Axsome Therapeutics, Inc. (AXSM) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlighted strong financial performance with a 62% YoY revenue growth and an improved net loss. Product pipeline initiatives and clinical programs show significant progress, with optimistic guidance for AXS-05 and expanding sales strategies. Despite some management avoidance on specifics, the overall sentiment is positive due to strategic expansions and anticipated NDA submissions. The market cap suggests moderate sensitivity, supporting a positive prediction.
Key Financial Performance
Total Revenue $150 million for the quarter, representing a 72% year-over-year increase and a 24% quarter-over-quarter increase. The growth was driven by outperformance for both Auvelity and Sunosi.
Auvelity Net Product Sales $119.6 million, up 84% year-over-year and 24% quarter-over-quarter. The growth was attributed to increased new patient starts, prescriber engagement, and expanded sales force.
Sunosi Net Product Revenues $30 million, up 35% year-over-year and 19% quarter-over-quarter. This includes $28.9 million in net product sales and $1.1 million in royalty revenue from out-licensed territories.
SYMBRAVO Net Sales $410,000 for the partial quarter since its launch on June 10. Early feedback from the migraine community has been encouraging.
Total Cost of Revenue $13.4 million compared to $8.1 million for the second quarter of 2024. The increase was due to higher sales volumes.
Research and Development Expenses $49.5 million compared to $49.9 million for the second quarter of 2024. The slight decrease was due to the completion of certain trials, partially offset by higher personnel costs.
Selling, General and Administrative Expenses $130.3 million compared to $103.6 million for the second quarter of 2024. The increase was primarily due to commercialization activities for Auvelity and the launch of SYMBRAVO.
Net Loss $48 million or $0.97 per share, compared to $79.3 million or $1.67 per share for the second quarter of 2024. The improvement was due to increased revenues and controlled expenses.
Cash and Cash Equivalents $303 million at the end of the quarter, compared to $315.4 million at the end of 2024. The decrease was attributed to operational expenses.
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Operating Highlights
SYMBRAVO launch: SYMBRAVO, a new product for acute migraine treatment, was launched in mid-June 2025. It generated $410,000 in net sales for the partial quarter. Early feedback from the migraine community has been positive, highlighting its effectiveness, safety, and tolerability.
Auvelity performance: Auvelity achieved $119.6 million in net product sales, marking an 84% year-over-year growth. It led the market in TRx growth with 192,000 prescriptions in Q2, a 15% quarter-over-quarter increase. Approximately 4,800 new prescribers were activated, with 28 million new covered lives added in the commercial channel.
Sunosi performance: Sunosi generated $30 million in net product revenues, a 35% year-over-year increase. Total prescriptions exceeded 50,000 for the first time, with 9% sequential growth. Payer coverage remains at 83% across channels.
Market access for Auvelity: Coverage for Auvelity expanded to 83% of lives across all channels, including 73% of commercial lives and 100% of government lives.
SYMBRAVO market access: SYMBRAVO achieved 38% coverage across all channels, including 26% of commercial lives. A commercial contract with a major GPO was executed to enhance formulary coverage.
Revenue growth: Total revenue for Q2 2025 was $150 million, a 72% year-over-year increase. This growth was driven by strong performance of Auvelity and Sunosi.
Cost management: Total cost of revenue increased to $13.4 million from $8.1 million in Q2 2024. R&D expenses slightly decreased to $49.5 million, while SG&A expenses rose to $130.3 million due to commercialization activities.
Pipeline advancements: Progress was made on late-stage programs, including AXS-05 for Alzheimer's agitation and smoking cessation, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. Multiple Phase III trials are planned for Q4 2025.
Solriamfetol development: Development programs for solriamfetol are advancing across ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. Phase III trials are planned for Q4 2025.
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Risk or Challenges
Regulatory hurdles: The company is on track to submit the sNDA for AXS-05 in Alzheimer's disease agitation this quarter and plans to address the FDA's feedback for AXS-14 in fibromyalgia. These regulatory processes pose risks as delays or rejections could impact the company's strategic objectives and financial performance.
Market access challenges: SYMBRAVO, the newly launched product, currently has limited coverage at approximately 38% of lives across all channels, including 26% of commercial lives. Expanding payer coverage is critical for its success, and failure to achieve broader access could hinder revenue growth.
Financial sustainability: The company reported a net loss of $48 million for the quarter, which includes $24.6 million in stock-based compensation expenses. Although the company believes its cash balance is sufficient to fund operations into cash flow positivity, any unexpected financial strain could disrupt operations.
Commercial execution risks: The success of newly launched and existing products like SYMBRAVO, Auvelity, and Sunosi depends on effective commercialization strategies. Any missteps in market penetration or prescriber engagement could adversely affect revenue.
Pipeline development risks: The company is advancing multiple late-stage programs, including AXS-12 for narcolepsy and solriamfetol for various indications. Delays or failures in clinical trials or regulatory approvals could impact the company's growth trajectory.
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Guidance & Outlook
AXS-05 in Alzheimer's disease agitation: The company is on track to submit the sNDA for AXS-05 in Alzheimer's disease agitation this quarter, marking it as a key priority.
AXS-05 for smoking cessation: A Phase II/III trial is expected to initiate in the fourth quarter of this year.
AXS-12 for narcolepsy with cataplexy: Progress continues on the NDA submission to the FDA, slated for the fourth quarter.
AXS-14 in fibromyalgia: A Phase III trial is planned for the fourth quarter to address FDA feedback from a previously disclosed refusal to file letter.
Solriamfetol development programs: Advancing across four indications: ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. Specific plans include initiating a Phase III trial in pediatric ADHD patients and MDD with excessive daytime sleepiness in the fourth quarter. The ENGAGE Phase III trial for binge eating disorder is on track to read out next year, and the sustained Phase III trial for shift work disorder is progressing with top-line results expected in 2026.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What is the payer coverage expansion for Auvelity and its impact on volume?
A:The coverage expansion represents pull-through of previously announced GPO contracts, with successful engagement with pharmacy benefit managers. While acceleration in volume is expected, it is too early to share exact volume growth expectations. The gross-to-net (GTN) for Auvelity remains in the mid-50s.
Q:What is the market positioning of AXS-12 against oxybate and orexin 2 agonists, and what data will be included in the NDA filing package?
A:AXS-12 is positioned as a rapid-acting narcolepsy treatment with significant reductions in cataplexy, improvements in excessive sleepiness, and cognitive function. The NDA package will include data from three controlled trials (SYMPHONY, ENCORE, and CONCERT) and a long-term safety extension.
Q:What is the utilization and conversion trend for SYMBRAVO's sampling program?
A:SYMBRAVO has a sampling program alongside a patient savings program. Early trends show samples being accompanied by prescriptions and strong utilization of the savings program. Coverage for the product is expanding, and early claims indicate positive access.
Q:What is the revenue recognition and gross-to-net assumption for SYMBRAVO?
A:SYMBRAVO's GTN was in the low 80% range for Q2 and is expected to remain high for the rest of the year. Early launch dynamics involve a high proportion of new patient starts, and refill rates are expected to develop over time.
Q:What are the expectations for AXS-05 in Alzheimer's agitation compared to Rexulti?
A:AXS-05 is expected to have strong efficacy and a favorable safety profile, setting it apart from antipsychotics and Rexulti. The company plans to expand promotional efforts to geriatric psychiatry, neurodegenerative specialists, and long-term care facilities.
Q:What is driving the 24% net sales growth for Auvelity despite stable GTN?
A:The growth is driven by slightly improved GTN within the mid-50s range, higher demand impacting inventory, and a small change in liability estimates from the previous quarter.
Q:What are the expectations for SYMBRAVO's gross-to-net and coverage percentages?
A:SYMBRAVO's GTN is expected to remain high in the low 80% range for the rest of the year. Coverage percentages are expected to improve as the product gains traction in the market.
Q:What is the strategy for AXS-05 in Alzheimer's agitation and its potential adoption?
A:The strategy involves leveraging the existing Auvelity sales force and expanding promotional efforts to new areas. AXS-05 is expected to have strong adoption due to its efficacy and safety profile.
Q:What is the mix of second and third-line usage for Auvelity, and is there a need to expand the sales force?
A:Approximately 50% of Auvelity's usage is in early lines (second and third-line). The company is comfortable with the current sales force size and has seen positive impacts from its recent expansion.
Q:What is the status of the AXS-05 NDA submission for Alzheimer's agitation?
A:The NDA submission is on track for this quarter, with alignment achieved with the FDA during a pre-NDA meeting earlier this spring.
Q:What is the commercial strategy for AXS-05 in community centers and long-term care?
A:The strategy involves targeting high-value prescribers in outpatient and long-term care facilities, leveraging existing data on prescription utilization.
Q:What is the pediatric ADHD study design for solriamfetol, and why has it taken time to start?
A:The study will use a parallel group design with a pediatric scale. The delay is due to ensuring alignment with the FDA on the study design, which involves complexities in pediatric populations.
Q:What is the strategy for AXS-12 and Sunosi in narcolepsy?
A:The strategy leverages the existing Sunosi sales team for AXS-12, with potential for combination use based on distinct indications. The company is optimistic about the benefits of both products.
Q:What is the seasonality impact on sales for the three commercialized products?
A:There is some seasonality across all three markets, with depression showing the most pronounced effect. SYMBRAVO may not show seasonality due to its early launch stage.
Q:What are the expectations for IRA pricing for Auvelity?
A:IRA pricing negotiations for Auvelity are expected around 2029-2030, with potential implementation in 2031-2032.
Q:What drove the strong quarter for Sunosi, and what is the patient mix?
A:The strong quarter was driven by increased prescriber activity and productivity. There was no significant change in the patient mix between narcolepsy and OSA.
Q:What is the expected inflection point for Auvelity sales, and what is the average duration of use?
A:The inflection point is expected in the back half of the year, driven by sales force expansion, improved access, and a planned DTC campaign. The average duration of use is around 6-7 prescriptions per year.
Q:What is the confidence in solriamfetol's efficacy in pediatric ADHD, and why is a single trial sufficient?
A:Confidence is based on the efficacy demonstrated in adults and the continuum of ADHD from childhood to adulthood. A single trial may be sufficient by including both children and adolescents in one study.
Q:What is the strategy for AXS-12 in narcolepsy, and how does it address competitive dynamics?
A:The strategy involves leveraging the Sunosi sales team and addressing polypharmacy in narcolepsy. AXS-12 is expected to complement existing treatments and find its place in the treatment paradigm.
Q:Review of Unclear Management Responses
A:Management avoided giving a direct answer to the expected volume growth for Auvelity following the payer coverage expansion, stating it was too early to share exact expectations. Similarly, they did not provide specific details on the expected gross-to-net trends for SYMBRAVO beyond stating it would remain high. Additionally, they did not clarify the exact timing or details of the pediatric ADHD study for solriamfetol, citing the need for alignment with the FDA.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ADHD Phase
AG Research
AXS Alzheimer
AXS standard
Auvelity Sunosi
Auvelity market
Bank
Co Research
III trial
Inc Research
LLC Research
MDD daytime
Opland
Phase III
Pizzie Chief
QA
Research Division
Securities LLC
Tabuteau
Therapeutics
addition
approach
class
completion
coverage SYMBRAVO
daytime sleepiness
development program
end
feedback
launch SYMBRAVO
mid
momentum portfolio
need
neuroscience
opportunity
population
prescription comparison
trial solriamfetol
AXSM Transcript
Axsome Therapeutics, Inc. (AXSM) Presents at Piper Sandler 37th Annual Healthcare Conference Transcript
Neutral12-4
Axsome Therapeutics, Inc. (AXSM) Q3 2025 Earnings Call Transcript
Positive11-3
The earnings call summary indicates strong progress in product development, with multiple Phase III trials and regulatory submissions on track. The Q&A section highlights positive growth trends and strategic plans, although some details were withheld. The market cap suggests a moderate reaction. Considering the strategic plans, strong product pipeline, and positive indications from the Q&A, a positive stock price movement of 2% to 8% is expected over the next two weeks.
Axsome Therapeutics, Inc. (AXSM) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Neutral9-8
Axsome Therapeutics, Inc. (AXSM) Q2 2025 Earnings Call Transcript
Positive8-4
The earnings call highlighted strong financial performance with a 62% YoY revenue growth and an improved net loss. Product pipeline initiatives and clinical programs show significant progress, with optimistic guidance for AXS-05 and expanding sales strategies. Despite some management avoidance on specifics, the overall sentiment is positive due to strategic expansions and anticipated NDA submissions. The market cap suggests moderate sensitivity, supporting a positive prediction.
AXSM Slides
AXSM Report
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