Jaguar Health, Inc. Q1 FY2025 earnings call

• Mytesi dispensed prescriptions increased by approximately 2% in the first quarter of 2025 versus the first quarter of 2024, indicating increased demand for treating HIV-related diarrhea.
• Initial proof-of-concept results from an independent study in pediatric patients of a novel liquid formulation of crofelemer showed reduction in TPN for MVID and pediatric SBS patients. The study was presented at the Elite Ped-GI conference. Jaguar has been developing rare disease programs for close to eight years and has ongoing trials.
• OnTarget Phase 3 prophylactic clinical trial for adult patients with solid tumors did not achieve statistical significance overall, but prespecified subgroup analysis in breast cancer patients showed significant results. FDA granted a Type C meeting to discuss the responder analysis for bringing crofelemer to breast cancer patients with cancer therapy related diarrhea.
• Business development conversations ongoing for Canalevia-CA1, conditionally approved for chemotherapy induced diarrhea in dogs, to expand approval to all non-infectious acute diarrhea in dogs.

Total net revenue for the first quarter of 2025 was approximately $2.2 million, a decrease of approximately 6% versus the first quarter of 2024 and 13.5% versus net fourth quarter 2024 revenue of $3.5 million. Mytesi prescription volume increased by approximately 1.8% in the first quarter of 2025 over the first quarter of 2024 but decreased by approximately 13.5% in the first quarter of 2025 over the fourth quarter of 2024. Loss from operations increased from $8.2 million in Q1 2024 to $9.4 million in Q1 2025. Non-GAAP recurring EBITDA for Q1 2025 was a net loss of $9.7 million, compared to a net loss of $8.8 million in Q1 2024. Net loss attributable to common shareholders increased from $9.2 million in Q1 2024 to $10.4 million in Q1 2025.

• Proof-of-concept results from investigator-initiated trials in adult short bowel syndrome intestinal failure and MVID are expected throughout 2025 and into 2026.
• Placebo-controlled Phase 2 trials for MVID and SBS are expected to conclude and have results in the first half of 2026.
• Type C meeting with FDA in Q2 2025 to discuss pathway for crofelemer in breast cancer patients with cancer therapy related diarrhea.
• Potential business development deals for Canalevia-CA1 to expand its approval in dogs.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. These include uncertainties regarding market acceptance of products, impact of competitive products and pricing, industry trends, and product initiatives not achieving scientific objectives or meeting regulatory requirements.
• Risks related to regulatory approval processes for rare disease indications and Phase 2/3 trials not yielding expected results.