Axsome Therapeutics, Inc. (NASDAQ: AXSM) Q2 2025 Earnings | 08/04/2025

18 days ago

55:27

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Axsome Therapeutics Q2 2025 Earnings Call Summary

Key Highlights:

Strong Revenue Growth: Total Q2 revenue reached $150M (+72% YoY, +24% QoQ), driven by strong performance of Auvelity (MDD) and Sunosi (narcolepsy/OSA), plus the recent launch of Simbruvo (acute migraine).
- Auvelity: $119.6M (+84% YoY, +24% QoQ) – leading antidepressant in TRx growth (192K prescriptions, +15% QoQ).
- Sunosi: $30M (+35% YoY, +19% QoQ) – surpassed 50K prescriptions for the first time.
- Simbruvo: Launched June 10, generated $410K in partial Q2 sales.
Pipeline Progress:
- AXS-05 (Alzheimer’s agitation): NDA submission on track for Q3 2025.
- AXS-12 (narcolepsy): NDA submission expected Q4 2025.
- AXS-14 (fibromyalgia): Phase 3 trial to start in Q4 2025.
- Solriamfetol (ADHD, binge eating disorder, shift work disorder):
  - Pediatric ADHD trial to begin Q4 2025.
  - Phase 3 binge eating disorder trial on track for 2026 readout.

Commercial Execution:

Auvelity: Expanded payer coverage to 83% of lives (73% commercial, 100% government).
Sunosi: Stable growth, strong prescriber adoption.
Simbruvo: Early launch success with 38% coverage; strong physician/patient feedback on rapid onset & tolerability.

Financials:

Net Loss: $48M ($0.97/share), improved from $79.3M YoY.
Cash Position: $303M (sufficient to fund operations into cash flow positivity).
R&D Spend: $49.5M (flat YoY).
SG&A: $130.3M (up due to commercialization efforts).

Key Upcoming Milestones:

Q3 2025: AXS-05 NDA submission (Alzheimer’s agitation).
Q4 2025: AXS-12 NDA submission (narcolepsy), AXS-14 Phase 3 start (fibromyalgia).
2026: Data readouts for solriamfetol in binge eating disorder and shift work disorder.

Analyst Q&A Highlights:

Auvelity Growth: Driven by new prescribers (4,800 in Q2) and expanded access.
Simbruvo Launch: Early demand strong, GTN in low 80s (expected to remain elevated near-term).
AXS-05 (Alzheimer’s): Potential differentiation vs. antipsychotics; commercial strategy includes geriatric psych & long-term care.
AXS-12 (Narcolepsy): Positioned as once-daily option with potential for combination use.
ADHD & Binge Eating Programs: Pediatric ADHD trial design aligning with FDA; binge eating disorder remains high unmet need.

Conclusion

Axsome delivered strong Q2 growth, driven by Auvelity and Sunosi, while successfully launching Simbruvo. With multiple late-stage catalysts (AXS-05, AXS-12, AXS-14) and a growing commercial footprint, the company is well-positioned for sustained growth in neuroscience therapeutics.

About this video

Axsome Therapeutics, Inc. achieved record second quarter 2025 results, with net product revenue surging 72% year-over-year to $150 million and 24% sequentially, fueled by outstanding growth of AUVELITY (up 84% to $119.6 million), strong SUNOSI sales (up 35% to $30 million), and initial contributions from migraine therapy SYMBRAVO (U.S. launch in June, $0.4 million). Despite SG&A expenses rising 26% to $130.3 million as Axsome expanded its commercial presence, the company’s net GAAP loss narrowed by 39% to $48 million, or $0.97 per share, from a $79.3 million loss in Q2 2024. Gross margin remained robust at around 91%. Operating cash burn improved to $75.8 million, while R&D investment was steady at $49.5 million, supporting a diversified late-stage CNS pipeline. Cash and equivalents stood at $303 million, further bolstered by a new $570 million credit facility with Blackstone, which refinanced existing debt and is expected to lower future interest expense. Axsome’s total debt was $188 million at quarter-end. Two upcoming NDA/sNDA submissions—AXS-05 for Alzheimer’s agitation (Q3 2025) and AXS-12 for narcolepsy (Q4 2025)—anchor a robust clinical pipeline, with new Phase 3 trials for solriamfetol in ADHD and MDD commencing in Q4. Management is confident that current liquidity will fund operations to positive cash flow. Management and analysts highlighted Axsome’s commercial momentum, pipeline expansion, and improved operational leverage, which drove the stock higher post-report. While not providing formal updated guidance, the company reaffirmed its commitment to sustained top-line momentum, pipeline advancement, and achieving long-term profitability. About Inside Ticker: For more expert analysis and real-time updates on Axsome Therapeutics, Inc. (NASDAQ: AXSM) and other market movers, follow Inside Ticker and visit http://www.insideticker.com/ for in-depth reports, financial insights, and the latest news on leading companies. #Axsome #AXSM #Q22025 #Earnings #FinancialResults #NetRevenue #AUVELITY #SUNOSI #SYMBRAVO #ClinicalPipeline #R&D #GrossMargin #DebtRefinancing #CashFlow #Profitability #NDA #CNS #InsideTicker #2025Outlook

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