Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q4 2021 Earnings Presentation
23 slides from Acadia Pharmaceuticals's earnings presentation, Feb 28, 2022
Slide 1: Fourth Quarter and Full Year 2021 Earnings Call
Fourth Quarter and Full Year 2021 Earnings Call February 28, 2022
Slide 2: 4Q and Full Year 2021 Earnings Call Agenda
4Q and Full Year 2021 Earnings Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Financial Update Mark Schneyer | Chief Financial Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial
Slide 3: Forward-Looking Statements
Forward-Looking Statements 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 r
Slide 4: CEO Opening Remarks
CEO Opening Remarks Steve Davis CEO
Slide 5: Acadia's Growth Strategy
Acadia’s Growth Strategy Drive Growth of Advance Three Late-Stage Develop the Next Wave NUPLAZID® Franchise Opportunities of Breakthroughs Building a Leading CNS Company NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment of hallucinations and delusions associated with
Slide 6: 2021 Full-Year Highlights
2021 Full-Year Highlights Net Sales (in millions) Highlights: $500 • $484.1M net sales; 10% YoY growth $400 • Bottle and share growth in FY21 $300 • NUPLAZID® grew as PD market contracted $200 • Outperformed basket of other top $100 brands in Neurology and Parkinson’s across channels $0 • FY22 Guida
Slide 7: Advance Three Late-Stage Opportunities
Advance Three Late-Stage Opportunities • Includes new analyses from the previously conducted HARMONY and -019 studies Resubmission for ADP • Resubmission of sNDA is opportunity for FDA to thoroughly review additional analyses (Pimavanserin) • Expect 6-month review; action date expected 3Q22 • Agreed
Slide 8: Develop the Next Wave of Breakthroughs
Develop the Next Wave of Breakthroughs Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Alzheimer’s Disease Pimavanserin2 Psychosis Trofinetide3 Rett Syndrome Negative Symptoms of Pimavanserin Schizophrenia Postoperative and ACP-
Slide 9: Finance Update
Finance Update Mark Schneyer Chief Financial Officer
Slide 10: 4Q21 Financial Highlights
4Q21 Financial Highlights Millions, Except EPS 4Q21 4Q20 YoY Change (GAAP) (GAAP) Total Revenue $130.8 $121.0 +8% R&D $67.1 $62.1 +8% SG&A $105.8 $120.8 -12% Net Loss $43.1 $66.8 -35% EPS ($0.27) ($0.42) -36% NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment of halluc
Slide 11: FY2021 Financial Highlights
FY2021 Financial Highlights Millions, Except EPS 2021 2020 YoY Change (GAAP) (GAAP) Total Revenue $484.1 $441.8 +10% R&D $239.4 $319.1 -25% SG&A $396.0 $388.7 +2% Net Loss $167.9 $281.6 -40% EPS ($1.05) ($1.79) -41% Cash Balance 12/31/20211 $520.7 1Cash balance includes cash, cash equivalents and in
Slide 12: FY2022 Financial Guidance
FY2022 Financial Guidance FY22 Guidance Commentary • Midpoint of the range reflects similar demand to 2021 NUPLAZID® Net Sales $510 to $560M • PDP related revenue only • ~$60M related to Stoke collaboration GAAP R&D Expense $355 to $375M • ~$25M of stock-based compensation expense • ~7% reduction in
Slide 13: Commercial Update
Commercial Update Brendan Teehan Chief Operating Officer, Head of Commercial
Slide 14: NUPLAZID Growth Amidst Contracting PD Market
NUPLAZID® Growth Amidst Contracting PD Market Office-based Channel Long-term Care Channel 4Q21 vs. 20191 (TRX monthly avg) 4Q21 vs. 20191 (TRX monthly avg) Strong Relative Performance NUPLAZID +30% NUPLAZID +4% Carbidopa / Levodopa -3% Carbidopa / Levodopa -11% Avg. Top 10 PD Medications -7% Avg. To
Slide 15: Preparing for New Commercial Opportunities
Preparing for New Commercial Opportunities NUPLAZID® for ADP • ADP market dynamics very similar to DRP (providers, payers, care setting, etc.) • Leverage existing infrastructure and previous investments made for DRP • Target action date for ADP expected 3Q22 Trofinetide for Rett syndrome • Partnersh
Slide 16: R&D Update
R&D Update Serge Stankovic President
Slide 17: Pimavanserin for the Treatment of ADP
Pimavanserin for the Treatment of ADP High Unmet Need1: Pimavanserin for ADP in Clinical Studies • No FDA-approved treatment • HARMONY Study3: Clinically meaningful reduction • ~900K ADP patients treated w/ in risk of relapse of psychosis in ADP subgroup off-label drugs in the U.S. (n=123; ~40% redu
Slide 18: Trofinetide for Treatment of Rett Syndrome
Trofinetide for Treatment of Rett Syndrome Proposed Mechanism of Action: Pivotal Lavender Study Results • Novel synthetic analog of amino‐terminal tripeptide of IGF-1 • Co-Primary Endpoints: Statistically significant separation from placebo; RSBQ • Potential to reduce neuroinflammation (p=0.0175), C
Slide 19: Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia
Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia High Unmet Need1: ADVANCE-1 Results2 • No FDA-approved treatment • Primary endpoint: Improvement in NSA-16 • >700K patients receiving treatment in the U.S. have compared to placebo at 26 weeks (p=0.043) persistent negative symp
Slide 20: Early-Stage Pipeline Opportunities
Early-Stage Pipeline Opportunities ACP-044 program with two ongoing Phase 2 studies in models of acute Phase 2 and chronic pain ACP-319 lead compound from M1 PAM program licensed from Vanderbilt Phase 1 Collaboration with Stoke Therapeutics focused on development of ASO Preclinical preclinical progr
Slide 21: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 22: Significant Growth Opportunities
Significant Growth Opportunities PDP FY22 Guidance = Significant opportunity for accelerated long-term growth Commercial $510 - $560M Expected action date for pimavanserin sNDA resubmission 3Q22 2 NDAs Trofinetide NDA submission for Rett syndrome Mid-22 Phase 3 ADVANCE-2 top-line results evaluating
Slide 23: Q&A Session
() ACADIA Q&A Session
ACADIA Pharmaceuticals — Q4 2021 Earnings Presentation on 6ix