Welcome, everyone, to the 43rd Annual JP Morgan Healthcare Conference. My name is Tess Romero, and I'm one of the Senior Biotech Analysts here at JP Morgan. We're pleased to welcome Cytokinetics as our next presenting company. And speaking on behalf of the company, we have President and CEO Robert Blum. Robert?
Thank you, Tess, and thank you, JP Morgan, for inviting Cytokinetics to provide an update today. A year ago, Cytokinetics was here amidst a lot of speculation about our company as a potential M&A candidate. That deal did not come together. We executed in 2024 on key milestones, as I'll be sharing with you, as we set the table for 2025 and beyond. During the last year, Cytokinetics raised over $1 billion, some of that through equity capital fundraising, some through access to capital from a royalty monetization, and we advanced our pipeline. I'll be talking about that today. When we did so, admittedly, we were criticized for the fact that we did not sell the company. We indicated through an SEC filing that Cytokinetics did, in fact, engage in M&A discussions. We thought we had agreed on a deal. That deal did not happen for reasons we don't know.
But what I'm going to be sharing with you today is how Cytokinetics is executing on a plan that can maximize shareholder value in ways that can produce uncommon returns in shareholder equity. So, if I may, I'd like to advance. I'll be making some forward-looking statements. I'll draw your attention to SEC filings. We do not undertake an obligation to update those, but continue to draw your attention to those SEC statements. This is our mission. This mission has not changed. It didn't change when we were in M&A discussions, and it's been the mission that's guided this company for over 25 years. We're a pioneer and a leader in an area of biology, specifically muscle biology, and we're focusing that area to a new pharmacology for potential new medicines for patients who are suffering from muscle weakness and dysfunction, in particular around cardiology and neuromuscular indications. This is a video about Eric. Eric has hypertrophic cardiomyopathy.
And the loneliness are the hardest parts about hypertrophic cardiomyopathy. Having the unknown of what it is, what it meant for my life, it sent me kind of into a tailspin of just depression and loneliness. The limitations that it has put upon me socially, mentally, physically, I try not to limit it, but I have to listen to my body. And I know that I can't be Superman, but I still try.
You're going to be hearing more about patients like Eric and what aficamten may mean for them. But at the same time, we'll be talking about the specialty cardiology franchise business that Cytokinetics is executing on and building. It's a franchise that's rooted in a pipeline, a pipeline that has advanced very substantially since a year ago. A year ago, when I stood here, we talked about aficamten. We had recently top-lined the results of SEQUOIA, that being the pivotal phase III study in obstructive HCM. Since then, we've submitted regulatory applications for approval in the United States, in China, and in Europe, and those are pending review. At the same time, since a year ago, we've advanced aficamten in additional clinical trials. You'll be hearing more about that this morning. But at the same time, we've advanced the rest of our pipeline through the benefit of that funding I mentioned, omecamtiv mecarbil into a confirmatory phase III study. CK-586 will soon, in the next couple of weeks, be entering a phase II study. We further advanced CK-089 in phase I and other programs from research towards development.
Cytokinetics has been executing better than in prior years on all of our corporate goals, as I'll be sharing with you today and as sets the table for the company we still aspire to be. A company for which news flow will be abundant. We've turned the page from 2024 to 2025, and in this year, we can expect results from MAPLE-HCM, another study of aficamten in patients with oHCM. We can expect a complete enrollment in ACACIA, and at the same time, we can expect the potential first approval of aficamten, a new medicine for patients with hypertrophic cardiomyopathy, for which we're well prepared to go to market later this year. And as you can see, this is just the beginning of the hit parade that will follow with additional milestones next year, results from ACACIA, results from AMBER, completing enrollment in COMET, and again and again, news flow that speaks to why a company like ours is investing in pipeline and advancing later-stage development for the benefit of augmenting shareholder value, not just as would be a one-and-done, but for an enduring, sustainable enterprise.
And you can see over the next couple of years how many important catalysts and milestones we can look forward to as we advance our platform. This morning, we not only announced our milestones for 2025, we also announced our Vision 2030, how these milestones for 2025 connect the dots to a company that can be building even more substantial value over the next couple of years. I'll walk through these very quickly. Innovation, we expect to advance two new products, two medicines to patients in this timeframe across three indications, and at the same time, augmenting pipeline, as would be in total 10 novel molecular entities. We expect to achieve broad market access. We're committing not just to Asia-Pacific through partnerships, but ourselves go to market in North America and Europe, and we expect to be ensuring access to medicines across 15 countries in North America and Europe. We expect to be reaching over 100,000 patients with medicines that came from our research laboratories. And at the same time, continue that which has got us here.
Cytokinetics has a very strong cohesive culture, and that now extends to how we go to market, and we expect to be putting emphasis not just to access through affordability of our medicines, but by addressing inequities in cardiovascular care and maintaining our history and hallmark of innovation and ingenuity at Cytokinetics, and not just in small molecule therapeutics, but also as we extend to other modalities. Cytokinetics will continue to be the pioneer, the leader in muscle pharmacology. Yesterday, in preparing for this presentation, I came across an article McKinsey published in November. It talked about first-time commercial companies that launch and how 2/3 of them underperform expectations. So what's unique about those 1/3 that exceed expectations? And what that article concluded is that these are companies that have pipeline. These are companies that have concentrated customer segments. These are companies that have high profit margins, payer leverage.
These are companies that produce bespoke patient experience, rely on omnichannel micro-marketing to ensure lean sales and marketing infrastructure, high return on sales and marketing investment. These are companies that create specialized patient models and distribution models, high-touch patient experiences. I'm proud to say that Cytokinetics has already been investing for two to three years already in just those very same tenets as we look forward to building our specialty business and as would be started with aficamten. But we're also doing other things. We're leveraging our pioneering leadership, as has been established credibly, with key opinion leaders across the academic cardiology space. Science to medicine, medicine to business. Cytokinetics is carrying forward that through line to how we build a specialty business, and all at the same time, maintaining continuity of team. Our head of R&D, Fady Malik, is sitting in the audience.
He and I have worked together for over 25 years. In the last years, we've augmented team, but at the same time, the same vision, the same biology, the same discipline, and how we build that going forward is what I'll now talk to you about. Cytokinetics is focused not just to cardiology, but specialty cardiology indications where there are few available therapies, very high unmet need, concentrated customer segments, payers manage to label. We don't expect that they will be extracting high-level discounts, and that's not true just for hypertrophic cardiomyopathy. That's true in those subsets of heart failure, HFrEF, advanced and severe, HFpEF with supernormal ejection fraction, where we could expect the same tenets that McKinsey was heralding for those companies that often exceed expectations with commercial launch. These are the defining principles of a specialty cardiology business. And unlike other rare disease or ultra-orphan companies, we're looking at those markets that are defined by hundreds of thousands of patients, but still, which we can get to with a limited sales and marketing infrastructure.
Later this year, if regulatory interactions go according to plan, we expect to hire 125-150 sales reps in the United States. I can assure you that that's a lean infrastructure that could penetrate the roughly 10,000 patients that we think account for over 80% of the prescriptions for hypertrophic cardiomyopathy. At the same time, you can expect from Cytokinetics not just what could be the potential for a first launch in 2025, but multiple launches, as you see on this slide. Our specialty cardiology business has the potential for high return on investment, high return on shareholder equity as we navigate now the path to market and do so as an independent company. You can see on this slide. I won't go through it in detail, but all those tenets that I was speaking of a moment ago, concentrated prescriber base, higher revenue per prescriber, opportunities for payer leverage, differentiated patient experience, and a specialty model for distribution.
We've already begun. In the last few weeks, we launched an HCM awareness campaign underscoring the humanistic side of this disease for healthcare professionals, and soon you can expect the same thing, unbranded, of course, at this stage, but as will be directed to patients, and we're leveraging CRM and other omnichannel systems to ensure that we're building a relationship with our customers. It's all going to be initially focused to aficamten, and aficamten is addressing major markets starting with oHCM, obstructive hypertrophic cardiomyopathy, and then, as would be extended to non-obstructive hypertrophic cardiomyopathy. You can see here the U.S. prevalence and how that breaks down between those patients that are available, but also a subset that are diagnosed and symptomatic. We're ruthlessly focused to those that are already diagnosed and symptomatic, and those patient numbers are depicted on this slide.
As we think about the potential, and now I'm going to be looking at both North America and Europe, you can see how this is a category that could achieve over $10 billion in sales across North America and Europe over these next several years. Cytokinetics, by launching aficamten as a next-in-class opportunity for these patients, would be expecting to grow the category. It's not important that we compete with the current entrant in that category. That entrant is doing just fine, and I think we'll meet or exceed Wall Street expectations for 2024. What's essential is that with a next-in-class opportunity, we address the still over 80% of patients who are diagnosed, symptomatic, eligible for treatment, and not yet receiving treatment. It's important that we grow the category as well and get more physicians comfortable prescribing a cardiac myosin inhibitor, more patients potentially using these medicines. Our market research has shown that for the data that we generated in phase III, we can reasonably anticipate a majority of market share based on the differentiating features and how those address patient unmet need.
We anticipate that those features that at one time were part of an aspirational product profile, and now the data, the evidence from SEQUOIA make that real. We anticipate that that'll translate into preferred share for aficamten and as the category continues to grow. Here are those primary efficacy data from SEQUOIA, large, highly statistically significant effects on peak VO2. As Fady likes to say, as a cardiologist, he's oftentimes confronted with choices of medicines where patients don't necessarily feel the benefit, but have achieved outcomes that were in their interest by preventing a heart attack, for instance. In this case, these are patient symptoms.
Patients feel and can experience the improvements in exercise capacity, and this magnitude of difference at 24 weeks is extremely high, and that's concurrent with other data that were generated and now published from SEQUOIA, significant and rapid decreases in outflow tract gradients sustained through the course of treatment, and as are reversible, if that ever may be needed, both resting and Valsalva gradients, accompanied by significant large magnitude improvements in how patients' symptom burden is relieved and quality of life is experienced. The NYHA, New York Heart Association improvements, the KCCQ improvements, these are large. These are reasonably unprecedented in cardiology that we're seeing these kinds of magnitude effects for a drug that could improve symptoms for patients that live with the severity of hypertrophic cardiomyopathy, like Eric, who you saw in that video. All of these data now is published in The New England Journal of Medicine, were accompanied by a safety profile where the adverse effects were no different between placebo and treatment. This is extremely important because safety wins.
Safety advantages matter. Here's another example of where safety can ultimately provide differentiation. Wall Street seems a bit fixated on the number of EF excursions, still 3% or less in SEQUOIA or the open label extension, but I can assure you that what matters to clinical medicine, what matters to regulatory authorities, is the absence of treatment interruptions, the absence of heart failure episodes and heart failure hospitalizations. These are the things that ultimately will drive distinction and differentiation in the marketplace, and we believe provide competitive advantage. And as such, our aspirational profile has now evolved, and where we believe there's a potential for aficamten, if approved later this year, to have a distinct risk mitigation strategy and approach in the marketplace with more flexible echo monitoring, a wider dosing window, and the absence of drug-drug interaction monitoring. Those are the things that will matter to these cardiologists, the roughly 10,000 cardiologists that account for about 80% of prescription volume in this marketplace. We know who they are. We know where they are.
We've already defined sales territories and configurations, medical affairs and area business managers already interacting in a compliant way pre-launch. And as we think about building out our U.S. sales team, we're taking a different design approach from the classical conventional model. We're not looking at confusing these folks with many different representatives, but rather creating a bespoke experience not just for patients, but also for healthcare professionals in general, with nurse navigators and with single point of contact cardiovascular account specialists. This is how we show up in the marketplace. This is how we think Cytokinetics as a company that has already established R&D legitimacy becomes the leader in the commercial space. So our strategy in place to support market access at launch is described here. We've already been engaging for a couple of years with payers, again in a compliant way to ensure they know who we are and data, and they can prepare for what we hope will be launched later this year.
We're doing similar things, although in a bit of a staggered way in Europe, starting with a nucleus of about a dozen people currently based in Europe representing our company, and with focus to expanding that group primarily in Germany in 2025, as we expect first approvals in 2026, and then we go beyond that to other major markets. As we think about our responsibility and the privilege to bring aficamten to patients, we're thinking about the roughly 80%-90% of the patient business as depicted in these green markets on this slide. Cytokinetics will represent its own medicine in North America and Europe. And as you saw last year, again executing well on strategy, we have two new partners, one in Japan, that's Bayer, one in China, that's Sanofi. Between those deals and our own go-to-market strategies, we believe we're doing the right thing by patients and also shareholders by addressing the business opportunities in major markets. It doesn't stop there, and Cytokinetics is continuing to execute on additional clinical trials.
This year, shareholders should please pay attention to the fact that we expect data from MAPLE, a clinical trial that could elevate aficamten to potential monotherapy versus beta blockers. Those data are expected in the first half of this year, even before we might expect approval for aficamten in the second half of the year. That's very important in terms of what could be unlocking yet additional value for aficamten. Think of that as a phase IV study that we brought forward last year into a phase III timeline to be enabling of a go-to-market with more wind in our sails. At the same time, we're conducting these other studies, and this year you can expect us to complete enrollment in ACACIA and the adolescent portion of the study, CEDAR. That's aficamten. In the last couple of minutes, I'll speak briefly about how that then sets the stage for omecamtiv mecarbil and then also CK-586, rounding out the specialty cardiology franchise. Omecamtiv mecarbil was the subject of a positive 8,000 patient phase III study published in the New England Journal. FDA asked us to do one smaller confirmatory study and in a sicker population as could meaningfully move the needle.
That study we funded not through equity fundraising, but through a Royalty Pharma deal we announced last year. I'm pleased to say that we've begun with that funding a confirmatory phase III study called COMET. It's a lean study by design. It should enroll rapidly. It started already. We expect it to conclude enrollment next year. This roughly 1,800 patient study is outcomes-driven, and we expect that it can potentially set the stage for omecamtiv mecarbil as would be a novel mechanism drug to increase cardiac function for those patients depicted on this slide that aren't being well addressed by guideline-directed medical therapy. We've got good drugs for most heart failure patients. We don't have a good drug for these patients that are suffering from low ejection fraction, less than 30% heart failure, where these are the patients, and they roughly upwards of a million in the United States and similarly that number in Europe. These patients who are frequent flyers in U.S. hospitals because they aren't seeing their disease managed well by existing treatments.
These are the patients that represent the leading drivers of Medicare cost for this, and these are the patients that could benefit, we believe, based on what we've already seen in GALACTIC, a doubling of the effect size for patients that have lower ejection fraction. Keep an eye on this study. I do believe it's very important, and frankly, it's where I think the cardiology community is most interested in what we're doing. Here you can see the business case that could be enabling of omecamtiv to be low-lying fruit after we go to market with aficamten and obstructive and then non-obstructive disease. This is what shareholders should be expecting of us. How do we continue to build enduring value in pipeline?
Like we're going to be doing also in CK-586, a next cardiac myosin inhibitor, but here directed to the other side of heart failure, preserved ejection fraction, but for those patients where a myosin inhibitor that can be addressing the supernormal ejection fraction anatomy for these patients, this is where we believe we can have a unique positioning for those patients who may not respond well to GLP-1s or SGLT2s and where we believe a myosin inhibitor can play a meaningful role. We're going to be starting a study called AMBER based on these phase I data. That'll be starting in the next couple of weeks. That's a phase II study. You'll be hearing more about that. Here it is by its design, and that study will enroll at least two cohorts this year, should be completing next year with data next year. All of that speaks to how we are from a year ago to this point in time, building enduring shareholder value and at the same time addressing it in a fiscally prudent, capital-efficient way of building our business. Last year, I mentioned we raised over $1 billion between existing cash and access to new capital.
Here you can see, in addition to the equity financing through Royalty Pharma, our third deal with the same royalty player, we now have access to additional $500 million as we advance the pipeline, omecamtiv mecarbil and CK-586. This affords us not only capital to the balance sheet, but ways that we can think about what's in the best interest of shareholders as we deploy capital in a more capital-efficient manner. Here's the way you can think about Cytokinetics in summary form. I won't go through all of these again, but what I will point you to in concluding is our expected milestones for this year. First and foremost, we expect a potential approval for aficamten in the second half of the year to be enabling of our first commercial launch later this year, and before then, reporting results from MAPLE in the first half of the year while concluding ACACIA enrollment this year and at the same time CEDAR enrollment this year, advancing pipeline lead story aficamten.
Right behind it, omecamtiv mecarbil completing COMET enrollment next year and completing the first two cohorts of AMBER this year, completing a phase I study of CK-089 as we'll make a decision about advancing that to phase II. And if you think about where we were a year ago, where we are today, we're executing on a proven strategy, building a specialty business around a pipeline where we are pioneers and leaders translating that science into a new pharmacology for the benefit of patients and shareholders, shareholders like Eric, patients like Eric, and folks that we believe ultimately can benefit from our medicines. With that, I'll conclude. I'll invite my colleagues, Fady and Andrew. Fady, our Head of R&D. Andrew, our Chief Commercial Officer, and we'll be available for questions. Thank you.
So Robert, Robert, you just talked about your key priorities and the targets you're looking to achieve in 2025 and longer term as well. Can you talk a little bit about your strategy around resource allocation and how do you think about investing behind aficamten and its launch and also your broadening pipeline?
So last year, we gave guidance to operating spend between, say, $440 million and $470 million. And while we aren't yet updating our Q4 financials, you'll see that with our Q4 earnings call in February. I will say that in this year, you can expect operating spend to go up as we go to market with aficamten later this year. But however, a majority of spending relating to clinical trials continues to go towards aficamten in MAPLE, in ACACIA, and in CEDAR and in FOREST. So a majority of R&D spending going to aficamten, that's where we think the greatest return on investment can come. You will see us increasing investment in other areas in research and early development, but that'll be balanced also by we expect commercial returns from our investment in the launch of aficamten. So capital deployment and capital efficiencies is top of mind. Sung, our CFO, is here in the audience, and if anybody has any questions about that, we can speak to that in the one-on-ones afterwards.
So as we think about aficamten, what do you think you need to succeed on in order to have a strong launch here out of the gate and also longer term?
Maybe I'll ask Andrew to speak to that, please.
So the key thing will be communicating differentiation, making sure we get contracting and access for affordability, creating a bespoke patient support program. Patients need support in specialty categories, education, reimbursement assistance, and kind of going through that journey. They're the elements that we'll focus on to ensure a successful launch and longer-term success.
All right. Okay. And along these same lines, can you talk a little bit about how you arrived at over 100,000 patients globally, hopefully on your medicines in your 2030 vision?
Sure. So what we did looking at where prevalence came from in the U.S. is there's two ICD-10 codes that speak to HCM. There's an oHCM code and a code for all HCM, and the split between nHCM and oHCM is kind of described in the literature where we get that 2/3, 1/3 split. nHCM is growing at a much faster rate in terms of diagnosis, so that split will probably get closer to 50-50 over time. Where we got the 100,000 is really looking at getting in and drilling into the data, those that are New York Heart Association Class II, III. That's where reimbursement would occur because that's consistent with how we did our recruitment for the clinical trial. So we're very confident in the number. We've looked at it several times where 200,000 is the diagnosed obstructive HCM and about 120,000 of those would be eligible for treatment, and that's where those numbers came from.
Can you orient us to where you stand in your regulatory processes in both the U.S. and Europe?
Sure. Some of the proudest achievements from 2024 related to regulatory submissions in the U.S., in China, and also in Europe. All of those are accepted. In the United States, we are accepted with standard review, so our PDUFA date is late September of this year. In China, we are accepted for priority review. We can anticipate potential approval in China in 2025. In Europe, towards the tail end of December, we announced that the MAA application as submitted to the EMA was accepted and validated, so we can anticipate that we'll hit the day 120 point milestone with questions sometime in the first half of this year. We do expect a mid-cycle review meeting with FDA in Q1 this year.
Can you talk a little bit about who you've been interacting with at the FDA?
Sure. I'm going to ask Fady to speak to that, please.
The FDA brings a multidisciplinary team to any review. Obviously, the cardiorenal division is key in leading the review, but they also bring in their safety colleagues. They bring in colleagues from clinical pharmacology, biostatistics. As we've had several meetings with FDA prior to submission of our NDA, we had attendees from all of those functions because they really address not only the simple safety and efficacy data, but also questions in terms of how risk mitigation might be approached in terms of data sets and how they would like to see them and other aspects of the filing. All of those functions are involved and have been active in our review.
Is it the same team that was involved with omecamtiv mecarbil?
Many of the members actually do have crossover, so we're quite familiar with them. They also have experience with reviewing another cardiac myosin inhibitor, and so there is some specialization, if you will, within the division as the team members gain expertise in this area of myosin modulation.
Do you think the FDA needs to see data with the updated FOREST-HCM protocol before approval of aficamten, given those insights could potentially guide a potential REMS strategy? And maybe you could recap the key events that led to the adjusted protocol for anyone that might not be familiar.
Sure. So FOREST-HCM is the open-label extension. All patients that come out of SEQUOIA-HCM, the phase III trial or other trials that we do, are offered the opportunity to go into FOREST-HCM, and over 90% of them elect to do so. We performed a cut of the data about in parallel a little before SEQUOIA-HCM read out last year so that we could prepare filings for both that included data from SEQUOIA-HCM and FOREST-HCM in our original NDA filing. But because it's an open-label extension, we've continued to accumulate data in those patients, and we've committed to FDA to supply them with another cut of the data that was done late last year. We'll eventually report on those data this year, but they'll be included in the NDA during what's called a 120 safety update, which is routine in any NDA.
And I can say really that the data are supportive. They continue to be supportive, and the profile continues to be similar to what we've seen and reported already.
You know, that's probably worth underscoring and emphasizing because oftentimes when you do a controlled clinical trial, you have data that isn't recapitulated in an open label extension where you remove some of the guardrails and clinicians have more latitudes to evaluate the medicine, but with fewer of those same constraints as would be in a clinical trial of randomized nature. What's reassuring in FOREST-HCM, as Fady points out, is we're not seeing in that setting of FOREST-HCM anything different. We're not seeing heart failure hospitalizations. We're not seeing dose terminations. And in fact, as you remove those guardrails, patients continue to be maintained safely on aficamten out to beyond one year. I think that's reassuring and should provide supportive evidence for the kind of differentiated risk mitigation profile we anticipate.
I might just also add the second part of your question was how did it allow us to modify FOREST-HCM? And with a review of those data, we propose liberalizing the FOREST-HCM protocol to add flexibility to the way that we escalate dose so that there's a larger window between sort of more flexibility in terms of the timing of each dose escalation and then also to increase the time between monitoring from every three months to every six months. And those changes are being implemented now after we've had agreement with FDA on those points.
Given the overall profile of aficamten, the strength of your data, its pharmacology, how might this lend itself to a differentiated growth curve versus Camzyos? And maybe what have you learned from others in terms of any potential challenges to anticipate as you launch the drug?
So I'll ask Andrew to speak to that. We've asked Andrew and his team to do a deep dive in next-in-class cardiology drugs and how they typically perform and what they do to exceed expectations when they do. And in particular, as he'll elaborate, you need to leverage what's already been accomplished with the first to market, but do so in a way that grows category.
Sure. So as Robert alluded to, there is great awareness of cardiac myosin inhibitors because of the information out in the public domain, both for healthcare providers as well as patients. I think the critical element, as we alluded to earlier, was around differentiation. Differentiation from an efficacy point of view in terms of speed of onset, differentiation from a safety point of view around no hospitalization, heart failure, drug-to-drug interaction, and overall safety profile, as well as the administration and utilization of or potential utilization of aficamten relative to monitoring things like echoes and windows, the protocol changes that Fady alluded to in FOREST. In terms of what we've learned, I think we're great students in cardiovascular launches across our commercial leadership team. We have dozens and dozens of launch experience that we're really calling on, as well as understanding recent launches.
Critical to success will be that differentiation in communicating so physicians are aware, communicating and educating to patients. We do have marketing materials and campaigns that are fairly complete. We're doing market research on those, and they'll be communicated through our sales organization, our medical organization, and digitally, making sure we give access and reimbursement, as I was speaking to earlier. We anticipate having comparable access to competitors, both on the Medicare Part D and commercial, and that's really what drives a launch. Very important is the support of patients. Patients, when they get diagnosed, it's a very difficult time to understand what the different treatment options are, the impact of treatment, how they're going to afford it, their medication, and ongoing throughout their journey, not only in starting a medication, but staying on a medication. And we have a very customized patient education and support program that we're building now and that will be ready for launch as well. I think they're the key aspects that we feel will make a successful launch again in the beginning and long term.
Last question for me. Where are you most excited in your broader pipeline, and what do you think might be more overlooked by investors?
I would say that as we engage with investors right now, and maybe that's appropriate, folks are focused on aficamten in oHCM. I think the nHCM represents a major opportunity that's being overlooked by the street and where I think aficamten may similarly make a significant dent in the universe for those patients who are suffering, but where their disease is characterized by nHCM. But at the same time, I do believe that Cytokinetics is unique amongst biopharma companies for having already completed a successful phase III study with a compound like omecamtiv mecarbil and now moving forward in a sicker population, as was already demonstrated to evidence a doubling of the effect size. I do believe that omecamtiv mecarbil represents a major upside for where ultimately shareholders will derive value from our pipeline investments.
Thanks, everyone, for joining.