Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q2 2026 Earnings Presentation
46 slides from Axsome Therapeutics's earnings presentation, Aug 10, 2026
Slide 1: 2Q 2026 Financial Results
2Q 2026 Financial Results August 10, 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 to improve the brain health of millions of individuals 3 © Axsome Therapeutics, Inc.
Slide 4: Positioned for significant and durable growth
Positioned for significant and durable growth 3 6 10 Psychiatry + Neurology marketed novel product pipeline products candidates indications Singular CNS portfolio COMMERCIAL PORTFOLIO BROAD PIPELINE MDD AD agitation Psychiatry Neurology Expanding franchise Smoking cessation Narcolepsy EDS in OSA or
Slide 5: 2Q 2026 performance
2Q 2026 performance COMMERCIAL GROWTH PIPELINE PROGRESS UPCOMING MILESTONES Total product revenue • NDA submission for AXS -12 for • AXS -12 PDUFA target action cataplexy in narcolepsy accepted (May 1, 2027) $218.4M (+46% YoY) by the FDA • Initiation of pivotal Phase 2/3 • Initiated FOCUS -2 and FOC
Slide 6: Leading neuroscience pipeline with deep stratification
Psychiatry Neurology Leading neuroscience pipeline with deep stratification Phase 1 Phase 2 Phase 3 NDA AXS -05 NMDA antagonist and Smoking Cessation (dextromethorphan -bupropion) sigma -1 agonist ADHD Binge Eating Disorder Solriamfetol DNRI and TAAR1 agonist MDD with EDS Shift Work Disorder AXS -12
Slide 7: Advancing new frontiers across 10 serious CNS conditions
Advancing new frontiers across 10 serious CNS conditions PSYCHIATR Y NEUROLOGY Smoking cessation Narcolepsy adults in the U.S. smoke of smokers say they want people in the U.S. are of patients suffer from 34M+ ~70% 185K affected by narcolepsy ~70% cigarettes 1 to quit 2 8 cataplexy 9 ADHD Fibromyalg
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 Epilepsy $0.3 -$0.5B AXS -20 $1 -$3B Schizophrenia Solriamfetol Solriamfetol Shift work disorder ADHD $0.5 -$ 1 B AXS -14 $0.5 -$1B Fibromyalgia AXS -20 AXS -12 $0.5 -$1B Tourette syndrome Narcolepsy Solria
Slide 9: Financial Highlights
Financial Highlights 9 © Axsome Therapeutics, Inc.
Slide 10: 2Q 2026 financial summary
2Q 2026 financial summary $ millions 2Q 2026 2Q 2025 % Change Net Product Revenue $218.4 $150.0 46% AUVELITY $180.3 $119.6 51% SUNOSI * $35.8 $30.0 20% SYMBRAVO $2.3 $0.4 461% R&D Expense $46.2 $49.5 -7% SG&A Expense $208.1 $130.3 60% 2Q = three months ended June 30; * Includes royalty revenue assoc
Slide 11: AUVELITY quarterly net revenue performance
AUVELITY ® quarterly net revenue performance +51% $200 $180.3 $175 $155.1 $153.2 $150 $136.1 $119.6 Millions $125 $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 1Q '26 2Q '26 AU
Slide 12: SUNOSI quarterly net revenue performance
SUNOSI ® quarterly net revenue performance +20% $40 $36.7 $35.8 $35 $33.9 $32.8 $30.0 $30 $26.2 $25.2 $24.4 $25 Millions $22.5 $21.6 $22.1 $19.2 $20.1 $20 $19.1 $16.8 $15 $13.1 $10 $8.8 $5 $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
Slide 13: Financial snapshot
Financial snapshot Runway to reach cash flow positivity , based on the current operating plan Cash Balance: (as of June 30, 2026) $319.9M Debt (Face Value): (as of June 30, 2026) $190M Market Cap: (as of August 7, 2026) $11.0B Shares Outstanding: (as of June 30, 2026) 52.3M Options, RSUs, and Others
Slide 14: Commercial Update
Commercial Update 14 © Axsome Therapeutics, Inc.
Slide 15: Well-positioned for accelerating commercial growth
Well -positioned for accelerating commercial growth HIGHLIGHTS / GROWTH DRIVERS PEAK SALES POTENTIAL • Launched AUVELITY in Alzheimer’s disease agitation in June • Expanded sales force of ~630 representatives • Acceleration in new patient starts and new prescriber activation $8B+ • Strong early NBRx
Slide 16: First and only oral NMDA antagonist and sigma-1 agonist for MDD and Alzheimer's disease agitation
First and only oral NMDA antagonist and sigma -1 agonist for MDD and Alzheimer’s disease agitation 1,2 MAJOR DEPRESSIVE DISORDER Only oral antidepressant with rapid -acting efficacy reflected in FDA label 1 Rapid symptom improvement starting at week 1 and remission as early as week 2, sustained at w
Slide 17: Continued momentum reflects underlying MDD growth and early impact from the sales force expansion
Continued momentum reflects underlying MDD growth and early impact from the sales force expansion Quarterly TRx Launch to Date 280,000 ACCELERATING PRESCRIBER GROWTH ~69,000 +21% 240,000 Unique writers since launch QoQ growth in activated new writers 200,000 160,000 GROWING PATIENT ADOPTION +26% >35
Slide 18: First and only dopamine and norepinephrine reuptake inhibitor 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 continues to drive growth
Durable demand continues to drive growth Quarterly nTRx Launch to Date EXPANDING PRESCRIBER REACH 65,000 >17,000 60,000 Unique writers since launch 55,000 50,000 45,000 40,000 STEADY PATIENT GROWTH 35,000 ~109,000 ~61,000 30,000 Patients treated since launch TRx in 2Q 2026 25,000 20,000 15,000 10,00
Slide 20: Novel, oral, rapidly-absorbed, multi-mechanistic approach for the acute treatment of migraine
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 21: Prescription growth driven by increasing demand
Prescription growth driven by increasing demand Weekly TRx Launch to Date 2,000 PRESCRIBER GROWTH ~4,700 1,800 Unique writers since launch 1,600 1,400 1,200 PATIENT GROWTH 1,000 ~19,500 ~23,500 Patients treated since launch TRx in 2Q 2026 800 600 400 ESTABLISHED MARKET ACCESS 200 ~57% ~56% ~57% 0 To
Slide 22: Development Pipeline
Development Pipeline 22 © Axsome Therapeutics, Inc.
Slide 23: AXS-05 for smoking cessation
AXS -05 for 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 $300 smoke cigarettes, ~50% of preventable disease and death billion in annual costs in
Slide 24: 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 25: Solriamfetol Phase 3 development programs
Solriamfetol Phase 3 development programs ADHD MDD with EDS BED SWD Positive FOCUS Phase 3 • Ongoing CLARITY • Ongoing ENGAGE • Ongoing SUSTAIN trial in adults with ADHD Phase 3 trial in MDD Phase 3 trial in adults Phase 3 trial in adults (N=516) with EDS symptoms with binge eating with shift work d
Slide 26: Attention deficit hyperactivity disorder (ADHD)
Attention deficit hyperactivity disorder (ADHD) Chronic neurobiological and Characterized by a persistent Associated with significant developmental disorder affecting pattern of inattention and/or impairment in social, academic, an estimated ~22M people in the hyperactive -impulsive behaviors 3 and
Slide 27: Statistically significant improvements in ADHD symptoms with solriamfetol treatment
Statistically significant improvements in ADHD symptoms with solriamfetol treatment FOCUS Phase 3 Trial a 0 Primary endpoint: Change from baseline Placebo in AISRS total score at Week 6 Solriamfetol 150 mg Solriamfetol 300 mg -5 17.7 -point reduction in the AISRS total score at Week 6 AISRS Total Sc
Slide 28: Solriamfetol in ADHD pediatric Phase 3 trial designs
Solriamfetol in ADHD pediatric Phase 3 trial designs 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) Solriamfetol (Dose 1) Solriamfetol (Dose 1)
Slide 29: MDD with excessive daytime sleepiness symptoms
MDD with excessive daytime sleepiness symptoms Major depressive disorder Approximately 50% of patients MDD patients with EDS have (MDD) is one of the most with MDD also experience difficulty maintaining common mental disorders in excessive daytime sleepiness wakefulness, resulting in the U.S., impac
Slide 30: CLARITY Phase 3 trial design
CLARITY Phase 3 trial design 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 eligibility criteria Primary endpoint • 18-65 years of age with diagnosis of MDD
Slide 31: Binge eating disorder
Binge eating disorder 1 BED is 1.75x more common in women than in men 1 >7 million people in the U.S. have BED 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 disorde
Slide 32: 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 33: 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 34: 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) (up to 12 weeks) (1 week) Solriamfetol (150 mg) 1:1 R N=450 Placebo Key eligibility criteria Primary endpoint • 18-65 years of age with diagnos
Slide 35: 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 36: Narcolepsy
Narcolepsy Rare and debilitating Characterized by cataplexy, Up to 70% of patients suffer neurological condition that excessive daytime sleepiness from cataplexy, or the affects approximately 185,000 (EDS), hypnagogic sudden reduction or loss of people in the U.S. 1 hallucinations, sleep paralysis,
Slide 37: 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 38: 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 39: 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 reduced resulting from a dysfunction in disturbed
Slide 40: Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment
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 4 mg 8 mg LS mean change from baseline (SE) Weekly mean pain score LS mean change from baseline (SE) LS mean change from baselin
Slide 41: FORWARD Phase 3 trial design
FORWARD Phase 3 trial design 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 criteria Primary endpoint • ≥18 years of age with diagn
Slide 42: AXS-17
AXS -17 Novel oral GABA A receptor α2,3 subtype -selective positive allosteric modulator (PAM) for epilepsy Epilepsy is a chronic and debilitating neurological disorder affecting ~3.4M people in the U.S. 1 Despite currently available AXS -17 was safe and well tolerated Phase 2 trial -enabling activi
Slide 43: AXS-20
AXS -20 Potential first -in-class selective PDE10A inhibitor for neuropsychiatric conditions Schizophrenia Tourette syndrome • Demonstrated a favorable safety and • Evaluating AXS -20 as a potential tolerability profile in clinical studies in >360 treatment for Tourette syndrome individuals to date
Slide 44: Strong intellectual property portfolio
Strong intellectual property portfolio Product Highlights • Protected by a robust patent estate extending to at least 2043, multiple pending AUVELITY • Proprietary drug product formulation and methods of treatment • Protected by a robust patent estate extending to at least 2042, multiple pending SUN
Slide 45: 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 46: Thank you
Thank you 46 © Axsome Therapeutics, Inc.