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Mar 31
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.
Cytokinetics
Cytokinetics
Cytokinetics Revenue by Segment
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CapyFin.com 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.
- Financial guidance does not include the effect of GAAP adjustments from future business development activities.
- Potential for delays or difficulties in development, testing, regulatory approvals, or product sale/manufacturing.