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Axsome Therapeutics, Inc. (AXSM): BCG Matrix [Dec-2025 Updated] |
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Axsome Therapeutics, Inc. (AXSM) Bundle
You're looking for a clear, no-nonsense assessment of Axsome Therapeutics' portfolio as of late 2025, and the BCG Matrix is the perfect tool to map their current commercial success against their future pipeline bets. Right now, Auvelity is the undeniable Star, driving revenue with $136.1 million in Q3 sales and 69% growth, while Sunosi remains a solid Cash Cow; however, the picture isn't perfect, as the regulatory hit to AXS-14 makes it a clear Dog, leaving the future heavily dependent on Question Marks like the potential Alzheimer's Agitation launch. Dive in to see the full breakdown of where Axsome Therapeutics, Inc. needs to invest or divest.
Background of Axsome Therapeutics, Inc. (AXSM)
Axsome Therapeutics, Inc. is a biopharmaceutical company you're looking at that focuses squarely on developing and commercializing novel therapies for central nervous system (CNS) disorders in the United States. Honestly, the company has built its foundation on addressing conditions where the unmet medical need is quite high, spanning from major depressive disorder to Alzheimer's agitation and narcolepsy.
As of late 2025, Axsome Therapeutics has three marketed products driving its revenue stream. The clear leader is AUVELITY, which is indicated for major depressive disorder. For the third quarter of 2025, AUVELITY generated net product sales of $136.1 million, marking a substantial 69% year-over-year growth. That quarter also saw prescription volume hit 209,000 written scripts, showing strong uptake since its launch.
Next up is SUNOSI, which treats excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. In Q3 2025, SUNOSI contributed $32.8 million in net product revenues, representing a 35% increase over the prior year. The newest addition to the commercial portfolio is SYMBRAVO, approved for acute migraine in January 2025 and launched in June 2025; it brought in $0.4 million in net product sales in its first partial quarter of reporting in Q2 2025.
Overall, the company reported total net product revenue of $171 million for the third quarter of 2025, which was up 63% compared to the same period last year. Despite this strong top-line growth and an impressive 91.86% gross profit margin, Axsome Therapeutics, Inc. is still operating at a net loss, reporting a net loss of $47.2 million for Q3 2025. The company maintains a solid balance sheet, ending Q3 2025 with $325.3 million in cash and cash equivalents, which management believes is sufficient to fund operations into cash flow positivity.
Beyond the current commercial base, Axsome Therapeutics, Inc. has several high-potential assets in the pipeline that are key to its valuation story. They have a supplemental New Drug Application (sNDA) pending for AXS-05 in Alzheimer's disease agitation, and they are targeting an NDA submission for AXS-12 for narcolepsy in the fourth quarter of 2025. Furthermore, the company plans to launch AXS-14 for fibromyalgia before the end of 2025, which you should definitely keep an eye on. The market capitalization for Axsome Therapeutics, Inc. hovered around $7.57 billion in late 2025.
Axsome Therapeutics, Inc. (AXSM) - BCG Matrix: Stars
The Star quadrant in the Boston Consulting Group Matrix represents products with a high market share in a growing market. For Axsome Therapeutics, Inc., this designation clearly belongs to its flagship product, Auvelity, for major depressive disorder (MDD).
Auvelity is the clear leader in this segment, driving significant top-line performance. You see this reflected in the latest reported figures. Auvelity (MDD) is the flagship product with Q3 2025 net sales of $136.1 million. It shows explosive growth, up 69% year-over-year in Q3 2025, driving total revenue. This growth is supported by strong underlying demand, evidenced by approximately 209,000 prescriptions written in the third quarter of 2025, which was a 46% increase compared to the same period in 2024.
Management projects Auvelity is on track to reach blockbuster potential, with peak sales estimated at $1-$3 billion. This potential is being realized as the product gains access across the payer landscape. It shows high market share in the rapid-acting oral antidepressant segment with expanding payer coverage to 85% of patient lives as of the third quarter of 2025.
Stars like Auvelity require substantial investment to maintain their growth trajectory and market leadership. Axsome Therapeutics, Inc. is clearly investing, as indicated by the increase in Selling, General and Administrative expenses, which totaled $150.2 million in Q3 2025, up 57.1% year-over-year, reflecting commercial activities for Auvelity. The company is funding this growth from its current resources, holding cash and cash equivalents of $325.3 million as of September 30, 2025.
Here's a quick look at the key performance metrics supporting the Star classification for Auvelity:
- Q3 2025 Net Product Sales: $136.1 million
- Year-over-Year Growth (Q3 2025): 69%
- Payer Coverage (All Channels): Approximately 85% of lives
- Peak Sales Potential Estimate: $1-$3 billion
Sustaining this success is the key strategy; if market share holds as the overall market growth rate eventually slows, Auvelity is positioned to transition into a Cash Cow for Axsome Therapeutics, Inc. The company's total net product revenue for Q3 2025 reached $171.0 million, with Auvelity being the primary contributor.
Axsome Therapeutics, Inc. (AXSM) - BCG Matrix: Cash Cows
You're looking at the established products that are reliably filling the company's coffers, which is exactly what a Cash Cow should do. For Axsome Therapeutics, Inc., Sunosi (solriamfetol), indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA), fits this profile well. It's a market leader generating the necessary cash to fund the riskier, high-growth Question Marks in the pipeline.
Sunosi provides a steady, established revenue stream, which is critical for a company investing heavily in development. The financial performance in the third quarter of 2025 clearly demonstrates this stability and growth. Q3 2025 net product revenue was $32.8 million, a solid 35% year-over-year growth. This revenue figure is comprised of $31.6 million in net product sales and $1.2 million in royalty revenue from out-licensed territories.
The product has high market penetration with approximately 83% payer coverage across all channels. This broad access supports the consistent revenue generation you expect from a Cash Cow. To give you a sense of the demand supporting this revenue, approximately 53,000 prescriptions were written for Sunosi in the U.S. in the third quarter of 2025, marking a 12% increase compared to the same period in 2024.
This consistent cash flow is vital because it helps fund the high research and development (R&D) costs of the pipeline. For context, Axsome Therapeutics, Inc.'s R&D expenses for the third quarter of 2025 were $40.2 million. The gains from Sunosi help bridge the gap between current investment and future potential. Sunosi's estimated peak sales are a stable $300-$500 million, indicating a mature, profitable market position.
Here's a quick breakdown of the key metrics for this established asset as of the third quarter of 2025:
| Metric | Value |
| Q3 2025 Net Product Revenue | $32.8 million |
| Year-over-Year Revenue Growth (Q3 2025) | 35% |
| Total Payer Coverage (Approximate) | 83% of lives |
| Q3 2025 Prescription Volume | Approximately 53,000 |
| Estimated Peak Sales Potential | $300-$500 million |
The strategy here is to maintain this market position without overspending on promotion, letting the established formulary status do the heavy lifting. You want to invest just enough to keep the infrastructure efficient and the cash flow steady. The focus for Axsome Therapeutics, Inc. is definitely on milking these gains passively while pouring resources into the Stars and Question Marks.
- Sunosi provides a steady, established revenue stream.
- Q3 2025 net product revenue was $32.8 million.
- Year-over-year growth for Q3 2025 was 35%.
- Payer coverage is approximately 83% across all channels.
- Revenue helps fund R&D expenses, such as the $40.2 million reported in Q3 2025.
- Estimated peak sales are projected to be $300-$500 million.
Axsome Therapeutics, Inc. (AXSM) - BCG Matrix: Dogs
AXS-14 (esreboxetine) for fibromyalgia represents a classic Dog within the Axsome Therapeutics, Inc. portfolio as of late 2025. This late-stage asset is currently stalled, consuming valuable Research and Development (R&D) capital without generating revenue, despite targeting a significant patient population of approximately 17 million Americans affected by fibromyalgia in the U.S.. The asset's low market share is currently zero, as regulatory hurdles prevent any near-term commercialization.
The primary issue stems from the U.S. Food and Drug Administration (FDA) issuing a Refusal to File (RTF) letter on June 9, 2025, for the New Drug Application (NDA). The FDA found the submission incomplete, specifically citing inadequacies in one of the two pivotal placebo-controlled trials, which used an 8-week endpoint and a flexible-dose paradigm. The other trial, utilizing a 12-week endpoint and a fixed-dose paradigm, was deemed adequate.
This regulatory setback has significantly delayed commercialization, forcing Axsome Therapeutics, Inc. to initiate a new controlled trial in the fourth quarter of 2025, as requested by the FDA. This required pivot means the asset is now a high-risk investment with an uncertain path to market, representing sunk costs from prior development efforts.
| Metric | Value/Date | Context |
| R&D Expense (Q3 2025) | $40.2 million | Most recently reported R&D spend, which will be impacted by the new trial. |
| Estimated Unplanned R&D Cost | $15-25 million | Estimated expenditure required for the additional study. |
| New Trial Initiation Target | Q4 2025 | Planned start date for the new fixed-dose, 12-week trial. |
| Analyst Program Valuation (Pre-RTF) | $3.38 | Ascribed value for the AXS-14 program in one analyst model before the setback. |
| Analyst Program Valuation (Post-RTF) | $1.89 | Ascribed value after the launch model was delayed to H2 2028. |
The asset currently has zero market share and a low probability of near-term success due to the regulatory delay pushing the potential launch into 2027-2028 in some models. This situation perfectly embodies the Dog quadrant: low market share in a market with high unmet need, where expensive turn-around plans, like a new Phase 3 trial, are required, making it a prime candidate for divestiture if resources were not already committed.
- Low market share: Zero as of late 2025.
- Market Growth Rate: Low/Stalled due to regulatory hold.
- Cash Flow: Frequently breaks even or consumes cash (R&D spend).
- Strategic Implication: Prime candidate for divestiture or harvest.
If onboarding takes 14+ days, churn risk rises, and similarly, if the Q4 2025 trial initiation slips, the path to market will extend further past the current H2 2028 estimate. Finance: review the Q4 2025 cash flow projection to explicitly model the $15-25 million unplanned expenditure for the AXS-14 trial commencement.
Axsome Therapeutics, Inc. (AXSM) - BCG Matrix: Question Marks
You're looking at the products in Axsome Therapeutics, Inc.'s portfolio that are currently burning cash but hold the promise of becoming future Stars. These are the high-growth market plays where market share is still being fought for, and they require significant investment to gain traction or risk becoming Dogs.
For AXS-05 targeting Alzheimer's Disease Agitation, this is a high-risk, high-reward proposition in a market with a significant unmet need. Axsome Therapeutics, Inc. submitted the supplemental New Drug Application (sNDA) in Q3 2025. Analysts see the peak sales potential for this indication landing in the range of $1.5 to $3 billion annually. This potential is a primary reason for the heavy investment required here; it's a bet on capturing a massive, underserved patient population.
Then there's Symbravo (AXS-07) for acute migraine, which is in its very early launch phase following its commercial availability in June 2025. The initial results are modest, as expected for a new launch consuming resources, with Q3 2025 sales of only $2.1 million. The strategy here is clearly to invest heavily to drive script growth and secure payer access, aiming to move this asset out of the Question Mark quadrant.
Here's a quick look at the key pipeline assets currently positioned as Question Marks, based on their late-stage development or early commercial status:
| Product/Indication | Market Growth Profile | Key 2025 Milestone/Status | Financial Metric/Potential |
| AXS-05 (Alzheimer's Agitation) | High Unmet Need | sNDA submitted in Q3 2025 | Peak Sales Potential: $1.5 - $3 billion |
| Symbravo (AXS-07 for Migraine) | Growing Market | Early launch phase (Launched June 2025) | Q3 2025 Net Sales: $2.1 million |
| AXS-12 (Narcolepsy w/ Cataplexy) | Growing Market | NDA submission targeted for Q4 2025 | Positioned for 2026 launch |
| Solriamfetol (Sunosi) for MDD w/ EDS | New Indication Development | Phase 3 trial initiation planned for Q4 2025 | Outcome uncertain post-Phase 3 proof-of-concept |
AXS-12, targeting narcolepsy with cataplexy, is another major cash consumer with high upside. Axsome Therapeutics, Inc. is targeting an NDA submission in the fourth quarter of 2025, setting up a potential 2026 launch. While the clinical data is strong, this launch will occur into a competitive market, meaning the initial returns will be low relative to the investment needed to establish market share.
The development of Solriamfetol (Sunosi) into new indications represents significant cash burn with highly uncertain returns. You have to watch the investment in these Phase 3 trials closely. Here's what the pipeline advancement looks like for these extensions:
- Solriamfetol for ADHD: Positive topline results from the FOCUS Phase 3 trial in adults were announced.
- Solriamfetol for MDD with EDS: A Phase 3 trial is planned for initiation in Q4 2025, following mixed results in the proof-of-concept study.
- Solriamfetol for ADHD in children/adolescents: A Phase 3 trial initiation is also targeted for Q4 2025.
- Solriamfetol for Binge Eating Disorder: Topline results from the ENGAGE Phase 3 trial are anticipated in 2026.
These assets are consuming R&D dollars now, with the hope that positive Phase 3 outcomes will convert them into Stars by 2026 or beyond. If the data doesn't materialize as hoped, these will quickly shift to the Dog quadrant.
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