Axsome Therapeutics (AXSM) investor relations material

Commercial performance and strategic expansion

• AUVELITY achieved $155 million in quarterly sales, annualizing over $600 million, with plans to double the sales force from 300 to 600 reps to drive further growth and prepare for a potential Alzheimer's disease agitation indication.

• Operating leverage is strong, with revenues outpacing operating expenses 3:1 in 2025, and further leverage expected even with expansion and new launches.

• Direct-to-consumer (DTC) campaigns launched nationally in late 2023, with plans for continued but moderated investment through 2026, aiming for higher ROI as the sales force expands.

• Primary care clinicians now account for about a third of AUVELITY prescriptions, with significant opportunity remaining in the broader antidepressant market.

• Sales force expansion will also target Alzheimer's agitation, with a dedicated team planned for long-term care settings upon approval.

Pipeline and clinical development updates

• The pipeline includes five product candidates across nine indications, with robust late-stage activity and pre-launch preparations underway for AXS-05 in Alzheimer's agitation.

• AXS-05 for Alzheimer's agitation is under priority review, with a PDUFA date set for April 30; the clinical package includes both parallel group and randomized withdrawal studies, providing efficacy and safety data.

• Simbravo's targeted launch focuses on headache centers and high-prescribing clinicians, with recent GPO contracts and positive early feedback on efficacy and safety.

• AXS-12 for narcolepsy is nearing NDA submission, with a differentiated profile in daytime dosing and cataplexy efficacy, leveraging an existing sleep-focused sales team.

• Sunosi is advancing in adult ADHD with compelling phase III data, and parallel pediatric and adolescent studies are set to begin, targeting a $1–3 billion peak sales opportunity.

Market opportunities and competitive positioning

• AUVELITY currently holds just 0.2% of the antidepressant market, indicating substantial room for growth, especially in primary care.

• For Alzheimer's agitation, over 70% of the 7 million U.S. Alzheimer's patients experience agitation, with 20 million+ scripts written off-label, highlighting a large addressable market.

• If approved, AXS-05 will benefit from 100% Medicare Part D coverage, similar to Rexulti, but with a differentiated product profile and sales strategy.

• Sunosi's ADHD indication is expected to be the largest value driver, with additional studies ongoing in binge eating disorder, shift work disorder, and MDD with excessive daytime sleepiness.

• AXS-14 for fibromyalgia is progressing with a new phase III trial after FDA feedback, addressing an area of unmet need with few approved therapies.