The following is excerpted from the question-and-answer section of the transcript.
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Question: Akash Tewari - Jefferies - Analyst
: Sure. So I wanted to start off a bit on -- it's very -- you're SMID cap biotech and yet you're not just running one Phase 3 study, you're running multiple
Phase 3 studies for aficamten. And you're doing -- almost outside of the drugs being the same class, different endpoint, different timepoints,
different trial. In many ways, you're answering almost a different biological questions in some instances as well.
So if you step back and you take the totality of evidence that we're going to generate on aficamten by the time we are two years from now and
you compare that versus what Camzyosm has. Where do you think you're really going to differentiate for a clinician, right? And not only just in
these specialist centers, but also for, let's say, a community doc who isn't necessarily used to treating HCM patients in his practice?
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JUNE 08, 2023 / 1:30PM, CYTK.OQ - Cytokinetics Inc at Jefferies Healthcare Conference
Question: Akash Tewari - Jefferies - Analyst
: And maybe to that point, it's so overlooked in the Camzyos data was -- there was like a 70/30 split beta-blockers, non beta-blockers. Almost the
entirety of the benefit. Not on secondary endpoint, but on primary, was on patients who were off beta-blockers.
So can you talk to me about what does a patient experience when they get off of beta-blocker? I know like Fady uses the analogy of like driving
with your air brake on. What happens when a patient is on aficamten or even Camzyos and they're getting off a beta-blocker in terms of patient
experience and how they actually feel.
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now, --
Question: Akash Tewari - Jefferies - Analyst
: We just got a thumbs up for those who are on webcast. Now, on your primary endpoint, right, peak VO2. I find some of the paranoia on this to be
a little amusing because A, you can pick whatever endpoint you want; B, there does seem to be a relationship between the PD effect of this class
of drugs and pVO2. Maybe we can see it in a publication, but that -- logically, it would make sense.
So when I look at the Camzyos study, 11% of patients actually got on the high dose. And my last call was actually with Bristol and they're saying
most patients are in 2.5 and 5 right now in the real world for Camzyos.
So talk to me about what makes you confident because we've seen about 60% or more patients get onto higher doses for aficamten. What is the
relationship, PD relationship between getting patients onto a higher dose of your drug and what you're seeing with peak VO2? And how does that
make you confident about choosing that as your primary endpoint versus what Bristol did or what Myokardia did?
Question: Akash Tewari - Jefferies - Analyst
: Maybe to hit on that, I know this is actually a discussion we had back at JPMorgan where I was saying, just release the baseline, A, I do that selfishly
because I can do a lot of work with your baseline and figure out your PK/PD effect. But B, talk to me about why it's important for you to release that
to the Street, right?
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JUNE 08, 2023 / 1:30PM, CYTK.OQ - Cytokinetics Inc at Jefferies Healthcare Conference
And when you look at your baseline characteristics, you've talked about more severe patients post-exercise, they still have an issue on their gradient.
Changes in terms of baseline beta-blockers. What are some of the things that we should be looking at when we see that baseline population and
we can -- we think about chances of success here?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now, it's funny, I just had a convo with the Chief Commercialization Officer at Bristol. And one of the things that he -- I asked him, is
Camzyos an inflection over a period of time or is it kind of a slow grind? And when you look at the characteristics of HCM, some people might say
is it more like amyloidosis, where tafamidis really annualize to a big amount relatively quickly?
Is it more like every other kind of cardiovascular market where it's a slow ramp up to diagnose these patients, get them onto drug. I'd love to hear
your view of what you think the demand really is for HCM from a bullish perspective? And if there is a drug that can be used in a community setting,
has a less restrictive REMS, has a different safety and efficacy profile, do you feel like our view of what the HCM market might be different than what
we're seeing right now with Camzyos?
Question: Akash Tewari - Jefferies - Analyst
: Understood. And --
Question: Akash Tewari - Jefferies - Analyst
: Interesting. Makes sense. Now, maybe also just touching on non-obstructive. It's different, right? Like, you don't have the obstruction, you don't
have necessarily as clear cut of a marker on efficacy. The remodeling takes a longer period of time. But I think one of the things that was very
interesting is that there does seem to -- the dose is just even more critical. And the PD effect is even more critical on non-obstructive, and I think
that will also translate over time.
So talk to me about A, interpret the early kind of non-obstructive data sets you guys have put out. But B, as patients are adherent for a greater
period of time, where do you feel aficamten might be able to really differentiate versus other drugs in the class and also versus standard of care
for those subsets of patients?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now, I remember we spoke earlier this year, I think we were in California. And we had this discussion about Cytokinetics as a platform
company versus a single asset company. And obviously, we've had -- whether it's omecamtiv or we've seen the news on ALS, I want you to revisit
that question. Do you view Cytokinetics as a platform company at this point? And if not, and it's really about maximizing the value of aficamten,
how does that change the way that you view the company as a whole?
Question: Akash Tewari - Jefferies - Analyst
: I didn't know that.
Question: Akash Tewari - Jefferies - Analyst
: Understand. Now, maybe just lastly, on the recent earnings call, I think there was a comment on EU partnership for aficamten, which I think --
because I'll put you in my seat. I'm obviously very bullish on aficamten and its commercial potential. I didn't have anything in my model, let's say,
for ALS. And I don't think I had a lot on omecamtiv either. It didn't change anything in my opinion about Cytokinetics.
And I would say, if you were to ask most of your -- our colleagues on the buy-side, they'd probably say that as well. They value on the potential on
aficamten and maybe your backup for [heptet]. But it did seem to change something for your team in terms of your strategy and your outlook.
So talk to me about what changed in terms of how you view Cytokinetics as a strategic asset after those card flips? And can you maybe clarify for
the nervous investors like, oh, no, they're now for sure going to partner out aficamten in Europe, why that may not be the correct way to view your
comments from last quarter?
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JUNE 08, 2023 / 1:30PM, CYTK.OQ - Cytokinetics Inc at Jefferies Healthcare Conference
Question: Akash Tewari - Jefferies - Analyst
: And it's fair to say there's a good amount of interest in the asset, whether it's partnership or anything else.
Question: Akash Tewari - Jefferies - Analyst
: Okay. Thank you so much. I really appreciate it.
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