Cytokinetics, Incorporated (CYTK) Earnings

Management highlights

- Commercial Launch of myCORSO (U.S. and Europe) * Five months post-U.S. launch, myCORSO has exceeded growth expectations, with Q2 exit new-to-brand share in the cardiac myosin inhibitor (CMI) category exceeding 40%. The sales force has reached over 90% of high-volume CMI prescribers, who generate ~80% of category prescriptions, and more than 50% of current myCORSO prescribers are low-volume or first-time CMI writers, indicating category expansion. * By end of Q2 2026, 1,500 patients have received dispensed myCORSO, nearly tripling the 400 dispensed patients at the end of Q1 2026. Over 80% of dispensed prescriptions are paid, with the remainder covered by patient assistance programs. Nearly 90% of Medicare lives have parity coverage, and over 50% of commercial lives have coverage, on track to full parity access by end of 2026. * myCORSO launched successfully in Germany (first European market) in June 2026. The MHRA granted marketing authorization in the UK, and NICE issued a positive reimbursement recommendation for England and Wales, with full UK launch expected in Q4 2026. Ten HTA dossiers have been submitted across Europe, with reimbursement approval already granted in the Netherlands effective August 1, 2026. Additional European launches are planned for late 2026 and first half of 2027. - Research and Development Pipeline Progress * The pivotal Phase 3 Acacia HCM trial for aficamptin in non-obstructive HCM (NHCM), a population with no currently approved therapies, met both dual primary endpoints (statistically significant improvements in KCCQ clinical summary score and peak VO2 at week 36 vs placebo) and all key secondary endpoints, with no new safety signals. Full trial results will be presented at the upcoming European Society of Cardiology (ESC) Congress. * Following FDA discussions after the Acacia HCM top-line release, Cytokinetics plans to submit a supplemental New Drug Application (sNDA) for aficamptin in NHCM in Q4 2026, with similar regulatory discussions planned for EU authorities. The sNDA for OHCM based on the Maple HCM trial is currently under FDA review with a PDUFA date of November 14, 2026. * For the broader pipeline: enrollment in the adolescent cohort of the pediatric CDER-HCM trial for aficamptin was completed ahead of schedule; the confirmatory Phase 3 COMET-HF trial for omicamptin mccarville in heart failure with severely reduced ejection fraction has enrolled just over one-third of planned patients, with >90% of sites activated, and enrollment will continue through 2026; enrollment in Cohort 1 of the Phase 2 AMBER-HEpPE trial for eulacampin in heart failure with preserved ejection fraction remains on track to complete in the second half of 2026. * A leadership transition: Steve Heitner was promoted to Chief Medical Officer, with former CMO Stuart Kupfer remaining as Senior Vice President of Clinical Development focused on pharmacovigilance. - Financial and Operational Highlights * The company ended Q2 2026 with $1.7 billion in cash and investments, up from $1.1 billion at the end of Q1 2026, driven by $760 million in net proceeds from a successful public offering in May 2026. Q2 2026 net loss was $198.8 million ($1.50 per share), compared to a $134.4 million net loss ($1.12 per share) in Q2 2025, with the larger loss driven by higher commercial launch costs for myCORSO.

Guidance

- Full year 2026 combined GAAP R&D and SG&A expense guidance was revised upward to a range of $860 million to $890 million, from the prior range of $830 million to $870 million. - Stock-based compensation included in the combined GAAP R&D and SG&A guidance was adjusted upward to $130 million to $140 million, from the prior range of $120 million to $130 million; excluding stock-based compensation, the combined expense range is $720 million to $760 million. - The upward guidance revision is primarily to fund increased commercial readiness investments for a potential 2027 launch of myCORSO in NHCM, following the positive Acacia HCM trial results. - Key 2026 corporate milestones maintained: sNDA submission for NHCM in Q4 2026, potential FDA approval of the Maple HCM sNDA for OHCM in Q4 2026, UK launch of myCORSO in Q4 2026, completion of enrollment in Cohort 1 of the AMBER-HFpEF trial in H2 2026, continued enrollment in the COMET-HF trial through 2026, and potential Health Canada approval of aficamptin in H2 2026.

Segment performance

Cytokinetics reports total Q2 2026 revenue of $28.6 million, down from $66.8 million in Q2 2025. The only commercial product segment, myCORSO (aficamptin) for symptomatic obstructive hypertrophic cardiomyopathy (OHCM), generated net product revenue of $25.3 million, accounting for 88.5% of total Q2 2026 revenue. Of this myCORSO revenue, the U.S. contributed $23 million (80.4% of myCORSO revenue, 80.4% of total revenue), and Europe contributed $2.3 million (9.1% of myCORSO revenue, 8.0% of total revenue), which reflects initial distributor inventory for the newly launched German market. The remaining 11.5% of total Q2 2026 revenue came from collaboration revenue of $3.3 million, with no licensing or milestone revenue recorded in the quarter (Q2 2025 included $64.4 million in milestone revenue from the Bayer collaboration for aficamptin in Japan).

Risks & headwinds

- There is no guarantee that the FDA or EU regulators will approve the sNDA for NHCM or the expanded indication for OHCM, and approval timelines and final labeling terms cannot be predicted at this stage. - Reimbursement approval and patient access in Europe proceeds country-by-country, with a slower expected revenue build than in the U.S. market. - Pending regulatory and prior authorization processes for prescriptions create a multi-week lag between written prescriptions and dispensed doses, which could near-term impact near-term revenue visibility. - Late-stage pipeline trials for omicamptin and eulacampin are still ongoing, and there is no guarantee they will meet their clinical endpoints to support eventual approval. - Commercial penetration of CMI therapy in the HCM patient population is still at an early stage (estimated at ~20% penetration today), and growth depends on continued physician education, expanded insurance access, and increased disease diagnosis, which may progress slower than expected.

Analyst Q&A

• Q: An analyst asked for clarification on total Q2 2026 prescriptions versus dispensed prescriptions for myCORSO, and the consistency of the dispense ratio from Q1.

  A: Management confirmed there were ~2,000 total written prescriptions in Q2 2026, compared to 1,500 dispensed prescriptions by quarter end. The ~25% gap is primarily driven by the multi-week process of REMS certification, benefit investigation, and prior authorization, with only a mid-single-digit percentage of prescriptions ultimately canceled. The ratio of pending to dispensed prescriptions is consistent with Q1, and the company is focusing on dispensed numbers because this is what drives product revenue.

• Q: An analyst asked how management expects messaging to work for multiple upcoming new indications (expanded OHCM use and potential NHCM approval) over the next year, to avoid confusing prescribing physicians.

  A: Management noted the medical team first disseminates full trial data via peer-reviewed publications, then conducts educational outreach (including CME and industry symposia) to key physician groups. From a commercial perspective, the Maple HCM data for expanded OHCM use broadens the definition of appropriate CMI patients for low-volume and first-time prescribers, while potential NHCM approval expands the total patient pool eligible for myCORSO treatment. Messaging is organized and cascaded clearly to keep the information simple for prescribing physicians.

• Q: An analyst asked how current CMI penetration of the eligible OHCM market stands today, and what peak penetration the company expects for the class.

  A: Management estimates there are 110,000 to 120,000 currently eligible diagnosed OHCM patients in the U.S., and current CMI penetration is only around 20% of that group. Peak penetration for the CMI class is expected to eventually reach 60% to 70% of eligible patients, depending on access, safety evidence, and REMS requirements, and the eligible patient pool could grow as more patients are diagnosed now that effective new therapies are available.

• Q: An analyst asked about the timeline and profile for European launches, and how Europe will contribute to overall growth relative to the U.S.

  A: Launches are staggered across Europe as the company completes HTA and reimbursement review in each market, with the UK launching next in Q4 2026 and additional launches rolling out through the end of 2027. The company expects Europe will contribute to long-term growth but will not be a near-term primary driver; peak European revenue is expected to represent roughly 15% of the company's total myCORSO revenue over time, with pricing in Europe 10% to 20% lower than U.S. pricing on average.

• Q: An analyst asked what factors are driving the small share of patients switching to myCORSO from competing CMI products, and what feedback the company has received on efficacy after switching.

  A: Switching currently accounts for only 5% to 7% of total myCORSO dispenses, and the company does not have a systematic large dataset on switching outcomes. Anecdotally, common drivers of switching include myCORSO's more favorable pharmacokinetic profile (faster onset and offset) for patients who may need to interrupt dosing, the lack of a black box warning for reproductive use compared to the competitor, and fewer required drug-drug interaction monitoring that allows patients to keep using other common medications (like antidepressants or GERD treatments) without modification.