Axsome Therapeutics (AXSM) Q4 2025: Avelity Scripts Jump 42% as Commercial Platform Scales

2026-02-23 | By EarningsIQ Research

Axsome Therapeutics delivered a quarter marked by robust prescription growth and expanding commercial reach, underpinned by disciplined operating leverage and a maturing CNS pipeline. The company’s investments in sales force expansion and digital-centric commercialization are positioning it for continued revenue acceleration, especially with a potential Alzheimer’s agitation launch on the horizon. Management’s confidence in sustained growth is matched by a focus on payer access, pipeline diversification, and execution across multiple late-stage programs.

Summary

• Primary Care Traction Accelerates: Avelity’s prescriber base is expanding fastest among primary care clinicians, signaling broader market penetration.
• Pipeline Diversification Advances: Multiple late-stage CNS programs and new asset AXS-17 support long-term growth optionality.
• Operating Leverage Emerges: Revenue growth is outpacing expense increases, driving improved financial efficiency heading into 2026.

Performance Analysis

Axsome’s Q4 performance was defined by strong top-line growth across its commercial portfolio, led by Avelity, which notched over 225,000 prescriptions in the quarter, up 42% year-over-year, outpacing a flat antidepressant market. Synosy continued its steady expansion, with more than 54,000 prescriptions and a 40% YoY revenue increase, while Sembravo contributed incremental growth following its recent launch. Gross-to-net discounts for Avelity and Synosy remained in the high 40% range, though management flagged these will rise to the mid-50s in Q1 due to typical seasonal dynamics.

Disciplined expense management was evident in the company’s financials: sales and marketing investments, including a national direct-to-consumer campaign and a sales force expansion from 300 to 600 reps, drove a 39% YoY increase in SG&A, yet revenue grew roughly three times faster than operating expenses. R&D spend declined on the completion of major clinical trials, partially offset by new pipeline activity and one-time acquisition costs. Net loss narrowed significantly, and Axsome exited the year with a solid $323 million cash position, supporting its claim of funding through to cash flow positivity under the current plan.

• Prescription Volume Surges: Avelity’s 42% YoY script growth and 8% sequential gain highlight robust demand even as the broader market stagnates.
• Market Access Expands: Commercial coverage for Avelity rose from 75% to 78%, with total coverage now at 86% and further gains targeted.
• Sales Force Investment: Expansion to 600 reps aims to capture Alzheimer’s agitation opportunity and deepen primary care engagement.

The combination of commercial momentum, improving leverage, and pipeline catalysts sets up Axsome for a pivotal 2026, with management focused on execution and access as key levers for continued outperformance.

Executive Commentary

Strategic Positioning

1. Digital-Centric Commercialization and Market Penetration

Axsome’s commercialization strategy is increasingly digital-first, exemplified by its national direct-to-consumer campaign and data-driven optimization of marketing spend. The sales force expansion, particularly targeting primary care, is designed to unlock new prescriber segments and accelerate uptake in both major depressive disorder (MDD) and potential new indications such as Alzheimer’s disease agitation (ADA).

2. Payer Access as a Growth Lever

Market access remains a central focus, with Avelity’s coverage now at 86% and ongoing efforts to remove prior authorizations and step edits, especially as ADA approval could shift the payer mix more toward Medicare Part D. Sembravo’s contracting with all major commercial GPOs enables negotiation with national payers and PBMs, setting the stage for improved coverage and pull-through in 2026.

3. Pipeline Breadth and Late-Stage Optionality

Axsome’s pipeline spans five novel product candidates across nine CNS indications, with late-stage programs in narcolepsy (AXS-12), ADHD, binge eating disorder, and fibromyalgia. The recent acquisition of AXS-17, a GABA-A modulator for epilepsy, adds another differentiated asset, with phase 2 readiness underway. This breadth supports long-term growth and mitigates single-product risk.

4. Operating Leverage and Cash Discipline

Operating leverage is emerging as a differentiator, with revenue growth well ahead of expense increases. Management’s guidance that current cash is sufficient to reach cash flow positivity, even with stepped-up investments, reflects a disciplined approach to capital allocation and scaling.

Key Considerations

Axsome’s quarter was shaped by commercial execution, pipeline advancement, and foundational investments in scale and access.

Key Considerations:

• Primary Care Expansion: Rapid growth in primary care prescribers is unlocking new patient segments and supporting Avelity’s outperformance in a flat MDD market.
• Sales Force Scaling: Doubling the sales force to 600 reps is a proactive move to maximize the ADA launch and sustain MDD momentum.
• Medicare Dynamics: ADA scripts are expected to be 70%+ Medicare Part D, with more favorable gross-to-net economics than the commercial channel.
• Pipeline Catalysts: Multiple late-stage trials (e.g., phase 3 in ADHD, binge eating disorder, narcolepsy) provide near-term data flow and potential label expansion.
• Market Access Progress: Ongoing negotiations and GPO contracting for Sembravo and continued push for Avelity coverage are key to future script growth.

Risks

Axsome faces execution risk in scaling its sales force and achieving full market access, especially as payer dynamics shift with new indications. Pipeline programs carry inherent clinical and regulatory risk, and delays or negative outcomes could disrupt growth expectations. Competitive threats, particularly from new mechanisms in narcolepsy and migraine, require continued differentiation and payer advocacy. Rising gross-to-net discounts, especially during launch phases, may pressure near-term profitability despite top-line momentum.

Forward Outlook

For Q1 2026, Axsome expects:

• Gross-to-net discounts for Avelity and Synosy to rise to the mid-50% range due to seasonal factors.
• Completion of the Avelity sales force expansion to 600 reps by Q2, supporting the anticipated ADA launch.

For full-year 2026, management maintained guidance that:

• Current cash resources are sufficient to fund operations through to cash flow positivity.

Management highlighted several factors that will shape 2026:

• ADA approval and launch readiness activities are on track for a potential April 30th PDUFA date.
• Market access expansion, especially for Sembravo and Avelity in new indications, remains a top priority.

Takeaways

Axsome enters 2026 with commercial momentum, operating leverage, and a pipeline rich with late-stage catalysts.

• Script Growth Outpaces Market: Avelity’s robust prescription gains, especially in primary care, validate the commercial model and position the brand for further share gains.
• Strategic Investments Set Up Next Phase: Sales force expansion and payer contracting are proactive moves to capture upside from upcoming label expansions and launches.
• Pipeline Execution Remains Central: Investors should monitor clinical milestones and regulatory progress closely, as pipeline outcomes will shape long-term value realization and risk profile.

Conclusion

Axsome’s Q4 results highlight a company executing on multiple fronts, balancing near-term commercial growth with disciplined investment and late-stage pipeline advancement. The coming quarters will test its ability to translate scale and access into durable market leadership, especially as new indications and assets come online.

Industry Read-Through

Axsome’s execution underscores the importance of primary care engagement and payer access in CNS markets, providing a template for peers navigating similar commercial and regulatory dynamics. The rise of digital-centric commercialization and direct-to-consumer campaigns reflects an evolving playbook for specialty pharma, while the company’s pipeline breadth and rapid sales force scaling signal that late-stage assets and market access will remain key battlegrounds across neurology and psychiatry. Competitors and investors should watch for shifts in gross-to-net management and the impact of Medicare channel mix as CNS portfolios broaden into older adult populations.

AXSM Healthcare Pharmaceuticals CNS Commercialization Pipeline Market Access