Cytokinetics Inc at Morgan Stanley Global Healthcare Conference Transcript

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

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Great. Thank you. So maybe we just touch on MAPLE first, if you can give the high-level datasets. The fact what struck me, and I think highlighted by KOL feedback is the fact that beta blockers in regards to exercise capacity, it also deteriorated, and it was significant with aficamten. Any highlights there? And maybe if you can call out key KOL feedback, that would be great.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : And potentially, this would be submitted as a supplemental application after the PDUFA date in December. But overall, this is a significant milestone. How is it shaping Cytokinetics' positioning in HCM overall? What's your approach going into the potential launch in December?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : And you said 2027.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Base case.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Yeah. And any gating factors in regards to getting that on label? Would you -- what would be the bull case in that scenario? Or just --

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Yes.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. That's very helpful. And so moving over to the potential launch, the PDUFA date in December, and so you have a late cycle review this month. Is there any expectation that you'll put something out regarding that late cycle review or any commentary around that or expectations?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And maybe this is a good opportunity just to ask how are interactions going with the regulators? Or is everything consistent? Any changes there?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And I believe you just said in regards to having fluid discussions, ongoing discussions with regulators, will this be the first formal meeting where they basically give their response to the REMS that the team submitted?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And then in regards to the potential label, the proposed REMS, I don't want to push you too far on details, but I'm just trying to think about how potentially it could be differentiated from Camzyos. I know there's differences in drug-drug interactions, the titration schedule. But anything you'd like to comment there?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And based on the fact that Camzyos, the REMS was updated this year, it's been on the market for a bit, what kind of learnings are you taking from that launch and applying to your own launch? Or specifically in the United States, patient demographics you're targeting, physicians, community setting, where can you be differentiated in regards to Camzyos?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : So in many ways, with MAPLE potentially on the label, that's where the inflection could come from expanding beyond centers of excellence to community setting. Do you think that's a reasonable expectation?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And then without providing specific guidance or launch metrics, how are you communicating to investors, the investing community in regards to what 2026 looks like in regards to the launch?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. That's very helpful. And so moving on, you noted it, Fady, at the beginning in regards to ODYSSEY, Camzyos, the data in non-obstructive HCM, is there anything you'd like to call out there before maybe some questions on that program?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Could you speak to the patient journey for someone with non-obstructive HCM? What does it look like? What are the diagnostic criteria? My sense from both your presentation and reviewing the ODYSSEY data, it seems like it could be a heterogeneous population, but any commentary around that would be helpful.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : So just touching again on the inclusion criteria for ACACIA versus ODYSSEY. I know you've noted previously that you have a team that's reviewing echocardiograms. How confident are you that you've enrolled a differentiated patient population compared to ODYSSEY?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And then for the non-obstructive patients, how reflective is the enrollment criteria for ACACIA in regards to the overall patient population? I'm trying to get a sense of the TAM here.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : So would you say the opportunity is larger, but less defined in regards to which patients would go on therapy right away in non-obstructive?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : And sorry, just going back to the beta blocker dynamic, when do you plan to get feedback from payers? Do you expect the MAPLE data to potentially support shrinking the time patients are on beta blockers to start? Yeah, just any commentary around that.

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And so I'd like to touch on the pipeline also. I know most of the questions have been around aficamten, but you have a pipeline -- expanding pipeline. And is there any highlights or catalysts we should keep an eye out for over the next 12 to 18 months?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : I think that leads in well. Maybe we can just discuss financials. I believe with over -- or around $1 billion in cash at the end of 2Q, additional potential tranches from Royalty Pharma, how are you thinking about capital allocation? And any thoughts on business development?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And that leads into a couple of quick questions we've been asking several of our companies. Just with the China's recent rise in biotech innovation, how are you thinking about your competitive position here? And will this influence your R&D or BD strategy at all? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 09, 2025 / 3:30PM, CYTK.OQ - Cytokinetics Inc at Morgan Stanley Global Healthcare Conference

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : And would the opportunity potentially -- or is the China opportunity becoming more significant now, I guess? Or is it equal with anything else you can find across the world?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Okay. And I guess last question. Is there anything I missed? Or is there something you would like to highlight, or you think are top of mind among investors?

Question: Maxwell Skor - Morgan Stanley & Co Ltd - Analyst : Great. Well, thank you very much.