Cytokinetics (NASDAQ:CYTK) used its fourth-quarter 2025 earnings call to highlight a major transition for the company: the approval and initial U.S. launch execution of MYQORZO for adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM), alongside advancing late-stage clinical programs and providing 2026 expense guidance.
MYQORZO approvals mark shift to commercial-stage company
President and CEO Robert Blum said the fourth quarter represented a “defining moment” for Cytokinetics following the FDA approval of MYQORZO in December for symptomatic obstructive HCM. Blum also noted that in the span of one week the company received approvals for MYQORZO in the U.S. and China, as well as a positive CHMP opinion in the European Union, which preceded the European Commission approval announced “last week,” according to his remarks.
Early U.S. launch indicators: REMS certifications and physician engagement
EVP and Chief Commercial Officer Andrew Callos outlined launch steps taken immediately after FDA approval on December 19. He said Cytokinetics built customer support around “HCM Navigators” who provide one-on-one patient support, and deployed patient and healthcare professional (HCP) marketing campaigns across multiple channels. Sales representatives (“Cardiovascular Account Specialists”) began engaging with HCPs after the New Year’s holidays, and the company brought its REMS portal online within weeks, enabling MYQORZO to become available for prescription.
Callos said the company also launched “MYQORZO & You,” a patient support program offering personalized support, reimbursement and affordability assistance, and programs including a free trial, bridge program, copay assistance, and patient assistance for eligible patients. He said HCPs began REMS certification and patients began enrolling in support programs on the first day of product availability, with the first prescriptions dispensed within days.
Management repeatedly emphasized that the launch remains in early stages, but shared several indicators they view as encouraging:
- Callos said that within three weeks more than 700 HCPs were REMS certified across HCM specialty and non-specialty centers.
- He said the company has logged more than 12,000 customer engagements, including engagement with over 95% of the 700 HCPs who account for the majority of cardiac myosin inhibitor (CMI) prescribing.
- Post-launch market research cited on the call suggested roughly 90% of HCPs surveyed were aware of MYQORZO “on a needed basis,” and the majority stated they plan to prescribe it for obstructive HCM.
On REMS logistics, Callos said certification consists of a self-study training and a scored 10-question assessment that generally takes 10–20 minutes, adding that it has “really not been a barrier.” He also said many cardiologists were already accustomed to REMS requirements because MYQORZO is the “second cardiac myosin inhibitor.”
Callos attributed interest to several aspects of the product’s profile as characterized by the company, including flexible dosing and titration as early as every two weeks, an echocardiogram monitoring window of two to eight weeks after initiation or dose changes, and that drug-to-drug interaction counseling is not required as part of the MYQORZO REMS program. He also pointed to findings the company referenced from SEQUOIA-HCM, including sustained reduction in obstruction and symptom improvement and “no treatment discontinuation due to ejection fraction drops” as described on the call.
Beginning with its first-quarter 2026 earnings call, Cytokinetics said it plans to report three launch metrics: the number of HCPs actively writing prescriptions, prescription volumes per HCP, and the number of patients on MYQORZO. Callos said the company’s goal is to achieve greater than 50% of CMI new patient preference share by the end of 2026, while also growing the overall CMI category.
Pipeline updates: ACACIA-HCM, MAPLE-HCM sNDA, and heart failure trials
On label expansion and pipeline milestones, Blum said Cytokinetics submitted a supplemental NDA to the FDA during the first quarter for MYQORZO tied to MAPLE-HCM results, with an expected FDA review conclusion in the fourth quarter of 2026. He added that expanded labeling could increase category penetration and allow more patients to benefit.
Stuart Kupfer, SVP and Chief Medical Officer, said the next key clinical catalyst will be ACACIA-HCM, a pivotal Phase 3 trial of aficamten in non-obstructive HCM. The company said it remains on track to announce top-line results for the primary cohort (excluding Japan) in the second quarter of 2026. Management indicated the top-line press release is expected to be “relatively high level” to preserve the ability to present full results at a medical congress later in the year.
In the Q&A, Blum and colleagues clarified that the trial would be considered positive if it meets statistical significance on either of the pre-specified co-primary endpoints (KCCQ or peak VO2), with management stating neither endpoint is weighted more heavily than the other. When asked about placebo response expectations, the company said it remains blinded and could only discuss design assumptions: placebo response for peak VO2 is typically near zero based on prior studies, and KCCQ expectations were described as roughly four to six points, while emphasizing that powering relied on the difference between active and placebo responses, citing a five-point delta for KCCQ in the study design.
On heart failure programs, Kupfer said the company continued COMET-HF, a confirmatory Phase 3 trial of omecamtiv mecarbil in symptomatic heart failure patients with severely reduced ejection fraction (less than 30%). He said 100% of U.S. sites and over 90% of European sites have been activated, and the company plans to expand into China. Kupfer also provided an update on AMBER-HFpEF, a Phase 2 trial of ulacamten in symptomatic HFpEF with ejection fraction of at least 60%, stating enrollment in Cohort 1 is expected to complete in the first quarter of 2026, followed by an interim safety review before potentially proceeding to a higher-dose Cohort 2.
Separately, Fady Malik, EVP of R&D, said Cytokinetics’ partner Bayer completed enrollment in CAMELLIA-HCM, a Phase 3 trial of aficamten in Japanese obstructive HCM patients, and that the Japanese cohort for non-obstructive HCM in ACACIA-HCM has been fully enrolled, supporting potential marketing authorization in Japan. Malik also described additional MAPLE-HCM data presentations and said a responder analysis showed more patients on aficamten achieved a positive or complete response versus metoprolol, alongside greater improvements on symptoms and cardiac biomarkers, as characterized on the call.
Financial results and 2026 expense guidance
EVP and CFO Sung Lee reported that Cytokinetics ended 2025 with approximately $1.22 billion in cash, cash equivalents, and investments, compared with $1.25 billion at the end of the third quarter. The year-end balance included $100 million in proceeds from drawing on Tranche 5 of the Royalty Pharma multi-tranche loan; excluding that draw, Lee said cash, cash equivalents, and investments would have declined by approximately $134 million in the fourth quarter.
Total revenue was $17.8 million in the fourth quarter of 2025, compared with $16.9 million in the fourth quarter of 2024. Full-year 2025 revenue totaled $88 million versus $18.5 million in 2024, driven primarily by a $52.4 million technology transfer completion payment to Bayer in the second quarter of 2025 and $15 million in milestones recognized in the fourth quarter tied to U.S. and China MYQORZO approvals under the Sanofi license agreement. Lee said MYQORZO became available to patients near the end of January, and product sales are expected to be reported with first-quarter 2026 results.
R&D expense rose to $104.4 million in the fourth quarter (from $93.6 million a year earlier) and to $416 million for the full year (from $339.4 million), reflecting clinical trial advancement, higher personnel costs including stock-based compensation, and medical affairs activities. G&A expense increased to $91.7 million in the fourth quarter (from $62.3 million) and to $284.3 million for the full year (from $215.3 million), driven by commercial readiness investments including hiring a U.S. sales force and higher personnel-related costs.
Net loss was $183 million, or $1.50 per share, for the fourth quarter of 2025 versus $150 million, or $1.26 per share, in the prior-year quarter. Full-year net loss was $785 million, or $6.54 per share, compared with $589.5 million, or $5.26 per share, in 2024.
For 2026, Cytokinetics said it is not providing MYQORZO product sales guidance in its first launch year. Lee guided to combined GAAP R&D and SG&A expense of $830 million to $870 million, including $120 million to $130 million in stock-based compensation. Excluding stock-based compensation, the combined expense range was $700 million to $750 million. Lee also outlined capital allocation priorities centered on the U.S. launch and European readiness for MYQORZO, pipeline advancement including label expansion opportunities and ongoing trials, and continued investment in its muscle biology platform.
Looking ahead, Blum reiterated a slate of 2026 milestones, including ACACIA-HCM top-line results in the second quarter, a planned MYQORZO launch in Germany in the second quarter, and a potential FDA decision on the MAPLE-HCM supplemental NDA by the fourth quarter of 2026. He also cited ongoing enrollment plans for COMET-HF and AMBER-HFpEF and continued preclinical research in muscle biology-focused programs.
About Cytokinetics (NASDAQ:CYTK)
Cytokinetics, Inc is a late‐stage biopharmaceutical company focused on the discovery and development of novel small‐molecule therapeutics that modulate muscle function. Founded in 1998 and headquartered in South San Francisco, California, the company applies its proprietary insights in muscle biology to address diseases characterized by impaired muscle performance. Its research spans both cardiac and skeletal muscle targets, aiming to deliver innovative medicines for conditions with significant unmet medical need.
The company’s most advanced program, omecamtiv mecarbil, is being evaluated for the treatment of heart failure by enhancing cardiac muscle contractility.
