Thank you for standing by and welcome to the Cytokinetics Q3 2026 earnings 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 1 again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. 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 myCORSO 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. As you can see on this slide, today's discussion will include forward-looking statements which are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. And now, I will turn the call over to Robert.

Thank you, Diane, and thanks to all for joining us on the call today. The third quarter was another period of strong execution for cytokinetics, as we continue to build a leading muscle-focused specialty cardiology company. In Q3, we made progress on each of our priorities underlying that strategy. Nearly nine months in, the launch of Mycorso continues to exceed our expectations. In the third quarter, Mycorso generated $44.5 million in net revenue, up 76% from Q2. As Andrew will describe, The number of prescribers prescribing per physician and patients dispensed all increased. We believe these trends reflect the differentiated profile of mycorrhizal and we see significant room for continued growth. Outside the United States, our launch in Germany is off to a strong start and we continue to secure approvals in additional geographies, including recently in Canada and the United Kingdom. We expect to launch in the UK this quarter and in additional countries in 2027. We're also looking forward to the PDUFA date for data relating to Maple HCM, which is November 14th. Beyond OHCM, we're working diligently to bring Affy Campton to more patients living with HCM. In August, we presented the full results from Acacia HCM in a hotline session at ESC with simultaneous publication in the New England Journal of Medicine. In fact, the presentation was included in the opening plenary session for ESC, a clear sign of enthusiasm from the cardiology community, which today has no approved therapy that addresses the underlying disease for NHCM. We also presented additional results at ESC from pre-specified analyses from Acacia HCM that further underscore the potential of afecamptin in NHCM. These results bring us closer to the potential commercial availability of a treatment for the full spectrum of symptomatic HCM patients. Based on these results, we're on track to submit a supplemental NDA to FDA this quarter and an application to the EMA in early 2027. At the same time, pending regulatory approval, we're preparing for the potential launch in NHCM, building on the commercial foundation we've established with myCORSO in OHCM. Andrew will share more on our commercial readiness in a moment. And beyond Affy Campton, we continue to advance our pipeline during the quarter. Our later stage clinical trials for omicamptomacarbo and eulacamptin continued to make progress and earlier in our pipeline, we achieved a preclinical milestone in our collaboration with ACUTAR, which is focused on targeted protein degraders for muscle related diseases. Taken all together, our third quarter results demonstrate the progress we're making towards our vision 2030. Looking ahead, Our priorities are clear. Submit the SNDA in NHCM, prepare for a potential NHCM launch, expand myCORSO into additional geographies, and importantly, continue our commercial momentum in OHCM while advancing our pipeline, all while staying disciplined to how we deploy capital. And with that, I'll now turn the call over to Andrew, please.

Thank you, Robert. Mycorrhizae delivered another quarter of strong growth, and the launch continues to exceed our expectations. In Q3, we are pleased to see growth across prescribing, patient demand, and market access, all while the CMI category itself continued to expand. These trends show that Mycorrhizae is on a strong trajectory in the first year, and we're focused on building that momentum into 2027. As we committed at launch, we continue to measure performance using three key metrics, breadth of prescribing, depth of prescribing, and patient volume. In the third quarter, we saw continued growth across all three, driven by an expanding prescriber base. By the end of the third quarter, nearly 1,100 unique healthcare providers in the U.S. had prescribed mycorrhizal up from more than 700 at the end of Q2. On average, these HCPs have prescribed mycorrhizal to nearly four of their patients up from three last quarter. Among high-volume CMI writers, the figure is seven patients up from five in the second quarter. We believe this increase in prescribing reflects growing physician confidence in mycorrhizal. Turning to patient demand by the end of the third quarter, mycorrhizal had been dispensed to more than 2,800 patients, up approximately 86% from 1,500 at the end of Q2. While syndicated data has limitations, our internal analysis suggests that new-to-brand exit share for mycorrhizal in the CMI category is continuing to grow and approaching 45% in the third quarter, up from approximately 40% in the second quarter. Our launch strategy was to focus on high-volume CMI prescribers, and our NVRx share is highest among these HEPs, approaching 50%, a leading indicator of future growth. We remain committed to our goal of achieving greater than 50% new-to-brand exit share by year-end, which would represent a strong result for the second entrant in less than a year of launch. Beyond capturing new-to-brand share, my Corso is also helping to expand the CMI category. Q326 versus Q325 new-to-brand prescription grew. 56%. When comparing year-to-date growth for the same period in 25, the CMI market has grown 45% since the introduction of mycorrhizal. And there is still significant room to grow. Of approximately 120,000 eligible OHCM patients in the U.S., only about 28,000 are treated with a CMI today. That leaves over 75 of CMI-eligible patients who could benefit from therapy, and that's where our launch continues to be focused. As we said prior to our launch, prescribing was concentrated among high-volume CMI prescribers who historically accounted for approximately 80% of CMI volume. By the end of Q3, our sales team had reached more than 95% of these HCPs. Since launch, as we've continued to grow share among high-volume prescribers, adoption has also broadened beyond this core group. Specifically, low volume CMI prescribers now represent 30% of all mycorrhizal prescribers, while prescribers naive to CMI represents another 35%. Importantly, in Q3, we estimate that the CMI naive prescriber segment accounted for approximately 70% of total CMI growth since Q2. We continue to expand access and end at the third quarter with over 60% of commercialized covered, up from 50% of lives covered at the end of Q2, while continuing to maintain a consistent level of Medicare coverage throughout 2026. In Q3, we continue to achieve over 80% of paid prescriptions, showing continued success in access and our ability to manage payer appeal process. Outside the United States, our lunch in Germany is continuing to gain traction. By the end of August, myCORSO had already captured more than 50% of new CMI patient starts. We also recently received approval in Canada and we expect a launch in the UK this quarter and in additional countries in 2027. As a result, we expect myCORSO to be available in all key European markets in 2027. At the same time, as we move towards our planned SMDA submission for NHCM this quarter, we're preparing for a potential commercial launch in that indication in 2027. Our fuel force was designed from the start to reach the physicians who treat both obstructive and non-obstructive patients. So the infrastructure is already in place. We're also building disease awareness to run branded education and our payer account teams are preparing to engage payers in compliant pre-approval information exchange in preparation for coverage discussions. In the U.S., we estimate that over 200,000 patients have been diagnosed with NHCM and over 120,000 are symptomatic and eligible for treatment. Recent market research reacting to Acacia HCM suggests that if mycorso is approved for the treatment of symptomatic patients with an HCM, physicians see a meaningful role for their therapy, particularly among patients with greater symptom burden or persistent functional limitations where unmet need is highest. Importantly, physicians indicated that patients with the greatest symptom burden may be the most likely to receive treatment, potentially driving higher utilization within this segment. Moreover, a dual indication label could further strengthen mycorrhizal position in OHCM as physicians gain broader experience and confidence with mycorrhizal across both obstructive and non-obstructive HCM. Ultimately, we hope mycorrhizal will be approved to address this important unmet need. Overall, we are very encouraged by the performance in our launch markets. It reflects a differentiated profile of mycorrhizal and the execution of our colleagues across the U.S. and Europe. Together, this progress is building a strong foundation for continued growth. And with that, I'll turn the call over to Fady.

Thanks, Andrew. The third quarter was an important period for further differentiating the clinical profile of apicanthus. In August, we presented the full results from ACACIA-HCM, our pivotal Phase III clinical trial of Affy-Campson in patients with symptomatic NACM, in a hotline session at the European Society of Cardiology. These results were published at the same time in the New England Journal of Medicine. As we previously reported, Affy-Campson met both dual primary endpoints. with statistically significant improvements versus placebo in patient-reported health status, as measured by KCCQ, and in exercise capacity, as measured by peak VO2. Apicanthin also achieved significance on three of five key secondary endpoints, including NYHA class and NT-proBNP. Importantly, the treatment effect was consistent across all pre-specified subgroups, including patients on beta blockers, and those with intercavitary obstruction and across genotype positive and negative patients. The response from the cardiology community at ESC was quite positive. Leading HCM experts called the results a transformative moment for patients with non-obstructive HCM, a population where there are currently no approved treatments. Since ESC, we've seen strong engagement from the HCM community, including centers of excellence, patient advocacy groups, and physicians who treat these patients every day. With no approved therapies that address the underlying disease in NHCM, we believe these results have the potential to meaningfully change how HCM is treated. We also presented additional analyses from Acacia HCM at ESC and HFSA that further characterized the treatment effect and safety of africans in NHCM. At ESE, we presented data showing that apicanthin significantly improved diastolic function, meaning how well the heart relaxes and feels, and reduced left ventricular wall thickness, effects that strengthen with longer treatment. These findings related to the mechanism of apicanthin help elucidate the underlying effects on the heart that lead to improvements in symptoms and exercise capacity. At the Heart Failure Society of America meeting in October, We presented data showing that Afikampton improved global exercise performance across multiple domains of the cardiopulmonary exercise test in addition to peak VO2. In a second presentation of a responder analysis, 53% of patients on Afikampton achieved a clinical meaningful response in three or more domains, compared with 13% on placebo, which puts the mean treatment effect in a clinical context. With respect to safety, an analysis from Acacia's HCM shows that heart failure events occurred early during titration, often after a triggering event such as atrial fibrillation or infection, and generally resolved with standard therapy. Importantly, in an open-label extension, Forrest HCM, where patient judgment guides dose titration or more closely reflects clinical practice, these events have been rare. The view of leading HCM experts see these events as manageable in clinical practice, and it gives us confidence in how Apikampton can be used in the real world. On the regulatory front, our supplemental NDA based on Acacia HCM remains on track for submission to FDA this quarter. As Robert mentioned, we're also preparing to submit to the European Medicines Agency in early 2027. In O-HCM, our SNDA based on Maple HCM Thank you. Thank you. and to NHCM, we see a substantial opportunity to reach a broader population of patients in the U.S. and around the world. And with that, I'll hand it over to Steve.

Thank you, Fady. In the third quarter, we made meaningful progress across our clinical development programs. Starting with the africans, we continued to strengthen its evidence base. We recently began Aspen HCM, a real-world study of mycorrhizae in obstructive HCM. We believe that this data will help us better understand real-world safety, clinical effectiveness, and healthcare resource impact of mycorrhizae in routine clinical practice, and will help inform future discussions with regulators, particularly with respect to the REMS. We also completed the adolescent cohort of CDER-HCM, a phase three clinical trial evaluating the efficacy pharmacokinetics and safety of africamtin in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy. And we expect to share the top line results in early 2027. Additionally, our partner Bayer completed the main study treatment period of Familia HCM, a phase three clinical trial of africamtin in Japanese patients with obstructive HCM. And we recently completed the conduct of the Japan cohort of Acacia HCM. Beyond Epicampton, we continue to advance our late-stage cardiovascular pipeline. For Omicancet-Macabre, enrollment continued in COMET-HS, our conservatory phase three clinical trial in patients with heart failure with severely reduced ejection factors. Enrollment has now accelerated as expected now that all sites are active, and we expect enrollment to continue through 2027. Even on standard of care, these patients remain poorly served, with about 35% re-hospitalized rate within a year. In galactic HF, the benefit of omicamptomacabal was greatest in patients with the most severely reduced ejection fraction. And common HF is specifically designed to enroll exactly those patients. The baseline characteristics we've collected so far indicate that we are matching the patient population are we intended to enroll. This gives us confidence in the trial and the potential to address the significant unmet need with omicamptomacabal. For eulocamptin, enrollment continued in cohort one of AMBER HESPET, our phase two study in patients with heart failure with preserved ejection fracture. We remain on track to complete enrollment this quarter. With this trial's focus, We're generating data to help define the potential role of a cardiac myosin inhibitor in health care. We're pleased with our execution across a promising later stage pipeline, and we look forward to several important milestones ahead. With that, I'll turn it over to Sung.

Thanks, Steve. Beginning with revenue, total revenues for the third quarter were $47.6 million, compared with $1.9 million and the same period in 2025. Net product revenues for myCORSO were $44.5 million representing 76% growth quarter over quarter. U.S. net product revenues were $43.1 million driven by robust demand. Europe contributed $1.4 million to net product revenues in the third quarter following the launch in the second quarter which was comprised of initial inventory build in Germany. Collaboration revenue was $3.1 million in the third quarter compared with $1.9 million in the same period in 2025. Turning to operating expenses, R&D expenses for the third quarter were $99.3 million compared with $97.3 million in the same period in 2025. The increase was primarily driven by higher clinical trial activity and personnel-related costs. SG&A expenses for the third quarter were $113.1 million compared with $69.5 million in the same period in 2025. The increase was primarily driven by external costs associated with the commercial launch of myCorso, as well as higher personnel-related costs, including stock-based compensation. Cost of goods sold for myCorso in the third quarter was a credit of $0.5 million primarily reflecting a credit related to drug supply optimization activities. Collaboration cost of revenues, which primarily reflects partner costs for which the company is reimbursed, was $2.7 million in the third quarter compared with $1.9 million in the same period in 2025. Net loss for the third quarter was $190.1 million or $1.37 per share compared with a net loss of $306.2 million or $2.55 per share in the same period in 2025. Turning to the balance sheet, we ended the third quarter with approximately $1.6 billion in cash and investments compared with $1.7 billion at the end of the second quarter of 2026. Turning to financial guidance, we are reaffirming our full year 2026 gap combined Thank you, Sung.

Before we open up the call to questions, I'd like to highlight how far we've come this year and what's ahead. Since launching MyCorso, we've built a strong commercial foundation with nearly 1,100 U.S. prescribers, a growing presence in Europe, and approvals across four additional regions. Acacia HCM became the first positive Phase III clinical trial in non-obstructive HCM and we continue to advance our later stage pipeline, which we expect to drive longer term growth beyond Affy Campton. Now, we're focused on finishing the year strong with several significant milestones ahead. Next week, we expect an FDA decision relating to Maple HCM. Before year end, we plan to submit our SNDA relating to results from Acacia HCM. We expect to launch myCORSO in the UK in this quarter and complete enrollment in cohort one of AMBER FPEF. And in early 2027, we expect to submit our application relating to the results of Acacia HCM in the EU and launch in additional countries in 2027, as well as share top line results from the adolescent cohort of CEDAR HCM. We're pursuing all of this from a position of financial strength with a strong balance sheet that supports our launch activities, as well as our pipeline advancement and our longer term value creation. We believe we're well positioned to drive continued growth and to execute on our priorities as guided by our Vision 2030. And with that, operator, we'd like to now open up the call to questions, please.

We will now begin the question and answer session. A reminder that we are only taking 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. Please stand by while we compile the Q&A roster. Your first question comes from the line of Carter Gold with Cantor Fitzgerald. Your line is open. Please go ahead.

Great. Good afternoon. Thanks. Hey, Robert. Good afternoon. Thanks for taking the question. Robert and Andrew, appreciate all the metrics. Trying to square some of the implied sequential growth at the market level with some of your commentary there, it seems to sort of indicate a step up of around 400 to 500 incremental patients at the CMI level quarter on quarter. I guess, to some extent, I'm asking you to bless that math, but also maybe comment if you think that sort of is a sustainable step up as we think about the quarters going forward, or there are governors at the site level that may tamp down the ability for that to step up sequentially. Thank you.

Sure. I'll ask Andrew to comment, please.

We are seeing sequential growth to your point. The number is probably more like the 300 range in terms of prescriptions. If you factor in free drug, you might get up to a higher number, but I think the math is probably closer to a little over 3,000 patients for the category, which is up around 300 from the second quarter. In terms of sustained growth, as we mentioned in the call, and the remarks earlier that there's nearly 80% of the market still available. If we continue to see these, what we called naive, meaning they didn't prescribe a CMI before our launch, if we continue to see the good growth of new prescribers for the category, that certainly is what fueled most of the growth as I mentioned in Q3 and our expectation is we will continue to see that. So you'll continue to see growth in the category. Thank you.

Carter, I might add a comment. What's especially encouraging is where that growth is coming from. It's coming not just simply from the velocity accounts, but also from a broader foundation of new to the category prescribing. So not only should we expect sequentially sustained growth, but at some point that may hopefully translate into a higher velocity growth as well.

Your next question comes from the line of Tess Romero with JP Morgan. Your line is open. Please go ahead.

Hi, Robert and team. Thanks so much for taking our question. Will you be providing longer-term guidance for mycorso at our small conference in January, or is that something that will be farther out for cytokinetics? And then just to double-click on Carter's question, Andrew, is north of 3,000 ads the right way to think about the run rate for this category? Thanks.

So regarding your first question, I'll mention we're still discussing how we're going to approach 2027 and what we're going to speak to in the way of guidance. And certainly over the longer term, you can expect that we'll speak to where we see this ultimately going for the benefit of the company. But it's premature, I think, to comment on that today. Andrew, do you want to address the comment about 3,000? Sure.

So if you look at kind of year-to-date factoring in, you know, an estimate for free drugs, we're close to around 9,000 patients in our estimate for the category through the end of the third quarter, you know, with that growth factored in. So yeah, I certainly feel that 3,000 plus per quarter. Moving on, and obviously when NHCM comes on board, the HCM categories should certainly grow even more than that.

Thank you.

And put that in context of where we were a year ago, substantial growth in the category year over year.

Thank you both. Your next question comes from the line of Akash Tiwari with Jeffries. Your line is open. Please go ahead.

Hey, thanks so much. So I wanted, I wonder if you could comment on, you know, Edgewise is proposing kind of a phase three design without echo guided dose adjustments, more of a kind of symptomatic paradigm. I, you know, how much have you engaged with the FDA on improving the REMS you have with your titration with mycorrhizal? Could we get into a symptomatic paradigm for your drug? I know only about, I think 1.3% of your patients even had a and many more. Thank you. Thanks, Akash.

So before I turn it over to Fady, I'll just make the following comment. There's nothing that any FAST follower is contemplating that we haven't been discussing here at cytokinetics already for quite some time, and we do believe that it'll be incumbent upon us with real world evidence to demonstrate where we can go with a potentially relaxed or even removed REMS over time. But that does require, based on our intuitions and communications with regulatory authorities, some evidence of real world evidence that will come with what will ultimately be thousands of patients, but certainly within line of sight to what we expect to be able to accomplish here over a period of time. I'll ask Fady to comment on where we could go with these potential strategies.

Thanks, Robert. You know, I think first of all, there's certainly the ability to simplify the titration protocol and there are things that we can do. I'm not going to lay out any specifics at the moment, that can enable more flexible use of ECHOs during titration or different starting doses, things like that. I think Robert's point is a strong one, which is that any new drug in the market is not likely going to have its safety profile informed by a few hundred patients treated for a couple dozen weeks. In fact, it's clear the FDA wants to see real-world data from thousands of patients treated over many, many months or years even. So I would anticipate in the two- to three-year timeframe as we see data coming out of the REMS, out of our real-world evidence experiences, that it will reinforce the safety we've already observed with that in Campton and enable us I might also add that even our real-world experience now suggests that the majority of patients are entering the maintenance phase with treatment of 5 or 10 milligrams of apicanthin. That suggests that physicians and patients feel those doses are effective in reducing their symptoms. That's for them to judge as they integrate both symptom and assessment as well as as biomarkers and LVOP assessments.

And ultimately, the question of simplifying dose titration may frankly take care of itself if patients are doing fine on the starting dose or one dose later. And hopefully to underscore, cytokinetics believes very strongly in the credibility and integrity of how we engage around these matters. And we believe the best way to enable achieving those outcomes Your next question comes from the line of Corey Kasimov with Evercore ISI. Your line is open. Please go ahead.

Hi, this is Josh for Corey. Can you help characterize the size of the EU opportunity in relation to the US? And when do you expect to see a significant step up here? Thanks.

Sure. So I'm going to ask both Andrew and Sung to speak to that question. Starting with Andrew, please.

Thanks for the question. I've mentioned we've launched Germany. Germany is the largest market. Overall, we're expecting Europe to be around 15% of revenue when Europe's mature, when the U.S. is mature. Europe does take a little longer to get going. Germany, you can launch at approval while you're negotiating price. The other major markets you need to, after you get regulatory approval, submit to a health technology assessment body to get reimbursement, which generally takes, say, 12 to 18 months after the approval. So you'll see more meaningful revenue probably in the 2028, 2029 timeframe. And I'll turn over to Sung if he has any additional comments.

Yeah, Josh, and I'll just simply add, when you look at Europe, it's not just for us, but across our industry, it's generally characterized with long, gradual, steady launches, right? Especially as you go through the HTA process for each country, you have staggered launches. So I think you have to keep that in perspective. And in the end, this is a long game for us, and we expect meaningful contributions. from Europe. As Andrew said, it could be 15% of our total mycorrhizal net product sales. Thank you. Thank you.

Your next question comes from the line of Maxwell Score with Morgan Stanley. Your line is open. Please go ahead.

Great. Thank you very much for taking my question. Could you expand a bit more on the profile of potentially eligible NHCM patients? For example, what share of those diagnosed would meet Acacia's entry criteria, and is that kind of the right starting point for sizing the market? Thank you. Thank you.

I'll ask Steve to comment on that, please.

Hi, Max. Thanks for the question. The criteria that we implemented in Acacia really simply put our patients with symptomatic non-obstructive HCM. And the data that we presented at the ESC with particular reference to that forest plot did not show any heterogeneity of the treatment effect according to the pre-specified subgroups that we looked at. So age and sex and whether they had a particular ejection fraction or pre-existent atrial fibrillation, none of those seem to impact. The way we would foresee this being implemented should we achieve regulatory approval would be that patients would come in and if they had any symptoms and a diagnosis of non-obstructive HCM and an ejection fraction above 55 or 60%, Those patients would be eligible for a treatment trial, at least, of epicampus.

Great. Thank you. Thank you.

Your next question comes from the line of Salim Syed with Mizuho. Your line is open. Please go ahead.

Great. Good afternoon, Robert. Thanks for the question. Congrats on the progress, guys. One from us actually I know came to McCarble. So I think of the comments during the call, you mentioned you've accelerated enrollment, but the press release now lists continuing enrollment through 2027, if I'm not mistaken, versus in the 2Q was through 2026. So I'm just wondering if you could just square those. What exactly is happening with enrollment for you to change the language on when you expect enrollment to go through in 2027 versus 2026? Thank you. Sure.

I want to ask Scotty to comment on that, please. Yeah, absolutely.

You know, the language in the prior releases just referred to what was happening in 2026. You know, if you look through our milestones, it basically says what We're planning for 2026 and enrollment was continuing through 2027, rather through 2026. We didn't expect enrollment to conclude in 2026. Otherwise, we would have said that in that guidance. Obviously, enrollment won't conclude in 2026. It'll conclude sometime in 2027. And we'll give guidance to that matter when we give guidance to the rest of 2027.

Okay. Got it. Thanks so much.

Your next question comes from the line of Rowana Ruiz with LeRank Partners. Your line is open. Please go ahead.

Hey, everyone. Good afternoon. I was curious about the mycorrhizal naive prescribers. Are they more in the community hospitals rather than large academic centers or more of a mix? And in terms of greater penetration into that group, How are you thinking about driving breadth and depth and maybe converting some of them to high volume prescribers?

Andrew, can you take that, please?

Sure. So thanks for the question. Yes, they are. The majority of those, the vast majority of those are community cardiologists. The depth of those, you know, prescribers right now, you know, one to two scripts generally you see with each. I think what, you know, one, they do have less patients that they see as compared to the academic centers. So we're not expecting that same level of, you know, demand driven. But as they get more experience, I mean, what we're learning is Thank you so much for joining us. Thank you so much for joining us today.

Got it. Thanks. Sure.

Thanks for the question.

Your next question comes from the line of Eric Joseph with Citi. Your line is open. Please go ahead.

Good evening. Thanks for taking the questions. Just from your discussions with the cardiology community with the full Acacia data, can you talk a little bit about the feedback you may have received regarding the titration data? I'm just wondering, kind of going into your planned S&DA submission, whether you might be proposing a scheme that varies a bit from the protocol, focused more on positive symptom or symptom improvement rather than safety-driven stopping rules. Thanks.

Sure. As you know, we're both looking at the data from Acacia HCM as well as Forest HCM. And I'll ask both Fady and Steve to comment, please.

Eric, yeah, thanks for the question. So as Robert kind of alluded, if you think back to how we approached the obstructive HCM attrition schedule, we used data from both the randomized clinical trials of COIA and complemented that with the experience from forest HCM. And, you know, that's Part of the plan that we're implementing for the SNDA for the non-obstructive cohorts. The feedback that we've gotten so far, and it's more than feedback, it's evidence that has been generated, and actually we showed this at the investor meeting that we had after the presentation of the data in Munich, was that The implementation of the dosing schedule that was designed in forest appeared to be easier, firstly for physicians and patients due to the flexibility, and also associated with fewer adverse events than had been seen in the clinical trial. So I think the feedback that we're getting is, please can we do our very best to get that sort of titration regimen implemented in the real world, which also would actually harmonize nicely with what's already in the real world for obstructive HCM. I hope that answers your question.

It does. Great. Thanks for taking it and congrats on a good quarter. Thank you.

Your next question comes from the line of Ashwani Verma with UBS. Your line is open. Please go ahead.

Great. Thanks for the question. So maybe just wanted to get your thoughts on the competitive associations here that are not having an echo Thank you. Thanks.

So I don't want to spend too much time talking about speculation relating to another company's development program, but what I will say is that FDA can be permitting of you to do any sort of thing in a clinical trial and ultimately it'll be post availability of data and upon review of An NDA that the FDA may consider what ultimately it wants to see in a potential approval and labeling. We've experienced that firsthand. As you may recall, in Sequoia HCM, we saw no dose terminations relating to EF excursions, and it would not have been thought necessary to even have the kinds of regulatory restrictions on Those titration and echoes based on those data, but for the fact that FDA upon review thought it prudent until such time as it had real-world evidence to put in place the REMS requirements, we complied, and that's what we have now for myCORSO. I might ask Fady to comment on In the course of a regulatory review, who gets involved in making these decisions? Because it may not always be obvious to those on this call.

Yeah, in assessing these things, there are more than one division of the FDA that's involved, not just the cardiorenal division, which generally reviews protocols and, you know, efficacy and safety of clinical trials, but Also, if a question about whether REMS or not is necessary, the Division of Risk Management gets involved. They can often have a very different view than the Division of Cardiology. In fact, you can read our publicly released documents around the approval of Abhicampton and see such a discussion between the Division and the Division of Risk Management. It's hard to know what you'll see from a protocol and how that ultimately translates into a REMS or not a REMS and what the structure will be.

And I think we probably should wait until we see data before we have a discussion again. Yeah, I might ask Steve also to weigh in here.

I just wanted to add from a clinician's perspective, it's not that ECHOs are in themselves necessarily burdens them or not indicated in these patients. In fact, in the setting of obstructive HCM, if you speak to cardiologists, that's the tool that they go to in order to evaluate the effectiveness of any treatment. So I think that it is presumptuous to assume that you're going to take a patient with obstructive HCM and never get another echo on. It's the ability to be flexible as to when you need that echo and ultimately how many echoes that patient is going to require. And as Fady alluded to earlier on, what we're seeing in the clinic is that many patients are seeing their providers and exiting the titration phase with just 5 or 10 milligrams being sufficient. That's in the real world. And that's a similar story to what was seen with the EXPLORER HCM clinical trial and what subsequently occurred with Candias in the real world, where lower doses were actually seen as being the required ultimate dose for patients. So you might imagine that patients in the current environment only need one or two ECHOs on an annual basis with mycorrhizal. and it's hard to beat that especially when you put in context the fact that those echoes are already you know flexible in their requirements based on the REMS program that we have.

Hopefully that helps. I think put specifically we do believe again as a pioneer and a leader in this space as we will leverage real-world evidence, we're in a good position to ensure we continue to be the innovator in this space, even as it may relate to frequency of echoes.

Your next question comes from the line of James Kondoulis with Stiefel. Your line is open. Please go ahead.

Hey, thanks for taking our question. It's Mark on for James. A quick one from us on the So, you know, do you think the kinetics or cadence of the NHCM rollout will follow the obstructive launch? You know, basically, is OHCM the right analog here for how we should be thinking about the overall NHCM uptake or trajectory? And then, in general, do you expect anything with respect to the REMS or monitoring to change with the label expansion? Thanks.

So, before I turn it over to Andrew, I'll just underscore If approved in NHCM, my CORSA will be the first and only. And in that regard, there needs to be some education, awareness, market development, and other activities to occur, even as we will be building on the base of already a strong business and launch momentum in OHCM. But then, Andrew, do you want to add anything to that?

Sure. So we've actually thought about this a good bit, done some research. And I guess the key finding is we do expect faster uptake for existing mycorrhizal writers because they're familiar with mycorrhizal. They've used it. They're familiar with the REMs. They're familiar with the dosing and the echo requirements. So We will expect faster uptake with a subset, and that subset is those that are kind of experienced CMI users.

You also asked about REMS, and maybe I'll ask Fady to comment on how we may be approaching REMS for the FNDA relating to NHCM.

So, I mean, the things that you monitor in NHCM are the same things that you monitor for in OHCM. As the patients have gone into porous, they essentially follow the same timing, the same cutoffs for whether they've down titrate or they have interrupt run, things like that. So, we would hope that there would be minimum changes to the way the REMS is currently implemented, but, of course, that will Negotiation with FDA.

Thanks. Your next question comes from the line of Kripa Devarakonda with Truist Securities. Your line is open. Please go ahead.

Hi, thanks for taking our question. This is Alex on for Kripa. We wanted to know ahead of the launches in the additional XUS markets next year, Can you provide any color on the discussions that you've had with prescribers and how would you classify the physician appetite for mycorrhizal versus how much additional physician education may be needed to drive growth in the market? Thanks.

Your question relates to Europe specifically?

Yes. Yeah.

Okay. Andrew, do you want to take that on as we are approaching launches sequentially country by country?

Certainly. So we've submitted every dossier in all the major countries in Europe. We're expecting, as we said, to launch in every major market. We've spent more time on the major markets, you know, think Italy, Spain, France, UK, Germany, although we've certainly spent time on the Western European markets. We have teams in place in Europe. Medical colleagues that are field-based. We have our general management teams, our marketing teams. We've done market research. So we're expecting uptake similar to what we see in Germany. In Germany, in five or six months, for neuter brand, our market leaders are doing very well. You have to also remember that in Europe, there is not a REMS. program associated with launch. There's not patient support. Once you get payer access, there generally isn't that much of a barrier from an access point of view. That's why you do negotiation. So it is a country by country launch. The price is lower, but we are expecting good uptake and we are seeing from our research physicians seeing a clear differentiator like we're seeing in Germany.

Your next question comes from the line of Alethea Young with William Blair. Your line is open. Please go ahead.

Hey, guys. Thanks for taking my question. I think that's on all the progress, you know, with my course. I just wanted to dig a little bit more into how when we're thinking about kind of the opportunity, how broad it could be for perhaps in the second half of the year. The benefit of potential first-line use and having that label, just talk a little bit about how you think that will frame for doctors and also just ultimately when you get to a broader label, potentially non-obstructive. I mean, do you think that's kind of what doctors are looking for is like a one-stop shop answer perhaps?

Yeah, so Andrew can comment on some of the market research that he's done in and around this area and what the addition of NHCM may mean both across O and N HCM. Andrew, please.

Sure. So you're saying the second half, are you referring to the fourth quarter or are you talking about next year? Just want to make sure I'm clear on your question.

Next year, I'm not obstructive. Fourth quarter for first line.

I see. Okay. So if we're not obstructive, you know, as I mentioned, it's the same size of market overall as O HCM, although obviously there's two players in the market today. For a non-obstructive, if we're approved, we would be the first and only. And, you know, from our research, especially in the community, physicians are looking for more of a one-stop shop. They did talk about Fester uptake. They did talk about having experience and with a dual indication both for O and N to drive share. On the maple side of things, we're not looking for a monotherapy or first-line therapy. We're really looking to generate evidence from what is in the guidelines today and what most community cardiologists consider that Metoprolol specific beta blocker really has been the standard of care and showing them the difference in data as well as educating patients that are taking metoprolol that there's you know potentially something better assuming we get our you know that in the label and everything this year so I think both of those are going to be a lift obviously the NHM is a much broader lift from a revenue opportunity. You know, Maple, the direct really just extends our differentiation and I think gives us some good data to educate community cardiologists on. Thanks for the question.

Great, thank you. Your next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is open. Please go ahead.

Hi, team. Thank you so much for all the updates. Maybe you would love to understand with maple coming onto the label, how soon it could actually change the pair's views on actually removing the requirement of being on a beta blocker and making Mycorsa is the first choice and therefore could increase the potential TAM of patients. An uptake would appreciate your color.

Sure. So certainly as we hope the Maple data will be reflected in an expanded label, that's one step towards the objective that you mentioned. But payers may have their own agenda. And I'll ask Andrew to comment on What may factor into payer decisions, including as ultimately may be enabled by changes in guidelines?

Thanks for the question, Yaz. We're not expecting, nor are we pushing first line. You know, beta blockers are going to have a place. I think every cryo-auth criteria I'm aware of from a payer point of view, beta blocker use or prior beta blocker use is required. So we're not looking to change that. We're really looking to accelerate use of mycorso. We're looking to help inform guidelines. I think that'll have a bigger influence both on community cardiology and perhaps payers over time. Thank you so much for joining us. Thank you.

Your next question comes from the line of Josh Brewer with RBC Capital Market. Your line is open. Please go ahead.

Hey, Josh Schoenfer, Leo Timashev here. Thanks for taking my question, guys. I was wondering, how should we think about expectations for the HF-PATH data for Euler-Campden in 27? And how do you plan to share those data across the cohorts? Thanks so much.

Certainly. So, obviously, this is early in a development program for Euler-Campden and HF-PATH, and we're very interested in understanding in this first phase two study what that might look like from a PK and PD standpoint. Maybe I'll turn it over to Fady to speak about cohort one and what we may be communicating.

Yeah, I think in 2027, we will have data from cohort one. You know, cohort one is really a dose finding exercise and understanding safety and tolerability. So the data from that may just be summarized in one of our calls as we describe progress. Ultimately, you know, we always try to get those data out into the public domain, but we don't have a specific timeline or plan for that.

Your next question comes from the line of Yanan Ju with Wells Fargo. Your line is open. Please go ahead.

Great. Thanks for taking the OHCM launch. Now that you are getting close to the 50% goal for year-end in terms of new-to-brand share, I was wondering, looking into 2027, If there are any expectations for this metric, and if there are any reasons why this couldn't be further increased substantially. And then, so that's on the new brand side of things. In terms of switching, could you give any color in terms of the percentage of prescriptions this quarter that are switching patients? Thank you.

Sure, so I'll start and turn it over to Andrew. Obviously, it was already a very bold statement we made earlier this year that we would be committing to a goal of north of 50% of due to brand share and at the same time experiencing such significant category growth. Andrew, do you want to comment on what may be our objectives from this point forward?

So I mean, we're very focused on the new to brand share of, you know, greater than 50%. I think a good leading indicator, our share, if you look at the different segments, our share among the highest writers, what we call velocity accounts, you know, that was historically 80% of the business were pretty close to 50 already with that group. So I think that's a good leading indicator, given that's a majority of the volume. So When you look into 2027, I think we're really going to be looking at establishing a stronger foothold, growing that 50 to beyond 50. But at the same time, that expanded prescriber base, leveraging Maple before Acacia would come on, assuming Acacia gets approved, that's really what we'll be focusing. We'll focus on continuing to build share in that area. who are velocity accounts while expanding the markets to these naive prescribers. Those that have started to prescribe increased depth, those that haven't, you know, leverage Maple, leverage Sequoia to start to get experience and then assuming a case that gets on board, you know, then as I mentioned earlier, that kind of doubles the patient base for each one of these groups. and we will continue to look to expand prescribing there. So that's really kind of how we're thinking about 2027 beyond the successful ones we've had to date.

Great. Any comments on the switching?

Oh, the switching, sorry. Yeah, switching is mid-single digits. So it's not a major factor. It's not something we promote. It's not something we discuss. That's really between a physician and a patient. and it's not a major driver for us it's you know again mid single digit percent of our overall patients came from switches.

Yeah and in terms of growing the category you can expect more publications from more patients longer in the open label extension study forest and as it relates to switching there is a study underway that is a investigator initiated study that may inform Great.

Thanks for all the cover.

Your next question comes from the line of Jason Zemanski with Bank of America. Your line is open. Please go ahead.

Good evening. Congrats on a strong quarter and I appreciate you taking our question. Maybe to connect a few dots here, you framed category growth at 3,000 new patients a quarter today. I guess, what do you see as the main hurdle to expanding the patient funnel before NHCM? Is it primarily expanding the prescriber base? Is it access? Is it patient activation? And when could we see the run rate inflect? Is this a 2027 event, or is it NHCM, the real catalyst? Thanks. Sure.

This is four years into this category. As you know, Cam Zayas preceded us. And now with my Corso in this market, it's a reasonable ask, when might we see an exponential inflection in that growth? So Andrew, do you want to comment on those things?

Sure. So I think in terms of uptake, I don't really see an impediment at launch. There's a pretty good prescriber base now. There's several thousand prescribers in the CMI category. We have over a thousand prescribers and growing Thank you for joining us. Thank you so much for joining us. We really need to continue as a category to expand those prescribers. Acacia, again, as I mentioned, doubles their patient population. I don't want to put a date on it, but I think that is the inflection point where you get enough of these expanded prescribers that have three or four patients each. They've gained enough experience, and they're at the point now where they feel comfortable Thank you for joining us. and it's been as cardiology launches often go for several years linear but I do think we will see an inflection point. Hopefully that answers your question.

But also to your question in terms of headwinds and impediments we've come a long way from the types of conversations we would have on these calls relating to REMS and differentiated REMS and whether that would itself be a major impediment and what we're seeing already just in these relatively short few quarters since myCORSO has been available is a significant expansion of the prescriber base of those that were low volume prescribers as well as those that were never prescribers and I do think that's underscoring how our positioning in this category has driven category growth and

Your next question comes from the line of Amin Cheherly with B. Reilly Securities. Your line is open. Please go ahead.

Good afternoon, team. Congratulations on the quarter. This is Amin on for Mike Montani. I had a question for Fady. Acacia showed the strongest effect in patients with, I guess, higher NT-proBNP and preserved filling pressure physiology. You also put some real numbers behind that on the diastolic side. I guess, how has that informed patient selection and dosing in AmberHealthPath? And with cohort one completing enrollment this quarter, how should we think about what you would need to move Ula Kempton into a pivotal? Thank you so much.

Yeah, I think that when you look at the forest plots for Keisha HCM, I wouldn't say there's any strong driver. I have to go back but I don't think it's maybe as strong as you're stating. Of course, we know that higher NC-proBNPs generally imply greater filling pressures, larger left atrial size. Those things are positively impacted by cardiac myelin inhibitors and NHCM and certainly inform our patient selection for a trial like AMBER. So, you know, we've had NT-PRO-BMP criteria in an AMBER that we have. So I think, you know, figuring out the right patient population and FPEP is one of our goals. And you may see the cohort one data pointing us in the same or different direction. We'll adapt as we begin to hone in on where we think the MOA may be useful.

But it is to a competitive advantage as we think about how best to design a study in HFPEF that we have the benefit of the Acacia results given where there is a blurring of the lines in some respects between some of the patients who have NHCM and where we're pointing to with eulachemptin in HFPEF.

Your next question comes from the line of Serge Belanche with Needham. Your line is open. Please go ahead.

Hi, good evening. Thanks for squeezing me in. Maybe a question for Andrew. May have missed this in your prepared comments, but just the level of swishing that you saw this quarter from Cam Zayas to Mike Corso, you know, whether it was stable and whether it's behind The down take that they reported in sales in the third quarter in the U.S. last week. Thanks.

Sorry, the switching.