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Cytokinetics Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 24 February 2026: press release. Guidance figures: 2 new. The quarter’s numbers.

Key takeaways

  • Full-year net loss $785.0 million: The full-year net loss was $785.0 million, or $(6.54) per share, against $589.5 million, or $(5.26) per share, in 2024. The Q4 net loss was $183.0 million, or $(1.50) per share. Source
  • MYQORZO approved for symptomatic oHCM: The FDA approved MYQORZO (aficamten) in December 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy. The approval is the basis for the U.S. launch. Source
  • U.S. launch underway, first prescriptions: The U.S. launch began in January. Management said first prescriptions were dispensed within days of drug availability. Source
  • MAPLE-HCM sNDA submitted to FDA: A supplemental NDA for MAPLE-HCM was submitted to the FDA in the first quarter of 2026. Source
  • ACACIA-HCM topline expected Q2 2026: ACACIA-HCM, a pivotal Phase 3 trial in non-obstructive HCM, continues, including the Japan cohort. Topline results are expected in Q2 2026. Source
  • G&A rose on sales force hiring: G&A expense was $91.7 million in Q4 against $62.3 million a year earlier. Full-year G&A was $284.3 million, mainly from commercial readiness and U.S. sales force hiring. Source
  • Cash about $1.22 billion at year end: Cash, equivalents and investments were about $1.22 billion at December 31, 2025, against $1.25 billion at September 30. The year-end balance includes $100 million from the Royalty Pharma Tranche 5 drawing. Source
  • Cash excluding loan fell $134 million: Excluding the $100 million loan proceeds, cash, cash equivalents and investments would have declined by about $134 million during the fourth quarter. Source

“The fourth quarter of 2025 marked a defining moment for Cytokinetics with the FDA approval of MYQORZO and our transition into a commercial-stage company”

Robert I. Blum, Cytokinetics’ President and Chief Executive Officer

Guidance

AreaPeriodFigureAgainst last quarter
GAAP Combined R&D and SG&A Expense Sourcefull year 2026$830 million to $870 millionNew
Non-cash stock-based compensation within GAAP Combined R&D and SG&A Expense Sourcefull year 2026$130 million to $120 millionNew

What changed from last quarter

  • New guidance: 2026 financial guidance was introduced for GAAP combined R&D and SG&A expense and related stock-based compensation. Q3 guidance covered 2025 only. Source
  • New: The FDA approved MYQORZO in December 2025. The Q3 release said the NDA review was ongoing ahead of a December 26, 2025 PDUFA date. Source
  • New: China NMPA approval of MYQORZO for NYHA class II-III oHCM was announced. The Q3 release described the China review as ongoing. Source
  • New: European Commission approval of MYQORZO was received. The Q3 release expected a potential EMA decision in 1H 2026. Source
  • New: The U.S. commercial launch began in January 2026. The Q3 release had described launch preparations as on track. Source
  • New: A supplemental NDA for MAPLE-HCM was submitted to the FDA in the first quarter of 2026. Source
  • New: Health Canada accepted the NDS for aficamten for review. Source
  • New: Enrollment of CAMELLIA-HCM, the Japanese oHCM trial run by Bayer, was completed. The Q3 release described the trial as continuing. Source

Results and growth drivers

  • Q4 revenue was $17.8 million: Q4 revenue was $17.8 million against $16.9 million a year earlier. Collaboration revenues were $2.8 million and license and milestone revenues were $15.0 million. Source
  • Full-year revenue from Bayer and Sanofi: Full-year revenue of $88.0 million included a $52.4 million technology transfer to Bayer Consumer Care AG in Q2 and $15.0 million of Sanofi milestones tied to U.S. and China approvals. Source
  • Full-year net loss $785.0 million: The full-year net loss was $785.0 million, or $(6.54) per share, against $589.5 million, or $(5.26) per share, in 2024. The Q4 net loss was $183.0 million, or $(1.50) per share. Source

U.S. commercial launch

  • MYQORZO approved for symptomatic oHCM: The FDA approved MYQORZO (aficamten) in December 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy. The approval is the basis for the U.S. launch. Source
  • U.S. launch underway, first prescriptions: The U.S. launch began in January. Management said first prescriptions were dispensed within days of drug availability. Source
  • Cardiovascular specialists began promotion: Account specialists began promoting to healthcare providers in early January. Patient and HCP marketing campaigns launched across promotional channels. Source
  • MYQORZO & You support program launched: The MYQORZO & You program offers personalized patient support, access and reimbursement help, and affordability programs. The MYQORZO REMS online portal was activated with drug availability. Source

“Early prescribing activity and initial customer feedback reinforce that our differentiated label and REMS are resonating with HCPs and patients.”

Robert I. Blum, Cytokinetics’ President and Chief Executive Officer

Ex-U.S. approvals and launches

  • China approval announced: China NMPA approved MYQORZO for NYHA class II-III oHCM to improve exercise capacity and symptoms. The Q3 release said the China review was ongoing. Source
  • European Commission approval received: The European Commission approved MYQORZO for symptomatic NYHA class II-III oHCM in adults after a positive CHMP opinion. The Q3 release had expected an EMA decision in 1H 2026. Source
  • Germany launch expected Q2 2026: Health Technology Assessment dossiers were prepared for all key European markets. Medical and commercial teams were hired in Germany ahead of the planned Q2 launch. Source
  • Health Canada review accepted: Health Canada accepted the NDS for aficamten for review. The company expects potential Health Canada approval in 2H 2026. Source

Clinical programs and filings

  • MAPLE-HCM sNDA submitted to FDA: A supplemental NDA for MAPLE-HCM was submitted to the FDA in the first quarter of 2026. Source
  • ACACIA-HCM topline expected Q2 2026: ACACIA-HCM, a pivotal Phase 3 trial in non-obstructive HCM, continues, including the Japan cohort. Topline results are expected in Q2 2026. Source
  • CAMELLIA-HCM enrollment completed: Bayer conducts CAMELLIA-HCM with Cytokinetics to support potential marketing authorization in Japan. Enrollment is complete. Source
  • AMBER-HFpEF enrollment continues: The Phase 2 trial of ulacamten in HFpEF continues. Cohort 1 enrollment is expected to complete in Q1 2026, and Cohort 2 by the end of 2026. Source
  • CEDAR-HCM pediatric enrollment continues: Enrollment continues in the pediatric trial of aficamten. The adolescent cohort enrollment is expected to complete in Q4 2026. Source
  • COMET-HF enrollment continues through 2026: The confirmatory Phase 3 trial of omecamtiv mecarbil continues. Patient enrollment is expected to continue through 2026. Source

“We are well-positioned to deliver for patients, advance our pipeline, and create long-term value.”

Robert I. Blum, Cytokinetics’ President and Chief Executive Officer

Operating expenses and guidance

  • Q4 R&D expense $104.4 million: R&D expense was $104.4 million in Q4, against $93.6 million a year earlier, including $14.2 million of non-cash stock-based compensation. Full-year R&D expense was $416.0 million. Source
  • G&A rose on sales force hiring: G&A expense was $91.7 million in Q4 against $62.3 million a year earlier. Full-year G&A was $284.3 million, mainly from commercial readiness and U.S. sales force hiring. Source
  • R&D rose on trials and personnel: The full-year R&D increase was attributed to advancing clinical trials, higher personnel-related costs including stock-based compensation, and medical affairs activities. Source
  • 2026 expense range excludes collaboration costs: The 2026 expense range excludes collaboration expenses, potential nHCM commercialization costs, and GAAP adjustments from events after the guidance, including business development. Source

Cash and balance sheet

  • Cash about $1.22 billion at year end: Cash, equivalents and investments were about $1.22 billion at December 31, 2025, against $1.25 billion at September 30. The year-end balance includes $100 million from the Royalty Pharma Tranche 5 drawing. Source
  • Cash excluding loan fell $134 million: Excluding the $100 million loan proceeds, cash, cash equivalents and investments would have declined by about $134 million during the fourth quarter. Source
  • Year-end debt and revenue participation liabilities: At December 31, 2025 the balance sheet showed term loan, net of $246,384 thousand, convertible notes, net of $869,597 thousand, and revenue participation liabilities, net of $520,559 thousand. Source

Corporate and scientific communications

  • AHA disparities initiative supported: The company supported a three-year American Heart Association initiative on disparities in access to care, diagnosis and treatment for people with HCM. Source
  • MAPLE-HCM data presented at meetings: Additional MAPLE-HCM analyses on symptom burden and cardiac biomarkers versus metoprolol were presented, with more patients on aficamten achieving positive or complete response. Source
  • Aficamten and omecamtiv manuscripts published: Manuscripts published in Q4 include aficamten analyses in JACC and European Heart Journal, and an omecamtiv mecarbil analysis of GALACTIC-HF in JACC Heart Failure. Source

Coming up, as management said on 24 February 2026

  • ACACIA-HCM topline results: Topline results from the ACACIA-HCM trial are due in Q2 2026. Source
  • Germany launch of MYQORZO: Launch of MYQORZO in Germany is planned for Q2 2026. Source
  • MAPLE-HCM FDA approval decision: Potential FDA approval of the MAPLE-HCM sNDA is expected in Q4 2026. Source
  • Health Canada approval: Potential Health Canada approval for aficamten is expected in 2H 2026. Source
  • CEDAR-HCM adolescent enrollment: Enrollment of the adolescent cohort of CEDAR-HCM is expected to complete in Q4 2026. Source
  • AMBER-HFpEF cohort enrollment: Cohort 1 enrollment is expected to complete in Q1 2026, and Cohort 2 by the end of 2026. Source

Figures management reported

FigureReported
R&D expense, Q4 2025 Source$104.4 million
R&D expense, full year 2025 Source$416.0 million
FDA approval, MYQORZO for oHCM SourceApproved December 2025
European Commission approval, MYQORZO SourceApproved for symptomatic NYHA class II-III oHCM
SNDA submission, MAPLE-HCM SourceSubmitted Q1 2026
Topline readout, ACACIA-HCM SourceExpected Q2 2026
Total revenues, Q4 2025 Source$17.8 million

Earlier plans management reported on

  • Not stated: The Q3 release expected to share primary cohort topline results in Q2 2026. The Q4 release repeats Q2 2026 for ACACIA-HCM topline results.
  • Not stated: The Q3 release expected a potential EMA decision in 1H 2026. The Q4 release reports European Commission approval.
  • Not stated: The Q3 release referred to launch readiness for potential approval in Germany in 1H 2026. The Q4 release expects the Germany launch in Q2 2026.
  • Not stated: The Q3 release referred to the PDUFA action date of December 26, 2025. The Q4 release reports FDA approval received in December.
  • Not stated: The Q3 release expected adolescent cohort enrollment to continue into 2026. The Q4 release expects that enrollment to complete in Q4 2026.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.