Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q1 2026 Earnings Presentation
49 slides from Axsome Therapeutics's earnings presentation, May 4, 2026
Slide 1: 1Q 2026 Financial Results
May 4, 2026 1Q 2026 Financial Results
Slide 2: Forward looking statements & safe harbor
Forward looking statements & safe harbor 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,” “mig
Slide 3: Our Mission
3 Our Mission Develop and deliver transformative medicines to improve the brain health of millions of individuals
Slide 4: A singular CNS platform
A singular CNS platform 10 high-unmet-need indications 6 novel product candidates 3 marketed products MDD 21M+ Migraine 39M+ AADAD 5M+ EDS in OSA or narcolepsy 22M+ 4 approved indications pipeline Singular
Slide 5: Significant advancements across our industry-leading pipeline
Significant advancements across our industry-leading pipeline AUVELITY PIPELINE PROGRESS UPCOMING MILESTONES NEW APPROVED INDICATION NDA for AXS-12 for cataplexy in narcolepsy submitted to the FDA Initiated CLARITY Phase 3 trial of solriamfetol in MDD with EDS symptoms Initiated FORWARD Phase 3 tria
Slide 6: Leading neuroscience pipeline with deep stratification
Leading neuroscience pipeline with deep stratification Phase 1 Phase 2 Phase 3 NDA AXS-05 (dextromethorphan-bupropion) AXS-12 (reboxetine) AXS-17 NMDA antagonist and sigma-1 agonist Highly selective NRI and dopamine modulator GABAA α2,3 subtype-selective PAM Smoking Cessation Tourette Syndrome Psych
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: Expansive portfolio positioned to generate >$18B in peak sales
Solriamfetol ADHD Expansive portfolio positioned to generate >$18B in peak sales $0.5-$1B AXS-14 Fibromyalgia AXS-12 Narcolepsy $0.5-$1B Solriamfetol MDD with EDS $0.5-$1B AXS-05 Smoking Cessation $1-$1.5B $0.3-$0.5B $8B+ $0.5-$1B AXS-17 Epilepsy AXS-20 Schizophrenia AXS-20 Tourette syndrome Psychia
Slide 9: Advancing the frontiers of brain health
Broad commercial portfolio Expanding AUVELITY Industry-leading CNS pipeline Three innovative medicines improving patient outcomes and driving durable growth Second approved indication expanding reach and accelerating growth Potential first-in-class, best-in-class treatments across ten serious CNS co
Slide 10: Financial Highlights
axsome Financial Highlights
Slide 11: 1Q 2026 financial highlights
$153.2M +59% $33.9M +34% $4.1M — 1Q 2026 financial highlights $191M Total revenue 1Q 2026 57% YoY growth 1Q 2026 REVENUE YoY GROWTH
Slide 12: AUVELITY quarterly net revenue performance
AUVELITY® quarterly net revenue performance AUVELITY 1Q 2026 net produce revenue of $507.1M (74% YoY growth) +59%
Slide 13: SUNOSI quarterly net revenue performance
+34% SUNOSI 1Q 2026 net produce revenue of $33.9M (34% YoY growth) SUNOSI® quarterly net revenue performance
Slide 14: 1Q 2026 financial summary
1Q 2026 financial summary 1Q = three months ended March 31; *Includes royalty revenue associated with sales in out-licensed territories Net Product Revenue $191.2 $121.5 57% AUVELITY $153.2 $96.2 59% SUNOSI* $33.9 $25.2 34% SYMBRAVO $4.1 — — R&D Expense $52.7 $44.8 18% SG&A Expense $185.0 $120.8 53%
Slide 15: Financial snapshot
Cash Balance: (as of March 31, 2026) $305.1M Debt (Face Value): (as of March 31, 2026) $190M Market Cap: (as of May 1, 2026) $10.6B Shares Outstanding: (as of March 31, 2026) 51.4M Options, RSUs, and Others Outstanding*: 8.8M Runway to reach cash flow positivity, based on the current operating plan
Slide 16: Commercial Update
axsome Commercial Update
Slide 17: Executing across a broad commercial portfolio
Executing across a broad commercial portfolio with significant combined peak sales potential Expanding adoption in primary care ~630 sales represents to increase reach across primary care, psychiatry, neurology, and geriatrics in MDD and Alzheimer’s disease agitation Continued steady growth across O
Slide 18: First-in-class treatment for agitation associated with Alzheimer's disease
First-in-class treatment for agitation associated with Alzheimer’s disease NMDA = N-methyl D-aspartate †Defined as ≥5% and more than twice placebo Efficacy demonstrated in short-term and long-term studies Only approved treatment for agitation associated with dementia due to Alzheimer’s disease demon
Slide 19: First and only oral NMDA receptor antagonist and sigma-1 agonist for MDD
First and only oral NMDA receptor antagonist and sigma-1 receptor agonist for MDD in adults1,2 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. 2022 On
Slide 20: Continued momentum driven by expanding adoption in primary care
Continued momentum driven by expanding adoption in primary care TRx = Total prescriptions Source: Symphony METYS Quarterly TRx Launch to Date EXPANDING PRESCRIBER BASE >223,000 TRx in 1Q 2026 (+35% YoY) >300,000 Patients treated since launch ~60,000 Unique writers since launch ~56% First- or second-
Slide 21: Strong commercial foundation for expansion into Alzheimer's disease agitation
Strong commercial foundation for expansion into Alzheimer’s disease agitation COMMERCIAL FOUNDATION Sales representatives HCP targets treating MDD and Alzheimer’s disease agitation Medicare and Medicaid lives covered Commercial lives covered ~630 100% ~68K 78% Educational efforts across community an
Slide 22: 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 OSA1 EDS = Excessive daytime sleepiness; OSA = Obstructive sleep apnea; DNRI = Dopamine-norepinephrine reuptake inhibitor 1. SUNOSI [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY;
Slide 23: Sustained growth and impact
Sustained growth and impact nTRx = Normalized total prescriptions Source: Symphony METYS. nTRx normalizes number of pills in each Trx for 30-day period. Quarterly nTRx Launch to Date Continued prescriber reach ~54,000 TRx in 1Q 2026 (+16% YoY) >103,000 Patients treated since launch ~16,500 Unique wr
Slide 24: Novel, oral, rapidly-absorbed approach for acute treatment of migraine
Novel, oral, rapidly-absorbed, multi-mechanistic approach for the acute treatment of migraine1 1. SYMBRAVO [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY Single, oral dose provided rapid migraine pain freedom and return to normal functioning within 2 hours1 Harnesses Axsome’s MoS
Slide 25: Momentum building through trial, access, and reach
Momentum building through trial, access, and reach TRx = Total prescriptions Source: Symphony METYS Weekly TRx Launch to Date INITIAL PRESCRIBER ADOPTION >17,000 TRx in 1Q 2026 (+36% QoQ) >13,500 New patients since launch ~3,400 Unique writers since launch ~60% Neurologist share of prescribers ~57%
Slide 26: Development Pipeline
axsome Development Pipeline
Slide 27: AXS-05 for smoking cessation
70% of smokers want to quit2 Only 3-5% who attempt to quit without assistance are successful for 6-12 months2 AXS-05 for 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 28: Solriamfetol unique pharmacology
1. Raony I, et al. 2022; 2. Halff EF, et al. 2023 Solriamfetol was initially developed as a dopamine and norepinephrine reuptake inhibitor (DNRI) with wake-promoting effects Preclinical and clinical evidence1,2 suggest TAAR1 plays a role in neuropsychiatric conditions related to the dysregulation of
Slide 29: Solriamfetol Phase 3 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) Initiation of two Phase 3 trials in children and adolescent
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 overall 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 CMAI = Cohen-Mansfield Agitation Inventory; LSM = least-squares mean; SE = standard error; SR = sustained release a. p-values shown for solriamfetol 150 mg p-values
Slide 32: MDD with excessive daytime sleepiness symptoms
MDD with excessive daytime sleepiness 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% of pat
Slide 33: CLARITY Phase 3 trial design
Placebo Solriamfetol (150 mg) CLARITY Phase 3 trial design Key eligibility criteria 18-65 years of age with diagnosis of MDD (DCM-5 criteria) Excessive daytime sleepiness symptoms Open-label Period Double-blind Phase Baseline CLARITY Phase 3 Trial 1:1 R Primary endpoint Time from randomization to re
Slide 34: 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 BED is thought to involve issues with food reward processing, impulse control, cognitive control, and appetite regulation1,3 Unmet medical need associated with a 2- to
Slide 35: Evaluating solriamfetol for binge eating disorder
Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-3 Pre-clinical and clinical data support potential effects of solriamfetol on appetite, food consumption, and weight4,5 Evaluating solriamfetol as a potent
Slide 36: 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 Shift work disorder 1. Sateia MJ. 2014; 2. Alterman T, et al. 2013; 3. Wickwire EM. 2017; 4. Smith L, et al. 1994; 5. Akerstedt T, Wright KP. 2009; 6. Czeisler CA
Slide 37: Evaluating solriamfetol for shift work disorder
Placebo Solriamfetol (150 mg) Evaluating solriamfetol as a potential treatment for shift work disorder MWT = Maintenance of Wakefulness Test Key eligibility criteria 18-65 years of age with diagnosis of SWD (ICSD-2 or ICSD-3) Screening (1-4 weeks) Double-blind Phase (up to 12 weeks) Baseline SUSTAIN
Slide 38: 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 39: 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 40: 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 New Drug Application (NDA) su
Slide 41: 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 42: Fibromyalgia
Fibromyalgia 1. Vincent, et al. 2013; 3. 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 43: Rapid and robust improvements in fibromyalgia symptoms with AXS-14
Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment Baseline * * *** * ** *** *** ** *** *** **** **** **** *** *** **** Baseline * ** *** *** *** ** *** *** ** **** Baseline * * Pain reductiona Phase 3 efficacy results (N=1,122) Efficacy and safety of AXS-14 compared to pla
Slide 44: FORWARD Phase 3 trial design
Placebo AXS-14 (8 mg) FORWARD Phase 3 trial design Key eligibility criteria ≥18 years of age with diagnosis of fibromyalgia Open-label Period (12 weeks) Double-blind Phase (up to 12 weeks) Baseline FORWARD Phase 3 Trial 1:1 R Primary endpoint Time from randomization to loss of therapeutic response A
Slide 45: AXS-17 for epilepsy
1. Epilepsy. CDC 2025; 2. Chen Z, et al. 2018 Despite currently available treatment options, <1/3 of patients do not response to treatment2 AXS-17 was safe and well tolerated in clinical studies in >700 patients to date and demonstrated compelling anti-convulsant activity in preclinical seizure mode
Slide 46: AXS-20 PDE10A inhibitor for schizophrenia and Tourette syndrome
1. Ringeisen H, et al. 2023; 2. Tourette Syndrome. CDC 2025 Potential first-in-class selective PDE10A inhibitor for neuropsychiatric conditions AXS-20 Schizophrenia Demonstrated a favorable safety and tolerability profile in clinical studies in >360 individuals to date Completed a proof-of-concept P
Slide 47: Strong intellectual property and barriers to entry
Strong intellectual property and barriers to entry AXS-05 AXS-12 AXS-14 SYMBRAVO SUNOSI AUVELITY 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 20
Slide 48: Leadership team
Leadership team Roger Jeffs, PhD CEO, Liquidia Corporation 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 Chi
Slide 49: Thank you
Thank you axsome