Axsome Therapeutics Inc

Latest Results (21.11.2025):

Axsome Therapeutics Inc third quarter of 2025 results show strong commercial revenue growth driven by AUVELITY, SUNOSI and the newly launched SYMBRAVO, with total net product revenue of $171.0 million (63% year‑over‑year growth; 14% sequential). The company reported investments in commercialization and a reduced net loss versus prior year, while maintaining a cash balance it expects is sufficient to fund operations into cash‑flow positivity.

Key financials

Total net product revenue was $171.0 million in 3Q 2025 (up 63% YoY, up 14% sequential). Cost of revenue was $11.9 million. R&D expense was $40.2 million (down from $45.4 million in 3Q 2024). SG&A was $150.2 million (up from $95.6 million), primarily reflecting AUVELITY commercialization and the SYMBRAVO launch.

Product revenue breakdown

AUVELITY net product sales: $136.1 million in 3Q 2025 (69% YoY, 14% sequential). SUNOSI net product revenue: $32.8 million (consisting of $31.6M net sales + $1.2M royalty; 35% YoY, 9% sequential). SYMBRAVO net product sales: $2.1 million in its first full commercial quarter after the June 2025 launch.

Profitability and per‑share impact

Net loss was $47.2 million, or $(0.94) per share, in 3Q 2025 versus a net loss of $64.6 million, or $(1.34) per share, in 3Q 2024. The 3Q 2025 loss includes $23.1 million of stock‑based compensation and a $13.2 million non‑cash contingent consideration charge.

Balance sheet and liquidity

Cash and cash equivalents totaled $325.3 million at September 30, 2025 (vs. $315.4 million at December 31, 2024). Shares outstanding were 50,307,834. Management states current cash is expected to fund operations into cash‑flow positivity under the current plan.

Commercial performance and access

AUVELITY: ~209,000 prescriptions in 3Q 2025 (up 46% YoY, 9% sequential); payer coverage ~85% overall (≈75% commercial, 100% government). SUNOSI: ~53,000 prescriptions (up 12% YoY, 5% sequential); coverage ~83% (≈95% commercial, 60% government). SYMBRAVO: ~5,000 prescriptions in 3Q 2025; coverage ~52% as of Oct 1 (≈48% commercial, 56% government). Axsome added GPO contracts for AUVELITY and SYMBRAVO during 3Q.

Pipeline and regulatory updates

Axsome submitted an sNDA to the FDA for AXS‑05 for Alzheimer’s disease agitation and expects an FDA acceptance decision. Planned near‑term initiations in 4Q 2025 include a Phase 2/3 smoking cessation trial for AXS‑05, Phase 3 pediatric ADHD and Phase 3 MDD with EDS trials for solriamfetol, Phase 3 for AXS‑14 in fibromyalgia, and an NDA submission for AXS‑12 (narcolepsy). Topline results for solriamfetol ENGAGE and SUSTAIN trials are anticipated in 2026.