Cytokinetics Q2 2026 Earnings Call: Complete Transcript

On Thursday, Cytokinetics (NASDAQ: CYTK ) discussed second-quarter financial results during its earnings call. The full transcript is provided below. This content is powered APIs. S.

3 million from Europe, marking their first European launch in Germany. Key strategic initiatives include the international expansion of Mycorzo, notably with regulatory approvals in the UK, and progress towards a supplemental NDA submission for aficamten in nHCM. The company highlighted positive Phase 3 trial results for aficamten in nHCM, meeting primary endpoints, and emphasized ongoing discussions with the FDA and European regulators. 8 million compared to 2025, while SG&A expenses increased due to commercial launch costs.

7 billion in cash and investments, bolstered by a public offering generating $760 million in net proceeds. Management remains optimistic about achieving over 50% new-to-brand prescription share by year-end, driven by physician engagement and patient demand. The company anticipates presenting ACACIA-HCM trial results at an upcoming European Society of Cardiology Congress and plans further European market launches in 2027. Full Transcript OPERATOR Thank you for standing by and welcome to the Cytokinetics Q2 2026 earnings conference call.

This call is being recorded and all participants are in a listen-only mode. 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 this time, simply press star followed by the number one on your telephone keypad.

If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead. Diane Weiser, Senior Vice President Good afternoon and thanks for joining us on the call today.

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. S. and Europe.

Patti Malik, EVP of R&D, will provide updates related to aficamten. Stephen B. Heitner, Chief Medical Officer, will provide updates related to our ongoing clinical development program. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter.

And 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 discussion of these factors. And now I will turn the call over to Robert.

Robert Blum, President & CEO Thank you, Diane, and 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 Mycorzo 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 Mycorzo, we are demonstrating increased velocity that's exceeding expectations, as Andrew will discuss.

Growth in prescribing and dispensing for Mycorzo 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 Mycorzo and its clinical, therapeutic and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy with the launch of Mycorzo 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 Mycorzo marketing authorization across the United Kingdom for the treatment of symptomatic NHCM in adult patients, and at the same time NICE issued guidance recommending Mycorzo for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help Mycorzo reach patients sooner. We expect drug supply and full launch in the UK 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, which showed that the Phase 3 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, and 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 and 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 Mycorzo available to more patients with oHCM in the United States and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with NHCM, and AS could lead to Mycorzo being the only approved therapy for patients across the wider spectrum of HCM.

Moreover, in the second quarter, as you'll hear, we continue 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, and 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, and with that I'll turn the call over to Andrew. Andrew Callos, EVP and Chief Commercial Officer Thank you, Robert. In the second quarter, the launch of MyCorzo 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 MyCorzo is resonating well with healthcare providers, payers, and most importantly with patients. Since our commercial launch at the end of January, MyCorzo 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 MyCorzo 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 United States.

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 MyCorzo among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of MyCorzo. Treating physicians that we surveyed also view MyCorzo favorably across several attributes, including the convenience of dosing, flexibility, safety and tolerability, and 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 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 that historically high-volume CMI writers. In fact, by the end of the second quarter more than 50% of MyCorzo 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 MyCorzo is gaining traction across a wider segment in the oHCM treating community, something we anticipated based on the differentiated profile of MyCorzo, 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 3 trial of aficamten both support findings from SEQUOIA-HCM and further demonstrate that MyCorzo is superior to the beta blocker metoprolol, an important point of differentiation that resonates with physicians, to further reinforce the safety, efficacy, and utility of MyCorzo in patients with oHCM.

As we committed at launch, we continue to evaluate performance using three 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 MyCorzo; and patient volume, which reflects the total number of unique patients prescribed MyCorzo. Across all three metrics, we are encouraged by the progress and rate of growth achieved during the quarter. S. had prescribed MyCorzo, including approximately 300 physicians from the high-volume CMI writer segment.

On average, HCPs prescribed MyCorzo to approximately 3 of their patients. The figure is even higher among the subset of high-volume CMI writers, who have now already prescribed MyCorzo 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 MyCorzo 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 MyCorzo prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, MyCorzo was dispensed to 1,500 patients, nearly tripling the number of new patients dispensed MyCorzo in the quarter. The majority of prescriptions continued to be dispensed within approximately three weeks once all patient documentation and benefits investigation is complete. Going forward, we plan to report on patient dispense versus prescriptions to better align with product revenue.

In Q2, over 80% of the dispensed prescriptions were paid for, with the remainder associated with either free trial, bridge, or other patient assistance programs. These, too, are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels. We ended the quarter with nearly 90% parity coverage for Medicare lives.

We also continued to broaden our commercial lives coverage, achieving over 50% commercial coverage by quarter end, and remain on track to achieve parity access by the end of 2026. Outside the United States, we successfully launched MyCorzo in Germany in June to support expanding access throughout Europe.

We have also submitted 10 HTA dossiers across Europe, with reimbursement approval received effective August 1st in the Netherlands, and in England and Wales, NICE published guidance recommending MyCorzo for use, as we continue to make progress broadening the pathway to further patient access in key markets, with additional markets anticipated to launch later this year during the first half of 2027. We are very encouraged by the performance we have seen in our launch markets. S. and Europe who are delivering excellence with both integrity and focus.

With that, I'll turn the call over to Fady. Fady I. Malik, EVP of Research & Development Thanks, Andrew. The second quarter was an important period for our HCM portfolio, most notably with our announcement of positive top-line results from ACACIA-HCM, our pivotal Phase 3 clinical trial in patients with symptomatic nHCM.

As we shared by top-line press release in May, ACACIA-HCM met both 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 addition, statistically significant improvements compared to placebo were observed across key secondary endpoints, and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of aficamten in nHCM, which represents as much as one half or more of the overall HCM population and for which there are no currently approved therapies.

For many years, treatment options for patients with nHCM have been limited despite the significant burden associated with the disease. We believe the results from ACACIA-HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress.

Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints, and of course safety, we'll also be presenting additional analyses regarding the effect of aficamten on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of aficamten in this population. At ESC, we also plan to hold an event both in person and online for investors and analysts to hear perspectives and insights on the results from prominent HCM KOLs.

As Robert mentioned, after we shared the top-line results publicly, we then met with FDA to discuss the results of ACACIA-HCM and next steps for aficamten, which informed our plan to submit a supplemental NDA expected during the fourth quarter of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency. There is still much work ahead, but the positive top-line results and our regulatory interactions to date reinforce our continued confidence in opportunities for aficamten in nHCM.

In oHCM, we continue to support review activities and engage constructively with FDA regarding the sNDA based on MAPLE-HCM that's currently under review with a PDUFA date of November 14, 2026. We continue to believe that the results from MAPLE-HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of aficamten as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamten observed in MAPLE-HCM are consistent with our labeling, our field medical team has been sharing these results with potential prescribers.

In addition, our field medical team continued to support the launch of MyCorzo.