Cytokinetics, Incorporated

Thank you for standing by and welcome to the Cytokinetics fourth quarter 2025 earnings call. This call is being recorded and all participants are in a listen only mode. After the speaker's 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. And if you'd 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. 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 discuss the commercial launch of MyCorso in the U.S. and readiness in Europe. Patty Malek, EVP of R&D, and Stuart Kupfer, SVP and Chief Medical Officer, will provide updates related to our clinical development programs. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview of 2025 and discuss our 2026 financial guidance. And finally, Robert will then make closing remarks and review 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. These include, without limitation, statements regarding expected timing, potential outcomes of clinical trials, including ACACIA HCM, expectations regarding regulatory interactions and the potential for regulatory approval, expectations regarding commercial performance, and statements about our financial guidance and capital allocations. 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 is contained in our SEC filing, including our current report regarding our fourth quarter 2025 financial results filed on Form 8K that was furnished to the SEC today and our annual report to be filed on Form 10K in the coming days. 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 2025 marked a defining moment for cytokinetics with the FDA approval of mycorrhizal for the treatment of adults with symptomatic obstructive HCM, the first medicine we've advanced from discovery to commercialization, in fact, In the span of a single week, cytokinetics received approvals for mycorrhizal in both the US and China, plus a positive opinion from CHMP for mycorrhizal in the European Union. That latter milestone preceding last week's announcement of the European Commission's approval of mycorrhizal in the EU. Together, these milestones represent the culmination of years of focused scientific, clinical, and regulatory execution and we now turn the page onto a new chapter for cytokinetics as a global commercial stage biopharmaceutical company. More importantly, the approval of mycorrhizal offers a new treatment option to patients living with obstructive HCM, a serious condition that can profoundly impact quality of life. As Andrew will discuss, since the FDA approval in December, our teams have been focused on executing a disciplined and deliberate commercial launch. Our ongoing priority is to implement the systems, the education, the promotion, and market access pathways to support physicians, patients, and payers while also building initial and sustainable launch velocity and momentum. While it's still early, we are encouraged by our progress thus far and the initial engagements we're seeing from the cardiology community. In fact, the level of interest in mycorrhizal as a new treatment option is high. With an eye towards the longer-term U.S. commercial launch trajectory, during the first quarter, we submitted the supplemental NDA for maple HCM to the FDA. We expect FDA to conclude its review of the SNDA in Q4 2026. We believe that The potential inclusion of results from Maple HCM into an expanded label for mycorrhizal could boost category penetration, depth, and breadth, so more patients may ultimately benefit. Of course, we also anticipate the readout of results from Acacia HCM in nonobstructive HCM, and we're on track for top line announcement in the second quarter of this year. is a different patient population with significant unmet medical need. Should this trial prove positive, it could also represent a potential growth driver for mycorrhizal. Outside the U.S., following the recent approval of mycorrhizal in the EU, we've now shifted into full execution of our commercial readiness planning with our first planned launch in Germany expected in the second quarter. During the fourth quarter of last year, Health Canada accepted for review the new drug submission for Affy Campton, and a potential approval for Affy Campton in Canada could come later this year. As we look ahead, we enter this next phase of our corporate development with strong momentum and also solid financials. The progress we delivered last year positions us well for continued growth and value creation while we also keep a close eye on capital structure and capital allocation. Sung will speak to our financial guidance and position as we end in 2025, as well as operating expense guidance for 2026. That guidance reflects the priorities of launching myCORSO and advancing our muscle biology pipeline, both with disciplined execution and attention to capital efficiencies. We're confident in the foundation we're building for our specialty cardiology franchise and to deliver for both patients as well as shareholders. And with that, I'm going to now turn the call over to Andrew, please.