CYTK

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Transcript Summary

Cytokinetics, Incorporated achieved a significant milestone in Q1 2026 with the successful U.S. launch of MYCorzo (aficamtin) for symptomatic oHCM, generating $4.8 million in net product revenue in just nine weeks. The launch has seen strong HCP engagement, with over 1,100 patients prescribed the drug by the end of April and a new-to-brand market share exceeding 30%. The company also announced positive top-line Phase 3 results from the Acacia HCM trial in nonobstructive HCM, meeting primary endpoints for both symptom improvement (KCCQ) and exercise capacity (peak VO2). These results may allow aficamtin to treat the full spectrum of HCM patients. Geographically, the company is expanding into Europe, with a German launch imminent and multiple HTA dossiers submitted. Financially, Cytokinetics remains well-capitalized with $1.1 billion in cash, supporting its transition to a leading muscle-focused specialty biopharma firm. While SG&A costs rose significantly to support the launch, the company’s pipeline continues to progress, including Phase 3 heart failure trials for omecamtiv mecarbil and Phase 2 studies for ulicamten. Management maintains a bullish outlook for the remainder of 2026 as they pursue supplemental NDA filings and broader global market access.

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Cytokinetics, Inc.: Expensive Royalty Debt and Securities Litigation Cloud Product Launch

Full Earnings Call Transcript — Q1 • 2026-05-05

Operator: Thank you for standing by, and welcome to the Cytokinetics, Incorporated Q1 2026 earnings conference call. This call is being recorded, and all participants are in a listen-only mode. There will be no question and answer session after the company's prepared remarks. I would now like to turn the call over to Diane Weiser, Cytokinetics, Incorporated’s Senior Vice President of Corporate Affairs. Please go ahead.
Diane Weiser: Good afternoon, and thanks for joining us on the call today. Robert I. Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew M. Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYCorzo in the United States and readiness in Europe. Fady Ibraham Malik, EVP of R&D, will address the results from Acacia HCM. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung H. Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. And finally, Robert I. Blum will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today’s discussion will include forward-looking statements that are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. I will now turn the call over to Robert I. Blum.
Robert I. Blum: 2026 has been a remarkable period for Cytokinetics, Incorporated and one that I believe reflects the emerging promise of what we have been building here for over 25 years. Most notably, we launched MYCorzo, our first approved medicine for the treatment of adults with symptomatic oHCM in the United States. This is a milestone many years in the making and reflects our unwavering dedication to translating our science into impact for patients. As Andrew M. Callos will discuss, our initial commercial launch, while representing only a partial quarter, is exceeding our internal expectations with net product revenue of $4.8 million in the first quarter. The level of engagement from prescribers, the pace of REMS certifications, and the early demand all reinforce our conviction in the significant opportunity ahead for MYCorzo. And based on its clear differentiation, we believe this initial momentum builds a strong foundation for longer-term commercial success. Beyond the United States, during the quarter, the European Commission approved MYCorzo for patients with oHCM, and we are now moving quickly towards our first European commercial launch in Germany in the second quarter. The global market for MYCorzo is significant, and we are prudently building the right infrastructure to realize its potential. And then, of course, there is Acacia HCM. This morning, we reported positive top-line results from this pivotal Phase 3 clinical trial of aficamtin in nonobstructive HCM. We were very pleased to see that aficamtin improved both symptoms and exercise capacity with no new safety signals observed. Fady Ibraham Malik will speak more to the results that we reported, but we are excited by what these results represent for patients living with nHCM who have no currently approved therapies and for aficamtin, which, depending on the results of regulatory review, may now have the opportunity to be the first product approved to treat the full spectrum of HCM. With a statistically significant and clinically meaningful effect on both endpoints, we believe we have a very clear picture of the treatment effect that aficamtin has in nHCM. Given the trial results, we plan to meet with regulatory authorities, including the FDA, to discuss our plans for promptly submitting a supplemental NDA. During the quarter, there were several meaningful regulatory updates for aficamtin beyond that. In the United States, our sNDA for MAPLE HCM was accepted for filing by the FDA, and we were assigned a PDUFA date of 11/14/2026. We believe the results of MAPLE HCM will enable us to accelerate expansion of the prescriber base, especially with cardiologists in the community setting. Outside of the United States, we submitted an MAA for aficamtin in oHCM in Switzerland, and as a reminder, we also have a marketing application already under review in Canada. Plus, our partner Sanofi is continuing to progress potential approvals in Hong Kong and Taiwan. Taken together, the progress we made in this first quarter is a testament to what we have built in service of our vision of becoming the leading muscle-focused specialty biopharma company intent on meaningfully improving the lives of patients through global access to our innovative medicines. As we look ahead, we enter the remainder of 2026 with strong commercial momentum, conviction in our pipeline, and a deep sense of purpose. Our priorities remain the continued growth of MYCorzo in the United States, advancing our planned launches in oHCM in Europe, pursuing expansion into nHCM, and advancing our muscle biology pipeline, all with disciplined execution and careful attention to capital allocation. I will now turn the call over to Andrew M. Callos.
Andrew M. Callos: Thanks, Robert I. Blum. I am thrilled to be reporting on our first quarter of commercial performance for MYCorzo. MYCorzo became available to patients on January 27, and we saw HCP prescribing within days. We have had a strong start that exceeded our expectations. Our launch is grounded in the foundation of clinical evidence and differentiation. The results from SEQUOIA-HCM demonstrate that MYCorzo provides rapid and sustained reduction in obstruction with improvement in symptoms, outcomes that resonate with HCPs. MYCorzo also offers an adaptable monitoring schedule with echocardiograms permitted within a flexible two- to eight-week window and a REMS that does not require DDI counseling. Over 80% of treating HCPs report awareness that they have seen the prescribing information for MYCorzo on an as-needed basis. We are pleased to see continued growth in perceptions of clinical differentiation favoring MYCorzo. In our most recent ACT survey, we see a higher majority of HCPs favoring the clinical profile of MYCorzo, especially among the high-volume HCM prescribers surveyed. In addition, HCPs surveyed view MYCorzo favorably across metrics such as dosing flexibility, safety and tolerability profile, and REMS program requirements. Beyond the clinical profile, treating physicians are also responding favorably to the practical elements of prescribing MYCorzo. Across key metrics of ease of prescribing, echocardiogram monitoring flexibility, and the absence of DDI restrictions within REMS, HCPs appear to view MYCorzo as differentiated. Following FDA approval in December, our team of 100-plus cardiovascular account specialists began engaging HCPs in early January, a few weeks ahead of when product became available in late January. Since then, they have reached HCPs at all levels of HCM prescribing. Our initial launch prioritized focusing our promotional and sales force activity on deepening prescribing among the high-volume HCM prescribers that have historically generated 80% of HCM prescriptions. While our call points span over 10,000 HCPs, we are currently putting greater emphasis in call allocation on the high-volume HCM prescribers. In Q1, our sales teams detailed over 90% of these HCPs. We plan to continue this emphasis on high-volume prescribers until we achieve over 50% new-to-brand prescription share among these HCPs, which we anticipate will occur by year-end. Once we see strong share performance in the high-volume HCM prescribers, we will put greater emphasis on increasing the breadth of prescribing, while still maintaining leadership and growth in the high-volume HCM prescribers. We are already seeing uptake outside the high-volume prescribers. In Q1, more than 40% of MYCorzo prescriptions are from the combination of low-volume HCM prescribers and first-time HCM prescriber segments. In Q1, our field force reached an estimated 40% of these HCPs. Beyond personal and non-personal promotion, our surround-sound approach to reaching HCPs has also delivered strong interest with robust participation in our peer-to-peer physician speaker programs and engagement with our digital advertising. By the end of Q1, over 2,100 people were already enrolled in the MYCorzo patient community. In addition to our clinical profile, we are taking the time to educate HCPs on our REMS program and patient services, as they are different from what HCPs have become accustomed to. Since launch, we have moved quickly to release enhancements to these systems that are consistent with HCPs’ feedback and clinical practice. To measure launch performance overall, we have committed to sharing three launch metrics: the depth and breadth of prescribing, and volume of patients. Breadth of HCP prescribing is measured by the number of HCPs who have written prescriptions. Depth of HCP prescribing is measured by the number of patients each HCP prescribed MYCorzo. Volume of patients is measured by the number of unique patients prescribed MYCorzo. In Q1, we saw strong demand, with more than 275 unique HCPs prescribing MYCorzo, with over 50% from the high-volume HCM prescriber segment. Through April, we have seen continued prescriber growth, with more than 425 HCPs prescribing MYCorzo. Overall, these HCPs have written an average of 2.4 prescriptions per HCP, while the high-volume prescribers have prescribed MYCorzo to approximately 2.6 patients per HCP. While it is difficult to be precise about our new-to-brand Q1 exit share due to some limitations in data availability, our internal analysis leveraging projected syndicated data suggests that the MYCorzo new-to-brand Q1 exit share was greater than 30%. These are very encouraging numbers at such an early stage of our launch. We also see positive momentum in the 1,400-plus HCPs who became REMS certified during the quarter, a potential leading indicator of HCPs who plan to prescribe MYCorzo. The differentiated profile of MYCorzo and our targeted HCP engagement since the beginning of the year has resulted in approximately 680 patients prescribed MYCorzo by the end of Q1 2026, and through April the number of patients has increased to 1,100. Importantly, in Q1, over 70% of dispensed patients are on a paid prescription. On average, patients convert to a paid prescription in less than two weeks. Most of these metrics exceed our launch expectations. This is particularly due to our limited distribution model with dedicated focus on MYCorzo patients, which has helped us achieve a high percentage of patients on a paid prescription very early in the launch phase. As we continue to accelerate our launch, we are also focused on expanding and reducing barriers to prescribe. As we have shared, we have been engaging with payers for quite some time regarding the clinical evidence from our clinical trial program and the clinical and economic burden of oHCM. We currently have comparable access for nearly 90% of Medicare lives and expect to have parity in Medicare within Q2. We are also building commercial access and expect to reach 50% of commercial lives by early Q3 and remain on target to achieve commercial access at parity by the end of Q4. Simultaneously, we are continuing to expand our commercial readiness and planning in key geographies around the world. We secured approval for MYCorzo in the EU in February and continue to move quickly towards our first European commercial launch in Germany, planned in the second quarter. In support of that milestone, we finished hiring and onboarding our full German team inclusive of sales, marketing, medical, and leadership teams. Across the EU, we have also now submitted six HTA dossiers, with five more expected to be submitted this quarter, on the path to broaden European patient access. We also submitted an MAA to Swissmedic, and beyond Europe we continue to look forward to receiving a decision in Canada in the second half of this year. Cytokinetics, Incorporated is now firmly a commercial-stage company, and while it is early in our U.S. launch, we are very encouraged by the initial performance. Both in the U.S. and in Europe, our commercial teams are dedicated to delivering excellence in this new chapter of our company’s history. I will now turn the call over to Fady Ibraham Malik.
Fady Ibraham Malik: Thanks, Andrew M. Callos. This morning, we were thrilled to report the top-line results from Acacia HCM. The trial met both of its dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ Clinical Summary Score and peak VO2 compared to placebo. In patients treated with aficamtin, KCCQ increased by 11.4 points compared to 8.4 points for patients on placebo, resulting in a least squares mean difference of 3 points with a p-value of 0.021. Similarly, peak VO2 increased by 0.64 mL/kg/min in patients on aficamtin, while it decreased by 0.03 mL/kg/min for patients on placebo, resulting in a least squares mean difference of 0.67 mL/kg/min and a p-value of 0.003. Statistically significant improvements were also observed in key secondary endpoints, including the proportion of patients with improvements in NYHA functional class, the composite Z score of ventilatory efficiency and peak VO2, and NT-proBNP. Importantly, there were no new safety signals identified. The percentage of patients who completed treatment in Acacia HCM was similar between those receiving aficamtin or placebo. Incidence of LVEF less than 50% was 10% in patients taking aficamtin, of which two patients experienced a serious adverse event of heart failure. LVEF less than 50% occurred in 1% of patients taking placebo. Treatment interruptions due to LVEF less than 40% occurred in 3% of the patients taking aficamtin. The improvement in KCCQ was robust and consistent throughout the treatment period in patients on aficamtin. Following washout, KCCQ decreased for patients on aficamtin to match the placebo group. At week 36, peak VO2 increased for patients on aficamtin, while it remained unchanged for patients on placebo, consistent with prior trials of aficamtin. What makes the data particularly compelling is the consistency across what the primary, secondary, and other exploratory endpoints capture. The KCCQ is the patient-reported measure that reflects how they feel and function, their symptoms, their quality of life, while peak VO2 reflects an objective functional measure of exercise capacity. NYHA functional class, the first key secondary endpoint, is also a measure of symptom and functional burden, but is physician assessed. To have improved both symptoms and functional capacity in a meaningful way reflects the depth of the potential impact of aficamtin in this patient population. This is a historic moment for the HCM community. nHCM is a serious condition for which no therapies have ever been approved. These results suggest that aficamtin has the potential to change that and to become a treatment to support the full spectrum of the disease. We could not be more enthusiastic about what we have seen in these top-line results. I want to take this moment to express my gratitude to our team for their relentless conduct of this trial to ensure the quality and robustness of the findings. Additionally, we are deeply grateful to the patients who participated in Acacia HCM, to their families, and to the investigators and site staff across the globe who conducted this trial with such dedication and rigor. Our thanks go to all for everything they have contributed to this program, and, in turn, to the entire HCM community. Next, we plan to submit Acacia HCM for presentation at an upcoming medical meeting and look forward to presenting the results in a more fulsome fashion at that time. Until then, we will not be able to share any additional detail on top of what was reported in today’s press release. As Robert I. Blum mentioned, we will be discussing these results with the U.S. FDA and other regulatory authorities. It has been an extremely exciting start to the year, to say the least. I will now hand it over to Stuart Kupfer to speak more about our ongoing clinical trials in both HCM and heart failure.
Stuart Kupfer: Thanks, Fady Ibraham Malik. First, I will touch on our ongoing global clinical programs for aficamtin in HCM. During the quarter, we continued to advance three trials that together are building a comprehensive clinical foundation across indications, geographies, and patient populations. In obstructive HCM, our partner Bayer advanced conduct of CAMELLIA-HCM, a Phase 3 clinical trial evaluating aficamtin in Japanese patients. In pediatric patients with obstructive HCM, we continued enrolling CEDAR-HCM, our global clinical trial evaluating aficamtin in adolescents and younger children. We expect to complete enrollment in the adolescent cohort by the end of 2026. In nonobstructive HCM, we continued enrollment of the Japanese cohort of Acacia HCM. Japan represents an important market where aficamtin is not yet approved for either obstructive or nonobstructive HCM. Both CAMELLIA-HCM and the Japanese cohort of Acacia HCM are designed to support potential marketing authorization for both indications in that country. To that end, I am also pleased to note that aficamtin received orphan drug designation from the Japan Ministry of Health, Labour and Welfare for the treatment of nonobstructive HCM in adults and for obstructive HCM in pediatric patients, reflecting the unmet need that remains in these populations. Now I will move on to our clinical development programs in heart failure. COMET-HS, the confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction less than 30%, is progressing well. All sites in the U.S. and Europe are now activated, and we are working to bring on additional trial sites in China. We are pleased with the progress we have made so far this year and plan to continue enrollment through 2026. We also continued AMBER-HFpEF, the Phase 2 clinical trial of ulicamten in patients with symptomatic heart failure with preserved ejection fraction of at least 60%. During the quarter, we expanded enrollment in cohort one following a recommendation from the dose level review committee to collect more data at the current doses, and we expect to complete patient enrollment in cohort one in the second half of this year. Across these programs, we remain focused on rigorous execution and are encouraged by the progress we continue to make in building what we believe will be a leading specialty cardiology franchise. With that, I will pass it to Sung H. Lee.
Sung H. Lee: Thanks, Stuart Kupfer. Beginning with revenue, total revenues for the first quarter were $0.4 million compared to $1.6 million for the same period in 2025. In the first quarter, we recorded $4.8 million in net product revenues for MYCorzo, which reflects approximately nine weeks of commercial sales following the U.S. launch near the end of January. As Andrew M. Callos stated earlier, we saw strong demand for MYCorzo, and the net product revenue is reflective of over 70% of dispensed patients on a paid prescription, with the balance receiving drug through either our 30-day free trial bridge or patient assistance programs. We expect the majority of patients receiving MYCorzo through free trial and bridge programs to transition to paid prescriptions on a timely basis, and this dynamic is expected to repeat in future quarters. Other components that contributed to total revenues in the first quarter include $2.6 million in collaboration revenue compared to $1.6 million for the same period in 2025, and $11.9 million from the achievement of a milestone under the Bayer license agreement tied to the first commercial sale of MYCorzo in the U.S. Turning to expenses, R&D expenses for the first quarter were $95.5 million compared to $98.3 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity in 2025, partially offset by higher personnel-related costs in 2026. SG&A expenses for the first quarter were $104.9 million compared to $57.4 million for the same period in 2025. The increase was primarily due to external costs associated with the commercial launch of MYCorzo, the U.S. sales force, and higher non-sales personnel-related costs, including stock-based compensation. Cost of goods sold for the first quarter of 2026 was $0.2 million. Collaboration cost of revenues for 2026 was $2.4 million compared to $1.6 million for the same period in 2025. Collaboration cost of revenues includes cost reimbursements as well as costs incurred in connection with manufacturing drug supplies for collaboration partners. Net loss for 2026 was $[inaudible] or $1.67 per share compared to a net loss of $161.4 million or $1.36 per share for the same period in 2025. Turning to the balance sheet, we ended the first quarter with approximately $1.1 billion in cash and investments compared to $1.2 billion at the end of 2025. Cash and investments declined by approximately $144 million during 2026. Moving on to our financial guidance, we are maintaining our full-year 2026 financial guidance, with GAAP combined R&D and SG&A expense expected to be between $830 million and $870 million. Stock-based compensation included in the GAAP combined R&D and SG&A expense is expected to be between $120 million and $130 million. Excluding stock-based compensation from the GAAP combined R&D and SG&A expense results in a range of $700 million and $750 million. As we have just announced positive top-line results from Acacia HCM, we will update you accordingly in the future on the potential impact of this development on our financial guidance. Looking ahead, we remain focused on disciplined capital allocation and prioritizing our investments on the launches of MYCorzo in the U.S. and Europe, advancing our development pipeline, and investing in our muscle biology platform and research pipeline. With that, I will hand it back to Robert I. Blum.
Robert I. Blum: Thank you, Sung H. Lee. This was a first quarter we will long remember at Cytokinetics, Incorporated. Our first medicine reached the hands of patients in the United States. We recorded our first product sales revenues. We progressed readiness for future global launches. And more recently, this morning, we reported positive top-line results from Acacia HCM, results that we believe may open a new chapter for patients living with nHCM. I am incredibly proud of what we have accomplished so far in 2026, and I am even more energized by what lies ahead. The opportunity in HCM has never looked brighter; we have never been better positioned to deliver. We look forward to keeping you updated as we progress through the year. I will now recap our 2026 milestones. For aficamtin, we expect to meet with regulatory authorities, including the U.S. FDA, to discuss the results of Acacia HCM and our potential plans for submitting a supplemental NDA. We expect to launch MYCorzo in Germany in the second quarter of 2026. We expect to potentially receive FDA approval of the supplemental NDA for MAPLE HCM in Q4 2026. We expect to complete enrollment in the adolescent cohort of CEDAR-HCM in the fourth quarter this year, and we expect to potentially receive approval from Health Canada in the second half of this year. For omecamtiv mecarbil, we expect to continue patient enrollment in the conduct of COMET-HS through 2026. For ulicamten, we expect to complete patient enrollment in cohort one of AMBER-HFpEF in 2H 2026. And for CK-089, we expect to begin conduct of a second Phase 1 study. Finally, for our preclinical development and our ongoing research, we expect to continue those activities directed to additional muscle biology–focused programs through the year. As a reminder, there will not be a question and answer session following these prepared remarks on today’s call. We want to thank all the participants on this call today for your continued support and your interest in Cytokinetics, Incorporated. Operator, with that, we can now please conclude the call.
Operator: This concludes today’s call. Thank you for attending. You may now disconnect.