Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cirrus Corporation third quarter 2025 earnings conference call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Tim Lee, Cirrus Head of Investor Relations. Tim, you may begin.

Thank you, and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the investor relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cirrus' President and Chief Executive Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer, Kevin Green, Cirrus' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President. Cirrus issued a press release today announcing our financial results for the third quarter ended September 30, 2025, and describing the company's recent business highlights. You can access a copy of the announcement on the company's website at www.cirrus.com. I'd like to remind you that some of the statements we will make on this call relate to future events and performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2025 product revenue guidance, our fourth quarter 2025 expected product revenue range, our expectations for operating cash flow and non-GAAP adjusted EBITDA performance, and our expected expense levels, expected future growth and our growth trajectory, the availability and related timing of data from clinical trials, planned regulatory submissions, and product launches. product expansion prospects, and other statements that are not historical facts. These forward-looking statements involve risk and uncertainties that can cause actual events, performance, and results to differ materially. They are identified and described in today's press release, in our slide presentation, and under risk factors in our Form 10Q for the quarter ended September 30, 2025, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA and the percentage growth in EMEA product revenue and constant currency. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures to the extent reasonably available, please refer to today's press release and the slide presentation available on our website. We will begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review your financial results and expectations for the balance of 2025, and lastly, closing remarks from Obie. And now, it's my pleasure to introduce Obie Greenman, CSRS President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. I'm pleased to report that Cirrus continues to build on its strong momentum, delivering another quarter of solid commercial, operational, and financial execution, as well as continued progress across our development priorities that we spelled out at the beginning of the year. As we close in on the end of 2025, it's clear that our disciplined focus on execution, coupled with the commitment of our global team and blood center partners, is contributing to the sustainable revenue growth that has a solid base. the evolving standard of care in transfusion medicine that incorporates pathogen inactivation has been established for about 25% of the global platelet supply, providing a great foundation for expected future revenue growth associated with our growing Intercept product portfolio and our goal to address all transfused blood components. In the US, Intercept adoption continues to grow as hospital demand for 100% pathogen inactivated platelet inventory increases because of the benefits associated with managing the logistics and inventories of platelet transfusion. We estimate the current U.S. market penetration in the mid-60% vicinity up from the low 60s a year ago, and we believe we have additional runway well into the 70% range and ultimately north of 80% as we continue to enhance the value proposition of Intercept with improvements in ease of use and new label claims. Adding to the growth from our platelet and plasma businesses, IFC continues to gain clinical traction as hospitals recognize its ability to meaningfully improve patient outcomes and streamline transfusion workflows. We continue to believe IFC provides tremendous growth potential for our base business as we move forward. Over the past two quarters, we experienced an acceleration in IFC kit sales to blood centers and a shift away from the direct sales to hospitals. as blood thinners began to champion IFC as an important part of their product portfolio in the face of hospital demand. Vivek will provide additional color on this transition and the expected growth prospects of our U.S. IFC business in his prepared remarks. In international markets, Intercept's position as the standard of care in multiple European countries, including Switzerland, France, Austria, and Belgium, is supporting the interest in growth in other geographies. Cirrus was recently selected by the German Red Cross Blood Service, Baden-Württemberg Hessen, to support the INITIATE study, a prospective multicenter study evaluating pathogen-reduced platelets under routine conditions at multiple blood center production sites and across many hospitals in Germany. This follows the publication of a new recommendation from the German National Blood Advisory Committee, or ACABLUT, which recommends proactive measures, including pathogen reduction, as core measures to enhance the safety of platelet transfusions. We believe these are important steps and serve as precursors for potential future growth coming from Germany. Shifting to our development pipeline, we're happy to report enrollment of the last patient in the U.S. Phase III REDIS trial in October. As you may recall, REDIS is the second U.S. Phase III clinical trial for red blood cells, and the study enrolled almost 600 patients requiring RBC transfusion for both acute and chronic anemia. Results from the study are expected in the second half of 2026, at which time we will discuss with the FDA next steps in the U.S. regulatory pathway. In Europe, the regulatory review of intercept RBCs continues with a notified body, TUV-SUD, based out of Germany, while the competent authority review will transition from the State Institute of Drug Control, SUCL, in the Czech Republic, to the French National Agency for Medicines and Health Product Safety, or ANSM. With ANSM's agreement to take on this consultation, we now expect the CE-MARC decision on the intercept RBCs to be delayed by at least six months prior to prior expectations. Switching to our next generation LED-based INT200 illumination device, Following the successful European CE mark approval earlier this year, the regulatory team continues to prepare for the planned US PMA submission to the FDA in mid-2026. Concurrently, with the planned PMA submission, we plan to initiate a new platelet clinical study designed to expand the shelf life of intercept blood system for platelets from the current five-day indication and provide greater value to customers. Lastly, switching to our financials, we continue to execute against our stated objectives and remain focused on our goal to achieve full-year positive non-GAAP adjusted EBITDA. Kevin will provide additional details on this and our full financial results in his prepared remarks. With that, I'll turn the call over to Vivek to provide more detail on our three-quarter commercial performance.