Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Q3 2020 Earnings Presentation
21 slides from Axsome Therapeutics's earnings presentation, Nov 5, 2020
Slide 1: 3Q 2020 Financial Results and Business Update
NASDAQ: AXSM 3Q 2020 Financial Results and Business Update November 5, 2020 © Axsome Therapeutics, Inc.
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
Slide 3: Agenda and Presenters
Agenda Axsome Therapeutics 1Q 2020 Financial Results and Business Update Introduction Mark Jacobson, Chief Operating Officer Business Update Herriot Tabuteau, MD, Chief Executive Officer Commercialization Update Lori Englebert, Sr VP, Commercial & Business Development Financial Results Nick Pizzie,
Slide 4: Axsome Therapeutics 3Q 2020 Corporate Update
Corporate Axsome Therapeutics 3Q 2020 • COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine completed • NDA submissions for AXS-05 in depression expected in January 2021, and for AXS-07 in migraine expected in 1Q 2021 • Launch read
Slide 5: Commercial Update
Commercial Update Lori Englebert SVP, COMMERCIAL & BUSINESS DEVELOPMENT AXSOME THERAPEUTICS, INC. © Axsome Therapeutics, Inc. 5
Slide 6: Prevalence of Depression Symptoms Before and During Pandemic
Depression Prevalence of Depression Symptoms Before and During Pandemic • Depression increased more than 3 fold due to pandemic and skewed toward those with more severe symptoms 22M 71M U.S. Adults with U.S. Adults with Depression Depression Symptoms Symptoms prior to the during the Pandemic1 Pandem
Slide 7: High Unmet Needs Exist for MDD Patients
Depression High Unmet Needs Exist for MDD Patients Unmet Need1 Reason for Unmet Need There have been no new oral MOA to treat MDD since New, patient-friendly treatment options 1959 (61 years)2 Current therapies typically take 6-8 weeks to reach Faster onset of action meaningful response3 Only ~1/4 o
Slide 8: AXS-05 would be the first new oral MOA to treat MDD in over 60 years
Depression AXS-05 would be the first new oral MOA to treat MDD in over 60 years Tetracyclics, Tricyclics and Dopamine Monoamine Class SSRI/SNRIs NMDA+ NMDA+ MAOIs targeting targeting Products 8 approved 6 approved 10 approved 5 approved Esketamine AXS-05 Approved / Oral Oral Oral Oral Intranasal Ora
Slide 9: Summary of AXS-05 Clinical Profile in Completed MDD Trials
Depression Summary of AXS-05 Clinical Profile in Completed MDD Trials MOA • First new orally administered MOA to treat MDD in over 60 years • Oral NMDA receptor antagonist targeting the glutamatergic pathway • Monotherapy Clinician • Rapid and sustained improvement in MADRS total score vs. placebo a
Slide 10: Digital Centric Commercialization (DCC) Platform
DCC™ Preparing For AXS-05 Launch: Digital Centric CommercializationTM (DCC) Platform Using digital to redefine patient care by providing meaningful, optimized customer engagements © Axsome Therapeutics, Inc. 10
Slide 11: Preparing For AXS-05 Launch: Key Trends – HCPs
DCC™ Preparing For AXS-05 Launch: Key Trends – HCPs Percent of HCP Detailing by Remote Details % of Total Time spent in rep call Type Cardio Derm 45% Gastro <5 ~25 Endo 90% PCP Min Min Neuro 55% Rheum 10% Psych Traditional Remote Detail Engagement Pre-COVID Normalizing 0% 20% 40% 60% Remote Detail T
Slide 12: Preparing For AXS-05 Launch: Key Trends – Patients
DCC™ Preparing For AXS-05 Launch: Key Trends – Patients Time spent per day with digital versus traditional media in the United States from 2011 to 2020 (in minutes) In 2018, time spent with digital surpassed traditional media for the first time and in 2020 is almost 25% higher Digital includes mobil
Slide 13: Preparing For AXS-05 Launch: Initial Engagement Launch Strategy
DCC™ Preparing For AXS-05 Launch: Initial Engagement Launch Strategy • Extensive use of remote detailing, with • Primarily digital engagement traditional as needed • Omnichannel approach • Focused targeting of psychiatrists and • Focused targeting mental health focused PCPs © Axsome Therapeutics, In
Slide 14: Digital Centric Commercialization (DCC) Platform
DCC™ Preparing For AXS-05 Launch: Digital Centric CommercializationTM (DCC) Platform Using digital to redefine patient care by providing meaningful, optimized customer engagements © Axsome Therapeutics, Inc. 14
Slide 15: Financial Update
Financial Update Nick Pizzie CHIEF FINANCIAL OFFICER AXSOME THERAPEUTICS, INC. © Axsome Therapeutics, Inc. 15
Slide 16: Key Financial Information
Financial Key Financial Information (in millions) 3Q '20 2Q ‘20 Cash and Cash Equivalents $ 202.4 $ 190.7 3Q '20 3Q '19 Research & Development $ 14.8 $ 15.8 General & Administrative $ 6.3 $ 3.1 Interest Expense $ 0.6 $ 0.3 Tax Credit $ - $ (0.1) Debt Extinguishment $ 1.2 $ - Net Loss $ 22.9 $ 19.1 •
Slide 17: Q&A
Q&A © Axsome Therapeutics, Inc. 17
Slide 18: Concluding Remarks
Concluding Remarks Herriot Tabuteau, MD CHIEF EXECUTIVE OFFICER AXSOME THERAPEUTICS, INC. © Axsome Therapeutics, Inc. 18
Slide 19: 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 2034-2040, worldwide rights for most product candidates Product Phase 1 Phase 2 Phase 3 NDA Candidate / MOA Major Depressive Disorder: Breakthroug
Slide 20: Our Clinical and Regulatory Milestones
Corporate Our Clinical and Regulatory Milestones Product Indication Milestone Candidate AXS-05 MDD ✓ STRIDE-1 topline results ✓ Pre-NDA meeting NMDA receptor ✓ COMET completion antagonist with ● COMET-AU / SI / TRD sub-study results (4Q 2020) multimodal activity ● MERIT results (1H 2021) ● NDA submi
Slide 21: 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