensing deals, and the opportunity to bring in non-dilutive dollars to support bringing these late-stage products and programs to regulatory approval and reimbursed patient access. This concludes our webcast for today. Thank you all for joining. Have a wonderful Thanksgiving and holiday with your families, and we'll get together again next quarter. Thank you.