Cytokinetics Inc (CYTK) November 10, 2026 Conference Transcript

Awesome.

Well, thanks, everyone, for joining another session here. Excited to be here with the Cytokinetics team of Isaac Chicanover, CBO, Steve Heitner, CMO, Jeff Lotz, U.S. Sales and Ops VP, and then Sung Lee CFO. A lot to discuss, a lot going on in the HM space, so maybe we can just get right into it and be great to maybe just start with a brief overview of sort of the quarter and kind of, you know, some of your key takeaways now that we're kind of into the Affikampton launch. Sure.

So, first of all, thanks so much for giving us the opportunity to come and speak. It was a great quarter. Look at it from all metrics. Revenue was up 76% versus Q2. Patient dispense greater than $2,800 versus $1,500. CMI market, year-over-year growth of 45%. On the regulatory side, we're now approved in five countries, five regions, and Europe is expanding. We have a number of upcoming important events with the S&DA of Maple. Next week, we've got NACM by the end of the year, the submission. Earlier in 27, we'll have in Europe. On the pipeline side, we released the date of acacia at ESC. We just have completed the main study treatment period for chameleon in Japan. And so all of this great movement forward and really puts us in a very strong position.

Yeah. Yeah, no, totally. And, you know, I think there's a pretty strong appreciation that the AffiCampton launch is going really well. And I think one of the most interesting metrics is you're already nearing new to brand share sort of preference or, you know, new start preference. And I guess maybe what's really like driving that and what have you seen so far in sort of the launch in terms of like the pushes and pulls here And what's really having Docs gravitate towards Affie Hampton over Kim Zayos.

So we're seeing, obviously, an expansion of prescribers and then increased productivity in each one of those trialists that start up. The primary drivers are... A differentiated clinical profile, you know, which directly translates into a REMS that is, I guess, less burdensome on a comparative basis. But all the things that you would expect to hear, you know, rapidity with efficacy, flexible dosing and monitoring, shorter half-life, you know, on the safety side. And, you know, no excursions in Sequoia, which translates into a REMS where we just monitor safety at the current dose, you know, and it doesn't have, you know, some of the other complicated or burdensome measures that the competition has.

Yeah. Yeah. Makes sense. And are you seeing docs sort of take advantage of that flexibility as it relates to dosing, the monitoring echoes? Like, are they sort of fitting it into their workflow in an easier way?

Yeah, so, you know, the titration and monitoring window two to eight weeks, we see them using the full window. So there's some that are very aggressive, and it's usually patient dependent, and they'll try to push the dose every two. But I think on average right now, we're seeing people in that four to six weeks. Some people just put it into the same workflow that they're accustomed to and monitor at week four, but we are seeing use of the full window.

Yeah, yeah. And I think one of the other, especially as a rates of sort of like expanding the prescriber breadth of this class is that you already have a meaningful number of prescribers in these like low volume or CMI naive patients or prescribers. You know, maybe kind of just like expand on that dynamic, how you see that evolving over time. And like, who are these docs? Are they people who wanted to use this class, but just didn't want to use Kim's iOS? Or is it just part of this broader momentum of the community getting more comfortable with these agents?

So, I would say it's a couple things. It's definitely, you know, the early innings of a space that's developing, right? So, the prescriber base has been growing for four or five years now, and it certainly has accelerated a bit with the launch of MyCorso. So the Naive group is largely a group of community cardiologists that don't have the staff that you would see at a COE or at an established HCM clinic. So they stayed off on the sidelines with the CAMS-IOS launch. And with the differentiation in the clinical profile and, again, translating into a REMS with a flexible window and no need for DDI counseling and DDI coaching on a monthly basis, no need to thread a needle on monitoring and prescriptions, you know, in the 30 to 35 days, it creates enough flexibility that they're willing to try. There's probably two other components, too, with that group. One is... The maple study is definitely a study that gets people to move quicker. And in the naive group, it's caused people to try a CMI, or at least, you know, they're more inclined to give it a shot. And then lastly, with the release and readout of Acacia. Some of these physicians are thinking ahead and saying, well, if there's an approved agent for NHCM in the future, maybe I should start thinking about managing these patients myself, so I'm not referring all my HCM patients to someone else.

Yeah, makes sense. And are you seeing these docs write multiple scripts and become repeat prescribers, or is it kind of more one-on?

Yeah, so on average right now... The productivity across our prescriber group is about four patients per doc, and that's been growing. In the CMI, like the concentrated high CMI user group, it's seven. In the naive group, we've seen them move on average from one to two. So they're still in the onesie, twosies, like we like to call them, you know, and dabbling, but definitely seeing productivity incrementally increasing.

Yeah. Yeah. And then I guess as it just relates to broader prescriber breadth here, like, you know, how many… Docs are REM certified? What percent are prescribing today? And, you know, what is sort of the timeline to kind of that expanding further in terms of capturing all of them?

Yeah. So there's an interesting dynamic with REM certification. So not everybody that REM certifies is going to write. And it's based on the dynamic of a practice. In a lot of the clinics, you'll have a decision maker. And then you'll have the writers. So you may have a cardiologist that leads a lot of the decisions on which agent to use or how to treat a patient, but then the mid-levels do the writing. All three of those would end up being certified HCP, but not necessarily show up as a prescriber. So when we look at our REM certified HCPs, there's over 3000 of them now. Two thirds of them are either writing or affiliated to a writer in the same clinic, and then a third of them are not, and that's an opportunity. And we add HCPs to the REMS every week. So it's one of those things where, you know, we're sort of always catching up to those certified writers as patients present themselves in their clinics.

Yeah, yeah, makes sense. So, I mean, it seems like a lot of these sort of underlying fundamentals are going, you know, really strong here. Are there really sort of like any rate limiters? And what does access look like? Has that been sort of like a rate limiter at all? Just like curious.

Yeah. So, so far, no. Our access has been, has been improving. You know, of course, all the, all the payers now have new to market blocks. You know, I think 10, 15 years ago, it was maybe one or two, and now everybody uses that mechanism. Yeah, right. But we've seen, you know, on the Medicare side, 90% of the lives covered at parity to Cam's iOS. And then on the commercial side, we're at 60% coverage, up from 50 a quarter ago, it seems, you know, continues to improve. We still have a few plans that have the new to market blocks in place. And we expect, you know, that to continue to improve as we go to 27.

Yeah, makes sense. So I think, you know, like one of the pushbacks that I hear in sort of this launch is a view that Camp Zios is maybe like a little bit more potent where, you know, patients can kind of stay at five milligrams. They don't need to titrate up. Whereas AFI, maybe you do. I mean, just curious if you guys have a perspective there and sort of what have you seen in the real world as it relates to, you know, efficacy, safety, and like how patients are kind of being titrated up as they need to.

And so I'll take that. I think I'll start out by saying in the real world, what we've seen is actually quite similar to what was seen when you look at the data that came out of Explorer, and translating that to the real world with Mavicampton. So what we've seen is that in the real world, about 80% of prescriptions are in the maintenance phase at 5 to 10 milligrams. So the lower side of what we're seeing, so the dose distribution has shifted to the left. But what that means for africampton in practice, really, is that if a patient shows up at a physician's office, and they get started on africampton five milligrams, and that's all they need. The very next visit is going to be their maintenance visit. So they go, they get one echo, and then they move to maintenance every six months as it stands in the rims. Now, this potency claim really is, I don't know if you want to talk to what Mavicampton's been from the up and down titration perspective.

You mean in excursions or?

Yeah. Well, I mean, I'll carry on. So in essence, what's happened in practice is, you know, Mavicampton has been saying, well, it's more potent. Therefore, less patients need to be on higher doses. So they end up on two and a half and five milligrams. What isn't spoken to is the patients that end up on two and a half milligrams actually have to down titrate. And that implies that they have to get another echo and another monitoring echo. So it's actually quite burdensome from a patient perspective to actually end up on the two and a half milligram dose. And I believe that about 40 percent, you know, 30 to 40 percent of Maverick Hampton prescriptions end up on that maintenance of two and a half milligrams.

Yeah. Yeah, makes sense. And yeah, again, it seems like you highlighted the flexibility is really sort of what's sort of, you know, gaining traction with Affycampton. And I know you have had some Kim's IO switchers. Just like curious if you could comment on sort of like that dynamic and how that's going to evolve, if at all, over time.

Yeah, so switching is not like an area of focus for us. It's been pretty consistent through the first three quarters of launch. It's in the mid single digits, so it's a really small percentage.

Yeah. Yeah. Okay. So, you know, I think on earnings, it was 45% sort of new to brand share, 50% in sort of the higher or nearing 50% in the higher volume, you know, prescribers. You seem really confident in your ability to kind of get above 50% by the end of this year. You know, just sort of curious, kind of. What is needed to kind of get above that 50%? And then what is sort of like the ultimate number here in terms of, like, is it 75% over time that you're going to get new to brand starts? Like, where do you think that number kind of lands?

Yeah, so we haven't really guided, I guess, in terms of like, you know, what our aspirational share is. I'm sure this is definitely a bit of a marathon, not a sprint, right? It's a longer term game. Um, we'll, um, I would expect to see continued share growth. Um, you know, we had rapid share growth in the beginning of our launch, but that exceeded maybe 30% just in the first couple of months. And every SharePoint is, uh, from this point on is just a little harder to get.

Right.

Um, but it just comes with, you know, adoption. We have, uh, like I mentioned before, we have, we're adding, uh, HCPs to rent our REM certified HCP list every week. Um, we have, um, You know, accounts that are just getting started for whatever the reason may be. You know, in some cases, it was waiting for their support staff to adjust workflows to a new type of REMS, right? In some cases, it's a health system waiting for their own specialty pharmacy to come on board to have access to the product. So we continue to add accounts and add prescribers on a weekly basis.

James, I'll just add, we've only been on the market for eight months when we got close to 45% NBRX share. So that's quite an accomplishment. And simply, we believe this is a function of time. We simply need more quarters on the market to achieve our objectives. And I think it's too early to call a ceiling on market share. We're focused on execution, and our goal is to get this medicine in the hands of as many patients as possible.

Yeah. The other aspect, of course, is NACM. I don't think there's anybody who would question that if we were successful in moving forward with the FDA and getting the label, ultimately, to have one drug in the hands of physicians to treat all patients, remove the burden of actually having to have two different REMS programs, all of that is going to have the impact, ultimately, on... Totally.

Yeah. Yeah. And I definitely want to get to non-constructive. And maybe one last sort of question, kind of like looking at 27, and maybe this is a question for Sung. Just like, you know, I think some of the interesting, one of the interesting metrics you reported on earnings is just the overall growth of this class is like 3,000 patients a quarter, and it's continuing to grow. Like, and you're about to sort of get preferential share within that. You know, going into next year, just as you kind of like look at 27, like, are people, and I guess beyond to like modeling this the right way, based on those numbers and the dynamics here? Are people being too conservative, too optimistic? Just like curious how you think how the street is on the model.

Yeah, so without endorsing any estimates out there, we're in growth mode. As I mentioned before, we're still very early in the launch, yet I think it's well understood from a demand perspective, from a revenue perspective. We are ahead of where our competitor was, same point in time. So as we look to next year, you know, the focus will remain on execution. But Isaac mentioned before, we have this potential doubling of opportunity in NHCM. So this will be a very important thesis for our company in the coming years, as well as OHCM.

Yep, makes sense. And yeah, just, you know, on that point with non-obstructive, obviously, I think people are super interested in that. Just curious, sort of, as we think about that label expansion, should we be expecting any changes to the label, the rems, sort of, what's your kind of perspective going into that potential expansion?

For Maple?

For non-obstructive, just as that expands.

Well, I mean, obviously, we need to get the approval first, but, you know, assuming things go according to what we want, there will be a label expansion. It's a new indication. One obstructive HCM is considered different enough. The REMS and prescribing information, so I'll just take a step back and remind you how we We got the current label for obstructive HCM, and that's the rubric that we were hoping to implement for the non-obstructive program. So for obstructive, we used the Sequoia study. As the evidence, but we also used data from forest and forest is where this concept of flexible titration came from. And in forest, that's where the six monthly monitoring came from. So the FDA took the totality of that evidence, and then, you know, generated the label as we see it and know it now. So for non-obstructive HCM, we're going to be using Acacia HCM, which is our body of evidence. Now, 400 patients from the Acacia study, that's 95% of eligible patients have enrolled in forest HCM. And we've gotten a ton of data from them as they've moved through the flexible titration, physician-guided titration schedule of FOREST. And we would certainly like to use that as the platform to actually mirror, if possible, the timing and the thresholds that are in the obstructive to make it as simple as possible for providers. The only difference being that obviously in non-obstructive HCM, you don't have the LVOT obstruction gradient to use as your metric for titration. It's just based on your ejection fraction.

Yeah, makes sense. And I think like in the context of sort of some of those data, maybe the one thing that people were, you know, had a question around coming out of ESC or was new was this non-ejection fraction sort of heart failure dynamic and in sort of the titration. And obviously that was with Acacia and kind of like this force sort of algorithm. Maybe just sort of comment. I'm sorry, your perspective of that dynamic and sort of the right, what's the right way to, like, think about what those, what that safety sort of dynamic means?

All right. So just to level set, you're referring to the imbalance. There were 12 patients who developed heart failure in acacia during titration, and that was an imbalance as to the three patients on placebo who developed it later on during the study. And when we looked at the same period of time, the titration period during forest, we didn't see that. So the question was why? And, you know, it actually is quite simple. It's because in acacia... The titration algorithm was driven by a computer. There was no input from the treating physician. There was no clinical thought put into whether to titrate a patient or not. So a patient could have come in feeling sick, and the machine would titrate them up. Whereas in Forrest, the physician would see the patient, have a conversation with them, examine them, look at the echocardiogram, just like we would in normal clinical practice, and that risk disappeared, even in the patients who had previously been exposed to placebo. So you can't really say that there was a selection bias or the patients who had an event didn't participate. And therefore, what we're saying is that the implementation of clinical judgment and the ability to skip a titration if the patient isn't feeling up to it made all the difference.

Yeah. Yeah, no, that makes sense. And I guess just sort of in the context of safety more broadly, the efficacy data that you've seen in Acacia. Non-obstructive is maybe a little bit more heterogeneous than obstructive. Do you think CMIs are good candidates for all non-obstructive patients, or are docs maybe going to have to work a little bit harder to find the right patient for one of these drugs, or for athecamptin?

I'll actually correct you and say that it wasn't heterogeneous. So the treatment effect was actually remarkably homogenous. So if you look at the forest plot, there were no pre-specified subgroups that looked like there was a concentration of efficacy. They all had the point estimate to the side of the line that indicated benefit. Now, the way I would see this being implemented in practice is that because you cannot reliably predict who's going to respond and who isn't. And you really have to treat all patients with symptomatic non-obstructive HCM as if they could respond. Now, the beautiful thing about this drug is that there is a great biomarker as to whether the drug is being efficacious or not, and that's asking the patient how they feel. So, you know, I would see it being implemented as, in a way, a patient shows up with symptoms and non-obstructive HCM. You have a conversation about the risk-benefit. You start them on the low dose, you titrate them to the maximal tolerated dose, and then you say, when you've been on that dose for a period of time, let's have a conversation as to whether you're feeling better or not. And if you're feeling better, then we continue down this path. And if you're not, then we need to think about some other strategy.

Yeah, yeah, makes sense. And I guess like as it relates to the launch, the non-obstructive launch, you know, assuming approval, is the obstructive launch kind of the cadence that we've seen here sort of like the best analog for what that may look like? Or is it going to be faster, slower? Like, just curious how we should think about that.

We think about it as the same, a similar cadence. You know, I guess there's a couple considerations. One is in the CMI experience group and certainly the Mike Corzo experience writer group, we would expect an acceleration, but, you know, could potentially be offset by the fact that we still have work to do to develop the NHCM market. There's still disease state education. In contrast to when we launched, the market had about four years of development by BMS, and they did a tremendous job doing that. So we still have that work to do with N. Yeah.

And I guess you've talked about the halo effect, which I think totally makes sense and something that resonates very clearly when talking to docs. Like, do you also expect the obstructive launch to inflect with this approval, or are we already starting to see some of that, like, halo effect pull through?

Yeah, so it's hard to quantify any type of halo effect because we don't see NHCM prescriptions, right? There's no way to tell whether – and you also have payers. Who should be limiting the ability for an NHCM patient to get that therapy. The only thing I would say is that, you know, anecdotally, we do hear about people who are thinking about the future, and it potentially is starting to have them prepare in a certain way. And maybe there's a bias on selection now, but it's probably a little early to say that.

Yeah. I think from a mechanical standpoint, when you have a practice. You know, and we have an indication for both non-obstructive and obstructive. It just seems logical that, you know, the non-obstructive will pull all potential obstructive patients into the same rubric.

Yeah, and there's no doubt that, you know, the research says there's a halo effect come the approval. But I just think to say that it's already starting to happen would probably be too early.

Yeah, no, that totally makes sense. And just last on sort of this non-obstructive launch. From a payer perspective, you know, do you get like a lot of leverage and sort of like are your interactions with within the obstructive side? Like, is there another sort of like big lag to get non obstructive approved? Or should that be like, much quicker than even what we've seen with obstructive?

Yeah, so those Payers are definitely looking ahead to that event. To say that it would be quicker, I wouldn't want to say that with certainty, but we're definitely planning for access to improve as part of that approval.

Makes sense. All right, maybe in the last five minutes here, we can talk about just like the broader competitive landscape, because I think that's a very topical one for folks. You know, obviously, Edgewise has had their recent updates in terms of a trial design, their mechanism reveal, you know, just sort of curious your perspectives on kind of the updates and, you know, how you think about them.

Sure. I mean, I can start. Look, first of all, we congratulate them. I think any drugs that can help patients, we support. But there's certain realities. We're not standing still. The ability for them or for any other competitor to go into a phase three study and then ultimately get approved, we're going to be years in the market. So four years from now, we see ourselves continuing this trajectory and being, you know, the leaders in this space. Also, we're collecting real-world data. We talked a little bit about forests. We now have another study called Aspen. You've seen it with Chemzius with experience, and there's really no substitute for real-world experience. You can say what you want, but ultimately the agency wants to see that data. That's going to affect our ability, and we hope to change our REMS and how physicians use the drug. So from that perspective, we feel really good. The other aspect to it is, look, you can go to the agency, and as long as you have a reasonable protocol, you can move forward and do it at your own risk. That's very different than saying that the agency is approved, and now you have a label that somehow removes certain requirements. I mean, you know our own experience as it relates to REMS. You know, when you get to the Division of Risk Management, as you're negotiating the label four years from now, then we'll see ultimately how that goes. So all of that, per se, you know, again, I think it's a little premature. Our focus really is about making sure that we can drive our launch. We can continue to – we'll be the first drug, hopefully, to be approved in HCM. We showed with the Akisha study itself that that is not an easy feat to do. So all of that gives us a lot of confidence about where we'll be, and we'll continue to drive shareholder value and invest in our pipeline along the way. And, again, I'll let the other companies focus on what they need to do because the bar is pretty high.

Yeah. Yeah, no, definitely. And, yeah, I think that was an interesting comment you made. And, you know, designing a phase three with, like, the cardiorenal division is very different than who's, like, deciding the REMS. Is that, like, the right sort of take there?

Yeah, look, the agency is about mitigating risk at the end of the day. I know you're a new therapy, and you – look, we can only talk about precedent, right? From the CMLA market, there are now two approved, and they both required it, and the agency asked for both. I mean, we'll see what happens, but we'll only see years from now. That, I think, is non-controversial. But the reality of it is I don't see them changing their practice.

Yeah. And then I think, you know, you mentioned this Aspen study. You know, I think it's really interesting. Maybe just kind of talk a little bit about exactly like what that study is designed to show. And is that really like. A design study specifically for going to the agency about easing a REMS. Sure.

Yeah, that's probably the main strategy behind that study. So essentially, it's looking at the real world safety and efficacy of afficampton using obstructive HCM. And the intent is to collect a broader group of patients that aren't necessarily clinical trial patients and follow them for a longer period of time from an exposure perspective and generate data that will furnish the several thousands of patient years necessary that is part of the precedent for unwinding a REMS program. So there are several components of that strategy with Aspen and Forrest, you know, just being two of them.

Would one of the sort of ideas maybe be, you know, you don't need to do echoes at five and 10 milligrams or something. And that's like, in a community setting, a doc could just not have to worry about using a REMS. And then if they need more, they can get referred to a community center. Just like curious how you think it is going to evolve in practice as it relates to this REMS easing.

Well, I mean, I think the first thing to bear in mind is that echoes are cardiologists' friends. They like doing them on patients. It's not like they want to divorce themselves entirely of having to get an echo on a patient. It's the fixed nature of the REMS program that patients and cardiologists hate. And we've built that into our current REMS program so that patients can have tremendous flexibility as to when to get those echoes. Titrating, according to, you know, whether it's your clinical acumen or whatever you use to titrate is, I guess, cute. But it's not necessarily what's going to happen in the real world. You know, you have to put yourself in the shoes of treating cardiologists when they start a medication. They're going to want to know whether it's working.

Yeah. And the best way to do that is with an echo.

Yeah. Yeah.

Fair enough. I know we're just like 20 seconds over, but maybe the last question is sung. Just in terms of the balance sheet runway, you know, where should our heads be at in terms of kind of your financial position?

Sure. So we're in a very strong financial position. We ended the last quarter with $1.6 billion in cash and investments. This will allow us to fund the launch, not only continue in the U.S., but also launches in Europe that are coming up. Also to advance our pipeline. We have some important programs, late stage, Oma Campton McCarvel, Oula Campton, Phase 2. So those are very important programs for us to continue to advance. Now, of course, our future depends a lot in the near term on the trajectory of OHCM, but there are scenarios where, based on our current cash balance and our internal projections, we could be cash flow positive in two to two and a half years.

Okay. That's really helpful. A lot more we could talk about, but thanks, guys, for being here, and thanks, everyone, for listening in.

Thank you.

Thanks for having us.