Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q2 2023 Earnings Presentation
25 slides from Acadia Pharmaceuticals's earnings presentation, Aug 2, 2023
Slide 1: Second Quarter 2023 Earnings Call
Second Quarter 2023 Earnings Call August 2, 2023
Slide 2: Call Agenda
Call Agenda Welcome Jessica Tieszen | Associate Director, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Doug Williamson, M.D. | Head of Research and Development Financial Update M
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: Opening Remarks
Opening Remarks Steve Davis, Chief Executive Officer 4
Slide 5: Cash Flow Positive Base Business with Dynamic Growth Opportunities
Cash Flow Positive Base Business with Dynamic Growth Opportunities Early-Stage Programs Multiple Late-Stage and BD Provide Long- Programs Drive Term Opportunities DAYBUE International Further Growth • Includes disclosed and Opportunity • ADVANCE-2 of undisclosed programs • New Drug Submission Pimava
Slide 6: NUPLAZID is a Highly Profitable Franchise
NUPLAZID is a Highly Profitable Franchise Significantly Profitable and Cash Flow Positive Franchise • Increasing cash flow every year since becoming cash flow positive in 2019 • Significantly reduced expense base to substantially grow bottom-line contribution YoY Demand Growth • $142M in net sales o
Slide 7: Deep CNS Pipeline Positions Acadia for Long-term Growth
Deep CNS Pipeline Positions Acadia for Long-term Growth Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis DAYBUE™ Rett Syndrome (trofinetide) Negative Symptoms of Pimavanserin2 Schizophrenia Hyperphagia in ACP-1013 4 Prader-Willi
Slide 8: Commercial Update
Commercial Update Brendan Teehan, Chief Operating Officer, Head of Commercial 8
Slide 9: Early Feedback on DAYBUE
Early Feedback on DAYBUE Testimonials “She is more alert, will move her head back and forth following a conversation between two people, she laughs appropriately during conversations.” - Caregiver “She is more alert and focused and was able to sit and play cards. At a therapy session today, she was
Slide 10: Strong Demand and Broad Reach Since DAYBUE Launch
Strong Demand and Broad Reach Since DAYBUE Launch • Demand is broad based • 400+ prescribers have written subscriptions • Enrollment forms from all sectors: every region of the country and across COE’s, high volume institutions and community practices • Seeing prescriptions from all 18 COEs • About
Slide 11: Acadia Connect Support Services Contributing to Sustained Demand
Acadia Connect Support Services Contributing to Sustained Demand HUB/Nurse Care Coordinators Sales Team and Rare Disease Proactive Education of HCPs and FAMs Demonstrating Medical Science Liaisons and Caregivers Early Value Supporting HCPs • Engaged with HCP’s, COE’s, • FAMs developing strong • Pair
Slide 12: Payer Coverage Policies for DAYBUE are Accelerating
Payer Coverage Policies for DAYBUE are Accelerating Status of Coverage Adoption • Formal plans have already adopted covering ~1/3 of covered lives • Number of plans publishing coverage policies for DAYBUE is accelerating • For ~2/3 of patients with plans without formal policies, prescriptions fulfil
Slide 13: NUPLAZID 2Q23 Commercial Update
NUPLAZID 2Q23 Commercial Update Key Takeaways • Franchise is increasingly cashflow positive • $142.0M in net product sales; up 6% YoY • Real World Evidence studies driving new patient starts • NUPLAZID new patient starts growing despite contracted market; continuing to increase market share Office-B
Slide 14: R&D Update
R&D Update Doug Williamson M.D., Head of Research and Development 14
Slide 15: Addressing Unmet Need of Predominant Negative Symptoms of Schizophrenia
Addressing Unmet Need of Predominant Negative Symptoms of Schizophrenia No FDA-approved treatment for the negative symptoms of schizophrenia patients receiving treatment >700K in the U.S. have persistent negative symptoms1 Negative symptoms include social withdrawal, lack of motivation and blunted a
Slide 16: Completed Enrollment of ADVANCE-2 for the Negative Symptoms of Schizophrenia
Completed Enrollment of ADVANCE-2 for the Negative Symptoms of Schizophrenia • Acadia already completed one positive pivotal study, ADVANCE-1 • Phase 3, ADVANCE-2 study nearly identical to positive ADVANCE-1 study design, with two key differences; • Only treating patients with optimal therapeutic do
Slide 17: ACP-101 Phase 3 Study in Prader Willi Syndrome to Initiate in 4Q23
ACP-101 Phase 3 Study in Prader Willi Syndrome to Initiate in 4Q23 Developing as a treatment for ACP-101 Phase 3 Study Design hyperphagia in PWS Carbetocin 3.2 mg • 8,000-10,000 patients with PWS in the United States1 Primary Screening Double-blind Treatment Period Endpoint: • No FDA-approved treatm
Slide 18: ACP-204 in Alzheimer's Disease Psychosis
ACP-204 in Alzheimer’s Disease Psychosis Phase 1 Study Overview • Evaluated ACP-204 in both healthy adult and elderly patients • Favorable safety and tolerability profile and drug-drug interaction Target Product Profile Phase 1 Observations Mitigate or eliminate QT ✓ No sign of QT prolongation prolo
Slide 19: ACP-204 Clinical Development Plan in Alzheimer's Disease Psychosis
ACP-204 Clinical Development Plan in Alzheimer’s Disease Psychosis • Aligned with FDA on program design and dose selection of 30 mg and 60 mg • Plan to initiate Phase 2 in patients with Alzheimer's disease psychosis in 4Q23 • Familiarity with target and experience with pimavanserin gives confidence
Slide 20: Financial Update
Financial Update Mark Schneyer, Chief Financial Officer 20
Slide 21: 2Q23 Financial Highlights
2Q23 Financial Highlights 2Q23 2Q22 YoY Millions, Except EPS (GAAP) (GAAP) Change TOTAL Net Sales $165.2 $134.6 +23% NUPLAZID Net Product Sales $142.0 $134.6 +6% DAYBUE Net Product Sales $23.2 R&D $58.8 $75.6 -22% SG&A $96.0 $89.9 +7% Net Income (Loss) $1.1 ($34.0) EPS $0.01 ($0.21) Cash Balance $37
Slide 22: Q3/FY 2023 Financial Guidance
Q3/FY 2023 Financial Guidance 3Q23 Guidance Commentary DAYBUE™ Net Sales $45 to $55M • Unchanged FY23 NUPLAZID® Net Sales $530 to $545M • Unchanged NUPLAZID® Gross-to-Net 22% to 25% • Unchanged • $100M upfront payment to Neuren related to $335 to $355M GAAP R&D Expense expanded licensing agreement (
Slide 23: Closing Remarks
Closing Remarks Steve Davis, Chief Executive Officer 23
Slide 24: Cash Flow Positive Base Business with Dynamic Growth Opportunities
Cash Flow Positive Base Business with Dynamic Growth Opportunities Early-Stage Programs Multiple Late-Stage and BD Provide Long- Programs Drive Term Opportunities DAYBUE International Further Growth • Includes disclosed and Opportunity • ADVANCE-2 of undisclosed programs • New Drug Submission Pimava
Slide 25: Q&A Session
Q&A Session
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