Jaguar Animal Health Q4 Earnings Call Highlights
by Doug Wharley · The Cerbat GemJaguar Animal Health (NASDAQ:JAGX) executives highlighted a new U.S. out-license agreement for Mytesi and advancing development plans for crofelemer in rare disease intestinal failure indications during the company’s investor webcast covering fourth-quarter 2025 results.
Future Pak agreement reframes Mytesi as a supply-and-manufacturing profit center
Founder, President, and CEO Lisa Conte said the “key event” for the company was closing a U.S. out-license agreement with Future Pak covering Mytesi, Jaguar’s FDA-approved tablet formulation of crofelemer, as well as Canalevia-CA1 for chemotherapy-induced diarrhea in dogs (conditionally approved). Conte described the deal as “fully aligned” with Jaguar’s strategy to focus crofelemer development on rare disease intestinal failure indications.
Conte said the agreement brought “non-dilutive dollars that provide the fuel for the development of our rare disease pipeline.” She stated the deal included $18 million up front, with $16 million already received at signing in January and $2 million to be paid based on certain conditions, plus an additional $20 million in milestone payments and other future payments. Conte also said Jaguar had “already received close to $4 million of additional payments above and beyond the $16 million.”
Importantly for ongoing operations, Conte said Jaguar continues to manufacture crofelemer and sell it to Future Pak “at a profit,” calling it “now…a profit center.” CFO Carol Lizak added that under the license agreement, Future Pak is responsible for all commercial efforts and will receive all proceeds from U.S. sales of Mytesi and Canalevia-CA1 as of Jan. 12, 2026, while Jaguar will supply product “at a premium price” and will recognize manufacturing revenue.
Lizak also noted Future Pak had purchased product from Jaguar and paid the $16 million upfront license fee and a $3 million payment. She said the $3 million payment followed Jaguar’s termination of a buyback provision in the licensing agreement, which “allows Future Pak to continue to commercialize Mytesi beyond five years.”
Fourth-quarter revenue up sequentially; 2025 losses widened
Lizak reported fourth-quarter 2025 total net revenue of approximately $3.2 million across prescription products (Mytesi, Gelclair, and Canalevia-CA1), non-prescription products, and license revenue. That represented an increase of about 5% versus third-quarter 2025 revenue of approximately $3.1 million, but a decrease of about 8% compared with fourth-quarter 2024 revenue of approximately $3.5 million.
For full-year 2025, Lizak said approximately $11.2 million of Jaguar’s $11.5 million total net revenue was generated by sales of Mytesi and Canalevia-CA1.
On profitability, Lizak said loss from operations increased by $15.1 million from $30.8 million in 2024 to $45.9 million in 2025. Non-GAAP recurring EBITDA was a net loss of $48.1 million in 2025 compared with a net loss of $35.9 million in 2024, she said. Net loss attributable to common shareholders increased by approximately $15.1 million, from $38.5 million in 2024 to $53.6 million in 2025.
Lizak also discussed other line items affecting results, including fair value changes and debt-related items. She said the fair value of financial and hybrid instruments designated at the fair value option decreased by $3.2 million, from a loss of $9.5 million in 2024 to a loss of $6.3 million in 2025, “primarily due to fair value adjustments in notes payable designated as FVO.” Loss on extinguishment of debt increased by $3 million, from a gain of $1.2 million in 2024 to a loss of $1.8 million in 2025, which she attributed primarily to modifications to expected payments of a royalty interest agreement that triggered extinguishment accounting.
Mytesi prescription volumes declined in 2025
Lizak said Mytesi prescription volume declined approximately 3.7% in 2025 versus 2024, fell about 5.8% in fourth-quarter 2025 versus third-quarter 2025, and declined about 12.2% compared with the same quarter a year earlier. She cautioned that prescription volume differs from invoiced sales volume due to factors including buying patterns among specialty pharmacies in a closed network as they manage inventory levels.
Conte emphasized Future Pak’s commercial capabilities and strategic fit in HIV. She noted Future Pak’s acquisition of Theratechnologies, which she said brought two HIV products with overlap among physicians treating patients with gastrointestinal disorders and HIV-related diarrhea. Conte also pointed to demographic trends, stating that about 50% of people living with HIV in the U.S. are now over age 50 and may have long-term gastrointestinal effects.
Rare disease intestinal failure program: proof-of-concept data and regulatory timeline
Conte said Jaguar is in late-stage development for crofelemer in rare disease intestinal failure indications, highlighting microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF). She said the company is targeting a New Drug Application in the first half of 2027 for MVID, coincident with completing a Phase II placebo-controlled trial in SBS-IF.
Conte described intestinal failure as a condition where patients cannot absorb essential nutrients and may require parenteral nutrition or support for up to 20 hours a day, seven days a week. She said a key clinical endpoint is reduction in parenteral support, noting that even a 5% reduction could be meaningful to patients’ daily lives.
Conte highlighted results from an independent proof-of-concept study in pediatric patients in the U.A.E. presented Nov. 8, 2025 at NASPGHAN by primary investigator Dr. Mohamad Miqdady. She said the study evaluated crofelemer in pediatric intestinal failure due to MVID (one patient) and SBS (two patients), and showed reductions in parenteral support ranging from 12% to 37%. Specifically, Conte said the two pediatric SBS-IF patients who completed treatment had reductions of 12.5% to 15.6%, while the MVID patient’s parenteral support needs were reduced by up to 37%.
Conte said there were no safety issues, consistent with crofelemer’s profile in prior trials and commercial use in the Mytesi HIV indication. She added that in the investigator-initiated protocol, patients were treated for about three months with increasing doses, then taken off the drug, and “very, very quickly” relapsed—prompting physicians and parents to restart treatment, which she said was an important indication of benefit in a non-placebo-controlled setting.
She also said the MVID placebo-controlled trial is fully enrolled and uses a “highly concentrated liquid formulation” suitable for intestinal failure patients and pediatric administration. Conte said a protocol amendment supported by the FDA would allow patients to enter a treatment-only extension phase, and she indicated the company expects participating patients to receive crofelemer for the rest of their lives.
Conte said Jaguar expects to pursue Breakthrough Therapy designation with the FDA and potentially the European Medicines Agency’s PRIME pathway. She also said Jaguar has orphan designation in the U.S. and Europe for both MVID and short bowel syndrome.
Business development focus for 2026
Conte repeatedly underscored business development as the company’s strategy for 2026, describing a goal to secure additional non-dilutive funding through partnering for its intestinal failure program. She said Jaguar is seeking a partner to assist in funding final development and commercialization of crofelemer for MVID and SBS-IF, with commercialization efforts outside the U.S. addressing global need.
Looking ahead, Conte said Jaguar expects to provide clinical proof-of-concept milestones and business development updates through the rest of 2026 and into 2027, with the “clear goal” of bringing in non-dilutive funds from a potential licensee partner or partners.
About Jaguar Animal Health (NASDAQ:JAGX)
Jaguar Animal Health, Inc is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the gastrointestinal health of food-producing animals, with an emphasis on swine and poultry. The company’s research and development efforts target common enteric disorders such as post-weaning diarrhea in pigs and clostridial overgrowth in broiler chickens, aiming to provide effective alternatives to traditional antibiotic treatments.
Jaguar Animal Health was formed in early 2019 through the acquisition of the animal health business of Aratana Therapeutics by Actinium Animal Health, followed by a corporate rebranding.