Cytokinetics Q2 2026 Earnings Report

Cytokinetics EPS Results

• Actual EPS: -$1.50
• Consensus EPS: -$1.63
• Beat/Miss: Beat by +$0.13
• One Year Ago EPS: -$1.12

Cytokinetics Revenue Results

• Actual Revenue: $28.62 million
• Expected Revenue: $17.59 million
• Beat/Miss: Beat by +$11.04 million
• YoY Revenue Growth: -57.10%

Cytokinetics Announcement Details

• Quarter: Q2 2026
• Date: 8/6/2026
• Time: After Market Closes
• Conference Call Date: Thursday, August 6, 2026
• Conference Call Time: 4:30PM ET

Cytokinetics (NASDAQ:CYTK), Inc. is a late‐stage biopharmaceutical company focused on the discovery and development of novel small‐molecule therapeutics that modulate muscle function. Founded in 1998 and headquartered in South San Francisco, California, the company applies its proprietary insights in muscle biology to address diseases characterized by impaired muscle performance. Its research spans both cardiac and skeletal muscle targets, aiming to deliver innovative medicines for conditions with significant unmet medical need.

The company’s most advanced program, omecamtiv mecarbil, is being evaluated for the treatment of heart failure by enhancing cardiac muscle contractility. In parallel, Cytokinetics has advanced reldesemtiv, a skeletal muscle activator, into clinical development for neuromuscular disorders such as amyotrophic lateral sclerosis and spinal muscular atrophy. A third key program, apitegromab, seeks to preserve and restore muscle function in patients with muscle‐wasting diseases by inhibiting myostatin activation. Beyond these lead assets, Cytokinetics maintains a pipeline of early‐stage candidates targeting both cardiac and skeletal muscle biology.

While based in the United States, Cytokinetics conducts clinical trials across North America, Europe and Asia, and has forged strategic collaborations with major biopharmaceutical firms to support global development and commercialization. Led by a management team with extensive experience in drug discovery, clinical development and regulatory affairs, the company continues to expand its scientific platform and pursue strategic partnerships. Through its targeted approach to muscle biology, Cytokinetics seeks to bring new therapeutic options to patients suffering from debilitating cardiac and neuromuscular diseases.

Cytokinetics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: MYQORZO launch momentum exceeded expectations, with $25.3 million in Q2 net product revenue, 1,500 patients dispensed, more than 700 U.S. prescribers, and greater than 40% exit share of new-to-brand prescriptions. Medicare coverage reached nearly 90% parity, while commercial coverage exceeded 50%.
• Positive Sentiment: Aficamten’s ACACIA-HCM Phase III trial met both primary endpoints in non-obstructive HCM, improving KCCQ scores and peak VO2 without new safety signals. The company plans to submit a supplemental NDA for the nHCM indication in Q4 2026, potentially expanding MYQORZO to a substantially larger patient population.
• Positive Sentiment: International expansion progressed with the German launch, U.K. marketing authorization and NICE reimbursement guidance, and reimbursement approval in the Netherlands. The company expects a U.K. launch later this year, followed by additional European launches through 2027.
• Neutral Sentiment: Cytokinetics ended Q2 with approximately $1.7 billion in cash and investments after raising $760 million, providing funding for commercialization and pipeline development. However, the net loss widened to $198.8 million, and full-year combined R&D and SG&A expense guidance was increased to $860 million–$890 million.
• Positive Sentiment: The broader specialty-cardiology pipeline continued advancing, with COMET-HF enrolling more than one-third of patients, AMBER-HFpEF expected to complete its first cohort in the second half of 2026, and the adolescent cohort of CEDAR-HCM enrolling ahead of schedule.

Presentation

[Operator]

Thank you for standing by, and welcome to the Cytokinetics Q2 2026 earnings conference call. This call is being recorded, and all participants are in a listen-only mode. After the speaker's remarks, we will open the call to questions. We will allow for one question per participant. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead.

[Diane Weiser, SVP of Corporate Affairs at Cytokinetics]

Good afternoon. Thanks for joining us on the call today. The slides accompanying today's webcast can be found on the investors and 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, Executive Vice President and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the U.S. and Europe. Fady Malik, Executive Vice President of R&D, will provide updates related to aficamten. Steve Heitner, Senior Vice President and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung Lee, Executive Vice President and Chief Financial Officer, will provide a financial overview for the quarter. Finally, Robert will make closing remarks and review key milestones for the year ahead.

[Diane Weiser, SVP of Corporate Affairs at Cytokinetics]

As you can see on the slide, today's discussion will include forward-looking statements which are subject to risks and uncertainties.

[Diane Weiser, SVP of Corporate Affairs at Cytokinetics]

Please refer to our SEC filings for a discussion of these factors. Now I will turn the call over to Robert.

[Robert Blum, President and CEO at Cytokinetics]

Thank you, Diane. 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 five 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.

[Robert Blum, President and CEO at Cytokinetics]

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 6-12 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. 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.

[Robert Blum, President and CEO at Cytokinetics]

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 non-obstructive HCM showed that the phase III trial met both of its dual primary endpoints, 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. 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. We posed questions to which the FDA responded.

[Robert Blum, President and CEO at Cytokinetics]

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. As could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM.

[Robert Blum, President and CEO at Cytokinetics]

Moreover, in the second quarter, as you'll hear, we continued 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. We fortified our balance sheet with a successful financing that supports our plans and objectives. Taken altogether, the progress we made this 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. With that, I'll turn the call over to Andrew.

[Andrew Callos, EVP and CCO at Cytokinetics]

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 healthcare 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.

[Andrew Callos, EVP and CCO at Cytokinetics]

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 are 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.

[Andrew Callos, EVP and CCO at Cytokinetics]

Treating physicians that we surveyed also view MYQORZO favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability, and then 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 whole universe spans in more than 10,000 healthcare 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.

[Andrew Callos, EVP and CCO at Cytokinetics]

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.

[Andrew Callos, EVP and CCO at Cytokinetics]

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 three 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 the total number of unique patients prescribed MYQORZO. Across all three metrics, we are encouraged by the progress and rate of growth achieved during the quarter.

[Andrew Callos, EVP and CCO at Cytokinetics]

By the end of the quarter, more than 700 unique healthcare providers in the U.S. had prescribed MYQORZO, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately three of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately five 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 healthcare providers who have now completed REMS certification since launch. Turning to patient demand.

[Andrew Callos, EVP and CCO at Cytokinetics]

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, approximately nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continued to be dispensed within approximately three 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 program. These two 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.

[Andrew Callos, EVP and CCO at Cytokinetics]

We also continue to broaden our commercial lives 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, with reimbursement approval received effective August 1st in the Netherlands. In England and Wales, NICE published guidance recommending MYQORZO for use as we continue to make progress broadening the pathway to further patient access in key markets with additional markets anticipated to launch later this year during the first half of 2027. We are very encouraged by the performance we have seen in our launch markets.

[Andrew Callos, EVP and CCO at Cytokinetics]

The launch velocity we are seeing reflects a 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. With that, I'll turn the call over to Fady.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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 endpoints, 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.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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 analyses 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 KOLs.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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 and 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, or CASs, 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.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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. Before I do, I'd like to formally announce that Steve has been promoted to Chief Medical Officer.

[Fady Malik, EVP of Research and Development at Cytokinetics]

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. Certified as experienced in treating patients with HCM and deep expertise in this disease, Steve's 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. Steve'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.

[Fady Malik, EVP of Research and Development at Cytokinetics]

This transition represents a passing of the 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. With that, I'll hand it over to Steve.

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

Thank you, Fady. First, 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, we 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.

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

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, Heart Failure with severely reduced ejection fraction, in whom the treatment effect appeared most concentrated and whom informed the design of this trial. We expect to continue enrollment through 2026. For ulacamten, we continue to enroll cohort one of AMBER-HFpEF, our phase II study in patients with heart failure, 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, preserved ejection fraction.

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

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.

[Sung Lee, EVP and CFO at Cytokinetics]

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.

[Sung Lee, EVP and CFO at Cytokinetics]

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.

[Sung Lee, EVP and CFO at Cytokinetics]

The increase was primarily due to commercial launch costs for MYQORZO, the U.S. sales force, and higher non-sales 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 non-routine 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 reimbursements. 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.

[Sung Lee, EVP and CFO at Cytokinetics]

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-$890 million from the previous range of $830 million-$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-$140 million, up from the previous range of $120 million-$130 million. Excluding stock-based compensation from the updated GAAP combined R&D and SG&A expense results in a range of $720 million-$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 my MYQORZO in nHCM.

[Sung Lee, EVP and CFO at Cytokinetics]

With that, I'll hand it back to Robert.

[Robert Blum, President and CEO at Cytokinetics]

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 six 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.

[Robert Blum, President and CEO at Cytokinetics]

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.

[Robert Blum, President and CEO at Cytokinetics]

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, continue conduct of the adolescent cohort of CEDAR-HCM throughout the year, and potentially receive approval from Health Canada in the second half of 2026.

[Robert Blum, President and CEO at Cytokinetics]

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 one of AMBER-HFpEF in the second half of this year. For CK-089, we expect to continue the second phase I study. Finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs. Operator, with that, we can now open up the call to questions, please.

[Operator]

Thank you. We will now begin the question and answer session. We will allow for one question per participant. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Your first question comes from the line of Salim Syed with Mizuho. Salim, your line is open.

[Salim Syed, Analyst at Mizuho]

Great. Good afternoon, guys. Thanks for the question and congrats on the great number. Robert and Andrew, maybe just one from us on the dispensed versus prescribed. We're certainly getting a lot of emails just on the clarification here. Could you, just so we have the apples to apples on the Rx. 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? Is the ratio of 59% consistent between the two quarters, if you don't want to get too granular? Thanks so much.

[Robert Blum, President and CEO at Cytokinetics]

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

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. Yeah. Thanks for the question, Salim. Happy to clarify. You're right, 680 to 400 in Q1, to around 2,000 to 1,500 in Q2. Launch to date overall. That difference of pending patients. We described patients in the process. Once a prescription is sent in, that's really the underlying demand. 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. There is a process. A REMS enrollment has to occur, a prescription has to occur, signatures for both on physician and patient side, benefit investigation, oftentimes prior auth. There's a process that takes several weeks. We're getting about 100+ prescriptions per week. The majority of the difference is that pending patient in process of getting a prescription filled and dispensed.

[Andrew Callos, EVP and CCO at Cytokinetics]

There is a small mid-single digit of prescriptions that do get canceled. The vast majority are in process and will wind up as a dispense, hopefully that answers your question.

[Salim Syed, Analyst at Mizuho]

Okay. About 2,000.

[Andrew Callos, EVP and CCO at Cytokinetics]

Yep. You got it.

[Salim Syed, Analyst at Mizuho]

Okay. Got it. Thanks so much for the clarification.

[Robert Blum, President and CEO at Cytokinetics]

Thank you, Salim.

[Operator]

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

[Roanna Ruiz, Analyst at Leerink Partners]

Hi. Afternoon, everyone. I was curious, regarding the different metrics that you're tracking for MYQORZO's U.S. launch, just like big picture, are there any that seem to be accelerating more than others into the quarter? 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?

[Robert Blum, President and CEO at Cytokinetics]

Sure. Maybe I'll turn that also to Andrew, please.

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. Thanks for the question. We are seeing a couple changes. One, the higher percentage of paid-for prescriptions, which is encouraging. Around the same in terms of how long it's taking to get that prescription paid. We're seeing acceleration in that low volume to first-time-ever 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%-7% of our overall dispenses are from switching. The switching has increased slightly, not dramatically and not a major driver. Thanks for the question.

[Operator]

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

[Robert Blum, President and CEO at Cytokinetics]

Hey, Carter.

[Carter Gould, Analyst at Cantor Fitzgerald]

Great. Good afternoon. Hey, Robert. Good afternoon. Thanks for taking the question. Doing a bunch of math on the fly here, it would seem to suggest that the overall class sort of adds per month or per week are only sort of up modestly, what you're seeing so far is primarily share capture versus growing the pie. Is that sort of a fair characterization? Separately, I guess a clarification question, was there any impact from stocking in that $23 million figure? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

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

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. 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. You're seeing a growth in terms of new patients entering the market. There really hasn't been a change in kind of compliance and persistency overall. You're seeing an increase in patients dispensed. I'll other question over to Sung around stocking relative to revenue.

[Sung Lee, EVP and CFO at Cytokinetics]

Yeah. Thanks, Carter. As demand increases, our distributors would carry higher inventory, that inventory is commensurate with the demand. This quarter was demand-led.

[Carter Gould, Analyst at Cantor Fitzgerald]

Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Thank you, Carter.

[Operator]

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

[Ash Verma, Analyst at UBS]

Hey, guys. Thanks for taking my question. Yeah, I have kind of like a similar question, just a prescription with a dispense. I know when you provided the first quarter update, you mentioned about the April prescription. If I take that 420 number and apply the 60%, I get to 250 dispensed during April. Versus when you did it for the full quarter, it's like 1,500. One month had 250, 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? Anything that you can share about how July has shaped out to be? Thanks.

[Robert Blum, President and CEO at Cytokinetics]

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

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. You can see from the ratios we do see an increase in dispense. I would expect dispenses to level out once managed care and access levels out. Oftentimes that timeframe of a pending patient, and the REMS certainly adds to it because of certifications needed. A pending patient often stays in pending longer because of a benefits investigation and a prior auth process. We would look to shrink that timeframe down over time, but I would not anticipate that in the near term. Thanks for the questions.

[Operator]

Our next question comes from the line of Tess Romero with JPMorgan. Tess, your line is open.

[Tess Romero, Analyst at JPMorgan]

Hi, Robert and team. Hope you are all well, and thanks so much for taking our question. 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? 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? Thank you so much.

[Robert Blum, President and CEO at Cytokinetics]

Let's take the first part of your question regarding ESC, what might be elaborated from with regard to 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.

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

Hi, Tess. We have both the top-line data, which kind of goes through the endpoints delineated in the SAP. Those are going to be put into both a clinical and mechanistic context. The clinical context will be deliberated by Dr. Masri in his hotline presentation on Friday. 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 what the mechanism by which these clinical benefits are being enjoyed by patients. I think that that's going to be very elucidating to scientists and patients, hopefully, moving forward.

[Robert Blum, President and CEO at Cytokinetics]

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, let's 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. Maybe, Andrew, if there's anything more you want to elaborate.

[Andrew Callos, EVP and CCO at Cytokinetics]

Yeah, I mean, that's 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. We're not going to report July. We'll report the third quarter during that call.

[Robert Blum, President and CEO at Cytokinetics]

Tess, 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. 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. Certainly, it's moving very swiftly in that direction.

[Tess Romero, Analyst at JPMorgan]

Thank you. See you soon.

[Robert Blum, President and CEO at Cytokinetics]

Thank you.

[Andrew Callos, EVP and CCO at Cytokinetics]

Thank you.

[Operator]

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

[Analyst at Jefferies]

This is Manoj. Hey. Sorry. This is Manoj on for Akash. Just one from our end. Are you hearing any feedback from the prescribers who switched from the CAMZYOS, especially like the efficacy with the lower doses? Approximately what percentage of your new patient adds are outside the treatment of the center of excellence? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

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

[Analyst at Jefferies]

Yeah. The patients who's from mavacamten and your efficacy with the lower doses of aficamten.

[Robert Blum, President and CEO at Cytokinetics]

Yeah. It's not for us really to comment on CAMZYOS and lower doses. Andrew, is there anything you want to say about aficamten, MYQORZO, and how doses are being titrated? Then perhaps tackle the second question, which relates to prescribing outside of Velocity accounts.

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. 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 two weeks, and other patients are being increased dose as long as two months. That's really between the logistics of a center, a patient's, and a physician's scheduling. 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. That low volume category is about 30%. The CMI naive, meaning they had not written a CMI until we've entered the market, is 30% of our prescribers.

[Andrew Callos, EVP and CCO at Cytokinetics]

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 on that slide around differentiation. It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of DDI monitoring as part of it, the overall REMS program, and they're the reasons we hear from those, generally from that CMI naive in terms of why initiation of a CMI at this point. Hopefully, that answers your question.

[Analyst at Jefferies]

Yeah. Thank you.

[Robert Blum, President and CEO at Cytokinetics]

If you think about what may be auguring well with regard to exceeding of 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 scripted 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 are otherwise new or low volume prescribers. That suggests to me that we're seeing category expansion as you should expect of us.

[Analyst at Jefferies]

Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Next question, please.

[Operator]

Our next question comes from the line of Paul Choi with Goldman Sachs. Paul, your line is open.

[Paul Choi, Analyst at Goldman Sachs]

Hi, good afternoon, and thanks for taking my questions. 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 to put in front of doctors. As you think about your messaging, can you maybe clarify for us how you'll sort of think about all these opportunities and present them to doctors as your salesforce is in the field over the next year? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

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

[Fady Malik, EVP of Research and Development at Cytokinetics]

It really starts with dissemination of the data through the published literature. Steve and his team have been extremely 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, help them walk them through it in concise but complete manners. Finally, through executing a number of educational programs, either through CME or industry-sponsored symposia. A pretty complete program from the primary publications through to delivering the information through a variety of channels. Ultimately, our commercial colleagues will build on what gets into label and be able to then also disseminate the information broadly to their customer base.

[Paul Choi, Analyst at Goldman Sachs]

Thanks.

[Fady Malik, EVP of Research and Development at Cytokinetics]

Thanks for the question.

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. I can add.

[Fady Malik, EVP of Research and Development at Cytokinetics]

Andrew, do you want to add?

[Andrew Callos, EVP and CCO at Cytokinetics]

Yeah. Sorry. Thanks, Fady. I can 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-HCM, 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. 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, or they certainly feel like they have the appropriate patient when you consider them relative to a beta blocker. Guidelines have certainly fueled that. More of that were to change in 2027.

[Andrew Callos, EVP and CCO at Cytokinetics]

nHCM really just broadens the spectrum of the number of patients a physician in a cardiology office can have with a single agent, in MYQORZO, if it's approved for nHCM, to treat a broader range of patients. We have our messaging cascaded. We have our visual aids cascaded, et cetera, I think we'll be ready to take well advantage of that further differentiation, should those approvals come in from a regulatory point of view.

[Robert Blum, President and CEO at Cytokinetics]

Paul, to your question, we aim to keep it simple, 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 manuscripts. There's a plethora of information that's informing physicians about how best to think about aficamten, 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, the commercial folks can keep it simple when they are out there detailing physicians.

[Operator]

Our next question comes from the line of James Condulis with Stifel. James, your line is open.

[James Condulis, Analyst at Stifel]

Hey, thanks for taking my question and congrats on all the progress. Maybe on the non-obstructive side, curious, as you started sort of these sNDA discussions, do you expect any sort of differences on the label or the REMS with the potential approval of non-obstructive? Appreciate any color you can share. Thanks.

[Robert Blum, President and CEO at Cytokinetics]

Yeah. 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. I do expect that for what could be this being a separate trial, there will be some distinctions that'll have to reflect nHCM versus oHCM. Maybe we shouldn't front run any of that until we have actually interacted with FDA following a submission.

[James Condulis, Analyst at Stifel]

Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Sure.

[Operator]

Our next question comes from the line of Jason Butler with Citizens. Jason, your line is open.

[Jason Butler, Analyst at Citizens]

Hi, and thanks for taking the question and congrats on the quarter. Robert, can you just walk us through your expectations for the cohort one of ulacamten? How are you thinking about what you can learn from that cohort specifically about the safety profile as well as PK/PD? Thanks.

[Robert Blum, President and CEO at Cytokinetics]

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

[Fady Malik, EVP of Research and Development at Cytokinetics]

Yeah. I think as we've said before, AMBER-HFpEF is a mostly a dose-finding trial and to understand how the unique mechanism of ulacamten might play out in the HFpEF population. We'll have initial PK. We'll be looking broadly across echocardiographic parameters. Of course, we'll have safety. We'll also understand the feasibility of enrolling a population focused to where we think the impact might be felt with a mechanism like ulacamten. I think over the course of this study, that'll help inform the continued development of ulacamten in this indication.

[Robert Blum, President and CEO at Cytokinetics]

Thanks, Jason.

[Operator]

Our next question comes from the line of Cory Kasimov with Evercore. Cory, your line is open.

[Analyst at Evercore]

Hey, this is Josh on for Cory. Thanks for taking our question. What percent of the oHCM market is penetrated by CMIs today, and what do you anticipate a peak penetration could be for the class? Thanks.

[Robert Blum, President and CEO at Cytokinetics]

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

[Andrew Callos, EVP and CCO at Cytokinetics]

Our guess is around 110,000-120,000. It's more than a guess. Based on the analytics we've done from an epi point of view around that number is the eligible patient population. That's if diagnosis doesn't increase. There's probably in the 20,000-25,000 range of treated patients. You get a penetration in around 20% range. Peak penetration I think will depend over time on access, demonstrated safety, if REMS programs change, et cetera. I would anticipate peak penetration in the 60%-70% range.

[Robert Blum, President and CEO at Cytokinetics]

Yeah. What Andrew's citing would suggest that we've got a long way to go still to see CMIs penetrate a majority of the patients who are diagnosed and eligible, and there could be still others that could be diagnosed now that there's new medicines available to those patients. This is the beginning of what hopefully will be penetration of MYQORZO into more and more of those patients. Assume we're closer to 20% of the total eligible today, and that number, hopefully denominator grows. Next question, please.

[Operator]

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

[Leonid Timashev, Analyst at RBC]

Yeah, thanks for taking my question. I wanted to ask on COMET-HF, just given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim, and then ultimately, what would be clinically meaningful on COMET-HF? Thanks.

[Robert Blum, President and CEO at Cytokinetics]

Thank you. Fady, please.

[Fady Malik, EVP of Research and Development at Cytokinetics]

Yeah, I mean, the pace of enrollment in COMET-HF has been pretty pleasing to us over the last few months. We're, I would say, not providing specific guidance on when we think it'll complete enrollment, but it'll be into the beginning of 2027 for sure. The interim analysis has a pretty high bar to stop the trial on the basis of efficacy. My expectations for stopping at the interim analysis are pretty low because there's a very minute bit of alpha that's spent there. Clinically, we think trial was designed, and we always try and do this, design a trial with the number of patients you think to demonstrate a minimally clinically beneficial effect and not overpower it to show de minimis effects, if you will. This trial was powered with that in mind.

[Fady Malik, EVP of Research and Development at Cytokinetics]

I think it should be statistically significant around 0.86, 0.87, 0.88, in that range in terms of a hazard ratio for the primary endpoint. Of course, I think when you looked at this treatment effect in GALACTIC-HF, we saw more sizable treatment effects in that, and we hope to see that in COMET-HF emerge as well. I hope that addresses your question, Leo.

[Leonid Timashev, Analyst at RBC]

Yes. Thank you.

[Operator]

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

[Amine Chaherli, Analyst at B. Riley Securities]

Hi, team. Congratulations on the quarter. This is Amine on from Mayank. Just had a question for Andrew on the greater than 40% exit on NBRx share. Can you talk about what gets you to 50+ by the end of the year? Is that mostly the 300 high-volume docs going deeper, or do you need the rest of that Velocity group coming on? Relatedly, when you put the full ACACIA-HCM data up at ESC, what do you think that does to oHCM prescribing near term?

[Robert Blum, President and CEO at Cytokinetics]

Andrew, do you want to take that?

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. Thanks for the question. In terms of what gets us there, it's not going to be any one segment that gets us there. It really is continuing utilization across all segments. The definition of a Velocity account for us was 80% of the market. That is actually shifting in terms of who are the Velocity prescribers as compared to who they were when we launched. Our expectation is that on a physician-by-physician basis, especially the academic centers and centers of excellence, where we certainly want to continue to grow share as we have been doing for the majority of them. Also getting on board the CMI-naive segment as well as that kind of the segment who hasn't really written much from a CMI. Many of them were referring. With nHCM, getting to your second question, obviously it's not approved.

[Andrew Callos, EVP and CCO at Cytokinetics]

We're not going to be promoting it or discussing it until it is approved. The fact that it will be published in the public domain, our expectation there probably will be some kind of overhang effect, if you will, in terms of increasing prescribing. When you have a third clinical trial, the obstructive HCM, two trials with SEQUOIA-HCM and MAPLE-HCM and a third one with ACACIA-HCM, the continuous safety evidence efficacy is very reassuring to a physician as well. I think all this collectively will have an effect on oHCM. We anticipate continuing to grow share over time, and as we've said all along, our aspiration is to have greater than 50% of share by the end of the year. We're certainly on our way to do that.

[Amine Chaherli, Analyst at B. Riley Securities]

Thank you.

[Andrew Callos, EVP and CCO at Cytokinetics]

Thanks for the question.

[Operator]

Our next question comes from the line of Maxwell Skor with Morgan Stanley. Maxwell, your line is open.

[Maxwell Skor, Analyst at Morgan Stanley]

Thank you very much for taking my question. If we draw on the CAMZYOS experience, how should we think about persistence as the treated base builds? Could it look different for MYQORZO given that it's differentiated dosing and titration regimen? If I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Andrew, do you want to take that?

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. From a persistence point of view, our expectation is that we will be the same, if not slightly better from CAMZYOS point of view, just given the profile of the drugs and some of the programs were put in place. I think it's reasonable to assume they'd be similar, if not slightly improved for MYQORZO. In terms of your second question was around, can you repeat that part again? I'm not sure if I heard.

[Maxwell Skor, Analyst at Morgan Stanley]

Yeah. Just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into 2027.

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. I think we always see a lag right before or right during a holiday week. There is flattening during the summertime. Physicians are on holiday or vacation, as are patients. We see an uptick again in the fourth quarter. The seasonality you'll see is usually around holidays, which is a minor point, but it's more flattening during that summertime, especially in the months of July and August.

[Maxwell Skor, Analyst at Morgan Stanley]

Great. Thank you.

[Andrew Callos, EVP and CCO at Cytokinetics]

Thank you.

[Operator]

Our next question comes from the line of Yasmeen Rahimi with Piper Sandler Company. Yasmeen, your line is open.

[Analyst at Piper Sandler Company]

Hi, this is Dominic on for Yas. Thank you for taking our question, and congrats on a good quarter. We 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 that will be a driver for subsequent launches? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Yeah. Maybe I'll start there and ask Andrew, and also Sung maybe to comment. We're very committed to ensuring that MYQORZO is available to patients throughout Europe. Now with our focus on certain countries and in partnering discussions as relate to others, we believe we can make that happen. But at the same time, we're realistic about what moves the needle for the revenue line, and that's going to be more primarily, obviously, the U.S. business. With that said, we're off to a great start in Germany, and we are very pleased with how we got some initial traction there in terms of stocking towards really just the last few weeks of the quarter. Now we got to ensure that we're going to be enabling of demand and pull-through. Andrew, do you want to speak to expectations in Europe and relative to U.S.?

[Robert Blum, President and CEO at Cytokinetics]

Sung, anything you want to add after that?

[Andrew Callos, EVP and CCO at Cytokinetics]

Yeah, sure. From a German point of view, it's early. We just launched in June. Data lags, but the data we've seen beyond the stocking is at, if not above our expectations from a German point of view. Other major markets we're starting to get reimbursements in. We've talked about England and Wales, we've talked about the Netherlands. We have major markets launching, probably one at the end of this year, several first half of next year. Europe takes more time to build up from a revenue point of view. Pricing is in the 10%-20% range. My expectation would be that Europe will be a contribution, but not a driver of growth, and over time, it'll probably be in the 15% range of our overall revenue. Maybe Sung wants to add to that.

[Sung Lee, EVP and CFO at Cytokinetics]

Yeah. I think 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 that we will launch in Q4 is the U.K., and we will have subsequent launches into 2027, all the way to the end of 2027.

[Robert Blum, President and CEO at Cytokinetics]

We do not underestimate the challenges of going to market in the United States and also multiple countries in Europe at the same time. I do believe we are executing very well across all these geographies and setting the table for the kinds of things that matter to shareholders, including the top-line growth. Thank you for the question.

[Analyst at Piper Sandler Company]

Great. Thank you.

[Operator]

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

[Srikripa Devarakonda, Analyst at Truist]

Hey, guys. Thank you so much for taking my question, and congratulations on the quarter. Given the launch curve that you're seeing now, PDUFA date for MAPLE-HCM 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-HCM? Just 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? If you're seeing any bottlenecks going from certification to prescription. Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Andrew, do you want to tackle those, please?

[Andrew Callos, EVP and CCO at Cytokinetics]

Sure. I'll go backwards. From a REMS certification point of view, the ratio is about a 30% ratio in terms of those who prescribed versus those who are certified from a REMS point of view. We continue to get REMS enrollments week after week. That certainly shows an attention to prescribe overall. Sometimes a certification occurs and prescribing occurs within the institution by another physician. It's a good indicator of future prescribing, and again, we're confident that growth is going to continue from broad-based prescribing. In terms of MAPLE-HCM, assuming MAPLE-HCM gets added to the label, that certainly provides greater ability from a promotion point of view.

[Andrew Callos, EVP and CCO at Cytokinetics]

Probably the two things that I discussed earlier that really MAPLE-HCM does is, one is it paints a picture, especially for low to non-prescribers of appropriate patients for a CMI, and it broadens or it widens their mind in terms of who that appropriate patient is for. The other thing it does, it certainly increases preference share and market growth. There's a kind of a multiplier factor there. If guidelines do get updated relative to MAPLE-HCM, that certainly would, as many physicians want to follow guidelines and understand guidelines, that would be a further accelerator, obviously that would take more time. To answer your question specifically, I would expect that we would get some level of impact.

[Andrew Callos, EVP and CCO at Cytokinetics]

Whether it'll be noticeable right at launch or if it's going to take a bit of time, I would expect that it's probably going to take a bit of time more likely than this big bolus of prescribing change.

[Srikripa Devarakonda, Analyst at Truist]

Thank you so much.

[Andrew Callos, EVP and CCO at Cytokinetics]

Yep. Thanks for the question.

[Operator]

Our next question comes from the line of Eric Joseph with Citi. Eric, your line is open.

[Eric Joseph, Analyst at Citi]

Thanks for fitting me in. I just wanted to actually follow up on this point about REMS-certified HCPs. Given the growth that you saw this past quarter, can you just talk about how that metric contrasts with the number of REMS-certified potential prescribers for CAMZYOS, and what does that metric look like fully baked? Thanks.

[Andrew Callos, EVP and CCO at Cytokinetics]

Are you asking how our REMS certification number compares to the CAMZYOS certification number? Is that your question?

[Eric Joseph, Analyst at Citi]

Yes. That and sort of what you anticipate the total number of potential REMS-certified providers would be in the U.S.

[Andrew Callos, EVP and CCO at Cytokinetics]

Got it. I can't comment on the CAMZYOS REMS certification number. I don't know that number. I don't even know if that number is reported. I know BMS reported it early in their launch, it stopped reporting it at some point in time. In terms of our expectation, we sized our field force for around 11,000 prescribers. Those 11,000 prescribers are around 80% of the treaters of HCM. Meaning that the majority of them are obviously using beta blockers, calcium channel blockers. We were going to where we thought the market would go with CMI penetration over time. With oHCM, if nHCM could get approved, our expectation is that prescribing base from around 3,000 in total today will increase to probably in the 7,000-10,000 range. Over time, I would expect we'd have greater than 5,000 REMS certifications.

[Andrew Callos, EVP and CCO at Cytokinetics]

We're very happy with the pace. The pace is outpacing the number of prescribers, which is exactly where we want to be.

[Robert Blum, President and CEO at Cytokinetics]

Yes. To talk about exceeding expectations, we're seeing those numbers track in terms of REM-certified HCPs and how that's converting so promptly to new prescriptions, prescribers, especially outside of Velocity accounts.

[Eric Joseph, Analyst at Citi]

Great. Thanks for taking the questions.

[Operator]

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

[Yanan Zhu, Analyst at Wells Fargo]

Thanks for taking our questions, and congrats on the quarter. Maybe a question on your FDA interaction for the filing of the nHCM indication. I was curious, has there been any particular questions or focuses from the agency? A quick question on the pattern of the final doses patients land on in a commercial setting, and whether that is similar or different compared with your clinical trial experience. Thank you.

[Robert Blum, President and CEO at Cytokinetics]

I'll ask Fady to comment, but caution you that it's not our practice to be speaking on a play-by-play basis with regard to ongoing FDA interactions. Maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical.

[Fady Malik, EVP of Research and Development at Cytokinetics]

Sure. I think as we presented the data, the natural questions that anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoints and the results, the safety that was observed, how we might deploy those things and understand the interplay of those with the patient population. I think those are some of the themes of our discussion without getting too granular, and I think we're well-placed to be able to address any questions in those areas.

[Robert Blum, President and CEO at Cytokinetics]

What I can say is we were pleased that there were no surprises. Andrew, do you want to talk about the dose levels that people are achieving already commercially, and then Steve can comment about that in the context of clinical research?

[Andrew Callos, EVP and CCO at Cytokinetics]

Yes, sure. I mean, we are seeing a broad range of dosing all the way up to the 20 milligram. I think it's too early to tell exactly where the mix is going to wind up, given the number of new patients we continue to have, the dosing window that the physicians and patients are taking advantage of, that two to eight-week window. I think that certainly is something we're monitoring and trying to understand exactly where is dosing going to compare to clinical trials. Typically, what I've seen is dosing usually winds up slightly lower in terms of a percentage in clinical trials, but we'll certainly report on that number in the future. Steve, anything you want to add?

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

Well, I mean, nothing more than to state the obvious that the clinical trials did show the preponderance of patients ended up on the 15 milligram and 20 milligram doses, both in MAPLE-HCM, SEQUOIA-HCM, and the data that we published out of the FOREST-HCM experience.

[Robert Blum, President and CEO at Cytokinetics]

That gives an opportunity to underscore one of the things that we think is important regarding MYQORZO is that one can uptitrate, and that's enabling of convenience and flexibility for physicians and patients to feel like they can be moving to that dose, which is most likely to be the best balance between efficacy and safety without having to compromise.

[Yanan Zhu, Analyst at Wells Fargo]

Super helpful. Thank you. Congrats again.

[Robert Blum, President and CEO at Cytokinetics]

Thank you.

[Operator]

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

[Serge Belanger, Analyst at Needham]

Good afternoon, maybe the first one is for Andrew. In your slides, you mentioned that about 300 of the 700 unique prescribers of MYQORZO through June were high volume CMI users. I assume these are also CAMZYOS users. 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 discussions in your FDA meeting about a potential priority review for the upcoming nHCM sNDA? Thank you.

[Robert Blum, President and CEO at Cytokinetics]

Andrew, I'm not sure if you heard all of that question. Did you get it?

[Andrew Callos, EVP and CCO at Cytokinetics]

I think I got the essence of it. The very beginning of it was very broken up. Serge, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other. There certainly are those that are advocates for one product or the other that prescribe that way. The vast majority will use both products over time. Our expectation is that use of MYQORZO is greater than that of CAMZYOS for most prescribers, hence our aspiration in terms of greater than 50% share. I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert?

[Robert Blum, President and CEO at Cytokinetics]

To your question about FDA and reasonableness of a priority review, I don't think we'll comment again on any of our specific interactions with FDA. As we've stated publicly already, independent of any interactions with FDA, it's not unreasonable. It's reasonable to assume that a priority review might be possible. It's not a base case assumption, but it certainly would be great if that happens. We'll see if we can't make that happen.

[Serge Belanger, Analyst at Needham]

Great. Thank you.

[Operator]

Our next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open.

[Jason Zemansky, Analyst at Bank of America]

Hey, good afternoon. Congrats on the quarter and appreciate you squeezing us in. Maybe as a follow-up, potentially to the last question. You indicated, I think, that about 5%-7% of MYQORZO dispenses are for those switching therapies. What are the primary factors driving those switches? Then among those transitioning from mavacamten, what sort of feedback are you getting regarding the maintenance of symptoms and gradient control? Thanks.

[Robert Blum, President and CEO at Cytokinetics]

Yeah. Obviously there's nothing so systematic about that understanding that we can speak to it with any kind of robust fidelity. There are anecdotes that we hear. Maybe Steve, if you want to comment on what might motivate a physician who would switch from CAMZYOS to MYQORZO?

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

Sure. Before I get to that, I'll just point out that in MAPLE-HCM, prior exposure to mavacamten was allowed. Those participants had an expected therapeutic response to mavacamten in that setting. To Robert's point, there are some pharmacologic benefits that we believe suits certain patients more. Those are related firstly to the speed of onset and offset. Patients who may have specific indications where they may need to start and stop the drug with a rapid onset and offset, those are patients who would naturally be selected for aficamten. Individuals who are considering starting a family. As you might be aware with the CAMZYOS label, it's a black box warning. With MYQORZO, on the other hand, it certainly hasn't been studied, but it isn't a black box warning based on our preclinical data. The drug-drug interactions is something that you're well aware of.

[Steve Heitner, SVP and Chief Medical Officer at Cytokinetics]

Patients who have had good experiences on certain kinds of antidepressants or therapies for things like gastroesophageal reflux disease may not necessarily want to switch medications in order to start a new medication for their hypertrophic cardiomyopathy. That would be another indication to preferentially use MYQORZO.

[Robert Blum, President and CEO at Cytokinetics]

Yes. Maybe just an entertaining update on what Steve said. It is fundamentally not our strategy to drive switches. We are observing that there are certain physicians who are asking questions about how to switch, and some investigators have chosen to do a study that will inform that practice, were that to be of interest. As Andrew has spoken to prescribing and new prescriptions and share of new scripts, it's a modest percentage of the total that's driven by switches, and that's potentially something for which there was more of a bolus of that activity early on the launch. As we get deeper into the launch, we expect that that may not continue to be a motivating factor for some of those physicians.

[Robert Blum, President and CEO at Cytokinetics]

All in all, what we're focused on is those patients who are naive to CMI and where they may benefit from the addition of MYQORZO to their regimen. That's where we're seeing the velocity, that's where we're seeing the growth, and that's where we see ultimately the potential and upside for MYQORZO. Thank you.

[Operator]

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

[Robert Blum, President and CEO at Cytokinetics]

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. That which speaks to how we go commercial and enabling a strong commercial launch momentum and velocity here initially in the United States and hopefully also as we're building the foundation in Europe. Having that occur at the same time, we're enabling a better information to inform patient and market access, and also preparing for what we hope will be an expanded label to include nHCM based on the ACACIA-HCM data. I'll remind you that we're going to have several presentations, including hotline presentation at ESC later this month.

[Robert Blum, President and CEO at Cytokinetics]

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, advancing our pipeline. That's a key tenet and hallmark 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.

[Operator]

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

Participants

Executives

• Diane Weiser, SVP of Corporate Affairs
• Robert Blum, President and CEO
• Andrew Callos, EVP and CCO
• Fady Malik, EVP of Research and Development
• Steve Heitner, SVP and Chief Medical Officer
• Sung Lee, EVP and CFO

Analysts

• Salim Syed, Analyst at Mizuho
• Roanna Ruiz, Analyst at Leerink Partners
• Carter Gould, Analyst at Cantor Fitzgerald
• Ash Verma, Analyst at UBS
• Tess Romero, Analyst at JPMorgan
• Analyst at Jefferies
• Paul Choi, Analyst at Goldman Sachs
• James Condulis, Analyst at Stifel
• Jason Butler, Analyst at Citizens
• Analyst at Evercore
• Leonid Timashev, Analyst at RBC
• Amine Chaherli, Analyst at B. Riley Securities
• Maxwell Skor, Analyst at Morgan Stanley
• Analyst at Piper Sandler Company
• Srikripa Devarakonda, Analyst at Truist
• Eric Joseph, Analyst at Citi
• Yanan Zhu, Analyst at Wells Fargo
• Serge Belanger, Analyst at Needham
• Jason Zemansky, Analyst at Bank of America