Cerus Corporation

Welcome to the Sears Corporation First Quarter 2025 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 ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Tim Lee, Sears Head of Investor Relations, Tim, you may begin.

Thank you, and good afternoon, everyone. 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's President and Chief Executive Officer, Vivek Jaraman, 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 first quarter and March 31, 2025, and describing the company's recent business highlights. 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 the 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 expectations for bottom line and non-GAAP adjusted EBITDA performance, our operating expense and gross margin expectations, And our expectations for positive operating cash flows for 2025. Expected future growth in our growth trajectory. Expectations with respect to our enhanced CE mark submission for intercept red blood cells. Expectations with respect to our new INT200 elimination device. Expectations with respect to patient enrollment in our phase three RETA study. And other statements that are not historical facts. These four linking 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 March 31st, 2025, which we will file shortly. We undertake no duty or obligation to update our four linking statements. On today's call, We will also be discussing our non-GAAP financial measures, including our non-GAAP adjusted EBITDA and non-GAAP constant currency metrics, which exclude the impact of foreign exchange rates. 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, please refer to today's press release and the slide presentation available on our website. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review our financial highlights, expectations for the rest of 2025, and lastly, closing remarks from Obie. And now, it's my pleasure to introduce Obie Greenman, CIRS's President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. I'm very happy to report to you all today the solid position Sears is in as we continue to grow our global business upon the strong foundation that we have built in establishing a new standard of care in transfusion medicine. During these times of uncertainty in the global financial markets, we are confident in our ability to continue to execute against our important mission as a company. Our mission at Cirrus has always been to fundamentally transform the safety and availability of transfused blood components and to provide unwavering customer support to deliver safe and effective blood products to patients. Our perseverance continues unabatedly. Our products have treated approximately 20 million intercept units globally based on the cumulative number of platelet and plasma kits sold. Intercept is now used in over 40 countries, and is the standard of care in approximately a third of those countries. In mid-Q1, we received CE Mark for the INT200, our next-generation LED-based illumination device, earlier than expected. This foundational device platform was designed with input and feedback from our global customer base to enhance the usability and efficiency of the system. Initial feedback from our customers has been very positive, and we now look forward to submitting the PMA for the INT200 device to the FDA in 2026 for the planned launch in the U.S. in 2027. We expect that the phased global launch of the new INT200 over the course of the next few years will provide our blood center customers with a reliable platform which will also enable the future geographic expansion of Intercept through the end of the decade. We expect that the effort and expense that went into the development of the IIT 200 will pay dividends for years to come. In the U.S., our core platelet customers continue to be an important driver of top line growth as we look to further expand our platelet market share in line with the hospital demand for 100% pathogen inactivated platelet inventory. In addition, we continue to improve IFC supply to meet growing customer demand, which has been exceeding our ability to supply. These activities, combined with another quarter of solid cross-functional execution, resulted in double-digit revenue growth, and we are reiterating our full-year product revenue guidance range of $194 to $200 million. The bank will provide additional color on our commercial performance in its prepared remarks. Regarding the Intercept Red Blood Cell Program, we continue to work closely with TUV SUD, our notified body, I'm happy to report that in mid-April, we submitted our updated CE-MARC application for the intercept red blood cell system to TUV, and the review has begun. The enhanced submission includes updated documentation from our positive phase three recipe study and additional data accumulated since our original filing. Leveraging the feedback from both the notified body and competent authority review from the initial submission, And integrating the new clinical data from Recipe into a new submission over less than a couple of quarters was a coordinated team effort. And I want to thank the cross-functional team at Cirrus for all of their hard work. As CUV completes its review of the various modules of this submission over the coming months, including the updated and more comprehensive clinical module, we look forward to updating you on our application on our Q2 earnings call. Turning to our U.S. red cell development program, the second phase three study called REDIS is gating the U.S. PMA submission pathway. Since commencing the study in 2019 on the back of the Zika virus epidemic and navigating the challenges of study enrollment during the COVID pandemic, we have enrolled more than 500 patients in the study to date. Enrollment continues, and we expect to enroll the last patient in the second half of this year. Switching to our financials, we are off to a strong start and are building upon last year's achievement of positive non-GAAP adjusted EBITDA for the full year. With the financial markets consumed by concerns about the impact of global tariffs on company operating plans, we believe we are in a unique and enviable position to continue to selectively invest in many key initiatives during 2025, while maintaining our goal to once again achieve positive non-GAAP adjusted EBITDA. Kevin will provide additional details in his prepared remarks. I would like now to turn the call over to the bank to discuss our first quarter commercial results along with color on our outlook for 2025.