Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by and welcome to the Sears Corporation first quarter 2024 earnings conference call. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, 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 Jessica Hanover, Sears Corporation. Vice President of Corporate Affairs, Dr. Hanover, 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 of Regulatory Affairs and Quality. Cirrus issued a press release today announcing our financial results for the first quarter ended March 31, 2024, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cirrus.com. I'd like to remind you that some of the statements we will make on this call related 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 2024 product revenue guidance, our expectations for operating cash flows 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 risks and uncertainties that could 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 ended March 31, 2024, 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. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For 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 results and expectations for the rest of 2024, And lastly, closing remarks from Obi. And now it's my pleasure to introduce Obi Greenman, Cirrus's President and Chief Executive Officer.

Obi Greenman Thank you, Jessica, and good afternoon, everyone. I'd like to open the call by spending a few minutes reviewing our recent positive performance, as well as looking ahead to key milestones on tap for the company. The first quarter of 2024 was an important one in the history of the company, as we reported positive top-line results from the Phase III RECIPE clinical trial, the first of our two U.S. BARDA-funded trials for intercept red blood cells, or RBCs. We are thrilled that RECIPE met its primary efficacy endpoint of non-inferiority of intercept RBCs compared to conventional RBCs in complex cardiovascular surgery patients. And while RECIPE was powered specifically for this primary efficacy endpoint, we are nonetheless also very pleased by the outcomes for the safety endpoints that we reported in March. We recognize that there is great interest in the details of the RECIPE results, and we look forward to being able to share more by way of media presentations and journal publications targeted for later this year, once the publications have been accepted. As we continue to enroll the RETIS study, our second U.S. part of funded Phase III trial for intercept RBCs, we view the RECIPE readout as meaningful for the overall RBC program and supportive of our planned launch in Europe. We are looking forward to meeting with the recipe trial investigators next month to review the findings from the study and to gain their insights into the opportunities for how to position this important data set with the transfusion medicine community. In summary, at this stage, the recipe data give us confidence in our Intercept RBC program, and we look forward to sharing more with you in 2024. On the commercial front, We are increasingly confident in our expectations for 2024 and are reiterating our overall product revenue guidance of $172 to $175 million, inclusive of our intercept by bridging complex guidance of $8 to $10 million. The bank will provide color into the continued traction we see across our portfolio and geographies. Importantly, we also remain committed to justice EBITDA breakeven for the full year 2024. Kevin will provide more insight into our pathway for continued improvement in this metric over time. I would like now to turn the call over to Vivek to discuss our commercial results and progress for the first quarter of 2024, as well as our outlook for the rest of the year.