CYTOKINETICS INC (CYTK) Q2 2026 Earnings Call Transcript

Thank you for standing by, and welcome to the Cytokinetics Q2 2026 Earnings Conference Call. This call is being recorded. Operator Instructions: I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead.

Good afternoon, and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors & Media section of our website at cytokinetics.com, along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the U.S. and Europe. Fady Malik, EVP of R&D, will provide updates related to aficamten. Steve Heitner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. And finally, Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward-looking statements, which are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. And now I will turn the call over to Robert.

Thank you, Diane, and thanks to all for joining us on the call today. The second quarter was another solid period of execution for Cytokinetics, marked by strong commercial momentum for MYQORZO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally and continued advancement of our later-stage specialty cardiology pipeline. Just 5 months into the commercial launch of MYQORZO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for MYQORZO reflects increasing awareness and physician engagement, expanding patient access and adoption across multiple segments of the targeted prescriber base, all of which reinforce confidence in MYQORZO and its clinical, therapeutic and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy with the launch of MYQORZO in Germany, the first in a series of European launches expected over the next 6 to 12 months. This is a key milestone for Cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years. To that end, more recently, the MHRA granted MYQORZO Marketing Authorization across the United Kingdom for the treatment of symptomatic oHCM in adult patients. And at the same time, NICE issued guidance recommending MYQORZO for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help MYQORZO reach patients sooner. We expect drug supply and full launch in the U.K. later this year. During the second quarter, we highlighted the opportunity for aficamten to potentially treat the full spectrum of HCM as we shared the top line results from ACACIA-HCM in patients with nonobstructive HCM showed that the Phase III trial met both of its dual primary end points, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ Clinical Summary Score and Peak VO2 compared to placebo. These results represent an important scientific achievement for an nHCM patient population with no currently approved therapies and they define a meaningful step toward expanding the potential reach of aficamten beyond oHCM, subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top line results from ACACIA-HCM, we met with the FDA to discuss our next steps. We reviewed the clinical trial results together, and we posed questions to which the FDA responded. Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for aficamten in nHCM in the fourth quarter of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from ACACIA-HCM in a hotline session at the European Society of Cardiology Congress to occur later this month. Alongside progress towards making MYQORZO available to more patients with oHCM in the United States and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with nHCM and that could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM. Moreover, in the second quarter, as you'll hear, we continue to advance our later-stage specialty cardiology pipeline with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. And we fortified our balance sheet with a successful financing that supports our plans and objectives. Taken all together, the progress we made in the second quarter underscores that Cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity, expanding global scale and access, proceeding towards expanded product labeling and advancing pipeline. All with focus and discipline to capital access and allocation. I look forward to sharing more about that now from our colleagues. And with that, I'll turn the call over to Andrew.

Thank you, Robert. In the second quarter, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we're seeing across physician awareness, prescribing activity, patient demand and market access. We believe these early indicators are beginning to demonstrate that the differentiated profile of MYQORZO is resonating well with both health care providers, payers and most importantly, also with patients. Since our commercial launch at the end of January, MYQORZO has accelerated quarter-over-quarter growth in new-to-brand prescriptions within the CMI category, by 24% in Q1 and 15% in Q2 compared to the single-digit growth rate observed when only a single CMI was available. The introduction of MYQORZO is helping drive increased breadth and depth of new patient starts as well as greater engagement and awareness among a broad range of physicians and prescribers within the category. In fact, in our most recent market research survey, which was conducted during the second quarter, unaided awareness among HCPs increased to 68% compared to 52% in the first quarter. We're also seeing encouraging engagement among patients. Our patient marketing campaign has driven early and increased awareness, resulting in over 30% awareness among oHCM patients in the United States. In addition, we have generated more than 390 million impressions and 2.1 million social media clicks through our focused and directed digital media campaigns across a broad range of channels and platforms. We're also pleased to see continuing perception of clinical differentiation favoring MYQORZO among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of MYQORZO. Treating physicians that we surveyed also view MYQORZO favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability and the flexibility associated with differentiated REMS requirements. In this stage of our commercial launch, our emphasis remains on deepening prescribing among high-volume CMI prescribers. Historically, these physicians have generated approximately 80% of CMI prescriptions. While our call universe spans more than 10,000 health care providers we are prioritizing engagement with high-volume prescribers. And at the end of the second quarter, our sales team had reached more than 90% of these HCPs. We plan to maintain that same priority emphasis to high-volume prescribers until we achieve greater than 50% new-to-brand prescription share, which we believe could occur by the end of this year, if not sooner. At the same time, we're encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers. In fact, by the end of the second quarter, more than 50% of MYQORZO prescribers were either low-volume CMI prescribers or first-time CMI writers. Our field force reached more than half of these physicians during the second quarter. We see prescribing from this cohort as an important signal that MYQORZO is gaining traction across a wider segment in the oHCM treating community, something we anticipated based on the differentiated profile of MYQORZO and it is validating to see that in actual prescribing. Importantly, our field-based teams are also bringing the data from MAPLE-HCM to the attention of the oHCM treating community. These important data from our second Phase III trial of aficamten both support findings from SEQUOIA-HCM and further demonstrate that MYQORZO is superior to beta-blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy and utility of MYQORZO in patients with oHCM. As we committed at launch, we continue to evaluate performance using 3 key metrics: breadth of prescribing measured by the number of HCPs who have written prescriptions, depth of prescribing measured by the number of patients to which each HCP prescribed MYQORZO, and patient volume, which reflects a total number of unique patients prescribed MYQORZO. Across all 3 metrics, we are encouraged by the progress and rate of growth achieved during the quarter. By the end of the quarter, more than 700 unique health care providers in the U.S. have prescribed MYQORZO including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately 3 of their patients, the figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately 5 of their patients on average. Although limitations with syndicated data make it difficult to precisely calculate new-to-brand Q2 exit share in the CMI category, our internal analysis suggests that the exit share for MYQORZO has increased to greater than 40% in the second quarter. We also continue to see encouraging leading indicators of future demand, including more than 2,500 health care providers who have now completed REMS certification since launch. Turning to patient demand. In the first quarter, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, MYQORZO was dispensed to 1,500 patients, nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continue to be dispensed within approximately 3 weeks, once all patient documentation and benefits investigation is complete. Going forward, we plan to report on patient dispense versus prescriptions to better align with product revenue. In Q2, over 80% of the dispensed prescriptions were paid for with the remainder associated with either free trial, bridge or other patient assistance programs. These too are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels. We ended the quarter with nearly 90% parity coverage for Medicare lives. We also continue to broaden our commercial wide coverage achieving over 50% commercial coverage by quarter end and remain on track to achieve parity access by the end of 2026. Outside the United States, we successfully launched MYQORZO in Germany in June to support expanding access throughout Europe. We have also submitted 10 HTA dossiers across Europe and reimbursement approval was received effective August 1 in the Netherlands. And in England and Wales, NICE published guidance recommending MYQORZO for use. We continue to make progress broadening the pathway to further patient access in key markets with additional markets anticipated to launch later this year and during the first half of 2027. We are very encouraged by the performance we have seen in our launch markets. The launch velocity we are seeing reflects the differentiated profile of MYQORZO, but also the dedication and execution of our colleagues across the U.S. and Europe who are delivering excellence with both integrity and focus. And with that, I'll turn the call over to Fady.

Thanks, Andrew. The second quarter was an important period for our HCM portfolio, most notably with our announcement of positive top line results from ACACIA-HCM, our pivotal Phase III clinical trial in patients with symptomatic nHCM. As we shared by top line press release in May, ACACIA-HCM met both dual primary end points, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ Clinical Summary Score and Peak VO2 compared to placebo. In addition, statistically significant improvements compared to placebo were observed across key secondary endpoints, and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of aficamten in nHCM, which represents as much as one-half or more of the overall HCM population and for which there are no currently approved therapies. For many years, treatment options for patients with nHCM have been limited despite the significant burden associated with the disease. We believe the results from ACACIA-HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress. Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints and of course, safety, we'll also be presenting additional analysis regarding the effect of aficamten on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of aficamten in this population. At ESC, we also plan to hold an event both in person and online for investors and analysts to hear perspectives and insights on the results from prominent HCM key opinion leaders. As Robert mentioned, after we shared the top line results publicly, we then met with FDA to discuss the results of ACACIA-HCM, and next steps for aficamten, which informed our plan to submit a supplemental NDA, expected during the fourth quarter of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency. There is still much work ahead, but the positive top line results and our regulatory interactions to date reinforce our continued confidence in opportunities for aficamten in nHCM. In oHCM we continue to support review activities and engage constructively with FDA regarding the sNDA based on MAPLE-HCM that's currently under review with a PDUFA date of November 14, 2026. We continue to believe that the results from MAPLE-HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of aficamten as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamten observed in MAPLE-HCM are consistent with our labeling, our field medical team have been sharing these results with potential prescribers. In addition, our field medical team continued to support the launch of MYQORZO. They completed more than 800 scientific exchanges with U.S.-based HCPs across a variety of topics, including questions related to the USPI and our public announcement of the results from ACACIA-HCM. Our medical science liaisons also supported our cardiovascular account specialists with introductory HCP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first ever investigator-initiated research study utilizing aficamten. Studies investigating the feasibility, safety and efficacy of physicians seamlessly transitioning patients from mavacamten to aficamten in patients with oHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of aficamten to address the full spectrum of HCM. With MYQORZO now available for adults with symptomatic oHCM and the positive results from ACACIA-HCM supporting a potential expansion into nHCM, we continue to see a substantial opportunity to bring this medicine to a broader population of patients in the United States and also around the world. Next, I'm pleased to hand it over to Steve Heitner, but before I do, I'd like to formally announce that Steve has been promoted to Chief Medical Officer. Steve, who joined Cytokinetics in March 2020, will continue to lead clinical research with responsibility for conception, conduct and execution of our clinical trials as well as contributing to the expansion of our pipeline and evolution of our clinical research infrastructure as we move into a new age of artificial intelligence aided R&D. Served by his experience in treating patients with HCM and deep expertise in this disease, Steve has been an exemplary leader in helping to bring aficamten to patients. His insights and guidance contributed immeasurably to the approvals of MYQORZO in the U.S., EU and China. He's also played major roles in the innovative study designs and quality of conduct of ACACIA-HCM for aficamten, AMBER-HFpEF for ulacamten and COMET-HF for omecamtiv mecarbil. This transition represents a passing of a baton from Stuart Kupfer, who had served as Chief Medical Officer at Cytokinetics since 2020 and who contributed enormously to many of our successes in recent years through his seasoned leadership and expert oversight of clinical research, clinical pharmacology and drug safety. We're pleased that Stuart will remain at Cytokinetics as Senior Vice President of Clinical Development; contributing to our clinical programs and external innovation with a special focus on pharmacovigilance. And with that, I'll hand it over to Steve.

Thank you, Fady. Starting with our ongoing programs for aficamten, we continue to advance studies supporting broader availability worldwide. During the third quarter, we expect to complete the conduct of the Japan cohort of ACACIA-HCM and for our partner, Bayer, to complete the conduct of CAMELLIA-HCM evaluating the treatment of obstructive HCM patients in Japan. We also advanced CEDAR-HCM, a study evaluating aficamten in pediatric patients with obstructive HCM. In fact, during the quarter, we completed enrollment in the adolescent cohort ahead of prior expectations. In addition to the progress for aficamten, we continue to advance the remainder of our cardiovascular pipeline during the second quarter. Starting with omecamtiv mecarbil, the continued conduct of COMET-HF, our confirmatory Phase III clinical trial in patients with heart failure and severely reduced ejection fraction. We've now enrolled just over one-third of patients across North America, Europe and China. With the additional sites from China this past quarter, more than 90% of planned sites are now activated. We are encouraged that the baseline characteristics of patients with heart failure and their severity are tracking very closely with those in the subgroup of heart failure patients from GALACTIC-HF with severely reduced ejection fraction in whom the treatment effect appeared most concentrated and who informed the design of this trial. We expect to continue enrollment through 2026. For ulacamten, we continue to enroll Cohort 1 of AMBER-HFpEF, our Phase II study in patients with heart failure with preserved ejection fraction towards our expected completion of enrollment in the second half of this year. We remain focused on continuing trial conduct and generating data to help define the potential role of cardiac myosin inhibition in heart failure with preserved ejection fraction. Overall, we are pleased with the continued progress across our later-stage specialty cardiology development portfolio and look forward to important milestones over the coming quarters. With that, I'll hand over to Sung.

Thanks, Steve. Beginning with revenue. Total revenues for the second quarter were $28.6 million compared to $66.8 million for the same period in 2025. Net product revenues of MYQORZO reached $25.3 million, serving as the foundational driver of our top line moving forward. Of this amount, U.S. net product revenues were $23 million powered by robust demand and more than 80% of patients on paid prescriptions. Europe contributed $2.3 million in net product revenues, reflecting initial inventory purchased by distributors in Germany. Other components that contributed to total revenues in the second quarter include $3.3 million in collaboration revenue compared to $2.4 million for the same period in 2025. No licensing or milestone revenues were recorded in the second quarter of 2026 compared to $64.4 million in the second quarter of 2025, which benefited from the achievement of milestones from our collaboration agreement for aficamten in Japan with Bayer. Turning to operating expenses. R&D expenses for the second quarter were $97.8 million compared to $110.1 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs and medical affairs activities in 2025, partially offset by higher personnel-related costs in 2026. SG&A expenses for the second quarter were $104.4 million compared to $65.7 million for the same period in 2025. The increase was primarily due to commercial launch costs for MYQORZO, the U.S. sales force and higher nonsales personnel-related costs, including stock-based compensation. Cost of goods sold for the second quarter of 2026 was $2.7 million driven almost entirely by a nonroutine charge related to drug supply optimization. Collaboration cost of revenues for the second quarter of 2026 was $2.9 million compared to $2.4 million for the same period in 2025, reflecting primarily partner cost reimbursement. Net loss for the second quarter of 2026 was $198.8 million or $1.50 per share compared to a net loss of $134.4 million or $1.12 per share for the same period in 2025. Turning to the balance sheet. We ended the second quarter with approximately $1.7 billion in cash and investments compared to $1.1 billion at the end of the first quarter of 2026. The increase in cash and investments in the second quarter was primarily driven by our May public offering generating approximately $760 million in net proceeds. Turning to financial guidance. We are updating full year 2026 GAAP combined R&D and SG&A expense to a range of $860 million to $890 million from the previous range of $830 million to $870 million. Stock-based compensation included in the GAAP combined R&D and SG&A expense is being adjusted to a range of $130 million to $140 million, up from the previous range of $120 million to $130 million. Excluding stock-based compensation from the updated GAAP combined R&D and SG&A expense results in a range of $720 million to $760 million. This increase in guidance is primarily driven by commercial readiness investments prompted by the positive results from ACACIA-HCM to support the potential 2027 launch of MYQORZO in nHCM. With that, I'll hand it back to Robert.

Thank you, Sung. As we reflect on the first half of 2026, I believe the progress that we've made demonstrates the strength of our execution and our strategic positioning as a maturing global growth enterprise. In less than 6 months of our commercial launch, we've seen encouraging demand for MYQORZO, growing physician adoption and expanding patient access, the breadth of prescribing increasing depth of use amongst physicians and growth in patient volume all provide evidence that our launch is gaining momentum. We also executed a successful launch in our first European market. And while we're early in our commercial journey, the trajectory we're seeing reinforces our belief that MYQORZO has the potential to become the CMI of choice in oHCM. Our near-term priorities for aficamten are clear. In oHCM firstly, executing successful global launches for MYQORZO and pursuing additional approvals across Europe. In nHCM, presenting the primary results from ACACIA-HCM at ESC and preparing and submitting an sNDA to FDA later this year as well as planning for the commercialization in nHCM. Beyond Europe, regulatory reviews for aficamten also remain active in multiple geographies, including Canada, Hong Kong and Taiwan. In parallel, we continue to evaluate opportunities to broaden global access through potential partners in additional regions outside of North America, Europe and Asia where we believe MYQORZO may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both omecamtiv mecarbil and ulacamten, which we're pleased are progressing well in respective later-stage trials. As we look ahead, I believe our strategic positioning has never been stronger. We're entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of MYQORZO and continuing investing across our pipeline to pursue opportunities that can enhance longer-term shareholder value. Together with our growing commercial presence, expanding clinical evidence base, and advancing pipeline, we believe we're well positioned to create meaningful value for patients and shareholders in the years ahead. Now I'll recap our 2026 milestones. For aficamten, we expect to submit a supplemental NDA in nHCM in Q4 later this year. And we potentially will receive FDA approval of the sNDA for MAPLE-HCM also in Q4 later this year. We expect to prepare to launch aficamten in the U.K. later in Q4, continued conduct of the adolescent cohort of CEDAR-HCM throughout the year and potentially receive approval from Health Canada in the second half of 2026. For omecamtiv mecarbil, we expect to continue patient enrollment and the conduct of COMET-HF through this year. For ulacamten, we expect to complete patient enrollment in Cohort 1 of AMBER-HFpEF in the second half of this year. And for CK-089, we expect to continue the second Phase I study and finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs. And operator, with that, we can now open up the call to questions, please.

Operator Instructions: Your first question comes from the line of Salim Syed with Mizuho.

Congrats on the great number. Robert, Andrew, maybe just one from us on the dispensed versus prescribed. We're certainly getting a lot of e-mails just on the clarification here. Could you just so we have the apples-to-apples on the Rx. So I think you said it was 400 dispensed versus the 680 in the 1Q and then 1,500 dispensed this quarter. What's the Rx this quarter, if you could provide that? And is the ratio of 59% consistent between the 2 quarters if you don't want to get too granular?

Yes. I'll turn that over to Andrew to address. But obviously, it's the dispensing that drives the revenue. So we thought it important to align to that number. But Andrew, could you address the specific prescriptions and dispensing in Q2?

Yes. Thanks for the question, Salim. Happy to clarify. So you're right, 680 to 400 in Q1 to around 2,000 to 1,500 in Q2, launched to date overall. That difference is pending patients. We described patients in the process. Once a prescription is sent in, that's really the underlying demand and there has not been a change. Actually, there's a growth in underlying demand as you saw from the market share for new-to-brand that we reported. But there is a process, a REMS enrollment has to occur, a prescription has to occur, signatures, both on physician and patient side, benefit investigation, oftentimes prior auths. So there's a process that takes several weeks. We're getting about 100-plus prescriptions per week. So the majority of the difference is that pending patient in process of getting a prescription filled and dispensed. There is a small mid-single-digit prescriptions that do get canceled, but the vast majority are in process and will wind up as a dispense. Hopefully, that answers your question.

Okay. So about 2,000?

Yes, you got it.

Our next question comes from the line of Roanna Ruiz with Leerink Partners.

So I was curious regarding the different metrics that you're tracking for MYQORZO's U.S. launch, just a big picture. Are there any that seem to be accelerating more than others into the quarter? And could you comment on what you can see in terms of number of switches versus new patient starts? Is that proportion holding from last quarter? Or are you seeing some changes there?

Sure. So maybe I'll turn that also to Andrew, please?

Sure. Thanks for the question. So we are seeing a couple of changes. One, the higher percentage of paid for prescriptions, which is encouraging. Around the same in terms of how long it's taking that prescription to be paid. We're seeing acceleration in that low volume to first-time CMI prescribers from a switching point of view and both of those certainly speak to breadth of prescribing. Switching, we reported very low single digit. We are actually seeing probably in the 5% to 7% of our overall dispenses are from switching. The switching has increased slightly, but not dramatically and not a major driver.

Our next question comes from the line of Carter Gould with Cantor Fitzgerald.

Doing a bunch of math on the fly here, but it would seem to suggest that the overall class sort of adds per month or per week are only sort of up modestly and what you're seeing so far is primarily share capture versus growing the pie. Is that sort of a fair characterization? And separately, I guess, a clarification question. Was there any impact from stocking in that $23 million figure?

So Andrew, again, I'll turn to you, please.

Sure. So we are actually seeing an increase in growth. I showed you the new-to-brand prescription growth overall. I think last year, we were seeing at least in syndicated data about 2,000 new prescriptions per quarter. I think in the first quarter, the number was probably around 2,500. In the second quarter, it's starting to approach 3,000. So you're seeing a growth in terms of new patients entering the market. And there really hasn't been a change in kind of compliance and persistency overall. So you're seeing an increase in patients dispensed. And I'll send the question over to Sung around stocking relative to revenue.

Yes. So thanks, Carter. As demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. So this quarter was demand led.

Our next question comes from the line of Ash Verma with UBS.

So yes, I have kind of like a similar question just on prescription versus dispense. So I know when you provided the first quarter update, you mentioned about the April prescription. And if I take that 420 number and apply this 60%, I get to 250 dispensed during April, versus like when you did it for the full quarter is like 1,500. So 1 month had 250. And then for the full quarter, you have 1,500. As you're thinking about month-over-month, are you seeing more of a growth acceleration at this point? And anything that you can share about how July is shaped out to be?

So we will resist the temptation to talk about July, but Andrew, could you speak to the second quarter?

Sure. So you can see from the ratios, we are seeing an increase in dispense. I would expect dispenses to level out once managed care and access level out, oftentimes that time frame of a pending patient. The REMS certainly adds to it because of certifications needed, but pending patient often stays pending longer because of the benefits investigation and a prior auth process. So we would look to shrink that time frame down over time, but I would not anticipate that in the near term.

Our next question comes from the line of Tessa Romero with JPMorgan.

So taking a step back, as you think about ESC here coming up in a few weeks, what do you believe will be better understood by physicians and investors on the other side of the conference? And then secondly, just to double click here, you talked about reaching 50% new-to-brand share by end of the year, if not sooner, for MYQORZO. With that in mind, where do you sit now?

So let's take the first part of your question regarding ESC, what might be elaborated from what has already been disclosed in our top line press release. Firstly, we've been very clear that we believe that when we actually present the fuller data that investors will better understand what we've meant by words like consistent and robust. As we now can speak to magnitudes of change across all endpoints, including secondary endpoints and how we believe that tells a very consistent robust story of efficacy measured by those various endpoints. Maybe I'll ask Fady and Steve, if they want to speak more to that before we address your second question, which relates to a proportion of new scripts.

So we have both the top line data, which kind of goes through the endpoints delineated in the SAP. But those are going to be put into both clinical and mechanistic context. So the clinical context will be deliberated by Dr. Masri in his presentation on Friday. And then on the Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde where we'll be talking about the mechanism by which these clinical benefits are being enjoyed by patients. I think that will be very elucidating to scientists and patients moving forward.

I do think that as these data will be fully presented, we'll be able to speak much more completely about the effects, how they were observed across time, as well as ultimately across endpoints that measure both function and quality of life. With regard to your second question, I'll turn to Andrew. I think he may have already addressed it in part by speaking to over 40% proportion of new scripts coming out of second quarter, but maybe Andrew, if there's anything more you want to elaborate?

Yes. That is the number we're reporting at the end of Q2 as an exit share, meaning our share in the month of June was over 40% new-to-brand share. So we're not going to report July. We'll report the third quarter during that call.

Tessa, to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to MYQORZO than might have been expected. And when we talk about exceeding expectations, we are coming out of the gate very strongly with respect to new scripts, knowing that some of that could be a transient effect. I think we're going to be still conservative with respect to timing on when we might expect majority share. But certainly, it's moving very swiftly in that direction.

Our next question comes from the line of Akash Tewari with Jefferies.

This is Manoj on for Akash. Just one from our end. Are you hearing any feedback from the prescribers who switched from Camzyos, especially like the efficacy with the lower doses? And approximately what percentage of your new patients are outside the treatment of the center of excellence?

So if I understood your question correctly, are we hearing anything with respect to mavacamten as it relates to lower uses and prescription?

Yes, the patient switch from mavacamten, like your efficacy with the lower doses of aficamten?

Yes. So it's not for us really to comment on Camzyos and lower doses. But Andrew, is there anything you want to say about aficamten and MYQORZO and how doses are being titrated and then perhaps tackle the second question, which relates to prescribing outside of velocity accounts?

Sure. So in terms of dosing, we do have a flexible dosing window. A physician can increase a dose with each echo and we're seeing that dosing window play out in real world where some patients are being dosed as quickly as 2 weeks and other patients are being increased dose as long as 2 months. And that's really between the logistics of a center of patients and the physicians scheduling. So that window is taking place across every dose change. Relative to breadth and depth of prescribing we have a really good mix in terms of breadth. The majority of our prescriptions and prescribers are in that high CMI category, that's about 40% overall. And then that low volume category is about 30% and the CMI-naive, meaning they had not written a CMI until we've entered the market is 30% of our prescribers. So we're doing really well across a broader range of prescribers. When we talk to those CMI-naive prescribers anecdotally, we're really hearing what you saw in that slide around differentiation. It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of drug-drug interaction monitoring as part of the overall REMS program. Those are generally the reasons we hear from that CMI-naive segment in terms of why initiation of a CMI is happening at this point. Hopefully, that answers your question.

If you think about what may be auguring well with regard to exceeding expectations associated with prescribing down the road, it's going to be the number of prescriptions, repeat prescriptions coming from each of these segments and an expansion of the category. And I think Andrew commented on both of those in his comments. We're especially encouraged to see the high-volume writers writing the number of prescriptions that they are, but also that 50% of the prescriptions are coming from folks who were otherwise new or low-volume prescribers. That suggests to me that we're seeing category expansion, as you should expect.

Our next question comes from the line of Paul Choi with Goldman Sachs.

Apologies for any background noise. As you think about your commercialization efforts over the coming year, you'll be launching in symptomatic oHCM frontline oHCM and then nHCM, which is a lot of data put in front of doctors. And as you think about your messaging, maybe clarify for us how you'll think about all these opportunities and presenting them to doctors as your sales force is in the field over the next year.

So maybe I'll ask both Fady and Steve to start because they're obviously on the forward edge of these studies and as they get reported, presented and published, the medical colleagues are already speaking to some of these things. And then Andrew and his commercial team pick up from there. So Fady, do you want to start and then Andrew afterwards?

It really starts with dissemination of the data through the published literature. Steve and his team have been very productive in terms of not just the primary publications, but secondary publications that expand on the initial findings. With that, our medical affairs team is regularly interacting with the most elite prescribers and physicians taking care of these HCM patients, bringing them the information, helping walk them through it in a concise but complete manner. And finally, through executing a number of educational programs either through CME or industry-sponsored symposia. So a complete program from the primary publications through to delivering the information through a variety of channels. And ultimately, our commercial colleagues will build on what gets into a label and be able to then also disseminate the information broadly to their customer base. Andrew, do you want to add?

Sure, maybe just add to it from a commercial point of view. It's a great challenge in terms of having so much data in this period of time. When we think about MAPLE, we've done a lot of research on this as well. From a physician point of view, it broadens their horizon in terms of who they think an appropriate patient is for a CMI. So we'll certainly highlight that for a physician. That's especially true for those low writers and the naive CMI writers meaning they haven't written before where they certainly feel like they have the appropriate patient when you consider them relative to a beta blocker. Guidelines will certainly fuel that more if that were to change in 2027 for nHCM, which would broaden the spectrum of the number of patients a physician and a cardiology office can have with a single agent in MYQORZO if it's approved for nHCM to treat a broader range of patients. So we have our messaging cascaded and I think we'll be ready to take advantage of that further differentiation should those approvals come from a regulatory point of view.

Paul, we aim to keep it simple. And what I especially am pleased to see is how we have great coordination across functions at Cytokinetics. You asked about publications and communications in the field. What I'll also point you to is the abundance of secondary manuscripts and other publications that build off of the primary manuscript. There's a plethora of information that's informing physicians about how best to think about aficamten and MYQORZO. I do think that's translated to awareness, significant education and pull-through in patient demand as is enabling of our commercial colleagues to do so well. Hats off to the medical colleagues who make it happen on the publication side and then the commercial folks can keep it simple when they are out there detailing physicians.

Our next question comes from the line of James Condulis with Stifel.

And congrats on all the progress. Maybe on the nonobstructive side, I'm curious, as you started sNDA discussions, do you expect any differences on the label or the REMS with the potential approval of nonobstructive? I appreciate any color you can share.

Yes. So it's premature to speak to that. Obviously, we haven't even submitted the sNDA nor had conversations with FDA following their review of a submitted sNDA, but I do expect that because this is a separate trial, there will be some distinctions that will have to reflect nHCM versus oHCM. We shouldn't front-run any of that until we have actually interacted with the FDA following the submission.

Our next question comes from the line of Jason Butler with Citizens.

Congrats on the quarter. Robert, can you just walk us through your expectations for Cohort 1 of ulacamten. How are you thinking about what you can learn from that cohort specifically about the safety profile as well as PK/PD?

Sure. So I'll turn that over to Fady, please.

As we've said before, AMBER-HFpEF is a dose-finding trial to understand how the unique mechanism of ulacamten might play out in this population. We'll have initial PK, broad cardiographic parameters, safety, and we'll also understand the feasibility of enrolling a population focused where we think the impact might be felt with a mechanism like ulacamten. Over the course of the study that will help inform the continued development of ulacamten in this indication.

Our next question comes from the line of Cory Kasimov with Evercore.

This is Josh on for Cory. What percent of the oHCM market is penetrated by CMI today? And what do you anticipate a peak penetration could be for the class?

Maybe I'll turn it to Andrew for that, please.

Our estimate is around 110,000 to 120,000 eligible patients based on epidemiology analytics. There's probably in the 20,000 to 25,000 range of treated patients, so you get a penetration in around the 20% range today. Peak penetration will depend on access, demonstrated safety, REMS programs and other factors, but I would anticipate peak penetration in the 60% to 70% range over time.

Yes. So what Andrew is citing suggests we've got a long way to go. We expect the denominator could grow as diagnosis increases. This is the beginning of penetration of MYQORZO into more of those patients. Assume we're closer to 20% of the total eligible today, and that denominator may grow.

Our next question comes from the line of Leonid Timashev with RBC.

I wanted to ask on COMET, given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim? And ultimately, what would be clinically meaningful in COMET?

Fady, please?

The pace of enrollment in COMET has been pleasing over the last few months. We're not providing specific guidance on when we think it will complete enrollment, but it will be into the beginning of 2027 for sure. The interim analysis has a high bar to stop the trial on the basis of efficacy, so my expectation for stopping at the interim is low because a very small amount of alpha is spent there. Clinically, the trial was designed to detect a minimally clinically beneficial effect and not be overpowered to show de minimis effects. The trial was powered with that in mind and I think it should be statistically significant around hazard ratios in the 0.86 to 0.88 range. Of course, in GALACTIC we saw more sizable treatment effects and we hope to see that in COMET as well.

Our next question comes from the line of Amine Chaherli with B. Riley Securities.

Congratulations on the quarter. On the greater than 40% exit on NBRx share, can you talk about what gets you to 50 plus by the end of the year? Is that mostly the 300 high-volume doctors going deeper? Or do you need the rest of that velocity group coming on? And then relatedly, when you put the full ACACIA data up at ESC what do you think that does to oHCM prescribing near term?

Andrew, do you want to take that?

In terms of what gets us there, it's not any single segment. It's continuing utilization across all segments. The definition of a velocity account for us was 80% of the market. That is shifting in terms of who the velocity prescribers are as compared to when we launched. Our expectation is that on a physician-by-physician basis, especially academic centers and centers of excellence where we certainly want to continue to grow share, but also getting on board the CMI-naive segment as well as those who haven't written much CMI in the past. Regarding ACACIA data at ESC, we won't be promoting an unapproved indication, but the fact that data will be in the public domain may have some overhang effect in terms of increasing prescribing. A third Phase III trial, combined with continued safety evidence, is reassuring to physicians. Collectively, this will have an effect on oHCM and we anticipate continuing to grow share over time. Our aspiration is greater than 50% share by the end of the year and we're on our way.

Our next question comes from the line of Maxwell Skor with Morgan Stanley.

If we draw on the Camzyos experience, how should we think about persistence as the treated base builds? And could it look different from MYQORZO given the differentiated dosing and titration regimen? Also, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027?

From a persistence point of view, our expectation is that we will be the same, if not slightly better compared to Camzyos, given the profile of the drugs and some of the programs we've put in place. Regarding seasonality and cadence, we typically see a lag during holiday weeks and flattening during summertime as physicians and patients take vacations. We usually see an uptick again in the fourth quarter. So seasonality is minor but generally flattening in July and August and some increases later in the year.

Our next question comes from the line of Yasmeen Rahimi with Piper Sandler Company.

This is Dominic on for Yas. Congrats on a good quarter. Just had a quick question on European launch. How are you envisioning that panning out especially as you continue to progress with U.S. launch and launches in other European countries? Do you think that will be a driver for subsequent launches?

We're committed to ensuring MYQORZO is available to patients throughout Europe. With focus on certain countries and partnering discussions for others, we believe we can make that happen. At the same time, we are realistic about what moves the needle for revenue, which will be primarily the U.S. business. We're off to a great start in Germany with initial traction in stocking toward the last few weeks of the quarter. We must enable demand and pull through. Andrew, any expectations in Europe relative to U.S. and Sung, if you'd like to add?

From Germany, it's early; we launched in June. Data lags, but initial data beyond stocking is at or above our expectations. Other major markets are starting to get reimbursements. We've talked about England and Wales and the Netherlands. Major markets are launching likely at the end of this year and several in the first half of next year. Europe takes more time to build up from a revenue point of view; pricing is generally in the 10% to 20% range versus the U.S. My expectation is Europe will be a contribution, but not the primary driver of growth; over time it may be around 15% of overall revenue.

Andrew characterized the pace in Europe well. The launches are staggered as we go through the HTA process in each country and the next likely country we will launch in Q4 is the U.K., with subsequent launches into 2027 all the way to the end of 2027.

We don't underestimate the challenges of going to market in the United States and multiple countries in Europe at the same time. But we are executing well across geographies and setting the table for the things that matter to shareholders, including top line growth.

Our next question comes from the line of Srikripa Devarakonda with Truist.

Congratulations on the quarter. Given the launch curve you're seeing now and PDUFA date for MAPLE in November, how are you expecting a potential approval to change this curve? Do you expect it to have an immediate effect? Or do you think it could take time for doctors to be more educated about MAPLE? And then a quick follow-up on the doctors that are REMS-certified, it looks like about 1,400 of them are REMS-certified. Can you remind me what percentage of them have prescribed the drug and if you're seeing any bottlenecks going from certification to prescription?

Andrew, do you want to tackle those?

From a REMS certification point of view, the ratio is about 30% of those certified who have prescribed. We continue to get REMS enrollment week after week. Certification shows intention to prescribe and sometimes certification occurs and prescribing occurs within the institution by another physician. Regarding MAPLE, when MAPLE is added to the label, that provides greater ability from a promotion point of view. Two things MAPLE does: it paints a picture for physicians, especially low to nonprescribers, of appropriate patients for a CMI; it broadens the spectrum of appropriate patients. The other thing is it increases preference share and market growth. Guidelines updates, should they occur, would be a further accelerator but would take more time. I would expect some level of impact, but it's more likely to take some time rather than immediate.

Our next question comes from the line of Eric Joseph with Citi.

Following up on REMS-certified HCPs, can you talk about how that metric contrasts with the number of REMS-certified writers for Camzyos? And what does that metric look like fully baked?

I can't comment on the Camzyos REMS certification number. BMS reported early in their launch and stopped reporting at some point. We sized our field force for around 11,000 prescribers, covering about 80% of the treaters of HCM. With oHCM and potentially nHCM, our expectation is the prescribing base will increase from around 3,000 today to probably in the 7,000 to 10,000 range. Over time, I would expect we'd have greater than 5,000 REMS certifications. We're happy with the pace; it's outpacing the number of prescribers, which is where we want to be.

We're seeing those numbers track in terms of REMS-certified HCPs and how that's converting to new prescriptions and prescribers, especially outside of velocity accounts.

Our next question comes from the line of Yanan Zhu with Wells Fargo.

Great, congrats on the quarter. Maybe a question on your FDA interaction for the filing of the nHCM indication. Has there been any particular questions or focuses from the agency? And then a quick question on the pattern of the final doses patients land on in a commercial setting? How does that compare with your clinical trial experience?

I'll ask Fady to comment but it's not our practice to share a play-by-play of ongoing FDA interactions. Andrew and Steve can talk about dosing patterns commercially relative to clinical.

We presented themes commonly reviewed for product approval including clinical meaningfulness of the endpoints, safety observed, and how those apply to the patient population. Those were themes in our discussions and I think we're well placed to address any detailed questions in those areas.

We were pleased there were no surprises. Andrew, can you talk about the dose levels you're seeing commercially and then Steve can comment relative to clinical?

We are seeing a broad range of dosing up to the 20-milligram dose. It's too early to tell exactly where the mix will wind up given the number of new patients. Physicians are taking advantage of the dosing window; some uptitrate quickly and others take longer. We'll monitor dosing and report in the future. Typically, dosing in the real world can wind up slightly lower as a percentage compared to clinical trials, but we'll report as we have more data.

The clinical trials showed the preponderance of patients ended up on the 15-milligram and 20-milligram doses in MAPLE, SEQUOIA and the FOREST data.

That underscores one of the important things about MYQORZO: physicians can uptitrate which provides convenience and flexibility to achieve the balance between efficacy and safety without having to compromise.

Our next question comes from the line of Serge Belanger with Needham.

Maybe the first one for Andrew. In your slides, you mentioned stocking. Is there any indication at this point on whether these high-volume prescribers will continue using both products? Or eventually, they'll adopt just one? And then secondly for Robert, was there any discussion with FDA about a potential priority review for the upcoming nHCM sNDA?

I don't anticipate the majority of prescribers will go 100% one way or the other. There are advocates for one product or the other. The vast majority will use both products over time. Our expectation is that use of MYQORZO will be greater than that of competitors for most prescribers, hence our aspiration for greater than 50% share, but I don't anticipate we would have anywhere near 100% share for most prescribers.

On the question about priority review, we won't comment specifically on interactions with FDA, but I will say it's not unreasonable to assume that a priority review might be possible. It's not a base case assumption, but it would be a positive outcome if that happens and we'll see how it proceeds.

Our next question comes from the line of Jason Zemansky with Bank of America.

Congrats on the quarter. You indicated about 5% to 7% of MYQORZO dispenses are from switching therapies. What are the primary factors driving those switches? And among those transitioning from mavacamten what sort of feedback are you getting regarding maintenance of symptoms and gradient control?

It's not systematic, but we hear anecdotes. Steve, do you want to comment on motivations for switching?

In MAPLE-HCM, prior exposure to mavacamten was allowed and those participants had an expected therapeutic response to aficamten. There are pharmacologic benefits that may suit certain patients more; these relate to speed of onset and offset. Patients who may need to start and stop the drug with rapid onset and offset may be selected for aficamten. Individuals considering starting a family—mavacamten has specific labeling considerations—may prefer aficamten based on the current preclinical data and labeling differences. Drug-drug interactions are another consideration; patients on certain antidepressants or reflux medications may prefer to avoid switching those medications to start a CMI, making aficamten preferable clinically in some cases.

It's not our strategy to drive switches. We are observing physicians asking about how to switch and some investigators have chosen to do a study to inform that practice. As Andrew has spoken to prescribing and new prescriptions and share of new scripts, switching is a modest percentage and may have been a transient early-launch effect. Our focus is on patients naive to CMIs and where they may benefit from MYQORZO. That's where we're seeing velocity and growth.

We have reached the end of our Q&A session. I will now turn the call back to Robert Blum, CEO, for closing remarks.

Thank you, operator. I want to thank the participants on the call today. I want to thank you for your continued support and interest in how we're doing here at Cytokinetics. I do believe that our Q2 report here is a very positive one, reflecting on the things that we've indicated matter: executing commercial momentum and velocity in the United States while building the foundation in Europe, enabling better information to inform patient and market access and preparing for what we hope will be an expanded label to include nHCM based on the ACACIA data. I'll remind you that we're going to have several presentations, including a hotline presentation at ESC later this month. Coming out of that, we'll also have an investor event that we look forward to communicating to you from Munich. At the same time, we are advancing our pipeline, which is a key tenet of how we see our business growing over time for the benefit of patients, science and shareholders. With that, operator, we're going to bring this call to a conclusion, and we thank you very much for all of your time and attention today.

Thank you. This concludes today's call. Thank you for attending. You may now disconnect.