ACADIA Pharmaceuticals (ACAD) Q4 2021 earnings summary

Executive summary

• 2021 net product sales rose 10% YoY to $484.1M, despite COVID-related pressure on Parkinson’s patient visits and long-term-care occupancy. NUPLAZID remained the sole marketed product.

• Positive Phase 3 LAVENDER results advanced trofinetide toward an NDA filing; the ADP sNDA was resubmitted, while ADVANCE-2 continued toward 2023 results.

Financial highlights

• Revenue was $484.1M vs. $441.8M in 2020; 2021 growth reflected higher average gross selling price and ~3% unit-sales growth.

• Operating loss was $170.4M vs. $286.6M; net loss was $167.9M vs. $281.6M, and diluted EPS was $(1.05) vs. $(1.79).

• R&D expense fell to $239.4M from $319.1M; 2020 included $52.8M for CerSci and $10.0M for Vanderbilt upfront payments and transaction costs.

• SG&A increased to $396.0M from $388.7M, mainly from higher personnel costs, partly offset by lower stock-based compensation.

Outlook and guidance

• ADP sNDA resubmission has an FDA target action date of August 4, 2022; trofinetide NDA submission was planned around mid-2022, with priority review expected and a likely first-half 2023 action date.

• ADVANCE-2 top-line results are expected in 2023; ACP-044 bunionectomy study results were expected near Q1-end 2022 and osteoarthritis results near year-end 2022.

• Cash, cash equivalents and investment securities were expected to fund planned operations for at least 12 months; operating losses were expected to continue for the next few years.