Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q3 2025 Earnings Presentation
46 slides from Axsome Therapeutics's earnings presentation, Nov 3, 2025
Slide 1: 3Q 2025 Corporate Presentation
November 3, 2025 3Q 2025 Corporate Presentation
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
Our Mission Develop and deliver transformative medicines for the hundreds of millions of people impacted by central nervous system conditions
Slide 4: How we drive innovation in brain health
Develop first-in-class or best-in-class medicines Enabled by clinical research and regulatory innovation Deliver novel mechanisms of action Apply precision approaches in novel, underserved indications Leverage our deep expertise in neuroscience How we drive innovation in brain health
Slide 5: Positioned to deliver compounding growth and enduring value
Positioned to deliver compounding growth and enduring value Novel medicines delivering real-world impact and driving robust growth Late-stage clinical trials fully underway or initiating in the near term New indications expanding the potential of our approved medicines Potential approvals through 20
Slide 6: 3Q 2025 performance
3Q 2025 performance Innovation Discipline Execution sNDA for AXS-05 in Alzheimer’s disease agitation submitted to the FDA NDA submission for AXS-12 for cataplexy in narcolepsy anticipated 4Q 2025 Phase 3 trial of solriamfetol in children and adolescents with ADHD anticipated 4Q 2025 Advancing multip
Slide 7: Strategic focus across high-impact CNS conditions
>50% people in the U.S. have fibromyalgia10 39M+ 17M+ Strategic focus across high-impact CNS conditions 1. Major Depression. NIMH 2023; 2. Rush AJ, et al. Am J Psychiatry 2006; 3. Benjafield AV, et al. Lancet Respir Med. 2020; 4. Watson N, et al. Sleep 2025; 5. American Migraine Foundation 2023; 6.
Slide 8: Advancing a diversified late-stage pipeline
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 inhibitor; Please see full Prescribing Information for AUVELITY
Slide 9: Multiple paths to value creation with >$16B peak sales potential
Multiple differentiated paths to value creation with >$16B in combined peak sales potential AXS-05 AD Agitation $0.5-$1B AXS-14 Fibromyalgia AXS-12 Narcolepsy $0.5-$1B $1.5-$3B Solriamfetol MDD with EDS Solriamfetol ADHD $1-$3B $0.5-$1B Solriamfetol BED $0.3-$0.5B Solriamfetol SWD $0.5-$1B AXS-05 Sm
Slide 10: Continued execution with key upcoming milestones ahead
Continued execution with key upcoming milestones ahead 2025 & 2026 Clinical Trial Topline Results Clinical Trial Initiations & Progress Positive topline results from EMERGE Ph 3 trial of SYMBRAVO in oral CGRP non-responders (1Q 2025) Positive topline results from FOCUS Ph 3 trial of solriamfetol in
Slide 11: Shaping the frontier of differentiated innovation in brain health
Shaping the frontier of differentiated innovation in brain health
Slide 12: 3Q 2025 financial summary
3Q 2025 financial summary 3Q = three months ended September 30; †Includes royalty revenue associated with sales in out-licensed territories Net Product Revenue $171.0 $104.8 63% $442.5 $266.9 66% AUVELITY Net Product Sales $136.1 $80.4 69% $352.0 $198.8 77% SUNOSI Net Product Revenue† $32.8 $24.4 35
Slide 13: Financial snapshot
Cash Balance: (as of September 30, 2025) $325.3M Debt (Face Value): (as of September 30, 2025) $190M Market Cap: (as of October 31, 2025) $6.7B Shares Outstanding: (as of September 30, 2025) 50.3M Options, RSUs, and Warrants Outstanding*: 9.3M Runway to reach cash flow positivity, based on the curre
Slide 14: Commercial Highlights
Commercial Highlights axsome
Slide 15: Commercial execution driving accelerating growth across CNS portfolio
Commercial execution driving accelerating growth across our expanding CNS portfolio EDS = Excessive daytime sleepiness; OSA = Obstructive sleep apnea Rx, sales, and revenue growth vs. comparable periods in 2024 ~$5B combined peak sales potential Continued strong demand growth and broadening prescrib
Slide 16: AUVELITY: 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, D.V. et al.
Slide 17: AUVELITY demand and expanding market access
Source: Symphony METYS Quarterly TRx Launch to Date Continued strong demand and expanding market access driving further growth TRx = Total prescriptions; NBRx = New-to-brand prescriptions +50% NBRx growth in primary care since Q1 expansion ~250,000 New patients since launch ~46,000 Unique writers si
Slide 18: AUVELITY quarterly net sales performance
AUVELITY® quarterly net sales performance 3Q 2025 net product sales of $136.1M represents 69% YoY growth +69%
Slide 19: SUNOSI: first and only wakefulness promoting agent through 9 hours
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 reported feeling better with SUNOSI 150 mg2 First and only dopamine and norepinephrine reuptake inhibitor for ED
Slide 20: SUNOSI quarterly nTRx launch to date
Quarterly nTRX Launch to Date Steady growth supported by durable demand and high patient satisfaction nTRx = Normalized total prescriptions ~94,000 New patients since launch ~15,100 Unique writers since launch ~83% Covered lives all channels Source: Symphony METYS. nTRx normalizes number of pills in
Slide 21: SUNOSI quarterly net revenue performance
SUNOSI® quarterly net revenue performance 3Q 2025 net product revenue of $32.8M represents 35% YoY growth +35%
Slide 22: SYMBRAVO: rapid migraine pain freedom within 2 hours
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 migraine attack Superior efficacy demonstrated across a broad range of migraine severity (mild, mode
Slide 23: SYMBRAVO strong foundation with growing clinician awareness
Establishing a strong foundation with growing clinician awareness and broader patient access TRx = Total prescriptions Weekly TRx Launch to Date Source: Symphony METYS >5,000 Total prescriptions in 3Q 2025 >3,300 New patients in 3Q 2025 ~48% Covered commercial lives ~52% Covered lives all channels
Slide 24: Development Pipeline
Development Pipeline axsome
Slide 25: AXS-05 for Alzheimer's disease agitation
AXS-05 is believed to modulate the function of neurotransmitters and receptors implicated in Alzheimer’s disease (glutamate, sigma-1, norepinephrine, and dopamine)1-4 In Alzheimer’s disease, insoluble Aβ production and accumulation triggers secondary steps leading to synaptic loss and neuronal cell
Slide 26: Alzheimer's disease agitation
Alzheimer’s disease (AD) agitation 1. 2025 Alzheimer’s Disease Facts and Figures; 2. Trachtenberg et al. J Neuropsychiatry Clin Neurosci. 2002 Number of U.S. adults aged 65+ with Alzheimer’s dementia expected to double by 20601 26 Alzheimer’s disease (AD) is the most common form of dementia, affecti
Slide 27: Improvements in Alzheimer's disease agitation
Statistically significant and clinically meaningful improvements in Alzheimer’s disease agitation CMAI = Cohen-Mansfield Agitation Inventory p=0.069 p=0.007 p=0.010 0 Weeks from Randomization Probability of Freedom from Relapse (%) ACCORD-2 100 75 50 25 0 2 4 6 8 10 12 14 16 18 20 22 24 26 + Censore
Slide 28: Smoking cessation
70% of smokers want to quit2 Only 3-5% who attempt to quit without assistance are successful for 6-12 months2 Smoking cessation Single largest cause of preventable disease and death in the U.S., accounting for nearly 1 in 5 deaths1 Associated with over $300 billion in annual costs in the U.S.1 ~34M
Slide 29: Unique pharmacology of solriamfetol
Unique pharmacology of solriamfetol supports potential utility in a broad range of CNS conditions 1. Raony I, et al. Prog Neuropsychopharmacol Biol Psychiatry 2022; 2. Halff EF, et al. Trends Neurosci. 2023 Solriamfetol was initially developed as a dopamine and norepinephrine reuptake inhibitor (DNR
Slide 30: Solriamfetol Phase development programs
Solriamfetol Phase 3 development programs Topline data 2026 Topline data 2026 Complete Complete Substantial and statistically significant improvements in ADHD symptoms and disease severity Initiation of Phase 3 pediatric trial anticipated in 4Q 2025 Solriamfetol FOCUS Phase 3 (N=516) PARADIGM Phase
Slide 31: Attention deficit hyperactivity disorder (ADHD)
Attention deficit hyperactivity disorder (ADHD) Chronic neurobiological and developmental disorder affecting an estimated ~22M people in the U.S.1, including ~7M children aged 3-17 years old2 Characterized by a persistent pattern of inattention and/or hyperactive-impulsive behaviors3 Associated with
Slide 32: Significant improvements in ADHD symptoms in FOCUS Phase 3 trial
1. p-values shown for solriamfetol 150 mg dose vs. placebo only (primary analysis) Significant improvements in ADHD symptoms with solriamfetol treatment in FOCUS Phase 3 trial in adult patients Substantial reduction in the AISRS score of 17.7 points at Week 6, representing a 45% improvement in ADHD
Slide 33: Major depressive disorder
Major depressive disorder ~2/3 of patients experience inadequate response to first-line treatment1 1. Rush AJ, et al. Am J Psychiatry 2006; 2. Major Depression. NIMH 2023; 3. Hasin DS, et al. JAMA Psychiatry 2018; 4. Hein M, et al. J Affect Disord. 2019 Approximately 50% of patients with MDD also ex
Slide 34: Binge eating disorder
Binge eating disorder 1. Hudson JI, et al. Biol Psychiatry 2007; 2. Swanson SA, et al. Arch Gen Psychiatry 2011; 3. Kessler RM, et al. Neurosci Biobehav Rev. 2016; 4. McElroy SL, et al. J Clin Psychiatry 2020; BED is thought to involve issues with food reward processing, impulse control, cognitive c
Slide 35: Ongoing Phase 3 trial of solriamfetol in binge eating disorder
Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-3 Topline results from the ENGAGE Phase 3 trial of solriamfetol in binge eating disorder anticipated in 2026 Pre-clinical and clinical data support potenti
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 No new medications approved since 2007 and considerable residual sleepiness reported when medication is used6 ~15 million U.S. workers may suf
Slide 37: Evaluating solriamfetol as a potential treatment for SWD
Evaluating solriamfetol as a potential treatment for SWD Solriamfetol (150 mg) Solriamfetol (300 mg) Placebo Screening (1-4 weeks) Double-blind Phase (12 weeks) Follow-up (1 week) Baseline SUSTAIN Phase 3 Trial N=450 Key eligibility criteria 18-65 years of age with diagnosis of SWD (ICSD-2 or ICSD-3
Slide 38: AXS-12 novel pharmacological approach for narcolepsy
1. Szabo ST, et al. Sleep Med Rev. 2019; 2. Krahn LE, Zee PC, & Thorpy MJ. Adv Ther. 2022; 3. Scammell TE. N Engl J Med. 2015; 4. Stahl SM & Grady MM. J Clin Psychiatry 2003; 5. Burgess CR & Peever JH. Curr Biol. 2013; 6. Wu MF, et al. Neuroscience 1999; 7. Bruinstroop E, et al. J Comp Neurol. 2012
Slide 39: Narcolepsy
Narcolepsy Rare and debilitating neurological condition that affects approximately 185,000 people in the U.S.1 Characterized by cataplexy, excessive daytime sleepiness (EDS), hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep2-4 An estimated 70% of patients suffer from cataple
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 novel approach for 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-inhibitory effects AXS-14 is a more potent and selective enantiomer of racemic reboxetine that inh
Slide 42: Fibromyalgia
Fibromyalgia 1. Vincent, et al. Arthritis Care Res (Hoboken) 2013; 3. Choy E, et al. BMC Health Serv Res. 2010; 3. Arnold LM, et al. Patient Educ Couns. 2008; 4. Bair MJ & Krebs EE. Ann Intern Med. 2020; 5. Clauw DJ. Ann Rheum Dis. 2024 Chronic and debilitating neurological pain syndrome resulting f
Slide 43: Efficacy of AXS-14 in Phase 2 and Phase 3 fibromyalgia trials
Rapid and robust efficacy demonstrated in Phase 2 and Phase 3 trials of AXS-14 in fibromyalgia Baseline * * *** * ** *** *** ** *** *** **** **** **** p<0.05 * p<0.01 ** p<0.001 *** p<0.0001 **** *** *** **** Baseline * ** *** *** *** ** *** *** ** **** Baseline * * Pain reduction Phase 3 efficacy r
Slide 44: Strong intellectual property and barriers to entry
Strong intellectual property and barriers to entry 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 2041; Multiple pending Proprietary MoSEICTM form
Slide 45: 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 46: Thank you
Thank you axsome