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Mar 31, 2025
Cytokinetics Q1 2025 Earnings Report
Cytokinetics reported its first quarter 2025 financial results, highlighting progress in commercial readiness and pipeline advancement, with a PDUFA date extension for aficamten and upcoming topline results for MAPLE-HCM.
Key Takeaways
Cytokinetics reported a net loss of $161.4 million for Q1 2025, with total revenues of $1.6 million. The company maintained a strong cash position of approximately $1.1 billion and continued to advance its clinical pipeline, including the extension of the PDUFA date for aficamten and completion of enrollment for ACACIA-HCM.
The PDUFA date for aficamten in obstructive HCM was extended by the FDA to December 26, 2025, to allow time for REMS submission review.
Topline results from the MAPLE-HCM clinical trial are expected in May 2025.
Enrollment for the ACACIA-HCM trial has been completed, with topline results anticipated in 1H 2026.
The company reported approximately $1.1 billion in cash, cash equivalents, and investments as of March 31, 2025.
Revenue by Segment
Forward Guidance
Cytokinetics is maintaining its full year 2025 financial guidance, with anticipated increases in GAAP operating expenses due to investments in commercial readiness for aficamten.
Positive Outlook
- Anticipated approval and launch of aficamten for patients with obstructive HCM.
- Continued progress towards commercial readiness for aficamten.
- Expectation to report topline results from MAPLE-HCM in May 2025.
- Completion of enrollment in ACACIA-HCM with topline results expected in 1H 2026.
- Strong balance sheet to support regulatory, clinical, and commercial milestones.
Challenges Ahead
- PDUFA date for aficamten extended to December 26, 2025, due to REMS submission review.
- GAAP operating expense guidance of $670 million to $710 million, indicating significant expenditures.
- Non-cash stock-based compensation expense included in GAAP operating expense is $120 million to $110 million.
Historical Earnings Impact
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