Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q4 2025 Earnings Presentation
47 slides from Axsome Therapeutics's earnings presentation, Feb 23, 2026
Slide 1: 4Q and Full Year 2025 Financial Results
4Q and Full Year 2025 Financial Results February 23, 2026 © Axsome Therapeutics, Inc.
Slide 2: Forward looking statements & safe harbor
Forward looking statements & safe harbor Certain matters discussed in this presentation are the Company’s ability to fund additional clinical trials to The factors discussed herein could cause actual results “forward-looking statements” . The Company may, in continue the advancement of the Company’s
Slide 3: Our Mission
Our Mission Develop and deliver transformative medicines for the hundreds of millions of people impacted by central nervous system conditions 3 © Axsome Therapeutics, Inc.
Slide 4: 2025 was a year of significant innovation and growth across the business
2025 was a year of significant innovation and growth across the business How we drive Positioned for long -term 2025 highlights growth value creation Deep neuroscience Delivered $639M in total revenue across three commercial Deep CNS portfolio across expertise products, representing 66% year -over -
Slide 5: 2026 strategic focus areas
2026 strategic focus areas Drive continued Position AUVELITY for a strong growth across successful potential launch in our commercial portfolio Alzheimer’s disease agitation Advance high -value pipeline Scale efficiently and maintain programs and deliver on key operational excellence toward regulato
Slide 6: Robust path to durable value creation and long-term growth
Robust path to durable value creation and long -term growth 11 9 CNS conditions 7 of critical unmet Programs with need blockbuster 5 Late -stage clinical trials potential 3 Novel product candidates underway or initiating Innovative medicines >$16B >150M Robust intellectual property portfolio with pa
Slide 7: Broad and expanding CNS pipeline
Broad and expanding CNS pipeline Phase 1 Phase 2 Phase 3 NDA Marketed Major Depressive Disorder AXS-05 Alzheimer’s Disease Agitation FDA Breakthrough Therapy Designation (dextromethorphan-bupropion) Psychiatry NMDA antagonist, sigma -1 agonist, and aminoketone CYP2D6 inhibitor Smoking Cessation Atte
Slide 8: Advancing new frontiers in high-impact CNS conditions
Advancing new frontiers in high -impact CNS conditions Approved indications Advanced programs Lifecycle expansion and driving today’s growth in key indications future growth opportunities Major depressive disorder Alzheimer’s disease agitation ADHD 1 U.S. individuals with Alzheimer’s 22M+ people in
Slide 9: Strong pipeline execution with multiple upcoming milestones
Strong pipeline execution with multiple upcoming milestones 2025 & recent achievements Upcoming milestones • FDA approval and launch of SYMBRAVO in the U.S. • NDA submission for AXS -12 for cataplexy in narcolepsy (1Q 2026) Regulatory & Commercial • sNDA for AXS -05 in Alzheimer’s disease agitation
Slide 10: Diversified growth drivers supporting >$16B in combined peak sales potential
Diversified growth drivers supporting >$16B in combined peak sales potential AXS -17 Epilepsy Solriamfetol BED Solriamfetol ADHD $0.5-$1B AXS -12 $1-$3B Narcolepsy $0.5-$1B AXS -05 AXS -14 AD Agitation Fibromyalgia Solriamfetol $1.5-$3B SWD $0.5-$1B $0.3-$0.5B $0.5-$1B Solriamfetol AXS -05 $1-$3B MD
Slide 11: 4Q and full year 2025 financial summary
4Q and full year 2025 financial summary $ millions 4Q 2025 4Q 2024 % Change FY 2025 FY 2024 % Change Net Product Revenue $196.0 $118.8 65% $638.5 $385.7 66% AUVELITY Net Product Sales $155.1 $92.6 68% $507.1 $291.4 74% SUNOSI Net Product Revenue † $36.7 $26.2 40% $124.8 $94.3 32% SYMBRAVO Net Produc
Slide 12: Financial snapshot
Financial snapshot Runway to reach cash flow positivity, based on the current operating plan Cash Balance: (as of December 31, 2025) $322.9M Debt (Face Value): (as of December 31, 2025) $190M Market Cap: (as of February 20, 2026) $9.4B Shares Outstanding: (as of December 31, 2025) 50.9M Options, RSU
Slide 13: Commercial Highlights
Commercial Highlights axsome.
Slide 14: Scaling commercial growth and adoption across our innovative CNS medicines
Scaling commercial growth and adoption across our innovative CNS medicines Major depressive disorder EDS in narcolepsy or OSA Migraine with or without aura • Expanding adoption across • Continued strong growth across OSA • Disciplined launch driving growing psychiatry and primary care and narcolepsy
Slide 15: First and only oral NMDA receptor antagonist and sigma-1 receptor agonist for MDD
First and only oral NMDA receptor antagonist and sigma -1 receptor agonist for MDD in adults 1,2 Only oral antidepressant with rapid -acting efficacy reflected in FDA label 1 Rapid symptom improvement starting at week 1, sustained at week 6 vs. placebo 1 Rapid remission as early as week 2, sustained
Slide 16: Broadening adoption and scaling growth
Broadening adoption and scaling growth Quarterly TRx Launch to Date 240,000 >225,000 (+42% YoY) >60% 220,000 Total prescriptions in 4Q 2025 YoY growth in primary care 200,000 TRx prescribers in 4Q 2025 180,000 160,000 >280,000 ~52,000 140,000 New patients since launch Unique writers since launch 120
Slide 17: AUVELITY quarterly net sales performance
AUVELITY ® quarterly net sales performance +68% $175 $155.1 $150 $136.1 $125 $119.6 Millions $100 $92.6 $96.2 $80.4 $75 $65.0 $49.0 $53.4 $50 $37.7 $27.6 $25 $15.8 $5.2 $0 4Q '22 1Q '23 2Q '23 3Q '23 4Q '23 1Q '24 2Q '24 3Q '24 4Q '24 1Q '25 2Q '25 3Q '25 4Q '25 FY 2025 net product sales of $507.1M
Slide 18: First and only DNRI for EDS associated with narcolepsy or OSA
First and only dopamine and norepinephrine reuptake inhibitor for EDS associated with narcolepsy or OSA 1 First and only wakefulness promoting agent proven to improve wakefulness through 9 hours 1 90% of patients reported feeling better with SUNOSI 150 mg 2 Improvements in cognitive functioning vs.
Slide 19: Durable demand driving continued strong performance
Durable demand driving continued strong performance Quarterly nTRx Launch to Date 60,000 >54,000 (+11% YoY) ~98,000 55,000 Total prescriptions in 4Q 2025 New patients since launch 50,000 45,000 40,000 35,000 ~15,600 ~82% 30,000 Unique writers since launch Covered lives all channels 25,000 20,000 15,
Slide 20: SUNOSI quarterly net revenue performance
SUNOSI ® quarterly net revenue performance +40% $40 $36.7 $32.8 $30.0 $30 $26.2 $25.2 $24.4 $22.5 $21.6 $22.1 Millions $20 $19.2 $19.1 $20.1 $16.8 $13.1 $10 $8.8 $0 2Q '22 3Q '22 4Q '22 1Q '23 2Q '23 3Q '23 4Q '23 1Q '24 2Q '24 3Q '24 4Q '24 1Q '25 2Q '25 3Q '25 4Q '25 FY 2025 net product revenue of
Slide 21: Novel, oral, rapidly-absorbed, multi-mechanistic approach for acute migraine treatment
Novel, oral, rapidly -absorbed, multi -mechanistic approach for the acute treatment of migraine 1 Single, oral dose provided rapid migraine pain freedom and return to normal functioning within 2 hours 1 Superior efficacy demonstrated across a broad range of migraine severity (mild, moderate, severe)
Slide 22: Growing awareness and improving patient access
Growing awareness and improving patient access Weekly nTRx Launch to Date 1,400 >13,000 ~5,300 1,200 Total prescriptions New patient starts in 4Q 2025 in 4Q 2025 1,000 800 600 ~52% ~49% Covered lives all Covered lives commercial 400 channels ~57% Covered lives government 200 0 11/14 11/21 7/11 11/7
Slide 23: Development Pipeline
Development Pipeline axsome.
Slide 24: AXS-05 (dextromethorphan-bupropion)
AXS -05 (dextromethorphan -bupropion) Potentially first -in-class, best -in-class treatment for Alzheimer’s disease agitation In Alzheimer’s disease, insoluble A β production and accumulation triggers secondary steps leading to synaptic loss and neuronal cell death 1,2 Reductions in certain neurotra
Slide 25: Alzheimer's disease (AD) agitation
Alzheimer’s disease (AD) agitation Number of U.S. adults aged 65+ Alzheimer’s disease (AD) is the most common form with Alzheimer’s dementia of dementia, affecting over 7M people in the U.S. 1 expected to double by 2060 1 14M Agitation is one of the most common and debilitating neuropsychiatric symp
Slide 26: Statistically significant and clinically meaningful improvements in Alzheimer's disease agitation
Statistically significant and clinically meaningful improvements in Alzheimer’s disease agitation 0 ADVANCE -1 ACCORD -2 -2 -4 100 + Censored AXS-05 Probability of Freedom Bupropion CMAI Total Score -6 from Relapse (%) Change from Baseline Placebo 75 -8 -10 50 Hazard Ratio for Time to Relapse -12 Ha
Slide 27: Smoking cessation
Smoking cessation 70% of smokers Only 3-5% who attempt to quit without want to quit 2 assistance are successful for 6 -12 months 2 ~34M adults in the U.S. Single largest cause of Associated with over smoke cigarettes, ~50% of preventable disease and $300 billion in annual whom live with a smoking -
Slide 28: Solriamfetol
Solriamfetol Unique pharmacology supports potential utility in a broad range of CNS conditions Solriamfetol was initially developed as a dopamine and norepinephrine reuptake inhibitor (DNRI) with wake -promoting effects Preclinical and clinical evidence 1,2 suggest TAAR1 plays a role in neuropsychia
Slide 29: Solriamfetol Phase 3 development programs
Solriamfetol Phase 3 development programs ADHD MDD with EDS BED SWD Positive FOCUS Phase 3 • Initiation of Phase 3 trial • Ongoing ENGAGE Phase • Ongoing SUSTAIN Phase trial in adults with ADHD in MDD with EDS 3 trial evaluating efficacy 3 trial evaluating efficacy (N=516) symptoms anticipated in an
Slide 30: Attention deficit hyperactivity disorder (ADHD)
Attention deficit hyperactivity disorder (ADHD) Chronic neurobiological and Characterized by a persistent Associated with significant developmental disorder affecting an pattern of inattention and/or impairment in social, academic, and estimated ~ 22M people in the U.S. 1, hyperactive -impulsive beh
Slide 31: Statistically significant improvements in ADHD symptoms with solriamfetol treatment
Statistically significant improvements in ADHD symptoms with solriamfetol treatment 0 FOCUS Phase 3 trial Substantial reduction in the AISRS score of 17.7 points at Week 6, representing a 45% improvement in ADHD symptoms from baseline (p=0.039, solriamfetol 150 mg) Placebo LS Mean Change from Baseli
Slide 32: MDD with excessive daytime sleepiness symptoms
MDD with excessive daytime sleepiness symptoms Major depressive disorder Approximately 50% of patients with MDD patients with EDS have (MDD) is one of the most MDD also experience excessive difficulty maintaining wakefulness, common mental disorders in the daytime sleepiness (EDS) 4 , for which resu
Slide 33: Binge eating disorder
Binge eating disorder >7 million people in the U.S. have BED 1 BED is 1.75x more common in women than in men 1 Binge eating disorder (BED) is the BED is thought to involve issues Unmet medical need associated most common eating disorder, with food reward processing, with a 2 - to 3-fold increased ri
Slide 34: Evaluating solriamfetol as a potential treatment for binge eating disorder
Evaluating solriamfetol as a potential treatment for binge eating disorder ENGAGE Phase 3 Trial Screening Double -blind Phase Follow -up Baseline (4 weeks) (12 weeks) (1 week) Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of bi
Slide 35: Shift work disorder
Shift work disorder ~15 million U.S. workers 10-43% Approximately 1 in 3 people working in the U.S. may suffer from SWD have SWD 1,3 work an alternate shift 2 Shift work disorder (SWD) is a Shift work has long been No new medications approved combination of excessive associated with multiple serious
Slide 36: Evaluating solriamfetol as a potential treatment for shift work disorder
Evaluating solriamfetol as a potential treatment for shift work disorder SUSTAIN Phase 3 Trial Screening Double -blind Phase Follow -up Baseline (1-4 weeks) (12 weeks) (1 week) Solriamfetol (150 mg) 1:1:1 Solriamfetol (300 mg) R N=450 Placebo Key eligibility criteria Primary endpoint • 18-65 years o
Slide 37: AXS-12 (reboxetine)
AXS -12 (reboxetine) Novel pharmacological approach for the treatment of narcolepsy Norepinephrine and dopamine play important roles in sleep -wake regulation (both) and in maintaining muscle tone during wakefulness (norepinephrine) 1-3 The loss of orexin input inhibits the production of these neuro
Slide 38: Narcolepsy
Narcolepsy Rare and debilitating Characterized by cataplexy, An estimated 70% of patients neurological condition that excessive daytime sleepiness suffer from cataplexy, or the affects approximately (EDS), hypnagogic sudden reduction or loss of 185,000 people in the U.S. 1 hallucinations, sleep para
Slide 39: Rapid and robust reductions in cataplexy with AXS-12 treatment
Rapid and robust reductions in cataplexy with AXS -12 treatment CONCERT SYMPHONY 25 Placebo Placebo AXS-12 Weekly cataplexy attacks 4 AXS-12 20 Change in weekly cataplexy attacks 15 (median) 0 10 -4 5 (median) -8 0 Baseline Week 1 Week 2 Week 3 Week 4 Week 5 -12 1.0 p=0.007 Rate ratio* p=0.006 p=0.0
Slide 40: AXS-14 (esreboxetine)
AXS -14 ( esreboxetine ) Novel pharmacological approach for the management of fibromyalgia (FM) Fibromyalgia pain is thought to be partially caused by dysregulated signaling in the descending analgesic system Norepinephrine, one of the key neurotransmitters in this pathway, has predominantly pain -i
Slide 41: Fibromyalgia
Fibromyalgia An estimated ~17 million people in the U.S. are impacted by fibromyalgia 1 Chronic and debilitating Characterized by widespread Associated with substantial neurological pain syndrome musculoskeletal pain, fatigue, physical disability and resulting from a dysfunction in disturbed sleep,
Slide 42: Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment
Rapid and robust improvements in fibromyalgia symptoms with AXS -14 treatment Pain reduction Phase 3 efficacy results (N=1,122) 0.0 0.0 0.0 Placebo Placebo Placebo 10 mg 4 mg 8 mg p<0.05 * LS mean change from baseline (SE) Weekly mean pain score -0.5 -0.5 -0.5 **p<0.01 LS mean change from baseline (
Slide 43: FORWARD Phase 3 trial design
FORWARD Phase 3 trial design FORWARD Phase 3 Trial Double -blind Phase Open -label Period Baseline (up to 12 weeks) (12 weeks) 1:1 Randomization (Patients achieving treatment response) AXS -14 (8 mg) AXS -14 (8 mg) 1:1 R Placebo Key eligibility criteria Primary endpoint • ≥18 years of age with diagn
Slide 44: AXS-17
AXS -17 Expanding our innovative CNS portfolio with a complementary early -stage product candidate Acquired AXS-17*, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM), licensed from AstraZeneca AXS-17 was safe and well tolerated in AXS-17 to be evaluated for the
Slide 45: Strong intellectual property and barriers to entry
Strong intellectual property and barriers to entry • Protected by a robust patent estate extending to at • Protected by a robust patent estate extending to at least 2043; Multiple pending least 2045; Multiple pending • Proprietary drug product formulation and methods • Proprietary MoSEIC TM formulat
Slide 46: Leadership team
Leadership team Management Board of Directors Herriot Tabuteau, MD Roger Jeffs, PhD Founder & CEO CEO, Liquidia Corporation Former President, Co -CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Nick Pizzie, CPA, MBA Chief Financial Officer Mark Saad CEO, NuLid
Slide 47: Thank you
Thank you © Axsome Therapeutics, Inc.