BioXcel Therapeutics (BTAI) investor relations material

Commercial strategy and launch plan

• Preparing for IGALMI's potential approval for at-home treatment of acute agitation in bipolar and schizophrenia, with a PDUFA date set for November 14th and a targeted launch in Q1 2027.

• Market research shows high unmet need and strong interest from physicians, patients, and payers for an at-home solution, with projections of 70% physician adoption and 80% patient use for future episodes.

• The at-home market is significantly larger than the institutional setting, with an estimated 1.8 million addressable patients and 86 million episodes annually.

• Launch strategy includes scientific communication, physician education, payer engagement, and targeted patient messaging, with a small, focused sales force covering the majority of prescribers.

• Exploring potential partnerships and co-commercialization options to maximize reach and impact.

Market opportunity and value proposition

• IGALMI is positioned as the first FDA-approved at-home treatment for acute agitation, offering rapid onset (as fast as 20 minutes) and a non-sedating profile.

• Current at-home treatments are off-label, slow-acting, or have significant side effects; IGALMI addresses these gaps.

• Payers expect formulary coverage with restrictions like prior authorization and quantity limits, given the episodic use and unmet need.

• Pricing at $105 per film is seen as reasonable by payers, with strategies in place to manage copays and ensure patient access.

• Medicaid access will require state-by-state efforts, but protections for severe mental illness support coverage.

Clinical and patient impact

• Clinical studies show IGALMI can be safely and effectively self-administered at home, reducing escalation to ER visits.

• Works across mild, moderate, and severe agitation, with broad anticipated use to prevent escalation.

• Patients and caregivers value the ability to manage agitation proactively, likened to having an EpiPen for mental health crises.

• Safety measures include quantity limits and packaging to prevent misuse or overdose.

• Ongoing efforts to expand indications, including Alzheimer's agitation and opioid withdrawal, with additional trials planned.