Cytokinetics Inc Q4 2024 Earnings Call Transcript

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

Question: Paul Choi - Goldman Sachs - Analyst : Hi, everyone. Good afternoon to you too. This is Kahlil calling in for Paul. I guess our question could be on MAPLE-HCM. If the results are positive, how should we think about the timeline for potential label expansion assuming approval in September? And then how would the positive results fit into the company's marketing strategy in the interim? Thank you so much.

Question: Paul Choi - Goldman Sachs - Analyst : Great. Thank you.

Question: Cory Kasimov - Evercore ISI - Analyst : Hey, good afternoon. Thanks for taking the question. So following up on Andrew's prepared comments on market expansion, I think it's pretty well established that HCM is a highly under diagnosed condition. So curious, as to your expectations as to how this changes over time when there's two companies on the market educating and promoting the benefits of cardiac myosin inhibitors. If it really is on the order of 70% to even 80% percent of patients as yet undiagnosed, is there a good proxy of where this rate may get to say 3 to 5 years from now? Thank you.

Question: Cory Kasimov - Evercore ISI - Analyst : All right. Sounds good. Appreciate it. Thanks, guys.

Question: Salim Syed - Mizuho - Analyst : Hey, Robert. Thanks for the question. One question we're getting a lot on, I'm sure you guys are as well, I would just love to get your view, is just the upcoming Edgewise dataset, the 28-day. We just sort of look to see how your framework in it, anything you're looking out for there? And also, just related to that, do you think there's any even remote possibility that they if they were to progress come out of this without any REMS at all? Thank you, based on the preclinical data at least. Thank you.

Question: Salim Syed - Mizuho - Analyst : Okay, perfect.

Question: James Condulis - Stifel - Analyst : Good afternoon. Thanks for taking my question and congrats on all the progress. I just want to ask one kind of quick question on the REMS and totally appreciate there's only so much you can say, but wanted to get your thoughts on if you expect mavacamten's REMS to be eased in The U. S. As well and sort of if that happens like how does that change how you sort of think about the range of scenarios for kind of what aficamten 's REMS looks like? Again, sort of like in that scenario, would you define differentiated REMS as still differentiated in sort of the maintenance setting as well? Or does that become more about some of the other aspects of the REMS? Just curious what you can share there. Thanks.

Question: James Condulis - Stifel - Analyst : Yes, I appreciate the color. Thank you.

Question: Tess Romero - JPMorgan - Analyst : Hi, Robert and team. Thanks for taking our questions tonight and look forward to ACC. So do you think based on your physician and KOL interactions that it is appreciated that there is not the same pharmacogenomic and DDI liability with aficamten as there is with Camzyos due to the way that the drug is metabolized related to a patient's CYP2C19 genotype versus yours? If not, how do you think you will go about educating doctors around this point? And then relatedly, to be clear, will any monitoring be needed by the pharmacy around concomitant meds with aficamten? Thanks so much.

Question: Tess Romero - JPMorgan - Analyst : Thank you, guys.

Question: Leonid Timashev - RBC Capital Markets - Analyst : Good afternoon, guys. Yes. Thanks for taking my I wanted to ask on the endpoints for ACACIA and maybe some comparisons to the competitor in HCM study. And I don't mean a corner unit commenting on someone else's study, but can you talk about any potential differences in KCCQ-23 versus KCCQ-12? And maybe why you settled on a single primary focusing on KCCQ rather than also including pVO2 as a primary and sort of REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, CYTK.OQ - Q4 2024 Cytokinetics Inc Earnings Call whether that was based on your own diligence of your own data or in consultation with the FDA? Just any thoughts, I would appreciate it. Thank you.

Question: Leonid Timashev - RBC Capital Markets - Analyst : That's great. Thank you.

Question: Akash Tewari - Jefferies - Analyst : Thank you, guys so much.

Question: Sean McCutcheon - Raymond James - Analyst : Hi, guys. Good afternoon and thanks for taking the question. Maybe to build on the last question. For MAPLE, you're enrolling patients with percent predicted Peak VO2 of less than 100%, whereas in SEQUOIA, for the most part, outside of one patient, you are enrolling less than 80% predicted. How should we be thinking of this patient population as it relates to obstruction driving exercise capacity deficits and how that contrasts with SEQUOIA, if at all? Thanks.

Question: Roanoke Ruiz - Leerink Partners - Analyst : Hi, good afternoon, everyone. So slightly different question for me. I was curious if you could elaborate a bit more on your future goals for, I think you mentioned BD and corporate development in the coming years. It sounds like you're willing to consider augmenting your R&D pipeline, curious of any color on stage of asset, mechanisms, indications, etcetera that you'd be interested in internally or externally? And how would you balance that with your current cash runway expectations today?

Question: Roanoke Ruiz - Leerink Partners - Analyst : Understood. Thanks.

Question: Joe Pantginis - H.C. Wainwright - Analyst : Hey, everybody. Thank you for taking the question. Good afternoon. So I'm not sure if you could discuss this right now because everything is active. But upcoming to your mid cycle meeting with the FDA, anything you could discuss about key questions that are still outstanding or any potential rate limiting steps? And then also with regard to omecamtiv, something anything you might be that you can share regarding COMET-HF and the enrollment trajectory, say, related to GALACTIC, since there are additional screening criteria? Thanks.

Question: Joe Pantginis - H.C. Wainwright - Analyst : Thanks again.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Good afternoon, team. Thanks for taking our questions and congrats on the progress. Just maybe switching gears to CK-586 HFpEF study. I think you mentioned the first two cohorts, low and mid dose level enrolling and completion by end of this year. Could you maybe just talk to the higher dose cohort is contingent on completion of the first two cohorts and maybe just what you're looking to learn on both the tolerability and obviously the biomarkers there in the HFpEF study? Thanks for taking our question.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Yes, it does. Thank you. Appreciate it.

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Hi, Robert. Thank you so much for all the great updates. I guess one of the questions that we were wondering about is recently the baseline demographics of the odyssey study was published. And I would love to maybe get Fady's thoughts on that study and what stood out to you. Just some commentary. I appreciate the commentary throughout the call that positive data from ODYSSEY, from MAPLE continue to grow the uptake of CMIs in this big market. I mean, we're talking about a million patients, which is a big mark, a high addressable population. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, CYTK.OQ - Q4 2024 Cytokinetics Inc Earnings Call So if you could just kind of comment around that. I know, ACACIA is currently fully in enrollment mode but maybe is there any some differences that stand out to you as you look at that baseline population would be helpful. And I'll jump back in the queue.

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Thank you, Fady.

Question: Charles Duncan - Cantor Fitzgerald - Analyst : Hey, good afternoon. Hey, Robert and team, congrats on a great year of progress. Lots of good questions asked, so I will send one in, in terms of biz dev. I'm just kind of wondering if you could characterize the kind of work that Sanofi did in terms of the China market. It seems like, obviously, it could be quite large. Wondering if you could provide any color on call it the unmet need there and how you might see it pace in terms of it being developed. And would you anticipate milestones yet this year in terms of cash payments or even early next year? Thanks.

Question: Jason Butler - Citizens JMP - Analyst : Hi, Robert. Thanks for taking the question. You mentioned that the safety update submitted to FDA had additional data from FOREST-HCM. Can you talk to how much of that data in terms of patients or patient years is from after the protocol amendment was implemented to lower the frequency of echo monitoring? And if you can make any comment as to whether the safety profile appears consistent before and after that protocol amendment was made? And then just lastly, are there any additional protocol amendments you're considering for forest in terms of echo monitoring? Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, CYTK.OQ - Q4 2024 Cytokinetics Inc Earnings Call

Question: Jason Zemansky - BofA Global Research - Analyst : Congrats on the progress. And appreciate you slipping us in. I was hoping to get some additional color on your comments regarding expansion into the first line setting. I was hoping you could speak to your strategy here, maybe if not to expand wholly into the community-based setting, but at least out of the centers of excellence where these patients are a lot more common. What are some of the challenges here getting prescribers on board who are maybe less comfortable administering a CMI? How dependent is it on the REMS itself and realistically you expect an uptake here?

Question: Jason Zemansky - BofA Global Research - Analyst : Yes. Appreciate the color. Thanks.