Cytokinetics (CYTK) investor relations material

Strategic milestones and commercial launch

• Transitioned to a commercial-stage company following FDA approval of Mycorrhiza for obstructive hypertrophic cardiomyopathy (OHCM), with launches in the US and China and anticipated European approval in Q1, enabling a Q2 Germany launch.

• Mycorrhiza is positioned as the first of several pipeline products, with ongoing studies in non-obstructive HCM (NHCM), heart failure with reduced ejection fraction (HFrEF), and preserved ejection fraction (HFpEF).

• Commercial strategy targets concentrated prescriber segments, aiming for high revenue per prescriber and leveraging a specialized sales force.

• Over $1 billion in cash reserves and access to additional capital support the commercial and R&D pipeline.

• Launch metrics focus on breadth and depth of prescribing, aiming for over 50% new patient share and at least 3,800 patients on therapy in year one.

Product differentiation and market approach

• Mycorrhiza demonstrated significant clinical benefits in the SEQUOIA-HCM study, including improved exercise capacity, symptom relief, and favorable safety profile.

• Differentiated REMS program and patient support services are designed to streamline physician and patient experience, with a one-to-one engagement model.

• Pricing set at $108,400 WAC, with a focus on clinical value rather than price competition; payer mix is expected to be 55-60% Medicare and 30-35% commercial.

• Market research indicates Mycorrhiza's REMS and support programs address key barriers to adoption seen with other cardiac myosin inhibitors.

• Promotional campaigns and materials were co-designed with patient input to enhance engagement and address patient needs.

Pipeline and future growth

• ACACIA phase III data for NHCM expected in Q2, with potential to double the addressable patient population if positive.

• Ongoing clinical trials include omecamtiv in HFrEF and eulacamten in HFpEF, with further data readouts anticipated by year-end.

• Supplemental NDA for MAPLE data to be submitted in Q1, aiming for label expansion by year-end.

• Vision for 2030 includes making Mycorrhiza available in multiple countries and serving over 100,000 patients, while expanding the pipeline.

• The same experienced team has overseen all major clinical trials, ensuring consistency and high data integrity.