CYTOKINETICS INC Q3 FY2024 earnings call

• Completed rolling submission and submitted NDA to FDA for aficamten, with priority review requested; NDA in China accepted. - Commercial preparations for aficamten in US: launched HCM disease awareness campaign, selected third-party partners for patient experience, refined sales territories/training. - In Europe: designed distribution model, refined strategies, hired initial team. - Presented SEQUOIA-HCM data showing aficamten benefits in exercise capacity, symptoms, etc. - Preparing to start COMET-HF (omecamtiv mecarbil) and AMBER-HFpEF (CK-586) trials. - CK-089 to start first-in-human study.

Total revenues in Q3 2024 were $0.5 million (vs $0.4 million in 2023). R&D expenses were $84.6 million (vs $82.5 million in 2023), driven by higher personnel-related costs. G&A expenses were $56.7 million (vs $40.1 million in 2023), driven by commercial readiness and personnel costs. Net loss was $160.5 million (vs $129.4 million in 2023). No product segments with revenue contribution % provided as focus is on pipeline and commercial preparations.

• Reiterating prior guidance. - Balance sheet strong with ~$1.3B in cash, etc., to prepare for aficamten launch and pipeline advancement. - Expect MAPLE-HCM results in H1 2025, start COMET-HF and AMBER-HFpEF in Q4 2024, start CK-089 Phase I.

• Actual results may differ from forward-looking statements due to various factors. - Uncertainties around FDA approval timeline, payer coverage, and competitive landscape affecting commercialization of products.

Q: Looking at the SEQUOIA data, it seems like the largest magnitude of LVF reductions were seen in hypercontractile patients with LVEF greater than 75. If you had a mechanism that could show gradient relief benefits without affecting LVF, first, would it be considered and would be clinically useful for patients with severe hypercontractility? And second, would you still expect to see a benefit on pVO2?

A: Fady Malik responded discussing that treating hypercontractility is important as just treating obstruction may not be sufficient long-term.

Q: On the Phase III MAPLE-HCM trial in patients with symptomatic OHCM, how confident are you in a positive trial here? And specifically, could you walk us through the magnitude of change for aficamten over metaprolol you need to hit a p-value that is significant?

A: Fady Malik discussed the study design, enrollment, and that aficamten has shown benefit on top of beta blockers, with the trial powered to detect meaningful changes in peak VO2.

Q: Could you think you can get the results of MAPLE published and into treatment guidelines prior to the actual approval?

A: Robert Blum stated they aim to get data published soon and guidelines are updated continuously, with efforts to get data peer reviewed and published quickly.

Q: On CK-586, can you speak to the lessons that you took from the EMBARK results? How are the target patients in and were meaningfully similar or different in your estimation from EMBARK?

A: Stuart Kupfer discussed that CK-586 trial is a placebo-controlled trial vs EMBARK, and they're enriching for HFpEF patients with ejection fraction of at least 60%, learning from prior data but with a more rigorous study design.

Q: Returning to MAPLE and any sort of clinical efficacy bar that has been potentially discussed with payers as they think about potential guideline changes there. And have they provided any feedback to you or any sort of physician community commentary on just sort of what would be considered clinically meaningful here versus metaprofile as to drive guideline changes here?

A: Andrew Callos mentioned focus on SEQUOIA data now, with plans to incorporate MAPLE into payer conversations and value arguments once data is available.

Q: On 089, can you just, at a high level, just tell us how 089 differs from the prior candidates?

A: Fady Malik discussed that CK-089 is a third molecule with better pharmaceutical properties, more potent, and better suited for dosing and dose ranging based on preclinical data.

Q: On omecamtiv mecarbil, what is your view on its competitive position within the heart failure market, specifically as other treatments for heart failure with reduced ejection fraction continue to develop?

A: Fady Malik, Stuart Kupfer, and Andrew Callos discussed omecamtiv mecarbil's position in treating severely reduced ejection fraction heart failure, with unique benefits, neutral effect on certain side effects, and strong clinical and economic arguments.