BioXcel Therapeutics, Inc. Q3 FY2022 earnings call

• Transitioned to a commercial organization and successfully launched IGALMI for acute agitation in schizophrenia and bipolar disorders.
• Expanding sales force to 70 reps by December 1 to cover ~1,700 target hospitals.
• Clinical pipeline for BXCL501 has multiple pivotal data readouts expected in H1 2023, including for Alzheimer's-related agitation, bipolar, and schizophrenia; also in development for MDD as adjunctive therapy.
• OnkosXcel's BXCL701 has promising data in small cell neuroendocrine cancer, with top-line data expected in early 2023; also presenting biomarker data for leukemia.
• Strengthened IP portfolio with multiple patents issued and allowed for BXCL501 and BXCL701.

Net revenue for the third quarter of 2022 was $137,000, driven by early IGALMI sales. Research and development expenses were $22.1 million, up from $11.9 million in 2021, primarily due to expanded clinical trials for BXCL501. Selling, general, and administrative expenses were $17.1 million, up from $14.9 million in 2021, due to IGALMI launch costs. IGALMI is the commercial product with initial revenue recorded, and OnkosXcel's BXCL701 is in development for oncology indications.

• Expand sales force to 70 reps covering ~1,700 target hospitals by December 1.
• Multiple pivotal data readouts from BXCL501 trials expected in H1 2023.
• Initiate TRANQUILITY 3 pivotal trial for BXCL501 in Alzheimer's-related agitation by end of 2022.
• Expect BXCL701 top-line data from Phase II SCNC trial in early 2023.

• Potential delays in formulary approvals for IGALMI due to P&T committee schedule changes.
• Market dynamics for new indications (e.g., dementia) may differ from schizophrenia and bipolar, affecting adoption pace.
• Uncertainty in the performance of BXCL701 as monotherapy in cold tumors.

Q: How should we think about timing from P&T decisions and rate of formulary wins?

A: P&T decisions scheduled now to end of year/Q1 2023; majority expected to vote on time, with uptake expected to double within first year post formulary access.

Q: Expectations for differences between BXCL701 monotherapy and KEYTRUDA combo?

A: Uncertainty in BXCL701 monotherapy in cold tumors; known single-agent activity in hot tumors, with synergy expected with KEYTRUDA.

Q: When to expect more substantive update on OnkosXcel's path forward?

A: Data from Phase II SCNC trial (28 patients) analyzed and to be presented early 2023, with strategic options including partnering explored.

Q: Early trends in IGALMI use and reorders?

A: Seen reorders, with early use concentration not geographically specific yet.

Q: Launch in dementia market vs schizophrenia/bipolar?

A: Developing market entry strategy; early research shows unmet need, expecting good penetration but different market dynamics.