Jaguar Health, Inc. (NASDAQ:JAGX) is a commercial-stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with gastrointestinal (GI) distress, including chronic, debilitating diarrhea. The company's wholly owned subsidiary, Napo Pharmaceuticals, Inc., is leading the development and commercialization of the proprietary plant-based human prescription drug crofelemer.
Business Overview
Jaguar Health was founded in San Francisco, California, as a Delaware corporation in 2013. The company was initially focused on developing and commercializing first-in-class prescription and non-prescription products for companion animals. In 2017, Jaguar completed a merger with Napo Pharmaceuticals, making Napo a wholly owned subsidiary focused on human health, including the ongoing development of crofelemer and commercialization of Mytesi.
Mytesi (crofelemer 125 mg delayed-release tablets) is Jaguar's first-in-class oral botanical drug product approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Crofelemer was granted Orphan Drug Designation by the FDA in February 2023 for microvillus inclusion disease (MVID) and by the European Medicines Agency (EMA) in October 2022. Crofelemer was also granted Orphan Drug Designation for short bowel syndrome (SBS) by the EMA in December 2021 and by the FDA in August 2017.
In the animal health segment, Jaguar's Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs.
Jaguar is currently focused on several key initiatives:
1. Advancing the pivotal Phase 3 OnTarget trial evaluating crofelemer for the prophylaxis of cancer therapy-related diarrhea (CTD). The company expects the top-line results from this trial to be released imminently.
2. Developing crofelemer for rare disease indications, including short bowel syndrome (SBS) with intestinal failure and microvillus inclusion disease (MVID). Jaguar is supporting third-party investigator-initiated proof-of-concept studies in these areas and plans to initiate its own clinical development program for crofelemer in SBS patients.
3. Expanding Jaguar's commercial footprint beyond HIV-related supportive care to include cancer-related supportive care. The company recently in-licensed the FDA-approved oral mucositis prescription product Gelclair for the U.S. market, which is expected to launch in the third quarter of 2024.
Financials
For the full year 2023, Jaguar reported annual revenue of $9.761 million and a net loss of $41.3 million. The company's annual operating cash flow and free cash flow were both -$33.242 million.
In the first quarter of 2024, Jaguar reported combined net revenue of approximately $2.4 million for its prescription and non-prescription products, representing an increase of 20% compared to the first quarter of 2023 and a 4% increase compared to the fourth quarter of 2023. The increase was primarily driven by higher sales of Mytesi.
Loss from operations decreased by $1.6 million from $9.9 million in the first quarter of 2023 to $8.2 million in the first quarter of 2024. Non-GAAP recurring EBITDA for the first quarter of 2024 was a net loss of $7.5 million, compared to a net loss of $9 million in the first quarter of 2023. Net loss attributable to common shareholders decreased by approximately $2.9 million from $12.2 million in the first quarter of 2023 to $9.2 million in the first quarter of 2024.
Mytesi Prescription Volume and Outlook
Mytesi prescription volume decreased by 7% in the first quarter of 2024 compared to the fourth quarter of 2023, which the company attributes to the annual reset of commercial and Medicare insurance deductibles, resulting in higher co-pays for patients in the first quarter. Prescriptions decreased slightly by 2.5% in the first quarter of 2024 compared to the first quarter of 2023.
The company noted that prescription volume differs from the invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.
Crofelemer Pipeline and Rare Disease Initiatives
Jaguar's lead product candidate, crofelemer, is a novel, first-in-class anti-secretory antidiarrheal drug that has a normalizing effect on electrolyte and fluid balance in the gut. The company is pursuing multiple potential follow-on indications for crofelemer, including the ongoing pivotal Phase 3 OnTarget trial evaluating the drug for the prophylaxis of cancer therapy-related diarrhea (CTD).
In addition to the OnTarget trial, Jaguar is focused on developing crofelemer for rare disease indications, including short bowel syndrome (SBS) with intestinal failure and microvillus inclusion disease (MVID). The company is supporting third-party investigator-initiated proof-of-concept studies in these areas and plans to initiate its own clinical development program for crofelemer in SBS patients.
Crofelemer has been granted Orphan Drug Designation by the FDA and EMA for both SBS and MVID, which could provide regulatory and commercial benefits. Jaguar is aiming to generate clinical proof-of-concept data for crofelemer in SBS and MVID patients in 2024 and 2025, which could support participation in early patient access programs in Europe, where such programs exist but not in the United States.
Expansion into Cancer Supportive Care
Jaguar has recently expanded its commercial footprint beyond HIV-related supportive care to include cancer-related supportive care. In April 2024, the company entered into an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC for the FDA-approved oral mucositis prescription product Gelclair. Jaguar plans to launch Gelclair in the U.S. market in the third quarter of 2024.
This move aligns with Jaguar's strategy to address the significant unmet need in cancer supportive care, as cancer patients often experience debilitating side effects from their treatments, such as oral mucositis and cancer therapy-related diarrhea, which can negatively impact their quality of life and ability to adhere to their treatment regimens.
Risks and Challenges
Jaguar faces several risks and challenges that investors should be aware of:
1. Reliance on the success of crofelemer: Jaguar's future success is heavily dependent on the successful development and commercialization of crofelemer, its lead product candidate. Delays or failures in the clinical trials or regulatory approval process for crofelemer could significantly impact the company's financial performance.
2. Competitive landscape: Jaguar faces competition from both pharmaceutical and botanical-based products in the gastrointestinal and supportive care markets it operates in. The company's ability to maintain its market position and pricing power will be crucial.
3. Regulatory and reimbursement risks: Obtaining regulatory approvals and securing favorable reimbursement for Jaguar's products, particularly in new indications or markets, can be a lengthy and uncertain process, which could impact the company's commercial success.
4. Liquidity and financing needs: Jaguar has incurred significant losses since its inception and may require additional capital to fund its ongoing operations and pipeline development. The company's ability to raise capital on favorable terms or at all could affect its long-term viability.
5. Reliance on third-party manufacturers and suppliers: Jaguar relies on third-party manufacturers and suppliers for the production and supply of its products, which introduces risks related to quality, availability, and pricing of these critical inputs.
Conclusion
Jaguar Health is well-positioned to capitalize on the significant unmet need in cancer supportive care and rare gastrointestinal diseases. The company's diversified pipeline, led by the promising crofelemer program, and its recent expansion into the oral mucositis market with the Gelclair in-licensing deal, demonstrate Jaguar's strategic focus on addressing debilitating symptoms that can negatively impact patients' quality of life and treatment adherence.
While the company faces several risks and challenges, Jaguar's strong commitment to developing novel, plant-based solutions and its growing commercial footprint in supportive care make it an intriguing investment opportunity for investors seeking exposure to the rapidly evolving pharmaceutical landscape.