Cerus Corporation

Good day and thank you for standing by. Welcome to the CEROS Corporation first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate, you will need to press star 1 1 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please see advice that today's conference is being recorded. Now it's my pleasure to hand the conference over to Tim Lee, Head of Investor Relations. Please proceed.

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 and incoming President and Chief Executive Officer, and Kevin Green, Cirrus' Chief Financial Officer. Cirrus issued a press release today announcing their financial results for the first quarter ended March 31st, 2026, the company's recent business highlights and outlook. You can access a copy of this announcement on the company's website at www.cirrus.com. I'd like to remind you that some of the statements we'll make on this call relate to future events and performance, rather than historical facts and our forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2026 product revenue guidance and our expectations for product gross margin non-GAAP adjusted EBITDA performance, P&L leverage, and our government-reimbursed R&D expenses and corresponding revenue. Expected future growth, the potential for us to achieve GAAP profitability, the availability and related timing of data from clinical trials, our mission to establish Intercept as a global standard of care, anticipated regulatory submissions and milestones, commercial expansion prospects, projected market opportunities for the Intercept blood system, including for IFC demand expectations with respect to our group purchasing agreement with Blood Centers of America and our multi-year agreement with the French National Blood Service, our potential platelet opportunity in Germany, the anticipated impact of tariffs and ongoing inflationary pressures, and related mitigatory effects of our business 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 10-Q for the quarter end of March 31st, 2026, which we will follow shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP-adjusted EBITDA, which is a non-GAAP financial measure. Non-GAAP-adjusted EBITDA should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For reconciliation of non-GAAP-adjusted EBITDA, the net loss attributable to Sears Corporation, the most comparable GAAP financial measure 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 Vivek, followed by Kevin to review our financial results, and lastly, closing remarks from Obi. And now, it's my pleasure to introduce Vivek Jayaraman, Cirrus' next President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. We appreciate you joining us today. At Cirrus, our mission is clear, to expand access to safe blood for patients around the world. As we enter 2026, we are focused on delivering against that mission while executing on three core priorities, driving sustainable double-digit growth, advancing innovation, and strengthening our financial foundation. Our first quarter results reflect disciplined progress across each of these areas and reinforce our confidence in the path ahead. 2026 is off to a great start, with strong first quarter results and increasing confidence in our sales outlook for the full year. In the first quarter, product revenue, which reflects our core commercial business, was $53.7 million, up 24% compared to the first quarter of 2025. This performance was driven by continued strength in our global platelet franchise and also accelerating demand in our U.S. IFC business. Based on our better-than-expected start to the year, as well as our growing conviction in the underlying demand for intercepts, we are raising our full-year 2026 product revenue guidance to $227 to $231 million. In addition, we are raising full-year IFC revenue guidance to $22 to $24 million. This updated guidance represents total year-over-year product revenue growth of 10 to 12 percent compared to 2025, and approximately 30 to 40% for IFC. From a top line perspective, North America accounted for nearly 70% of first quarter product revenue as our U.S. platelet franchise continues to serve as a foundation of our overall business. We are deeply grateful to our key customer partners like the American Red Cross who continue to place their trust in Intercept. First quarter North American platelet volumes and treatable doses increased six and 9% respectively when compared to the first quarter of 2025. This gain outpaced the overall historical market growth rate. Looking forward, we anticipate further platelet penetration as we continue to expand adoption among blood centers and hospitals. A key enabler of this growth is our group purchasing agreement with Blood Centers of America, whose members represent approximately half of the U.S. blood supply. Since the agreement took effect on January 1st, we have been focused on execution, educating members through targeted engagement, supporting implementation, and expanding both existing and new customer relationships. We are already seeing early signs of traction, including increased activity at existing Cirrus customers and new agreements to adopt PR platelets at BCA members who have yet to utilize Intercept. Internationally, our RMA business delivered another strong quarter, led by performance in France and Belgium. We continue to view the region as an important contributor to both near and midterm growth. The recently signed multi-year contract with the French Flood Establishment, or EFS, enhances visibility into our forward outlook. We are deeply grateful to EFS for their continued trust in Intercept. France was the first country of scale to fully adopt Intercept to safeguard their platelet supply and this contract renewal is a strong confirmation of the value they've seen intercept. In Germany, progress on the initiate study continues to build the clinical and operational foundation for broader adoption over time. While we remain encouraged by the global opportunity, we are also navigating near-term challenges in certain regions. In the Middle East, ongoing conflict has created logistical complexities that may impact shipment timing. That said, We are actively managing the situation and believe that potential disruptions can be mitigated by strength in other parts of the business. Importantly, we remain confident in our long-term growth prospects in that region, and these near-term challenges were considered when deciding to increase our product revenue guidance for the full year. Innovation remains central to how we expand access to safe blood and drive long-term growth. A key example is the continued successful rollout of our next generation I&T 200 Illuminator across international markets, where we are seeing encouraging adoption and operational performance. Domestically, we are on track to submit our PMA for the I&T 100 to the U.S. FDA this quarter, which represents an important milestone in bringing this technology to the U.S. market. Innovation is also evident in our U.S. ISD franchise, where demand continues to increase, supported by a growing number of blood centers manufacturing IFC, deeper utilization within hospitals, and increasing awareness of its clinical and logistical advantages, particularly the highly valuable combination of immediate availability of fibrinogen alongside five-day post-thaw shelf life. As with our platelet franchise, we are seeing a marked increase in IFC engagement and adoption from BCA member blood centers under our new agreement. As a result, IFC demand in the first quarter, measured by therapeutic dose equivalent, increased approximately 120% year-over-year, with revenue growth approaching 90%. We are seeing a continued shift towards kit-based sales, which supports both operational efficiency and long-term margin expansion. Taken together, these results reflect a business that is executing with focus, expanding access to safe blood, delivering sustainable double-digit growth, advancing innovation, and strengthening our financial profile. While there is much work to be done, we are encouraged by the progress we are making and confident in the opportunities ahead. At the end of the day, the most important point to note is that we were able to meaningfully expand access to Safer Blood in the first quarter of 2026. Thank you for your continued interest and service. I'll now turn the call over to Kevin to review our financial results in more detail.