Conference Transcript - CYTK 2026-06-03

Speaker 1

All righty. Good morning, everyone. We are kicking off the public portion of our New York City Jeffrey's Healthcare Conference in beautiful Times Square. It's not ironic. I really do appreciate it, and especially for investors who are coming back from ASCO. I know Manoj and I are doing that. We have the pleasure of hosting the cytokinetics management team. I'm going to pass it off to the birthday boy Robert happy birthday but maybe give some opening remarks and introduce some of your colleagues and we'll get started

Speaker 2

thank you Akash thanks very much to the team for inviting us to present an update at the conference so I'm joined today by two of our colleagues Jeff and Dan Jeff leads our sales organization Dan leads clinical research for AFI Campton, Mike Corzo, and I think it's only fitting that the two of them be up here for the fact that those are the two key areas that I think are driving investor sentiment these days. We're very excited about how things are shaping up for cytokinetics, and I'm sure we'll get into it during the Q&A, but suffice it to say that coming out of Q1, where we provided an update on approvals for Mycorso, U.S., Europe, and China, and launch in the United States yesterday, launch in Germany, alongside of recently top-line results for AFI-Campton in non-obstructive HCM, with Acacia HCM hitting on both of its dual primary endpoints, and with other data results hopefully to follow later this year. We believe cytokinetics is delivering on the promise, the promise of our science for the benefit of patients. And it gets better from there as we're also advancing pipeline. And I know that we'll probably get into a conversation about what's underneath the hood as well. So cytokinetics, with its over 25-year history to this area Science, Biology, and Pharmacology is taking that next step, turning the page onto a chapter where we are a global commercial enterprise and demonstrating that the same area of biology is tractable to other new indications, new medicines, and for that we believe that this warrants the attention of shareholders who are thinking about where we go from here.

Speaker 1

Perfect. I really do appreciate that. So, Robert, before I think we get into really the commercial launch, I'd wanted to get maybe your high-level feedback. We've had a few weeks, and you've gotten probably some feedback from clinicians about the non-obstructive data that came out with Acacia. You know, what are the big points you're hearing when you have conversations with physicians about the clinical meaningfulness of the data that you saw from Mike Corso? And then, And number two, what's your view on really the size of the non-obstructive market? I remember at J.P. Morgan, your team kind of gave an update at epidemiology. Talk to us about the potential size of this opportunity relative to obstructive.

Speaker 2

Yeah, so I'll start, I'll ask both of my colleagues to comment. Firstly, with regard to what we've top-lined, keep in mind that we are having to be somewhat careful not to disclose so much that it would jeopardize the proper presentation of these results at an upcoming medical meeting. And we only disclosed that which we thought was going to be material to shareholder interest, meaning we hit on both primaries as well as certain secondaries and with a tolerability and safety profile consistent with what's already known. In many respects, this is not unlike a situation a year ago where we toplined results from Maple HCM in the second quarter, and it was in the third quarter that we were able to both present and publish the full results. And there was so much more that I think Wall Street was very impressed with, as you can see by the stock price in second quarter versus third quarter. My hope is that we may be in a similar situation this year, as there's a lot more to this data set than we've been able to disclose, and we think it's going to be essential that we do it in the proper form. Hopefully that can be the European Society of Cardiology meetings in late August, Labor Day weekend. What we've done with this top-line press release is be clear, and we used words like consistent and robust and that's because we do believe that the effect size the magnitude of the effect for uh afi campton versus control is very persuasive and compelling but consistent across endpoints and when you see the forest plots when you see the subgroups and pre-specified Across the multiple endpoints, I hope it'll be viewed as very persuasive and impressive. What we showed in our top-line announcement was consistency across time points and magnitude for KCCQ and, as we measured, effect on peak VO2 at 36 weeks. Before I go into your question about size of market, Maybe I'll ask Dan to comment on what he's heard with regard to what we have disclosed.

Dan, Analyst — Other

Yeah, great question. So here, let me just move this a little bit. Generally, extremely positive feedback. You know, I don't think anybody has questioned the clinical meaningfulness of the results, even just as limited as we've presented. And for those who've heard more, because there are select folks who've heard more, part of the academic leadership of the program there's incredible enthusiasm words like home run transformative keep getting discussed and we're hearing now more and more questions about whether there may actually be um you know people clinicians out there who are looking for ways to potentially even kind of expand their use of of mycorso based on these data even now um so i don't think really is any question about the clinical meaningfulness and the clinical value that was seen in Acacia at

Speaker 2

this point. The change from baseline for patients on mycorso was large. Dan, maybe you could put that in a context of other KCCQ effects in other types of studies? Yeah, thanks. So if you look

Dan, Analyst — Other

across heart failure studies that have been done to date, there is not a single other heart failure study that has ever shown significant improvement in KCQ and exercise capacity. Both. It hasn't happened. And then if you just look at KCCQ, what you typically see are changes in the one to two range, which are considered actually robust. These are 8,000 patient studies, generally speaking. So they achieve statistical significance with these very, very small changes. We're talking about our studies of 500 patient study, which achieves double or more of what you typically see in other heart failure studies. So this is a very robust change. And by the way, of course, as part of Topline, we showed not just at week 36, but we showed the overall totality of the changes observed in KCQ across the population. And I think you can draw your own conclusions that are pretty obvious about what that kind of maps out to in the overall treatment of a patient. patients don't just get treated to week 36 in life. They get treated over a longer period of

Speaker 2

time. And what was elegant is that the effect as observed with Afi-Campden was consistent, observed early, and consistent and growing. There was some wobble in the placebo group that I think is noteworthy, but that doesn't subtract at all from the meaningful impact patients observed in those treated with mycorso. To your next question around size of market, it used to be thought that NHCM represented one-third to 40 percent of the total HCM market. We did some claims analyses research, and we're seeing that not only is it probably 50-50, but the nhcm diagnoses may even be growing at a faster rate so we're going to keep a close eye on that and jeff anything you want to add to that yeah maybe just a comment on the rate i mean with

Jeff, Analyst — Other

the new news we've had a lot of um uh you know just a lot of excitement from customers and of course they express that they believe the nhcm population is probably at least as big as l which is just, you know, it's good to hear because it validates the most recent work we did on the 50 split and the more accelerated growth on the end size. And then I think the other thing too, with the excitement of the data, some people are now gearing towards, you know, maybe what an approval could look like out in the future and already starting to think through what does that mean for their workflows and their first choice CMI in their individual centers.

Speaker 1

Now, maybe just hitting on that, and Dan, I think the way you described it is quite important because it's funny, we did a KOL call as well where you had a discussion about, hey, like a three-point placebo-adjusted effect size on KCCQ, not that interested in that. You then show the curve, and then he's like, oh, well, that looks very clinically meaningful. So it's funny if you just put it at the time course that you saw with Camzaios, there's a very different response that you'll get. But, you know, talk to me about, you know, what you're able to get on the label. Because, Robert, this was a discussion you had as well where you're like, we're going to make sure we give enough information with that top-line press release. It seemed like a concerted decision for your team to give that curve change over time. What is the appropriate way to think about the placebo-adjusted KCCQ effect size you're showing, and how are those conversations kind of resonating with the physician community?

Dan, Analyst — Other

Okay, well, there's a couple of questions in there. You know, with regard to the label, you know, that's obviously a negotiation and a discussion with regulators. I mean, the interest of regulators, not to speak on their behalf, but in my experience, is to provide the maximum amount of required data so that physicians and patients can make educated decisions. So, you know, I would anticipate a productive conversation around that that I think will be collaborative and I suspect will fulfill people's desire to get the right information so that they can make a good decision. Um, so, you know, secondarily, I think, um, look, when you design a clinical trial, as everybody knows, you don't know, uh, you have to pre-specify exactly when you're going to measure an endpoint, and you make your best guess as to when that should be, uh, but that doesn't describe the totality of the data, and actually, this is also true in regulatory interactions as well. Well, what ends up happening is the prescribed primary endpoint is the way that you assess whether your study has achieved its initial step into validity, but that doesn't describe the totality of the data. And I think the top line results that were decided to be released actually did us all a favor in terms of understanding really the beneficial effect of the totality of the data to a large extent, not completely, but to a large extent. and we're going to bring the rest of the data, you know our track record with what we've done with Sequoia, what we did with Maple, of bringing multiple looks from orthogonal views at the data at the time of presentation in order to allow people to make their own judgment. And we continue with that transparent approach to data discovery. And so we're making our best effort to give everybody everything they need to make a full assessment of the totality of the data themselves when we get around to displaying that.

Speaker 1

Now, you mentioned, and it's really important, it's consistency, totality of data, and I think that you've said that several times. I think that's quite important. When we think about endpoints, when you talk with physicians, you're like, hey, I would really love to see X, Y, Z. What are some of the endpoints that you think from the physician community, you're hearing feedback, I'd love to see this when the full data gets presented, and, you know, help us understand, maybe we'll hit on even NYH class, right? There seems to be a strong correlation between that and KCCQ. When we think about the kind of step change improvement you saw with africamptin and obstructive, could we see something similar to that in non-obstructive?

Speaker 2

Yeah, so in a clinical trial, you pick endpoints based on FDA guidance and also that which might have higher fidelity to test-retest reliability. But in clinical practice, physicians don't often perform a peak VO2 assessment. They do ask patients how they feel. So NYHA is important. So too is BNP. BNP is one of those things that is a harbinger or foretelling of how the heart may ultimately be responding longitudinally over time and could be indicative of what could be the potential for remodeling in this disease. So I'd keep a close eye on those secondary endpoints. Dan, anything you want to add?

Jeff, Analyst — Other

Well, yeah.

Dan, Analyst — Other

I mean, I guess getting to what actually clinicians care about. When I see a patient and when anybody sees a patient, the first thing, when you go to your doctor, they ask you, how are you doing and how are you doing compared to how you were doing before? Those are the two general questions that give you most information. those are described by NYHA, but also by something called PGI, which is a technical term for asking the question of, hey, how are you doing compared to how you were doing before, the PGIC? And I think those kinds of endpoints where you kind of look and get into that real, into the doctor's mind will provide a lot of added support. You specifically asked about whether we might see changes similar to OHCM in this NHCM population. And obviously, I can't comment directly on that. But I think what we need to do is kind of understand that this is highly valuable information for clinicians and for everybody, really, as you see the data. And again, I think we'll see, you know, as we've already presented, statistically important and, I think, clinically meaningful changes across the board.

Speaker 1

Now, I guess maybe lastly, just when we think about REMS monitoring and also risk-benefit in a non-obstructive population, it's interesting. You have data sets from multiple CMIs at this point in non-obstructive, where the rate seems to be higher of LAVF drops below 50 in a non-obstructive population than obstructive. You have different half-lives. You have different titration schedules. And it also seems like dose matters, right? Getting patients to a higher dose matters. When you think about the idea that any company that's developing a CMI could remove the monitoring requirement in this non-obstructive population, do you feel like that would be a prudent decision? Do you think that's even possible, given your team knows much more about the biology of these drugs than probably anyone?

Speaker 2

Yeah, all of these cardiac myosin inhibitors or modulators have effect to ejection fraction. It's a question of whether you look for it and how you measure it and when you assess it, but it's, I don't think, credible or legitimate to say they don't have some risk of impairing cardiac contractility at some exposure, and I think the FDA fully understands In the case of N-HCM, when you're not dosing to gradient, it's especially important to be able to monitor ejection fraction, and Dan can speak to how algorithmically in a clinical trial we are not surprised to see a few more EF excursions when you're not dosing to gradient, but rather to symptoms. And I think that's, in fact, real-world clinical practice.

Dan, Analyst — Other

Yeah, two points. So the first one is the time to measure ejection fraction when you're dosing, when you're trying to assess the PKPD for this is at peak value. So the way our study is designed, patient gets the dose in the morning, about two hours later in the clinic, they get it about two hours later, there's an echocardiogram. So that's peak effect, essentially, when you're looking at LVEF, which is the way you should be looking at safety in all cases. Now, the difference, and this is a key thing, the difference in design between the OHCM studies and the NHCM studies is that in OHCM, we're treating to minimal effective dose, meaning that as soon as the gradient goes below 30, you stop up titrating. So you have that cut off. In NHCM, we're treating to maximal tolerated dose. You're just maximizing the dose to whatever the EF allows. So you're chasing the low EF to get, like you said, to not leave any efficacy see on the tables. As you said, you need to get to these doses to kind of drive this to some extent, at least that's the hypothesis. And so it's to be expected that you're going to see an increase in LVF excursions because you're chasing that in the titration algorithm, which is of course blinded to the investigator and blinded to everybody. So there's no clinical judgment involved in that during the clinical study. We'll find out a little bit more in FOREST, which is our open label extension. These patients are all rolling. We'll find out what happens when Can you include investigator oversight and insight into the echocardiographic findings about how those LVEF excursions kind of map out in that setting, which is a more clinical environment?

Speaker 2

Yeah. I think the more important measure is less EF below 50, but dose interruption because of heart failure, those are the things that ultimately will factor more into the way FDA will look at this, as opposed to what may be down titrations because of EF drops below

Speaker 1

50. Final question on this point, and Robert, you said something which I think is quite important, which is it also depends on when you measure LEVF drops. Can you talk about, obviously you're submitting two major packages with the FDA, one that's already been through. What is the time course that the FDA ultimately looks at when you're thinking about measuring LEVFs? Is this something where they measure once, let's say 24 hours after, or is this something where you look at it on a time-to-TMAX basis?

Speaker 2

I think if you look at the way the FDA has behaved, you get a sense of how they're thinking about it. We had zero EFs that required dose interruption and heart failure, and yet FDA still imposed a REMS on mycorzo for OHCM. So what that tells you is that FDA, understanding that at some exposures, these drugs, cardiac myosin inhibitors, can have effect to EF. they want to ensure proper risk assessment and know about benefit risk. It's essential that you assess risk at C-max, not at C-trough. So in order to best understand that, we've been measuring EFs and excursions when, as Dan points out, the drug is at its maximal exposure, not its minimal exposure. And even if we didn't do that, and we do that, but even if we did not, FDA does its own PKPD modeling. They take your data, and they run their own models, and they understand the risk-benefit.

Speaker 1

Understood. Maybe switching to the commercial side, and Dan, I'd love to get your take, because you're in a unique position where you treat patients, and then you're also working on developing drugs to help them as well so you have a unique perspective you know there was always this idea I think with certain doctors especially in the centers of excellence where it's like look once we have you know my course on the market there would be kind of a very rapid step order change in terms of new patient starts right and your team's talked about getting to that kind of 50 range as we exit the year but what's been kind of the in the centers of excellence where I think you're particularly plugged in what is the new patient start split you're seeing out of the gate as you know you've gotten your um system you know online system set up and you're doing more

Dan, Analyst — Other

physician education um i'm gonna bounce that question over here to jeff you're the one best

Jeff, Analyst — Other

position for that that's true yeah yeah yeah yeah i mean so i we've uh we've disclosed what our goal is for the year to you know to have preferential uh new patient share um and we're definitely well on our way to do that. I mean, the prescribing, and we disclose this from the first four months, was the vast majority of it, you know, about 50%, a little over 50%, was coming from our Velocity accounts, which are the accounts where prior to our launch, 80% of the CMI prescribing was happening. The good news is that we also see, you know, prescribing coming from HCPs that had not prescribed CMIs before. But as far as new patient share, we're definitely on track to achieve the

Speaker 1

goal for the year. Understood. Now, I think one of the things you'll hear from your competitors is, look, they have more flexibility with how they can titrate patients, but doctors are already locked in, right, with the current paradigm established by Camzyos, and getting these scans and everything locked in is not necessarily easy. So ergo, well, there is a theoretical advantage. We've seen in clinical data that, let's say, AFI can get to max dose, let's say, two months, one and a half months earlier, that's not necessarily translating into the real-world setting. What's your, you know, give us some real-world feedback. Are, you know, are you seeing practices change and actually adopt the flexibility that's theoretically provided by the myCourser label, or is that something that will really take time to establish?

Jeff, Analyst — Other

Yeah, so we are. We are seeing that. But, however, you know, Kim's house has been on the market for a few years, and people have, the centers have established workflows. And we definitely have some of the clinics that have told us we're not going to change our echo schedule. We'll just put my core zone that is same every four-week echo schedule. Sometimes it's because of the inertia to change until they have more experience with the product. sometimes it's based on their echo capacity where they don't feel that they could actually do echoes any faster or more frequently. However, what our data shows right now early in launch with data titration or dose titration is that it is happening as early as two weeks and it can also be as long as eight. So we're seeing the data across the board. We also, as some of the clinics have gotten experience. I mean, I can tell you, I could probably give you half a dozen anecdotes in the past month where there are clinics that have gone to my Corzo 100% for all new CMI starts because they had enough experience and saw the flexibility and then did adjust their workflows. So it's just, I think it's just a matter of time. The other thing that's helped in addition to the experience is just candidly is there's a lot of excitement around what Acacia could mean for patients so when they look out into the future some have considered adjusting workflows now to prepare for what could come in the next couple years for the nhcm understood now um when we think

Speaker 1

about kind of patient ads i think your team on the q1 call gave provocative data point about ads as we saw from april right and there seemed to be an acceleration of growth that we're seeing um And when we, I think when you and I, Robert, have had previous conversations about launch expectations, I said, look, look at what we had, what we saw with Camzyos. That's a good framework to think about the Affecamp and launch. The patient ads you had in April are suggesting a different trajectory. Talk to us about what you saw post-April once you got, you know, your REMS and everything online and the cadence of uptake that we saw there. Is that something that's continued to translate as we've gotten deeper into the year?

Speaker 2

Yes, so with our Q1 earnings call, given that it was only nine weeks of Q1, we provided some provocative glimpse into April. And we were really encouraged by what we were seeing in terms of momentum in April compared to what already was a strong nine weeks of Q1. If your question is, are we continuing to be encouraged? Yeah, the answer is we're pleased. We do believe we're going to be in a good position to meet or exceed expectations. We'll provide more update, obviously, with our Q2 numbers. But we're measuring things that we think are metrics of velocity. And the team hears from me and others about velocity quite often. And those are things that we believe shareholders should expect of us. It's not enough that we do as well as Camzios did because they did some good spade work to invest in building a market. It's incumbent upon us not so much to compete with Camzios, but obviously as we can expand category for the benefit of more patients. And that's what we're doing. So Jeff can speak to strategy, but it's important that we be thinking about not only breadth and depth of prescribing, but that we're seeing it coming from outside of those high-volume velocity accounts, and that is, in fact, what we are seeing. Moreover, we have to demonstrate that we, as a company, solely focused to Mycorso commercially can produce a patient experience that is welcoming of a new innovation like this, and we're putting extra effort on ensuring that our hub, the way we engage on behalf of patients and their caregivers, is quintessentially defining of engaging with cytokinetics as an experience. And Jeff is leading a lot of that, too. So maybe, Jeff, you can comment on a couple of these things? Sure.

Jeff, Analyst — Other

Yeah, so you just talked a little bit about the jump in April. I mean, the way we've rolled out our REMS has, you know, a fair amount to do with that. We're rolling it out in phases. When we first launched, the REMS was set up to get HCP certified and get initial patients enrolled. And one of the things that we didn't have in that first phase was the ability for support staff to be involved in the workflow of the REMS. And that was implemented in April. So that was one of the reasons why you saw sort of this, like, I guess we'll call it some more unlocking of demand. The other thing, too, that's happening over time are many of the COEs and some of the high-volume clinics are in IDNs where they have SPs, and sometimes they're mandated to use their own specialty pharmacies as opposed to the two independents that we use. And so some of those COEs and clinics were latent trialists just because of waiting for their pharmacies to come on board. And now we're starting to see more of those in April and May get direct access to the

Speaker 1

Maybe last thing, because I know we're running out of time, when you think about the milieu of patients that you're entering into the funnel, right? Because I think one of the things, if you notice Kim's IOs, the patient ads are actually kind of consistent year over year. So there was, let's say, an investor perception that, hey, in terms of these centers of excellence, here's the capacity of patient ads that you can have, and then both of these drugs are going to be going into that limited pool. Obviously, the early trajectory doesn't suggest that's the case. It sounds like there is an expansion in terms of the actual amount of sites that are getting on board. Talk to us about who's getting on, you know, my Corzo. So do you feel like you're getting newer patients who would have never seek these treatments before? And how much is the TAM actually expanding as another product's entered?

Speaker 2

So you and I have talked about this. I've been in and around cardiology and commercialization for 40 years. This market is playing out much like others have, where a second entrant into a category can drive market expansion very meaningfully. We're seeing that play out in a more mature way in the amyloidosis space. And I think you're going to see that in spades here also for the benefit of cardiac myosin inhibitors. It's our strategy. It's been something we've articulated already for several years. With clinical research, with publications, and now with medical and commercial activities, we're seeing exactly that. We're seeing more physicians outside of centers of excellence. We're seeing more patients within centers of excellence all get comfortable with evidence to support the use of this category of drugs. And I think, as we've seen in other categories, knowing that flexibility, convenience, safety, tolerability can drive momentum, that's what you should expect here with MyCorzo also.

Speaker 1

Understood. We are out of time, but I really do appreciate it. Thanks so much. Thanks.