Earnings summaries and quarterly performance for Axsome Therapeutics.
Executive leadership at Axsome Therapeutics.
Board of directors at Axsome Therapeutics.
Research analysts who have asked questions during Axsome Therapeutics earnings calls.
CC
Cerena Chen
Wells Fargo & Company
4 questions for AXSM
Also covers: AMPH, HALO
David Amsellem
Piper Sandler Companies
4 questions for AXSM
Also covers: ABBV, ALKS, AMGN +27 more
Graig Suvannavejh
Mizuho Securities
4 questions for AXSM
Also covers: ADAP, ADVM, ALEC +11 more
Jason Gerberry
Bank of America Merrill Lynch
4 questions for AXSM
Also covers: ALKS, AMPH, ARWR +21 more
Leonid Timashev
RBC Capital Markets
4 questions for AXSM
Also covers: ADCT, ALKS, CMPS +8 more
MG
Marc Goodman
Leerink Partners
4 questions for AXSM
Also covers: ACAD, ALDX, ALKS +14 more
MM
Myles Minter
William Blair & Company
4 questions for AXSM
Also covers: ALEC, ARCT, ARGX +11 more
Ami Fadia
Needham & Company, LLC
3 questions for AXSM
Also covers: ACAD, ALKS, AVDL +10 more
CD
Charles Duncan
Cantor Fitzgerald & Co.
3 questions for AXSM
Also covers: ACAD, ALKS, ATAI +12 more
Joseph Thome
TD Cowen
3 questions for AXSM
Also covers: ALKS, AMLX, ARDX +12 more
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
3 questions for AXSM
Also covers: ABEO, ACOG, AQST +20 more
Yatin Suneja
Guggenheim Partners
3 questions for AXSM
Also covers: ACAD, ARGX, CLDX +10 more
AV
Ashwani Verma
UBS Group AG
2 questions for AXSM
Also covers: ACAD, ALKS, ALVO +12 more
AR
Asim Rana
Truist Securities
2 questions for AXSM
Also covers: CORT, CPRX, SAGE +2 more
DH
David Hoang
Citigroup
2 questions for AXSM
Also covers: ACAD, ALKS, AVDL +8 more
JB
Joel Beatty
Baird
2 questions for AXSM
Also covers: ACAD, ALKS, AMLX +11 more
JL
Joon Lee
Truist Securities
2 questions for AXSM
Also covers: ADVM, CNM, CORT +14 more
CC
Chris Coetzee
Baird
1 question for AXSM
EH
Eddie Hickman
Guggenheim Securities
1 question for AXSM
Also covers: OTLK, TARS, ZVRA
Linda Tsai
Jefferies
1 question for AXSM
Also covers: ADC, AKR, AMH +31 more
Matthew Hershenhorn
Oppenheimer & Co. Inc.
1 question for AXSM
Also covers: SKYE
MK
Matthew Kaplan
Ladenburg Thalmann
1 question for AXSM
Also covers: ARDX, CORT, ELDN +8 more
Parth Patel
Morgan Stanley
1 question for AXSM
Also covers: KYMR
PS
Pete Stavropoulos
Cantor Fitzgerald
1 question for AXSM
Also covers: ABOS, ALEC, ARCT +7 more
PK
Poorna Kannan
Needham & Company
1 question for AXSM
Also covers: NMRA, RVMD
Sam Beck
Deutsche Bank
1 question for AXSM
Sean Laaman
Morgan Stanley & Co.
1 question for AXSM
Also covers: ACAD, ARGX, BGNE +8 more
TL
Troy Langford
TD Cowen
1 question for AXSM
Also covers: ALKS, JAZZ, NTLA
VP
Vikram Purohit
Morgan Stanley
1 question for AXSM
Also covers: ABSI, ARGX, ARQT +11 more
Recent press releases and 8-K filings for AXSM.
Axsome Therapeutics Provides Updates on Auvelity, Elyxyb, and Pipeline at Piper Sandler Conference
AXSM
Product Launch
Guidance Update
New Projects/Investments
- 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.
Dec 3, 2025, 9:00 PM
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.
Dec 3, 2025, 9:00 PM
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.
Dec 3, 2025, 9:00 PM
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
Axsome Therapeutics Discusses Q3 Performance, Product Pipeline, and Financial Milestones
AXSM
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- Axsome Therapeutics reported strong Q3 2025 performance, with Auvelity achieving $136 million in net sales, representing 69% year-over-year growth and 14% quarter-over-quarter growth. The company also noted the positive early impact of its direct-to-consumer (DTC) campaign on new-to-brand prescriptions (NBRx), which recently surpassed 2,800 per week.
- The gross-to-net discount for Auvelity improved to the high 40s in Q3, with 85% total covered lives and 28 million additional lives gaining first-line or first-switch access.
- Sunosi recorded $33 million in Q3 sales, showing 35% year-over-year growth, while Elyxyb generated $2.1 million in its first full quarter post-launch. The company maintains peak sales guidance of $300 million-$500 million for Sunosi and $500 million-$1 billion for Elyxyb.
- Axsome achieved cash flow positive for the first time in Q3 2025, with approximately $1 million positive cash flow from operations. The company is progressing with its NDA-stage programs for AXS-05 in AD agitation and AXS-12 in narcolepsy, with an expansion of the sales force anticipated upon ADA approval.
Nov 10, 2025, 4:00 PM
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
Axsome Therapeutics Reports Strong Q3 2025 Performance and Provides Product Updates
AXSM
Revenue Acceleration/Inflection
Product Launch
Guidance Update
- Axsome Therapeutics reported Q3 2025 total net sales of $171 million, with AUVELITY sales of $136 million (69% year-over-year growth) and SUNOSI's 35% year-over-year growth. The company achieved cash flow positive from operations by approximately $1 million in Q3 2025.
- The direct-to-consumer (DTC) campaign for AUVELITY, launched in early September 2025, has led to increased new-to-brand prescriptions (NBRx), recently surpassing 2,800 weekly. AUVELITY's gross-to-net discount improved to the high 40s in Q3, and it now has 85% total covered lives.
- The NDA for AXS-05 for Alzheimer's Disease Agitation is under review, supported by three positive, controlled trials and a standalone ICH safety database, and is eligible for priority review. SYMBRAVO generated $2.1 million in its first full quarter and has a peak sales guidance of $500 million-$1 billion.
- R&D spend is projected to increase from $40 million in Q3 2025 to approximately $50 million in Q4 2025 and Q1 2026 due to the initiation of four new trials.
Nov 10, 2025, 4:00 PM
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
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
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
Quarterly earnings call transcripts for Axsome Therapeutics.
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