Jaguar Health, Inc. ($JAGX)

[Audio Gap] 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 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. Company's actual results may differ materially from those discussed during the webcast for a variety of reasons, including those described in the Forward-Looking Statements and Risk Factors 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 on 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 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's 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. Hello, and thank you for joining our investor webcast this morning. I hope you all had a great holiday weekend. 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. As usual, I may use the words Jaguar and Napo interchangeably to refer to our company. After our speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the first quarter of 2026. The theme of today's webcast is transformation and sharp strategic focus. I'm going to preempt Carol as we're pleased to report that the company's net revenue increased 816% in the first quarter of 2026 versus the first quarter of 2025 and increased 527% in the first quarter of 2026 versus the fourth quarter of 2025, buoyed by the transformative event of the U.S. out-license agreement we executed this past January, January 2026, with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer for adults living with HIV AIDS and experiencing diarrhea and included in the license was Canalevia-CA1, our conditionally approved formulation of crofelemer for dogs. We made the strategic decision to out-license Mytesi and Canalevia-CA1 to Future Pak, first, because they had recently acquired Theratechnologies, an HIV-focused commercial company with more than 4x the commercial effort of Jaguar in the United States; and secondly, to fulfill our strategic plan to bring in meaningful nondilutive dollars to fund our sharp development focus on our pivotal stage program for our novel proprietary powder for oral solution formulation of crofelemer, so a different formulation than the Mytesi tablet, powder for oral solution formulation of crofelemer for rare intestinal failure indications. Our strategy then continues with the goal of identifying a development and commercialization partner for this program as well. The near-term value driver in our intestinal failure development program is our lead target indication, pediatric microvillus inclusion disease, MVID, an ultra-rare disorder with no approved therapies. We've embarked on an ongoing clinical path toward a potential NDA, new drug application, submission in mid-2027; NDA, new drug application, submission to the FDA. Short bowel syndrome, which I'll refer to as SBS, with intestinal failure, SBS-IF, represents a larger follow-on indication using the same dosage form different from Mytesi tabs again, the same powder for liquid dosage form and physiological mechanism as IF with MVID patients. Our intestinal failure program represents a blockbuster global market opportunity in terms of addressing this catastrophic unmet medical need in patients with a lethal natural history, blockbuster in terms of the beneficial impact to morbidity, mortality and the cost to the health care systems and blockbuster in terms of financial return opportunity for all stakeholders and especially important to a potential corporate partner. As an example, the global market for short bowel syndrome, including short bowel syndrome with intestinal failure, is estimated to reach approximately $8 billion by 2033 according to a third-party market research study and a third-party estimate of the value of the global MVID marketplace puts it over $1 billion. I'd like to take a moment to describe the catastrophic impact of intestinal failure to patients in their caregiving community, their health care providers, doctors, nurses, nutritionists, family members and others involved in the care taking. Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition, TPN, with supplemental intravenous fluid, which altogether constitute parenteral support, PS, parenteral support. Many intestinal failure patients require parenteral support up to 7 days a week and sometimes for 20 hours a day or more, obviously, catastrophic and no quality of life. While crucial for survival for intestinal failure patients, parenteral support is associated with significant toxicities to patients, often causing serious health problems, including liver and kidney function problems, metabolic complications, infections, cognitive impairment and in children, significant growth impairment. These symptoms often become life-threatening. The cost of PS, parental support, is estimated at about $500,000 per year in the United States and the cost to the health care system with the inevitable complications can top $1 million per year per patient. The key benefit to IF patients on parental support and the key endpoint in clinical development is the possibility to reduce PS by even 10% to 15%. The value, for example, would allow the patient to receive most of their PS at night while sleeping, while preserving some quality of life during waking hours. As a further example, a child might then be able to attend school without the need to be attached to IV for parental support. In November 2025, last year, groundbreaking initial results of the ongoing and independent proof-of-concept study of crofelemer in pediatric patients in the UAE, United Arab Emirates, with intestinal failure due to MVID and SBS-IF were presented at NASPGHAN. That's the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition; that's a mouthful, NASPGHAN, the annual meeting and it was presented by the study's primary investigator. The initial results demonstrate disease progression modification with crofelemer through reduction of parenteral support in pediatric intestinal failure patients that ranged from 12% to 37%. Specifically, in the 2 pediatric IF patients who completed treatment, the results showed crofelemer reduced parenteral support between 12.5% and 15.6%. For the MVID patient, again, where there's no alternative treatments, parenteral support needs were reduced by up to 37%. It's worth saying, again, 37%, a remarkable result. Multiple patients with intestinal failure due to either MVID or SBS who are taking part in the trial in the UAE have now been treated for more than 1 year and longer-term data will be presented at the Annual Meeting of ESPGHAN, another mouthful, the European -- not North American, the European Society for Pediatric Gastroenterology, Hepatology and Nutrition next month in June 2026. An additional MVID infant patient is being treated with oral crofelemer under an FDA-authorized expanded access program and safety and efficacy data regarding crofelemer treatment in this infant will also be presented at the ESPGHAN conference. This is a fascinating situation where the patient, the young infant diagnosed with MVID right after birth was too young to enroll in our clinical trial, which I'm going to talk about in a moment. With the expanded access to crofelemer, the child is now 9 months old and thriving in the 27% growth curve in what is otherwise a catastrophic diagnosis with a lethal natural history. Crofelemer has been well tolerated and the pediatric MVID patients are gaining weight and height and demonstrating reductions in their daily and weekly needs for parenteral support. There have been no crofelemer-related safety issues in intestinal failure patients, which is consistent with the safety profile of crofelemer as demonstrated in thousands of patients in clinical trials for other disorders and years of commercial availability of the drug as the FDA approved for HIV-related diarrhea. We expect the pediatric intestinal failure patients participating in these ongoing programs to be provided with crofelemer from the company for the rest of their lives. We take great pride in that. We are simultaneously conducting a pivotal randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of the liquid formulation of crofelemer in pediatric patients with intestinal failure due to MVID. This trial is fully enrolled. In pursuit of an NDA filing, a new drug application filing, with the FDA based on patients in this trial, Napo submitted an amendment and received FDA support for a treatment-only extension phase for this study. The first MVID patient has entered the treatment-only extension phase of this trial, which is taking place at clinical sites in the United States, Italy and the UAE. We expect the rest of the enrolled patients to enter the treatment-only phase over the next 2 months as each participating institution provides their approval to supplement the acknowledgment from the FDA. Including the patients in the blinded trial and MVID patients in the expanded access and the investigator-initiated trials, the ones that will be presented at ESPGHAN next month, we estimate we're treating approximately 4% of the patient population of the global patient population of this ultra-rare disease, MVID. We are confident and as you can probably imagine here and here, passionate to bring the benefit of crofelemer to approval for the benefit of all MVID patients in as expeditious a manner as possible. Drugs get approved based on a benefit-risk ratio. Clinical trials have demonstrated no risk, excellent tolerance with crofelemer and the benefits in PS reduction, particularly compared to weight in a growing pediatric population speak for themselves. We feel this is a powerful result, providing breakthrough adjunctive therapy to reducing PS support needs and the concomitant toxicities that come with that life-saving PS. Because of the ultra-rare nature of MVID, again, a disorder for which there are no approved treatments and with the continuation of the benefit we are seeing, we hope to achieve breakthrough therapy designation from the FDA for crofelemer to accelerate even further the U.S. regulatory pathway to market. And we're also focused on potential EMA, European Medicines Agency, that's the equivalent of the FDA in Europe, pathways to accelerate the regulatory approval to market in all 27 EU countries as well. Breakthrough designation in the United States would give an approval time line of 4 months. As I mentioned, our crofelemer intestinal failure programs are also enhanced by clinical proof-of-concept data in pediatric patients with intestinal failure due to short bowel syndrome, SBS. Our oral liquid formulation of crofelemer is a non-growth hormone drug candidate for use as adjunctive therapy to parental support through its unique first-in-class physiological mechanism of action of reducing liquid stool output, thus reducing parental support needs. Crofelemer is a locally acting intestinal chloride ion channel modulator that reduces intestinal chloride-driven fluid accumulation, think osmosis, intestinal fluid chloride-driven fluid accumulation in the GI tract, resulting in reduction of electrolyte and fluid losses and concordant parenteral support reductions, a clinically relevant endpoint. In both MVID and SBS -- SBS-IF, the value proposition is a reduction in parenteral support requirements in patients with no available therapies other than lifelong life-sustaining parenteral support, which is associated with high comorbidities, often resulting in death. We have a Phase II randomized double-blind placebo-controlled trial of the liquid formulation of crofelemer, the same formulation as MVID ongoing in adult SBS-IF patients at various sites in Germany and Italy. SBS-IF affects a significantly larger patient population than MVID, although still an orphan indication. and it arises from congenital anomalies or surgical resection due to conditions like Crohn's disease, mesenteric ischemia, cancer and trauma. Adult and pediatric SBS-IF patients face chronic dependence on parenteral support due to insufficient absorptive surface area in their intestines. The U.S. SBS-IF patient population is estimated at 12,500 patients. We are targeting the new drug application filing of crofelemer for MVID in mid-2027, coincident with the expected timing of the availability of results of our Phase II blinded study for adults with SBS-IF. As the same IF formulation, this plan provides a CMC stepping stone to our planned pathway for ultimate approval for short bowel syndrome. Our entire IF program is the subject of business development discussions. Specifically, we are interested in a partner to assist in the funding for final development and commercialization of crofelemer for MVID and SBS-IF outside the United States. We established our ability to perform and close important nondilutive business development deals as we did in January of this year with Future Pak with $16 million nondilutive received upfront in January when the deal closed, $2 million due shortly to Jaguar upon completion of post-closing conditions. We've additionally received further non-dilutive funding from the deal terms of $3 million and ongoing meaningful dollars from inventory purchase, which is purchased at a profit to Jaguar. The intestinal failure market is considered to be approximately 100x larger than the HIV diarrhea market. So put that in perspective when you think about the size of the deals we're targeting for business development for IF. With the clinical proof-of-concept data we have in hand and near-term clinical and regulatory milestones ongoing, we are confident in our ability to execute upon our business development goals and strategy in our intestinal failure program to further the opportunity to bring in meaningful nondilutive dollars commensurate with the market size driven by a very serious unmet medical need. I'm now going to hand over the discussion to Carol for her recap of the financial highlights for the first quarter of 2026. Thank you, 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 first quarter of 2026. Buoyed by the license of U.S. commercial rights for Mytesi and Canalevia-CA1 in January 2026, the total net revenue for the company's Prescription Products, Mytesi, Gelclair and Canalevia-CA1, nonprescription products and license revenue was approximately $20.2 million in the first quarter of 2026, representing an increase of approximately 816% over the total net revenue in the first quarter of 2025, which totaled approximately $2.2 million and an increase of approximately 527% over the total net revenue in the fourth quarter of 2025, which totaled approximately $3.2 million. The total net revenue for the company's Prescription Products in the first quarter of 2026 was approximately $1.2 million, of which approximately $174,000 stemmed from sales of Mytesi inventory in the first 11 days of the first quarter of 2026, with the remaining bulk of the $1.2 million net revenue stemming from sales of Mytesi inventory to Future Pak later in the first quarter of 2026. In January 2026, as Lisa stated, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1 effective from January 12, 2026, are directed to Future Pak. This decision aligns to Jaguar's strategic focus on advancing the development of its powder for oral solution formulation of crofelemer for rare disease indications related to intestinal failure in humans. Net revenue for the company's Prescription Products decreased 62% compared to the fourth quarter of 2025 when total net revenue for Prescription Products was approximately $3.2 million. Additionally, Prescription Products net revenue decreased by 45% in the first quarter of 2026 compared to the same quarter of 2025 when total net revenue for prescription products amounted to approximately $2.2 million. Income from operations increased $19.6 million from a loss of $9.4 million in the quarter ended March 31, 2025, to income of $10.2 million in the quarter ended March 31, 2026, largely from the license revenue recognized under the Future Pak agreement and decreased operating expenses. Non-GAAP recurring EBITDA for the first quarters of 2026 and 2025 were a net loss of $6.4 million and $9.7 million, respectively. Net loss attributable to common shareholders decreased by approximately $3.4 million from a loss of $10.5 million in the quarter ended March 31, 2025, to a loss of $7.1 million in the quarter ended March 31, 2026. In addition to the loss from operations, interest expense increased by $800,000 from $56,000 for the quarter ended March 31, 2025 to approximately $700,000 in the quarter ended March 31, 2026, due to interest expenses accrued on new notes. The fair value of financial and hybrid instruments designated as fair value option or FVO decreased by $1 million from a loss of $1.3 million in the quarter ended March 31, 2025, to a loss of $300,000 in the quarter ended March 31, 2026, primarily due to fair value adjustments in liability classified warrants and notes payable designated as FVO. Loss on extinguishment of debt was $600,000 during the 3 months ended March 31, 2026, due to significant modifications that qualified for extinguishment accounting with none recorded in the same period in 2025. Well, that concludes my recap of high-level financials for the first quarter of 2026. I will now hand the discussion back to Lisa.

Thanks, Carol. As I mentioned, our intestinal failure program is expected to continue to provide clinical proof-of-concept milestones and is the subject of business development discussions with potential to bring in nondilutive funds from potential licensee partners. Importantly, crofelemer status as the first and only oral prescription drug approved by the FDA under botanical guidance functions as a de facto and perpetual IP shield. All members of the Jaguar Napo and Napo Therapeutics family 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, transformative and potentially transformative for patients as well as Jaguar. This concludes our webcast for today. Thank you all for joining, and have a wonderful week.