Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q1 2020 Earnings Presentation
27 slides from Acadia Pharmaceuticals's earnings presentation, May 7, 2020
Slide 1: First Quarter 2020 Earnings Call
First Quarter 2020 Earnings Call MAY 7, 2020
Slide 2: 1Q 2020 Earnings Call Agenda
1Q 2020 Earnings Call Agenda INTRODUCTION Mark Johnson | Vice President, Investor Relations OPENING REMARKS Steve Davis | Chief Executive Officer COMMERCIAL UPDATE Michael Yang | Chief Commercial Officer R&D UPDATE Serge Stankovic, M.D., M.S.P.H. | President FINANCE UPDATE Elena Ridloff | Chief Fina
Slide 3: Forward-Looking Statement
Forward-Looking Statement This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future re
Slide 4: Opening Remarks
Opening Remarks Steve Davis CEO 4 |
Slide 5: To my Favoricte Font line.
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Slide 6: Robust Response to COVID-19
Robust Response to COVID-19 Long-term business fundamentals strong SALES & MARKETING SUPPLY CHAIN RESEARCH & DEVELOPMENT VIRTUAL HCP ENGAGEMENTS DELIVERING UNINTERRUPTED COMMITTED TO ADVANCING & ONLINE PRESCRIBING CAPABILITIES SUPPLY OF NUPLAZID TO PATIENTS LATE-STAGE CLINICAL PROGRAMS FOR NUPLAZID®
Slide 7: 2020 Strategic Pillars
2020 Strategic Pillars Drive Deliver Develop NUPLAZID® Growth DRP Opportunity Innovative Treatments in PDP to the Market For Unmet Needs 2020: A Transformational Year 7 | NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment of hallucinations and delusions associated with
Slide 8: Drive NUPLAZID Growth in PDP
Drive NUPLAZID® Growth in PDP ➢ 1Q 2020 Net Sales = $90.1M; 43% YoY growth 1Q 2020 ➢ Strong commercial execution drove NUPLAZID performance ➢ FY 2020 Net Sales Guidance: $420 - $450M; +28% YoY1 FY 2020 ➢ Providing best-in-class virtual education and engagement ➢ Significant market opportunity Long-t
Slide 9: Deliver Dementia-Related Psychosis (DRP) Opportunity to the Market
Deliver Dementia-Related Psychosis (DRP) Opportunity to the Market ✓ Pre-sNDA Meeting with FDA in Q1 ➢ On-track for sNDA submission this summer ➢ Expecting priority review as pimavanserin has Breakthrough Therapy designation for DRP Potential Approval for DRP Around Year-End 2020 9 | NUPLAZID (pimav
Slide 10: Develop Innovative Treatments For Unmet Needs
Develop Innovative Treatments For Unmet Needs Late-Stage Pipeline Trofinetide: RPD Designation Vanderbilt Partnership Adjunctive Treatment of Major Depressive Disorder: Pursuing a strategy to not enroll additional patients and instead combine identical Phase 3 studies, CLARITY-2 and CLARITY-3, into
Slide 11: Commercial Update
Commercial Update Michael Yang Chief Commercial Officer
Slide 12: 1Q Commercial Performance
1Q Commercial Performance Continuing Patients Sustained consistently high monthly bottle fulfillment rates for established patients New Patients Delivered new-to-brand patients consistent with previous quarters from both specialty pharmacy and specialty distribution channels COVID-19 Impact • Short-
Slide 13: NUPLAZID 2020 Growth Initiatives in PDP
NUPLAZID® 2020 Growth Initiatives in PDP New Patient Identification: Establishing NUPLAZID Pivot to Virtual Engagements as Standard of Care for PDP Virtual peer-to-peer educational programs The inclusion of NUPLAZID in the Movement Disorders Society guidelines Treatment forms for NUPLAZID now availa
Slide 14: DRP Launch Preparations On-track
DRP Launch Preparations On-track ➢ Potential to be the first and only FDA-approved treatment for DRP ➢ Focus on market research and disease awareness, including: - Advisory boards - Payer engagements Dementia-Related Psychosis: ➢ Disease education website: www.morethancognition.com Understanding the
Slide 15: R&D Update
R&D Update Serge Stankovic, M.D., M.S.P.H. President
Slide 16: Regulatory Update on Dementia-Related Psychosis
Regulatory Update on Dementia-Related Psychosis ✓ Pre-sNDA meeting completed in Q1 • On-track to submit sNDA in summer 2020 sNDA will include the following: Pivotal Efficacy Supportive Efficacy Large Safety Database Positive Phase 2 (019) Alzheimer’s Disease Safety and Positive Phase 3 Psychosis Stu
Slide 17: Adjunctive Treatment for Major Depressive Disorder
Adjunctive Treatment for Major Depressive Disorder High Unmet Need • ~17M patients in the U.S. have MDD1 • ~2.5M treated with adjunctive therapy2 • Adjunctive use of existing antipsychotics can lead to significant side effects: • Sexual dysfunction • Sedation • Weight gain • Cognitive impairment • E
Slide 18: Adjunctive Treatment for Major Depressive Disorder
Adjunctive Treatment for Major Depressive Disorder Both Phase 3 studies, CLARITY-2 and CLARITY-3, slightly over 50% enrolled; enrollment currently paused due to COVID-19 • Ready to re-initiate new patient enrollment, however… • Pursuing strategy to not enroll any new patients and combine existing da
Slide 19: Negative Symptoms of Schizophrenia
Negative Symptoms of Schizophrenia High Unmet Need • No FDA-approved treatment for the negative symptoms of schizophrenia • ~40 - 50% of schizophrenia patients experience predominant negative symptoms1 • Negative symptoms include social withdrawal, lack of emotion, restricted speech, and blunted aff
Slide 20: Trofinetide for the Treatment of Rett Syndrome
Trofinetide for the Treatment of Rett Syndrome High Unmet Need • No FDA-approved treatment for Rett syndrome • Debilitating rare neurologic disease • 6,000 to 9,000 patients in the U.S.1 • Symptoms manifest primarily in young females: • Cognitive, sensory, emotional, and motor impairment • Loss of i
Slide 21: Innovative Development Pipeline
Innovative Development Pipeline COMPOUND/ INDICATION PHASE 1 PHASE 2 PHASE 3 MARKETED PROGRAM NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Dementia-Related Pimavanserin Psychosis Major Depressive Disorder Pimavanserin Adjunctive Therapy Trofinetide2 Rett Syndrome Negative Symptoms of Pima
Slide 22: Finance Update
Finance Update Elena Ridloff Chief Financial Officer
Slide 23: 1Q 2020 Financial Highlights
1Q 2020 Financial Highlights Millions, Except EPS 1Q20 1Q19 (GAAP) (GAAP) YoY Change Total Revenue $90.1 $63.0 +43% Cost of Product Sales, License Fees and $5.0 $4.6 +9% Royalties R&D1 $72.6 $52.9 +37% SG&A $102.0 $93.1 +10% Net Loss ($88.0) ($85.3) +3% Weighted Average Basic Shares 155.4 144.0 +8%
Slide 24: FY2020 Financial Guidance
FY2020 Financial Guidance FY 2020 Previous Guidance Revised Guidance Commentary NUPLAZID® $440 to $470M $420 to $450M +28% YoY Growth1 Net Sales Gross-to-Net 17-18% 17-18% - GAAP R&D Expect to be towards $270 to $285M $270 to $285M the low-end of the range Expense Reflects naturally lower costs GAAP
Slide 25: Closing Remarks
Closing Remarks Steve Davis CEO 25 |
Slide 26: ACADIA in 2020 – Building a Leading CNS Platform
ACADIA in 2020 – Building a Leading CNS Platform DEVELOP INNOVATIVE TREATMENTS FOR UNMET NEEDS DELIVER DRP OPPORTUNITY TO THE MARKET MULTI-YEAR CADENCE OF POTENTIAL APPROVALS DRIVE NUPLAZID® POTENTIAL APPROVAL: GROWTH IN PDP ~YE 2020 $420 - $450M FY2020 Net Sales Guidance 2020: A Transformational Ye
Slide 27: Q&A
Q&A First Quarter 2020 Earnings MAY 7, 2020
ACADIA Pharmaceuticals — Q1 2020 Earnings Presentation on 6ix