Cerus Corporation

Good day and welcome to the Cirrus Corporation's first quarter 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 hear an automated message advising you that your hand is raised. To withdraw your question, simply press 1-1 again. As a reminder, today's conference is being recorded. I would now like to turn the conference over to your host, Jessica Hanover, Vice President of Corporate Affairs. Jessica, please go ahead.

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 today are Obi Greenman, Cirrus's President and Chief Executive Officer, Kevin Green, Cirrus's Chief Financial Officer, Dr. Lawrence Korash, Cirrus's Chief Scientific Officer, Vivek Jayaraman, Cirrus's Chief Operating Officer, and Carol Moore, Cirrus's 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, 2023, 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 2023 product revenue guidance and goals, operating expenses, anticipated cash use from operations, gross profits and gross margins, as well as commercial development efforts, future growth and growth strategy, future product sales, product launches, ongoing and future clinical trials, ongoing and future product development, and our regulatory initiatives including the timing of these events and activities. These forward-looking statements involve risk and uncertainty that could cause actual events, performance, and results to differ materially. They are identified and described in today's press release and under risk factors in our form 10Q for the quarter ended March 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 comparable GAAP financial measures, please refer to today's press release. We'll begin today with some opening remarks from Obie, followed by Vivek to discuss some recent business highlights, and Kevin to review our financial results and expectations for 2023. And now, it's my pleasure to introduce Obie Greenman, Cirrus's President and Chief Executive Officer.

Thank you, Jessica, and good afternoon, everyone. 2023 has begun as we previously anticipated, and looking ahead, we are confident in our outlook for the full year. Accordingly, we are reiterating our full-year product revenue guidance range of $165 to $170 million. In the first quarter, we successfully completed a debt refinancing, which Kevin will cover later in greater detail, and we ended the quarter with a strong cash position. We remain committed to reaching adjusted EBITDA break-even this year as we grow the top line while managing operating expenses in a disciplined manner. This should allow us to self-fund the growth in our commercial business, our manufacturing capacity, and our pipeline. We are proud to see the continued and growing role that pathogen inactivation with the intercept blood system plays in efforts to safeguard the blood supply globally. Earlier this year, we were pleased by the acceptance and subsequent publication in the journal Transfusion of our longitudinal analysis of reported annual hemovigilance data from France's regulatory authority, ANSM, covering over 11 years and over 1 million intercept-treated platelet components transfused. The data shows stable platelet utilization trends coupled with reduced patient risk of adverse health effects during France's conversion to universal seven-day intercept platelets. In particular, no transfusion transmitted bacterial infections were reported with intercept platelets compared to 46 infections, including six deaths with conventional platelets. We're also making progress on our APAC strategy. During the quarter, we entered into a new supply agreement with the Hong Kong Red Cross Transfusion Service, which has now initiated use of intercept plasma to complement its ongoing use of intercept platelets. At a much larger scale, and in line with our previous comments during the 2022 year-end call in February, in collaboration with our China JV partner, ZBK, we have submitted our intercept playlet dossier to the Chinese regulatory authority, NMPA. I recently visited ZBK in China with our new board director, Dr. Hua Shan, I left our meeting with optimism for the opportunities ahead of us in China, where platelet demand outstrips supply, and the need for increased platelet transfusion safety and availability is high. Over 2.5 million platelet doses are transfused each year in China, and this figure is expected to grow in the low double digits for the next decade to become the largest market opportunity for Intercept globally. There's also strong interest by our partner, ZBK, in pathogen-reduced red blood cells in China, a market opportunity that is growing rapidly and expected to double the size of the U.S. market by 2030. We received MDR certification for intercept platelet processing sets in the European Union during the first quarter as well. I am proud of this year's team for achieving this milestone in such a timely manner. particularly as we know the MDR transition has created challenges across the industry. With respect to our Intercept red blood cell program, we've continued to work on the questions we received from our EU competent authority, CBG. In the U.S., enrollment continued during the first quarter in our Phase III red blood cell clinical trials, and we continue to track to our previously communicated timeline the completing enrollment this year for the RECIPE study and next year for the RETA study. supported by continued funding from BARDA. During the quarter, we received a commitment from BARDA for an additional $33 million. The ongoing partnership with BARDA for the development of the U.S. Red Blood Cell Clinical Program reminds us again of how pathogen reduction of blood components has also been incorporated into efforts around the globe to safeguard the blood supply. This was also evident a few weeks ago in an international symposium organized by Canadian Blood Services and HEMA Quebec to discuss strategies to mitigate the risk of transfusion transmitted infections following removal of blood donor deferrals. Multiple speakers recognized the important role of pathogen reduction for blood safety and availability, including positive commentary on the experience to date in Canada. From daily protection from bacterial contamination of platelets to pandemic preparedness against emerging pathogens, The Intercept blood system continues to be recognized and utilized to ensure patients have access to safe and effective blood components when needed. I would like now to turn the call over to Vivek to discuss the first quarter commercial highlights.