Cytokinetics (CYTK) Q2 2026 earnings call transcript

I would now like to turn the call over to Diane Weiser, Saito Kinetics, 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 Saito Kinetics. com, along with today's press release. Robert Blond, President and Chief Executive Officer will begin with an overview of the EVP and Chief Commercial Officer. We will discuss the commercial launch of my course, though, in the U. S. and Europe.

Fatty Malak, EVP of R&D, will provide updates related to Appi Camden. Steve Heitner, SVP and Chief Medical Officer will provide updates related to our ongoing clinical development programs. Some lay 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 the slides, 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 Saito Kinetics, marked by strong 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 mycorzo, we are demonstrating increased velocity that's exceeding expectations.

As Andrew will discuss, growth in prescribing and dispensing for mycorzo 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 mycorzo and its clinical, therapeutic, and commercial opportunities. During the quarter, we also executed well in our global commercialization strategy with the launch of mycorzo in Germany, the first in a series of European launches expected over the next six to 12 months.

This is a key milestone for Saito Kinetics 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 mycorzo 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 Afi-Campton to potentially treat the full spectrum of HCM. As we shared, the top line results from a CACM and 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 PvO2 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 Afi-Campton beyond OHCM, subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top line results from a CACM, 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 Afi-Campton 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 a CACM in a hotline session at the European Society of Cardiology Congress to occur later this month, alongside progress towards making mycoreso available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for Afi-Campton in patients with NHCM, and as could lead to mycoreso 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 Sato-Canetics is executing well on a global commercial stage and integrated bio-pharmaceutical 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 mycoreso 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 mycoreso is resonating well with both health care providers, payers, and most importantly, also with patients.

Since our commercial launch at the end of January, mycoreso has accelerated quarter over quarter growth and 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 mycoreso 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 mycoreso among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of mycoreso. Treating physicians that we surveyed also view mycoreso favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability, and the flexibility associated with differentiated REMS requirements.

In this stage of our commercial launch, our emphasis remains on deepening prescribing among high-volume CMI prescribers. Historically, these physicians have generated approximately 80% of CMI prescriptions. While our call universe spans 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 mycoreso 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 mycoreso is gaining traction across a wider segment in the OHCM treating community, something we anticipate based on the differentiated profile of mycoreso, 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 Apte Campin both support findings from Sequoia HCM and further demonstrate that mycoreso is superior to beta-blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy, and utility of mycoreso in patients with OHCM.

As we commit it at launch, we continue to evaluate performance using three key metrics. Breath of prescribing measured by the number of ACPs who have written prescriptions, depth of prescribing measured by the number of patients to which each HCP prescribed mycoreso, and patient volume which reflects a total number of unique patients prescribed mycoreso. 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 health care providers in the U. S. have prescribed mycoreso, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCP's prescribed mycoreso to approximately three of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed mycoreso 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 mycoreso has increased to greater than 40% in the second quarter. We also continue to see encouraging leading indicators of future demand, including more than 2,500 health care providers who have now completed REM certifications since launch.

Turning to patient demand, in the first quarter, we reported approximately 680 mycoreso prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, mycoreso was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed mycoreso in the quarter. The majority of prescriptions continued to be dispensed within approximately three weeks.

Once all patient documentation and benefit investigation is complete. Going forward, we plan to report on patient dispensed 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 up with nearly 90% parity coverage for Medicare lives. 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 mycoreso 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 1 in the Netherlands. And in England and Wales, nice published guidance recommending mycoreso 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 mycoreso, but also the dedication and execution of our colleagues across the US and Europe who are delivering excellence with both integrity and focus.

With that, I'll turn the call over to Fatty. The second quarter with an important period for ACM portfolio, most notably with our announcement of positive top line results from Acacia HCM, our pivotal phase three clinical trial and patients with symptomatic in HCM. As we shared by top line press release in May, Acacia HCM at 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 AFI captain in NHCM, which represents as much as one half or more of the overall HCM population and for which there are no currently approved therapies. For many years, treatment options for patients with NHCM have been limited despite the significant burden associated with the disease. We believe the results from Acacia HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from Acacia HCM during a hotline session at the European Society of Cardiology Congress.

Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints and of course safety, we'll also be presenting additional analyses regarding the effective AFI captain on cardiac structure and function known as separate late-breaker sessions to help further inform treatment effective AFI captain in this population. At ESE, 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 AFI captain, 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 and opportunities for AFI captain and NHCM. In OHCM, we continue to support review activities engaged and engaged constructively with FDA regarding the SNDA based on Maple HCM that's currently under review with a PADUFA date of November 14th, 2026. We continue to believe that the results from Maple HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of AFI captain as an earlier treatment option in appropriate patients.

In the meantime, given that the AFI and safety profile of AFI captain 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 mycorzo. They completed more than 800 scientific exchanges with U. S. -based ACM ACPs across a variety of topics, including questions related to the U. S. P. I. 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 AFI captain.

Studies investigating the feasibility, safety, and efficacy of physicians seamlessly transitioning patients from AFI captain to AFI captain in patients with OHCM. Taken together, the progress made this quarter reinforces our conviction and the potential role of AFI captain to address the full spectrum of HCM. With mycorzo now available for patients and 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. Servified his experience in treating patients with HCM and DeepEx were teased in this disease, Steve's been an exemplary leader in helping to bring AFI captain to patients. His insights and guidance contributed immeasurably to the approvals of my Corzo in the U. S. , EU, and China.

He's also played major role in the innovative study designs and quality of conduct of Acacia HCM for AFI captain, Amber Haftepfer, Eula captain, and common HF for Omicampson McCarble. This transition represents a passing of a baton from Stewart 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. For pleased that Stewart will remain at Cytokinetics, the Senior Vice President of Clinical Development, contributing to our clinical programs and external innovation with a special focus on pharmacovigilance. And with that, I'll hand it over to Steve.

Thank you, Farri. The first, starting with our ongoing programs for AFI captain, 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 community HCM, evaluating the treatment of obstructive HCM patients in Japan. We also advance cedar HCM, a study evaluating AFI captain 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 AFI cancer, we continue to advance the remainder of our cardiovascular pipeline during the second quarter. Starting with our mechanical McCarble, we continue conduct of common nature, our confirmatory phase three clinical trial in patients with heart failure and severely reduced ejection fractures. 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 percent of plant sites are now activated. We are encouraged that the baseline priority are tracking very closely with those in the subgroup of heart failure patients from galactic heart failure, with severely reduced ejection fracture, in whom the treatment effect appeared most concentrated, and in whom informed the design of this trial.

We expect to continue enrollment through 2026. For Eula Canton, we continue to enroll cohort one of our member head tests, our phase two study in patients with heart failure preserved ejection fracture, 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 mice in the inhibitions in heart failure preserved ejection fracture. Overall, we are pleased with the continued progress across our later stage, speciality, cardiology development portfolio, and look forward to important milestones of becoming quarters.

With that, I'll hand over to some.

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 my Corzo reached $25.3 million, serving as the foundational driver of our top line moving forward. Of this amount, US 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 purchase 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 Appacampton and Japan with buyer.

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 my Corzo, the US sales force, and higher non-sales personnel related costs including stop-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 logs for the second quarter of 2026 was $198.8 million for a $1.50 per share compared to a net loss of $134.4 million or $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 investment compared to $1.1 billion at the end of the first quarter of 2026. The increase in cash and investment 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 gap 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 gap 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 gap 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 a KSCM to support the potential 2027 launch of my Corzo in NHCM.

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

Thank you, Son. 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 my Corzo, 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 my Corzo has the potential to become the CMI of choice in OHCM.

Our near-term priorities for Athikampton are clear. In OHCM, firstly, executing successful global launches for my Corzo and pursuing additional approvals across Europe. In NHCM, presenting the primary results from Acacia HCM at ESC and preparing and submitting an SMDA to FDA later this year, as well as planning for the commercialization in NHCM. Beyond Europe, regulatory reviews for Athikampton 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 my Corzo may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both only Captain McCarble and Yula Canton, which are pleased or progressing well in respective later-stage trials.

As we look ahead, I believe our strategic positioning has never been stronger. We're entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of my Corzo 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-based 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 Athikampton, 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 Athikampton 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 only Captain McCarble, we expect to continue patient enrollment and the conduct of Comet HCF through this year. For Yula Canton, we expect to complete patient enrollment in cohort 1 of Amber Health Health in the second half of this year.

And for CK089, we expect to continue the second phase 1 study. And finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology focus programs. An operator with that, we can now open up the call to questions, please.

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?

Sorry, yeah. Thanks for the question, Salim. Happy to clarify. So you're right, six, eight, at a 400 in Q1, there are about 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 new to brand that we reported. But there is a process, a REMS enrollment has to occur, a prescription has to occur, signatures, growth on physician and patient side, benefit, investigation, oftentimes prior off. So there's a process that takes several weeks.

You know, 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 then it's his request.

Are you seeing some changes there? Sure. So maybe I'll turn that also to Andrew, please.

Sure. Thanks for the question. So we are seeing a couple changes. One, the higher percentage of paid for prescriptions, which is encouraging around the same in terms of how long it's taking that prescription 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, you know, breadth of prescribing.

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 you know, not dramatically and not a major driver.

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

Sure. So we are actually seeing an increase in growth. I showed you the new to brand prescription growth overall. I think last year, we were we were seeing at least incindicated data about 2000 new prescriptions per quarter. I think in the first quarter, the number was probably around 2500 and the second quarter, it's starting to approach 3000. So you're seeing a growth in terms of new patients entering the market. And there really hasn't been a change in kind of compliance and persistency overall. So you're seeing an increase in patients dispensed and I'll other question over to song around stocking relative to revenue.

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

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

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

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 Fadi 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 through the endpoints delineated in the SAT.

But those are going to be put into both in clinical and mechanistic context. So the clinical context will be deliberated by Dr. Masri and his hotline presentation on Friday.

And then on a Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde. We will 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 percent 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 percent new to brand share. So we're not going to report, you know, July will report the third quarter during that call.

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

Yeah, the patient who's from our campus and like you are efficacy with the lower doses of APE? Yes, it's not for us really to comment on Campsios and lower doses, but Andrew, is there anything you want to say about Apicamp in my core zone 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. 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, and that's really between the logistics of a center of patients and the physicians scheduling. So that window is taking place across every dose change. Relative to breadth and depth of prescribing, we have a really good mix in terms of breadth.

The majority of our prescriptions and prescribers are in that high CMI category, you know, that's about 40% overall, but then that low volume category is about 30%, and the CMI naive, meaning they had not written a CMI until we've entered the market as 30% of our prescribers. So we're doing really well across a broader range of prescribers. When we talk to those CMI naive prescribers anecdotally, we're really hearing what you saw 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 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 arguing well with regard to a 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.

Yeah, so maybe I'll ask both Patty 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 Patty, 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 Steve have been strictly productive in terms of not just the primary publications, but secondary publications 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 ACM patients, bringing them the information, helping walk them through it, and concise with complete manners. And finally, you know, through executing a number of educational programs, either through CME or industry sponsored symposia. So a pre-complete program from, you know, variety of channels. And, you know, ultimately, our commercial colleagues will build on what gets into the label and be able to then also disseminate the information broadly to their customer base.

So I have a question. Sure, I can add. Yeah, sorry.

Thanks, Patty. I can maybe just add to it from a having so much data in this period of time. When we think about maple, maple will, you know, 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 certainly feel 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 my course.

So if it's a proof for NHCM to treat a broader range of patients. So we have our messaging cascaded, we have our visades cascaded, et cetera. And I think we'll be ready to take a well advantage of that, you know, 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 SADO kinetics. 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 after captain Mike Orzo. And I do think that that's translated to awareness, a significant education, and pull through in patient 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.

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 run any of that until we have actually interacted with following your submission.

Sure, so I'll turn that over to Fatty, please. Yeah, so I mean, I think, as we've said before, Amber, FS is a, let's say, a dose-finding trial.

And to understand how the unique mechanism of Ola Canton might play out in FS population. So, you know, we'll have initial PK, we'll be looking broadly across the cartographic 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 Ola Canton. So, you know, I think over the course of the study, that'll help inform the continued development of you accounted in this indication. Thank you.

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 to 120,000. It's more than a guess, you know, based on the analytics we've done from an epic point of view around, you know, that number is the eligible patient population. That's if diagnosis doesn't increase. There's probably in the 20 to 25,000 range of treated patients, so you can you get a penetration in around 20 percent range. Peak penetration, I think, 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 percent range.

Yeah. So, 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 ineligible, 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 my corso into more and more of those patients, but assume we're closer to 20 percent of the total eligible today, and that number hopefully denominator grows.

Thank you, buddy, please. Yeah, I mean, the pace of enrollment and comment has been pretty pleasing to us over the last few months, and you know, where 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 mean, my expectations for stopping at the end 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're always trying to do this, design a trial with the group of patients, you think, to demonstrate a minimally clinically beneficial effect, and not overpower it, you know, to show the minimus effects, if you will. So, this trial was powered with that in mind that, you know, I think it should be statistically significant around . 86, . 87, . 88, and that remains in terms of the hazard ratio for the primary end point, but of course, I think when you looked at this treatment effect in galactic, we thought we saw more sizable treatment effects than that, and we hope to see that and comment emerge as well.

So, I hope that addresses your question, Leo.

Andrew, do you want to take that? Sure, that's my 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, you know, 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, share, as we have been doing for the majority of them, but also getting on board the CMA 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, obviously, it's not approved. We're not going to be promoting it or discussing it until it is approved, but the fact that it will be published in the public domain, or 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, you know, obstructive HCM-2 trials with Sequoia and Maple on 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% this year by the end of the year.

We're certainly on our way to do that. Thank you. Thanks for the question.

You want to take that? Sure. So, from a persistence point of view, in our expectation is that we will be the same if not slightly better from chem's IOS point of view, just, you know, given the profile of the drugs and, you know, 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 my course though. In terms of your second question was around, can you repeat that part again? I'm not sure if I heard.

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 it's 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 our 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. Yes, so maybe I'll start there and ask Andrew and also a song maybe to comment. We're very committed to ensuring that my core zone 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 got to ensure that we're going to be enabling a demand and pull through.

Andrew, do you want to speak to expectations in Europe and relative to U. S. and some anything you want to add after that? Sure, so 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 the 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% to 20% range.

So 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, but maybe some wants to add to that.

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 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 in 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 the top line growth. Thank you for the question. Great.

Sure. So from a REM, I'll go backwards, from a REM's 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 REM's point of view. We continue to get REM's enrollments week after week. It certainly shows an attention to prescribed.

Overall, sometimes a certification occurs and prescribing occurs within the institution by another physician. So 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, when Maple gets, 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.

The other thing it does is it certainly increases preference share and market growth. So there's a kind of a multiplier factor there. If guidelines do get updated relative to Maple, that certainly would, as many physicians, want to follow guidelines and understand guidelines. So that would be a further accelerator, but obviously that would take more time. So to answer your question specifically, I would expect that we would get some level of impact, 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 question.

Got it. So I can't comment on the Cam's IOS REM certification number. I don't know that number. I don't need to know if that number is reported. I know BMS reported it early in their launch and it stops reporting 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 seven 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, we're going 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. Great, thanks for your questions.

Thank you. So, I'll add to the 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 anybody would have around that reviewing product for potential approval in that indication include the clinical meaningfulness of the of the endpoints and the results, the safety that was observed, how we might deploy those things and you know, understand the interplay of those with the patient population.

I think those are, you know, some of the themes of our discussion without getting too granular. And I think we're, you know, 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? Yes, sir. So, 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 physicians and patients are taking advantage of that two to eight week window. So, I think that that certainly is something we're monitoring and trying to understand exactly where is dosing going to compare to clinical trials. 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, say, the obvious that the clinical trial 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 mycorzo 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.

Did you get it? I think I got the essence of it, the very beginning of it was very broken up, but, you know, sir, 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 prescribed that way. The vast majority will use both products over time. Our expectation is that use of mycorzo is greater than that of Camzio's 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, 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, independent of any interactions with FDA, it's not unreasonable. It's reasonable to assume that the priority review might be possible. It's not a base case assumption, but it certainly would be great if that happens and we'll see if we can't make that happen.

Great. Thank you.

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 Camzio's to mycorzo? Sure. Before I get to that, I'll just point out that in April, HCM, prior to MAVA Captain was allowed and those participants had an expected therapeutic response to ATHI Captain in that setting. Then to Robert's point, there are some form of logic benefits that we believe suit 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 start the drug with the rapid onset and offset, those are patients who would naturally be selected for ATHI Captain.

You know, individuals who are considering starting a family, as you might be aware, with the Camzio's label, it's a black box warning. With mycorzo, on the other hand, it certainly hasn't been studied, but it isn't a black box warning based on our pre-chemical data. The drug interaction is something that you are well aware of.

Patients who have had good experiences of anti-depressants 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 mycorzo maybe just the annotating of it 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 mycorzo 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 mycorzo. So thank you.

I will now turn the call back to Robert Blum, CEO, for closing remarks. Thank you, operator. I want to thank the participants on the call today. I want to thank you for your continued support and interest in how we're doing here at Sato Kinetics. 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 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 data.

I'll remind you that we're going to have several presentations, including hotline presentation at ESC later this month. And coming out of that, we'll also have an investor event that we look forward to communicating to you from Munich. And at the same time advancing our pipeline, that's the key tenant 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.