Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cirrus Corporation fourth quarter and full year 2023 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 during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. 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, Cirrus 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 fourth quarter and year ended December 31, 2023, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.siris.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 bottom line and non-gap 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, 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-K for the year ended December 31, 2023, 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 Obie. And now, it's my pleasure to introduce Obi Greenman, Cirrus's President and Chief Executive Officer. Obi Greenman, Cirrus's President and Chief Executive Officer Thank you, Jessica, and good afternoon, everyone.

I'd like to open the call by spending a few minutes reflecting on 2023 as well as our expectations for 2024. During the fourth quarter of 2023, we surpassed the 16 million mark for cumulative kits sold for trans-usable intercept platelet and plasma doses. It's a significant figure, particularly with respect to the absolute number of patients who receive intercept-treated blood components on a daily basis across the globe. And it also represents the ever-growing and significant role played by our pathogen inactivation technology in the evolving healthcare landscape. The importance and relevance of pathogen inactivation were also visible during a special webinar in January of this year hosted by Yale University the American Red Cross, and the Association for the Advancement of Blood and Biotherapies, or AABB. The event was focused on addressing platelet insecurity with speakers from blood centers such as the American Red Cross and Canadian Blood Services, as well as from hospitals, the military, and government organizations. In addition to the recognition of the growing demand for platelets in the face of blood supply vulnerabilities, It is also clear that pathogen inactivation has become a foundational aspect of today's transfusion medicine landscape. It is this dynamic that drives our excitement about the continued potential for the intercept business, both in the U.S. and across the globe. We anticipate the near future to be driven by both international expansion of intercept platelets, as well as an increasing growth trajectory for intercept fibrinogen complex, or IFC, in the U.S. The VAPE will provide additional commentary on our commercial expectations following my introductory comments. We ended 2023 on several high notes, posting double-digit sequential growth for the fourth quarter, narrowing gap net loss attributable to Cirrus, and importantly, delivering positive non-gap adjusted EBITDA for the first time. Per our 2024 product revenue guidance announcement earlier this year, we expect to post year-over-year double-digit growth along with sustaining if not improving bottom line results. Kevin will provide more details in his comments following the vague. I would now like to turn the call over to the vague to discuss our commercial results and progress for the fourth quarter and full year 2023, along with color on the outlook for 2024.