Axsome Therapeutics, Inc. · NASDAQ:AXSM

Axsome Therapeutics — Q1 2020 Earnings Presentation

16 slides from Axsome Therapeutics's earnings presentation, May 8, 2020

  1. Slide 1: 1Q 2020 Financial Results and Business Update

    NASDAQ: AXSM 1Q 2020 Financial Results and Business Update May 8, 2020 © Axsome Therapeutics, Inc.

  2. Slide 2: Forward-Looking Statements & Safe Harbor

    FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue

  3. Slide 3: Agenda

    Agenda Axsome Therapeutics 1Q 2020 Financial Results and Business Update Introduction Mark Jacobson, Chief Operating Officer Business Update Herriot Tabuteau, MD, Chief Executive Officer Financial Results Nick Pizzie, Chief Financial Officer Presenters Dave Marek, Chief Commercial Officer Q&A Cedric

  4. Slide 4: Axsome Therapeutics 1Q 2020 Corporate Highlights

    Corporate Axsome Therapeutics 1Q 2020 • Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company • Positive efficacy results in 5 significant CNS indications with 4 differentiated product candidates advance Axsome’s broad late-stage pipeline • Positive pivotal Phase 2/3

  5. Slide 5: Late-stage portfolio has positive data in conditions affecting >60M U.S. patients

    Corporate Our late-stage portfolio has generated positive data in conditions that affect >60M U.S. patients 37M 17M (of which 6M are TRD) 4M 5M 185K (~70% of 6M AD patients) Major Treatment Migraine Alzheimer’s Narcolepsy Fibromyalgia Depressive Resistant Disease Disorder Depression Agitation NDA Ra

  6. Slide 6: Late-Stage Indications with Potential Total U.S. Peak Sales of Up to $9B

    Corporate Late-Stage Indications with Potential Total U.S. Peak Sales of Up to $9B Program/ Launch Est. Peak Indication Key Highlights MOA Year Est. U.S. Sales AXS-05 MDD 2021 $1B - $2B • Novel, oral, NMDA receptor antagonist NMDA receptor • Rapid and substantial effect, as early as week 1 antagonis

  7. Slide 7: AXS-05 Depression Franchise

    Depression AXS-05 Depression Franchise MDD NDA-Enabling Efficacy Studies: Status: AXS-05 ASCEND  Positive 1:1 (N=80) results Bupropion AXS-05 GEMINI  Positive 1:1 (N=327) results Placebo TRD Efficacy Study: AXS-05  Met key STRIDE-1 secondary 1 Bupropion (N=799) endpoints Bupropion 1:1 inadequate

  8. Slide 8: AXS-07 Migraine Program

    Migraine AXS-07 Migraine Program NDA-Enabling Efficacy Studies: Status: MOMENTUM AXS-07 (N=1594) Rizatriptan 2:2:2:1  Positive MoSEIC™ Meloxicam results Placebo AXS-07 INTERCEPT 1:1  Positive (N=302) Placebo results Open Label Safety Study: • Completion AXS-07 1 6 months, N=300 1 year, N = 100 exp

  9. Slide 9: AXS-05 Alzheimer's Disease Agitation

    AD Agitation AXS-05 Alzheimer’s Disease Agitation NDA-Enabling Efficacy Studies: Status: ADVANCE-1 (N=366) AXS-05  Positive Randomization Bupropion results Placebo ADVANCE-2 (N=TBD) • Initiation AXS-05 1:1 2H 2020 Placebo © Axsome Therapeutics, Inc. 9

  10. Slide 10: Financial Update

    Financial Update Nick Pizzie CHIEF FINANCIAL OFFICER AXSOME THERAPEUTICS, INC. © Axsome Therapeutics, Inc. 10

  11. Slide 11: Key Financial Information

    Financial Key Financial Information (in millions) 1Q '20 4Q '19 Cash and Cash Equivalents $ 197.3 $ 220.0 1Q '20 1Q '19 Research & Development $ 27.5 $ 7.6 General & Administrative $ 5.0 $ 2.8 Interest Expense $ - $ 0.2 Net Loss $ 32.5 $ 10.6 One-time Expense - Pfizer License Agreement $ 10.2 $ - Pr

  12. Slide 12: Q&A

    Q&A © Axsome Therapeutics, Inc. 12

  13. Slide 13: Concluding Remarks

    Concluding Remarks Herriot Tabuteau, MD CHIEF EXECUTIVE OFFICER AXSOME THERAPEUTICS, INC. © Axsome Therapeutics, Inc. 13

  14. Slide 14: Our CNS Candidates and Pipeline

    Overview Our CNS Candidates and Pipeline • Four differentiated clinical-stage CNS assets targeting significant and growing markets • Patent protection to 2034-2036, worldwide rights for most product candidates Product Phase 1 Phase 2 Phase 3 NDA Candidate Major Depressive Disorder: Breakthrough Ther

  15. Slide 15: Our Clinical and Regulatory Milestones

    Corporate Our Clinical and Regulatory Milestones Product Indication 2020 Candidate MDD ● NDA submission (4Q) TRD ✓ STRIDE-1 Phase 3 topline results ● Phase 3 trial start (3Q) AXS-05 (DM + BUP) AD Agitation ✓ ADVANCE-1 Phase 3 topline results ● ADVANCE-2 trial start (2H) Smoking Cessation ● FDA meeti

  16. Slide 16: For more information, please contact Mark Jacobson

    For more information, please contact Mark Jacobson Chief Operating Officer 212-332-3243 mjacobson@Axsome.com axsome.com

Axsome Therapeutics — Q1 2020 Earnings Presentation on 6ix