CYTOKINETICS INC Q4 FY2025 earnings call

Robert Blum noted 2025 was a defining year with MYCorzo approval, U.S. and China approvals, and EU positive opinion. Andrew Callos discussed U.S. commercial launch with HCM navigators, marketing campaigns, REMS program, and goal to achieve >50% CMI new patient preference share by 2026. Fady Malik spoke about medical affairs engagement and Bayer's enrollment in CAMELLIA-HCM. Stuart Kupfer mentioned ACACIA-HCM top line results expected in Q2 2026, ongoing COMMUN-HF and AMBER-HFpEF trials. Sung Lee provided financial overview and 2026 guidance on expenses and capital allocation

In 2025, Cytokinetics had total revenues in Q4 2025 of $17,800,000 compared to $16,900,000 in 2024. Full year 2025 total revenues were $88,000,000 vs $18,500,000 in 2024. R&D expenses in Q4 2025 were $104,400,000 vs $93,600,000 in 2024. Full year 2025 R&D expenses were $416,000,000 vs $339,400,000 in 2024. G&A expenses in Q4 2025 were $91,700,000 vs $62,300,000 in 2024. Full year 2025 G&A expenses were $284,300,000 vs $215,300,000 in 2024. Net loss in Q4 2025 was $183,000,000 or $1.50 per share vs $150,000,000 or $1.26 per share in 2024. Full year 2025 net loss was $785,000,000 or $6.54 per share vs $589,500,000 or $5.26 per share in 2024. For 2026, expected GAAP combined R&D and SG&A expense between $830,000,000 and $870,000, with stock-based compensation between $120,000,000 and $130,000,000

For 2026, no product sales guidance for MYCorzo launch. Expected GAAP combined R&D and SG&A expense between $830M - $870M, stock-based compensation between $120M - $130M. Capital allocation priorities: launch MYCorzo in U.S. and Europe, advance pipeline, invest in muscle biology platform. 2026 milestones include ACACIA-HCM top line in Q2, MYCorzo launch in Germany in Q2, FDA review of MAPLE-HCM sNDA in Q4, completion of adolescent cohort in CEDAR-HCM in Q4, potential Health Canada approval in H2

Q: Is it true that the study will be successful if at least one of the endpoints reaches statistical significance?

A: Robert Blum said it is true as the trial is designed to be deemed positive if it hits on either or both of the prespecified clinical trial endpoints.

Q: How long is taking sites and clinical centers to get through the REMS certification and start to prescribe?

A: Andrew Callos said REMS certification is a quick self-study training and 10-question Q&A taking 10 to 20 minutes generally.

Q: Comment on your placebo arm response expectations for both KCCQ and peak VO2?

A: Fady Malik said placebo response to peak VO2 is close to zero, and for KCCQ, the difference between placebo and active was powered to be five points.

Q: Any color on early market uptake?

A: Andrew Callos said demand in U.S. was as expected, with broad awareness and strong engagement.

Q: View on whether one of the endpoints is more important than the other?

A: Robert Blum said co-primary endpoints were chosen not because one is more important, but due to regulatory harmonization.

Q: When you said high level, should we be thinking more along the lines of qualitative or quantitative?

A: Robert Blum said it depends on data and ability to present at medical congress.

Q: Have you done payer work or uptake work to understand whether the usage would still be strong if you showed a three-point placebo-adjusted difference in KCCQ?

A: Fady Malik said average response may color physician view, but study will inform what is clinically meaningful.

Q: How important or meaningful an ACACIA win would be helping to de-risk broader HFpEF opportunity?

A: Stuart Kupfer said ACACIA outcome could inform potential benefit in HFpEF.

Q: Color on the centers signing up in the REMS program?

A: Andrew Callos said majority are current CMI prescribers but there are also new prescribers.

Q: Can you report on patient start forms and uptake in community practices?

A: Andrew Callos said too early to give numbers but engagement is at or above expectations with good balance across prescribers.

Q: Could there still be an option to modify the REMS requirement in the future?

A: Robert Blum said real-world data could inform potential changes but too early to speak to specifics.

Q: How does the discontinuation rate in ACACIA compare to prior studies?

A: Fady Malik said study remains within design parameters but would not commit to updating discontinuation rate.

Q: Color on types of patients being started on aficamten?

A: Robert Blum and Andrew Callos said patient information is protected but likely 'all of the above' types of patients