Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q1 2024 Earnings Presentation
23 slides from Acadia Pharmaceuticals's earnings presentation, May 8, 2024
Slide 1: First Quarter 2024 Earnings Call
First Quarter 2024 Earnings Call May 8, 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 Kimberly Manhard | Senior Vice Pre
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: Acadia Investment Thesis
Acadia Investment Thesis Two successful Two late-stage assets with Financial commercial franchises strong early-stage pipeline strength $205.8M in Q1 2024 revenues Ongoing P3 trial of ACP-101 in 74% YoY revenue growth in 1Q24 • NUPLAZID® $129.9M Prader-Willi syndrome Ongoing seamless P2 / P3 Cash ba
Slide 6: DAYBUE Overview
DAYBUE Overview DAYBUE Today DAYBUE Outlook • 5,000 diagnosed population • Sizeable untreated population • 25% penetration to date • Growing body of real-world benefits • Persistency continues to track ~10 • Facilitate consistent application of GI percentage points above clinical management strategi
Slide 7: 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) Hyperphagia in ACP-1011,2 Prader-Willi Syndrome Alzheimer’s Disease ACP-2042 Psychosis Rett Syndrome; Fragile ACP-25912 X Syndr
Slide 8: Commercial Update
Commercial Update Brendan Teehan, Chief Operating Officer, Head of Commercial
Slide 9: Key Drivers of Long-Term Value for DAYBUE
Key Drivers of Long-Term Value for DAYBUE 1 out of 4 diagnosed Rett patients have received treatment with DAYBUE; large remaining untreated patient population • Successfully penetrated COEs; now have ~50% share of patients treated • Driving further depth of prescribing outside of COEs, where large m
Slide 10: Expanding DAYBUE Internationally
Expanding DAYBUE Internationally Pediatric investigation plan (PIP) filed with and accepted by EMA in Europe • Filing anticipated in 1Q25 Header text here Formal meeting with Japanese regulatory agency (PMDA) scheduled in 2Q24 to discuss clinical plan NDS in Canada accepted for filing and priority
Slide 11: DAYBUE Real-World Experience
DAYBUE Real-World Experience “It was her engagement level with the world outside of her; it just blossomed, and it was like a light “This child is 9 years old was turned on.” and just told her mom she loves her for the first time.” “I’ve re-met my daughter.” “She is more alert, will move her head ba
Slide 12: NUPLAZID Strategy: Optimize Cash Flow
NUPLAZID Strategy: Optimize Cash Flow Real-world evidence Carefully managed has grown new patient NUPLAZID SG&A starts and net sales spend Franchise generates >$300 million in annual cash flow 12
Slide 13: NUPLAZID 1Q24 Commercial Update
NUPLAZID 1Q24 Commercial Update PDP: Office-Based and LTC Channels 4Q23 vs 1Q24 Key takeaways $129.9M in net product sales in 1Q24 Carbidopa-Levodopa TRXs -1% NBRXs for Other APs* +4% NBRXs for both NUPLAZID and other atypical antipsychotics (APs) grew in Nuplazid NBRXs +6% 1Q24 relative to 4Q23; NU
Slide 14: R&D Update
R&D Update Kimberly Manhard, Senior Vice President, Global Strategic Planning and Execution
Slide 15: Prader-Willi Syndrome Opportunity
Prader-Willi Syndrome Opportunity Rare and complex neurobehavioral genetic disorder that often leads to social isolation Hyperphagia is a defining characteristic of Prader- Willi syndrome (PWS) and commonly begins between the ages of 3-8 Significant Unmet Need Hyperphagia is characterized by unrelen
Slide 16: Ongoing Phase 3 Study of ACP-101 for Hyperphagia in PWS
Ongoing Phase 3 Study of ACP-101 for the Treatment of Hyperphagia in PWS Phase 3 Study Design ACP-101 (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 sign
Slide 17: 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 18: ACP-204: Phase 2 / Phase 3 Seamless Program for ADP
ACP-204: Phase 2 / Phase 3 Seamless 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) 6-week P2 / P3 program ACP-204 (30 mg) tre
Slide 19: Financial Update
Financial Update Mark Schneyer, Chief Financial Officer
Slide 20: 1Q24 Financial Highlights
1Q24 Financial Highlights Millions, Except EPS 1Q24 1Q23 YoY Change TOTAL Net Sales $205.8 $118.5 74% NUPLAZID Net Product Sales $129.9 $118.5 10% DAYBUE Net Product Sales $75.9 - - R&D $59.7 $69.1 -14% SG&A $108.0 $101.2 7% Net Income (Loss) $16.6 ($43.0) EPS $0.10 ($0.27) Year End 2023 Cash Balanc
Slide 21: Reiterating FY 2024 Financial Guidance
Reiterating FY 2024 Financial Guidance FY24 Guidance DAYBUE Net Sales $370 - 420 Million NUPLAZID Net Sales $560 - $590 Million NUPLAZID Gross-to-Net 25% - 29% R&D Expense $305 - $325 Million SG&A Expense $455 - $480 Million 21
Slide 22: Building On Our Success
Penetrate substantial market opportunity for DAYBUE in the U.S. Strong growth from both DAYBUE and NUPLAZID franchises Building On Bring trofinetide to new markets outside the U.S. Our Success including Europe, Japan and Canada Progress P3 study of ACP-101 in Prader-Willi 2024 and Beyond syndrome Pr
Slide 23: Q&A Session
Q&A Session
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