Axsome Therapeutics (AXSM) Company Report

Axsome Therapeutics is awaiting an acceptance decision for the Supplemental New Drug Application (SNDA) for Auvelity in Alzheimer's disease (AD) agitation, with an expected standard review process and a projected peak sales opportunity of $1.5-$3 billion for this indication alone.
For Auvelity in Major Depressive Disorder (MDD), new-to-brand prescriptions (NBRXs) have increased to approximately 2,750 per week following a direct-to-consumer (DTC) campaign launch in September. Monotherapy usage is now over 50%, with 15% first-line and 35% second-line usage.
Auvelity's gross-to-net improved to the high 40s% in Q3 from the mid-50s% in Q1 and Q2, achieving 85% total covered lives. The company anticipates 100% access in the government channel for AD agitation upon approval.
The early launch of Elyxyb for migraine has achieved 52% total covered lives as of Q3, with a 100-rep sales force focused on headache centers.
Axsome's Solriamfetol pipeline includes studies for shift work disorder and binge eating disorder, both with top-line data expected next year, and studies for pediatric adolescent ADHD and MDD with excessive daytime sleepiness starting this quarter.

1 day ago

Transcript

Axsome Provides Updates on Auvelity Filings, Commercialization, and Pipeline

AXSM

Product Launch

New Projects/Investments

Guidance Update

Axsome submitted a Supplemental New Drug Application (SNDA) for Auvelity in Alzheimer's disease (AD) agitation, anticipating a standard review and a $1.5-$3 billion peak sales opportunity for this indication.
The Auvelity national TV DTC campaign for Major Depressive Disorder (MDD), launched in September, has driven new-to-brand prescriptions (NBRx) from 2,500 to approximately 2,750 per week.
Auvelity's gross-to-net (GTN) improved from the mid-50s% in Q1 and Q2 to the high 40s% in Q3, with a slight uptick to the low 50s% projected for Q4.
Axsome plans a meaningful expansion of its 300-rep commercial team upon Auvelity's approval for AD agitation, including a dedicated long-term care field force.
Pipeline updates include Solriamfetol studies for shift work disorder, ADHD, MDD with excessive daytime sleepiness, and binge eating disorder, with top-line data expected next year for several trials.

1 day ago

Transcript

Axsome Provides Updates on Auvelity, Symbrava, and Pipeline Development

AXSM

Product Launch

New Projects/Investments

Guidance Update

Axsome has submitted the SNDA for Auvelity in Alzheimer's disease (AD) agitation, awaiting an acceptance decision, with an expectation of a standard review. Commercial plans include leveraging the existing 300 reps and expanding the field force, including a dedicated long-term care team, targeting peak sales of $1.5-$3 billion for this indication.
For Auvelity in Major Depressive Disorder (MDD), a DTC campaign launched in September has helped increase weekly new-to-brand prescriptions (NBRx) from 2,000 to 2,750-2,800. Monotherapy use is now over 50%, with 15%+ as first-line and 35% as second-line therapy. Gross-to-net improved to the high 40s% in Q3, with 85% total covered lives.
The Symbrava launch is receiving positive clinician feedback, with 52% total covered lives as of Q3. Axsome launched with 100 reps focusing on headache centers.
Axsome is advancing its Solriamfetol pipeline, with shift work disorder and binge eating disorder trials expected to topline next year , and has in-licensed a GABA-A alpha 2/3 positive allosteric modulator for early-stage development.

1 day ago

Transcript

Fortress Biotech Reports Third Quarter 2025 Financial Results and Strategic Highlights

AXSM

Earnings

M&A

New Projects/Investments

Fortress Biotech reported total net revenue of $17.6 million for the third quarter ended September 30, 2025, a 20.5% increase compared to the third quarter of 2024.
The company achieved consolidated net income attributable to common stockholders of $3.7 million, or $0.13 per share basic, for Q3 2025, a significant improvement from a net loss of $(15.0) million, or $(0.76) per share basic, in Q3 2024.
As of September 30, 2025, Fortress' consolidated cash and cash equivalents totaled $86.2 million, an increase of $28.9 million year-to-date from December 31, 2024.
Strategic monetization updates include the acquisition of Fortress subsidiary Checkpoint Therapeutics by Sun Pharma, which provided Fortress with approximately $28 million at closing and potential for additional contingent value rights and a 2.5% royalty on future net sales of UNLOXCYT™. Additionally, the acquisition of Baergic by Axsome makes Avenue, a Fortress subsidiary, eligible for an upfront payment, milestone payments, and tiered royalties.
The company's late-stage pipeline continues to progress, with dotinurad advancing in two Phase 3 clinical trials for gout, supported by Crystalys Therapeutics' $205 million Series A financing.

Nov 14, 2025, 1:30 PM

Press Release

Axsome Reports Strong Q3 Sales, Achieves Cash Flow Positivity, and Advances Pipeline

AXSM

Product Launch

Revenue Acceleration/Inflection

New Projects/Investments

Axsome reported Q3 total net sales of $171 million, with Auvelity sales reaching $136 million, representing 69% year-over-year growth and 14% quarter-over-quarter growth. Sunosi also saw strong performance with $33 million in the quarter, a 35% year-over-year increase.
The company achieved cash flow positive for the first time in Q3, with approximately $1 million positive cash flow from operations.
Auvelity's direct-to-consumer (DTC) campaign, launched in early September, is showing early impact, with new prescriptions (NBRxs) recently surpassing 2,800 per week. The gross-to-net discount for Auvelity improved to the high 40s in Q3, and it now has 85% total covered lives.
Axsome is preparing for the potential approval and launch of AXS-05 for Alzheimer's disease agitation (ADA), with the commercial and medical affairs infrastructure already established and a sales force expansion planned upon approval.
Cymbalta, launched at the end of Q2, generated $2.1 million in its first full quarter of sales and has a peak sales potential of $500 million to $1 billion.

Nov 10, 2025, 4:00 PM

Transcript

Axsome Therapeutics Reports Strong Q3 2025 Revenue Growth and Pipeline Progress

AXSM

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

Axsome Therapeutics reported total net product revenue of $171.0 million for Q3 2025, representing a 63% year-over-year increase.
This growth was primarily driven by AUVELITY net product sales of $136.1 million (+69% YoY) and SUNOSI net product revenue of $32.8 million (+35% YoY), with SYMBRAVO contributing $2.1 million.
The company maintained a strong financial position with $325.3 million in cash and cash equivalents as of September 30, 2025.
Key pipeline advancements include the submission of an SNDA for AXS-05 in Alzheimer's disease agitation to the FDA and the anticipated NDA submission for AXS-12 for cataplexy in narcolepsy in 4Q 2025.

Nov 3, 2025, 1:00 PM

Presentation

Axsome Therapeutics Reports Strong Q3 2025 Revenue Growth and Pipeline Progress

AXSM

Earnings

Product Launch

Revenue Acceleration/Inflection

Axsome Therapeutics reported total revenue of $171 million for the third quarter of 2025, representing a 63% increase year-over-year.
Auvelity net product sales reached $136.1 million, up 69% versus last year, with approximately 209,000 prescriptions written, reflecting 46% year-over-year growth.
The company submitted a supplemental NDA for AXS-05 in Alzheimer's disease agitation and continues to target the submission of an NDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.
Sunosi net product revenues were $32.8 million, a 35% increase versus the prior year, while Sembravo, in its first full quarter on the market, generated $2.1 million in net sales.
Axsome ended the third quarter of 2025 with $325.3 million in cash and cash equivalents and believes its current cash balance is sufficient to fund anticipated operations into cash flow positivity.

Nov 3, 2025, 1:00 PM

Transcript

Axsome Therapeutics Reports Strong Q3 2025 Revenue Growth and Pipeline Progress

AXSM

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

Axsome Therapeutics reported total revenue of $171 million for Q3 2025, marking a 63% increase year-over-year, driven by the performance of its three marketed products.
AUVELITY net product sales reached $136.1 million, growing 69% year-over-year, with approximately 209,000 prescriptions written, representing 46% year-over-year growth. Commercial coverage for AUVELITY expanded to 85% of all lives.
SUNOSI net product revenues were $32.8 million, up 35% year-over-year, and SYMBRAVO generated $2.1 million in net sales during its first full quarter on the market.
The company recorded a net loss of $47.2 million, or $0.94 per share, for the quarter, and ended with $325.3 million in cash and cash equivalents.
Key pipeline advancements include the submission of a supplemental NDA for AXS-05 in Alzheimer's disease agitation and the target NDA submission for AXS-12 for narcolepsy in the fourth quarter of 2025. The company continues to anticipate cash flow positivity based on its current operating plan.

Nov 3, 2025, 1:00 PM

Transcript

Axsome Therapeutics Reports Strong Third Quarter 2025 Financial Results and Key Pipeline Progress

AXSM

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

Axsome Therapeutics, Inc. reported total net product revenue of $171.0 million for the third quarter of 2025, marking a 63% year-over-year growth. The company's net loss for the quarter was $47.2 million, or $(0.94) per share.
Product sales were driven by AUVELITY net product sales of $136.1 million, representing 69% year-over-year growth, and SUNOSI net product revenue of $32.8 million, up 35% year-over-year. SYMBRAVO generated $2.1 million in net product sales in its first full quarter of commercialization.
The company submitted a supplemental New Drug Application (sNDA) for AXS-05 for the treatment of Alzheimer’s disease agitation to the FDA.
Axsome Therapeutics concluded the third quarter of 2025 with $325.3 million in cash and cash equivalents as of September 30, 2025, and anticipates its current cash will be sufficient to fund operations into cash flow positivity.

Nov 3, 2025, 12:06 PM

8-K

Axsome Therapeutics Reports Q2 Sales and Outlines Key Commercial and Pipeline Milestones

AXSM

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Axsome Therapeutics reported Q2 net sales of $150 million, with Auvelity sales at $120 million and Sanofi at $30 million. Symbravo, launched two and a half weeks before quarter-end, generated approximately $400,000.
Commercial progress for Auvelity includes an increase in weekly MBRXs from 2,000 to 2,500, securing 28 million additional covered lives effective July 1, and launching a national direct-to-consumer TV advertising campaign.
Key pipeline milestones include an sNDA filing for AXS-05 in Alzheimer's disease agitation in Q3 and an NDA submission for AXS-12 in narcolepsy in Q4.
The company estimates the market for AXS-05 in Alzheimer's disease agitation to be 5 million patients, with potential peak sales ranging from $1.5 billion to $3 billion.

Sep 17, 2025, 12:40 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Axsome Therapeutics.

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