Cytokinetics (CYTK) investor relations material

Launch performance and commercial trends

• Revenue rose 76% QoQ; patient dispenses exceeded 2,800 vs. 1,500 in Q2, while the CMI market grew 45% YoY.

• New-to-brand share was close to 45% after eight months on market; management expects continued growth as prescribers and accounts are added, without setting a long-term share target.

• Prescriber productivity averaged about four patients per prescriber, seven among high-volume CMI users; CMI-naive prescribers increased from one to two patients on average.

• More than 3,000 HCPs were REMS-certified; two-thirds were writing or affiliated with a writer at the same clinic. Medicare coverage was 90% of lives at parity with CAMZYOS; commercial coverage rose to 60% from 50% QoQ.

• Prescribers use the 2–8-week titration and monitoring window; average titration timing was four to six weeks. Flexibility, rapid efficacy, and a less burdensome REMS were cited as drivers.

Clinical and regulatory outlook

• A MAPLE-HCM sNDA was expected the following week; an nHCM submission was planned by year-end, with European activity expected in early 2027. Aficamten was approved in five countries/regions, and European expansion was underway.

• The main treatment period of CAMELLIA-HCM in Japan was complete. Management described nHCM as a potential doubling of the opportunity and a key focus in coming years.

• For a potential nHCM label, management hopes to use ACACIA-HCM and FOREST-HCM evidence to align titration timing and thresholds with oHCM; nHCM titration would use ejection fraction rather than LVOT gradient.

• ACACIA-HCM had 12 heart-failure cases during titration vs. three placebo cases later in the study; management attributed the difference to computer-driven titration and said physician-guided FOREST-HCM titration did not show the same signal.

• Management characterized ACACIA-HCM treatment effects as consistent across prespecified subgroups and described a potential approach of starting symptomatic nHCM patients at a low dose, titrating to maximum tolerated dose, then assessing symptom improvement.

REMS strategy and competition

• ASPEN is intended to collect longer-term, real-world aficamten safety and efficacy data in a broader oHCM population; ASPEN and FOREST-HCM are among several components supporting a potential future REMS change.

• Management said any REMS change would depend on agency review and accumulated evidence; two approved CMI therapies currently require REMS.

• Switching from CAMZYOS remained in the mid-single digits through the first three launch quarters; management said switching was not a focus.

• Management expects a similar launch cadence for nHCM, with potential acceleration among experienced CMI prescribers balanced by continued disease-state education; payer access is being planned ahead of a potential approval.

• Management expects to remain in market for years before potential competitors reach approval and cited real-world experience and data collection as strategic advantages.