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Cytokinetics (CYTK) investor relations material
Cytokinetics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary5 Nov, 2025
Executive summary
Significant progress made toward potential FDA approval of aficamten for obstructive hypertrophic cardiomyopathy (OHCM), with commercial launch readiness activities completed and capital structure fortified.
NDA for aficamten in OHCM is under FDA review with a PDUFA target action date of December 26, 2025; MAA under review by EMA, and regulatory reviews ongoing in China.
Positive results from the MAPLE-HCM trial demonstrated aficamten's superiority to metoprolol, supporting a supplemental NDA filing post-approval.
Broader pipeline momentum maintained, including progress in clinical trials for omecamtiv mecarbil and ulacamten, and continued pre-clinical research.
Significant collaborations and licensing agreements in China (Sanofi) and Japan (Bayer) for aficamten, with upfront and milestone payments received.
Financial highlights
Ended Q3 2025 with $1.25 billion in cash and investments, up from $1.04 billion in Q2, primarily due to convertible note offering and note exchange.
Total revenues for Q3 2025 were $70.3 million, driven by $64.3 million in license and milestone revenues from Bayer.
R&D expenses were $99.2 million (up from $84.6 million YoY); G&A expenses were $69.5 million (up from $56.7 million YoY), mainly due to clinical and commercial investments.
Net loss for Q3 2025 was $306.2 million, or $2.55 per share, including a $121.2 million debt conversion expense.
Full-year 2025 GAAP operating expense guidance narrowed to $680–$700 million.
Outlook and guidance
Anticipates FDA approval and U.S. launch of aficamten by year-end, with immediate commercial rollout and support services.
EMA approval for aficamten expected in H1 2026, with German launch targeted for H1 2026 and other EU markets to follow.
Top-line results from Acacia HCM (nHCM) expected in Q2 2026; ongoing patient enrollment in other key trials through 2026.
No immediate need for additional capital, with $1.2 billion in cash and access to further financing if needed.
Anticipated increase in operating expenses due to commercial readiness for aficamten and ongoing clinical trials.
Aficamten's differentiated label and REMS impact
Aficamten payer engagement strategy focus
Cash runway implications of recent financing?
How to expand CMI prescribing universe?
ACACIA: Impact if only one primary endpoint hits?
Strategy for parity access by H2 2026?
Aficamten: Time to commercial drug conversion?
Acacia HCM: Can endpoint weighting be changed?
Future capital needs for launches and pipeline?
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Next Cytokinetics earnings date
Stifel 2025 Healthcare Conference11 Nov, 2025
Next Cytokinetics earnings date
Stifel 2025 Healthcare Conference11 Nov, 2025
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Frequently asked questions
Cytokinetics Inc is a biopharmaceutical company focused on developing small-molecule therapies aimed at muscle function. The company targets diseases associated with impaired cardiac and skeletal muscle performance, including heart failure and neuromuscular disorders. Its operations include clinical development and research. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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