Cytokinetics Q2 Earnings Call Highlights
Key Points
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- MYQORZO’s U.S. launch is gaining traction: The drug reached 1,500 dispensed patients and more than 700 prescribers in the second quarter, with over 80% of prescriptions paid and new-to-brand share above 40% in June.
- Cytokinetics plans to expand aficamten into nHCM: After positive Phase III ACACIA-HCM results, the company expects to file a supplemental application with the FDA in the fourth quarter; it also made progress toward broader European commercialization.
- Financial results reflected launch investment: Q2 revenue fell to $28.6 million due to lower licensing income, while the net loss widened to $198.8 million. The company ended the quarter with approximately $1.7 billion in cash and raised its 2026 operating-expense guidance.
Cytokinetics (NASDAQ:CYTK) reported second-quarter results marked by early commercial momentum for MYQORZO, international market-access progress and plans to seek an expanded indication for aficamten in non-obstructive hypertrophic cardiomyopathy, or nHCM.
Chief Executive Officer Robert Blum said the company was seeing launch performance for MYQORZO that was “exceeding expectations” five months after the product’s U.S. introduction at the end of January. MYQORZO is approved for adults with symptomatic obstructive hypertrophic cardiomyopathy, or oHCM.
MYQORZO Launch Gains Momentum
During the second quarter, MYQORZO was dispensed to 1,500 patients, compared with 400 patients at the end of the first quarter, according to Executive Vice President and Chief Commercial Officer Andrew Callos. The company said approximately 2,000 prescriptions were written in the second quarter, with the difference largely reflecting patients progressing through REMS enrollment, benefits investigations, prior authorization and other dispensing requirements.
More than 80% of dispensed prescriptions in the quarter were paid prescriptions, while the remainder were associated with free trials, bridge programs or other patient-assistance initiatives. Callos said most prescriptions were dispensed within about three weeks after documentation and benefits reviews were completed.
Cytokinetics said its internal analysis indicated that MYQORZO’s new-to-brand prescription exit share in the cardiac myosin inhibitor, or CMI, category exceeded 40% in June. The company is targeting more than 50% new-to-brand prescription share by the end of 2026, though management said it expects adoption to continue across multiple physician segments rather than relying on one group alone.
- More than 700 U.S. healthcare providers had prescribed MYQORZO by quarter-end.
- About 300 prescribers were high-volume CMI writers.
- More than half of MYQORZO prescribers were low-volume CMI prescribers or first-time CMI writers.
- More than 2,500 healthcare providers had completed REMS certification since launch.
- Cytokinetics had reached more than 90% of its targeted high-volume prescribers by the end of the quarter.
Callos said roughly 5% to 7% of total MYQORZO dispenses came from patients switching therapies, but management emphasized that switching is not the company’s principal commercial strategy. The company instead is focused on patients who are new to the CMI category and broader adoption among treating physicians.
On the access front, Cytokinetics ended the quarter with nearly 90% parity coverage for Medicare lives and more than 50% commercial coverage. The company said it remains on track to achieve commercial parity access by the end of 2026.
Europe Launches and Market Access
Cytokinetics launched MYQORZO in Germany in June, its first European launch. European net product revenue totaled $2.3 million in the quarter and reflected initial distributor inventory purchases in Germany.
The company also submitted 10 health technology assessment dossiers across Europe and said reimbursement approval became effective in the Netherlands on Aug. 1. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency granted marketing authorization for MYQORZO in symptomatic oHCM, while the National Institute for Health and Care Excellence recommended the treatment for use in England and Wales.
Management expects full U.K. launch and drug supply later this year, followed by additional European launches through 2027. Callos said Europe is expected to become a contributor to revenue but not the primary driver of growth, estimating it could represent about 15% of overall revenue over time.
nHCM Filing Planned After Positive Phase III Results
The company highlighted positive top-line findings from ACACIA-HCM, its Phase III trial of aficamten in symptomatic nHCM. Cytokinetics said the study met both dual primary endpoints, showing statistically significant improvements from baseline to week 36 in Kansas City Cardiomyopathy Questionnaire clinical summary score and peak oxygen consumption, compared with placebo.
Fady Malik, executive vice president of research and development, said key secondary endpoints also showed statistically significant improvements and that no new safety signals were identified. Cytokinetics plans to present full ACACIA-HCM results, including analyses of cardiac structure and function, at the European Society of Cardiology Congress later this month.
Following discussions with the FDA, Cytokinetics plans to submit a supplemental new drug application for aficamten in nHCM during the fourth quarter. The company also plans discussions with European regulators regarding potential submissions. Management noted there are currently no approved therapies for nHCM.
Separately, an sNDA based on the MAPLE-HCM trial in oHCM remains under FDA review, with a PDUFA target date of Nov. 14, 2026. The company said MAPLE-HCM could support use of aficamten as an earlier treatment option in appropriate patients if approved.
Financial Results and Pipeline Updates
Total second-quarter revenue was $28.6 million, down from $66.8 million a year earlier. The prior-year period included $64.4 million in licensing and milestone revenue from Cytokinetics’ aficamten collaboration with Bayer in Japan. MYQORZO generated $25.3 million in net product revenue in the latest quarter, including $23 million in the U.S.
Research and development expense declined to $97.8 million from $110.1 million a year earlier, while selling, general and administrative expense rose to $104.4 million from $65.7 million, primarily due to MYQORZO launch costs, the U.S. sales force and personnel expenses. Cytokinetics reported a net loss of $198.8 million, or $1.50 per share, compared with a loss of $134.4 million, or $1.12 per share, in the prior-year quarter.
The company ended the quarter with approximately $1.7 billion in cash and investments, up from $1.1 billion at the end of the first quarter, following a May public offering that generated about $760 million in net proceeds.
Cytokinetics raised its 2026 guidance for combined GAAP R and SG expense to $860 million to $890 million, from $830 million to $870 million. The increase reflects commercial-readiness investments for a potential 2027 MYQORZO launch in nHCM.
Elsewhere in its pipeline, the company said it had enrolled more than one-third of patients in COMET-HF, a confirmatory Phase III trial of omecamtiv mecarbil in heart failure with severely reduced ejection fraction. Enrollment is expected to continue through 2026. Cytokinetics also expects to complete enrollment in the first cohort of the Phase II AMBER-HFpEF trial of ulacamten in the second half of 2026.
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.
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