|
Axsome Therapeutics, Inc. (AXSM): Business Model Canvas [Dec-2025 Updated] |
Fully Editable: Tailor To Your Needs In Excel Or Sheets
Professional Design: Trusted, Industry-Standard Templates
Investor-Approved Valuation Models
MAC/PC Compatible, Fully Unlocked
No Expertise Is Needed; Easy To Follow
Axsome Therapeutics, Inc. (AXSM) Bundle
Honestly, you're looking at a company that has definitively moved past the pure R&D phase; the Q3 2025 financials clearly show the cost of becoming a commercial CNS powerhouse, with Selling, General, and Administrative expenses hitting $150.2 million. They are betting big on their marketed assets, Auvelity and Sunosi, to fuel the next phase. So, if you want to see the precise structure behind their projected near $631.6 million in 2025 net product revenue, dive into the nine core components of their business model below.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Key Partnerships
You're looking at how Axsome Therapeutics, Inc. structures its external relationships to drive commercial success and pipeline advancement as of late 2025. These partnerships are critical for market penetration and risk sharing.
Group Purchasing Organization (GPO) contracts for market access
Axsome Therapeutics, Inc. has actively secured contracts with major Group Purchasing Organizations (GPOs) to improve formulary access for its marketed products. This is a key lever for reducing gross-to-net discounts over time, though initial launch phases see higher discounts.
For AUVELITY, the company contracted with a third largest GPO effective August 1, 2025, supporting continued coverage efforts. This follows strong coverage growth reported in Q3 2025.
SYMBRAVO, launched in June 2025, also secured its first major GPO contract, one of the three largest, effective July 1, 2025.
| Product | Partnership Type | Effective Date / Latest Data Point | Coverage Metric | Value/Percentage |
| AUVELITY | Largest GPO Contract (Third) | Q3 2025 (Effective August 1, 2025) | Total Payer Coverage (All Channels) | 85% of all lives |
| AUVELITY | Commercial Coverage | Q3 2025 | Increase in Covered Lives | From 73% to 75% this quarter |
| SYMBRAVO | Largest GPO Contract (First) | Q2 2025 (Effective July 1, 2025) | Total Payer Coverage (All Channels) | 52% of patient lives (Q3 2025) |
| SYMBRAVO | Commercial Coverage | Q3 2025 | Percentage of Lives Covered | 48% |
Gross-to-Net discounts for the established products in Q3 2025 were in the high 40% range for both AUVELITY and SUNOSI, with management anticipating an increase to the low 50% range for Q4 2025.
Out-licensing partners for international Sunosi sales and royalties
Axsome Therapeutics, Inc. utilizes out-licensing to generate non-US revenue streams for SUNOSI (solriamfetol). The primary agreement mentioned is with Pharmanovia for Europe and the Middle East and North Africa (MENA) regions.
The financial structure of the Pharmanovia agreement includes:
- Upfront payment received: $66 million.
- Total potential sales-based and other milestones: up to $101 million.
- Royalty rate: In the mid-twenties percentage on net sales.
This partnership is already contributing to revenue, with SUNOSI royalty revenue reaching $1.2 million in the third quarter of 2025, up from $1.1 million in the second quarter of 2025.
Furthermore, Axsome Therapeutics, Inc. settled patent litigation with Hetero Labs Ltd. regarding a generic version of SUNOSI. This settlement grants Hetero a license to sell its generic version beginning on or after September 1, 2040, or March 1, 2040, depending on pediatric exclusivity status.
Contract Manufacturing Organizations (CMOs) for drug production
Specific details regarding the names of Contract Manufacturing Organizations (CMOs) utilized by Axsome Therapeutics, Inc. for the production of AUVELITY, SUNOSI, or SYMBRAVO, along with associated contractual financial terms, were not explicitly detailed in the latest public financial reports available as of late 2025.
Clinical research organizations (CROs) for late-stage trials
While Axsome Therapeutics, Inc. is advancing multiple late-stage programs, including Phase 3 trials for solriamfetol in ADHD and MDD starting in the fourth quarter of 2025, specific contractual agreements or financial commitments with external Clinical Research Organizations (CROs) managing these trials are not publicly itemized in the provided data.
Academic and institutional research collaborators for pipeline development
Axsome Therapeutics, Inc. is advancing a broad pipeline, often involving external expertise to discuss clinical development programs, as highlighted by physician key opinion leaders at the July 2025 R&D Day. The company has several late-stage programs where external collaboration is implied for trial execution and data review.
Key pipeline milestones that would involve research partners include:
- Initiation of a Phase 3 trial of solriamfetol in Major Depressive Disorder (MDD) with excessive daytime sleepiness in the fourth quarter of 2025.
- Initiation of a Phase 3 trial of solriamfetol in children and adolescents with ADHD in the fourth quarter of 2025.
- Anticipated New Drug Application (NDA) submission for AXS-12 for cataplexy in narcolepsy in the fourth quarter of 2025.
The potential peak sales for the diversified late-stage pipeline is stated to exceed $16 billion. Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Key Activities
You're managing a commercial engine that's scaling rapidly, so the key activities are centered on driving adoption for three distinct products while simultaneously pushing pipeline candidates toward market. This requires heavy investment in sales and marketing, which you see reflected in the SG&A spend.
Commercialization and Marketing of Auvelity, Sunosi, and Symbravo
The core activity here is executing the commercial strategy across the growing portfolio. For the third quarter of 2025, this effort resulted in total product revenues reaching $171 million, a 63% increase year-over-year. Year-to-date net product revenue for 2025 hit $442.5 million.
The performance breakdown for the third quarter of 2025 shows the momentum:
Auvelity net product sales were $136.1 million, marking 69% growth versus the prior year. Prescriptions written totaled approximately 209,000, which is a 46% year-over-year increase.
Sunosi contributed net product revenue of $32.8 million, up 35% year-over-year, with U.S. prescriptions growing 12% year-over-year to 53,000.
Symbravo, in its first full commercial quarter following its June 2025 launch, generated net product sales of $2.1 million, with more than 5,000 prescriptions written.
This commercial push is resource-intensive; selling, general, and administrative expenses for Q3 2025 totaled $150.2 million, which is up 57.1% year-over-year, reflecting the investments in these three marketed assets.
Late-Stage Clinical Development and Regulatory Filings
You are actively managing a pipeline that is moving several assets toward potential market entry, which keeps R&D expenses relatively controlled at $40.2 million for Q3 2025, an 11% decrease compared to the same period last year, largely due to trial completions.
Key activities in late-stage development and regulatory submissions include:
| Product Candidate | Indication/Status | Key Activity/Target Date |
|---|---|---|
| AXS-05 | Alzheimer's disease agitation | Supplemental New Drug Application (sNDA) submitted to the FDA. |
| AXS-12 | Narcolepsy with cataplexy | New Drug Application (NDA) submission targeted for the fourth quarter of 2025. |
| AXS-14 | Fibromyalgia | Phase III trial preparations finalizing, with launch planned before year-end. |
| Sunosi | Binge Eating Disorder (BED) / Shift Work Disorder (SWD) | Phase III trials ongoing; top-line results expected next year (2026). |
Also, the development for Sunosi in Major Depressive Disorder with Excessive Daytime Sleepiness is set to initiate a Phase III trial this quarter (Q4 2025).
Intellectual Property Management and Patent Defense
Protecting the revenue streams from generic competition is a critical, ongoing activity, and Axsome Therapeutics, Inc. has secured significant runway for its key assets.
The overall intellectual property portfolio currently provides protection extending through 2040.
For Sunosi, a patent settlement with Hetero Labs blocks generic entry until at least March 1, 2040, or September 1, 2040, if pediatric exclusivity is granted.
For Auvelity, a settlement with Teva Pharmaceuticals ensures generic entry will not occur before September 30, 2038, or March 31, 2039, with pediatric exclusivity.
Auvelity is protected by 125 US drug patents filed between 2022 and 2025, with an estimated generic launch date of April 20, 2043.
Expanding the Specialized Neuroscience Sales Force
This activity involves scaling the commercial infrastructure to support the launch of Symbravo and the continued growth of Auvelity. You saw the impact of this in the Q3 2025 SG&A increase. Earlier in 2025, there was a reported 10%-15% increase in salesforce size to support overlap in migraine treaters, particularly in primary care settings. Furthermore, management indicated that incremental representatives are planned for the Alzheimer's Disease Agitation indication upon approval, with final sizing expected early in 2026.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Key Resources
You're looking at the core assets Axsome Therapeutics, Inc. uses to deliver its value proposition in the central nervous system (CNS) space. These aren't just line items; they are the tangible and intangible drivers of their current revenue and future growth potential.
Approved CNS Drugs: The Commercial Engine
Axsome Therapeutics, Inc. has three marketed products contributing to its revenue stream as of late 2025. The performance of these assets is central to funding the rest of the business, including pipeline development. For the third quarter of 2025, the company reported total net product revenue of $171.0 million.
Here's a breakdown of the key revenue contributors for Q3 2025:
| Approved Drug | Q3 2025 Net Product Sales (USD Millions) | Key Metric/Status |
| Auvelity | $136.1 million | 209,000 prescriptions written |
| Sunosi | $32.8 million | 53,000 prescriptions in the United States |
| Symbravo | $2.1 million | First full quarter of commercialization post-June 2025 launch |
The commercial traction is evident in the prescription volume; Auvelity saw 46% year-over-year growth in prescriptions, and Sunosi achieved 35% year-over-year net product sales growth in the quarter. Market access is also a key resource, with Auvelity's commercial coverage rising to 75% and Sunosi maintaining approximately 83% of lives covered across channels.
Late-Stage Pipeline Assets: Future Value Drivers
The pipeline represents significant potential upside, with a combined peak sales potential exceeding $16 billion. The focus is heavily on advancing several late-stage candidates toward regulatory submission or pivotal trial initiation by the end of 2025.
The status of the key late-stage assets as of the Q3 2025 update includes:
- AXS-05 (for Alzheimer's disease agitation): Supplemental New Drug Application (sNDA) submitted; awaiting FDA acceptance decision.
- AXS-05 (for smoking cessation): Planned pivotal Phase 2/3 trial initiation in the fourth quarter of 2025.
- AXS-12 (for cataplexy in narcolepsy): Target New Drug Application (NDA) submission to the FDA in the fourth quarter of 2025.
- AXS-14 (for fibromyalgia): Planned Phase 3 trial launch before year-end (Q4 2025).
These near-term milestones are critical for converting R&D investment into future revenue streams.
Financial Strength and Liquidity
A solid balance sheet provides the runway to execute on commercial growth and pipeline advancement. As of September 30, 2025, Axsome Therapeutics, Inc. held $325.3 million in cash and cash equivalents. Management expressed confidence that this reserve is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan. This cash position is a primary resource enabling sustained operations without immediate external capital dependency.
Intellectual Property and Human Capital
The value of the pipeline is intrinsically tied to the extensive intellectual property portfolio with long patent life protecting the novel compounds and formulations. While specific patent expiration dates aren't detailed here, the company's focus on developing potentially first-in-class or best-in-class medicines suggests strong, defensible exclusivity periods for its marketed and pipeline assets.
The specialized neuroscience commercial and R&D teams are evidenced by the financial commitment to these functions. In the third quarter of 2025, Research and Development (R&D) expenses totaled $40.2 million, while Selling, General and Administrative (SG&A) expenses were $150.2 million, reflecting the investment in the commercial infrastructure supporting Auvelity, Sunosi, and the Symbravo launch. That SG&A spend represented a 57.1% year-over-year increase, showing the scaling of the commercial team.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Value Propositions
You're looking at the core value Axsome Therapeutics, Inc. is delivering to the market, which is all about offering differentiated, needed treatments for serious Central Nervous System (CNS) disorders. Honestly, the numbers from the third quarter of 2025 really show where the value is landing right now.
Rapid-acting oral treatment for Major Depressive Disorder (Auvelity)
The flagship offering, Auvelity (AXS-05), is clearly the main growth engine. It's positioned as the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for Major Depressive Disorder (MDD). This mechanism is a big part of the value proposition for patients who need faster relief than traditional options.
The commercial traction is strong, showing real-world adoption. For the third quarter of 2025, Auvelity pulled in net product sales of $136.1 million. That's a 69% year-over-year jump. We saw 209,000 prescriptions written in that quarter alone, which was a 9% sequential increase. Plus, the total prescriber base has hit 46,000 since launch. Market access is also improving, with commercial coverage now at 75% of patient lives, pushing total coverage to 85%.
Here's a quick look at the commercial momentum:
| Metric | Value (Q3 2025) | Context |
| Net Product Sales | $136.1 million | Primary growth driver for Axsome Therapeutics, Inc. |
| Prescription Volume | 209,000 | Reflecting continued demand and prescriber activation. |
| Total Prescribers (Cumulative) | 46,000 | Indicates broad physician adoption. |
| Total Payer Coverage | 85% of patient lives | A key driver for patient access. |
What this estimate hides is the impact of the expected patent exclusivity until 2039 following the settlement regarding generic entry.
First and only DNRI for excessive daytime sleepiness (Sunosi)
Sunosi (solriamfetol) offers a unique mechanism as the first and only dopamine and norepinephrine reuptake inhibitor (DNRI) approved for excessive daytime sleepiness (EDS) in narcolepsy or obstructive sleep apnea (OSA). This differentiation is key in a market where patients may not respond to older agents.
For the third quarter of 2025, Sunosi contributed $32.8 million in net product revenue, marking a 35% year-over-year increase. Prescription volume was approximately 53,000, up 5% sequentially. Payer coverage remains quite stable and robust at approximately 83% of all lives covered across channels.
Novel mechanism of action for serious CNS disorders (e.g., AXS-05)
Axsome Therapeutics, Inc. is focused on developing products with novel mechanisms to address critical gaps in care. While Auvelity's mechanism is established, the pipeline is built on this principle, aiming for first-in-class or best-in-class potential across several serious conditions. The company estimates a combined peak sales potential exceeding $16 billion across its approved medicines and pipeline programs.
The pipeline itself represents future value propositions:
- Advancing AXS-12 for narcolepsy with an NDA submission anticipated in 4Q 2025.
- Advancing solriamfetol (Sunosi) for MDD with EDS, planning a Phase 3 trial initiation in 4Q 2025.
- Developing AXS-05 (Auvelity) for smoking cessation, with a pivotal Phase 2/3 trial planned for 4Q 2025.
Acute migraine treatment with a differentiated profile (Symbravo)
Symbravo (meloxicam and rizatriptan), approved in January 2025, targets acute migraine with or without aura. Its value is in the combination and rapid absorption technology, MoSEIC, which provides a multi-mechanistic approach. For patients with an inadequate response to oral CGRP inhibitors, the data is compelling.
In a head-to-head trial (EMERGE), 47.9% of patients on Symbravo reported pain freedom within 2 hours, compared to only 1.0% for oral CGRPs (p<0.001). Furthermore, 85% of patients in the INTERCEPT trial did not require rescue medication within 24 hours post dose. Commercially, Symbravo generated net product sales of $2.1 million in its first full commercial quarter (Q3 2025), with more than 5,000 prescriptions written. Payer coverage is still building, sitting at approximately 52% of lives as of October 1, 2025.
Addressing high unmet needs in Alzheimer's agitation and narcolepsy
This is where the near-term pipeline value proposition is most apparent. For Alzheimer's disease agitation, there is only one medicine approved by the FDA, despite over 5 million patients in the U.S. suffering from it. Axsome, Inc. is on track to submit its supplemental New Drug Application (sNDA) for AXS-05 in this indication in the third quarter of 2025.
For narcolepsy, the company is advancing AXS-12, with an anticipated NDA submission in the fourth quarter of 2025. These programs target significant gaps in care, which is defintely why investors are watching the pipeline progress so closely.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Relationships
You're looking at how Axsome Therapeutics, Inc. connects with the healthcare ecosystem to drive adoption for its CNS portfolio, which includes AUVELITY, SUNOSI, and the recently launched SYMBRAVO. The relationship strategy is multi-pronged, focusing heavily on the prescribing physician and the payer gatekeepers.
Dedicated sales force engagement with high-volume prescribers
Axsome Therapeutics, Inc. deploys a specialized sales force to engage directly with prescribers, a critical touchpoint for specialty pharmaceuticals. As of late 2025, the company maintained a dedicated field force focused on its core indications. The selling, general, and administrative expense increased by 57% year-over-year, reflecting significant investment in commercialization activities, including this sales force expansion and the launch of SYMBRAVO. This investment is key to driving prescription volume.
The structure and size of the sales force are calibrated to the product opportunity. For Major Depressive Disorder (MDD) with AUVELITY, the company had roughly 300 reps detailing as of December 2025. There were earlier plans for a 10%-15% increase in the sales force to better cover migraine treaters, especially in primary care settings, ahead of the SYMBRAVO launch. Future expansion is planned upon potential approval for Alzheimer's Disease Agitation (ADA), though the final size will not double the current field force.
Prescriber engagement metrics show traction:
- AUVELITY activated 5,000 new prescribers in Q3 2025, bringing the total to 46,000 since launch.
- SUNOSI added more than 460 new clinicians in Q3 2025, totaling approximately 15,100 since launch.
- The primary care segment for AUVELITY grew to represent one-third of its prescriber base.
Market access negotiations with payers and GPOs
Securing favorable formulary placement is paramount, as it directly impacts patient access and the realized net price. Axsome Therapeutics, Inc. has been aggressive in negotiating with Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs) across its portfolio.
By the third quarter of 2025, AUVELITY achieved total payer coverage across all channels of approximately 85% of covered lives. This includes 100% coverage in the government channel (Medicare and Medicaid) and 75% in the commercial channel (up from 73% sequentially). The company successfully contracted with each of the three largest GPOs for AUVELITY, with the third contract effective August 1, 2025.
For the newer product, SYMBRAVO, overall payer coverage reached approximately 52% of patient lives as of October 1, 2025, with 48% in the commercial channel and 56% in the government channel. Axsome Therapeutics, Inc. also secured a contract with a second large GPO for SYMBRAVO, effective August 1, 2025. SUNOSI maintained approximately 83% payer coverage across all channels.
The realized net price, reflected in the Gross-to-Net (GTN) discount, is a direct outcome of these negotiations. You can see the difference in the GTN profiles below:
| Product | Reporting Period (Q3 2025) | Total Payer Coverage (Approx.) | Government Coverage (Approx.) | Commercial Coverage (Approx.) | GTN Discount (Approx.) |
| AUVELITY | Q3 2025 | 85% of lives | 100% of lives | 75% of lives | High 40% range (expected low 50% range in Q4/Q1) |
| SUNOSI | Q3 2025 | 83% of lives | Not specified | Not specified | High 40% range (expected low 50% range in next quarter) |
| SYMBRAVO | As of Oct 1, 2025 | 52% of lives | 56% of lives | 48% of lives | Mid-70% range (anticipated to remain elevated) |
Patient support and co-pay assistance programs (implied by specialty pharma)
While specific utilization numbers for patient support or co-pay assistance programs weren't explicitly detailed in the latest reports, these programs are an implied necessity for specialty pharma products, especially given the GTN figures and the focus on patient access. The company is actively managing gross-to-net adjustments, which include rebates and discounts often tied to patient access programs. For instance, the AUVELITY GTN improved from the mid-50% range in Q2 to the high 40% range in Q3 2025. Management also mentioned calibrating patient support and patient savings as part of their commercial strategy.
Direct-to-Consumer (DTC) advertising for brand awareness
Axsome Therapeutics, Inc. is using DTC advertising to build brand awareness and drive patient-initiated conversations with their doctors. The SG&A increase of 57% year-over-year was partly attributed to the direct-to-consumer advertising campaign for AUVELITY. The company planned for a national DTC campaign for AUVELITY to be in full execution by the end of Q1 2025, with heavy spending initially to establish brand awareness, continuing through 2026. The overall pharmaceutical industry DTC spend in the U.S. for 2025 was estimated to be a significant portion of a global spend approaching $10 billion.
The DTC investment supports the growth in prescription volume, as seen by the 46% year-over-year increase in AUVELITY prescriptions to 209,000 in Q3 2025. Finance: review the Q4 2025 SG&A spend against the planned DTC intensity by end of year.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Channels
You're looking at how Axsome Therapeutics, Inc. gets its products, like AUVELITY, SUNOSI, and the newly launched SYMBRAVO, into the hands of the right prescribers and patients as of late 2025. The channel strategy is clearly multi-pronged, heavily leaning on direct engagement supported by broad access agreements.
Expanded in-house sales force targeting psychiatrists and neurologists
Axsome Therapeutics, Inc. has been actively building out its commercial infrastructure to support its growing portfolio. The investment in this direct channel is significant, as reflected in the financial reporting. Selling, General, and Administrative (SG&A) expenses reached $150.2 million in the third quarter of 2025, marking a 57% year-over-year increase. This rise directly accounts for commercialization efforts for AUVELITY, the sales force expansion, and the launch activities for SYMBRAVO. Management indicated that incremental representatives are planned to support the anticipated launch of a pipeline asset, with final sizing expected in early 2026. The sales force is focused on key prescribers in the major depressive disorder (MDD) and migraine spaces, driving prescription growth across the board.
Digital and traditional Direct-to-Consumer (DTC) media campaigns
To support the in-house efforts, Axsome Therapeutics, Inc. is using both digital and traditional media to drive patient awareness and demand. The SG&A increase in Q3 2025 also covers the direct-to-consumer advertising campaign, which is a key component of the channel strategy for driving patients to ask their doctors about the therapies. This advertising spend is timed to align with periods of high patient flow, as noted by commercial leadership.
Specialty pharmacies and wholesale distributors for drug delivery
The physical movement of the drugs relies on established distribution networks. For SYMBRAVO, which became commercially available in June 2025, the company secured its first group purchasing organization (GPO) contract in the second quarter of 2025. By the third quarter, Axsome Therapeutics, Inc. had contracted with a second large GPO for SYMBRAVO, effective August 1, 2025, to facilitate formulary coverage decisions. For AUVELITY, the channel strength is even more established, with contracts now in place with each of the three largest GPOs, following the signing of the third large GPO contract on August 1, 2025. These agreements are critical for ensuring the products move efficiently through wholesale distributors and specialty pharmacies to reach the patient.
Hospital and headache centers for Symbravo launch
The launch of SYMBRAVO for the acute treatment of migraine required specific targeting of specialists. In its first full commercial quarter (Q3 2025), SYMBRAVO generated $2.1 million in net sales, with over 5,000 prescriptions written. The initial access strategy focused on securing favorable payer coverage, which reached approximately 52% of all lives by October 1, 2025. This coverage breakdown shows 48% in the commercial channel and 56% in the government channel. To support the patient journey through these specialized channels, Axsome Therapeutics, Inc. is offering comprehensive patient support, including the SYMBRAVO On My Side savings program.
Here's a quick look at the access metrics achieved across the commercial channels as of late 2025:
| Product | Overall Payer Coverage (Approx. % of Lives) | Commercial Payer Coverage (Approx. % of Lives) | Government Payer Coverage (Approx. % of Lives) | Key GPO Status (As of late 2025) |
| AUVELITY | 85% | 75% | 100% | Contracted with all 3 largest GPOs |
| SUNOSI | 83% | Not specified | Not specified | Not specified |
| SYMBRAVO | 52% (as of Oct 1) | 48% | 56% | Contracted with 2 of 3 largest GPOs |
The company is also focused on patient support mechanisms to ensure adherence and persistence once a prescription is written:
- Providing educational resources and tools for providers and patients.
- Offering a savings program for eligible SYMBRAVO patients.
- Achieving $136.1 million in AUVELITY net product sales in Q3 2025, supported by its 85% overall coverage.
- SUNOSI maintained approximately 83% coverage across channels.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Segments
You're hiring before product-market fit is fully established across all indications, so knowing exactly who you are selling to-and the size of that pool-is critical for resource allocation. Here's the quick math on Axsome Therapeutics, Inc. (AXSM)'s key customer segments as of late 2025, based on their marketed products and late-stage pipeline targets.
US patients with Major Depressive Disorder (MDD)
The primary target for AUVELITY is US patients with Major Depressive Disorder (MDD). The National Institute of Mental Health (NIMH) estimates that about 8.3% of American adults have MDD each year, equating to approximately 21 million adults in the U.S.. Axsome Therapeutics, Inc. (AXSM) is specifically targeting the segment of this population that may not respond adequately to first-line treatments, including those with co-occurring severe Excessive Daytime Sleepiness (EDS), which affects approximately 50 percent of MDD patients. In the third quarter of 2025, 209,000 prescriptions were written for AUVELITY.
US patients with excessive daytime sleepiness (EDS) from narcolepsy or OSA
SUNOSI targets patients suffering from EDS associated with narcolepsy or Obstructive Sleep Apnea (OSA). Narcolepsy alone is estimated to affect approximately 185,000 individuals in the U.S.. Axsome Therapeutics, Inc. (AXSM) notes that its entire portfolio of potentially first-in-class or best-in-class medicines has the potential to address serious conditions that affect more than 150 million people in the United States alone. In the third quarter of 2025, approximately 53,000 prescriptions were written for SUNOSI.
US patients suffering from acute migraine attacks
The customer base for SYMBRAVO includes US adults suffering from acute migraine attacks with or without aura. The US migraine treatment market was valued at USD 3.46 billion in 2025. Within this market, oral triptans, a class that SYMBRAVO is compared against, accounted for an estimated 48.90% revenue share in 2025. SYMBRAVO generated $2.1 million in net sales in its first full quarter of commercial launch in the third quarter of 2025.
Neurologists and psychiatrists who prescribe CNS medications
The professional customer segment consists of the clinicians who write the prescriptions. As of the third quarter of 2025, the total number of unique prescribers for AUVELITY reached 46,000 since its launch. For SUNOSI, the total cumulative prescriber base reached approximately 15,100 since launch, with more than 460 new clinicians prescribing in Q3 2025. A notable point is that approximately 1/3 of AUVELITY prescribers are primary care clinicians, whose NBRxs increased by approximately 50% since the sales force expansion.
Here is a summary of the key customer-facing metrics for the marketed products as of Q3 2025:
| Product | Indication Focus | Q3 2025 Prescriptions (Volume) | Total Unique Prescribers (Cumulative) | Payer Coverage (Approximate) |
| AUVELITY | Major Depressive Disorder (MDD) | 209,000 | 46,000 (Total Unique Prescribers) | Increased from 73% (prior period) |
| SUNOSI | EDS (Narcolepsy/OSA) | Approx. 53,000 | Approx. 15,100 (Total Cumulative) | Approx. 83% of patient lives |
| SYMBRAVO | Acute Migraine | Approx. 5,000 (First full quarter) | Not explicitly stated for SYMBRAVO | Approx. 52% across all channels |
Future: Patients with Alzheimer's disease agitation and narcolepsy cataplexy
Axsome Therapeutics, Inc. (AXSM) is targeting significant future segments with pipeline assets. AXS-05 is being developed for Alzheimer's disease (AD) agitation, a condition affecting up to 70% of the approximately 7 million people with AD in the U.S.. The company planned to submit the supplemental New Drug Application (sNDA) for AXS-05 in the third quarter of 2025. For narcolepsy, AXS-12 targets cataplexy, which is seen in an estimated 70% of people living with narcolepsy. The New Drug Application (NDA) submission for AXS-12 for cataplexy was targeted for the fourth quarter of 2025.
The potential future patient pool for these two indications represents a substantial opportunity, as shown below:
- US Patients with Alzheimer's Disease Agitation: Up to 70% of 7 million people with AD.
- US Patients with Narcolepsy Cataplexy: Up to 70% of the estimated 185,000 people with Narcolepsy.
- MDD patients with EDS targeted for a Phase 3 trial with solriamfetol.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Cost Structure
You're looking at the expense side of Axsome Therapeutics, Inc. as they scale up commercial operations, and the numbers definitely reflect that transition. The cost structure is heavily weighted toward getting their marketed products, like AUVELITY and the newly launched SYMBRAVO, into the hands of physicians and patients.
The Selling, General, and Administrative (SG&A) expenses are the largest component here, hitting $150.2 million for the third quarter of 2025. That's a significant 57% increase compared to the same period last year, showing the investment required to support a growing, multi-product commercial footprint.
Next up is the Research and Development (R&D) investment, which stood at $40.2 million in Q3 2025. Interestingly, this figure actually represented an 11% decrease year-over-year, largely because some clinical trials, specifically for solriamfetol in ADHD and MDD, were completed during the period.
The direct costs associated with generating sales, the Costs of Revenue (COGS) for marketed products, were $11.9 million in Q3 2025. This is up from $8.4 million in Q3 2024, which tracks with the increased sales volume from AUVELITY, SUNOSI, and the initial sales from SYMBRAVO.
Here's a quick look at those core operating expenses for the third quarter of 2025:
| Cost Category | Q3 2025 Amount (Millions USD) | Year-over-Year Change |
| Selling, General, and Administrative (SG&A) | $150.2 | Increased 57% |
| Research and Development (R&D) | $40.2 | Decreased 11% |
| Costs of Revenue (COGS) | $11.9 | Increased |
The jump in SG&A is directly tied to the commercial build-out you'd expect from a growing pharma company. You have to fund the boots on the ground and the awareness campaigns. Specifically, the cost drivers for that SG&A surge include:
- Intensified commercialization activities for AUVELITY.
- Expansion of the sales force headcount.
- The launch of the direct-to-consumer (DTC) advertising campaign in September 2025.
- Commercial launch activities for the new product, SYMBRAVO, which had its first full quarter of sales in Q3 2025.
On the R&D side, while the overall spend decreased, that's not an indication of slowing pipeline focus; it's a reflection of hitting milestones. The investment is shifting based on the development stage of their assets. The R&D spend is supporting:
- Advancing multiple late-stage programs.
- Two New Drug Application (NDA) stage programs.
- Multiple registrational trials underway or initiating across neurology and psychiatry.
- Costs related to AXS-07, partially offsetting the savings from completed trials.
To be fair, managing this cost structure while funding the pipeline is the core challenge; the company ended the quarter with $325.3 million in cash and cash equivalents, which management stated is sufficient to fund operations into cash flow positivity based on the current operating plan.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Revenue Streams
You're looking at the core money-making engine for Axsome Therapeutics, Inc. as of late 2025. This is where the revenue actually comes from, primarily driven by their growing portfolio of central nervous system (CNS) medicines. The numbers below reflect the strong commercial execution seen through the third quarter of 2025.
The total net product revenue for the third quarter of 2025 reached $171.0 million, marking a 63% year-over-year growth compared to $104.8 million in Q3 2024. Also, the year-to-date net product revenue as of September 30, 2025, stood at $442.5 million, which was a 66% increase versus the same period in 2024. That's serious momentum.
Here is the breakdown of the primary revenue sources for the third quarter of 2025:
| Revenue Source | Q3 2025 Amount (Millions USD) | Notes |
| Net product sales from Auvelity | $136.1 million | Flagship product for major depressive disorder. |
| Net product sales from Sunosi | $31.6 million | Sales component of total Sunosi net product revenue. |
| Net product sales from Symbravo | $2.1 million | Generated in its first full quarter of commercialization. |
| Royalty revenue from out-licensed Sunosi sales | $1.2 million | Revenue from Sunosi sales in out-licensed territories. |
The total net product revenue for Sunosi in Q3 2025 was $32.8 million ($31.6 million sales + $1.2 million royalty). The gross-to-net discounts for both Auvelity and Sunosi were in the high 40% range for the quarter.
Looking ahead, the financial expectations for the full year 2025 are quite strong based on the early performance. You should note the following projection:
- Full-year 2025 total net product revenue projected near $631.6 million.
This projection suggests that Axsome Therapeutics, Inc. is on track to significantly increase its annual revenue base, building on the strong quarter where Auvelity sales alone were up 69% year-over-year. Finance: draft 13-week cash view by Friday.
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.