Conference Transcript - CYTK 2026-04-13

Serge Belongi, Analyst — Needham

Hi, good afternoon. I'm Serge Belongi, one of the healthcare analysts at Needham. I want to welcome everybody to Needham's 25th Annual Healthcare Conference. For our next fireside chat session here this afternoon, we have Cytokinetics, an emerging specialty cardiology disease company. Started commercializing their first product earlier this year, and I think still has some important clinical development catalysts coming up. as well. So from the company, we have Fadi Malik, Executive VP of R&D, as well as Andrew Kalos, who's the Chief Commercial Officer of the company.

Fady Malik

So I'll hand it over to you gentlemen for a quick overview of the company, and then we'll jump to Q&A. sure thank you serge uh so there's probably many of our listening know cytokinetics is a company that's been around for quite some time uh now having really pioneered the modulation of muscle contractility is the therapeutic mechanism both in heart failure with omocampin macarble and now in hypertrophic cardiomyopathy with afi campton or now known as mycorzo our first approved product which received fda approval at the end of 2025 approval in china as well at the end of 2025 and then the european commission decision soon to follow there in February of this year. It's been an exciting beginning of 2026 for us as we've launched Mycorso in the United States and we're preparing to do so in Europe as well. Our partner Sanofi in China is also moving forward with the launch there and we're very excited to see Mycorso get out to patients as I'm sure you'll hear about more later on in this talk. So with that, I'll just turn it back to you, Serge, and we could go straight to Q&A.

Serge Belongi, Analyst — Needham

Maybe we'll start with the commercial launch of MyCorso. Product was approved in late December, launched in 1Q. Andrew, maybe just highlight for us the differentiation. I think there was a lot of focus on approval and the differentiation of the label and the rems versus the product that's already in the market. What are some of the key differences that are worth highlighting?

Andrew Kalos

So the research we've done market research-wise has really led to our positioning and our overall campaign. The differentiation really starts with efficacy in terms of the potential ability to make patients improve symptoms fairly rapidly with the ability to titrate as early two weeks and every two weeks, but with a window of flexibility that that titration could occur within two weeks or all the way up to eight weeks. So a six-week window. So rapid onset of effect, flexibility and titration. And in our clinical trial, we saw no symptoms of heart failure or heart failure hospitalization associated with EF lowering, which also is a point of differentiation that we certainly highlight in our campaign. But the campaign generally, you know, we typically start with efficacy. We talk about those safety elements that are important for physicians to understand and know, you know, the drug-to-drug interaction, the lack of drug-to-drug interaction, monitoring that is needed for REMS, and the dosing. So these are the elements in terms of reasons to believe, if you will, but it really does start with the efficacy component given the speed of onset.

Serge Belongi, Analyst — Needham

Got it. And like we mentioned earlier, launch got underway in January. May I just highlight how many reps are out there and what has been the initial focus of that launch?

Andrew Kalos

Sure. So we have over 125 commercial field sales colleagues in the U.S. that are focused on both market access as well as driving demand. And there's really the phases of launch. There's two phases of launch we're really looking at. The first phase that we're in now is those we call velocity accounts. There's about 750 prescribers who were 80% of the CMI market today. Those velocity accounts is where we're focused with the goal of achieving greater than 50% NBRX year, new to brand prescriptions, i.e. new patients. So all the new patients who get added this year, that more than half of them would be on MyCorso. So that's phase one of launch, and that's where we are today. Phase two is the increased breath. Maple certainly will help accelerate that, as will guidelines, assuming that Maple will help inform guidelines. Phase two will be to increase breath of prescribing. We're calling on around 11,000 cardiologists. the vast majority who have never written a CMI, probably around 8,000 or so, maybe 7,500 who have never written a CMI. And again, 700 of those 11,000 we call on are writing 80% of the market. So phase one is depth, you know, do well in where the vast majority of patients are being treated with the CMI. And phase two then is expand prescribing. And we already are seeing some expanded prescribing in our first quarter, which we'll highlight in our earnings call.

Serge Belongi, Analyst — Needham

Got it. On the reimbursement process here, obviously new product, you're starting off at zero, but how is that supposed to, how do you expect it to ramp up? And I guess in the initial phase, is it mostly medical exceptions or quick start programs that provide access to patients? Sure.

Andrew Kalos

So the vast majority of the CMI market today is in Medicare, over 60 percent. And Medicare, we're nearly at comparable access to ChemZios. Most of Medicare is not officially covered, if you will. It goes through medical exception. We're getting reimbursed very successfully through Medicare today. So Medicare, we're expecting parity this quarter. We're getting close to that position already. Commercial is about 30% of the overall mix of prescriptions. Commercial will ramp more slowly. Commercial, we do have some level of coverage by plans. It's a plan-by-plan decision. Most of the larger plans have what they call new-to-market blocks in place while they're reviewing the clinical details of mycorso to add the formulary. We do expect that by the fourth quarter of this year that we'll have comparable commercial access to chemzius, and we're on target and track to do that based on what we've achieved so far. For those who are commercially insured who don't have access, We do have a bridge program where a patient can receive up to 12 months of free drug while they go through that. These plans go through that review process or an individual goes through a medical exception or a prior approval. The Medicare side, if we can reimburse up to two months free of, you know, why are they going through the review process as well? So we do have support programs in place while coverage is coming online. and to date, you know, the commercial side, there's been a little bit of friction point in terms of slowing the launch down, but not meaningfully.

Serge Belongi, Analyst — Needham

Okay. And going back to Medicare, you mentioned most of it's getting through medical exception or just- Through medical exception. And you mentioned parity. So is that parity to Kamsios or parity to other products? Parity to Kamsios. okay got it okay um i believe in your last launch update for 4q which was late february um i don't remember the exact date but um minus again how many patients uh how many docs had been trained on the on the rems and uh i don't know if you gave any patient start details at that point But if there's any warehouse patients that were awaiting approval and availability of the product.

Andrew Kalos

Sure. You know, at that earnings call, there was a fourth quarter earnings call. We were, I think, three weeks or so into our product approval or available, I should say. So approval did occur at the end of December, the second half of December. Product was available the second half of January, as was the REMS program. You know, so at that earnings call, we talked, I think it was a little over 700 REM certified HCPs, if I recall correctly. And that number has obviously grown significantly. And, you know, we'll give those metrics at our earnings call what those numbers look like in terms of prescribers. Same with patients. What I can say is that, you know, we track, as you'd expect, many metrics associated with launch and trajectory of launch. We're looking at patients, time to pay dispense. We're looking at, you know, things like coverage, the number of hospital pharmacies that can order. and we're tracking from a metric point of view with each metric we look at we either add at or above uh what our internal expectations were for the first quarter and obviously we'll share those metrics uh and many of those metrics in our earnings call okay um i'm sorry warehousing patients who asked we did you know i can't um point to a metric we it's hard to track exactly what that number is there were many physicians who told us that they did warehouse some patients and um you know we do have um probably on the end of the spectrum of those who have many patients that were warehouse that have um more than maybe would be typical for a launch for a subset of physicians but it's you know it's really hard to give you a number in terms of number of warehouse patients we know what occurred i know there's you know um 10 plus pay uh physicians who stated they had warehouse patients but i don't know to what effect that is okay and then should we still look at the the launch of camsios as potential proxy for how things could unfold for my corzo um or kind of a baseline on which you can potentially improve upon Sure. So I think the Mycorso launch, we did point to Camzaios as, you know, same market, not that difference in timing, kind of same environment from a pair point of view. obviously a second to market to, you know, large pharma with lots of resources that was ambitious that, you know, our point of view would be despite second to market, despite, you know, sharing or competing for patients and growing the market overall, the expectation that we have is that my Corso will be, you know, from a launch trajectory at or better than where BMS launched in their first year. And we're maintaining that point of view.

Serge Belongi, Analyst — Needham

Okay. I think you've already filed the Maple data to update the label. That was done over this recently, I imagine. Okay. So just curious how you expect I could change the the overall kind of treatment paradigm and I'm asking I guess are CMI still kind of second line after beta blockers and the other options that are currently used for OHCM?

Andrew Kalos

Sure so maybe we'll start backwards I'm not expecting beta blockers not still to be first-line. I think really what Maple will do from a payer point of view is likely make less restrictive utilization management criteria, less restrictive prior-off criteria. And, you know, some payers have two steps, both beta blocker and calcium channel blocker. And having less, you know, getting patients on a CMI faster from a reimbursement point of view is really what Maple will do in the near term. You know, beta blockers do work for some. I know they don't change gradient as Maple saw, which is obviously the key indicator of efficacy, but beta blockers do help some patients feel better. They're easy to get reimbursed. They're cheap. So they're still going to play a role, likely. The expectation, I think, of our base cases in 2027 guidelines would be updated, as well as by the end of this year fourth quarter this year our label would be updated it's not a new indication it's the same patient population it's just further describing the utilization relative to standard of care beta blockers are first line therapy in the treatment guidelines and not expecting that to be you know changing overall i think what beta what maple does In terms of commercially, and this really gets back to those two phases of launch where I talked about in the 750 velocity accounts or prescribers where our focus is achieving greater than 50% new to brand share, which then over time would be, you know, leading the market. Phase two is expanding to general cardiology. And where Maple really does add to, and we did our market research several times and we got a pretty consistent answer, is that when a general cardiologist understands that what they're using, i.e. beta blocker, doesn't impact gradient or efficacy or many biomarkers, and they're not impacting the underlying disease, they feel a call to action. to utilize a therapy specific for the disease. If guidelines are updated to include CMIs faster to use or even alongside beta blockers as a first-line therapy, that'll certainly fuel that as well, as general cardiology is definitely influenced from a guideline and want to follow kind of best practice from a medical point of view and where the evidence is. So we certainly see Maple as a major accelerator for the breadth of prescribing increase, which our expectation would start, you know, probably start next year, larger scale.

Serge Belongi, Analyst — Needham

Do you expect a, clearly you're going to get a label change for my Corzo, but do you expect the Maple data to also impact the CMI class in general, including CAMSIOS? or will the changes simply just apply to my corso, I guess is the question.

Andrew Kalos

Yeah, so for a guideline point of view, I mean, maybe Fadi has a point of view on this. All I can say is that I'm sure it'll help the category. It informs patients, but from a clinical trial point of view, Maple really is the only thing that informs that. And from a promotional point of view, cytokinetics, you know, obviously we'll be promoting the MAPLE data given where the evidence got generated from, which certainly provides a level of advantage. From a guideline point of view, you know, I'm certain that guidelines will reference this trial, et cetera, how they're named. That's really hard to say. I don't know, Fat, if you have a point of view on that.

Fady Malik

I mean, historically, the U.S. guidelines have been very driven by published data, and, you know, they don't extrapolate beyond published data. Sometimes the European guidelines may be a bit more flexible in that regard, I suppose. But I think, as Andrew says, we're the only group that has the data that can really speak to it. And, um, it's a, you know, it's an important contribution to the field to understand how their standard of care performs and how apicampin performs relative to that. And we hope it elevates, uh, cardiac myosin inhibitors in general from, you know, at the bottom of the guidelines to higher up, um, right now they are kind of the last line of therapy. And I can tell you the, you know, the data for calcium channel blockers and diosopyramide are not a whole lot better than that for beta blockers. So we hope that they'll be considered on par with first line therapy.

Serge Belongi, Analyst — Needham

Andrew, you mentioned you were getting ready to launch in Europe. You just highlight the market opportunity here versus what it is in the U.S. and remind us of any inroads that Kamsaios has been able to achieve in the European market for CMIs.

Andrew Kalos

Sure. So, I mean, we entered the U.S. market with broad awareness of the CMI category as well as my Corso. Europe is the same. I mean, when you enter a specialty market where it's a subset of physicians or KOLs at major academic centers, Many of these centers were in clinical trials, and the awareness is also high. We are launching in Germany in the second quarter, so the quarter we're in, and our expectation is it will launch in probably one or two other markets by the end of the year, and all major markets across Europe, Western Europe, in 2027. So that's our expectation. The market opportunity from a patient population point of view is similar to the U.S. There's a little over 100,000 obstructive HCM patients across the European markets where we'll commercialize that are both symptomatic and eligible for treatment of a CMI. Obviously, the difference in Europe is where you get central approval, you know, plus the U.K., plus Swiss Medic. But those approvals allow you regulatory approval, but it doesn't allow for reimbursement. reimbursement is done on a country by country basis, which is why, you know, we go with Germany first. Germany allows you to launch with free pricing while you're negotiating. The other markets, you have to get access and reimburse at the government level as the government is the payer before you can launch. And hence, that's why the launch is kind of spread out in Europe overall. So given the population is the same, the only difference really is price point. And the price point in Europe is generally around 15% to 20% of the U.S. That's what we're expecting. So overall, Europe at peak, when you're in peak in U.S. and peak in Europe, Europe will be about 15% of the overall market for us. So meaningful. I know many companies do not, especially for their first launch in Europe, they really focus on the U.S. I think the difference in this market is it's because it is a specialty cardiology market where, one, you need a small footprint. You don't need a lot of sales representatives. We only have headquartered base personnel in the EU4 and UK. We hire reps and medical colleagues when reimbursement occurs on a country-by-country basis. So we're doing it in a very efficient way from an OPEX point of view. and confident that no one could bring my cores out of market better than we can.

Serge Belongi, Analyst — Needham

So I think the combination of what's really required from an investment point of view, understanding the market, understanding and knowing many of the KOLs and doing it in a cost-efficient way, even leveraging resources in the U.S. to do so is what gave us kind of the confidence that we can be successful in Europe. yeah well we'll be looking forward to uh the one q update on on the my corso launch that's for sure so let's move on to uh acacia and nhcm so fadi you have a big data readout coming up i think it's this quarter i don't know if you've given more granularity on that timing besides 2Q? Maybe we can start there.

Fady Malik

Just 2Q still? That's a simple one. Yeah, I know we haven't updated our guidance beyond Q2.

Serge Belongi, Analyst — Needham

All right, so it could be tomorrow.

Fady Malik

I'll say it won't be tomorrow. How about that?

Serge Belongi, Analyst — Needham

All right, thank you. Maybe to start off with, just highlight the differences between OHCM and NHCM, and then we can talk about the education study design and the endpoints?

Fady Malik

Right. Well, so, you know, with OHCM, you have a clear biomarker of disease severity, which is the gradient. And it's a means of selecting patients that may receive, you know, sizable or less sizable treatment effects. NHCM, by definition, there is no gradient. And so you rely on other things to help you assess patient severity, things like biomarkers of NT-proBNP, patient symptoms, reduced KCCQ scores. And so the most important thing, obviously, is making sure that you have NHCM patients in the study. and NHCM is often kind of a visual diagnosis. I mean, it certainly is a genetic disease in many, but you don't always have the genetics available at the time patients are eligible for trials. The visual appearance on echocardiography is what is something that is... um, sorry, uh, the visual appearance and echocardiography is really what is, uh, drives diagnosis. And in fact, the, um, the guidelines don't actually require a, you know, genetic diagnosis. It's a, it's a diagnosis of, um, visualization and sickness of the heart. So, you know, in, in our trial, we have obviously entry criteria that help us select patients, but we also have trained HCM experts who can visually assess each of the echoes of the patients coming into the trial and help to qualify them properly. I guess based on what you saw in the Redwood data, is that what gives you confidence for for acacia or is it from some warnings from the odyssey trial i mean is it a combination of both i think it's all the above i mean you know and in if you look at our development program and nhcm it built on what we obviously established with the obstructive patients range of tolerable doses how do we approach dosing and avoid treatment interruptions or episodes of heart failure in nhcm there's no gradient to tell you when to stop dosing the strategy is different it's sort of a maximum effective dose as opposed to a you know um i'm sorry maximum tolerated dose as opposed to a minimal effective dose and so we piloted that strategy in phase two and it was quite successful no treatment interruptions the patients improved their symptoms and functional class biomarkers responded in the right way and the echocardiographic parameters of cardiac relaxation improved as well those patients went on then you know for an open label extension where And now they've been studied for more than two years. And we continue to see very positive responses to AFI-Campton. And in some cases, in most cases, the patients have achieved an NYHA class one. So when you design a phase three trial, it's one of the most important things is how do you dose the drug? What's the right dose or the dosing scheme? I think we had that quite well described in the phase two. It gives us confidence that the treatment algorithm we're using in phase three is going to be effective at getting patients to the right exposure and not lead to excessive intolerance or treatment interruptions and other things. The conduct of the trial, I think, also gives us confidence. As I said, we have a very experienced team. they've been together through the conduct of all our HCM trials from from Redwood to where we are today and you know finally I would just say that the Odyssey data were quite encouraging I mean they didn't meet statistical significance on either their endpoints but both endpoints were trending in the right direction with effects on both Peak Dia 2 and the KCCQ that we think will translate ultimately in Acacia.

Serge Belongi, Analyst — Needham

I'll ask the question we get from investors, and we'll continue getting until the data reads out. I guess, what's the bar for success on the dual primary endpoints, and what is needed for, I guess, for approval?

Fady Malik

Well, the last question is an easy one. Nobody knows the answer, right? There's no drug that's ever been approved in non-obstructive HCM, and so there's no real standard set. I think what matters is that you have a drug that's clinically meaningful and impactful. If I believe the data we have from our phase two data, we certainly have a medicine that is meaningful and impactful in those patients. the um simplest thing would be for both endpoints to be statistically significant um we powered the trial in such a way that that i think if they're statistically significant then the effect size is meaningful uh we didn't overpower it to uh you know come up with non-meaningful treatment effects um and so you know the the statistically significant number should yield us a clinically meaningful effect, but obviously all of this is new ground to be plowed with regulators as we share the data with them and begin to discuss the effectiveness of africanptin in this patient population. So in terms of clinically meaningful, is that five points on a five-point delta on KCCQ? what does it look like we we powered the study it's it's a 90 power at a five point change in kccq relative to placebo but we also you know have good uh if you will the minimal detectable difference that we think would be statistically significant is it's closer to three and a half four um the same thing goes for peak vo2 where we powered it for change in 1.0 but But a statistically significant difference could probably be as low as 0.6, 0.7. So I think anything in that range, the higher the number is, the more obvious. But as I said, there are no established standards in NACM, and that's what the data will inform.

Serge Belongi, Analyst — Needham

Okay. And you mentioned, obviously, the most straightforward path here is stat sig on both endpoints.

Fady Malik

What happens in the alternative where only one is stat sig and just becomes an FDA decision or you still have confidence that it could support approval? you know it's always kind of the totality of the evidence and so um you know wouldn't wouldn't look good for instance if they went in the opposite direction um that would not be a great scenario on the other hand if one's a near miss and the other one's positive that's good the other secondary endpoints are important as well i mean the nyj class we have another measure of exercise performance um there are other there are other uh indicators there of of effects and biomarkers that we think are important so i think the overall picture ultimately will inform the discussion i think also just to think about this is it's not a first approval for afikampton drugs already out into the real world. And so when you think about a patient population with NHCM that really have no effective treatments, none of the medicines like beta blockers, calcium child blockers, and so forth have ever been shown to be effective in NHCM. there's no surgical alternative here like an OHCM, you'd hope that there'd be also regulatory flexibility exercised in that particular scenario.

Serge Belongi, Analyst — Needham

One of the other questions we get is the level of detail that we should expect in the initial readout. Are we going to be able to see? Yeah, that's basically how much are we going to be able to see? How much will you keep for disclosure at a medical meeting?

Fady Malik

Well, that's still really a matter of negotiation, right? So we know what our obligations are. We want to obviously meet them, but we also want to try and preserve a presentation of the trial at the C, which would be what we would target. And so we go through a process with the meeting organizers at the ESC, and we'll see where we land.

Serge Belongi, Analyst — Needham

So full details will be at ESC in late August.

Fady Malik

We haven't been accepted there, nor have we even submitted anything. But I presume this is going to be an important study for them and will eventually make its way to the program.

Serge Belongi, Analyst — Needham

Got it. Okay. Before we move on to Pipeline, we did have one question come in regarding maybe for Andrew, how do you think about launching a drug outside the U.S. given the uncertainty around MFN?

Andrew Kalos

Yes, sir. So, I mean, MFN, the guard model on MFN is really where the impact would be. Obviously, this is still a fluid situation and, you know, it's something we're tracking very closely, but we're not changing our plans currently in terms of launching. Even if MFN guard were to hit, one, it's five years, two, it would likely not be effective to 2028, because that would take that long for us to likely hit the threshold where it kicks in. And if it kicks in, then we only may have three years of impact, maybe four, at 20% of our Medicare population, which is a single-digit gross to net impact, if it launched the way that it's at least proposed in the latest we've seen around it. But it's something we're monitoring something that we feel um we can manage if it occurs but nothing that we're going to change our current plans our strategy or have access to our you know my corso for patients in europe but we'll adjust if we need to if it gets more um onerous than the original the initial proposal many of the experts we talk to uh feel like it will um if it is implemented it'll likely still be adjusted maybe even with a an orphan carve out or other mechanisms maybe to lessen the impact but we'll continue to monitor it okay and then uh another question for fadi regarding

Serge Belongi, Analyst — Needham

the the acacia study um remind us of the uh the alpha levels that you need to to meet for the the co-primary endpoints and the alpha recycling between those endpoints?

Fady Malik

So the endpoints are split evenly for the primary analysis 0.025 on KCCQ and P.025 on peak VO2. There is some accommodation for recycling alpha that allows for slightly more power and higher alpha to be pulled back onto one of the endpoints should it fail. But I think I don't need to go into the details really of that here.

Serge Belongi, Analyst — Needham

Let's move on to the pipeline. So, well, I guess Omecamtiv phase three comment trial is ongoing. Goal for this year is just recruitment. Is that kind of where we are or are we at a point where we can start talking about timelines for readout?

Fady Malik

I think we'll have a better sense of that later this year. I think, you know, we're well into the study. All the sites are open for the most part in the U.S., Canada, Europe. We're planning to open China shortly. uh we see good interest in um in enrolling this population and get a lot of positive feedback on the medical need for a medicine that can be used in a severe heart failure population where a standard of care can be tricky to implement um because of either effects on blood pressure or kidney function or other things uh and so you know i think later this year will be far enough into enrollment where we can probably project where we think it'll land and then from there down the road we'll you know give some estimate of where we think the trial will land from an event it's an event driven trial so you know even when you finish enrollment you you're sitting and waiting counting events until you complete study okay and then the the earlier stage program in in half peff um ulicampton maybe highlight the differences of the mechanism of action here how it differs from afi yeah so ulicampton uh we call it a cardiac myosin inhibitor because it decreases uh the uh contractile function of the sarcomere But the binding site for oolocampton is different and unique from that of either aficampton or the mavicampton binding site. It binds near the regulatory light chain of myosin. And so it provides sort of a unique biological mechanism to explore in patients. patients. We are enrolling a patient trial now in HEF-PEF. One of the goals is to understand dosing, and the other goal is to really think about the patient population, where this would be applicable, and the breadth of it. And so that study is called AMBER-HF, and we're in the midst of doing that as a relatively modest dose-finding study right now.

Serge Belongi, Analyst — Needham

When do you expect results from Amber or initial results?

Fady Malik

You know, we're enrolling the first cohort. We haven't really said when results would necessarily be available. Hopefully we'd have some preliminary results by the end of the year. But, you know, when we decide to report those, it hasn't really been firmed up.

Serge Belongi, Analyst — Needham

All right, we only have a couple of minutes left. Maybe just give us an overview of financials and your cash balance runway?

Fady Malik

Sure. My disclosure is that you're talking to the R&D guy who's now giving financial guidance. So I'll refer you to our quarterly press release at our Q4 for details. But we have over a billion dollars in cash and cash equivalents, very well capitalized. We have other access to capital as well, either through loans that we can access from our Royalty Pharma deal or other ways of accessing capital. The company is well positioned to execute on its goals, which are to launch in Europe this year to continue to expand the launch of Athe Campton in the U.S. And then, you know, the further it's pipeline with Comet HF being probably the most proximal value creator in the pipeline. And at the same time, we're interested in growing and continuing to expand the pipeline behind that. So it's an exciting time for cytokinetics, lots of balls in the air, good execution along all lines. And we look forward to what I think will be a very eventful and satisfying 2026.

Serge Belongi, Analyst — Needham

All right. I think with that said, we'll have to wrap it up. We're up on time. I want to thank you both for spending time with us this afternoon and giving us an overview of cytokinetics. And obviously we'll keep an eye out for that Acacia readout coming soon.

Fady Malik

Thank you, Serge. Thanks for having us, Serge.