CYTK

Hello, everyone. Thank you for standing by and welcome to the Cytokinetics 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 Senior Vice President, Corporate Affairs. Please go ahead.

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 Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the U.S. and readiness in Europe. Fady I. 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 Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. Finally, Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward-looking statements which are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. Now I will turn the call over to Robert.

Thank you, Diane, and thanks to all for joining us on the call today. The first quarter of 2026 has been a remarkable period for Cytokinetics and one that I believe reflects the emerging promise of what we have been building here for over 25 years. Most notably, we launched MYQORZO, 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 that reflects our unwavering dedication to translating our science into impact for patients. As Andrew 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 MYQORZO and based on its clear differentiation. We believe this initial momentum builds a strong foundation for longer-term commercial successes. Beyond the United States, during the quarter, the European Commission approved MYQORZO for patients with oHCM, and we're now moving quickly towards our first European commercial launch in Germany in this second quarter. The global market for MYQORZO is significant, and we're prudently building the right infrastructure to realize its potential. Then, of course, there is ACACIA-HCM. This morning we reported positive top-line results from this pivotal phase III clinical trial of aficamten in non-obstructive HCM. We were very pleased to see that aficamten improved both symptoms and exercise capacity with no new safety signals observed.

Fady will speak more to the results that we reported, but we're excited by what these results represent for patients living with NHCM who have no currently approved therapies. For aficamten, 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 aficamten 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 aficamten beyond that.

In the U.S., our sNDA for MAPLE-HCM was accepted for filing by the FDA. We were assigned a PDUFA date of November 14th, 2026. We believe the results of MAPLE-HCM will be enabling of us to accelerate expansion of the prescriber base, especially with cardiologists in the community setting. Outside of the U.S., we submitted an MAA for aficamten in OHCM in Switzerland. 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 1st quarter is a testament to what we've 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 MYQORZO 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. With that, I'll now turn the call over to Andrew, please.

Thanks, Robert. I'm thrilled to be reporting on our first quarter of commercial performance for MYQORZO. MYQORZO became available to patients on January 27th, and we saw HCP prescribing within days. We've had a strong start that exceeded our expectations. Our launch is grounded in a foundation of clinical evidence and differentiation. The results from SEQUOIA-HCM demonstrate that MYQORZO provides rapid and sustained reduction and obstruction with improvement in symptoms, outcomes that resonate with HCPs. MYQORZO also offers an adaptable monitoring schedule with echoes permitted within a flexible 2-to-8-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 MYQORZO on a needed basis. We're pleased to see continued growth in perceptions of clinical differentiation favoring MYQORZO.

In our most recent HCP survey, we see a higher majority of HCPs favoring the clinical profile of MYQORZO, especially among the high-volume CMI writers surveyed. In addition, HCP surveyed view MYQORZO 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 MYQORZO. Across key metrics of ease of prescribing, echo monitoring flexibility, and the absence of DDI restrictions within REMS, HCPs appear to view MYQORZO as differentiated. Following FDA approval at the end of December, our team of 100+ 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 CMI prescribing.

Our initial launch prioritized focusing our promotional and sales force activity on deepening prescribing among the high-volume CMI writers that have historically generated 80% of CMI prescriptions. While our call points span over 10,000 HCPs, we are currently putting greater emphasis and call allocation on the high-volume CMI writers. 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 CMI writers, we will put greater emphasis on increasing the breadth of prescribing while still maintaining leadership and growth in the high-volume CMI writers. We are already seeing uptake outside the high-volume prescribers.

In Q1, more than 40% of MYQORZO prescriptions are from the combination of low-volume CMI prescribers and first-time CMI writer 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 already enrolled in the MYQORZO patient community. In addition to our clinical profile, we're 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 enhancement to these systems that are consistent with HCP 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 MYQORZO, and volume of patients is measured by the number of unique patients prescribed MYQORZO. In Q1, we saw strong demand with more than 275 unique HCPs prescribing MYQORZO with over 50% from the high-volume CMI writer segment. Through April, we have seen continued prescriber growth with more than 425 HCPs prescribing MYQORZO. Overall, these CMI writers that have prescribed MYQORZO have written an average of 2.4 prescriptions per HCP, while the high volume writers have prescribed MYQORZO to approximately 2.6 patients per HCP.

While it's 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 MYQORZO 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+ HCPs who became REMS certified during the quarter, a potential leading indicator of HCPs who plan to prescribe MYQORZO. The differentiated profile of MYQORZO and our targeted HCP engagement since the beginning of the year has resulted in approximately 680 patients prescribed MYQORZO by the end of Q1 2026. Through April, the number of patients have 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 2 weeks. Both of these metrics exceed our launch expectations. This is particularly due to our limited distribution model with dedicated focus on MYQORZO patients, which has helped us achieve a high % of patients on a paid prescription very early in the launch phase. As we continue to accelerate our launch, we're also focused on expanding access and reducing barriers to prescribe. As we've shared, we've 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 end of Q4. We're continuing to expand our commercial readiness and launch planning in key geographies around the world. We secured approval for MYQORZO in the EU in February and continued 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 6 HTA dossiers with 5 more expected to be submitted this quarter on the path to broaden European patient access.

We also submitted an MAA to Swissmedic. Beyond Europe, we continue to look forward to receiving a decision in Canada in the second half of this year. Cytokinetics is now firmly a commercial stage company. While it's early in our U.S. launch, we're 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. With that, I'll turn the call over to Fady.

Thanks, Andrew. 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 aficamten, 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 mils per kilo per minute in patients on aficamten, while it decreased by 0.03 mils per kilo per minute for patients on placebo, resulting in a least squares mean difference of 0.67 mils per kilo per minute 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. Percentage of patients who completed treatment in ACACIA-HCM was similar between those receiving aficamten or placebo. Recurrence of LVEF less than 50%, with 10% patients taking aficamten, of which 2 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 aficamten. The improvement in KCCQ was robust and consistent throughout the treatment period in patients on aficamten. Following washout, KCCQ decreased for patients on aficamten to match the placebo group.

At week 36, peak VO2 increased for patients on aficamten, while it remained unchanged for patients on placebo, consistent with prior trials of aficamten. What makes the data particularly compelling is the consistency across what the primary, secondary, and other exploratory endpoints capture. The KCCQ is a patient-reported outcome that reflects how they feel and function, their symptoms and 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 aficamten in this patient population. This is a historic moment for the HCM community. HCM is a serious condition for which no therapies have ever been approved.

These results suggest that aficamten 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've 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 could not be more 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.

We plan to submit ACACIA-HCM for consideration in an upcoming medical meeting and look forward to presenting the results in a more fulsome fashion at that time. Until then, we won't be able to share any additional detail on top of what was reported in today's press release.

As Robert mentioned, we also look forward to discussing these results with the U.S. FDA and other regulatory authorities. It's been an extremely exciting start to the year, to say the least. Now I'll hand it over to Stuart to speak more about our ongoing clinical trials in both HCM and heart failure.

Thanks, Fady. First, I'll touch on our ongoing global clinical programs for aficamten 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 III clinical trial evaluating aficamten in Japanese patients. In pediatric patients with obstructive HCM, we continued enrolling CEDAR-HCM, our global clinical trial evaluating aficamten in adolescents and younger children. We expect to complete enrollment in the adolescent cohort by the end of 2026. In non-obstructive HCM, we continued enrollment of the Japanese cohort of ACACIA-HCM. In fact, Japan represents an important market where aficamten is not yet approved for either obstructive or non-obstructive 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'm also pleased to note that aficamten received orphan drug designation from the Japan Ministry of Health, Labour and Welfare for the treatment of non-obstructive HCM in adults and for obstructive HCM in pediatric patients, reflecting the unmet need that remains in these populations. Now we'll move on to our clinical development programs in heart failure. COMET-HF, the confirmatory phase III 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're working to bring on additional trial sites in China. We're pleased with the progress we've made so far this year and plan to continue enrollment through 2026.

We also continued AMBER-HFpEF, the Phase II 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 1 following a recommendation from the dose level review committee to collect more data at the current doses. We expect to complete patient enrollment in cohort 1 in the 2nd 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'll pass it to Sung Lee.

Thanks, Stuart. Beginning with revenue, total revenues for the first quarter were $19.4 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 MYQORZO, which reflects approximately nine weeks of commercial sales following the U.S. launch near the end of January. As Andrew stated earlier, we saw strong demand for MYQORZO, and the net product revenue is reflective of over 70% of dispensed patients on a paid prescription, with the balance receiving drugs through either our 30-day free trial, bridge, or patient assistance programs. We expect the majority of patients receiving MYQORZO through free trial and bridge programs to transition to paid prescriptions on a timely basis. 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 MYQORZO 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 expense 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 MYQORZO, 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 the first quarter of 2026 was $2.4 million compared to $1.6 million for the same period in 2025. Collaboration cost of revenues includes cost reimbursement as well as costs incurred in connection with manufacturing drug supplies for collaboration partners. Net loss for the first quarter of 2026 was $206 million, 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 the fourth quarter of 2025. Cash and investments declined by approximately $144 million during the first quarter of 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-$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 MYQORZO in the U.S. and Europe, advancing our development pipeline, and investing in our muscle biology platform and research pipeline. With that, I'll hand it back to Robert.

Thank you, Sung. This was a first quarter we will long remember at Cytokinetics. Our first medicine reached the hands of patients in the U.S. We recorded our first product sales revenues. We progressed readiness for future global launches. 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'm incredibly proud of what we've accomplished so far in 2026. I'm even more energized by what lies ahead. The opportunity in HCM has never looked brighter. We've never been better positioned to deliver. We look forward to keeping you updated as we progress through the year. Now I'll recap our 2026 milestones.

For aficamten, 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 MYQORZO in Germany in this second quarter, 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 of this year. 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-HF through 2026. For ulicamten, we expect to complete patient enrollment in cohort 1 of AMBER-HFpEF in 2H, 2026. For CK-586, we expect to begin conduct of a 2 phase I 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 you all, the participants on this call today for your continued support and your interest in Cytokinetics. Operator, with that, we can now please conclude the call.

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