Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q1 2023 Earnings Presentation
22 slides from Acadia Pharmaceuticals's earnings presentation, May 8, 2023
Slide 1: First Quarter 2023 Earnings Call
First Quarter 2023 Earnings Call May 8, 2023
Slide 2: First Quarter 2023 Earnings Call Agenda
First Quarter 2023 Earnings Call Agenda Introduction Mark Johnson | Vice President, 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 Devel
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: Four Strategic Priorities for Acadia
Four Strategic Priorities for Acadia DAYBUE™ for NUPLAZID® for Parkinson’s Negative Symptoms Alzheimer’s Disease Rett Syndrome Disease Psychosis of Schizophrenia Psychosis • FDA-approved 3/10 • $118.5M net sales in 1Q23 • Positive pivotal results: • ACP-204 Phase 1 studies ADVANCE-1 complete • Avail
Slide 6: DAYBUE is FDA-Approved and Commercially Available for Rett Syndrome
DAYBUE is FDA-Approved and Commercially Available for the Treatment of Rett Syndrome DAYBUE Available Starting April 17, 2023 Committed to successful launch of first-in-class, first-to-market drug: • Rett community has been extremely supportive including HCPs, caregivers and families • Engaging payo
Slide 7: NUPLAZID 1Q23 Commercial Update
NUPLAZID 1Q23 Commercial Update Franchise Profitability • NUPLAZID franchise has been profitable since 2019 • Significantly reduced expense base to meaningfully grow bottom-line contribution YoY Demand Growth • $118.5M in net sales of NUPLAZID in PDP for 1Q23 • Demand growth up 2% YoY; sell-in volum
Slide 8: Addressing Significant Unmet Needs in CNS
Addressing Significant Unmet Needs in CNS Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Parkinson’s NUPLAZID® Disease (pimavanserin)1 Psychosis DAYBUE™ Rett Syndrome (trofinetide)2 Negative Pimavanserin Symptoms of Schizophrenia Alzheimer’s ACP-204 Disease Psychosis SYNGAP1; ASO Pr
Slide 9: Commercial Update
Commercial Update Brendan Teehan, Chief Operating Officer, Head of Commercial 9
Slide 10: DAYBUE Launch Update
DAYBUE Launch Update DAYBUE became the first and only drug approved by the FDA for the treatment of Rett syndrome on March 10th DAYBUE available for patients on April 17th DAYBUE (trofinetide) is only approved in the U.S. by the FDA for the treatment of Rett syndrome in adults and pediatric patients
Slide 11: DAYBUE Launch Execution
DAYBUE Launch Execution Enrollment Forms HCP Targeting and Rollover Patients KOL and Caregiver Engagement As expected, we are receiving >50% Rett population covered by ✓ KOL speaker programs ongoing enrollment forms representative of the currently engaged HCPs since launch broad Rett community: ✓ We
Slide 12: NUPLAZID 1Q23 Commercial Update
NUPLAZID 1Q23 Commercial Update Encouraging start to 2023 with NUPLAZID: • Demand growth of 2% year over year for 1Q23 • Growth in both office-based and long-term care channels • Early indicators of growth in new patient starts in 4Q22 and even further in 1Q23 • Signs that HCP conversations on the r
Slide 13: R&D Update
R&D Update Doug Williamson M.D., Head of Research and Development 13
Slide 14: Rett Syndrome
Rett Syndrome Medical Congresses • Medical Science Liaison (MSL) team focused on delivering important 1 scientific information and clinical education about DAYBUE • Presenting additional clinical data and information about treatment of Rett syndrome at multiple medical congresses in 2023 Upcoming Pu
Slide 15: Negative Symptoms of Schizophrenia
Negative Symptoms of Schizophrenia HIGH UNMET NEED CLINICAL DEVELOPMENT No FDA-approved treatment for the • One positive pivotal study, ADVANCE-1; leveraging negative symptoms of schizophrenia optimal therapeutic dose of 34mg in ADVANCE-2 • Enrollment completion of ADVANCE-2 expected patients receiv
Slide 16: Alzheimer's Disease Psychosis
Alzheimer’s Disease Psychosis PHASE 1 • Evaluated ACP-204 in both healthy adult and elderly patients • Demonstrated a favorable safety and tolerability profile • Confirmed potential for improved onset of action • Supports target product profile, including minimizing risk of QT prolongation CLINICAL
Slide 17: Financial Update
Financial Update Mark Schneyer, Chief Financial Officer 17
Slide 18: 1Q23 Financial Highlights
1Q23 Financial Highlights Millions, Except EPS 1Q23 1Q22 YoY (GAAP) (GAAP) Change Total Revenue $118.5 $115.5 +3% R&D $69.1 $128.9 -46% SG&A $101.2 $96.7 +5% Net Income (Loss) ($43.0) ($113.1) EPS ($0.27) ($0.70) Cash Balance $402.9 NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for
Slide 19: FY23 Financial Guidance Reiterated
FY23 Financial Guidance Reiterated FY23 Guidance Commentary • Midpoint of the range reflects ~1% volume growth YoY and includes ~2.5% net price growth YoY NUPLAZID Net Sales $520 to $550M • Parkinson’s disease psychosis (PDP) guidance only • No sales guidance for DAYBUE • Increased due to IRA inflat
Slide 20: Closing Remarks
Closing Remarks Steve Davis, Chief Executive Officer 20
Slide 21: Execution Across All Strategic Priorities
Execution Across All Strategic Priorities Rett Syndrome Parkinson’s Disease Negative Symptoms Alzheimer’s Disease Psychosis of Schizophrenia Psychosis DAYBUE NUPLAZID Pimavanserin ACP-204 Demand +2% YoY Phase 3 ADVANCE-2 Phase 1 Commercially available studies complete since April 17 in 1Q23 ongoing
Slide 22: Q&A Session
Q&A Session
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