Cytokinetics at Barclays Healthcare Conference: Strategic Launch Plans

On Wednesday, 12 March 2025, Cytokinetics (NASDAQ: CYTK) presented at the Barclays 27th Annual Global Healthcare Conference. The company shared its strategic plans for launching aficamten, a potential treatment for obstructive hypertrophic cardiomyopathy (OHCM). While the company is optimistic about its financial position and market strategy, challenges remain in navigating the competitive landscape.

Key Takeaways

• Cytokinetics plans to launch aficamten by September, with the FDA not expecting an ADCOM.
• The company holds approximately $1.2 billion in cash, ensuring financial strength for upcoming launches.
• Aficamten is expected to be priced near $100,000 per patient annually, aligning with market standards.
• A full year of revenue from aficamten is anticipated in 2026, with initial earnings starting in late 2025.
• The MAPLE study results, expected in Q2, could influence treatment guidelines and expand market share.

Financial Results

• Cash Position: Cytokinetics reported having $1.2 billion in cash and cash equivalents, highlighting its robust financial standing.
• Revenue Projections: Initial revenue from aficamten might start in late 2025, with a full revenue year projected for 2026.
• Pricing Strategy: Aficamten will be priced close to Chemsyos, the current market leader, at over $100,000 per patient annually.

Operational Updates

• Aficamten Regulatory Status: The FDA indicated no ADCOM is needed, with a late cycle review set for June and a PDUFA date on September 26.
• Commercial Launch Preparation: Plans include pricing and contracting work, hiring a field force of 125 to 150 people, and launching a non-branded marketing campaign.
• Clinical Trials: The MAPLE study results are expected in Q2, and Acacia enrollment is projected to complete this year.

Future Outlook

• Vision 2030: Cytokinetics aims to introduce multiple new medicines by 2030, targeting over 100,000 patients globally.
• Launch Trajectory: The company expects a linear launch trajectory for the first two years, with growth accelerating post-2026.
• Expansion Opportunities: Positive MAPLE study outcomes could enhance market penetration and influence cardiology treatment guidelines.

Q&A Highlights

• ADCOM Status: The FDA does not expect an ADCOM for aficamten, keeping the approval timeline on track.
• Pricing Expectations: Aficamten will be priced similarly to Chemsyos, fostering competitive positioning.
• Revenue Timeline: Full revenue is anticipated by 2026, with some earnings possible in late 2025.
• Launch Trajectory Benchmark: Cytokinetics hopes to surpass the launch success of Kemzyos, leveraging market awareness created by BMS.

For a detailed understanding, readers can refer to the full transcript of the conference call.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Gina Wen, SMICARE Biotech Analyst, Barclays: Good afternoon, everyone. My name is Gina Wen. I’m a SMICARE Biotech Analyst at the Barclays Conference of twenty seven’s Global Healthcare Conference. It’s my pleasure to introduce our presenting next presenting company Cytokinetics. On the stage with me, we have Robert Blum, President and Chief Executive Officer.

We also have Andrew Callas, EVP, Chief Commercial Officer. And, Rob, I think you wanted to give a brief introduction before we dive into the questions.

Robert Blum, President and Chief Executive Officer, Cytokinetics: Yes. So, thank you. Thanks to Gina for the introduction. Thanks to Barclays for inviting us back for us to provide an update on all the good things happening at Cytokinetics. I’ll be making a short presentation.

And we should start with this picture. This is Eric. Eric is a patient with OHCM and it’s people like Eric that inspire us to do the work we do as we seek to through our science, our portfolio, potential medicines empower muscle, empower lives. I’ll be making some forward looking statements. I’ll draw your attention to our SEC filings with regard to elaborations and caveats to those statements.

And we don’t take initiative and undertake any obligation with regard to updating those statements. We’ll appoint you to those risk factors and filings. Here’s our mission. It’s a mission that’s been in place for Cytokinetics for a good while. We are pioneers and leaders in an area of biology for which we’ve maintained a discipline and focus and we hope to bring forward new medicines to improve the health span of people with devastating cardiovascular and neuromuscular diseases as are rooted in the etiology of muscle function.

Our expertise is in muscle biology and translating that to a new pharmacology. On this slide, you see depicted all of those drug candidates that have emerged from our own research in muscle biology over twenty years with focus to those that are activators or inhibitors of muscle contractility or the mechanics of muscle performance, in particular advanced afikamten now pending review for potential approval by U. S. FDA as well as in China and in Europe for the potential treatment of obstructive hypertrophic cardiomyopathy. We’ll have more to share I’m sure about that.

But also as we’re developing it for non obstructive HCM and also as you see depicted here an activator omecamtiv, an inhibitor CK five eighty six also of cardiac myosin. So somewhat uncommon, three compounds, modulators of one molecular target validated for new pharmacology and has formed the cornerstone of our business strategy to build a franchise commercially that leverages our expertise in R and D, so all directed to the same concentrated customer segment. We also have other compounds in our pipeline earlier stage and over time we’ll have more to say about those. So that’s where we are. This is where we’re going.

This is our Vision 02/1930. Cytokinetics is committed to advancing these potential new medicines to patients and as we expect to have at least two of these medicines approved for patients over the next several years, we’re building out our commercial business as a forward integrated company. That’s not new. That’s always been our intention. And as we see to 02/1930, we hope to bring that forward to over 100,000 patients globally and with our own footprint commercially in North America and Europe, leveraging partnerships in other territories, including as we recently announced last year.

We expect to do that at the same time we maintain our ingenuity and innovation, expanding our pipeline, expanding our interest in muscle biology beyond small molecules and also maintaining the same commitment to culture and values and purpose and especially addressing where we can in equities and care. Ours is a company that’s always thought about being good stewards of capital and in particular thinking smartly about how we access and deploy capital. We currently have as reflected in our Q4 earnings call over $1,000,000,000 1 point 2 billion dollars approximately in cash and cash equivalents on the balance sheet at the December. And you can see we also have access to quite substantial additional capital that we would argue lower than market cost of capital for a company in our peer group and as we can draw on that to support our continuing business imperatives. So we do believe we’ve been good engineers of the financials to support the business we aspire to build.

With that, you can see here depicted on this slide quite ample news flow, call them catalyst if you will, for what could be increasing shareholder value and I’ll be speaking to a few of these in particular this year with a potential FDA approval, approval in China we hope and also additional clinical trial readouts like MAPLE in Q2 and completing enrollment in Acacia later this year. And you can see ours is a story that is not without its ample news flow to support what we hope can be enhanced and continuing growing shareholder value. First and foremost priority number one at the company is to bring Afikampton to patients and to do that in what amounts to at least 80% to 90% of where we think the business lies ourselves in North America and Europe. Europe albeit in a gated way as we go country by country and based on not just regulatory review, but investing as we get reimbursement approvals. In China partnered with Sanofi, in Japan partnered with Bayer and we believe that’s the best way to do that which we can ourselves muster while still leaning on others in areas beyond our own reach.

You can see we’ve already begun with awareness campaigns directed to healthcare professionals and patients unbranded as is important and compliant, but as we do our part to develop a market that we think is substantially larger than is currently penetrated by the first in class cardiac myosin inhibitor. Companies like ours don’t always go commercial and those that do sometimes are successful and oftentimes are not. We’ve been good students of those companies who are first time launchers, first time commercial. What are the things that they do well and as depicted in a recent McKinsey study, we think we’ve already been doing all of these things well and not recently, but over time, meaning over the last couple of years. We’re developing a program comprised of multiple drug candidates in an enduring pipeline and portfolio.

We’re investing meaningfully in our launch year and not otherwise being bashful about investment spending to support subsequent years. We’re also thinking about ways we can leverage digital marketing and omni channel marketing so as to be smart and efficient at how we deploy marketing dollars. We’re thinking about ways we can onboard market access sooner. We’ve been out there talking to payers already for two years making certain that they’re aware of we’re coming soon and doing it in a compliant way. We’re thinking about how best we can build a custom bespoke experience for healthcare professionals in their offices and also to support patients, knowing that you only get to show up once and build an impression.

We want that to be a white glove service for Cytokinetics in support healthcare professionals and patients who may benefit from our medicines. And that also speaks to a fit for purpose customized distribution strategy unique to Cytokinetics and affycamton. We also believe in evidence. Cytokinetics has a reputation for being strong in clinical research, strong and credible and we’re continuing to do clinical studies, some of which you might even think look like Phase four studies and accelerating them into this year. MAPLE is a study of afecamten head to head with metoprolol as could be supportive of potential first line treatment of a cardiac myosin inhibitor as we hope to grow the category.

ACATIA is a study of afacamten in non obstructive HCM. Maple should read out Q2 this year, ACATIA next year. CDER is a pediatric study. FOREST is a study that’s open label extension that’s already been presented and published with hundreds of patients going out beyond one in two years. And we think all of these together create ample evidence to support afacamten use.

My last slide speaks to our milestones this year. Here they are first and foremost as relates to afacamten, go to market in The U. S, prepare for launch in The U. S. And do that successfully focusing to uncommon launch momentum and velocity and how do we build category penetration and hopefully as ultimately may enable best in class preferential share.

And at the same time readout MAPLE, continue and complete enrollment in Acacia and also in CDER and support omecamtiv in Phase three, CK five eighty six in Phase two, CK089 in Phase one and demonstrate that we can continue to innovate and as could be advancing multiple medicines to patients over the next couple of years. With that, I’ll bring this presentation to a close and invite conversation and questions.

Gina Wen, SMICARE Biotech Analyst, Barclays: Thank you. So maybe I will start with the commercial launch preparation. So PDUFA day, September twenty six, and did the FDA definitive give answer that there will be Adacom or no Adacom?

Robert Blum, President and Chief Executive Officer, Cytokinetics: Thank you for asking. So earlier this week, we issued an eight ks just to ensure level set playing field for all conversations we’d be having here at this and other conferences in Miami and as we wanted to be Reg FD compliant. We communicated prior and at our earnings call that we expected a mid cycle meeting in March. We have now communicated that meeting occurred. At that meeting, FDA indicated we should not expect an ADCOM.

We should expect late cycle review to occur in June. So therefore, we believe we’re on timeline relative to a September PDUFA date. And we also came out of that meeting much as we went into that meeting with a belief that if afacamten is approved, we should expect a differentiated label and risk mitigation. That’s not a different statement than the one we had been making, but purposefully meant to be the same.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. Very helpful. And at what point do you think FDA would discuss with you regarding the label, potential label?

Robert Blum, President and Chief Executive Officer, Cytokinetics: So I probably shouldn’t comment too much more on that meeting, but I do believe that the kinds of conversations we had even before submitting the NDA with regard to label and risk mitigation and those that have continued including through our recent mid cycle meeting all read on label and therefore enable us to make the statement that we did.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. Very helpful. And maybe for Andrew, the pricing strategy And so maybe any thoughts there, what could be the good benchmark out there?

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: So there is a product in the market today that kind of establishes a baseline price. I think typical would be to be in proximity of that price. We don’t have to finalize our price until we launch and that’s the list price or the WACC price and we’ll publish that at that launch.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. I think on my calculation, Chemsyos is about $100,000 A

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: little north of that, right?

Gina Wen, SMICARE Biotech Analyst, Barclays: Yes. So, you think it will be north?

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: We’ll be in proximity to that price.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. What

Robert Blum, President and Chief Executive Officer, Cytokinetics: price? They are a little north of $100,000 per patient per year presently in The United States. And Andrew and his team are doing a nice job of thinking about how we might ultimately if approved also be priced. What I can say is they’re doing a fine job. They’re pointing to what could be sales north of $1,000,000,000 in The United States and Europe this year.

And at the same time, as we calculate and Andrew can elaborate on this, we think that they’re demonstrating where there’s opportunity for category growth and great awareness, great patient adherence, great repeat prescriptions, but all as is predominantly within a very concentrated number of prescribers. Andrew, you may want to comment.

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: Sure. I mean, we’ve talked about business model. This is a specialty cardiology business model. It’s a concentrated market. Vast majority of prescriptions are in specialized centers and centers of excellence and academic centers.

The community is starting to get involved. There’s 35,000 cardiologists or so in The U. S. And I think we’re just as a category scratching the surface and 1,000 to 2,000 physicians writing the vast majority of writing being maybe the top 500 to 600 physicians. So, the market availability based on our estimation of epi will be probably at least 80% of the market available when we go to market.

We’ll be focused on new patients and growing the market alongside BMS as a second option where we do think we have some levels of differentiation that Robert spoke to and that our eight ks spoke to as well. So, we’re continuing to progress the launch. We did kind of the strategy and design over the last eighteen months and we’re really in build phase right now. And I can elaborate there if you’d like.

Gina Wen, SMICARE Biotech Analyst, Barclays: Of course.

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: So in the build phase, we do have an account management team focused on payers, interacting with payers for reimbursement. We’ve done our pricing and contracting work, which we spoke to. We’ve made many ATOR publication that kind of speak to epi that link peak VO2 to outcomes that speak to cost associated with HCM. We’ll continue those publications this year. We’ve sized our field force, drone territories.

We’ll start recruiting in April that takes several months. We’ll hire post late cycle in proximity to approval, making sure that we are ready for launch. We’re building a custom patient support program. We’ve signed our strategic partners things like Nurse Navigators, co pay card, strategic partners in both distribution and specialty pharmacy and we’re testing our Visaid now. We’ve launched as you saw on the slide, we’ve launched our marketing campaign in terms of non branded to raise awareness both to physicians and patients.

We build our digital infrastructure in support of that campaign. So everything is progressing as is. We have our headquarter based employees. It’s just a fuel force which we’ll add and that’ll be about 125 to 150 people later this year.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. That’s great. So maybe like the should we this is September 26. So realistically, should we see any revenue in 2025 or that will be more likely 2026 story?

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: I mean, I think we’ll have a full year in 2026 from a revenue point of view. If you consider late September with getting inventory and implementing with two holidays with getting payers on board, we’re really focused more on patient acquisition. We’ll bridge patients through our support program. And I think you’ll start to see there may be a little revenue this year, but the revenue really starting to pick up in 2026.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. And then the launch trajectory, is there any should we use KEMZYOS as a benchmark the first few quarters or you think you can do much better than that?

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: That’s the best analog we have of launch trajectory. It’s something that Robert and I debate constantly in terms of what does that launch trajectory look like. We’re pretty bullish in terms of the BMS has done a wonderful job of creating awareness. Awareness levels are very high. Again, as I mentioned earlier, it’s a very concentrated market.

It’s going to start in the specialized centers and academic centers. We have relationships, so we’re bullish at the launch trajectory. When I say launch, I’m speaking twelve to twenty four months that we will do at least as good if not better than BMS.

Robert Blum, President and Chief Executive Officer, Cytokinetics: Just to add, I think Andrew is right. But cardiovascular launches are somewhat of a unique animal. And this one has shown with BMS and Chemsyos similar trends. They go linear for what amounts to sometimes two or more years before they start to go exponential or hyper linear. And in our similar specialty markets for what may be possible.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay. So, why the first two years linear and become exponential after two years?

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: So, we’ve, I myself have been part of many cardiovascular launches, but we’ve studied the last, say, eight to 10 cardiovascular launches. In general, it’s two to four years linear to hit a high growth. I think there’s several reasons for that. One is it takes a little bit time for payer uptake. Generally, you start with a subspecialty, if you will, within a specialty in a market like cardiology.

So in this instance, specialized centers and then you grow out to the community. So that growth out to the community in terms of expanding prescribers, building awareness, getting on board, educating physicians, having them prescribed meaningfully beyond a few patients to really penetrate the market. So I think it’s a combination of payer adoption, physician adoption, patient adoption that collectively once that experience collectively is there, then you start to see and if the experience is good and meaningful in the kind of the balance of safety efficacy with reimbursement, then that’s when you really start to see a meaningful change. I think a second player in the market certainly helps. Usually, you do see categories grow faster when you have multiple companies engaged with multiple medicines.

Right.

Robert Blum, President and Chief Executive Officer, Cytokinetics: I was involved in my first commercial cardiovascular launch in 1985, my second one in 1998 and there are many others that have occurred in between. It’s rare that a first in class drug becomes the category leader in cardiology. It’s oftentimes a second in class that becomes the category leader and oftentimes as is determined by safety even more sometimes than efficacy. And at the same time what’s somewhat unique to cardiovascular drug launches relative to others is the tail is much longer and it takes while longer to get to peak sales, the tail is longer and you see this for instance classically with drugs like Eliquis that Andrew co led as he was then at Pfizer or Entresto if you look at how Novartis has done a nice job with Entresto. I remember many on the street questioning whether it was ever going to get to the forecasted sales of $4,000,000,000 to $6,000,000,000 for Entresto and it blew way past that now as they’ve done a nice job with Entresto.

And that’s sort of a story amongst cardiovascular drug launches that repeats itself pattern after pattern.

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: I think the other thing that gives us confidence of a successful trajectory not only if we get approved with SEQUOIA in September, as Robert showed, MAPLE, which is a head to head study in the same population will top line in the second quarter if that’s positive. We’d be adding that about a year after launch, a year after that Acacia a whole different population. So in a way this is a portfolio in a pill that have three datasets with two populations in a very, very short time frame that should hopefully accelerate launch beyond just centers of excellence.

Gina Wen, SMICARE Biotech Analyst, Barclays: The last few minutes I want to ask on Maple, since you also mentioned and this is next quarter. So maybe the expectation there, maybe share with us the initial study design, thoughts and how confident you think that that will be positive study?

Robert Blum, President and Chief Executive Officer, Cytokinetics: Maybe I’ll talk about it from the clinical standpoint, if you want to talk about it from the commercial. Sure. So MAPLE is a study that borrows from leanings our learnings I should say from SEQUOIA. In SEQUOIA, the first pivotal study of afacamten in OHCM, we noted that patients whether they were on beta blockers or not as background therapy, they in both cases saw increases clinically meaningful increases in change from baseline peak VO2. And that was a wonderful thing to see for affecamten.

In the continuing open label extension study, physicians who have this discretion were increasingly comfortable taking patients off of beta blockers, which absent evidence became a first line treatment, but for which there’s never really been a study conducted with them in this population to test effects on peak VO2. As that was occurring in the open label extension, it was clear that patients were still benefiting and physicians were still quite comfortable. So we thought why not do a head to head study, afikamten versus metoprolol. One could argue it may not be a fair fight, but for which we do believe that afacamten has demonstrated effects with and well beta blockers in this population of OHCM patients. And there’s reasons to believe that beta blockers may be neutral to negative when studied this way in this population.

But this is going to be a real clinical study to test that hypothesis and we’re looking forward to seeing those data in Q2. Yes. And then quickly Maple from

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: a commercial point of view, a second dataset gives more assurance to especially community cardiology around efficacy and safety as confirmatory to what we’ve seen in Sequoia. It should grow the market influence guidelines in terms of first line therapy. And based on our research expecting that MAPL for the OHCM category would expand category penetration, so more patients treated than would have otherwise, as well as expand share preference in favor of afacamten given that second dataset.

Gina Wen, SMICARE Biotech Analyst, Barclays: Okay, great. Well, thank you very much. We look forward to the other updates later this year.

Andrew Callas, EVP, Chief Commercial Officer, Cytokinetics: Thank you very

Gina Wen, SMICARE Biotech Analyst, Barclays: much.

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