Cytokinetics Inc Q2 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Salim Syed - Mizuho Securities USA, LLC - Analyst : Good afternoon, Robert. Thanks for taking the question, and congrats on the progress. I guess -- and want to welcome Isaac to the company. I had a question on just that related matter with Isaac joining, is it possible to just give us how your framework into thinking here -- I know there was no 8-K or press release that I came across, but it seems like something that's important to the business. So just maybe the cadence of the business development activities we should be expecting and primarily and updated thoughts around aficamten Europe, if that's in the cards. Or was this more gated to potentially doing business development around the omecamtiv mecarbil? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 8:30PM, CYTK.OQ - Q2 2024 Cytokinetics Inc Earnings Call

Question: Akash Tewari - Jefferies LLC - Analyst : Hey, good afternoon. I realize you can't talk about your meeting with the FDA, but how much should we read into this protocol amendment on FOREST, which now allows a six-month echo for patients with an LVEF of above 55. Shouldn't this strongly predicts what in the REM should ultimately be? And is there a possibility of the FDA won't require a REMS at all pending more follow-up data from FOREST. And maybe, Robert, if I could sneak in one more. You talked about why you might spin off some assets. Can you talk about why it might be preferable to spin off certain assets ahead of, let's say, pending M&A, if let's say, there is an overlap in a company that has a HFpEF portfolio. I'm thinking specifically about CK-586 five and spinning that asset off. Thank you.

Question: Roanna Ruiz - Leerink Partners LLC - Analyst : Hi, afternoon, everyone. So maybe tagging on to the discussion about MAPLE. I was curious if you could elaborate a bit more. It sounded like you mentioned that you could leverage some of the MAPLE data or initial results to help provide that to the FDA while they're reviewing aficamten's filing? And is there any impact that could happen with aficamten's possible labeling as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 8:30PM, CYTK.OQ - Q2 2024 Cytokinetics Inc Earnings Call

Question: Roanna Ruiz - Leerink Partners LLC - Analyst : Got it. And physicians would be able to reference this as well, right?

Question: Paul Choi - Goldman Sachs & Company, Inc. - Analyst : Hi. Good afternoon and thank you for taking our question. Robert and Fady, I want to ask your view just on sort of next stages and planning of developments for both HFpEF and HFrEF in the context of recently positive GLP-1 data and just your thoughts there as to how that might be a potential treatment target in the algorithm or modality for them for heart failure, and just your thoughts on planning trials for 586 and omecamtiv mecarbil down the road here. Thank you very much for taking our questions.

Question: Srikripa Devarakonda - Truist Securities - Analyst : Good afternoon, Robert. Thank you so much for taking my questions. Your slides seem to indicate CMI preference share for aficamten in eligible patient population is about 60%. I was wondering about the potential of patients to switch from mavacamten to aficamten if especially they're concerned about safety or not satisfied with the efficacy. That may not be your base case, but was just wondering whether based on your market survey or are survey of KOLs, you see this as a possibility. Thank you.

Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst : Hey, Robert and team. Congrats on the good progress and recent meeting with the agency. I had a quick question on MAPLE enrollment. Yeah, it looks like it's going to be done soon. Comments from Fady, though, suggested absolutely anticipate that to be post approval. And so I guess I'm wondering if you could provide a little bit of color on what you anticipate to be the timeline to review for afi. Are you assuming a rapid review and approval or is it possible that the MAPLE results could be requested or included upon the initial NDA?

Question: Jason Butler - Citizens JMP Securities, LLC - Analyst : Hi, Robert. Thanks for taking the question. Just another one on the omecamtiv study. Just when we think about the targeted patient population and the positive data you've already generated, how should we think about enrollment timelines? And is there any comparison to the prior study here in terms of potential enrollment timelines?

Question: Sean McCutcheon - Raymond James & Associates, Inc. - Analyst : Hi, guys. Thanks for the question. Can you speak to the importance of dosing optimization, specifically in the context of the 36-week, non-obstructive cohort in FOREST? Thinking about the necessity of getting patients to those higher doses maybe as a advantage you have over your competitor, what's your interpretation of how this has and potentially will impact the KCCQ results? Maybe speak to the prior KCCQ data and how it's informed your powering assumptions for ACACIA? Thanks.

Question: John Gionco - Needham & Company, LLC - Analyst : Hi, Robert. This is John on for Serge today. Thanks for taking our question. We just wanted to touch on whether you guys had any updated thoughts or learnings from mavacamten launch regarding the HCM market opportunity and how you may be able to improve on their launch trajectory when the time comes for you guys. Thanks.

Question: Rohan Mathur - Oppenheimer & Co. Inc. - Analyst : Hi, this is Rohan on for Leland Gershell. Thanks for taking my question. Just on CK-586, are there any learnings from the aficamten studies that might inform design of the Phase 2 trial for 586 with respect to how health safety and efficacy findings might be evaluated, given that it's a greater severity of disease in HFpEF population. Thank you.

Question: Rohan Mathur - Oppenheimer & Co. Inc. - Analyst : Yes.