The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tessa Romero - JPMorgan Chase & Co - Analyst
: Congrats, Robert, Fady and to the whole team on this approval and all the work it took to get to here. Can you give us a little bit of a preview
of what's in store for us at our JPMorgan Healthcare Conference next month from Cytokinetics? Congratulations.
Question: Tessa Romero - JPMorgan Chase & Co - Analyst
: Thank you.
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DECEMBER 19, 2025 / 9:30PM, CYTK.OQ - Cytokinetics Inc To Discuss FDA Approval of MYQORZO
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Question: Roanna Ruiz - Leerink Partners LLC - Analyst
: Yes, afternoon, everyone. So for me, I was just curious, could you elaborate on some of the remaining steps that are left for payer engagement
now that you have MYQORZO's label in hand? And how quickly could payers update their formularies and decisions to offer coverage of
MYQORZO?
Question: Roanna Ruiz - Leerink Partners LLC - Analyst
: Makes sense. Thanks.
Question: Paul Choi - Goldman Sachs Group Inc - Analyst
: Hi. Good afternoon, Robert, and congratulations to you and the team. As we look at the indication statement on the label, there's no specific
requirement for prior therapies. And so I'm just curious, as you've engaged in your pre-approval conversations with payers, just sort of what
the receptivity to potential frontline utilization is for MYQORZO. Thanks for taking our question.
Question: Paul Choi - Goldman Sachs Group Inc - Analyst
: Okay, very good. Okay, thank you.
Question: Salim Syed - Mizuho Securities USA LLC - Analyst
: Great. Congratulations, guys. Label looks great. Andrew, one from us on the commercial side. Did I hear you correct? You said a 50%
preference. Was that the correct number?
Question: Salim Syed - Mizuho Securities USA LLC - Analyst
: Okay. Got it. Just curious, what was that -- when was that market share data calculated? What was it calculated on? Was it based on -- like
did the physicians putting in that data have access to a profile that's similar to this label?
And just the other piece here that would not be preferred to go to AbbVie, what was the color that you got from there that maybe you can
now counter detail? Like, why wouldn't anybody prefer Minerva here?
Question: Salim Syed - Mizuho Securities USA LLC - Analyst
: Okay, super helpful. Thanks so much, guys, and congrats again.
Question: Joshua Chazaro - Evercore Inc - Analyst
: Hi, this is Josh Chazaro on for Cory. Congrats on getting this over the finish line. The question is, what kind of launch metrics do you expect
to give investors with the second half of 2026 -- or second half of January 2026 launch?
Question: Joshua Chazaro - Evercore Inc - Analyst
: Perfect. Thank you.
Question: Jason Butler - Citizens JMP Securities LLC - Analyst
: Hi, thanks for taking the question and congrats. Just wondering if you could speak to your plans to now submit the MAPLE data to expand
the label and ultimately, what you think that can do to the launch over the midterm?
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DECEMBER 19, 2025 / 9:30PM, CYTK.OQ - Cytokinetics Inc To Discuss FDA Approval of MYQORZO
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Question: Srikripa Devarakonda - Suntrust Robinson Humphrey Capital Markets - Analyst
: Hi, Robert and hi team. Congratulations on the approval. In the initial launch, I was wondering if you can help us understand a little bit about
what your plan for the distribution footprint is expected to be. (inaudible) you have at launch, what percent of HCM centers of excellence,
for instance, would you expect to cover within the first quarter of launch?
Question: Srikripa Devarakonda - Suntrust Robinson Humphrey Capital Markets - Analyst
: One was distribution footprint, and the other one was HCM centers of excellence covering -- coverage of centers of excellence. Yes.
Question: Srikripa Devarakonda - Suntrust Robinson Humphrey Capital Markets - Analyst
: Okay, great, congrats once again.
Question: Joseph Pantginis - H C Wainwright & Co LLC (Pre-Merger) - Analyst
: Hey everybody, huge congratulations. So my question is, besides the payers, what do you consider to be the rate-limiting steps with regard
to the launch, for example, the rapidity of getting docs certified? Or anything else you'd like to add? Congrats again.
Question: Martin Auster - Raymond James - Analyst
: Hey Robert, thanks for taking the call. My question has been asked and answered. Congratulations to you.
Question: Yasmeen Rahimi - Piper Jaffray Inc - Analyst
: Good afternoon, team. Congrats on that accomplishment. Have you guys -- maybe this question is for Andrew. What is the distribution of
HCM patients, obstructive [blockage], patients that are under cardiology centers versus centers of excellence? And maybe also your color
around this really flexibility and echoes, how that could actually be very helpful when we think about general cardiology practices?
Question: Yasmeen Rahimi - Piper Jaffray Inc - Analyst
: Yes, that's exactly right. Yes.
Question: Yasmeen Rahimi - Piper Jaffray Inc - Analyst
: Yes.
Question: Yasmeen Rahimi - Piper Jaffray Inc - Analyst
: Thank you. Congrats.
Question: Serge Belanger - Needham & Company LLC - Analyst
: Hi, good afternoon, and Congratulations on the early Christmas present. I guess a question for Fady. I believe in the SEQUOIA trial, about
80% of patients were on the top two doses and maybe 50% were on the top dose. Just curious if you expect a similar distribution outside
of the clinical trial setting.
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DECEMBER 19, 2025 / 9:30PM, CYTK.OQ - Cytokinetics Inc To Discuss FDA Approval of MYQORZO
(aficamten)
Question: Serge Belanger - Needham & Company LLC - Analyst
: Got it. Thanks, and congrats again.
Question: Maxwell Skor - Morgan Stanley - Analyst
: Great. Thank you very much for taking my questions and congratulations, team, on the approval. So based on your conversations with
physicians, I was just wondering, do you anticipate that the flexibility in monitoring and the risk mitigation strategy could facilitate broader
use or able streamline REM requirement, basically unlock a certain group of patients that maybe physicians were hesitant to put on Camzyos?
Are there any qualities or specifics within the label or REMS you'd like to call out?
Question: Maxwell Skor - Morgan Stanley - Analyst
: Yes. Or if there's any you would call out that you think physicians are really focused on or you're excited about it being included.
Question: Maxwell Skor - Morgan Stanley - Analyst
: Great. Thank you very much and congratulations again.
Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst
: Yes, thanks for taking our questions and many congrats on the approval in US and China and also the positive CHMP opinion. Sorry if I
missed this, could you touch on how the label grant informs sort of your thinking on pricing and your expectation of proportion of patients
getting on the patient assistance program within the initial few months?
And Andrew, I know this has been discussed before. Anything you can comment on your expectation for 2026, 2027 market penetration
you're sort of working to get to relative to where we are today at the end of 2025?
Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst
: No, no, you answered it all. Thank you so much, Robert, and I appreciate it. Congrats again.
Question: Ashwani Verma - UBS AG - Analyst
: Hi, thanks for taking our questions and congratulations on this big milestone for the company. I had a commercial question. Maybe, Andrew,
if you can comment on this. As you're launching the drug, do you have a sense of like how many naive patients are there in play for a CMI
every quarter? And how quickly can you penetrate that group?
Question: Ashwani Verma - UBS AG - Analyst
: Yes, yes. So naive patients in play for either of the CMI every quarter.
Question: Ashwani Verma - UBS AG - Analyst
: Great. Thank you.
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Good afternoon. Congrats on the approval. You've talked about broadening the market both here and in the past, including moving into
the community setting. So when you look at the four components of the ETASU, based on your market research, can you speak to how
easy this transition is going to be? I mean, how quickly can your average prescriber outside of the center of excellence meet these criteria?
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: It does. Thank you so much for the deep color. Appreciate it and have a great holiday.
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