BioXcel Therapeutics, Inc. Q4 FY2022 earnings call

• Launched IGALMI in 2022, the first drug approved for acute agitation in schizophrenia and bipolar disorder.
• Clinical pipeline: Expect Q2 2023 data from Phase 3 trials for BXCL501 in Alzheimer's related agitation (TRANQUILITY II fully enrolled, TRANQUILITY III accelerating enrollment) and bipolar/schizophrenia agitation (SERENITY III near complete enrollment), plus Phase 1b data for major depressive disorder.
• Developing BXL502, a serotonergic receptor antagonist with prototype formulation developed and IND enabling studies initiated.
• Advancing R&D pipeline with AI approach, focusing on neuro rare diseases with over 10 product concepts identified.
• OnkosXcel's BXCL701 showed positive efficacy in cancer types, with plans for pivotal studies in small cell neuroendocrine cancer and other indications.

Net revenue for the fourth quarter of 2022 was approximately $238,000, and $375,000 for the full year 2022. Research and development expenses for Q4 2022 were $32.5 million compared to $12.5 million in the same period of 2021; full-year R&D expenses were $91.2 million vs. $52.7 million in 2021. SG&A expenses for Q4 2022 were $20.7 million vs. $13.6 million in 2021; full-year SG&A was $68.8 million vs. $54.2 million in 2021. Net loss for Q4 2022 was $54.8 million vs. $26.1 million in 2021; full-year net loss was $165.8 million vs. $106.9 million in 2021. Cash and cash equivalents totaled $193.7 million at Dec 31, 2022, compared to $233 million at Dec 31, 2021.

• No specific revenue guidance for 2024 yet; will provide as launch metrics and demand become clearer.
• Revenue is a lagging indicator, and metrics like formulary wins and sales force deployment will inform future guidance.

• Delays in clinical trial data readouts.
• Uncertainties in hospital formulary adoption timelines.
• Competition in the neuropsychiatric and oncology markets.

Q: Colin Bristow asked about IGALMI formulary wins, timeline to drug availability, TRANQUILITY III enrollment, and 2024 guidance.

A: Matt Wiley responded on formulary wins (majority expected to result in wins), timeline from formulary win to drug availability (6-12 months for formulary process, then trial uptake), and TRANQUILITY III enrollment progress; Vimal Mehta and Richard Steinhart discussed 2024 guidance being based on 2023 performance.

Q: Robyn Karnauskas inquired about IGALMI sales, formulary wins with purchases, and cost adjustment.

A: Vimal Mehta and Matt Wiley addressed sales tracking, formulary win to purchase patterns, and no immediate plans to adjust drug price but focusing on contracting with GPOs and IDNs.

Q: Greg Harrison asked about provider responses to IGALMI and data disclosure for SERENITY II and TRANQUILITY III.

A: Rob Risinger shared positive provider anecdotes about patient response, and Vimal Mehta stated data would be disclosed via press release and conference call.

Q: Graig Suvannavejh asked about uptake, marketing initiatives, and 600 pending P&T meetings.

A: Matt Wiley discussed uptake timeline (6-12 months for formulary process, then uptake), marketing initiatives including free trial program and clinician targeting campaigns, and P&T meetings ongoing with expected matriculation in coming quarters.

Q: Sumant Kulkarni asked about Q1 sales relative to 4Q, heavy P&T meeting quarters, and TRANQUILITY II data verification timeline.

A: Richard Steinhart noted no Q1 guidance provided, Matt Wiley discussed P&T meeting timelines depending on hospital schedules, and Rob Risinger explained data verification and cleaning taking 8-10 weeks for source data verification.

Q: Eddie Hickman asked about Alzheimer's disease agitation safety data and outpatient vs. hospital prescribing/reimbursement.

A: Rob Risinger and Vimal Mehta discussed no additional safety requirements and similar labeling expectations, with Rob Risinger explaining outpatient prescribing by mental health providers and traditional reimbursement.

Q: Corinne Jenkins inquired about free drug program design and TRANQUILITY program endpoint.

A: Vimal Mehta discussed free drug program limits (2 cartons per 6 months), and Vimal Mehta and Rob Risinger explained TRANQUILITY program endpoint focusing on 3-month efficacy and safety demonstration.

Q: Ram Selvaraju asked about formulary soft nos, neuroscience pipeline prioritization, and OnkosXcel spin-out.

A: Matt Wiley and Vimal Mehta addressed formularies seeking evidence on value, neuroscience pipeline prioritization with 501 and 502 timelines, and OnkosXcel pursuing partnering and independent investment opportunities.

Q: Samir Devani asked about operating costs and quarterly R&D/ marketing spend.

A: Matt Wiley and Richard Steinhart discussed incremental sales and marketing costs with full sales force deployed, and R&D spend expected to stabilize as pivotal trials progress.

Q: Graig Suvannavejh followed up on GPO discussions.

A: Matt Wiley reported progress with one GPO close to finish line and another protracted due to downstream hospital momentum requirements.