BioXcel Therapeutics, Inc. Q1 FY2023 earnings call

Commercial Progress

• IGALMI launch continues with over 130 formulary wins, doubling since the last earnings call, unlocking over $55 million in addressable market. The commercial team has a 70-person field force, with progress in hospital shelf availability and formulary adoption.

Clinical Milestones

• Three key data readouts for BXCL501 expected soon: SERENITY III Part 1 data on agitation in bipolar and schizophrenia (expected top line this month), TRANQUILITY II top line data on Alzheimer's-related agitation in June, and Phase Ib multiple ascending dose trial data on BXCL501 as adjunctive MDD treatment (expected this month).
• OnkosXcel expects to initiate a randomized Phase IIb trial for BXCL701 in small cell neuroendocrine prostate cancer in the second half of the year.

Real-World Examples

• Unsolicited anecdotes show IGALMI's effectiveness, with patients requesting it by name and caregivers reporting positive outcomes like calmer, more cooperative patients.

Net revenue for the first quarter of 2023 was approximately $206,000, similar to the prior quarter. Research and development expenses were $27.8 million in Q1 2023 compared to $18.6 million in the same period of 2022, driven by multiple clinical trials and CMC costs related to upcoming data readouts. Sales, general and administrative expenses were $23.6 million in Q1 2023 versus $12.9 million in 2022, primarily due to commercialization costs for IGALMI. BioXcel had a net loss of $52.8 million in Q1 2023, up from $31.5 million in the prior year. Cash and cash equivalents totaled $165.5 million as of March 31, 2023, with a cash runway expected into 2025.

Revenue Uptick

• Anticipate significant revenue growth later in 2023 due to IGALMI revenues and full execution of strategic financing.

Data Readouts

• Expect key BXCL501 data in the coming weeks to expand the asset's therapeutic potential.

Confidence

• Confident in meeting high expectations with a solid foundation laid for near-term developments.

• Uncertainties in clinical trial outcomes and regulatory approvals for new products.
• Potential delays in commercialization of IGALMI and pipeline products.
• Risks associated with strategic options for OnkosXcel.

Q: Regarding SERENITY III, what's the bar for successful PEC score change in regulatory approval?

A: Safety is critical for at-home use, and the study is engineered to achieve statistical separation from placebo with 80% power.

Q: How does commercialization strategy for at-home setting compare to institutional?

A: Building momentum with interest from patients requesting IGALMI at home, expecting a strong bridge to community market.

Q: Disconnect between formulary wins and flat sales performance?

A: Formulary wins are leading indicators; revenue is lagging, expected to inflect later in 2023.

Q: TRANQUILITY II study design and filing requirements?

A: Designed in consultation with FDA, double-blind placebo-controlled for 3 months, data to be presented to FDA.

Q: Adjunctive MDD study in healthy volunteers?

A: Principal focus on safety and tolerability, with plans to develop as accelerant to antidepressant response.

Q: FDA discussions on TRANQUILITY studies?

A: Designed in consultation with FDA, double-blind placebo-controlled for 3 months to demonstrate efficacy over time.

Q: OnkosXcel strategy and timing?

A: Exploring strategic options, including financing and partnering, with potential Phase IIb trial in SCNC in second half.