Q3 2025 Cytokinetics Inc Earnings Call

Speaker #1: Thank you for standing by and welcome to the CYTOKINETICS INC Q3 2020 Earnings Conference Call . This call is being recorded and all participants are in a listen only mode .

Speaker #1: After the speakers 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 that time , simply press the star followed by the number one on your telephone keypad .

Speaker #1: If you would like to withdraw your question , press star one again . Once more , I would now like to turn the call over to Diane Weiser CYTOKINETICS INC , Senior Vice President of Corporate Affairs .

Speaker #1: Please go ahead .

Speaker #2: Good afternoon , and thanks for joining us on the call today . Robert , President and Chief Executive Officer will begin with an overview of the quarter and recent developments .

Speaker #2: Andrew Callos EVP and Chief Commercial Officer will address commercial readiness activities for AFI canton Fady Malik , EVP of R&D , will provide updates related to the clinical Development program and Medical affairs activities for AFI .

Speaker #2: Camden , Stuart Kupfer , SVP and Chief Medical Officer , will provide updates on the Clinical Development program for Omecamtiv , Mecarbil and Camden .

Speaker #2: Sung Lee , EVP and Chief Financial Officer , will provide a financial overview of the past quarter . And finally , Robert will provide closing comments and review our expected key milestones for the remainder of 2025 .

Speaker #2: Please note that portions of the following discussion , including our responses to questions , contained statements that relate to future events and performance rather than historical facts , and constitute forward looking statements .

Speaker #2: Our actual results may differ materially from those projected in these forward looking statements . Additional information concerning factors that could cause our actual results to differ materially from those in these forward looking statements is contained in our SEC filings , including our current report regarding our third quarter 2020 financial results filed on form AK .

Speaker #2: That was furnished to the SEC today . We undertake no obligation to update any forward looking statements after this call . Now I will turn the call over to Robert .

Speaker #3: Thank you . Diane , and thanks to all for joining us on the call today . The past quarter was highly productive and defining for Cytokinetics .

Speaker #3: We made significant progress across the company's priority objectives as we advance towards the end of the year , when we hope to achieve our first potential FDA approval of AFI .

Speaker #3: Campton for patients with Ohcm , our major accomplishments this past quarter were dedicated to preparing for that milestone , including continuing constructive engagements with FDA , completing key commercial launch readiness activities , and fortifying our capital structure .

Speaker #3: During the quarter , we held our Late Cycle meeting with the FDA as we previously disclosed during the meeting , we discussed our proposed Rems program , including elements to assure safe use or Etsu , as well as anticipated Postmarketing requirements .

Speaker #3: Prior to the meeting , we had received FDA's responses to our proposed Rems and label for AFI , Campton , and based on our exchanges and discussions with FDA to date , we continue to expect a differentiated label and risk mitigation profile for AFI , Campton , if approved by the FDA , we've completed all GCP inspections by the FDA with no observations , noted .

Speaker #3: Moreover , to date , we have not been notified of the intention of FDA to conduct pre-approval inspections . We look forward to continuing our dialogue with FDA ahead of the Paducah date .

Speaker #3: In recent months , we've also leaned further into commercial readiness with the onboarding of our commercial field sales colleagues and the . Finalization of promotional campaigns and patient support programs with objective to further differentiate how we show up commercially .

Speaker #3: At the same time , in Q3 , we achieved an important clinical milestone within the development program for AFI , Campton . We presented the positive primary results from Maple HCM , which demonstrated superiority of AFI Campton to metoprolol in patients with Ohcm challenging the long held status quo of treatment .

Speaker #3: In this disease . Our intention is to file a supplemental NDA for Maple HCM following its potential initial FDA approval . But in the meantime , we believe these results may help catalyze certain prescribers and help unlock more of the market upon the initial introduction of AFI , Campton , as may result in increased commercial launch velocity , following closely behind the potential approval and launch of AFI , Campton in the United States is the expected potential approval of AFI Campton in the EU during the quarter , we received the day 120 list of questions from the EMA and we subsequently submitted our responses .

Speaker #3: More recently , we've continued EMA interactions and we're preparing day 180 responses . We're encouraged by ongoing interactions , and we expect a final decision from the European Commission in the first half of next year .

Speaker #3: Even possibly on the earlier side of the year . Given the pace of our review to date . In parallel , our European launch readiness activities are well underway , focused on market access planning , medical education and engagement with the cardiology community , and to ensure a strong foundation for a successful introduction of AFI Campton in Europe .

Speaker #3: We also continue to work closely with Sanofi to support the potential approval of AFI Campton in China . To further broaden the global opportunity and reinforce our commitment to making this therapy available to patients worldwide .

Speaker #3: To achieve all of this , we're fortunate to have a strong balance sheet , which we further bolstered during the quarter through our convertible note offering .

Speaker #3: A song will elaborate this transaction helped not only to provide additional capital at this important time , but also financial flexibility . And lastly , we continue to build momentum across our broader pipeline at this important inflection point in our corporate development , reflecting our ongoing commitment to sustained innovation and longer term growth .

Speaker #3: With that , I'll turn the call over now to Andrew . Please .

Speaker #4: Thanks , Robert . We continue to make strong progress with commercial readiness activities toward the potential FDA approval of next month . As Robert mentioned , our interactions with the FDA to date have reinforced our expectations for a differentiated risk mitigation profile anchored in Rems and label , and we have confirmed our go to market plans and promotional campaign following anticipated approval in December , our launch process will begin immediately .

Speaker #4: Within days , our website patient Navigators , Patient Support Services will go live to begin supporting physicians and patients on their treatment journey .

Speaker #4: Shortly thereafter, in early January, our fully trained cardiovascular sales and medical teams will be in the field engaging healthcare professionals with a full commercial launch, inclusive of product availability and REMS operations to follow to ensure a seamless and impactful launch.

Speaker #4: We've invested deeply in assembling the right team and creating the right infrastructure over the last several months. We've built a strong and highly experienced cardiovascular sales team, with our field sales representatives averaging over 20 years of industry experience and 14 years of cardiovascular experience.

Speaker #4: These are seasoned sales professionals who understand the nuances of launching a new medicine in a specialized market . Our sales team is on board and completing training to ensure that our full team will be prepared to begin HCP engagement within days of FDA approval , a subset of our sales team has already been in the field since early September , introducing Cytokinetics to key oh HCP and providing disease education to our launch strategy and consistent with the value in our vision of a differentiated , patient centric treatment experience , one that has been built from the ground up , specifically for AFI , Campton .

Speaker #4: Our approach is designed to be simple and integrated across all touchpoints for both Https and patients . At the heart of this model is a highly qualified team of patient navigators who will serve as a central point of contact throughout the patient journey .

Speaker #4: These navigators are also on board and have completed their training , or are completing their training and preparations ahead of their anticipated approval .

Speaker #4: To ensure readiness , we've developed a distinct and compelling promotional HCP campaign that highlights a differentiating characters of AFI , and key attributes of our Rems program .

Speaker #4: We believe this campaign will clearly communicate the clinical value of AFI , Campton and support broad awareness among cardiologists ahead of launch . We continue to engage with payers to educate them on the evidence from our clinical trial , as well as the clinical and economic burden of HCM .

Speaker #4: We remain confident in our ability to . Keep parity access by the second half of 2026 . Importantly , our strategy is comparable access with focus to differentiate based on the clinical profile of AFI , Campton .

Speaker #4: Our Rems program and our comprehensive bespoke patient support services . As we stand , several weeks out from our potential approval , I'm pleased with our commercial preparation and launch readiness , and I'm confident in our ability to execute quickly and effectively .

Speaker #4: If the captain is approved, as we look ahead to measuring the pace and velocity of our launch after approval, we will focus on a few key metrics.

Speaker #4: First , HCP Prescribing breadth as measured by the number of Hcp's who are actively writing prescriptions . Second , prescribing depth as measured by the volume of prescriptions in ASAP , Rif raff canton to achieve rapid uptake , we will quickly engage existing CMI prescribers with an eye to expanding the prescribing universe to those who treat HCM , but have yet to prescribe a CMI more specifically , our goal for our fuel based cardiology specialists was to reach nearly all the estimated 658 .

Speaker #4: GPS , who are approximately 80% of the Acme prescribing to date . Within the first few weeks of January . And third metric is the volume of patrons on AFI campaign .

Speaker #4: We will be closely monitoring and supporting patient uptake , including time of conversion to commercial drug adherence , compliance and persistency . These measures will provide us early insights into the speed and trajectory of our launch .

Speaker #4: Its rate of change in overall strength of our commercial execution focused on category growth and overall . Preferential share in an expanding market .

Speaker #4: Finally , our attention is not only on the US , but also in the EU , where we've made meaningful progress in preparing for potential commercial launch of applicant in that geography .

Speaker #4: We recently hired a general manager for Italy alongside colleagues that are already on board in the UK . France and Germany and also began recruiting and hiring our full German commercial team , inclusive of our field sales reps .

Speaker #4: In addition, we are preparing dossiers for upcoming discussions with HTA bodies across key EU countries, with potential EMA approval expected in the first half of 2026.

Speaker #4: We remain on track for a launch in Germany in the first half of 2026 , with other geographies to follow in 26 and 27 .

Speaker #4: With that , I'll turn the call over to Fatty .

Speaker #3: Thanks , Andrew .

Speaker #5: During the quarter , we were pleased to have presented new data that further reinforces the differentiation of AFI , Campton and its potential for patients with HCM , most notably at the ESC Congress .

Speaker #5: We presented positive primary results from Maple HCM , which were simultaneously published in the New England Journal of Medicine . The results , which showed superiority of Campton to metoprolol , represent a watershed moment in the treatment of ohcm .

Speaker #5: While patients treated with Afghanistan experienced a significant improvement in exercise capacity , those on metoprolol showed a decline challenging the long standing rationale for beta blocker use as the standard of care therapy .

Speaker #5: In this disease . This finding has resonated strongly across the cardiology community . As we heard firsthand from many healthcare professionals and key opinion leaders on site at ESC .

Speaker #5: In addition to improving exercise capacity , Campton also produced large improvements in symptoms , gradients and cardiac biomarkers as compared to metoprolol . Improvements were consistent across all prespecified subgroups and in confidence .

Speaker #5: The robustness of the findings . Importantly , adverse events were similar in the two groups and the safety of Campton observed in Maple .

Speaker #5: HCM was consistent with previous studies . To that end , does the evidence of Campton expand ? So too does our confidence in its consistent safety profile .

Speaker #5: An updated integrated safety analysis representing nearly 700 patient years of exposure from Redwood HCM , Sequoia HCM forest HCM and now Maple HCM , as well .

Speaker #5: Happy Campton was shown to be well tolerated with a low incidence of Lvef less than 50% over extended periods of exposure with no occurrences associated with a serious event of heart failure .

Speaker #5: Long term treatment with Campton has also been shown to not be associated with an increased risk for atrial fibrillation . Looking ahead , coming up this month at the Scientific Sessions , please have three late breaker presentations with additional data from Maple HCM providing new insights into these results with respect to the ongoing clinical trials program for Campton , the next major data milestone for us will be the readout of Acacia HCM , the pivotal phase three trial in HCM .

Speaker #5: We completed enrollment to the primary cohort excluding Japan , in the first quarter of 2025 , and we now expect to report the top line results from this cohort of Acacia HCM in the second quarter of 2026 .

Speaker #5: During the third quarter , we completed enrollment of patients in the Japan cohort closing enrollment of Acacia HCM worldwide . If the results of a KC , Acacia HCM are positive , it represents an opportunity to address the needs of a highly underserved patient population and an important opportunity to expand the therapeutic impact of Campton .

Speaker #5: Our belief in the therapeutic potential of Campton in HCM is founded in the existing body of evidence from the HCM cohort of Redwood HCM and strengthened by their longer term follow up in the forest .

Speaker #5: HCM trial . As recently reported at the heart Failure Society of America meeting in late September , we presented new data covering at least 96 weeks of treatment in these HCM patients .

Speaker #5: What you saw , albeit in an open label setting , was that 79% of the patients treated with Campton improved by at least one functional class .

Speaker #5: Patients also had a mean increase in their kccq clinical summary score of 11.2 points , as well as improvements in cardiac biomarkers . Few patients experienced Lvef less than 50 and all instances were reversible after Downtitration or a short treatment interruption .

Speaker #5: We are hopeful that these data may be replicated in the results of Acacia , given the similarity in patient populations and dosing scheme involved alongside our clinical research , our medical affairs organization has been very active .

Speaker #5: Engaging the HCM community broadly as we prepare for launches in both the US and Europe , they conducted recent advisory board meetings in the US and Europe and met with the ACM Community of physicians at ESC and Hfsa , alongside institutional visits in their territories .

Speaker #5: Our team of therapeutic medical scientists in Germany is in place , and we now have medical directors located in Germany . The UK and France , supported by our regional group located in Switzerland .

Speaker #5: Our field team in the U.S. has now also partnered with their newly hired sales colleagues. We will compliantly conduct introductory meetings with key opinion leaders and healthcare professionals.

Speaker #5: Now I'll turn it over to Stuart to provide updates on our ongoing clinical trials in heart failure . Thanks , Matti .

Speaker #6: During the quarter , we continued conduct of the confirmatory phase three clinical trial of Omecamtiv Mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction less than 30% .

Speaker #6: These are patients who remain at high risk for frequent hospitalization and mortality despite receiving maximally tolerated guideline directed therapies . Common HF is designed to confirm the findings of the positive phase three clinical trial Galactic-hf .

Speaker #6: In a more severe HFrEF population, in whom we believe this mechanism may be able to deliver greater cardiovascular risk reduction, we conducted an investigator meeting in Europe in October, which revealed tremendous enthusiasm for ADHF.

Speaker #6: Many of the investigators had participated in Galactic-hf , and it was really wonderful to see their continued enthusiasm for the potential benefits of Omecamtiv .

Speaker #6: Mecarbil . We now have over 75% of sites in North America and Europe activated and are continuing to activate sites around the world .

Speaker #6: We expect to continue patient enrollment and accommodate into 2026 . We also continued to conduct Amber Hf-pef , the phase two clinical trial of Hampton in patients with symptomatic heart failure with preserved ejection fraction of at least 60% by inhibiting cardiac myosin to attenuate hypercontractility .

Speaker #6: Ulick Hampton is uniquely positioned to address the underlying diastolic dysfunction in this subgroup of HFpEF patients . Hf-pef represents approximately half of all heart failure cases and remains an area of high unmet need with limited treatment options .

Speaker #6: Enrollment in amber is progressing , and we expect to complete cohorts one and 2 in 2026 to inform FDA interactions and the decision to proceed towards potential registrational studies .

Speaker #6: We're pleased with the continued execution of these ongoing clinical trials . Each in a different form of heart failure , which reflects our continuing commitment to further advance innovative medicines within our specialty cardiology franchise .

Speaker #6: And with that , I'll pass it to Seung .

Speaker #5: Thanks , Stuart . We're pleased to report our third quarter of 2025 financial results , starting with the balance .

Speaker #3: Sheet .

Speaker #5: We finished the third quarter with approximately $1.25 billion in cash and investments ,

Speaker #7: Compared to $1 billion at the end of the second quarter of 2025 . Our cash and investments increased quarter over quarter due to the net proceeds of $327 million received from the issuance of $750 million aggregate principal amount of the convertible senior Notes due 2031 , and a concurrent exchange of $399.5 million .

Speaker #7: Aggregate principal amount of our 2027 notes . These transactions together accomplish our goal of providing the company with financial flexibility ahead of the potential launch of Appy Captain for Okm .

Speaker #7: Excluding the net proceeds received from this transaction , our cash would have declined by approximately $112 million quarter over quarter in October , we received proceeds of $100 million from the tranche five loan provided by Royalty Pharma , which will enable us to finish 2025 with approximately $1.2 billion in cash and investments .

Speaker #7: R&D expenses for the second quarter were $99.2 million , compared to $84.6 million for the same period in 2024 . The increase was primarily due to advancing our clinical trials and higher personnel related costs , including stock based compensation .

Speaker #7: Ghana expenses for the third quarter of 2025 were $69.5 million , compared to $56.7 million for the same period in 2024 . The increase was primarily due to investments toward commercial readiness and higher personnel related costs , including stock based compensation , net loss for the third quarter of 2025 was $306.2 million , or $2.55 per share , compared to a net loss of $160.5 million , or $1.36 per share , for the same period in 2024 .

Speaker #7: The net loss for the third quarter of 2025 includes the debt conversion expense of $121.2 million due to the induced exchange of $399.5 million of aggregate principal amount of the 2027 notes .

Speaker #7: Turning to our financial guidance, we are narrowing our full year 2025 GAAP operating expense range to $680 million to $700 million, from the previous range of $670 million to $710 million.

Speaker #7: Stock based compensation that is included in GAAP operating expense is expected to be between 110 million and $120 million , excluding stock based compensation from GAAP operating expense results in a range of 560 million to $590 million .

Speaker #7: As we near the close of 2025, we have taken important steps to add flexibility and strength to our balance sheet. This positions us well ahead of the due date for Abbey Camden in the U.S.

Speaker #7: Potential approval in the EU in the first half of 2026 , and the readout of results from Acacia HCM expected in the second quarter of 2026 .

Speaker #7: With that , I'll hand it back to Robert .

Speaker #3: Thank you, Sun. This quarter, we made substantial progress across the company. We reported additional data that continues to validate our pioneering and leading science and reinforce the differentiated profile of AFI Campton.

Speaker #3: While also finalizing our commercial launch readiness and maintaining momentum across our pipeline . These accomplishments underscore the focus , rigor , and dedication of our teams as we move closer to the most important milestone in our company's history .

Speaker #3: To help us prepare for this pivotal phase in the company's evolution , we were pleased to welcome James Daly to our Board of Directors during the quarter .

Speaker #3: Jim brings more than 30 years of global biopharma commercial leadership experience , including long standing senior commercialization expertise from his time as Chief Commercial Officer at Incyte and in senior commercial roles at Amgen .

Speaker #3: Alongside now board roles at leading commercial biopharma companies . We look forward to his guidance and oversight . Now as a board member at Cytokinetics .

Speaker #3: As we approach our first potential FDA approval at Cytokinetics , I want to thank our employees , our partners , and our shareholders for their continued trust and support .

Speaker #3: We're approaching a pivotal moment in our company's history . Standing at an important threshold after many years of disciplined investment in our science pipeline and infrastructure , as well as capital structure .

Speaker #3: And that will enable our planned transition to a fully integrated commercial company at this juncture , we are not spectators , but instead we are active participants in shaping the next chapter for our company .

Speaker #3: Our near-term focus remains on potential regulatory approvals and commercial launch , and velocity . I'm confident in the strength of our teams and the clarity of our shared vision .

Speaker #3: Now translating to execution . With that , I'll recap our upcoming milestones for Camden . We expect to advance NDA review activities with FDA to support the potential US approval of Camden by the end of the year .

Speaker #3: We expect to advance go to market strategies and continue launch preparations for Camden in the United States . We expect to continue go to market planning in Germany and expand commercial readiness activities in Europe .

Speaker #3: In 2025 and in in preparation for potential approval of Camden by the EMA in the first half of 2026 . We expect to continue to coordinate with Sanofi to support the potential approval of Camden in China , pending approval by the Nmpa , and we expect to report top line results from the primary cohort of Acacia HCM in the second quarter of 2026 and continue patient enrollment and conduct of the adolescent cohort in Cedar , HCM into 2026 .

Speaker #3: For Omecamtiv Mecarbil, we expect to continue patient enrollment and conduct of COMET-HCF through 2026 for ULA. We expect to continue patient enrollment and conduct of AMBER HF-PEF through 2026.

Speaker #3: And finally , for preclinical development and ongoing research , we expect to continue ongoing preclinical development and research activities directed to additional muscle biology focused programs and operator with that , we can now open up the call to questions , please , certainly .

Speaker #1: And thank you . Ladies and gentlemen , joining today , if you would like to ask a question , live over your line , simply press star and one on your telephone keypad .

Speaker #1: If you find your question has been asked and you wish to remove yourself , repeat the steps of star and one , and that will also remove you from our queue .

Speaker #1: Once again , ladies and gentlemen , that is star and one . And we ask today that you please do limit yourself to a single question .

Speaker #1: We'll hear first from the line of Gina Wang at Barclays .

Speaker #3: Thank you Gina .

Speaker #8: Hi . Good afternoon . I have tons of questions on , you know , approval , but I will save that for my peers .

Speaker #8: So I will ask one question regarding Acacia data . I think you did mention that the

Speaker #8: coming out in two Q 26 . So you know , telephone as like a we remember that you add a pvo2 as a dual primary endpoint per regulatory feedback from Europe .

Speaker #8: And Japan . So technically the drug should receive approval as long as you hit one of the two primary endpoints . So but in the case of a missing pvo2 , do you anticipate any issue of approval in Europe and Japan ?

Speaker #8: I assume the U.S. will be totally okay as long as you're hitting one endpoint.

Speaker #3: That's fatty to respond to that .

Speaker #5: Yeah . Hi , Gina . You know , I think it's really difficult to know what will guarantee approval or not . Obviously it depends on the magnitude of the other result .

Speaker #5: It depends on safety profile , depends on lots of things . But I think , you know , the trial will be considered positive based on our statistical analysis plan of either endpoint is positive , but you'd like to see them at least minimally moving in the same direction you'd like to see magnitudes that , you know , we think are clinically meaningful , like see consistency across the other endpoints .

Speaker #5: So I think all of those things go into regulators evaluation of whether trial not only with statistically significant , but represents a clinically meaningful therapeutic in the field .

Speaker #8: Thank you .

Speaker #1: Our next question today will come from the line of Salim Sayed at Mizuho .

Speaker #9: Great . Good afternoon . Hey . Good afternoon Robert . Thanks for the question . I'll also ask one on Acacia . Just given the amount of attention this trial receiving and sorry for the granularity around the p value here , but fatty , so the acacia trial p value is split .

Speaker #9: So as I understand it between kccq and peakvo2 both at 0.025 . So equal . And if one wanted to play devil's advocate for a second here , just curious , why is that the better strategy at this point versus what Odyssey had , which was weighted to kccq at 0.04 and came in with a p value of 0.06 , which was close to hitting , and also a better p value than what we saw with in Odyssey .

Speaker #9: With their peak VO2 measure and the trial only needed again , statistically , one measure to hit to be successful . And to that point , while the study is still blinded , if you wanted to , could you change the weighting between the two endpoints in Acacia before unblinding the results ?

Speaker #9: Thank you .

Speaker #5: I again , I kind of go through the . What I said earlier is that any positive result is not necessarily a meaningful result .

Speaker #5: You could . I think you know the Odyssey trial , it missed and the Kccq Delta was two to 2 or 3 . I can't remember the exact number , but pretty modest .

Speaker #5: And I doubt would if you if you consider the magnitude of effect , would be that compelling to to regulators . So we propose , you know , we powered this trial at 0.025 for each based on what we think is a solid clinical effect at Kccq .

Speaker #5: That's five points . And with Peakvo2 , it's a improvement by 1.0 . Now that power powering the trial is powered at 90% power for each of those magnitudes .

Speaker #5: Doesn't mean that the trials positive only if we reach those magnitudes . The you know , the minimum . I guess positive difference for either of those endpoints as substantially smaller and gets into the range of , you know , where it's probably debatable if whether whether the size of the effect is meaningful or not .

Speaker #5: So we think we have adequately powered each endpoint . We think , you know , allocating the alpha equally provides us an opportunity to win the best on each endpoint .

Speaker #5: And , you know , at this point , I don't anticipate us making any changes to that .

Speaker #1: Our next question will come from Akash Tewari at Jefferies .

Speaker #3: Hey , cash .

Speaker #10: Hi , guys . This is actually Zaki on for Akash . Thanks so much for the question . So just again on Non-obstructive , you've talked about how Bristol's Odyssey study had an outlier placebo .

Speaker #10: And to us it almost seems like there's standard deviation on kccq in particular came in higher than they expected in their protocol . So for Acacia you've chosen to keep the trial actually at a similar size as Odyssey with an even more aggressive alpha split .

Speaker #10: So I just want to know , in terms of what you're seeing on blinded variability , what gives you confidence . That one , you're not underpowered versus Odyssey .

Speaker #10: And two , that placebo is actually tracking in line with your expectations around that five point placebo adjusted delta on kccq . Thank you .

Speaker #5: Well , I think your last point is impossible to answer because we're blinded . So we don't know what the placebo placebo effect is in Acacia .

Speaker #5: You know , we do monitor the very ability of the combined data set . And the for now , the variability appears to be within our assumptions .

Speaker #5: So I think we're adequately powered based on the global variability . And you know again I'll just say that the the variability that we've observed in the kccq and several trials that we've run using that metric is generally in about 15 point range , which , you know , is tracked with Sequoia .

Speaker #5: It's tracked with other trials we've done in that area . And I think in Asia , it's not really any different at this point .

Speaker #5: So I think we're , you know , tracking along our assumptions . And for now , you know , we'll just let things play out , see how they how they read out next year .

Speaker #3: You know , I might also underscore that variability is a function of a number of factors , including experience in the course of conduct of studies such as this .

Speaker #3: And please understand that we believe that one way to manage variability , as we have done , is to go to centers with ample experience conducting clinical research using ethical and as has already been historically validated in our prior studies .

Speaker #3: So we do believe that's something that serves to our favor .

Speaker #1: Our next question will come from Carter Gould at Cantor Fitzgerald .

Speaker #11: Hi , Robert and team . Good afternoon and thanks for taking the question . Maybe I'll give Acacia a break for a minute .

Speaker #11: Andrew detailed a lot of metrics that you'll be watching . Which of those metrics are you likely to share with the investment community and any of those I can get you to commit to today and do anticipate blocking third party prescription data during the launch .

Speaker #3: Thank you . Andrew .

Speaker #4: Sure . So those three metrics I talked about in terms of prescribing breadth and depth as well as . Volume of patients is what we plan on sharing .

Speaker #4: No , we're not going to give targets and share what those would be relative to data . This is a very limited distribution .

Speaker #4: You know , the Rems drives that as well . The specialty pharmacies , there's two of them will not report data . We will report that on that quarterly basis .

Speaker #4: There are also pharmacies that will be qualified . You know , IDM pharmacies through large healthcare systems . Many of those will be reported through syndicated data .

Speaker #4: But that'll be a very small portion of our overall volume . You know , maybe around 20 to 30% or so . So if you looked at syndicated data from Iqvia or Symphony or one of those sources , you're not going to see anywhere near the complete picture .

Speaker #4: But we certainly will give that picture on a quarterly basis .

Speaker #1: Our next question .

Speaker #4: Is .

Speaker #1: From our next question will come from the line of James at Stifel .

Speaker #12: Hey , thanks for taking my question . How's it going ? I like to ask one on back to Acacia and again on on blinded data .

Speaker #12: I was curious how much of a line of sight do you have on ? Kind of like blinded safety data and maybe what the Lvef less than 50% rate looks like ?

Speaker #12: Obviously not anything specific , but like how it compares to , say , what you saw in Sequoia and Obstructive . Just curious if there's any color there .

Speaker #12: Thank you .

Speaker #5: Yeah , I'm going to , you know , tread carefully here . I don't I'll just say that , you know , there's nothing out of the blinded data that are unexpected based on what we've seen so far .

Speaker #1: Moving on . We'll hear from Cory Kasimov at Evercore .

Speaker #3: Hey , Cory .

Speaker #13: Hey . Good . Hey , Robert . Guys . Good afternoon . Thanks for taking the question . So I want to go back to the pending launch .

Speaker #13: And I'm curious , do you anticipate the implementation of another Rems program at these HCM clinics where there are already prescribing Mavacamten is going to be a barrier that we should expect to kind of slow down the cadence of launch in the early days .

Speaker #13: Or is the process of registering centers relatively straightforward at this point ?

Speaker #3: So I'll ask Andrew to comment . I might just start by saying we're respectful of the fact that there are existing workflows that have already been adapted .

Speaker #3: And as Andrew has already highlighted , it's our goal . To be enabling of Rems program and implementation that should create for a more flexible and easy experience for physicians , patients , and pharmacists within established workflows .

Speaker #3: Maybe Andrew can elaborate .

Speaker #4: Yeah , it's a good question . You know , there was a lot of centers that physicians who weren't writing today . So part of the goal would be , what a differentiated Rems program alongside Maple , alongside Sequoia .

Speaker #4: Do these get more over the line , so to speak , to prescribing . So that would be new workflow for them . Those that have existing workflow , the workflow in the office really is around echo for titration and monitoring .

Speaker #4: That is similar . So you know you're going to have echo monitoring . You know , potentially with say , you know , a different frequency or the ability to titrate up at each at each point of monitoring .

Speaker #4: So it's the same kind of workflow , if you will . So we're not anticipating that the workflow around monitoring or the window for monitoring will cause much angst , especially among high users and high centers .

Speaker #4: So we are expecting that a differentiated Rems , a differentiated label and an overall profile will drive differentiated use when physicians certainly understand it .

Speaker #4: So that's the way we've been thinking about it .

Speaker #1: Next , we'll hear from Tess Romero at JPMorgan .

Speaker #3: Hey , Tess .

Speaker #14: Hey . Good afternoon team . This is Caroline Poacher on for Tess Romero . J.P. Morgan , thanks for taking our question . Just one from us on Apha Hampton and Oak .

Speaker #14: So acknowledging that the late cycle meeting took place on September 15th , can you just comment on if the Rems has been finalized yet at this point in the review process and if not , what are the remaining items of the Rems that need to be finalized ?

Speaker #14: And when would you expect this to be completed ?

Speaker #3: So we're continuing with interactions with FDA and we have not finalized those matters . We do anticipate that we're making progress towards enablement of finalization of those in order to meet the due date .

Speaker #3: With that said , we've had exchanges and interactions , and as I've indicated previously , we don't believe that we're engaging around framework , but rather some operational details .

Speaker #3: Things that speak more to things like web pages and that which is administrative. Those are things that we think should come together to be enabling of the FDA to review this and hopefully approve it in time for the date.

Speaker #1: Moving forward , Maxwell score with Morgan Stanley . Your line is open .

Speaker #13: Great .

Speaker #15: Thank you for taking my question . One more on Acacia . Could you just confirm whether there are any shared trial sites between Odyssey and Acacia ?

Speaker #15: Approximately how many the percentage overlap and if so , what potential impact that might have on , let's say , a placebo response or other factors relevant to interpreting Acacia results .

Speaker #15: Thank you .

Speaker #5: Yeah . Hi Max , I can't give you the exact overlap , but the overlap is not very large . You know , obviously if sites were conducting two trials that were simultaneously in the same patients , it would be a bit problematic .

Speaker #5: Some trials had finished their they're their commitment and odyssey . And then became Acacia sites later and things . But the overlap I don't think is very large .

Speaker #5: You know we ended up generally going to sites that we already had experience with or have visited ourselves either . Either , you know , our HCM team or clinical operations group .

Speaker #5: And so , you know , we ended up choosing a cadre of sites in South America . Europe , North America , Australia , China , Israel that represented either our own prior experience or had clearly had experience in other HCM trials .

Speaker #1: Yasmin Rahimi with Piper Sandler , you have our next question .

Speaker #16: Thank you so much , team . Thank you . Maybe a question for Andrew . You did such a nice job outlining your commercial strategy .

Speaker #16: How were you thinking about pricing ? It sounded like you're thinking about pricing and purity to Mavacamten . Obviously , given the product profile you may have flexibility to go higher .

Speaker #16: So appreciate any color around that .

Speaker #4: Sure . So we'll we'll communicate our price when it's set . But I think you can think about , you know , when a second product comes out or a category that's already been priced , that's typically priced in proximity to , you know , the initial product .

Speaker #4: So I would think , you know , we're going to be in that same kind of ballpark plus or minus , maybe a small percentage .

Speaker #4: But we're certainly going to be in that range .

Speaker #1: Our next question today will come from Rowena Ruiz at Leerink Partners .

Speaker #16: Great .

Speaker #17: Thanks and good afternoon , everyone . So a quick follow up of the AFI captain . Potential US launch . Could you share more details about what you expect in terms of time to conversion to commercial drug patient compliance over time and anything you're hearing or learning about the possible rate in which early adopters could prescribe AFI , Compton .

Speaker #4: Sure . So thanks for the question . So in terms of conversion , you know , in the beginning we'll have blocks as payers go through reviews , medical exception is certainly the path that that will go through .

Speaker #4: Medical exception can be as fast as , say 2 to 3 weeks . Or it could take , you know , 90 days .

Speaker #4: So it depends on the plan , depends on the doctor's office , the documentation . And if it's in compliance with what the plan wants .

Speaker #4: But I think you can think in that time frame , you know , we're going to have the patient support programs where we can have them for commercial patients to bridge them through that process .

Speaker #4: Medicare patients , of course , we can't do that . We'll provide free drug for those that are appropriate for patient assistance . And , you know , so that's how I would think about time to conversion until we have more , you know , broader access in terms of compliance .

Speaker #4: We are seeing that at least in this category , compliance and persistency is higher than you see for other cardiovascular drug . I'm guessing likely because of the time frame it takes to get on a drug that commitment of going through echoes and and the like that you're going to see compliance after two years , probably still be above 50% or so .

Speaker #4: And then your third question was , can you remind me ?

Speaker #1: Mr. Wiese , if you would like to hit star one once more , I can reactivate your line . Thank you ma'am .

Speaker #17: Yes , the last part was about early adopter physicians in prescribing captain out of the gate .

Speaker #4: Thank you . Yeah . So , you know , this is a very , very focused market . You know , 650 prescribers or so , about 80% of the market , those prescribers we know well , we've actually been interacting with many of them already .

Speaker #4: We will call on the vast majority , if not all of them , in the first few weeks of launch . When you think about those high users , if you will , when we've done even most recent market research , even in the last .

Speaker #4: Month or so , Maple , with a with Sequoia increases their urgency to treat . So we're expecting to get , you know , high use if you will , relative to other physicians in those physicians that were early adopters for cmis , we should see the same for applicants .

Speaker #4: And if it gets approved . So that's our expectation . Thanks for the questions .

Speaker #1: And thank you for resignalling . Miss Ruiz . We'll go next to my mom , Tony , at B Riley Securities .

Speaker #18: Yes . Good afternoon . Thanks for taking my questions . And congrats on a productive third quarter . Would love to hear your thoughts .

Speaker #18: Maybe for Andrew on what your latest thinking is on peak drug class penetration . Maybe if you can also comment on where it stands now and your expectation of , you know , scenarios where , you know , it could land in the kind of near near-term 1 to 2 years and like you said about your impact of the Maple ECM data , but also a lot of real world data coming from your peer , including at , you know , if you could maybe comment on that , that would be helpful .

Speaker #18: And a support question was around , you know , some of the patient navigator training that you're doing , you know , that happens around when you have a label in hand .

Speaker #18: Was just curious if any key FAQs or pushbacks you're preparing for would also be helpful to get color on .

Speaker #4: Sure , a lot of questions there , so I'll try to address those here . My penetration , I think , was your first question .

Speaker #4: I think right now the penetration is probably in the 15 to 20% range of , you know , OTM . And I'm defining that as the number of eligible patients , those that are class two , class three , those that are treated with a CMI .

Speaker #4: So we are expecting , as we've said all along , around 80% or so of the market to be available , meaning patients who are eligible but not currently on a CMI , you know , the expectation is that that probably penetration probably increases in the around five percentage points each year .

Speaker #4: So when you look at real world evidence , when you look at additional trials , that certainly will increase penetration . If guidelines are impacted , you know , if Maple helps influence guidelines and in 26 or 27 , that certainly will accelerate penetration .

Speaker #4: So I think there's things that can change the trajectory of penetration . But that's where it is now in terms of training . You know , we did provide a label to the FDA .

Speaker #4: We've had a few rounds of feedback . I think that we've alluded to that we can certainly train on address label . And then we'll we'll train again on the final .

Speaker #4: That's pretty typical around how you would train relative to a label and relative to a range .

Speaker #18: Thank you .

Speaker #4: Thank you .

Speaker #1: Moving , moving forward , we'll take our next question from Joe Pangonis at HC Wainwright .

Speaker #19: Hey everybody . Good afternoon . Thanks . Hey there . So curious . Just totally switching gears here to Omecamtiv . Mecarbil right now , the guidance is , you know , moving enrollment continuing into 2026 .

Speaker #19: When do you anticipate providing more visibility as to sites , enrollment numbers , and what levels of clarity can we get ? Do you think starting in 26 .

Speaker #3: Thank you Joe . We'll ask Stuart maybe to take that please .

Speaker #6: Yeah . Thank you Joe . You know , as I mentioned , we are making good progress in terms of site activation . We have 75% of sites activated in North America .

Speaker #6: And Europe . And , you know , the the we're seeing screening , picking up , randomization , picking up . And I mean , we're sort of not at a point where we can sort of start providing those numbers because I think we're going to hold off on that until we have all the sites activated , and we have a good trajectory .

Speaker #6: But so far , so good study conduct is going well . And so with site interaction and screening .

Speaker #19: Thank you .

Speaker #3: Joe , I think as we roll into the new year and have a better sense of how these new sites that have been activated are enrolling , we should be able to tighten some of that guidance to the expectation of when we might complete enrollment , and then from there , as you know , this is a study that's accruing events , it's event driven .

Speaker #3: And we can maybe point more generally to when we might expect data .

Speaker #1: Our next question will come from the line of Paul Choi with Goldman Sachs .

Speaker #3: Hey , Paul .

Speaker #20: Hi . Good . Hi . Good afternoon . Thank you for taking the question . I want to ask on your partner , Camelia trial .

Speaker #20: And just if you can provide any updates on on timing on that and just sort of maybe help us think about when your partner might be able to to launch in Japan and just sort of what would be a reasonable assumption .

Speaker #20: There . And then on the Amber trial study for Hf-pef , would you be in a position to potentially present some initial data on that in 2026 ?

Speaker #20: Thanks for taking the questions .

Speaker #3: Well , that's allowed you to tackle those . Please .

Speaker #5: Yeah . With regards to the progress of the trial in Japan , I mean , the strategy in Japan will be a little bit tied more to completion .

Speaker #5: Both of Acacia and Camellia . We expect them really to kind of complete in a similar time frame . And both leading to regulatory interactions and hopefully approval there .

Speaker #5: So I can't really give you specifics yet in terms of of where it is . But community is moving along with within line of that expectation .

Speaker #5: And then , Amber , you know , I think we're still too early for us to commit to data in 2026 . We should be able to say more about that probably at our next earnings call .

Speaker #20: Okay . Thank you .

Speaker #5: Thanks .

Speaker #1: Next , we'll hear from Serge Bélanger at . Needham .

Speaker #20: Hi .

Speaker #21: Good afternoon . This is John Gianco on for Serge today . Thanks for taking our question . So with the results of Maple now in the public domain , curious what your timelines look like in terms of how quickly you'd like to file the Snda to incorporate that data into API's label , and whether you think having it in the label will alter in any way prescribing habits for treating physicians .

Speaker #3: So I'll take the first part and ask Andrew to address the second part . But our goal is if we see efficacy and approved based on the Sequoia results by the end of this year , that we're moving very swiftly to submitting a supplemental NDA based on Maple data , promptly in early 2026 to be enabling of a potential expanded label .

Speaker #3: Even possibly by the end of 2026 . Andrew can comment on how that may factor into expanded use .

Speaker #4: , and we've we've tested this several times , including most recently this quarter . Each time we get a top line increased use of CMI .

Speaker #4: So CMI penetration goes up and increased brand share for Campton or preferential share if you will . So larger market , larger share of that market when you segment it .

Speaker #4: Those that are kind of the core users , they're basically saying it's confirmatory of safety and efficacy . And that gives them even more reason .

Speaker #4: And belief . When you look at those that are heavy beta blocker , it really challenges their belief in the efficacy of beta blockers .

Speaker #4: It increases their urgency to treat or urgency to refer . I think , you know , that second group is going to take a little longer .

Speaker #4: Some of them and guidelines , as well as continued education and promotion will certainly continue to move those . So at a high level , we're expecting , you know , a larger market , a larger share , and , you know , we're certainly seeing this as one of the expansion strategies we've talked about in terms of a bigger market .

Speaker #4: Thanks for the question .

Speaker #1: Next , we'll hear from Kripa Deverakonda at Truist Securities .

Speaker #13: Good afternoon .

Speaker #22: Hi , Kripa . Based on your updated late cycle meeting with the FDA and the nature of the day , 120 list of questions for the Chmp , is there anything we should be aware of to indicate that there that the Rems requirement could possibly be meaningfully different from the US and the EU ?

Speaker #3: Well , there is no Rems requirement in the EU . That's all handled through labeling . As you know . But I do think that to your question , we're expecting that Alpha Campton , if approved in the US and in the EU , will be addressed similarly in terms of risk mitigation .

Speaker #22: All right . Thank you .

Speaker #1: Our next question will come from Ash Verma at UBS . Your line is open . Hello , ash . You may have us unmute .

Speaker #1: Your line is open . And hearing no response , we'll move forward . Ash , please try to re signal with star and one .

Speaker #1: We'll hear instead from Jason Zamansky at Bank of America.

Speaker #15: Good evening .

Speaker #3: Jason .

Speaker #23: Afternoon . Congrats on the progress and thanks for taking our question . Maybe just to switch gears , but in light of your recent balance sheet updates , where do you stand in terms of your ability to to support both the US and EU launches ?

Speaker #23: I mean , do you foresee any need for additional capital , especially given your expectations for the launch ? Thanks .

Speaker #7: Yeah . Jason , this is fun . Thanks for the question . You know , we can't rule out future financing , but with that said , we expect to finish the year with $2.2 billion in cash and investments .

Speaker #7: 1.5 I'm sorry , 1.2 . Thank you . I got a little excited there . So that puts us in a very strong position , not only to launch a campaign in the US , but also to continue to build out in the EU and importantly , to continue to advance our pipeline .

Speaker #7: Keep in mind that we do have access to further capital , potentially up to $175 million . This is from the trunk seven loan from Royalty Pharma .

Speaker #7: So , you know , we'll continuously weigh our options in terms of capital requirements and capital structure .

Speaker #23: Thanks , son .

Speaker #1: And now we'll move to Ash Verma with UBS . Once again . Please go ahead . Your line is open . Hello , ash .

Speaker #1: We have you connected , and I do see your open . We're not hearing anything . If you are speaking to us , please check your mute .

Speaker #24: Hi there. Can you hear me?

Speaker #1: There you are . Thank you .

Speaker #24: Hi there . Can everyone hear me ? Annually on for ash .

Speaker #3: We can hear you .

Speaker #24: Hey there . This is Natalie . On for ash . Can you hear me ?

Speaker #3: We can hear you .

Speaker #24: Sorry about that . This is Natalie on for Ash Verma , UBS . So we just had a quick question on HCM . Now , I know there's a lot of discussion about the heterogeneity of this patient population .

Speaker #24: Have you guys been able to identify if there is a specific set of patients that see the most benefit from Cmis .

Speaker #5: Well I would say that , you know , that question remains unanswered . Maybe , perhaps . And we'll require both analyses of the Odyssey data .

Speaker #5: The patient data , when they come out , we think enrolling patients that are symptomatic that have classic HCM , a classic HCM phenotype , as evident on echocardiography that have certain biomarker increases , I think all of those things talk about a symptomatic , highly symptomatic and functionally limited patient population .

Speaker #5: And based on our prior experience and Redwood , we think that population should be responsive to captain . So I think we'll have more to say when we see the acacia data in next year .

Speaker #6: I think I would add that , you know , we've been following a cohort of Non-obstructive patients for over two years now , and the large majority of them are responding well symptomatically , and based on cardiac biomarker improvement .

Speaker #6: So I think what we're observing so far , at least in this cohort , in forest , is a pretty general improvement in response to treatment .

Speaker #1: And thank you , ladies and gentlemen . That was our final question from our audience today . Mr. Blum . I'm happy to turn it back to you for any additional or closing remarks .

Speaker #1: You have .

Speaker #3: Thank you . I want to thank all of our participants on the call today . I want to thank you for your continued support as well as your interest in Cytokinetics .

Speaker #3: This will conclude our Q3 earnings call, and my hope is that next time we convene one of these earnings calls, we'll talk about what could be the first potential approval for Campton and a product arising out of our longstanding research and development.

Speaker #3: A very important milestone for our company and all of our stakeholders , including our shareholders . With that operator , we can now conclude the call .

Speaker #1: Thank you . And ladies and gentlemen , thank you for joining today's Cytokinetics Q3 2020 Earnings Call . You may now disconnect your lines .