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5/5/2026
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 of Corporate Affairs. Please go ahead.
Good afternoon and thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent development. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of a mycorrhizal in the U.S. and readiness in Europe. Sadi 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. Sun 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 a discussion of these factors. And 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 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 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 mycorrhizal 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 mycorrhizal 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 mycorso is significant, and we're 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 III clinical trial of Afikampton in non-obstructive HCM. We were very pleased to see that Afikampton improved both symptoms and exercise capacity with no new safety signals observed. Patty 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. And for Affy-Campden, 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 afecamptin 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. And during the quarter, there were several meaningful regulatory updates for afecamptin 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 November 14, 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. And outside of the United States, we submitted an MAA for Afikante 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'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 myCORSO 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. And with that, I'll now turn the call over to Andrew, please.
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