Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q2 2020 Earnings Presentation
23 slides from Acadia Pharmaceuticals's earnings presentation, Aug 5, 2020
Slide 1: Second Quarter 2020 Earnings Call
Second Quarter 2020 Earnings Call AUGUST 5, 2020
Slide 2: 2Q 2020 Earnings Call Agenda
2Q 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: ACADIA Strategic Pillars
ACADIA Strategic Pillars Drive Deliver Develop NUPLAZID® On the DRP Innovative Treatments Growth in PDP Opportunity For Unmet Needs Building a Leading CNS Platform 5 | NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment of hallucinations and delusions associated with Pa
Slide 6: Drive NUPLAZID Growth in PDP
Drive NUPLAZID® Growth in PDP • 2Q 2020 Net Sales $110.1M; +32% YoY • FY2020 Net Sales Guidance $430 - $450M; +30% YoY1 • Significant and long-term market opportunity in PDP 1YoY growth number based on mid-point of the guidance range. 6 | NUPLAZID (pimavanserin) is only approved in the U.S. by the F
Slide 7: FDA Accepts sNDA for Dementia-Related Psychosis (DRP)
FDA Accepts sNDA for Dementia-Related Psychosis (DRP) PDUFA Date: April 3, 2021 sNDA includes the following: Pivotal Efficacy Supportive Efficacy Large Safety Database Positive Phase 2 (-019) Alzheimer’s Disease Safety and Positive Phase 3 Psychosis Study1 Tolerability Data HARMONY Study & from Comp
Slide 8: Develop Innovative Treatments For Unmet Needs
Develop Innovative Treatments For Unmet Needs Pimavanserin for the Negative Symptoms of Schizophrenia Initiated Phase 3 ADVANCE-2 study in 3Q20 Late-Stage Trofinetide for the treatment of Rett Syndrome Ongoing Phase 3 LAVENDER study with data expected in 2H21 Early-Stage M1 PAM program targeting var
Slide 9: Commercial Update
Commercial Update Michael Yang Chief Commercial Officer
Slide 10: Strong Commercial Execution in PDP
Strong Commercial Execution in PDP Net Sales (in millions) 2Q20 Highlights: $120 $110 • Best in class virtual engagement $100 $90 • Strong new patient growth in $80 $70 Specialty Pharmacy channel $60 $50 • Consistently high monthly fulfillment $40 rates for new and continuing patients $30 $20 $10 •
Slide 11: New Initiatives to Drive Continued PDP Growth
New Initiatives to Drive Continued PDP Growth ▪ Recent new patient start trends have returned to pre-COVID levels in Specialty Pharmacy channel ▪ On demand virtual speaker programs with nationally recognized KOLs ▪ Virtual patient case learning programs ▪ Educational materials to optimize care via t
Slide 12: DRP Launch Preparations On Track
DRP Launch Preparations On Track MoreThanCognition: Disease Education Site Leveraging Virtual Medical Congresses Syndicating content to HCP sites: Building Disease Awareness Today to be Well Positioned for a Successful Launch 12 | NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for t
Slide 13: R&D Update
R&D Update Serge Stankovic, M.D., M.S.P.H. President
Slide 14: Innovative Development Pipeline
Innovative Development Pipeline COMPOUND/ INDICATION PHASE 1 PHASE 2 PHASE 3 REGISTRATION MARKETED PROGRAM NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Dementia-Related Pimavanserin Psychosis Negative Symptoms Pimavanserin of Schizophrenia Trofinetide2 Rett Syndrome M1 PAM3 CNS Disorders
Slide 15: 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 16: ADVANCE-2 Study
ADVANCE-2 Study 26 Week, Randomized, Double-blind, Placebo-controlled, Multi-center Outpatient Study Treatment Period 34 mg PIMAVANSERIN + Primary Endpoint: ~386 patients with background antipsychotic Change from baseline on predominant negative the Negative Symptom symptoms of Assessment-16 (NSA-16
Slide 17: 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 18: Finance Update
Finance Update Elena Ridloff Chief Financial Officer
Slide 19: 2Q 2020 Financial Highlights
2Q 2020 Financial Highlights Millions, Except EPS 2Q20 2Q19 YoY Change (GAAP) (GAAP) Total Revenue $110.1 $83.2 +32% Cost of Product Sales, License Fees and Royalties $5.5 $5.0 +10% R&D $64.3 $67.3 -4% SG&A $84.3 $68.0 +24% Net Loss $42.1 $54.9 -23% Weighted Average Basic Shares Outstanding 156.5 14
Slide 20: FY2020 Financial Guidance
FY2020 Financial Guidance Previous Guidance Revised Guidance FY 2020 (5/7/2020) (8/5/2020) NUPLAZID® Net Sales $420 to $450M $430 to $450M $270 to $285M GAAP R&D Expense $265 to $280M (Low-end of range) GAAP SG&A Expense $425 to $445M $400 to $420M Non-Cash Stock-Based Compensation Expense $90 to $1
Slide 21: Closing Remarks
Closing Remarks Steve Davis CEO 21 |
Slide 22: ACADIA Strategic Pillars
ACADIA Strategic Pillars Develop Innovative Treatments For Unmet Needs Deliver DRP Opportunity to the Market Advancing Early and Late Stage Pipeline Drive NUPLAZID® PDUFA Date: Growth in PDP April 3, 2021 $430 - $450M FY2020 Net Sales Guidance Building a Leading CNS Platform 22 | NUPLAZID (pimavanse
Slide 23: Q&A
Q&A Second Quarter 2020 Earnings AUGUST 5, 2020
ACADIA Pharmaceuticals — Q2 2020 Earnings Presentation on 6ix