Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q2 2022 Earnings Presentation
26 slides from Acadia Pharmaceuticals's earnings presentation, Aug 8, 2022
Slide 1: Second Quarter 2022 Earnings Call
Second Quarter 2022 Earnings Call August 8, 2022
Slide 2: 2Q22 Earnings Call Agenda
2Q22 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 Trofinetide Updat
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 Grow and Maximize Value of Deliver Trofinetide Develop the Next Wave NUPLAZID® Franchise to Rett Community 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 associ
Slide 6: Drive Growth of NUPLAZID in PDP
Drive Growth of NUPLAZID® in PDP Net Sales Delivered net sales of $134.6M in 2Q22, increase of 17% YoY • NUPLAZID continues to outperform in the neurology and PD markets and in LTC facilities PD market dynamics remained constrained vs. pre-pandemic levels: PD Market • PD patient visits are down doub
Slide 7: Advancing Late-Stage Opportunities
Advancing Late-Stage Opportunities Rett syndrome Negative Symptoms of Schizophrenia NDA Submitted (Trofinetide) Phase 3 Program (Pimavanserin) • NDA submitted in July 2022 • Positive pivotal study, ADVANCE-1 • Expect priority review; action date in 1Q23 • Evaluating 34 mg dose of pimavanserin in sec
Slide 8: Evolution of CNS Portfolio
Evolution of CNS Portfolio Continual Optimization of R&D Portfolio • Investing in a new molecule ACP-204 • ACP-204 builds upon learnings of pimavanserin; currently in Phase 1 development Psychiatry Neurology • Discontinuing ACP-044 and ACP-319 candidates Investing in Future Growth Opportunities • Es
Slide 9: Finance Update
Finance Update Mark Schneyer Chief Financial Officer
Slide 10: Optimizing Business for Long-term Growth
Optimizing Business for Long-term Growth 1 Focused investments in PDP commercial to efficiently grow the brand Continual optimization of our business 2 Optimized SG&A spend enables successful launch of trofinetide without increasing SG&A expense next year enables us to generate sustainable growth wi
Slide 11: 2Q22 Financial Highlights
2Q22 Financial Highlights 2Q22 2Q21 Millions, Except EPS YoY Change (GAAP) (GAAP) Total Revenue $134.6 $115.2 +17% R&D $75.6 $56.9 +33% SG&A $89.9 $96.8 -7% Net Loss $34.0 $43.9 EPS ($0.21) ($0.27) Cash Balance1 $436.4 1Cash balance includes cash, cash equivalents and investments as of 6/30/2022. NU
Slide 12: FY22 Financial Guidance
FY22 Financial Guidance Previous Updated FY22 Guidance FY22 Guidance Commentary (5/4/2022) (8/8/2022) NUPLAZID® • Top end of net sales removed as significant $510 to $560M $510 to $540M Net Sales PD market recovery not yet seen GAAP R&D • R&D program spend trending lower $355 to $375M $340 to $360M
Slide 13: Commercial Update
Commercial Update Brendan Teehan Chief Operating Officer, Head of Commercial
Slide 14: NUPLAZID Growth and PD Market Dynamics
NUPLAZID® Growth and PD Market Dynamics Delivered net sales of $134.6M, increase of 17% YoY Net Sales • Demand volume up 1H22 vs. 1H21 & Volume Growth NUPLAZID continued to gain market share during pandemic • Market share increased ~15% since 2019 Office-based Channel Long-term Care Channel 2Q22 ove
Slide 15: Trofinetide Pre-Launch Activities Ongoing
Trofinetide Pre-Launch Activities Ongoing Developing the Market with Rett Caregivers & Patients at the Center Patients/Caregivers HCPs Payors Rett Syndrome Stakeholders Build awareness of Acadia and Increase disease education Educate payor ecosystem on treatment expectations for and community resour
Slide 16: Trofinetide Update
Trofinetide Update Kathie Bishop CSO and Head of Rare Disease
Slide 17: Rett Syndrome
Rett Syndrome High Unmet Need No FDA-approved drug for the treatment of Rett syndrome Estimated 6,000 to 9,000 patients in the U.S.1 Debilitating Symptoms2: • Fine and gross motor impairment • Loss of verbal and nonverbal communication • Hand stereotypies • Seizures • Gastrointestinal symptoms, incl
Slide 18: Positive Phase 3 Lavender Study Results
Trofinetide for the Treatment of Rett Syndrome: Positive Phase 3 Lavender Study Results Co-Primary Endpoints: RSBQ Change from Baseline by Visit RSBQ (Change from baseline to week 12) Two-sided p-value = 0.0175 Effect Size; Cohen’s d = 0.37 CGI-I (Score at week 12) Two-sided p-value = 0.0030 Effect
Slide 19: R&D Update
R&D Update Serge Stankovic President
Slide 20: Develop the Next Wave of Breakthroughs
Develop the Next Wave of Breakthroughs Program Indication Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed NUPLAZID® Parkinson’s (pimavanserin)1 Disease Psychosis Trofinetide2 Rett Syndrome Negative Pimavanserin Symptoms of Schizophrenia Neuropsychiatric ACP-204 Indications SYNGAP1; ASO Pro
Slide 21: Growing Body of Evidence of Pimavanserin Compared to Multi-receptor Antipsychotics
Growing Body of Evidence of Pimavanserin Compared to Multi-receptor Antipsychotics Published in Journal of Psychiatry: June 20221 Presented at ASCP Conference in June 20222 Favors Favors PIM other AAP Pimavanserin associated with lower mortality than other atypical antipsychotics The largest differe
Slide 22: Negative Symptoms of Schizophrenia
Negative Symptoms of Schizophrenia High Unmet Need No FDA-approved treatment for the negative symptoms of schizophrenia >700K patients receiving treatment in the U.S. have persistent negative symptoms Potential U.S. addressable population: >1M patients diagnosed1 Negative symptoms include apathy, la
Slide 23: Positive Pivotal Study, ADVANCE-1; Optimal Dose 34mg
Positive Pivotal Study, ADVANCE-1; Optimal Dose 34mg 34 MG DOSE1,2 ADVANCE-1 Results Primary Endpoint (Overall – all 3 doses tested) Improvement in NSA-16 vs. placebo at 26 weeks Two-sided p-value = p=0.043 At Week 26: p=0.0065 (unadjusted) p=0.031 Patients on 34 mg vs. placebo (unadjusted) Two-side
Slide 24: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 25: Building a Leading CNS Company
Building a Leading CNS Company Key Strengths: • Established infrastructure, commercial teams, clinical development Advance Late-Stage and • Committed to investing in Early-Stage Pipeline high-value CNS opportunities Execute Business Development • Optimized spend with focus Launch Potential on positi
Slide 26: Q&A Session
() ACADIA Q&A Session
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