Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q3 2026 Earnings Presentation
50 slides from Axsome Therapeutics's earnings presentation, Nov 2, 2026
Slide 1: Advancing the frontiers of brain health
Advancing the frontiers of brain health
Slide 2: Forward-looking statements
Certain matters discussed in this presentation are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that
Slide 3: Our mission
We develop medicines through novel therapeutic approaches to improve the lives of people with serious brain disorders Our mission
Slide 4: Positioned for significant and durable growth
BROAD PIPELINE Positioned for significant and durable growth 3 marketed products MDD Migraine AD agitation EDS in OSA or narcolepsy 6 novel product candidates Singular CNS portfolio Psychiatry & Neurology 10 pipeline indications COMMERCIAL Portfolio Psychiatry Neurology Smoking cessation ADHD Binge
Slide 5: 3Q 2026 results
3Q 2026 results COMMERCIAL GROWTH PIPELINE PROGRESS UPCOMING MILESTONES* Net product revenue $259.7M (+52% YoY) >$1 billion annualized revenue run rate Accelerating prescription growth for Alzheimer’s disease agitation, building on continued momentum in MDD AXS-12 NDA under FDA review for cataplexy
Slide 6: Industry-leading neuroscience pipeline with deep stratification
Industry-leading neuroscience pipeline with deep stratification NMDA = N-methyl-D-aspartate; CYP2D6 = Cytochrome P450 Family 2 Subfamily D Member 6; DNRI = Dopamine-norepinephrine reuptake inhibitor; TAAR1 = Trace amine-associated receptor 1; 5-HT = 5-Hydroxytryptamine; NRI = Norepinephrine reuptake
Slide 7: Advancing new frontiers across serious CNS conditions
Advancing new frontiers across 10 serious CNS conditions 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004; 3. Facts About ADHD in Adults. CDC 2024; 4. Sibley MH, et al. 2022; 5. Hudson JI, et al. 2007; 6. Hein M, et al. 2019; 7. Ringeisen H, et al. 2023; 8. Narcolepsy
Slide 8: Singular CNS portfolio with >$18B in annual peak sales potential
Singular CNS portfolio with >$18B in annual peak sales potential $8B+ $0.5-$1B AXS-17 Epilepsy AXS-20 Schizophrenia Psychiatry Neurology Solriamfetol Shift work disorder $0.3-$0.5B AXS-12 Narcolepsy $0.5-$1B $0.5-$1B AXS-14 Fibromyalgia $0.3-$0.5B Solriamfetol ADHD $1-$3B $0.5-$1B AXS-05 Smoking ces
Slide 9: Financial highlights
Financial highlights
Slide 10: 3Q 2026 financial performance
3Q 2026 financial performance 3Q = three months ended September 30; *Includes royalty revenue associated with sales in out-licensed territories and milestone revenue 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.
Slide 11: AUVELITY quarterly net revenue performance
AUVELITY® quarterly net revenue performance AUVELITY 3Q 2026 net product revenue of $207.6M (53% YoY growth) +53%
Slide 12: SUNOSI quarterly net revenue performance
SUNOSI 3Q 2026 net product revenue of $48.2M (47% YoY growth) SUNOSI® quarterly net revenue performance +47%
Slide 13: Financial snapshot
Runway to reach cash flow positivity, based on the current operating plan Financial snapshot Cash balance: (as of September 30, 2026) $313.9M Debt (face value): (as of September 30, 2026) $190M Market cap: (as of October 30, 2026) $7.6B Shares outstanding: (as of September 30, 2026) 52.6M Options, R
Slide 14: Commercial update
Commercial update
Slide 15: Robust commercial portfolio positioned for significant further growth
Robust commercial portfolio positioned for significant further growth *In approved indications only PEAK SALES POTENTIAL* Accelerating new-to-brand prescription growth Broadening prescriber base and deepening utilization Strong market access Durable demand and high patient satisfaction Multiple labe
Slide 16: AUVELITY: first and only oral NMDA antagonist and sigma-1 agonist
First and only oral NMDA antagonist and sigma-1 agonist for MDD and Alzheimer’s disease agitation1,2 NMDA = N-methyl-D-aspartate; MDD = Major depressive disorder 1. AUVELITY [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY; 2. Thomas D, Wessel C. BIO 2017; 3. Iosifescu DV, et al. 2
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 +21% QoQ NBRx growth ~77,000 Unique writers LTD ~89% Total covered lives ~82% Commercial covered lives ~100% Medicare and Medicaid covered lives Accelerating new patient starts S
Slide 18: AUVELITY approved for Alzheimer's disease agitation
AUVELITY was approved by the FDA for the treatment of agitation associated with dementia due to Alzheimer’s disease on April 30, 2026 Acceleration in prescription trends among patients aged 65+ following ADA label expansion, alongside continued growth for under 65 FDA approval FDA approval
Slide 19: Continued NBRx acceleration to drive compounding TRx growth
Continued NBRx acceleration to drive compounding TRx growth FDA approval FDA approval AUVELITY was approved by the FDA for the treatment of agitation associated with dementia due to Alzheimer’s disease on April 30, 2026
Slide 20: SUNOSI: first and only DNRI for EDS in narcolepsy or OSA
First and only dopamine and norepinephrine reuptake inhibitor for EDS associated with narcolepsy or OSA1 First and only wakefulness promoting agent proven to improve wakefulness through 9 hours1 Improvements in cognitive functioning vs. placebo demonstrated in clinical trials 90% of patients reporte
Slide 21: Steady demand continues to drive durable growth
Steady demand continues to drive durable growth Source: Symphony METYS. nTRx normalizes number of pills in each TRx for 30-day period. EXPANDING PRESCRIBER reach STEADY DEMAND GROWTH Broad payer COVERAGE >17,500 Unique writers LTD ~64,400 TRx in 3Q 2026 ~114,000 Patients treated LTD ~82% Total cover
Slide 22: SYMBRAVO: novel oral approach for acute migraine treatment
Novel, oral, rapidly absorbed, multi-mechanistic approach for the acute treatment of migraine1 Single, oral dose provided rapid migraine pain freedom and return to normal functioning within 2 hours1 Harnesses Axsome’s MoSEIC™ rapid absorption technology to target multiple pathways underlying a migra
Slide 23: Expanding prescriber and patient adoption
Expanding prescriber and patient adoption Source: Symphony METYS PRESCRIBER GROWTH PATIENT GROWTH market access >25,000 TRx in 3Q 2026 ~24,900 Patients treated LTD ~5,750 Unique writers LTD ~57% Total covered lives ~56% Commercial covered lives ~57% Medicare and Medicaid covered lives Total prescrip
Slide 24: Development pipeline
Development pipeline
Slide 25: Smoking cessation
70% of smokers want to quit2 Only 3-5% of smokers who attempt to quit without assistance are successful for 6-12 months2 Smoking cessation 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004 Single largest cause of preventable disease and death in the U.S., accounting for
Slide 26: Evaluating AXS-05 as a treatment for smoking cessation
Evaluating AXS-05 as a treatment for smoking cessation Key eligibility criteria 18-65 years of age Primary endpoint Change from baseline in smoking abstinence SUMMIT Phase 3 trial 26 AXS-05 Bupropion Placebo 1:1:1 R Screening Double-blind phase (12 weeks) Follow-up Baseline Topline results anticipat
Slide 27: Solriamfetol: unique pharmacology supports broad CNS potential
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 neuropsychiatric conditions related to the dysregulation of monoaminergic transmission Multimodal activity o
Slide 28: Solriamfetol Phase development programs
Solriamfetol Phase 3 development programs ADHD = Attention deficit hyperactivity disorder; MDD = Major depressive disorder; BED = Binge eating disorder; SWD = Shift work disorder ADHD Positive FOCUS Phase 3 trial in adults with ADHD (N=516) Topline data from FOCUS-2 and FOCUS-3 Phase 3 trials in chi
Slide 29: Solriamfetol potential to treat a broad range of conditions
Solriamfetol has the potential to treat a broad range of psychiatric and neurological conditions Excessive daytime sleepiness (EDS) in OSA and narcolepsy Approved indication ADHD: ~22M patients Binge eating disorder: ~7M patients Major depressive disorder with EDS symptoms: ~10.5M patients Shift wor
Slide 30: Attention-deficit/hyperactivity disorder (ADHD)
Attention-deficit/hyperactivity disorder (ADHD) 1. Facts About ADHD in Adults. CDC 2024; 2. Data and Statistics on ADHD. CDC 2024; 3. Attention-Deficit/Hyperactivity Disorder. NIMH 2024 Chronic neurobiological and developmental disorder affecting an estimated ~22M people in the U.S.1, including ~7M
Slide 31: Significant improvements in ADHD severity vs. placebo
Significant improvements in overall ADHD severity vs. placebo (CGI-S, p=0.017)c AISRS total score LSM change (±SE) FOCUS Phase 3 Triala AISRS = Adult ADHD Investigator Symptom Rating Scale; LSM = least-squares mean; SE = standard error; SR = sustained release; CGI-S = Clinical Global Impression–Seve
Slide 32: Solriamfetol Phase program in pediatric ADHD
Solriamfetol Phase 3 program in pediatric ADHD Key eligibility criteria 6 to <12 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from baseline in ADHD-RS-5 total score Key eligibility criteria 12 to <18 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from base
Slide 33: Binge eating disorder
Binge eating disorder 1. Hudson JI, et al. 2007; 2. Swanson SA, et al. 2011; 3. Kessler RM, et al. 2016; 4. McElroy SL, et al. 2020 >7 million people in the U.S. have BED1 BED is 1.75x more common in women than in men1 BED is thought to involve issues with food reward processing, impulse control, co
Slide 34: Solriamfetol for the treatment of binge eating disorder
Topline results anticipated 1Q 2027 Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-3 Preclinical and clinical data support potential effects of solriamfetol on appetite, food consumption, and weight4,5
Slide 35: Shift work disorder
Shift work has long been associated with multiple serious health complaints and a 23% greater risk of sustaining a work-related injury4-5 No new medications approved since 2007 and considerable residual sleepiness reported when medication is used6 ~15 million U.S. workers may suffer from SWD 10-43%
Slide 36: Solriamfetol for the treatment of shift work disorder
Solriamfetol for the treatment of shift work disorder Key eligibility criteria 18-65 years of age with diagnosis of SWD (ICSD-2 or ICSD-3) Primary endpoint Change from baseline in MWT Placebo Solriamfetol (150 mg) Screening (1-4 weeks) Double-blind phase (up to 12 weeks) Baseline 1:1 R N=450 Follow-
Slide 37: MDD with excessive daytime sleepiness symptoms
MDD with excessive daytime sleepiness (EDS) symptoms 1. Rush AJ, et al. 2006; 2. Major Depression. NIMH 2023; 3. Hasin DS, et al. 2018; 4. Hein M, et al. 2019 Major depressive disorder (MDD) is one of the most common mental disorders in the U.S., impacting ~21M adults each year2,3 Approximately 50%
Slide 38: Solriamfetol for the treatment of MDD with EDS symptoms
Placebo Solriamfetol (150 mg) Solriamfetol for the treatment of MDD with EDS symptoms Key eligibility criteria 18-65 years of age with diagnosis of MDD (DSM-5 criteria) Symptoms of excessive daytime sleepiness Double-blind phase Primary endpoint Time from randomization to relapse of depressive sympt
Slide 39: AXS-12 (reboxetine): novel approach for narcolepsy
1. Szabo ST, et al. 2019; 2. Krahn LE, Zee PC, Thorpy MJ. 2022; 3. Scammell TE. 2015; 4. Stahl SM, Grady MM. 2003; 5. Burgess CR, Peever JH. 2013; 6. Wu MF, et al. 1999; 7. Bruinstroop E, et al. 2012 Norepinephrine and dopamine play important roles in sleep-wake regulation (both) and in maintaining
Slide 40: Narcolepsy
Narcolepsy 1. Narcolepsy Network 2024; 2. Sateia MJ. 2014; 3. Narcolepsy. NINDS 2024; 4. España RA, Scammell TE. 2011; 5. Swick TJ. 2015 Rare and debilitating neurological condition that affects approximately 185,000 people in the U.S.1 Characterized by cataplexy, excessive daytime sleepiness (EDS),
Slide 41: Rapid and robust reductions in cataplexy with AXS-12
Rate ratio* p=0.007 p=0.006 p=0.031 p=0.031 p=0.018 p<0.001 p=0.002 *Ratio of change in the AXS-12 group divided by the ratio of change in the placebo group (rate ratio of 1 = no difference) CONCERT SYMPHONY Rapid and robust reductions in cataplexy with AXS-12 treatment PDUFA target action date: May
Slide 42: AXS-14 (esreboxetine): novel approach for fibromyalgia
Adapted from Siracusa, R. et al. 2021 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-inhibitory effects AXS-14 is a potent and selective enantiom
Slide 43: Fibromyalgia
Fibromyalgia 1. Vincent, et al. 2013; 2. Choy E, et al. 2010; 3. Arnold LM, et al. 2008; 4. Bair MJ, Krebs EE. 2020; 5. Clauw DJ. 2024 Chronic and debilitating neurological pain syndrome resulting from a dysfunction in central pain processing2,3 Characterized by widespread musculoskeletal pain, fati
Slide 44: Rapid and robust improvements in fibromyalgia symptoms with AXS-14
Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment Efficacy and safety of AXS-14 compared to placebo evaluated in >1,000 individuals with fibromyalgia across Phase 2 and Phase 3 clinical trials for up to 14 weeks Rapid and significant reductions in pain scores, improvements
Slide 45: AXS-14 for the management of fibromyalgia
AXS-14 for the management of fibromyalgia Key eligibility criteria ≥18 years of age with diagnosis of fibromyalgia Primary endpoint Time from randomization to loss of therapeutic response FORWARD Phase 3 trial Placebo AXS-14 (8 mg) Open-label period (12 weeks) Double-blind phase (up to 12 weeks) Bas
Slide 46: AXS-17 for epilepsy
Epilepsy is a chronic and debilitating neurological disorder affecting ~3.4M people in the U.S.1 1. Epilepsy. CDC 2025; 2. Chen Z, et al. 2018 Despite currently available treatment options, >1/3 of patients do not respond to treatment2 AXS-17 was safe and well tolerated in clinical studies in >700 p
Slide 47: AXS-20 for schizophrenia
~3.7M people in the U.S. have schizophrenia and related psychotic disorders1 1. Ringeisen H, et al. 2023 Completed proof-of-concept Phase 2 trial in patients with schizophrenia AXS-20 demonstrated a favorable safety and tolerability profile in clinical studies in >360 individuals to date Phase 3 ini
Slide 48: Strong intellectual property portfolio
Strong intellectual property portfolio AUVELITY AXS-12 SUNOSI AXS-14 SYMBRAVO Protected by a robust patent estate extending to at least 2043, multiple pending Proprietary drug product formulation and methods of treatment Protected by a robust patent estate extending to at least 2042, multiple pendin
Slide 49: Leadership team
Leadership team Former President, Co-CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Herriot Tabuteau, MD FOUNDER & CEO Management Board of Directors Nick Pizzie, CPA, MBA CHIEF FINANCIAL OFFICER Mark Jacobson, MA CHIEF OPERATING OFFICER Hunter Murdock, JD GEN
Slide 50: Thank you
Thank you. We develop medicines through novel therapeutic approaches to improve the lives of people with serious brain disorders