Axsome Therapeutics(AXSM) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 increased 65% year-over-year to $196 million, and for the full year increased 66% to $639 million [6][12] - Net product sales of Auvelity for Q4 were $155.1 million, up 68% compared to the prior year, and total sales for Auvelity reached $507.1 million, representing a 74% year-over-year increase [12][13] - Net loss for Q4 was $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share for Q4 2024 [16] - Net loss for the full year was $183.2 million, or $3.68 per share, compared to a net loss of $287.2 million, or $5.99 per share for 2024 [17] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth in prescriptions [6][19] - Sunosi generated net product revenue of $36.7 million for Q4, a 40% increase compared to Q4 2024, and $124.8 million for the full year, representing a 32% increase [13] - Symbravo generated $4.1 million in net sales for Q4 and $6.6 million for the full year, following its second full quarter of launch [13] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [19] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [20] - Symbravo's overall payer coverage is approximately 52% at the start of the year [22] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications [6] - Plans to conduct two Phase 3 trials in ADHD, one in children and one in adolescents, are on track for initiation in the first half of the year [9] - The company aims to expand its sales force to approximately 600 representatives to support growth in MDD and potential launch in Alzheimer's disease agitation [21][59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver new treatment options for patients living with CNS disorders, supported by a scalable commercial platform [6][11] - The company anticipates that its current cash balance is sufficient to fund operations into cash flow positivity based on the current operating plan [17] - Management is optimistic about the potential impact of the upcoming launch for Alzheimer's disease agitation, with preparations underway [69] Other Important Information - The company has made significant progress with its NDA package for AXS-12 in narcolepsy and expects to submit that imminently [8] - The acquisition of AZD7325, a novel oral GABA A alpha-2/3 receptor positive allosteric modulator, is planned for evaluation in epilepsy [10] Q&A Session Summary Question: Implications of the new FDA publication on the one trial policy - Management is assessing the implications and will continue to vet clinical plans with the FDA [28] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the focus is currently on preparing for Phase II readiness [33] Question: Coverage evolution for Auvelity post-ADA label approval - Existing coverage should generally apply to the new indication, but there may be additional efforts needed for Medicare coverage [36] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access across OSA and narcolepsy markets [44] Question: Sales force expansion rationale - The expansion aims to accelerate growth in MDD and prepare for potential Alzheimer's agitation indication [59] Question: Coverage evolution for Symbravo - The secured contract with a third large GPO allows for active negotiation with payers, with optimism for increased coverage [63]