Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q4 2023 Earnings Presentation
26 slides from Acadia Pharmaceuticals's earnings presentation, Feb 27, 2024
Slide 1: Fourth Quarter and Full Year 2023 Earnings Call
Fourth Quarter and Full Year 2023 Earnings Call February 27, 2024
Slide 2: Call Agenda
Call Agenda Welcome Al Kildani | Senior Vice President, Investor Relations and Corporate Communications CEO Opening Remarks Steve Davis | President and Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Doug Williamson, M.D. | Head of Re
Slide 3: Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would
Slide 4: Opening Remarks
Opening Remarks Steve Davis, President and Chief Executive Officer
Slide 5: Investment Thesis
Investment Thesis Two successful Three late-stage assets with Financial strength commercial franchises strong early-stage pipeline driving record revenues • 40% revenue growth in FY23 • Anticipating ADVANCE-2 top line • $726.4M 2023 FY revenues results in Negative Symptoms of • Cash balance of $438.
Slide 6: Deep CNS Pipeline
Deep CNS Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin) Psychosis DAYBUE Rett Syndrome (trofinetide) Negative Symptoms of Pimavanserin1 Schizophrenia Hyperphagia in ACP-1012,3 Prader-Willi Syndrome Alzheimer’s Disease ACP-2043 Ps
Slide 7: Commercial Update
Commercial Update Brendan Teehan, Chief Operating Officer, Head of Commercial
Slide 8: DAYBUE Commercial Dynamics 10 Months into Launch
DAYBUE Commercial Dynamics 10 Months into Launch Early surge of Led to faster Now seeing breadth of new patient than anticipated prescribing beyond top accounts starts uptake and and more linear adoption curve broad HCP consistent with other rare experience disease products Seasonal dynamics impacti
Slide 9: Real World DAYBUE Persistency Continues to Outperform Clinical Trial Experience
Real World DAYBUE Persistency Continues to Outperform Clinical Trial Experience Previously Current Real Lilac-1 Presented Real World Clinical World Persistency1 Experience Persistency1 Month 4 75% (Nov ‘23) 80% 66% Real world persistency Month 5 - 76% 64% consistently 10+ Month 6 68% (Jan ‘24) 70% 5
Slide 10: LILAC-2 Data Supports Long-Term Benefits Including Improvement Over Time
LILAC-2 Data Supports Long-Term Benefits Including Improvement Over Time LAVENDER Placebo Rolled Over Trofinetide in LAVENDER Placebo in LAVENDER to Trofinetide in LILAC and LILAC LAVENDER*1 LILAC-1†2 LILAC-2†3 0 0 0 Change from DB baseline All LAVENDER placebo Improvement -5 switched to Trofinetide
Slide 11: Real World Benefits Supported by LILAC-2 Caregiver Exit Interviews
Real World Benefits Supported by LILAC-2 Caregiver Exit Interviews Area/type of improvement with trofinetide reported by Caregivers N=25 (%) ≥15% of caregivers, n (%) Engagement with others 11 (42.3) Hand use 10 (38.5) The results of these qualitative interviews Eye gaze 8 (30.8) of caregivers of LA
Slide 12: DAYBUE Real World Experience
DAYBUE Real World Experience “It was her engagement level with the world outside of her – to me and to friends in school; it just blossomed, and it was like a light was turned on.” “Her verbalization definitely improved, and she started saying more things.” “Picking up things a lot more (mostly her
Slide 13: Advancing DAYBUE on three key fronts for a global opportunity
Advancing DAYBUE on three key fronts for a global opportunity EUROPE CANADA JAPAN • Engaging with EMA in • NDS filing expected • Engaging Japanese 1Q24 1Q24 regulatory agency (PMDA) in 2024 • MAA filing expected in • Potential approval Header text here 1H25 around YE24 Prevalence Prevalence Prevalen
Slide 14: NUPLAZID Strategy: Optimize Cash Flow
NUPLAZID Strategy: Optimize Cash Flow Reduced NUPLAZID Real world evidence SG&A spend by has grown new patient >$100M on an starts and net sales annualized basis (‘21 vs. ‘23) $549.2M in net product sales in 2023 Franchise generates >$300 million in annual cash flow 14
Slide 15: R&D Update
R&D Update Doug Williamson M.D., Head of Research and Development
Slide 16: Negative Symptoms of Schizophrenia
Negative Symptoms of Schizophrenia >700,000 patients No FDA-approved in the U.S. have treatment persistent negative symptoms1 Chronic, persistent negative symptoms include social withdrawal, restricted speech, lack of emotion, loss of motivation, and blunted affect and can lead to: Low social functi
Slide 17: Addressing Unmet Need in Predominant, Chronic Negative Symptoms of Schizophrenia
Addressing Unmet Need in Predominant, Chronic Negative Symptoms of Schizophrenia Topline results from ADVANCE-2 Completed one positive pivotal study, ADVANCE-1 Phase 3 study of ADVANCE-2 leverages optimal therapeutic dose of 34 mg pimavanserin 6-month study designed to evaluate impact on persistent
Slide 18: Prader-Willi Syndrome (PWS) Opportunity
Prader-Willi Syndrome (PWS) Opportunity Rare and complex neurobehavioral genetic disorder that often leads to social isolation Hyperphagia is a defining characteristic of Prader- Willi syndrome and commonly begins between the ages of 3-8 Significant Unmet Need Hyperphagia is characterized by unrelen
Slide 19: Ongoing Phase 3 Study of ACP-101 for the Treatment of Hyperphagia in PWS
Ongoing Phase 3 Study of ACP-101 for the Treatment of Hyperphagia in PWS Phase 3 Study Design Carbetocin 3.2 mg Trial builds on previous Double-blind Phase 3 clinical trial experience Screening Visit 12 Weeks Primary Endpoint: Change in HQ-CT1 ~170 Subjects 3.2 mg dose was observed to significantly
Slide 20: ACP-204 in Alzheimer's Disease Psychosis (ADP)
ACP-204 in Alzheimer's Disease Psychosis (ADP) ACP-204 is a next generation 5HT2A blocker that builds on the learnings of pimavanserin Target Product Profile Phase 1 Results Mitigate or eliminate QT prolongation No sign of QT prolongation Wide dose range established Explore doses higher than support
Slide 21: Phase 2 / Phase 3 Program for the Treatment of ADP
Phase 2 / Phase 3 Program for the Treatment of ADP Phase 2 Two Phase 3 Studies N=318, double-blind, of similar size and design randomized 1:1:1 Our clinical experience with pimavanserin Seamless Enrollment supports seamless ACP-204 (60 mg) Ph2 / Ph3 program ACP-204 (30 mg) 6-week treatment period AC
Slide 22: Financial Update
Financial Update Mark Schneyer, Chief Financial Officer
Slide 23: 4Q23 and FY23 Financial Highlights
4Q23 and FY23 Financial Highlights Millions, Except YoY YoY 4Q23 4Q22 FY23 FY22 EPS Change Change Total Revenue $231.0 $136.5 69% $726.4 $517.2 40% DAYBUE $87.1 - - $177.2 - - NUPLAZID® $143.9 $136.5 5% $549.2 $517.2 6% R&D $66.7 $75.7 (12%) $351.6 $361.6 (3%) SG&A $111.5 $104.4 7% $406.6 $369.1 10%
Slide 24: FY 2024 Financial Guidance
FY 2024 Financial Guidance FY23 FY24 Results Guidance DAYBUE Net Sales $177.2 $370 - 420 Million NUPLAZID® Net Sales $549.2 $560 - $590 Million NUPLAZID® Gross-to-Net 24.3% 25% - 29% R&D Expense $351.6 $305 - $325 Million SG&A Expense $406.6 $455 - $480 Million 24
Slide 25: Building On Our Success
Building On Our Success 2023 Recap 2024 and Beyond Launched second commercial drug, DAYBUE Further capitalize on successful DAYBUE launch Achieved 40% revenue growth from two Strong revenue streams from DAYBUE and commercial franchises, DAYBUE and NUPLAZID NUPLAZID franchises Completed enrollment in
Slide 26: Q&A Session
Q&A Session
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