Cytokinetics, Incorporated

Thank you for standing by and welcome to the Psychokinetics 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.

Good afternoon and 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, EVP and Chief Commercial Officer, will discuss the commercial launch of mycorrhizal in the U.S. and Europe. Fady Malik, EVP of R&D, will provide updates related to AfriCampden. 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 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 myCORSO 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 myCORSO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for mycorso 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 mycorso and its clinical, therapeutic, and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy with the launch of mycorso in Germany, the first in a series of European launches expected over the next six 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 mycorso marketing authorization across the United Kingdom. for the treatment of symptomatic OHCM in adult patients. And at the same time, NICE issued guidance recommending mycorzo for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help mycorzo reach patients sooner. We expect drug supply and full launch in the UK later this year. During the second quarter, We highlighted the opportunity for Afikampton 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 three 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 and they define a meaningful step toward expanding the potential reach of afecamtin 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 afikampton 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 mycorrhizal available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for Afikampton in patients with NHCM, and as could lead to mycorrhizal 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 evidence 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 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 and with that i'll turn the call over to andrew thank you robert in the second quarter the launch of my corso 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 mycorrhizal is resonating well with both healthcare providers, payers, and most importantly, also with patients. Since our commercial launch at the end of January, myCorso 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 myCorso 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 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 mycorrhizal among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of mycorrhizal. Treating physicians that we surveyed also view mycorrhizal 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 call 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. In fact, by the end of the second quarter, more than 50% of my Corso 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 mycorrhizal is gaining traction across a wider segment in the OHCM treating community, something we anticipated based on the differentiated profile of mycorrhizal, 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 three trial of AptiCampden both support findings from Sequoia HCM and further demonstrate that mycorrhizal is superior to beta blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy, and utility of mycorrhizal 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 mycorrhizal, and patient volume, which reflects a total number of unique patients prescribed mycorrhizal. Across all three 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 healthcare providers in the U.S. have prescribed mycorrhizal, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribe mycorrhizal to approximately three of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed mycorrhizal to approximately five of their patients on average. Although limitations with syndicated data make it difficult to precisely calculate nudibran Q2 exit share in the CMI category, our internal analysis suggests that the exit share for mycorso 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 REM certification since launch. Turning to patient demand, In the first quarter, we reported approximately 680 mycorrhizal prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, mycorrhizal was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed mycorrhizal 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 dispense 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. We also continue to broaden our commercialized 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 my Corso 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. And in England and Wales, NICE published guidance recommending mycorrhizal 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. The launch velocity we are seeing reflects a differentiated profile of myCORSO, 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.

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 three clinical trial in patients with symptomatic N-HCM. 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 afecamptin 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, Thank you for joining us today. for both primary endpoints, secondary endpoints, and, of course, safety. We'll also be presenting additional analyses regarding the effect of afikampton on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of afikampton 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. 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 ApiKempton, 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 Apicampton and 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 meaningly inform treatment guidelines and clinical practice by providing evidence supporting the use of afikampton as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamp and 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 myCORSO. They completed more than 800 scientific exchanges with US-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 count specialists or CASAs with introductory ACP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first ever investigator-initiated research study utilizing ApiCampden. Studies investigating the feasibility, safety and efficacy a physician seamlessly transitioning patients from avicamptin to apicamptin in patients with OHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of apicamptin to address the full spectrum of HCM. With my core zone 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 Heidner. 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. Certified as experienced in treating patients with HCM and deep expertise in this disease, Steve's been an exemplary leader in helping to bring applicants into patients His insights and guidance contributed immeasurably to the approvals of myCORSO 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 Apicampson, Amber Heftap for Eulacampson, and CommonHF for Omicampson-McCarville. This transition represents the 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, 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. So first, starting with our ongoing programs for AfriCanton, 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 Camelia HCM, evaluating the treatment of obstructive HCM patients in Japan. We also advanced CDER-HCM, a study evaluating africanthin 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 africanthin, we continue to advance the remainder of our cardiovascular pipeline during the second quarter. Starting with omicamptomacabal, we continued conduct of COMET-HF, are confirmatory phase three clinical trial in patients with heart failure and severely reduced ejection fracture. 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 for those in the subgroup of heart failure patients from galactic heart failure with severely reduced ejection fraction in whom the treatment effects appeared most concentrated and in whom informed the design of this trial. We expect to continue enrollment through 2026. For eulacumptin, we continue to enroll cohort one of Amber Hempeth, our phase two 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 inhibitions in heart failure preserved ejection fraction. Overall, we are pleased with the continued progress across our later stage speciality cardiology development portfolio and look forward to important milestones over the coming quarters. With that, I'll hand over to Seth.

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 myCORSO 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 Aficampton 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 mycorrhizal, 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 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 myCORSO 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 six months of our commercial launch, we've seen encouraging demand for myCORSO, 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 myCORSO has the potential to become the CMI of choice in OHCM. Our near term priorities for Affy Campton are clear. In OHCM, firstly, executing successful global launches for myCORSO 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 Affy Campton 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 myCORSO may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both Omicampton McCarville and Hewlett-Campden, which we're pleased are progressing well in respect of 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 myCORSO 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 Appy Campton, we expect to submit a supplemental NDA in N-HCM 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 Appy Campton in the UK later in Q4 continue conduct of the adolescent cohort of CDER HCM throughout the year and potentially receive approval from Health Canada in the second half of 2026. For Omicampton McCarble, we expect to continue patient enrollment and the conduct of Comet HCF through this year. For Eulacampton, we expect to complete patient enrollment in cohort one of Amber Hef-Pef in the second half of this year. And for CK089, we expect to continue the second phase one 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.

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 1 to raise your hand. To withdraw your question, press star 1 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.

Great. Good afternoon, guys, and thanks for the question and congrats on the great number. Robert, 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, So I think you said it was 400 dispensed versus the 680 and 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 two quarters if you don't want to get too granular? Thanks so much.

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?

Sure. Yeah. Thanks for the question, Salim. Happy to clarify. So you're right, 680 to 400 in Q1. It's around 2,000 to 1,500 in Q2. You know, launched to date overall. That difference of pending patients, we described patients in the process. Once a prescription is sent in, I mean, 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 Nudibrand 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 auth. 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 of 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. Yep, you got it.

Okay, got it. Thanks so much for the clarification. Thank you, Salim.

Our next question comes from the line of Rowana Ruiz with Learink Partners. Your line is open.

Hi, afternoon, everyone. So I was curious, regarding the different metrics that you're tracking for my course's U.S. launch, just the 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, that proportion holding from last quarter? Are you seeing some changes there?

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

Switching, we reported very kind of low single digit. We are actually seeing probably in the five to seven percent of our overall dispenses are from switching. The switching has increased slightly, but not dramatically and not a major driver. Thanks for the question.

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

Great. Good afternoon. Hey, Robert. Good afternoon. Thanks for taking the questions. Doing a bunch of math on the fly here, but it would seem to suggest that the overall class sort of ads 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 US figure? Thank you.

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

We are actually seeing an increase in growth. 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. Another question over to Sung around stocking relative to revenue.

Yeah, so thanks, Carter. So as demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. So this quarter was demand less.

Thank you.

Thank you, Carter.

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

Hey guys, thanks for taking my question. So 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. And if I take that 2020 number and apply this 60%, I get to 250 dispensed during April. versus like when you did it for the full quarter is like 1500. So one month had 250 and then for the full quarter you have 1500. So as you're thinking about like 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? Thanks.

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 do see an increase in dispense. I would expect dispenses to level out once managed care and access level outs, oftentimes that timeframe of a pending patient. And, you know, the REM certainly adds to it because of certifications need it. But a pending patient often stays in pending longer because of a benefits investigation and a prior auth process. So we would look to shrink that timeframe down over time, but I would not anticipate that in the near term. Thanks for the question.

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

Hi, Robert and team. Hope you are all well and thanks so much for taking our question. 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 my Corso. With that in mind, where do you sit now? Thank you so much.

So 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.

Hi, Tess. So we have both the top line data, which kind of goes to the endpoints delineated in the SAP. But those are going to be put into both the clinical and mechanistic context. So the clinical context will be deliberated by Dr. Masri and his Hotline 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 what the mechanism by which these clinical benefits are being enjoyed by patients. And I think that that's going to be very elucidating to scientists and patients hopefully moving forward.

So 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 you 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.

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. So we're not going to report, you know, July. We'll report the third quarter during that call.

You know, Tess, to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to my Corso 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.

Thank you. See you soon.

Thank you. Thank you. Our next question comes from the line of Akash Tiwari with Jefferies. Your line is open.

Hey, this is Manoj. Hey, sorry, this is Manoj on for our guys. This one from our end. Are you hearing any feedback from the prescribers who switched from the cancer, especially like the efficacy with the lower doses? And approximately what percentage of your new patient that's outside the treatment of the center of excellence? Thank you.

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

Yeah, the patient suits from Avicampt and like your efficacy with the lower doses of Api.

Yeah, so it's not for us really to comment on Camxios and lower doses, but Andrew, is there anything you want to say about Apicampt and Mycorzo 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, so we do have a flexible dosing window Thank you so much for joining us. Thank you so much for joining us. were 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 the overall REMS program. And there are the reasons we hear from those, you know, generally from that CMI naive in terms of why initiation of a CMI at this point. Hopefully that answers your question. Yeah, thank you.

If you think about what may be occurring well with regard to an exceeding of expectations associated with prescribing down the road, it's going to be the number of 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 riders are 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 of us. Next question, please.

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

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. And 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 sales forces in the field over the next year? Thank you.

Yeah, 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 picked up from there so Fady do you want to start and then Andrew afterwards yeah I mean it really starts with dissemination of the data through published literature and Steve and his team have been

are 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, helping walk them through it. and concise but complete manners. And finally, through executing a number of educational programs, either through CME or industry-sponsored symposia. So a pretty complete program from the primary publications through to delivering the information through a variety of channels. And ultimately, our commercial colleagues when we'll build on what gets into label and be able to then also disseminate the information broadly to their customer base.

Thanks for the question. Andrew, do you want to add? 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, we've done a lot of research on this as well. From a physician point of view, it broadens the 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 to certainly fuel that more if that were to change in 2027. NHCM then really just broadens the spectrum of the number of patients a physician in a cardiology office can have. with a single agent in mycorso if it's approved for NHEM to treat a broader range of patients. So we have our messaging cascaded. We have our vis-aids cascaded, et cetera. And 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.

You know, Paul, to your question, 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 manuscripts. There's a plethora of information that's informing physicians about how best to think about afikampton, mycorrhizal, and I do think that that's translated to awareness, significant education and pull through inpatient demand as is enabling of our commercial colleagues to do so well. So 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 Kondoulis with Stiefel. James, your line is open.

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

Yeah, so it's premature to speak to that. Obviously, we haven't even submitted the SNDA, nor had conversations with the FDA following their review of a submitted SNDA. But I do expect that for what could be this being a separate trial, there will be some distinctions that will have to reflect NHCM versus OHCM, but maybe we shouldn't

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

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

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

Yeah. So, I mean, I think, as we've said before, AMBER-FF is a, let's say, a dose-finding trial, and to understand how The unique mechanism of eulocampin might play out in the HFTF population. So, you know, we'll have initial PK. We'll be looking broadly across echocardiographic parameters. Of course, we'll have safety. And we'll also understand the feasibility of enrolling a population focused, you know, to where we think the impact might be felt with a mechanism. like Eulacanthin. So, you know, I think over the course of the study, that'll help inform the continued development of Eulacanthin in this indication. Thanks, James.

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

Hey, this is Josh on for Corey. 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?

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

So our guess is around 110,000 to 120,000. It's more than a guess, but 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 and many more. I think it will depend over time on access, demonstrated safety, if REMS programs change, you know, etc. But I would anticipate peak penetration in the 60 to 70% range.

Yeah, so what Andrew's citing would suggest that we've got a long way to go still to see CMI's 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. So this is the beginning of what hopefully will be penetration of mycorso into more and more of those patients. But assume we're closer to 20% of the total eligible today and that number hopefully denominator grows. Next question, please.

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

Thanks for taking my question. I wanted to ask on comment, 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 comment? Thanks.

Thank you.

Fady, please. Yeah, I mean, the pace of enrollment and comment has been pretty pleasing to us over the last few months. And 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. I wouldn't necessarily, I mean, my expectations for stopping at the end of an analysis are pretty low because it's a very minute bit of alpha that's spent there. Clinically, we think anything, 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 and many others. So this trial was powered with that in mind. I think it should be statistically significant around 0.86, 0.87, 0.88 and that remains in terms of the hazard ratio for the primary endpoint. But of course, I think when you looked at this treatment effect in galactic, we saw more sizable treatment effects than that and we hope to see that in comets emerge as well. So I hope that addresses your questions.

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

Hi, team. Congratulations on the quarter. This is Amin on from Mayank. I had a question for Andrew on the greater than 40% exit 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 docs going deeper or do you need kind of 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?

Sure, thanks for the question. So 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. So 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 and share as we have been doing for the majority of them. But 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 and with NHCM, you know, getting to your second question. Thank you for joining us. you know obstructive HCM two trials with Sequoia and Maple and a third one with Acacia the continuous safety evidence efficacy is very reassuring to a physician as well so I think all this collectively will have an effect on OHCM you know so we anticipate continuing to grow share over time and as we've said all along our aspiration is to have greater than 50 percent of the share by the end of the year we're certainly on our way to do that Thank you. Thanks for the question.

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

Great. Thank you very much for taking my question. So far, we draw on the chem-xios experience. How should we think about persistence as the treated base builds? And could it look different for mycorrhizal given that it's differentiated dosing and titration regimen? And also, if I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027? Thank you.

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

Yeah, just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into 27. Sure.

I mean, 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. So 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.

Great. Thank you.

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

Hi, this is Dominic on for Yaz. Thank you for taking our question and congrats on the good quarter. We just have 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.

Yes, so maybe I'll start there and ask Andrew and also Sung maybe to comment. We're very committed to ensuring that myCorso 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. And now we've 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.? And Sung, anything you want to add after that?

Thank you for joining us. England and Wales. We've talked about the Netherlands. We have major markets launching, probably, you know, one at the end of this year, several first half of next year. You know, Europe takes more time to build up over, you know, from a revenue point of view, pricing is in the 10 to 20% range. So, you know, my expectation would be that Europe will be a contribution to but not a driver of growth and over time it'll probably be in the 15% range of our overall revenue but maybe Sung wants to add to that.

Yeah, I think Andrew characterized the pace in Europe well. The launches are staggered as we go through the HPA process in each country and the next likely country that we will launch in in Q4 is the UK and we'll have subsequent launches into 2027 all the way to the end of 2027.

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

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

Thank you so much for taking my question and congratulations on the quarter. Given the launch curve that you're seeing now and the 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 just a quick follow up on the doctors that are REM certified. It looks like about 1,400 of them are REM 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. Thank you.

Andrew, do you want to tackle those, please?

Sure. So from a REMS, I'll go backwards. From a REMS certification point of view, the ratio is about a 30% ratio in terms of those who are prescribed versus those who are certified from a REMS point of view. We continue to get REMS enrollments week after week. It certainly shows an attention to prescribed overall. Sometimes a certification occurs and prescribing Thank you for joining us. Assuming Maple gets added to the label, that certainly provides greater ability from a promotion point of view. Probably the two things that I discussed earlier that really Maple does is one is it paints a picture, especially for low to non-prescribers of appropriate patients for a CMI. And it broadens or widens their mind in terms of who that appropriate patient is for. Thank you so much for joining us. Thank you so much.

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

Thanks for fitting me in. I just wanted to actually follow up on this point about HCT, or sorry, REM-certified HCTs, given the growth that you saw this past quarter. Can you just talk about sort of how that metric contrasts with the number of REM-certified are potential providers for CAM-XIOS. And what does that metric look like fully baked? Thanks.

So are you asking how our REM certification number compares to the CAM-XIOS certification number? Is that your question?

Yes, that and sort of what you anticipate the total number of potential REM certified providers would be in the U.S.

Got it. So I can't comment on the CHEMS IOSREM 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, and it stopped reporting it at some point in time. In terms of our expectation, so we sized our fuel 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. So we were going to where we thought the market would go with CMI penetration over time. So 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 to 10,000 range. So over time, I would expect we'd have greater than 5,000 REM certifications. But we're happy, very happy with the pace. The pace is outpacing the number of prescribers, which is exactly where we want to be.

Yes. 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.

Great. Thanks for taking the questions.

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

Great, 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? And then 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.

So 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. and then maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical.

Sure. You know, I think we presented, as we presented the data, the natural questions that meant anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoint, 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.

What I can say is we were pleased that there were no surprises. And then, 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.

Yeah, sure. So, I mean, we are seeing a broad range of dosing all the way up to the 20 milligram dose. Thank you so much for joining us. Typically, you know, 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?

Well, I mean, nothing more than the obvious that the clinical trials did show the preponderance of patients ended up on the 15 and 20 milligram doses, both in Maple, Sequoia, and the data that we published out of the forest experience.

You know, that gives an opportunity to underscore one of the things that we think is important regarding mycorrhizal is that one can uptight trade, 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.

Super helpful. Thank you and congrats again.

Thank you.

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

Maybe the first one for Andrew. I think in your slides you mentioned about and many hundreds of the 700 new prescribers in my quarters from high volume semi-users. I assume these are also CAMVOS users. So 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 NHCMS NDA. Thank you.

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

I think I got the essence of it. The very beginning of it was very broken up. But, you know, Sergeant, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other. You know, 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 mycorzo is greater than that of and Cam Zayos for most prescribers, hence our aspiration in terms of greater than 50% share, but I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert.

And then 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, but as we've stated publicly already, Our next question comes from the line of Jason Zemanski with Bank of America. Jason, your line is open.

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 five to seven percent of mycorrhizal dispenses are for those switching therapies. What are the primary factors driving those switches? And then among those transitioning from Mavacamptan, what sort of feedback are you getting regarding the maintenance of symptoms and gradient control? Thanks.

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

Sure. Before I get to that, I'll just point out that in Maple HCM, you know prior exposure to maverick campton was allowed and you know those participants had an expected therapeutic response to athlete campton in that setting then you know to Robert's point there are some pharmacologic benefits that we believe suits certain patients more and those are related firstly to the speed of onset and offset. So 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 africansin. Individuals who are considering starting a family, As you might be aware, with the Camzias label, it's a black box warning. With Mycorrhiza, 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 interaction is something that you're well aware of. 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 mycorrhizal clinically.

And maybe just entertaining a bit on what Steve said. It is not 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. But 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. And as we get deeper into the launch, we expect that that may not continue to be a motivating factor for some of those physicians. So 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 mycorso to their regimen. and 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 myCORSA. So thank you.

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 and 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 of strong commercial launch momentum and velocity here initially in the United States and hopefully also as we're building the foundation in Europe and having that occur at the same time we're enabling of better information to inform Thank you very much. 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.

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