Cytokinetics, Incorporated

Good afternoon, and welcome to Cytokinetics' fourth quarter 2024 conference call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call to questions after the presentation. We will allow for only one question per participant. I will now 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 developments. Andrew Kalos, EVP and Chief Commercial Officer, will address commercial readiness activities for AFI-Campden. Fatty Malik, EVP of R&D, will provide updates related to recent regulatory interactions in the clinical development program for AFI-Campden. Isaac C. Hanover, EVP, Corporate Development, and Chief Business Officer, will provide an update on recently announced business development deals in the context of our corporate development. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates regarding Omicamp de Macarbo, CK586, and our earlier stage development pipeline. Sung Lee, EVP and Chief Financial Officer, We'll provide a financial overview of the past quarter and discuss our 2025 financial guidance. And finally, Robert will review expected key milestones for the year ahead. Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements as contained in our SEC filings, including our current report regarding our fourth quarter 2024 financial results filed on Form 8K that was furnished to the SEC today. We undertake no obligation to update any forward-looking statements after this call. 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 fourth quarter of 2024 was an exceptionally productive quarter that rounded out a successful year. Most notably, we made major strides towards potential regulatory approvals and subsequent commercial launches of Afikampton across multiple geographies. Our NDA was accepted by FDA, our MAA was validated by EMA, and our NDA was accepted by the NMPA in China with priority review. Now, with regulatory submissions on file in the U.S., Europe, and China, we're engaging in parallel regulatory interactions that may deliver Afikampton to patients around the world. With our PDUFA date of September 26, 2025, our commercial readiness activities in the United States are reaching a peak while we also lay the foundation for our go-to-market activities in Europe. In the nearer term, We expect to continue already ongoing activities with FDA in support of their review of the NDA. We have been responding to questions as well as preparing for clinical site and other inspections, and we recently submitted our 120-day safety update to FDA. In March, we expect to participate in a mid-cycle meeting with FDA. Ahead of that meeting, I want to level set that we do not plan to share detailed updates following that meeting, given that the FDA review of the NDA will still be ongoing. However, we maintain our expectation for a differentiated label and mis-ritigation profile for AFI-CAMPTN were it to be approved by FDA. In both Sequoia HCM and Forrest HCM, in patients with OHCM, We observed a favorable overall safety profile, LVEF stability, rapid dose titration, as well as a lack of treatment interruptions related to episodes of heart failure or heart failure hospitalizations related to LVEF. Nor did we observe any clinically meaningful drug-drug interactions. We believe all of these characteristics are consistent with the intrinsic properties of AFI-CAMPTON. Moving on to the regulatory review of AFI-CAMPTON in Europe, following the validation of our MAA in late December, we expect to continue to engage with EMA during their review by responding to requests for information and preparing for inspections. Our next key milestone for these regulatory interactions with EMA is receipt of the day 120 list of questions expected in April. As you know, we plan to commercialize Affy Campton ourselves in the U.S. and Western Europe. In other key geographies in the fourth quarter, Sanofi acquired, with our participation from Corzell, the rights to develop and commercialize Affy Campton in China. Additionally, in November, we announced our new collaboration with Bayer that entails a license agreement for Affy Campton in Japan. These two strong pharmaceutical company partners in the two leading markets outside the U.S. and Europe both align with cytokinetics in their commitment to cardiology, and each brings great expertise, resources, and reach to enable us to hopefully deliver Afikampton to a greater number of HCM patients in need and contribute to our goal to reach patients globally with our medicines. Simultaneously, we're advancing our later stage development program for Afikampton with multiple ongoing potential label expansion clinical trials. In the near term, we expect to share top-line results from Maple HCM in Q2, and if positive, data from this trial may represent, again, a label expansion opportunity for Afikampton following potential FDA approval. Meanwhile, we continue to expand our specialty cardiology franchise and innovative pipeline advancements, ensuring that we're more than simply a one-product company. In Q4, we started COVID-HF, a confirmatory Phase III clinical trial of Omicamptive in patients with heart failure with severely reduced ejection fraction. And more recently, we started Amber Hef-Pef, a Phase II clinical trial of CK586 in patients with heart failure and preserved ejection fraction. Our successes over the past quarter reflect our clear vision, strategic execution, and responsible investment in our muscle biology platform. This year, we're approaching a defining moment with key milestones ahead that will shape our future. As multiple programs advance in our specialty cardiology franchise, Alongside progress in our early stage neuromuscular pipeline, as well as continued innovation in our research labs, we're poised to drive meaningful progress to positively impact the lives of patients, as well as create enduring value for shareholders who support our mission. With that, I'll now turn the call over to Andrew.