Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q2 2025 Earnings Presentation
45 slides from Axsome Therapeutics's earnings presentation, Aug 4, 2025
Slide 1: 2Q 2025 Corporate Presentation
August 4, 2025 2Q 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 is to develop and deliver transformative medicines for CNS conditions
Our mission is to develop and deliver transformative medicines for the hundreds of millions of people impacted by central nervous system conditions At Axsome, we are defining the future of clinical practice in brain health
Slide 4: Potential to reach >150M people in the U.S. across serious CNS conditions
Potential to reach >150M people in the U.S. across 10 serious CNS conditions We focus on conditions with high unmet need, strong value creation potential, and clear strategic fit Major depressive disorder Alzheimer’s disease agitation Smoking cessation ADHD Binge eating disorder Neurology Obstructiv
Slide 5: Develop first-in-class or best-in-class medicines
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 Our strategy positions us to advance the frontiers in b
Slide 6: Leading in neuroscience innovation with a robust path to long-term growth
Leading in neuroscience innovation with a robust path to significant long-term growth In-market innovations Phase 3 development programs ongoing New indications in development across approved products Potential approvals through 2028 CNS conditions with critical gaps in care 3 4 6 7 10 + + + +
Slide 7: Executing across a broad and deep 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 8: Combined peak sales potential of $16.5B
Differentiated portfolio enables multiple paths to value creation with combined peak sales potential of $16.5B 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
Slide 9: 2Q 2025 highlights
sNDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025 NDA submission for AXS-12 for cataplexy in patients with narcolepsy on track for 4Q 2025 Advancing late-stage programs in ADHD, binge eating disorder, shift work disorder, depression associated with excessive daytime sl
Slide 10: Strong progress toward near-term regulatory and clinical milestones
Strong progress to date with multiple programs advancing toward near-term regulatory and clinical milestones 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 top
Slide 11: 2Q 2025 financial summary
2Q 2025 financial summary 2Q = three months ended June 30; *Includes royalty revenue associated with sales in out-licensed territories Net Product Revenue $150.0 $87.2 72% $271.5 $162.2 67% AUVELITY Net Product Sales $119.6 $65.0 84% $215.9 $118.4 82% SUNOSI Net Product Revenue* $30.0 $22.1 40% $55.
Slide 12: Financial snapshot
Cash Balance: (as of June 30, 2025) $303.0 M Debt (Face Value): (as of June 30, 2025) $190 M Market Cap: (as of August 1, 2025) $5.1 B Shares Outstanding: (as of June 30, 2025) 49.8 M Options, RSUs, and Warrants Outstanding*: 9.9 M Runway to reach cash flow positivity, based on the current operating
Slide 13: Commercial Highlights
Commercial Highlights axsome
Slide 14: Building a leading commercial portfolio in CNS
Building a leading commercial portfolio in CNS Launched in the U.S. on June 10, 2025 EDS = Excessive daytime sleepiness; OSA = Obstructive sleep apnea Rx, sales, and revenue growth vs. comparable periods in 2024 MIGRAINE WITH OR WITHOUT AURA MAJOR DEPRESSIVE DISORDER EDS IN NARCOLEPSY OR OSA +56% TR
Slide 15: 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 16: Robust underlying demand and expanding access
Robust underlying demand and expanding access Source: Symphony METYS Weekly TRx Launch to Date TRx = Total prescriptions ~192,000 Total prescriptions in Q2 ~30,000 New to brand Rx in Q2 ~220,000 New patients since launch ~41,000 Unique writers since launch ~28M Additional new covered commercial live
Slide 17: AUVELITY quarterly net sales performance
AUVELITY quarterly net sales performance 2Q 2025 net product sales of $119.6M represents growth of 84% YoY and 24% QoQ +84%
Slide 18: SUNOSI: first and only wakefulness promoting agent proven 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 19: Continued success supported by strong fundamentals
Continued success supported by strong fundamentals nTRx = Normalized total prescriptions ~50,000 Total prescriptions in Q2 ~89,000 New patients since launch ~15,000 Unique writers since launch ~83% Covered lives all channels Source: Symphony METYS. nTRx normalizes number of pills in each Trx for 30-
Slide 20: SUNOSI quarterly net revenue performance
SUNOSI quarterly net revenue performance 2Q 2025 net product revenue of $30.0M represents growth of 35% YoY and 19% QoQ +35%
Slide 21: 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 rapid absorption technology to target multiple pathways underlying a migraine attack Superior efficacy demonstrated across a broad range of migraine severity (mild, moderate, se
Slide 22: Early launch metrics support SYMBRAVO
Early launch metrics support SYMBRAVO’s promise in the acute treatment of migraine 1. Symphony Health Claims, New to Brand Patients (2022-2023); 2. Lipton, et al. Neurology 2015 High patient dissatisfaction due to limited efficacy and/or burdensome side effects >80% of patients discontinue their acu
Slide 23: Development Pipeline
Development Pipeline axsome
Slide 24: AXS-05 for Alzheimer's disease agitation
AXS-05 modulates 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 death1,2 Reduc
Slide 25: Alzheimer's disease (AD) 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 25 Alzheimer’s disease (AD) is the most common form of dementia, affecti
Slide 26: Statistically significant 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 27: 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 28: Unique pharmacology of solriamfetol supports broad CNS potential
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 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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 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 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 36: Evaluating solriamfetol as a potential treatment for SWD
Evaluating solriamfetol as a potential treatment for SWD Solriamfetol (150 mg) Solriamfetol (300 mg) Placebo 1:1:1 R 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 o
Slide 37: 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 38: 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 39: 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 Weekly cataplexy attacks (median) 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 treat
Slide 40: AXS-14 (esreboxetine) 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 41: 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 42: Statistically significant improvements in fibromyalgia symptoms
Statistically significant improvements in key symptoms of fibromyalgia in Phase 2 and Phase 3 trials of AXS-14 Baseline * * *** * ** *** *** ** *** *** **** **** **** p<0.05 * p<0.01 ** p<0.001 *** p<0.0001 **** *** *** **** Baseline * ** *** *** *** ** *** *** ** **** Baseline * * Pain reduction Ph
Slide 43: Strong intellectual property and barriers to entry
Strong intellectual property and barriers to entry Protected by a robust patent estate extending out to at least 2043; Multiple pending Proprietary drug product formulation >99 issued U.S. patents and >150 issued O.U.S. patents Claims extending to at least 2041; Multiple pending Proprietary MoSEICTM
Slide 44: 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 45: Thank you
Thank you axsome