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- **Revenue Stability**: Q3 2025 revenue of $3.1 million flat year-over-year, with modest growth from sequential quarter.
- **Breakthrough in Rare Diseases**: Crofelemer reduces parenteral support by 37% in ultra-rare MVID patients, with no alternatives available.
- **Cancer Diarrhea Potential**: Phase III data supports label extension for metastatic breast cancer, with pivotal trial planned for 2026.
- **Animal Health Opportunity**: Conditional FDA approval for Canalevia in dogs; EU and expanded U.S. approvals under negotiation.
- **Financial Efficiency**: Net loss narrowed to $9.5 million in Q3 2025, down 4% year-over-year, reflecting cost management.

**【CEO Opening Remarks】**
- **Revenue Growth**: Q3 2025 revenue of $3.1 million, up 4% from Q2 2025, driven by prescription and non-prescription products.
- **Key Clinical Catalysts**: 
  - **MVID/SBS Program**: Crofelemer reduced parenteral support by 37% in MVID patients and 12% in SBS patients, with no approved alternatives.
  - **CTD Program**: Phase III trial data shows potential for label extension in metastatic breast cancer, with a randomized withdrawal trial planned for 2026.
  - **Canalevia (Animal Health)**: FDA conditionally approved for chemotherapy-induced diarrhea in dogs; negotiations underway for EU approval and expanded U.S. indication.
- **Strategic Focus**: Pursuing business development partnerships to secure non-dilutive funding for late-stage programs.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q3 2025 revenue flat year-over-year, with Mytesi prescription volume down 3.6% vs. Q3 2024.
- **Financial Metrics**: 
  - Loss from operations: $7.3 million (Q3 2025) vs. $7.2 million (Q3 2024).
  - Non-GAAP recurring EBITDA: Net loss of $8.9 million (Q3 2025) vs. $9.2 million (Q3 2024).
  - Net loss: $9.5 million (Q3 2025) vs. $9.9 million (Q3 2024), reflecting cost optimization.

**【CEO Closing Remarks】**
- **Upcoming Catalysts**: 
  - Potential NDA filings for MVID/SBS and CTD programs by end-2026.
  - Animal Health partnership expected to close soon.
- **Strategic Priority**: Leveraging late-stage pipeline to secure partnerships and accelerate product approvals without dilution.

Jaguar Health, Inc.(JAGX)-20251117-2025 Q3 Earnings call transcript

- **Revenue Surge**: Q2 2025 revenue up 35% QoQ, driven by prescription drug sales and licensing.
- **Breakthrough Crofelemer Results**: 27% TPN reduction in MVID patients, Phase II trials on track for 2026 approvals.
- **CTD Expansion**: FDA supports label extension for breast cancer-related diarrhea, with orphan drug designation pending.
- **Financial Challenges**: Net loss of $10.4 million, offset by strategic focus on high-margin clinical programs.
- **Animal Health Growth**: Canalevia seeking EU approval for dog diarrhea, targeting $150M U.S. market.

**【CEO Summary Section】**
- **Revenue Growth**: Q2 2025 revenue of $3 million, up 35% QoQ and 10% YoY, driven by prescription and non-prescription products.
- **Crofelemer Clinical Success**: 
  - Reduced TPN by 27% in MVID and 12.5% in SBS-IF patients in Abu Dhabi trials.
  - Phase II trials for MVID (U.S., EU, MENA) and SBS (U.S., EU) underway, with results expected in H1 2026.
  - FDA Type C meeting supports label expansion for cancer therapy-related diarrhea (CTD) in breast cancer patients.
- **Animal Health Expansion**: Canalevia for chemotherapy-induced diarrhea in dogs; seeking EU approval for general diarrhea and U.S. indication expansion.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q2 2025 revenue $3 million (vs $2.2M Q1 2025, $2.7M Q2 2024).
- **Prescription Volume**: Mytesi up 6.5% QoQ, flat YoY.
- **Financial Metrics**: 
  - Loss from operations: $8 million (vs $7.2M YoY).
  - Non-GAAP EBITDA: -$7.9 million (vs -$8.8M YoY).
  - Net loss: $10.4 million (vs $9.5M YoY).

**【Closing Remarks】**
- **Strategic Focus**: Pursuing business development deals for crofelemer's human and animal health programs to secure nondilutive funding.
- **Regulatory Catalysts**: PRIME designation in Europe and FDA breakthrough therapy designation for MVID, with potential 2026 approvals.
- **Pipeline Momentum**: Multiple clinical trials advancing, positioning for transformative partnerships.


Jaguar Health (JAGX)-14 Aug 25-2025 Q2 Earnings call transcript

- **Rare Disease Breakthrough**: Crofelemer reduces TPN dependency by 27% in MVID patients, positioning for FDA Breakthrough Therapy designation.
- **Cancer Supportive Care**: Statistically significant diarrhea prevention in breast cancer patients; FDA meeting scheduled for regulatory path.
- **Financial Focus**: Q1 2025 loss widens to $10.4M, with resources prioritized for late-stage clinical trials.
- **Partnership Potential**: Seeking non-dilutive deals for rare disease programs with $100M+ precedent valuations.

**【CEO Opening Remarks】**
- Q1 2025 net revenue decreased by 6% YoY to $2.2 million, driven by higher Q4 2024 sales and inventory levels. However, Mytesi prescriptions increased by 2% YoY, indicating rising patient demand for HIV-related diarrhea treatment.
- The company highlighted 2025 as a 'year of convergence' with key catalysts, including rare disease drug developments and oncology supportive care trials.

**【CEO Key Catalysts Update】**
1. **Rare Disease Programs**: 
   - **MVID/SBS-IF Trials**: Initial results show crofelemer reduced TPN dependency by 27% in MVID and 12.5% in SBS-IF pediatric patients. These ultra-rare disease programs are advancing toward potential FDA Breakthrough Therapy and EMA PRIME designations.
   - **Global Trials**: Ongoing Phase 2 trials in MVID and adult SBS-IF are expected to report results in H1 2026.
2. **Oncology Supportive Care**: 
   - **OnTarget Study**: Crofelemer showed statistically significant diarrhea prevention in breast cancer patients (65% of trial participants). A Type C FDA meeting is scheduled for Q2 2025 to discuss regulatory pathways.

**【CFO Financial Summary】**
- Q1 2025 non-GAAP recurring EBITDA loss widened to $9.7 million (from $8.8 million YoY), reflecting increased R&D and clinical trial expenses.
- Operating loss rose to $9.4 million, driven by higher clinical trial costs and lower revenue.
- Canalevia-CA1 (dog cancer diarrhea drug) is in active business development discussions for expanded indications.

**【Strategic Priorities】**
- Pursue non-dilutive partnerships for rare disease programs, leveraging $100M+ orphan drug deal precedents with limited clinical data.
- Accelerate regulatory engagement for breast cancer diarrhea indication, targeting 2026 approvals.
- Maintain focus on Mytesi as a steady revenue base while investing in high-growth pipeline opportunities.

Jaguar Health, Inc. (JAGX) Q1 2025 Earnings Call Transcript

- **Revenue Growth Accelerates**: 20% YoY revenue increase to $11.7 million, with Q4 2024 up 53% YoY to $3.5 million.
- **Breakthrough Potential in Rare Diseases**: MVID Phase II trials could qualify for PRIME designation, potentially leading to EU approval by 2026.
- **Mytesi Expansion Wins FDA Attention**: FDA granted Type C meeting for breast cancer diarrhea indication, with OnTarget trial showing 2x efficacy in breast cancer patients.
- **2025 Catalysts**: Q2 milestones include MVID data presentations, FDA meetings, and potential PRIME designation, supported by $11.7 million in 2024 revenue and improving cost management.


**【CEO Summary Section】**
- **Revenue Growth**: 2024 net revenue increased 20% to $11.7 million (from $9.8 million in 2023). Q4 2024 revenue rose 53% YoY to $3.5 million, driven by prescription product sales.
- **Rare Disease Pipeline**: 
  - **MVID/SBS-IF Program**: Phase II trials underway in the U.S., Europe, and MENA. First proof-of-concept data expected in Q2 2025. Potential PRIME designation in Europe for ultra-rare MVID could accelerate approval by 2026.
  - **Novel Formulation**: Lyophilized powder for oral solution developed for patients unable to take tablets. teduglutide pricing benchmark ($500k/year in U.S.) highlights orphan drug potential.
- **Mytesi Expansion**: 
  - FDA granted Type C meeting in Q2 2025 to discuss breast cancer diarrhea indication. OnTarget trial showed 2x responder rate vs. placebo in breast cancer patients.
  - Gelclair launched for oral mucositis in bone marrow transplant patients, with plans to expand into oncology market.
  - Canalevia-CA1 available for chemotherapy-induced diarrhea in dogs.
- **Catalysts**: Multiple Q2 2025 milestones include MVID IIT data presentations, FDA meetings, and potential PRIME designation. Bridge financing participants reflect confidence in 2025 value creation.

**【CFO Financial Highlights】**
- **Prescription Product Performance**: Mytesi prescription volume grew 3.9% YoY, 9.4% QoQ in Q4 2024. Gelclair and Canalevia-CA1 contributed to Q4 revenue growth.
- **Cost Management**: Loss from operations decreased 10% YoY to $30.8 million. Non-GAAP recurring EBITDA improved slightly to -$34.7 million (from -$34.5 million in 2023).
- **Liquidity**: Bridge financing participants included executives, directors, and long-term investors, signaling alignment with company strategy.

**【Key Catalysts】**
- **Q2 2025 Milestones**: 
  - Abu Dhabi conference presentation of MVID IIT data.
  - FDA Type C meeting for Mytesi breast cancer indication.
  - PRIME designation discussions for MVID.
- **Long-Term Opportunities**: Potential licensing deals, collaborations, and non-dilutive funding to accelerate approvals for rare disease programs.


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