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Created: 2025-02-18 19:52:27 UTC

$AXSM Axsome Therapeutics, Inc. Q4 2024 Earnings Call Key Highlights:

💊 Strong Commercial Growth & Pipeline Expansion

Total net product revenue for 2024: $XXX million, reflecting XX% year-over-year growth, driven by Auvelity and Sunosi.
Auvelity net sales: $XXXXX million, up XXX% YoY, reinforcing its potential as a blockbuster depression treatment.
Sunosi net revenue: $XXXX million, up XX% YoY, maintaining strong growth in excessive daytime sleepiness (EDS) treatment.
Symbravo (new migraine treatment) approved on Jan 30, 2025, with a commercial launch planned in the coming months.
📈 Financial Performance & Outlook

Q4 total revenue: $XXXXX million, up XX% YoY, with Auvelity leading demand growth.
Net loss for FY 2024: $XXXXX million ($5.99 per share), compared to $XXXXX million ($5.27 per share) in 2023, reflecting higher R&D and commercial investments.
R&D expenses: $XXXXX million, up XX% YoY, driven by multiple Phase III trials and pipeline expansion.
SG&A expenses: $XXXXX million, reflecting increased commercialization efforts.
Cash position: $XXXXX million, expected to fund operations until reaching cash flow positivity.
🧪 Advancing Late-Stage CNS Pipeline

AXS-05 (Alzheimer’s Disease Agitation): Completed X Phase III trials; NDA submission expected in H2 2025.
AXS-12 (Narcolepsy with Cataplexy): NDA submission expected in H2 2025, supported by X controlled efficacy trials.
AXS-14 (Fibromyalgia): NDA submission planned for Q1 2025, showing strong efficacy in pain, function, and fatigue reduction.
Upcoming Phase III data readouts (Q1 2025):EMERGE study: Symbravo in migraine patients with inadequate response to CGRPs.
FOCUS study: Solriamfetol in ADHD.
PARADIGM study: Solriamfetol in major depressive disorder (MDD).

Ongoing Phase III trials (Top-line data in 2026):ENGAGE study: Solriamfetol in binge eating disorder.
SUSTAIN study: Solriamfetol in shift work disorder.

📊 Auvelity Continues Strong Market Growth
Q4 prescriptions: 158,000, up XX% YoY, making it the fastest-growing branded antidepressant.
XXXXXX new patients started Auvelity in Q4, with a total of XXXXXXX patients since launch.
Primary care physicians driving new prescriber growth.
Payer coverage: XX% of all lives covered, with XX% commercial coverage.
🚀 Sunosi Expands in Wake-Promoting Market

Q4 prescriptions: 49,000, up XX% YoY; market share continues to grow.
Total patient base since launch: XXXXXX.
Prescriber base: XXXXXX HCPs, with XXX new prescribers added in Q4.
💡 Upcoming Symbravo (Migraine) Launch Strategy
Launch targeting headache specialists and neurology practices (~70% of branded migraine market).

High potential due to unique clinical profile (fast pain relief, extended 24-hour efficacy).
Expected competition from oral CGRPs, but positioning for underserved patient population.
🔍 Regulatory & NDA Submission Timeline
AXS-05 (Alzheimer’s Agitation): NDA submission H2 2025 (pending regulatory strategy decision).

AXS-12 (Narcolepsy with Cataplexy): NDA submission H2 2025.
AXS-14 (Fibromyalgia): NDA submission Q1 2025.
AXS-05 (Smoking Cessation): Phase III trial initiation in 2025.
📢 Strategic Expansion & M&A Outlook

Evaluating business development and potential acquisitions to expand the CNS portfolio.
Maintaining strong cash position while balancing commercial and R&D investments.
Key therapeutic focus: Depression, neuropsychiatry, sleep disorders, and pain management.
🔮 2025 Outlook & Key Priorities:
✅ Scaling commercialization of Symbravo (migraine) while driving continued Auvelity & Sunosi growth.
✅ Executing NDA submissions for AXS-05 (Alzheimer’s agitation), AXS-12 (narcolepsy), and AXS-14 (fibromyalgia).
✅ Advancing clinical trials, with multiple Phase III readouts in Q1 2025.
✅ Managing financial discipline to reach cash flow positivity.

Conclusion:
Axsome continues its strong trajectory in CNS, with blockbuster potential for Auvelity, growing adoption of Sunosi, and an exciting upcoming launch for Symbravo in migraine. With three NDA submissions planned in 2025 and multiple late-stage pipeline readouts, Axsome is well-positioned for long-term growth and value creation. 🚀

![](https://pbs.twimg.com/media/GkGEXAbWoAAqHuu.png)

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**Related Topics**
[quarterly earnings](/topic/quarterly-earnings)
[$axsm](/topic/$axsm)

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