Jaguar Health, Inc. Q1 FY2026 earnings call

Strategic Transformation and Focus - Executed a transformative non-dilutive out-license agreement in January 2026 with FuturePak for U.S. commercial rights to Mitessi (FDA-approved crofilmer for HIV/AIDS-related diarrhea in adults) and Canalivia CA-1 (conditionally approved crofilomer for dogs). - Selected FuturePak as a partner due to its acquired HIV-focused commercial infrastructure that is four times larger than Jaguar's existing U.S. commercial footprint. The deal generates non-dilutive capital to fund the company's core priority development program for crofilomer powder for oral solution for rare intestinal failure indications.

Intestinal Failure Program Clinical Progress - Lead indication is pediatric microvillous inclusion disease (MVID), an ultra-rare disorder with no approved therapies. The company is targeting a New Drug Application (NDA) submission to the FDA in mid-2027. - Short bowel syndrome with intestinal failure (SBS-IF), a larger follow-on indication using the same powder formulation, has an estimated global market of ~$8 billion by 2033, while the global MVID market is estimated at over $1 billion. - Initial proof-of-concept trial results presented in November 2025 showed crofilomer reduced parenteral support (PS, life-sustaining IV nutrition) by 12% to 37% in pediatric intestinal failure patients, including a 37% reduction in an MVID patient (a population with no approved treatment options). Longer-term trial data and expanded access data will be presented at the ESCPGHN conference in June 2026. - One MVID infant treated via FDA-authorized expanded access (too young for the pivotal trial) is 9 months old, thriving, and has shown no drug-related safety issues, consistent with crofilomer's long-established well-tolerated safety profile. - The pivotal randomized, double-blind, placebo-controlled trial for pediatric MVID is fully enrolled. The FDA approved a trial amendment for a treatment-only extension phase, with the first patient already enrolled; all remaining enrolled patients are expected to enter the extension phase within two months. The company currently treats ~4% of the global MVID patient population across all clinical and expanded access programs. - A Phase II randomized, double-blind, placebo-controlled trial for the same powder formulation in adult SBS-IF is ongoing at sites in Germany and Italy. NDA results for MVID are expected to coincide with Phase II adult SBS-IF readout in mid-2027, creating a streamlined CMC pathway for future SBS-IF approval.

Business Development and Funding - The January 2026 FuturePak deal delivered $16 million in non-dilutive upfront funding, with $2 million pending completion of post-closing conditions, plus an additional $3 million in non-dilutive funding to date and ongoing profit from FuturePak's inventory purchases. - The company is actively seeking a development and commercialization partner for the intestinal failure program (for MVID and SBS-IF outside the U.S.) to secure additional non-dilutive funding aligned with the intestinal failure market, which is approximately 100 times larger than the HIV diarrhea market. - Crofilomer's existing FDA approval as a botanical drug provides permanent intellectual property protection for the program.

Jaguar Health reports total net revenue of $20.2 million in Q1 2026, a 816% increase from $2.2 million in Q1 2025 and a 527% increase from $3.2 million in Q4 2025. Prescription product segments (Mitessi, Gelclair, Canalivia CA-1) generated $1.2 million in net revenue, representing ~5.94% of total Q1 2026 net revenue. Non-prescription product sales and license revenue (the majority driven by the FuturePak out-license agreement) contributed the remaining ~94.06% of total Q1 2026 net revenue at ~$19 million. Prescription product revenue decreased 45% year-over-year vs Q1 2025 and 62% quarter-over-quarter vs Q4 2025, following the January 12, 2026 transfer of U.S. commercial rights for Mitessi and Canalivia CA-1 to FuturePak, with all post-agreement U.S. revenue from these products accruing to FuturePak. Operating income improved from a $9.4 million loss in Q1 2025 to $10.2 million operating income in Q1 2026. Non-GAAP recurring EBITDA was a $6.4 million net loss in Q1 2026, improved from a $9.7 million loss in Q1 2025. Net loss attributable to common shareholders was $7.1 million in Q1 2026, a $3.4 million reduction in loss from Q1 2025.

- The company maintains its target timeline for an NDA submission for crofilomer for pediatric MVID to the FDA in mid-2027, which will coincide with availability of top-line results from the ongoing Phase II trial in adult SBS-IF. - All enrolled MVID pivotal trial patients are expected to enter the treatment-only extension phase of the trial within the next two months, pending site institutional approval. - Longer-term clinical data for intestinal failure patients and expanded access data will be presented at the ESCPGHN (F-SCAM) conference in June 2026. - Management is actively pursuing a partnership for the intestinal failure program to secure additional non-dilutive funding for late-stage development and commercialization outside the U.S., and expects to execute on this strategic goal given existing clinical proof-of-concept data and upcoming near-term milestones.

- Forward-looking statements (including clinical development timelines, regulatory approval expectations, partnership outcomes, and market opportunities) are subject to inherent uncertainties that could cause actual results to differ materially from projections. Key uncertainties include: failure of the clinical program to meet efficacy or safety endpoints, potential failure to gain required FDA/EMA regulatory approval, and failure to secure a strategic partnership for the intestinal failure program on favorable terms or at all. - Crofilomer for MVID has not yet completed pivotal trial testing or received regulatory marketing approval, and there is no guarantee it will meet all requirements for approval, even with positive early data. - The company recorded a $600,000 loss on debt extinguishment in Q1 2026 from debt modifications, and interest expense increased $800,000 year-over-year to $700,000 due to accrued interest on new debt obligations. - There is no guarantee the company will receive breakthrough therapy designation from the FDA, which is being pursued to accelerate the regulatory approval pathway.

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