Cytokinetics Inc Q3 2024 Earnings Call Transcript

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

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

Question: Tessa Romero - JPMorgan Chase & Co - Analyst : So 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 metoprolol you need to hit a p-value that is significant? And relatedly, what can you tell us on how the patients that enrolled jived with your expectations? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 9:30PM, CYTK.OQ - Q3 2024 Cytokinetics Inc Earnings Call

Question: Salim Syed - Mizuho - Analyst : I guess one for me on MAPLE as well. Assuming you guys actually get the results you want here, could you just maybe give us your thoughts on getting those results published and into treatment guidelines? Like how often does the committee meet and when that could potentially happen? Could it happen prior to the supplementary approval?

Question: Salim Syed - Mizuho - Analyst : Could you -- you think you can get it done prior to the actual approval? Because I think the threshold is publication, correct? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 9:30PM, CYTK.OQ - Q3 2024 Cytokinetics Inc Earnings Call

Question: Salim Syed - Mizuho - Analyst : Yes, correct. Yes.

Question: Nikola Gasic - Leerink Partners - Analyst : This is Nik Gasic on for Roanna. Maybe first on MAPLE -- maybe ask a different way. I guess, looking ahead to the results for afi relative to metoprolol next year, I guess, what could the Peak VO2 improvement with afi look like in this study relative to what you saw in SEQUOIA previously? And then I guess, like what's the outlook on the time line of possible guideline adoption for using afi in earlier lines of therapy if the MAPLE data are positive?

Question: Nikola Gasic - Leerink Partners - Analyst : Got it. And then maybe if I may, could you comment about how you're thinking about the European launch dynamics for afi if it's approved? And I guess any learnings that you could apply based on what you're seeing from the competitor launch throughout Europe?

Question: Cameron Bozdog - BofA - Analyst : This is Cameron Bozdog on for Jason. Congrats on the quarter. So in terms of leveraging afi's profile to warrant a potential pricing premium, I guess, what factors are likely to be critical here? Is it going to be efficacy, safety, the administrative profile? Or I guess, in other words, do you think less frequent LVEF reductions below 50% in SEQUOIA versus EXPLORER is enough to warrant a pricing premium? Or would you need to see the safety benefit reflected in the monitoring protocols or the label to establish a basis for a premium here?

Question: Sean McCutcheon - Raymond James - Analyst : On CK-586, can you speak to the lessons that you took from the EMBARK results? How are the target patients in AMBER meaningfully similar or different in your estimation from EMBARK? And what pharmacologic properties do you view as the most valuable provided the mechanism proves out in the subsegment of HFpEF patients?

Question: Paul Choi - Goldman Sachs & Company, Inc. - Analyst : I just want to return to the subject of MAPLE and with regard to 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 sort of what would be considered clinically meaningful here versus [metoprolol] as to drive guideline changes here?

Question: Jason Butler - Citizens JMP Securities, LLC - Analyst : Just a quick one on 089. You guys have a long history with this class. Can you, at a high level, just tell us how 089 differs from the prior candidates?

Question: Srikripa Devarakonda - Truist Securities - Analyst : I have a question on MAPLE as well. I think, Fady, you talked about getting imaging data in MAPLE that might suggest a difference in cardiac remodeling. I was wondering if 6 months -- you think 6 months is enough to demonstrate the difference? I think you've mentioned that it's the start of showing the difference. And do you think long-term data from FOREST would add to that? Or would you need to show longer data from MAPLE?

Question: Srikripa Devarakonda - Truist Securities - Analyst : Got it. So I think the point I was trying to get to is, would this help from a reimbursement perspective that this is not just the exercise capacity, but also the cardiac remodeling that you see at 6 months?

Question: Mayank Mamtani - B.Riley Financial - Analyst : Congrats on a strong third quarter. So for the CK-586 HFpEF Phase II trial, 12-week treatment period, what would be your expectation for functional improvement given what you've seen in the nHCM patients in REDWOOD? And are you able to quantify beyond, obviously, the proBNP information you'll get? Or should we just wait for the MYK-224 AURORA study data early next year to understand what good looks like in a placebo-controlled manner? And also thinking how this stacks up relative to the GLP-1 drugs being increasingly used in HFpEF?

Question: Yasmeen Rahimi - Piper Sandler - Analyst : It's so wonderful, this is the first call in two years that we did not bring up the word in the Q&A of REMS. So it's nice to see that. And nor am I going to ask a question on that. Okay. So I'm going to -- I feel pretty good about not talking about that anymore. But would love to continue the dialogue on MAPLE. I think ultimately, what maybe we need your help on is to understand what is the size of the obstructive market that fails beta blocker or even gets worse on beta blocker? And what kind of cost analyses could you potentially put together to kind of make the argument of down the line of aficamten being positioned as first line? But maybe to the extent you could educate us on the size of the market if MAPLE shows superiority, would greatly appreciate and I'll jump back into the queue.

Question: Rohan Mathur - Oppenheimer & Co. Inc. - Analyst : This is Rohan on for Leland Gershell. On aficamten, just as you think about implications from the ongoing launch of a cardiac myosin inhibitor, what sort of steps of the commercial process would you expect the incumbent therapy to maybe catalyze in terms of growing market awareness and helping an uptake and eventual payer coverage once aficamten is potentially available?