Cytokinetics Inc. 2026 Q2 Earnings Call

Thanks for joining us on the call today. The slides accompanying today's webcast can be found on the investors and media section of our website at cytokinetics.com, along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the U.S. and Europe. Fady Malik, EVP of R&D, will provide updates related to aficamten. Steve Heitner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. Robert will make closing remarks and review key milestones for the year ahead. As you can see on the 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. Thanks to all for joining us on the call today. The second quarter was another solid period of execution for Cytokinetics, marked by strong commercial momentum for MYQORZO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally, and continued advancement of our later-stage specialty cardiology pipeline. Just five months into the commercial launch of MYQORZO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for MYQORZO reflects increasing awareness and physician engagement, expanding patient access, and adoption across multiple segments of the targeted prescriber base, all of which reinforce confidence in MYQORZO and its clinical, therapeutic, and commercial opportunities.

During the quarter, we also executed well on our global commercialization strategy with the launch of MYQORZO in Germany, the first in a series of European launches expected over the next six to 12 months. This is a key milestone for Cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years. To that end, more recently, the MHRA granted MYQORZO marketing authorization across the U.K. for the treatment of symptomatic OHCM in adult patients. At the same time, NICE issued guidance recommending MYQORZO for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help MYQORZO reach patients sooner. We expect drug supply and full launch in the U.K. later this year.

During the second quarter, we highlighted the opportunity for aficamten to potentially treat the full spectrum of HCM. As we shared, the top-line results from ACACIA-HCM in patients with non-obstructive HCM showed that the phase III 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. These results represent an important scientific achievement for an nHCM patient population with no currently approved therapies. They define a meaningful step toward expanding the potential reach of aficamten beyond OHCM, subject of course to regulatory review and subsequent potential approval. Following our announcement of the top-line results from ACACIA-HCM, we met with the FDA to discuss our next steps. We reviewed the clinical trial results together. We posed questions to which the FDA responded.

Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for aficamten in nHCM in the fourth quarter of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from ACACIA-HCM in a hotline session at the European Society of Cardiology Congress to occur later this month. Alongside progress towards making MYQORZO available to more patients with OHCM in the U.S. and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with nHCM. As could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM.

Moreover, in the second quarter, as you'll hear, we continued to advance our later-stage specialty cardiology pipeline with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. We fortified our balance sheet with a successful financing that supports our plans and objectives. Taken altogether, the progress we made this second quarter underscores that Cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity, expanding global scale and access, proceeding towards expanded product labeling, and advancing pipeline, all with focus and discipline to capital access and allocation. I look forward to sharing more about that now from our colleagues. With that, I'll turn the call over to Andrew.

Thank you, Robert. In the second quarter, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we're seeing across physician awareness, prescribing activity, patient demand, and market access. We believe these early indicators are beginning to demonstrate that the differentiated profile of MYQORZO is resonating well with both healthcare providers, payers, and most importantly, also with patients. Since our commercial launch at the end of January, MYQORZO has accelerated quarter-over-quarter growth in new-to-brand prescriptions within the CMI category by 24% in Q1 and 15% in Q2 compared to the single-digit growth rate observed when only a single CMI was available. The introduction of MYQORZO is helping drive increased breadth and depth of new patient starts, as well as greater engagement and awareness among a broad range of physicians and prescribers within the category.

In fact, in our most recent market research survey, which was conducted during the second quarter, unaided awareness among HCPs increased to 68%, compared to 52% in the first quarter. We are also seeing encouraging engagement among patients. Our patient marketing campaign has driven early and increased awareness, resulting in over 30% awareness among OHCM patients in the U.S. In addition, we have generated more than 390 million impressions and 2.1 million social media clicks through our focused and directed digital media campaigns across a broad range of channels and platforms. We're also pleased to see continuing perception of clinical differentiation favoring MYQORZO among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of MYQORZO.

Treating physicians that we surveyed also view MYQORZO favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability, and then the flexibility associated with differentiated REMS requirements. In this stage of our commercial launch, our emphasis remains on deepening prescribing among high-volume CMI prescribers. Historically, these physicians have generated approximately 80% of CMI prescriptions. While our whole universe spans in more than 10,000 healthcare providers, we are prioritizing engagement with high-volume prescribers, and at the end of the second quarter, our sales team had reached more than 90% of these HCPs. We plan to maintain that same priority emphasis to high-volume prescribers until we achieve greater than 50% new-to-brand prescription share, which we believe could occur by the end of this year, if not sooner. At the same time, we're encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers.

In fact, by the end of the second quarter, more than 50% of MYQORZO prescribers were either low-volume CMI prescribers or first-time CMI writers. Our field force reached more than half of these physicians during the second quarter. We see prescribing from this cohort as an important signal that MYQORZO is gaining traction across a wider segment in the OHCM treating community, something we anticipated based on the differentiated profile of MYQORZO, and it is validating to see that in actual prescribing. Importantly, our field-based teams are also bringing the data from MAPLE-HCM to the attention of the OHCM treating community.

These important data from our second Phase III trial of aficamten both support findings from SEQUOIA-HCM and further demonstrate that MYQORZO is superior to beta blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy, and utility of MYQORZO in patients with OHCM. As we committed at launch, we continue to evaluate performance using 3 key metrics. Breadth of prescribing, measured by the number of HCPs who have written prescriptions. Depth of prescribing, measured by the number of patients to which each HCP prescribed MYQORZO. And patient volume, which reflects the total number of unique patients prescribed MYQORZO. Across all three metrics, we are encouraged by the progress and rate of growth achieved during the quarter.

By the end of the quarter, more than 700 unique healthcare providers in the U.S. had prescribed MYQORZO, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately 3 of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately 5 of their patients on average. Although limitations with syndicated data make it difficult to precisely calculate new-to-brand Q2 exit share in the CMI category, our internal analysis suggests that the exit share for MYQORZO has increased to greater than 40% in the second quarter. We also continue to see encouraging leading indicators of future demand, including more than 2,500 healthcare providers who have now completed REMS certification since launch. Turning to patient demand. In the first quarter, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1.