Cytokinetics, Incorporated ($CYTK)

Thank you for joining us. We'll continue with the next session. I'm Paul Choi, and I cover the SMID-cap biotech sector here at the firm. It's our pleasure to have the Cytokinetics team with us here on stage. Maybe what I'll do is let Robert kick it off with some high-level comments and just sort of what his strategic priorities are for the rest of the year and going into 2027. We're also joined on the stage by Dan Jacoby and Tricia, I'm going to apologize for butchering you, Ottaviani who can also speak to some other aspects of the Cytokinetics story, both on the marketing and the clinical side. And so I'll turn it over to Robert.

Thank you, Paul. Thank you to Goldman for inviting us back to provide an update. So here in 2026, we're off to a great start, and things are continuing to go very well for Cytokinetics. With our first approval of MYQORZO, formerly known as aficamten, at the end of last year in China and in the United States and more recently this year in Europe, we've launched successfully, and we reported on [indiscernible] as well as some earlier signs of increased momentum in April. And all is continuing to go well for support of MYQORZO in oHCM as that launch continues successfully. And we can talk about some of the metrics of velocity that we continue to monitor as are encouraging for how we think we're off and running there. We also recently reported results from a study called ACACIA as could be enabling of an expanded label for MYQORZO to include nonobstructive HCM. Those data were positive and will hopefully be presented and published in more detail in the next few months and lend support for our belief that MYQORZO could become ultimately standard of care across all of HCM. So we're encouraged by those clinical trials data that accompany are already pending review of a potential expanded label for MYQORZO in oHCM based on the MAPLE data, which were reported last year. So between SEQUOIA, MAPLE, ACACIA and the open-label extension FOREST that covers all of those studies, we believe that we're doing right by this science for the benefit of patients across all of o and nHCM. So that's the leading edge of our business and advancing pipeline. But just behind it are other programs, omecamtiv mecarbil in a confirmatory Phase III study, ulacamten in a Phase II study, each, respectively, across different portions of the heart failure spectrum, we think the company is executing well on its R&D as well. And then lastly, I'll just mention we recently accessed additional capital. We ended Q1 with about $1.1 billion on our balance sheet. We recently raised $800 million, net closer to $760 million. So pro forma in Q2, we have ample financial resources of approximately $1.8 billion to be enabling of us to further invest in the business. So we think we're firing on all cylinders here in 2026 and looking forward to a conversation and questions.

Great. Thank you for that recap, Robert. Maybe starting with the commercial piece, which you began with for either yourself or since we have Tricia here on stage as well, you can maybe address some of the key metrics you're guiding investors towards to help them gauge the success or early days of the MYQORZO launch and other figures that you would direct investors towards.

Sure. So I'll start and then turn it over to Tricia. Coming out of the gate, we felt it was very important to be guiding to the fact that, as a next-in-class compound, MYQORZO should be driving category growth. It's not that we should be, per se, competing with BMS and its drug CAMZYOS, but enabling of more physicians to be comfortable prescribing for more patients. So while there were roughly 700 centers accounting for about 80% of the historical CAMZYOS business, we wanted to, with our direct promotion, focus to those centers, but hopefully be enabling of through some other strategies, including several that Tricia lends oversight to enabling of information, education, awareness to be driving prescriptions from outside. So we began to see already in just the first several weeks of launch, prescribing as was predominantly in centers of excellence, but also at least 20% of which came from physicians who had never prescribed a cardiac myosin inhibitor. We wanted to ensure parity access, firstly, amongst Medicare accounts, then commercial accounts, Medicare representing about 2/3 of the business. And we believe we're well on track to ensuring parity Medicare access by midyear, commercial parity by end of year. We wanted to see that we were driving from REMS certification to prescribing to dispensing to reimbursement. And whereas we thought that might take months, we were encouraged by the fact that, that was happening in weeks. So that was a good sign. And lastly, we wanted to ensure that we were driving preferential share of new prescriptions where by the end of the year, we should hopefully accomplish a majority share for new prescriptions exiting on MYQORZO. And as Tricia can elaborate, we began to see at least coming out of Q1 that we're trending towards that end of year goal.

Tricia, can you maybe share with us what your sales force is hearing in the field?

Sure. So we've had our sales force out in the market since January following approvals and obviously, also after we had product availability at the end of January. And the team is continuing to hear very positive feedback from our prescriber base, both those core 700 that drive the velocity or 80% of the CMI prescriptions but also a broader group of physicians. As Robert mentioned, of our quarter 1 sales, 20% of those physicians that wrote in quarter 1 had not previously written a CMI. And we believe that's indicative of the clinical profile that MYQORZO has now brought to market. We see in our surveys that we complete with HCPs favorable differentiation for our clinical profile, both the rapid reduction of obstruction that MYQORZO can deliver as well as the safety profile, but also the differentiation of the REMS profile, the fact that you can titrate dose within 2 to 8 weeks with that echo profile that follows, that there are no DDI calls. We're hearing a lot of favorable feedback from the broader physician community, the 700 Velocity physicians that actively prescribe CMIs, but also the broader community of physicians that there's an appreciation for the clinical profile of MYQORZO.

You talked a little bit about 20% of your early business being from physicians who have never prescribed the CMI previously. Can you maybe tell us a little bit more about the patients that are getting drug? Are you seeing de novo patients mostly? Are you seeing -- can you maybe -- seeing some early evidence of CAMZYOS switches? And just sort of what is driving the prescriber behavior?

Yes. The majority of the prescriptions for quarter 1 were new-to-brand. There were a small subset of patients that were switched from CAMZYOS to MYQORZO, but the majority of those prescriptions were new-to-brand new patients.

Okay. Great. CAMZYOS is currently annualizing at comfortably north of $1 billion already. It's taken a few years to get there, but now it is officially sort of at a blockbuster rate. As you think about the category and the market, how do you think about how MYQORZO might ramp over the coming years? It did take CAMZYOS kind of a few years to get to that status. But Robert or Tricia, as you think about what your aspirations are for MYQORZO here, can you maybe comment on how you might be able to do better or faster than what Bristol experienced?

Yes. So when Bristol-Myers Squibb acquired MyoKardia, they made a public statement that they thought that CAMZYOS could do $4 billion at peak. And I still think they are trending towards that number. We believe that the total addressable market here for oHCM worldwide at peak exceeds $5 billion and could be as much as $10 billion, somewhere in between. And we hope to have a majority of that business in oHCM. We'll talk, I'm sure, about nHCM in a moment. How we get there depends on how quickly the category grows. So what's nice to see is even as we are trending towards our goal of preferential share of new scripts, so are new scripts growing and the category is growing. And I think as you look at comparable markets, cardiology and non-cardiology, a second to market, ultimately, if it has advantages as it relates to clinical profile can drive category growth and penetration well beyond what would be expected linear with the first. So Cytokinetics is focused to those things that differentiate MYQORZO from CAMZYOS and beta blockers. And I think we can be expecting an acceleration of CMI use ultimately to become first-line standard of care. Whether that happens in an asymmetric way or a more linear way will depend on things that we still need to see in the market.

Maybe speaking to frontline use of CMIs. Maybe we'll bring Dan into the conversation here and talk about, do you have a sense of how familiar cardiologists in the field are with the MAPLE data giving metoprolol or MYQORZO being effective here in frontline?

It's a great question. People are generally very familiar with the MAPLE data. It was a seismic shock to the system when we announced those full data at European Society of Cardiology. And in fact, the impact is worldwide. I was recently in Japan at the Japanese Cardiology Society where they presented an encore of the MAPLE data, and there was no way to get into the room and people bunched out in the hallway. And the reason for that is that for 60 years, we've been using beta blockers as a first-line therapy and thinking that, that might help patients and the MAPLE data shocked everyone into thinking that perhaps it might be minimally helpful or potentially even slightly harmful to patients. And what that's doing overall is accelerating physicians' enthusiasm around getting to a treatment that they believe in, which is a CMI treatment and one that is readily available. So I think that what we're seeing here is a tremendous amount of enthusiasm. And to be honest, our label already includes language that's very broad and would be generally inclusive of the types of patients that are included in the MAPLE study to begin with. And so those patients can be treated immediately.

Okay. Great. I want to play devil's advocate for maybe just a moment here with you, Dan, and just ask how much of this is generalizable from your perspective or what you're hearing from cardiologists given this is a single study and that the control arm was sort of shockingly underperformed relative to sort of historical understanding of metoprolol. And I guess my second question is, as you speak to cardiologists in the field, how much of this is generalizable to CMIs across the board and not just specifically to aficamten as a molecule?

Yes. I mean I have some personal opinions about the generalizability of data. I'm an evidence-based medicine physician. I grew up in that setting, and I believe that the data needs to be followed. That being said, I don't necessarily think it really matters that much. To speak to Robert's point earlier on, the growing of the overall market, the growing of the overall field is a good thing for patients. And I think in general, what's happening is there's a recognition that people want to move earlier to a CMI therapy. And hopefully, that will be the CMI therapy that is the easiest, most flexible, has the better safety profile and so on. I will say that there has been a little bit of criticism about the MAPLE study and that there was some [indiscernible] beta-blocker-resistant patient [indiscernible] I don't think that's a widely held view. And even if it is, we're bringing data to bear that may throw that into question, one. And number two, our goal here is not to kill -- the goal is not to kill beta blockers. It's a nice, useful therapy that's cheap and available worldwide. The goal here is to provide evidence to support the general efficacy and usability of aficamten. And I think the MAPLE study really did that. And in a population that was much more mildly affected than the SEQUOIA population, which is a really important point of that. If you look across our studies, look across ACACIA, MAPLE and SEQUOIA, you really have the full gamut, severe obstruction, moderate obstruction and then nonobstructive and including midventricular obstruction. So there is no type of symptomatic HCM patient that MYQORZO has not been able to be shown as an effective therapy to date.

Great. Robert, your sNDA filing based on the MAPLE data has a PDUFA coming up here in November. Can you maybe update us on what sort of the regulatory time lines are there and just your latest interactions with the agency, given we're roughly 6 months out from that -- 5 months out from that PDUFA date?

Yes. So we submitted in early 2026. It was accepted for filing, and we were given a PDUFA date of November, as you point out. We're in the midst of those conversations right now where it's pending review. We tend not to give updates to regulatory interactions except on our earnings call. So with our Q2 earnings call in early August, we should have more to say about that sNDA as well as, and you haven't asked this yet, but an sNDA should be expected for the results relating to ACACIA.

Okay. Great. Given the results of the MAPLE study, can you maybe help investors think about what might be included in a potential label update for MYQORZO here? Is there a goal to seek potentially superiority versus beta blockers in the data section or anything around that? Anything you could speak as to how it compares versus monotherapy? And then I had a follow-up question for how this might affect insurance approvals.

Yes. So Wall Street tends to look at the indication statement and maybe tends to overlook some of the information that's also within the package insert and the label. And the indication statement for MYQORZO as approved in oHCM is already enabling of the MAPLE data in part for the fact that the indication is for the treatment of symptomatic oHCM. It doesn't say anything about beta blockers. And our sales representatives, if asked, can be including MAPLE data in presenting a case for the use of MYQORZO in oHCM. But what's not in the label as informing of benefit risk to clinicians who may prescribe is some of the information pertaining to MAPLE as could be supportive of evidence to use either alongside of or even potentially ahead of beta blockers. So payers right now naturally for beta blockers being available and inexpensive are oftentimes asking that a physician who wants to use MYQORZO will step through the use of a beta blocker or a calcium channel blocker. When the label is hopefully updated as well as when guidelines are incorporated to reflect MAPLE data, we'll have the benefit of that information. And again, as Dan points out, not so much to substitute for use of beta blockers, but to inform either accelerating through the use of a beta blocker if patients are still symptomatic and in need and where CMI, in particular, MYQORZO would be potentially recommended as first-line treatment. So it has as much to do with guidelines as it does to label. And payers at that point will be perhaps more responsive to the use of MYQORZO earlier and even ahead of beta blockers once incorporated in the guidelines.

Maybe we can bring back Tricia here and just talk about how much beta blockers -- how often beta blockers are typically used as monotherapy. And as you think about the commercial piece, assuming a positive update to the label here later this year, how that might accelerate frontline adoption of MYQORZO for newly diagnosed patients?

Yes. So for those 50% of HCM patients that have oHCM, the large majority of them are on beta blocker or calcium channel blocker standard of care. I think where the opportunity really sits is, as you think about it, only about 20% of oHCM diagnosed symptomatic patients are on the CMI today. I think MAPLE further substantiates the need to drive to earlier use of the CMI for those patients that are still experiencing symptoms.

Okay. Great. I want to turn to your recent news from the ACACIA study where you had a positive top line result in nonobstructive HCM. Maybe, Robert, you can kick it off and share what has the clinical feedback been from the physician community. Dan, if you want to jump in here as well. And just how much did this surprise you? Because I think from the Wall Street perspective, at least based on our conversations, there was a fair amount of hesitancy whether the study would succeed or if it would only succeed on one of the 2 primary endpoints. And so maybe you could share some of your initial feedback ahead of your potential medical conference presentation this year.

So firstly, it's important to understand that nHCM represents based on claims analysis, we believe, at least 50% of the total HCM market and growing, growing at a faster rate perhaps than oHCM. And there are no approved treatments for patients with nHCM. So these data, and we hit not on just one, but on both of our primary efficacy endpoints as well as key secondaries. While they've only been top lined in a press release, they are being met with great enthusiasm and words shared with us by people who have seen the totality of the data, and that includes the steering committee of the study, words like game changer, transformative. These are words that are not that often used in medicine and certainly not in cardiology. So we foresee that these data when they are fully presented and published, will be met with a very high level of enthusiasm. And we've included certain words in our communications, words like consistent, because we believe not just are the data consistent between the 2 primary endpoints, but so too, are they consistent across the secondary endpoints as well as the prespecified subgroups that were enrolled in the study as is intended to represent a full broad spectrum of nHCM patients. So we believe this is a pivotal study to support the use of MYQORZO (aficamten) in nHCM.

Yes. I mean I think you pretty much covered it. I'll say that we were at the European Society of Cardiology Heart Failure meeting shortly after the top line, and that meeting is filled with heart failure -- not necessarily HCM specialists but heart failure specialists. And if you recall, the ACACIA study really was, in many ways, a heart failure study. It enrolled nHCM patients, but those patients don't have a specific hemodynamic lesion like the obstructive patients do. So it's sort of a heart failure type study. There has never in history been a study in heart failure that has demonstrated positivity on KCCQ and peak VO2 together. And that's including 5,000 to 10,000 patient studies. Mostly what you see in terms of KCCQ improvement in those studies are a 1 to 1.5 improvement in KCCQ. So this is at least double. And if you look over the span of the treatment, triple in many cases, what you see in heart failure studies that have shown successful impact on outcome. And the community responded incredibly positively to that. People are very excited. They view this as a complete game changer, another word that was used as home run by a very experienced heart failure trialist to describe it as such. So I'm very enthusiastic about it. I think that's reflected in the community [indiscernible] which is a complex over 100 site study globally [indiscernible]

Great. Robert, can you maybe inform us whether you've had your End-of-Phase III meetings either with U.S. or European regulators following the ACACIA top line? And maybe for the team here broadly, given the potential applicability of this data to a broad spectrum of -- now of oHCM and nHCM patients, how does this make you maybe think about driving a switch strategy pending a future label update from this ACACIA study?

So I'll answer the first part. I'm going to resist the temptation and maintain a discipline to what we said before that we'll provide updates on our regulatory interactions on the quarterly earnings call.

From a commercial perspective, we are not focused on a switch strategy and the majority of our patients that we have started on MYQORZO in quarter 1 were new-to-brand. We did have a handful of patients that were switched by their prescribers to MYQORZO. We do know there is interest in the idea of switch. Maybe Dan can speak to there was recently an investigator-initiated research project that was just posted on clinicaltrials.gov, where 2 leading thought leaders within the HCM space are embarking on understanding switch from one CMI to MYQORZO, but it's not actively where we are focused commercially.

Yes. And I think even those investigators honestly, are not really focused on switching patients. When you have a patient who's doing well on CAMZYOS or any therapy, they're doing well, and you generally don't change that. It's more to provide guidance really around when you -- there's going to be some switches. So how do you do it safely? That's really, I think, where these investigators are coming from and trying to explore that.

Robert, earlier, you and I were talking about the ex U.S. market. U.S. investors tend to focus on how the U.S. market is going, but you are also launching internationally. Can you maybe update us on sort of where you are approved and sort of where the launch preparations or launch activities are focused right now?

Yes. So Cytokinetics has, as part of its Vision 2030 [indiscernible] in the United States. So we have a partner in Japan, Bayer. We have a partner in China, Sanofi, and we ourselves are launching in major markets in Europe. The drug is approved and launched in China. We're in advanced clinical studies in Japan, and we launched in Germany last week. And over the course of this year, we hope to be readying to launch in the U.K., France, Italy and Spain and potentially other countries in 2027, 2028. We're seeking to do a partnership in countries where we ourselves don't expect to tee up infrastructure in Latin America, Middle East, Africa and Eastern Europe, for example. So Cytokinetics is taking this very seriously to advance science for the benefit of patients all around the world. In terms of commercial returns, I don't expect the work that we're doing in Germany or in Europe this year to be moving the needle appreciably, but it speaks to our commitment to patients. Over time, we do believe the work we're doing in Europe can support a profitable business and a meaningfully one at that, especially as we go from oHCM to nHCM and from nHCM to heart failure with the rest of our franchise in specialty cardiology. So we think it's good for science, good for patients, good for business. But I wouldn't be focusing on the German launch as will be meaningfully contributing to commercial revenue this year.

Great. I want to spend a moment just on the competitive landscape. Bristol has recently indicated that they're going to redo the ODYSSEY trial in a potentially accelerated time frame. Investors are carefully monitoring for the upcoming Edgewise CIRRUS-HCM data as well. Could you maybe speak to how you view Cytokinetics' competitive positioning versus some of these other companies, including Braveheart, among others? And then as you think about these companies, what is your outlook for the market over the coming, call it, next 5 years?

So Cytokinetics is the pioneer, and we are the innovator in this space. And it's been, I think, reassuring perhaps to Wall Street, in particular, that there are other companies that have entered the arena and compete here. We remain focused on being the leader in the space. And that means that we tell our story, our narrative and as could be benefiting more science and more patients. BMS seems to be looking at nHCM again. And Braveheart and Edgewise are advancing programs with Phase II data that still warrant doing a proper global Phase III program. In all cases, I guess, imitation is great flattery, but at the same time, it's good for science and good for medicine to have others entering. I would caution, however, there's nothing that any of these companies are doing that we don't think we have competitive advantage to do at least equal to, if not more so. And we keep a close eye on strategies. We keep a keen focus to what may be enabling of us to consider ways we can even expand our label, if needed, or lessen restrictions on our REMS, if needed, based on real-world evidence. So as a pioneer in this space, having committed over 25 years, shame on us if we're ever going to be ceding leadership to anyone else and instead focusing to more here could be benefiting category growth. We do believe that there are opportunities to continue to innovate, and we'll be doing that.

Okay. Great. I want to turn to omecamtiv mecarbil for a moment. And either Robert or Dan, can you maybe remind us on what is the current status of your Phase III trial? And is there an interim built into that study for potential mid-stage look before you top line the results?

So thank you for asking. I do think that this is one of the greatest opportunities for Wall Street to be refocusing to omecamtiv mecarbil. So omecamtiv mecarbil is a cardiac myosin activator, has already been the subject of an 8,000-patient study in advanced -- in heart failure with reduced ejection fraction, EF below 40 that showed clinically meaningful and statistically significant findings on hard endpoints. But the FDA asked us to do a confirmatory study because admittedly, the overall effect was more modest. And we're focusing to patients within that group of heart failure patients who have more severely reduced advanced heart failure who in the GALACTIC study saw a doubling of the treatment effect relative to the overall. So we're doing a confirmatory study called COMET, which will be roughly 2,000 patients and which will be event-driven. So we're very encouraged by the pace of enrollment in that study. And maybe I'll ask Dan to comment on your question about interim analysis.

Yes. There's no plan for an interim analysis. We're not -- I think your question gets to sort of can you expect any data updates per se before we get to the actual results of the study. And right now, we don't have any plans for that. The study is enrolling nicely. We'd anticipate completion of enrollment in the coming year and hopefully, results soon thereafter. As Robert has pointed out, it's an event-driven study, so I can't really project exactly when we'll get to that, but it shouldn't be too far into the future.

Great. In our last minute here, I want to maybe briefly touch on ulacamten on the HFpEF side and maybe how that study is going.

Yes. So ulacamten, another cardiac myosin inhibitor, is being studied in its first cohort of a Phase II study in patients with heart failure and preserved ejection fraction. We recently announced the expansion of the size of Cohort 1 to match that of Cohort 2 and Cohort 3. The study is enrolling well. This speaks to the third leg of our 3-legged stool as it relates to specialty cardiology and myosin modulators and where we expect to pioneer and innovate there, too.

Great. We're coming up on time. So I want to thank the Cytokinetics team for joining us today, and we'll end it there. Thank you.

Thanks very much.