Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Investor Presentation (November 2026)
50 slides from Axsome Therapeutics's investor presentation, November 2026
Slide 1: Advancing the frontiers of brain health
Advancing the frontiers of brain health
Slide 2: Forward looking statements & safe harbor
Forward looking statements & safe harbor Certain matters discussed in this presentation are “forward- the Company’s ability to fund additional clinical trials to The factors discussed herein could cause actual results and looking statements”. The Company may, in some cases, use continue the advancem
Slide 3: Our mission
Our mission We develop medicines through novel therapeutic approaches to improve the lives of people with serious brain disorders 3
Slide 4: Positioned for significant and durable growth
Positioned for significant and durable growth 3 6 10 Psychiatry & Neurology marketed novel product pipeline Singular CNS products candidates indications portfolio COMMERCIAL PORTFOLIO BROAD PIPELINE MDD AD agitation Psychiatry Neurology $8B+ peak sales potential • Smoking cessation • Narcolepsy EDS
Slide 5: 3Q 2026 results
3Q 2026 results COMMERCIAL GROWTH PIPELINE PROGRESS UPCOMING MILESTONES* AXS-12 NDA under FDA review for AXS-12 PDUFA target action (May 1, 2027) Net product revenue cataplexy in narcolepsy $259.7M Initiated SUMMIT Phase 3 trial of AXS-05 in smoking cessation ENGAGE Phase 3 topline results (1Q 2027)
Slide 6: Industry-leading neuroscience pipeline with deep stratification
Industry - leading neuroscience pipeline with deep stratification Phase 1 Phase 2 Phase 3 NDA NMDA AXS - 05 antagonist and Smoking cessation (dextromethorphan-bupropion) sigma-1 agonist ADHD Binge eating disorder DNRI and Solriamfetol TAAR1 agonist MDD with EDS symptoms Shift work disorder Highly se
Slide 7: Advancing new frontiers across serious CNS conditions
Advancing new frontiers across 10 serious CNS conditions people in the U.S. are of patients suffer from Narcolepsy 185K affected by narcolepsy8 ~70% cataplexy9 Psychiatry Fibromyalgia people in the U.S. have 17M+ fibromyalgia10 of patients discontinue >50% treatment in the first year11 Shift work wo
Slide 8: Singular CNS portfolio with >$18B in annual peak sales potential
Psychiatry Neurology Singular CNS portfolio with >$18B in annual peak sales potential AXS-17 $1- $3B Epilepsy $0.3- $0.5B Solriamfetol ADHD Solriamfetol Shift work disorder $0.5- $1B AXS-14 AXS-20 $0.5- $1B Fibromyalgia AXS-12 $0.5- $1B Schizophrenia Narcolepsy Solriamfetol Binge eating disorder $0.
Slide 9: Financial highlights
axsome. Financial highlights
Slide 10: 3Q 2026 financial performance
3Q 2026 financial performance $ millions 3Q 2026 3Q 2025 % Change Net product revenue $259.7 $171.0 52% AUVELITY $207.6 $136.1 53% SUNOSI * $48.2 $32.8 47% SYMBRAVO $3.9 $2.1 88% R&D expense $50.6 $40.2 26% SG&A expense $203.1 $150.2 35% 3Q = three months endedSeptember 30; *Includes royalty revenue
Slide 11: AUVELITY quarterly net revenue performance
AUVELITY ® quarterly net revenue performance +53% $225 $207.6 $200 $180.3 $175 $155.1 $153.2 $150 $136.1 Millions $125 $119.6 $92.6 $96.2 $100 $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 1Q '
Slide 12: SUNOSI quarterly net revenue performance
SUNOSI® quarterly net revenue performance +47% $50 $48.2 $40 $36.7 $35.8 $33.9 $32.8 $30.0 Millions $30 $26.2 $25.2 $24.4 $22.5 $21.6 $22.1 $19.2 $19.1 $20.1 $20 $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 1Q '26 2Q
Slide 13: Financial snapshot
Cash balance: (as of September 30, 2026) $313.9M Financial Debt (face value): snapshot (as of September 30, 2026) $190M Market cap: (as of October 30, 2026) $7.6B Shares outstanding: (as of September 30, 2026) 52.6M Runway to reach cash flow positivity, based on the Options, RSUs, and Others current
Slide 14: Commercial update
axsome. Commercial update
Slide 15: Robust commercial portfolio positioned for significant further growth
Robust commercial portfolio positioned for significant further gr HIGHLIGHTS / GROWTH DRIVERS PEAK SALES POTENTIAL* • Accelerating new-to-brand prescription growth • Broadening prescriber base and deepening utilization $8B+ • Strong market access • Durable demand and high patient satisfaction • Mult
Slide 16: First and only oral NMDA antagonist and sigma-1 agonist for MDD and AD agitation
First and only oral NMDA antagonist and sigma-1 agonist for MDD and Alzheimer’s 1,2 disease agitation MAJOR DEPRESSIVE DISORDER Only oral antidepressant with Rapid symptom improvement starting at rapid-acting efficacy reflected in week 1 and remission as early as week 2, FDA label1 sustained at week
Slide 17: Continued momentum reflects underlying MDD growth and sales force expansion
Continued momentum reflects underlying MDD growth and early impact from the sales force expansion GROWING PRESCRIBER BASE 320,000 ~77,000 +19% 280,000 Total prescriptions (TRx ) quarterly Unique writers LTD QoQ growth in newly activated writers 240,000 200,000 ACCELERATING NEW PATIENT STARTS 160,000
Slide 18: Acceleration in prescription trends among patients aged 65+
Acceleration in prescription trends among patients aged 65+ foll ADA label expansion, alongside continued growth for under 65 Auvelity TRx : 65+ Auvelity TRx : Under 65 20K 100K 18K FDA approval 95K FDA approval 88.2K 86.9K 14.8K 86.2K 16K 90K Total prescriptions (TRx ) monthly Total prescriptions (
Slide 19: New-to-brand prescriptions (NBRx) monthly
New- to- brand prescriptions (NBRx ) monthly 4K 1K 3K 2K 0K Sep-25 1.0K Oct-25 1.3K Nov-25 1.0K Dec-25 1.0K Jan-26 1.0K Feb-26 1.0K Mar-26 1.1K Apr-26 1.2K Auvelity NBRx : 65+ FDA approval May-26 1.7K Jun-26 2.1K Jul-26 3.0K Aug-26 3.1K Sep-26 3.6K New- to- brand prescriptions (NBRx ) monthly 6K 7K
Slide 20: First and only DNRI for EDS associated with narcolepsy or OSA
First and only dopamine and norepinephrine reuptake inhibitor for EDS associated with 1 narcolepsy or OSA First and only wakefulness promoting 90% of patients reported feeling agent proven to improve wakefulness better with SUNOSI 150 mg2 through 9 hours1 Improvements in cognitive functioning vs. pl
Slide 21: Steady demand continues to drive durable growth
Steady demand continues to drive durable growth EXPANDING PRESCRIBER REACH 70,000 65,000 60,000 Normalized total >17,500 prescriptions (nTRx ) Unique writers LTD 55,000 quarterly 50,000 45,000 STEADY DEMAND GROWTH 40,000 35,000 ~114,000 ~64,400 30,000 Patients treated LTD TRx in 3Q 2026 25,000 20,00
Slide 22: Novel, oral, rapidly absorbed, multi-mechanistic approach for acute migraine
Novel, oral, rapidlyabsorbed , multi-mechanistic 1 approach for the acute treatment of migraine Single, oral dose provided rapid migraine Superior efficacy demonstrated across a pain freedom and return to normal broad range of migraine severity (mild, functioning within 2 hours1 moderate, severe)1 H
Slide 23: Expanding prescriber and patient adoption
Expanding prescriber and patient adoption PRESCRIBER GROWTH 30,000 ~5,750 25,000 Total prescriptions Unique writers LTD (TRx ) quarterly 20,000 PATIENT GROWTH 15,000 ~24,900 >25,000 Patients treated LTD TRx in 3Q 2026 10,000 MARKET ACCESS 5,000 ~57% ~56% ~57% Total covered Commercial Medicare and Me
Slide 24: Development pipeline
axsome. Development pipeline
Slide 25: Smoking cessation
Smoking cessation 70% of smokers Only 3-5% of smokers who attempt to quit want to quit2 without assistance are successful for 6-12 months2 ~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 sm
Slide 26: Evaluating AXS-05 as a treatment for smoking cessation
Evaluating AXS-05 as a treatment for smoking cessation Evaluating AXS-05 as a treatment for smoking cessation SUMMIT Phase 3 trial Double-blind phase Follow-up Screening Baseline (12 weeks) AXS-05 1:1:1 R Bupropion Placebo Key eligibility criteria Primary endpoint • 18- 65 years of age • Change from
Slide 27: Solriamfetol: Unique pharmacology supports potential utility in CNS conditions
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 evidence1,2 suggests TAAR1 plays a role in neuropsychi
Slide 28: Solriamfetol Phase 3 development programs
Solriamfetol Phase 3 development programs ADHD MDD with EDS BED SWD Positive FOCUS Phase 3 • Ongoing CLARITY Phase • Topline data from • Ongoing SUSTAIN Phase trial in adults with ADHD 3 trial in MDD with EDS ENGAGE Phase 3 trial in 3 trial in adults with shift (N=516) symptoms adults with binge eat
Slide 29: Solriamfetol has the potential to treat a broad range of conditions
Approved indication • Excessive daytime sleepiness (EDS) in OSA and narcolepsy Potential label expansion programs • ADHD: ~22M patients Solriamfetol has the potential to• Binge eating disorder: ~7M patients treat a broad range of psychiatric• Major depressive disorder with EDS symptoms: ~10.5M patie
Slide 30: Attention-deficit/hyperactivity disorder (ADHD)
Attention - deficit/hyperactivity disorder (ADHD) Characterized by a persistent pattern of inattention and/or hyperactive-impulsive behaviors3 Chronic neurobiological and Associated with significant developmental disorder affecting an impairment in social, academic, and estimated ~22M people in the
Slide 31: Statistically significant improvements in ADHD symptoms with solriamfetol
Statistically significant improvements in Primary endpoint: ADHD symptoms with solriamfetol treatment Change from baseline in AISRS total score at Week 6 0 FOCUS Phase 3 Trial a 17.7 - point reduction in the AISRS total score at Week 6 with Placebo solriamfetol vs. 14.3-point reduction with placebo
Slide 32: Solriamfetol Phase 3 program in pediatric ADHD
Solriamfetol Phase 3 program in pediatric ADHD Solriamfetol Phase 3 program in pediatric ADHD FOCUS - 2 Phase 3 trial FOCUS - 3 Phase 3 trial Screening Double-blind phase Follow-up Screening Double-blind phase Follow-up Baseline Baseline (5 weeks) (6 weeks) (1 week) (5 weeks) (6 weeks) (1 week) Solr
Slide 33: Binge eating disorder
Binge eating disorder >7 million people in the BED is 1.75x more common in women than in men1 U.S. have BED1 Binge eating disorder (BED) is BED is thought to involve issues Unmet medical need associated the most common eating with food reward processing, with a 2- to 3-fold increased risk disorder,
Slide 34: Solriamfetol for the treatment of binge eating disorder
Solriamfetol for the treatment of binge eating disorder ENGAGE Phase 3 trial Solriamfetol inhibits the reuptake of dopamine and Screening Double-blind phase Follow-up Baseline (4 weeks) (12 weeks) (1 week) norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-
Slide 35: Shift work disorder
~15 million U.S. workers may Shift work disorder suffer from SWD 10-43% have SWD1,3 Shift work has long been associated with multiple serious health complaints and a 23% greater risk of sustaining a work- Approximately 1 in 3 U.S. workers related injury4-5 works an alternate shift2 Shift work disord
Slide 36: Solriamfetol for the treatment of shift work disorder
Solriamfetol for the treatment of shift work disorder Solriamfetol for the treatment of shift work disorder SUSTAIN Phase 3 trial Screening Double-blind phase Follow-up Baseline (1-4 weeks) (up to 12 weeks) (1 week) Solriamfetol (150 mg) 1:1 R Placebo N=450 Key eligibility criteria Primary endpoint
Slide 37: MDD with excessive daytime sleepiness (EDS) symptoms
Major depressive disorder MDD patients with EDS have (MDD) is one of the most difficulty maintaining common mental disorders in wakefulness, resulting in the U.S., impacting ~21M adults impaired daily functioning and each year2,3 increased safety risks MDD with excessive daytimeApproximately 50% of
Slide 38: Solriamfetol for the treatment of MDD with EDS symptoms
Solriamfetol for the treatment of MDD with EDS symptoms Solriamfetol for the treatment of MDD with EDS symptoms CLARITY Phase 3 trial Open-label period Baseline Double-blind phase 1:1 randomization (Patients achieving treatment response) Solriamfetol (150 mg) Solriamfetol (150 mg) 1:1 R Placebo Key
Slide 39: 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 40: Narcolepsy
Narcolepsy Rare and debilitating neurological condition that affects approximately 185,000 people in the U.S.1 Characterized by cataplexy, Up to 70% of patients suffer excessive daytime sleepiness from cataplexy, or the sudden (EDS), hypnagogic hallucinations, reduction or loss of muscle sleep paral
Slide 41: Rapid and robust reductions in cataplexy with AXS-12 treatment
Rapid and robust reductions in cataplexy with -12AXS treatment CONCERT SYMPHONY 25 Placebo Placebo AXS-12 20 AXS-12 4 Weekly cataplexy attacks 15 Change in weekly cataplexy attacks (median) 0 10 -4 (median) 5 -8 0 Baseline Week 1 Week 2 Week 3 Week 4 Week 5 -12 1.0 p=0.007 p=0.031 Rate ratio* p=0.00
Slide 42: AXS-14 (esreboxetine)
AXS - 14 (esreboxetine) Novel pharmacological approach for the management of fibromyalgia 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-inhibito
Slide 43: Fibromyalgia
Fibromyalgia An estimated ~17 million people in the U.S. are impacted by Chronic and debilitating neurological pain syndrome resulting from a fibromyalgia1 dysfunction in central pain processing2,3 Characterized by widespread Associated with substantial musculoskeletal pain, fatigue, physical disabi
Slide 44: Rapid and robust improvements in fibromyalgia symptoms with AXS-14
Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment Pain reduction a Phase 3 efficacy results (N=1,122) 0.0 0.0 0.0 Placebo Placebo Placebo 10 mg LS mean change from baseline (SE) 4 mg LS mean change from baseline (SE) LS mean change from baseline (SE) 8 mg -0.5 -0.5 -0.5 We
Slide 45: AXS-14 for the management of fibromyalgia
AXS-14 for the management of fibromyalgia AXS -14 for the management of fibromyalgia FORWARD Phase 3 trial Open-label period Double-blind phase Baseline (12 weeks) (up to 12 weeks) 1:1 randomization (Patients achieving treatment response) AXS-14 (8 mg) AXS-14 (8 mg) 1:1 R Placebo Key eligibility cri
Slide 46: AXS-17
Epilepsy is a chronic and debilitating neurological AXS-17 was safe and well tolerated in disorder affecting ~3.4M clinical studies in >700 patients to people in the U.S.1 date and demonstrated compelling AXS - 17 anti-convulsant activity in preclinical seizure models Novel oral GABAA receptor α2,3
Slide 47: AXS-20
~3.7M people in the U.S. have schizophrenia and AXS-20 demonstrated a favorable related psychotic safety and tolerability profile in disorders1 clinical studies in >360 individuals to AXS - 20 date Potential first- in- class selective PDE10A inhibitor for neuropsychiatric conditions Completed proof-
Slide 48: Strong intellectual property portfolio
AUVELITY SUNOSI • Protected by a robust patent estate • Protected by a robust patent estate extending to at least 2043, multiple extending to at least 2042, multiple pending pending • Proprietary drug substance, drug product • Proprietary drug product formulation and formulation, and methods of trea
Slide 49: Leadership team
Leadership team Management Board of Directors Herriot Tabuteau, MD Goldman Sachs Roger Jeffs, PhD FOUNDER & CEO Bank of America CEO, LIQUIDIA CORPORATION Former President, Co- CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Nick Pizzie, CPA, MBA Pierre Fabre–
Slide 50: Thank you.
We develop medicines through novel therapeutic approaches to Thank you. improve the lives of people with serious brain disorders
Axsome Therapeutics — Investor Presentation (November 2026) on 6ix