BioXcel Therapeutics, Inc. Q1 FY2024 earnings call

Management Statement and Operational Highlights

• Neuroscience Progress: Journey with BXCL501 to expand into retail and home settings for agitation indications. Advancing late-stage TRANQUILITY and SERENITY programs, with SERENITY At-Home potentially offering near-term label expansion and TRANQUILITY In-Care having long-term growth potential.
• IGALMI Traction: Revised strategy yielding revenue growth, with momentum continuing into Q2.
• Corporate Updates: Completed a $25 million registered direct offering, focusing on strengthening the balance sheet and exploring financing options, while optimizing operational efficiencies.
• IP Expansion: 30 granted/allowed patents and over 140 patent applications, with 8 U.S. patents for IGALMI in the FDA's Orange Book.

Segment Performance

• Neuroscience: The company is advancing late-stage clinical programs for BXCL501, including the TRANQUILITY and SERENITY programs for agitation-related indications. They have expanded intellectual property with new patents in the US and Japan.
• IGALMI Commercialization: Net revenue in Q1 2024 was $582,000, a 182% year-over-year increase and 55% sequential quarterly increase from Q4 2023. Growth driven by volume contracting, new customer acquisitions, increased utilization, and the permanent J-Code for IGALMI. Carton volume in Q2 already exceeds Q1.

Guidance

• Anticipate timelines and costs for TRANQUILITY and SERENITY trials similar to previous successful trials.
• Cash runway extended into the second half of 2024 with the $25 million registered direct offering.
• Potential for sNDA submissions for Alzheimer's-related and bipolar/schizophrenia-related agitation based on trial results.

Risks

• Regulatory uncertainties in clinical trial approvals and data submission for new indications.
• Dependence on successful outcomes of late-stage clinical trials for commercial and strategic growth.
• Uncertainties in financing and operational efficiencies impacting trial progress.

Question and Answer

Q: What is the timeline for data approval in Alzheimer's agitation and the cost of the program? What has the FDA said about 12-month safety data?

A: Can't give specific dates, but timeline and cost similar to TRANQUILITY II. Need for 12-month safety data is part of the package for the sNDA.

Q: Status of IGALMI group contracting discussions and impact on net revenue?

A: Continuing to matriculate contracts, with unit volume already increasing in Q2. Existing customers ordering and new accounts being acquired.

Q: Exploration of strategic options for earlier stage Neuroscience assets?

A: Focus on late-stage programs, but early programs may be explored for partnerships if interest arises.

Q: How do TRANQUILITY and SERENITY trials compare in capital needs and optimization of operating expenses?

A: TRANQUILITY In-Care trial cost similar to TRANQUILITY II; SERENITY At-Home has lower cost and faster recruitment. Operating expenses are being optimized.