Cytokinetics Inc Q2 2025 Earnings Call Transcript

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

Question: Gena Wang, PhD, CFA - Barclays Services Corp - Analyst : Thank you for taking my questions. I have so many, okay, but I will limit my question to one, that's regarding the ESC update. So you did mention the MAPLE data could be potentially guideline change. Can you elaborate a little bit, like what kind of a magnitude benefit, like you are looking -- what are the key data points we should be focusing on and what kind of a magnitude benefit the peer or physician are willing to use first line or switch those patient on beta blockers to aficamten?

Question: Akash Tewari - Jefferies LLC - Analyst : So look, it looks increasingly like either you're going to get the Kim's ODYSSEY data at ESC. What are the two or three things investors should be looking at in that data that would support the team's hypothesis that ACACIA will be successful where Kim's wasn't and also would support a clear exposure response relationship in this population?

Question: Tessa Romero - JPMorgan Chase & Co - Analyst : Thanks so much for taking our question. So what does an ideal label look like for aficamten and an obstructive HCM here? And Robert, can you just double click on any specifics you can give us on the updated REMS that it sounds like you submitted versus the original one, and how these updates track your expectations for a differentiated REMS? 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 07, 2025 / 8:30PM, CYTK.OQ - Q2 2025 Cytokinetics Inc Earnings Call

Question: Salim Syed - Mizuho Securities USA LLC - Analyst : I guess one for us on the OHHCM late cycle meeting. So Robert, what exactly are you planning to learn or discuss in that September late cycle meeting? And just can you remind us how much of the REMS negotiation here actually happens post the late cycle meeting actually during the label negotiations themselves?

Question: Cory Kasimov - Evercore Inc - Analyst : So I wanted to ask, go back to ACACIA, and wondering if you could walk us through how drug interruptions and discontinuation protocols differ versus ODYSSEY. I guess I'm particularly curious about how ACACIA should differ from the four-week dose interruption that is necessary if LVEF drops below 50%, as was the case in ODYSSEY. And maybe you can point out any other significant design differences you would maybe call out between the two studies.

Question: Ike Lee - Citi - Analyst : Thanks for taking our questions. This is Ike Lee on for David Lebowitz. I wanted to ask about the larger market opportunity and non-obstructive HCM, which we all know is there. Presumably, you will need to reach more community doctors is our understanding upon that launch. So thinking about that, how much larger do you think your sales force is going to be if and when that time comes?

Question: Jason Butler - Citizens JMP Securities LLC - Analyst : Just, I guess an extension of that. When you think about the expansion into Europe and the commercial work that you're doing there, can you maybe speak to some of the similarities and differences of what needs to be done to get ready for the European launch?

Question: Joseph Pantginis - H.C. Wainwright - Analyst : First, I guess maybe for Andrew, as you're preparing with all your broad commercial preparations, what do you feel are some of the components that you're required to do but won't necessarily need but needed to go through the motions depending on how a potential REMS may or may not play out? 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 07, 2025 / 8:30PM, CYTK.OQ - Q2 2025 Cytokinetics Inc Earnings Call And secondly, for Stuart, as you're looking at COMET, with the company's broad, very broad experience with omecamtiv long term, how would you characterize the site excitement with regard to enrollment versus all the other omecamtiv studies? Thanks.

Question: Joseph Pantginis - H.C. Wainwright - Analyst : Correct, based on how REMS may or may not play out.

Question: William Ong - B. Riley Securities - Analyst : Thanks for taking our questions. This is [William Ong] for Mayank. I just wanted to circle back to ACACIA. Today, you mainly focused on sort of the ODYSSEY and the Phase 2 to Phase 3 transition on how that supports potential positive results when that reads out next year. But I was also curious how new data from the MAPLE study, also, from past SEQUOIA, how those may -- that new data may support ACACIA and what specifically -- specific endpoints you may specifically can highlight that may support those claims. And then also just in terms of REMS, how should we think about the REMS in OHCM sort of to read through to non-obstructive HCM? Should we think that those would be relatively the same or potentially differing just based on profiles?

Question: Ashwani Verma - UBS AG - Analyst : I wanted to ask, like, this late cycle meeting push out from June to September. Is that the result of your prior three months PDUFA date extension, or is this a separate development which can now have a cascading effect on the relief date? What I'm trying to understand is, like, does the September late cycle meeting give FDA enough of a runway to now finish up the wrap-up activity from the review before the deadline?