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01/11 03:36
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents mixed signals: while there is a notable revenue increase and potential partnerships, the rising operational losses and dependence on successful partnerships pose risks. The market's acceptance of products and competitive pressures further add to the uncertainty. The Q&A section did not provide additional clarity, leaving the sentiment balanced. Without a clear catalyst or market cap information, the stock price is likely to remain stable over the next two weeks, resulting in a neutral prediction.
Combined net revenue for Q2 2025 Approximately $3 million, increased approximately 35% versus Q1 2025 ($2.2 million) and increased approximately 10% versus Q2 2024 ($2.7 million). The increase is attributed to higher sales of prescription and nonprescription products, including license revenue.
Mytesi prescription volume Increased by approximately 6.5% in Q2 2025 over Q1 2025. However, it remained equal to the volume in Q2 2024. The increase in Q2 2025 over Q1 2025 reflects improved sales performance.
Loss from operations Increased by $800,000 from $7.2 million in Q2 2024 to $8 million in Q2 2025. The increase is due to higher operational expenses.
Non-GAAP recurring EBITDA Net loss of $7.9 million in Q2 2025 compared to a net loss of $8.8 million in Q2 2024. The improvement reflects better cost management and operational efficiency.
Net loss attributable to common shareholders Increased by approximately $900,000 from $9.5 million in Q2 2024 to $10.4 million in Q2 2025. The increase is due to higher operational losses.
Crofelemer for MVID and SBS-IF: Initial proof-of-concept results showed crofelemer reduced TPN and IV fluids by 27% in MVID patients and 12.5% in SBS patients after 12 weeks. It also reduced stool volume and increased nutrient absorption. Regulatory pathways for expedited approval in the U.S. and EU are being pursued.
Crofelemer for Cancer Therapy-Related Diarrhea (CTD): Phase III trial showed significant results for breast cancer patients. FDA discussions are ongoing for label expansion to include metastatic breast cancer patients. A pivotal treatment trial is planned for completion in 2026.
Canalevia for Animal Health: Focus on expanding approval for general diarrhea in dogs globally. Discussions with potential partners are ongoing.
Business Development Partnerships: Seeking partnerships for licensing rights to human and animal health products to generate nondilutive funding.
Revenue Growth: Q2 2025 revenue increased by 35% compared to Q1 2025 and 10% compared to Q2 2024, reaching $3 million.
Operational Loss: Loss from operations increased to $8 million in Q2 2025 from $7.2 million in Q2 2024.
Focus on Orphan Drug Designation: Targeting orphan drug designation for crofelemer in metastatic breast cancer and MVID to expedite regulatory approval.
Global Expansion: Efforts to expand crofelemer trials and approvals in the U.S., EU, and MENA regions.
Market Acceptance of Products: Uncertainties regarding market acceptance of products, which could impact revenue and growth.
Competitive Pressures: The impact of competitive products and pricing, which could affect market share and profitability.
Regulatory Hurdles: Stringent regulatory requirements and the risk of not achieving scientific objectives for products in development.
Economic Uncertainties: Pullback in investor support for innovations in emerging pharma companies, which could limit funding opportunities.
Supply Chain Disruptions: No explicit mention of supply chain disruptions, but implied challenges in maintaining product availability and distribution.
Strategic Execution Risks: Dependence on achieving business development partnerships and licensing deals to generate nondilutive funding, which is critical for financial stability.
Financial Performance: Increased loss from operations and net loss attributable to common shareholders, which could strain financial resources.
Product Development Risks: Challenges in achieving regulatory approval for new indications and expanding product labels, which are critical for market growth.
Animal Health Business Risks: Dependence on finding a corporate partner to expand the animal health business, which is a smaller but important segment.
Business Development Partnerships: The company is actively seeking business development partnerships for licensed rights to the development and commercialization of Jaguar's Human and Animal Health products. The goal is to generate nondilutive funding for Jaguar.
Crofelemer for Intestinal Failure: Crofelemer is being developed for intestinal failure associated with MVID and SBS. The company expects expedited regulatory approval pathways in the U.S. and Europe, with potential approval as early as the end of 2026.
Phase II Trials for Crofelemer: Two placebo-controlled Phase II trials for crofelemer are underway, with results expected in the first half of 2026. These trials target pediatric MVID patients and adults with short bowel syndrome.
Cancer Therapy-Related Diarrhea (CTD) Program: The company is preparing to submit a protocol for a pivotal treatment trial for metastatic breast cancer patients with CTD. The trial is expected to be completed in 2026, supporting label expansion for Mytesi.
Animal Health Expansion: The company is in discussions with potential partners to expand Canalevia's indication from chemotherapy-induced diarrhea to general diarrhea in dogs and other companion animals. The goal includes obtaining EU approval and expanding U.S. indications.
The selected topic was not discussed during the call.
The earnings call presents a mixed picture. Positive aspects include strategic partnerships, orphan drug designation, and slight revenue growth. However, financial performance shows ongoing losses, and there are significant risks related to market acceptance, competition, and regulatory hurdles. The Q&A section did not provide additional insights to alter these perceptions. The absence of a shareholder return plan discussion and mixed financial metrics suggest a neutral impact on stock price.
The earnings call presents mixed signals: while there is a notable revenue increase and potential partnerships, the rising operational losses and dependence on successful partnerships pose risks. The market's acceptance of products and competitive pressures further add to the uncertainty. The Q&A section did not provide additional clarity, leaving the sentiment balanced. Without a clear catalyst or market cap information, the stock price is likely to remain stable over the next two weeks, resulting in a neutral prediction.
The earnings call reveals several negative factors: a significant EPS miss, decreased net revenue, and increased operational losses. The Q&A highlights uncertainties in regulatory approvals and market acceptance, with management providing vague responses. Although there are some positive developments like increased Mytesi prescriptions and potential transformative results in clinical studies, the overall sentiment is negative due to financial instability and competitive pressures. The absence of a shareholder return plan discussion further dampens sentiment. Thus, a negative stock price reaction is expected over the next two weeks.
The earnings call reveals several concerning factors: a decline in revenue, increased losses, and risks in market acceptance and regulatory challenges. The Q&A section highlights management's lack of clarity on future revenue projections, further raising concerns. Despite some positive developments like potential collaborations and licensing deals, the overall sentiment is negative due to financial instability, competitive pressures, and absence of shareholder return initiatives. These factors are likely to lead to a negative stock price reaction over the next two weeks.
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