Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q1 2021 Earnings Presentation
25 slides from Acadia Pharmaceuticals's earnings presentation, May 5, 2021
Slide 1: First Quarter 2021 Earnings Call
First Quarter 2021 Earnings Call May 5, 2021
Slide 2: 1Q 21 Earnings Call Agenda
1Q 21 Earnings Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Amanda Morgan | Chief Revenue and Customer Officer Commercial Update Charmaine Lykins | Global Product Planning and Chief Marketing Officer R&D Update S
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: Three Strategic Pillars Building a Leading CNS Company
Three Strategic Pillars Drive Deliver Develop Growth of On the DRP Next Wave of NUPLAZID® Opportunity Breakthroughs Building a Leading CNS Company DRP = Hallucinations and delusions associated with Dementia-Related Psychosis NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the tre
Slide 6: Drive Growth of NUPLAZID in PDP
Drive Growth of NUPLAZID® in PDP 1Q21 • Delivered net sales of $106.6M, increase of 18% YoY • Growth driven by strong YoY performance in the office-based channel • 1Q impacted by pandemic with lower patient visits and decline in LTC census FY21 • Reiterating FY21 net sales guidance: $510 - $550M • E
Slide 7: Deliver on the DRP Opportunity
Deliver on the DRP Opportunity Regulatory Updates • FDA issued a Complete Response Letter in April for our sNDA for DRP • Plan to conduct Type A meeting with the FDA to discuss the CRL and a potential approval path Significant Unmet Need • Current treatment involves off-label, antipsychotics that ca
Slide 8: Develop Next Wave of Breakthroughs
Develop Next Wave of Breakthroughs Program Indication Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Dementia-Related Pimavanserin2 Psychosis Negative Symptoms of Pimavanserin Schizophrenia Trofinetide3 Rett Syndrome ACP-044 Postoperative Pain ACP-044 Osteoa
Slide 9: Commercial Update
Commercial Update Amanda Morgan Chief Revenue and Customer Officer Charmaine Lykins Global Product Planning and Chief Marketing Officer
Slide 10: 1Q21 Performance Summary
1Q21 Performance Summary Delivered net sales of $106.6M, increase of 18% YoY Continued to grow base of NUPLAZID® prescribers and new patients Office Based Channel: Long Term Care Channel: • Patient visits down in quarter; starting to • Census levels declined in 1Q increase towards normal levels exit
Slide 11: Return to Growth in Long-Term Care Channel
Return to Growth in Long-Term Care Channel LTC Channel Growth Trends Supported by: 1. More facilities now allowing family visits • Visitor restrictions were a major impediment to new admissions 2. High vaccination rates for LTC residents and staff • COVID-19 transmissions down significantly in March
Slide 12: Driving Long-term Growth in PDP
Driving Long-term Growth in PDP Medical Congresses Integrated ➢ Leverage DTC campaigns to grow breadth and depth; DTC adding new prescribers and growing patients per prescriber Campaign ➢ Market share of new patients > overall market share Improving ➢ Significant increase in face-to-face detailing e
Slide 13: R&D Update
R&D Update Serge Stankovic President
Slide 14: Hallucinations and Delusions Associated with Dementia-Related Psychosis (DRP)
Hallucinations and Delusions Associated with Dementia-Related Psychosis (DRP) Current Status: • Finalizing briefing documents for the Type A meeting with FDA to discuss sNDA for DRP • Delivered highly statistically significant and clinically meaningful results from the FDA agreed upon pivotal Phase
Slide 15: Trofinetide for the Treatment of Rett Syndrome
Trofinetide for the Treatment of Rett Syndrome Trofinetide MOA: Phase 2 Study Results3 Novel synthetic analog of amino‐terminal tripeptide of IGF-1 with potential to reduce neuroinflammation and • 6-week, placebo-controlled dose ranging support synaptic function study in 82 young females (ages 5 – 1
Slide 16: 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 for the negative • 26-week pivotal study in 403 patients with symptoms of schizophrenia predominant negative symptoms3 • >700K patients receiving treatment have •
Slide 17: ACP-044 for the Treatment of Acute and Chronic Pain
ACP-044 for the Treatment of Acute and Chronic Pain ACP-044 MOA: Phase 2 Program • A novel, first-in-class, orally administered, non-opioid analgesic • Interrupts multiple pain pathways and sensitization of neurons to pain, by accelerating the decomposition of peroxynitrite, a nitroxidative agent el
Slide 18: ACP-319 for the Treatment of Cognition and Schizophrenia
ACP-319 for the Treatment of Cognition and Schizophrenia ACP-319 MOA: ACP-319 Development Status • Positive Allosteric Modulator of the M1 receptor (M1 PAM) • Phase 1 program ongoing • Targets muscarinic (M1) receptors • Challenge with targeting the muscarinic system has been tolerability; associate
Slide 19: Development Timelines
Development Timelines Expected Compound Indication Milestone Timing Acute Pain ACP-044 (Bunionectomy) ✓ Initiated Phase 2 Study 1Q21 Chronic Pain ACP-044 (Osteoarthritis) Initiate Phase 2 Study 2Q21 Trofinetide Rett Syndrome Top-line Results: Phase 3 LAVENDER Study 4Q21 Negative Symptoms of Pimavans
Slide 20: Finance Update
Finance Update Elena Ridloff Chief Financial Officer
Slide 21: 1Q21 Financial Highlights
1Q21 Financial Highlights 1Q21 1Q20 Millions, Except EPS YoY Change (GAAP) (GAAP) Total Revenue $106.6 $90.1 +18% Cost of Product Sales, License Fees and Royalties $4.7 $5.0 -6% R&D $57.0 $72.6 -21% SG&A $111.7 $102.0 +10% Net Loss $66.4 $88.0 -25% EPS ($0.42) ($0.57) +26% Cash Balance1 $577.8 1Cash
Slide 22: FY2021 Financial Guidance
FY2021 Financial Guidance Previous Guidance Updated Guidance FY 2021 Commentary (2/24/2021) (5/5/2021) Timing and pace of recovery from NUPLAZID® Net Sales $510 to $550M $510 to $550M the pandemic will affect FY21 net sales performance within range GAAP R&D Expense $300 to $320M $280 to $300M Includ
Slide 23: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 24: Building a Leading CNS Company
Building a Leading CNS Company 1 Significant long-term opportunity to grow NUPLAZID® in PDP 2 Committed to obtain approval of pimavanserin for DRP patients Focused on investing in clinical development pipeline and 3 compelling business development opportunities NUPLAZID (pimavanserin) is only approv
Slide 25: Q&A Session
() ACADIA Q&A Session
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