Cytokinetics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for Q3 2026 were $47.6 million, a significant increase from $1.9 million in the same period in 2025.
• Net product revenue from MYQORZO® (aficamten) was $44.5 million, comprising $43.1 million from the U.S. and $1.4 million from Europe.
• Collaboration revenue was $3.1 million in Q3 2026, compared to $1.9 million in Q3 2025.
• Research and Development (R&D) expenses were $99.3 million in Q3 2026, up from $97.3 million in Q3 2025, driven by higher clinical trial activity and personnel costs.
• Selling, General and Administrative (SG&A) expenses were $113.1 million in Q3 2026, compared to $69.5 million in Q3 2025, primarily due to external costs associated with the MYQORZO commercial launch and higher personnel costs.
• Cost of goods sold related to MYQORZO was a credit of $0.5 million in Q3 2026.
• Collaboration cost of revenues was $2.7 million in Q3 2026, compared to $1.9 million in Q3 2025.
• Net loss for Q3 2026 was $190.1 million ($1.37 per share), an improvement from a net loss of $306.2 million ($2.55 per share) in Q3 2025.
• As of September 30, 2026, the company held approximately $1.6 billion in cash, cash equivalents, and investments, down from $1.7 billion as of June 30, 2026.
• Total assets were $1.82 billion as of September 30, 2026, compared to $1.42 billion as of December 31, 2025.
• Total liabilities were $2.15 billion as of September 30, 2026, compared to $2.08 billion as of December 31, 2025.
• Stockholders' deficit was $321.2 million as of September 30, 2026, compared to $659.6 million as of December 31, 2025.

Guidance and Future Outlook:

• The company reaffirmed its full-year 2026 financial guidance for GAAP combined R&D and SG&A expense at $860 million to $890 million.
• Non-cash stock-based compensation expense included in the combined R&D and SG&A guidance is projected between $130 million and $140 million.
• The company expects to submit a Supplemental New Drug Application (NDA) for aficamten in non-obstructive HCM (nHCM) in the U.S. in Q4 2026.
• A Type II Variation for the European Union is expected to be filed in early 2027.
• MYQORZO launch in the United Kingdom is expected in Q4 2026, with additional country launches planned for 2027.
• Patient enrollment in the COMET-HF trial is expected to continue through 2027.
• Patient enrollment in Cohort 1 of the AMBER-HFpEF trial is expected to be completed in Q4 2026.
• Topline data from the adolescent cohort of CEDAR-HCM is expected to be presented in early 2027.

Business Segments and Product Lines:

• MYQORZO (aficamten) is approved in the U.S., China, EU, UK, and Canada for symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
• Year-to-date as of September 30, 2026, nearly 1,100 unique healthcare providers have prescribed MYQORZO, and over 2,800 patients have been dispensed the drug.
• Health Canada authorized MYQORZO for patients with symptomatic oHCM of NYHA class II-III.
• The UK's MHRA granted marketing authorization for MYQORZO, with NICE guidance recommending its use in England and Wales.
• Positive primary results from the ACACIA-HCM Phase 3 trial in nHCM were presented at the ESC Congress and published in the New England Journal of Medicine.
• The ASPEN-HCM real-world study for symptomatic oHCM was recently initiated.
• The main study treatment period of CAMELLIA-HCM (Phase 3 in Japan) was completed.
• The Japan cohort of ACACIA-HCM and the adolescent cohort of CEDAR-HCM were completed.
• Omecamtiv mecarbil (cardiac myosin activator) is in the confirmatory Phase 3 COMET-HF trial for heart failure with severely reduced ejection fraction.
• Ulacamten (cardiac myosin inhibitor) is in Phase 2 Cohort 1 of the AMBER-HFpEF trial for heart failure with preserved ejection fraction.
• CK-4015089 (fast skeletal muscle troponin activator) is in the second Phase 1 clinical study.

Market and Competitive Landscape:

• Management stated that aficamten has the potential to become the first and only cardiac myosin inhibitor approved across the full spectrum of HCM (both obstructive and non-obstructive).
• The company is expanding access to MYQORZO internationally to bring the medicine to more patients globally.
• The press release notes competition from other cardiac myosin inhibitors and other existing or future therapies as a risk factor.

Risks and Challenges:

• Risks include the degree of market acceptance among physicians, patients, and payors, as well as the availability of adequate coverage, pricing, and reimbursement.
• Regulatory risks include potential delays, limitations, or denials of the Supplemental NDA or Type II Variation by the FDA or foreign agencies.
• Safety risks involve the identification of new safety signals or adverse events as the drug is used more broadly.
• The company faces dependence on third-party manufacturers, suppliers, and collaboration partners (Bayer, Sanofi).
• Risks include the need for additional funding, which may not be available on acceptable terms, and outstanding indebtedness including agreements with Royalty Pharma.
• Potential difficulties in patient enrollment or delays in clinical trial conduct are noted.
• Changes in standards of care, competitive products, or intellectual property challenges could impact the business.
• Changes in laws, regulations, or government policies affecting drug pricing, reimbursement, tariffs, or trade are potential risks.

Management Commentary and Tone:

• Robert I. Blum, President and CEO, described the results as demonstrating "continued strong execution" as the company enters a "next phase of growth."
• Management noted that the MYQORZO launch in the U.S. has built "solid momentum" with "increased velocity" and "growing adoption across a broadening base of prescribers."
• The tone regarding the ACACIA-HCM results is positive, viewing them as a key step toward achieving the company's "Vision 2030."
• Management expressed confidence in moving "swiftly" to seek regulatory approvals in the U.S. and Europe.

Other Key Points:

• The company achieved a preclinical development milestone under its 2025 collaboration with Accutar Biotech, triggering a $2.5 million payment to Accutar.
• The collaboration with Accutar Biotech focuses on discovering and developing novel targeted protein degraders for muscle-related diseases.
• The company published four manuscripts regarding aficamten in the New England Journal of Medicine, Circulation, and JACC: Heart Failure.
• The company holds a significant amount of long-term investments ($453.6 million) and has operating lease right-of-use assets ($71.6 million).
• Liabilities related to revenue participation right purchase agreements increased to $579.6 million as of September 30, 2026.
• The company has convertible notes net of $732.8 million and a term loan net of $244.3 million.
• A conference call and webcast for senior management to review results was held on November 4, 2026.