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Mar 31, 2021
ACADIA Q1 2021 Earnings Report
Acadia Pharmaceuticals reported an increase in NUPLAZID net sales and reiterated its full-year net sales guidance. However, the company received Complete Response Letters from the FDA regarding its sNDA for NUPLAZID in dementia-related psychosis.
Key Takeaways
Acadia Pharmaceuticals reported a net sales increase for NUPLAZID in Q1 2021, reaching $106.6 million, an 18% increase compared to Q1 2020. The company is reiterating its full-year net sales guidance of $510 to $550 million. However, they also received Complete Response Letters from the FDA regarding their sNDA for NUPLAZID for dementia-related psychosis.
NUPLAZID net sales were $106.6 million, an 18% increase over 1Q20.
The company received Complete Response Letters from the FDA regarding its sNDA for NUPLAZID in dementia-related psychosis (DRP).
Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.
Acadia is reiterating its NUPLAZID net sales guidance of $510 to $550 million for the year.
Revenue by Segment
Forward Guidance
Acadia is reiterating its NUPLAZID net sales guidance of $510 to $550 million. GAAP R&D guidance is decreased to $280 to $300 million from the previous range of $300 to $320 million. GAAP SG&A guidance is decreased to $385 to $415 million from the previous range of $560 to $590 million.
Positive Outlook
- Reiterating NUPLAZID net sales guidance of $510 to $550 million.
- GAAP R&D guidance decreased to $280 to $300 million.
- GAAP SG&A guidance decreased to $385 to $415 million.
- Positive signs in the Parkinson’s disease psychosis market supporting revenue growth for the remainder of the year.
- Anticipate continued improvements in the conditions related to the pandemic.
Challenges Ahead
- Received a Complete Response Letter (CRL) from the FDA regarding its sNDA for NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).
- Uncertainty of future commercial sales.
- Risks and uncertainties inherent in drug development, approval and commercialization.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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