Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by and welcome to the Sears Corporation First Quarter 2022 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. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker host today, Mr. Matt Notaryani, Senior Director of Investor Relations. Mr. Notaryani, 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, Kevin Green, Cirrus' Chief Financial Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer, Carol Moore, Cirrus' Senior Vice President of Regulatory Affairs and Quality, and Jessica Hanover, Cirrus' Vice President of Corporate Affairs. Cirrus issued a press release today announcing our financial results for the first quarter ended March 31, 2022, 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 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 2022 product revenue guidance and goals, operating expenses, anticipated cash use from operation, 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 can 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 10-K for the year end of December 31st, 2021, and our Form 10-Q for the quarter ended March 31, 2022, which we will file shortly. We undertake no duty or obligation to update our forward-looking statement. On today's call, we'll begin with some opening remarks from Obie, followed by Vivek to discuss some recent business highlights, and Kevin to review our financial results. We will conclude with commentary from Obie with an update on our pipeline and closing remarks. 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 a reconciliation of non-GAAP financial measures to comparable GAAP financial measures, please refer to today's press release. And now, it's my pleasure to introduce Obi Greenman, CSRS President and Chief Executive Officer.

Thank you matt and good afternoon everyone our first quarter of 2020 to continue the momentum, we have seen over the past few years has intercepted option, particularly in the US is ramping. Our work is focused on establishing a new safety standard in transfusion medicine so blood centers and transfusion services can protect patients and ensure availability of blood components. In the context of the current pandemic and the prospect for future risk to the blood supply, the Cirrus mission is as relevant as it has ever been over the company's history. I am pleased that growing our top line means expanding access to intercept treated platelets and plasma for patients around the world. After I discuss our quarterly results, Vivek will spend some time today discussing recent significant announcements associated with long-term contract extensions with both the American Red Cross and Fresenius Cobby. But first, let's review the first quarter revenue highlights. Product revenues for the first quarter of 2022 are the highest for any first quarter in our history, as we report year-over-year growth in all major geographic regions to start 2022. With our 20th consecutive quarter of year-over-year revenue growth, we are demonstrating an enduring ability to expand access to intercept-treated blood components, even in the face of geopolitical and economic uncertainty. Our results were once again led by strong growth for platelets in the U.S., which was up over 130% on a year-over-year basis. Blood centers and hospitals are choosing the Intercept blood system for platelets as a means to comply with the FDA bacterial safety guidance because it provides proactive, broad-spectrum protection against pathogens beyond just bacteria, while also offsetting costs and generating operational benefits. As we look to diversify the ongoing growth of the Intercept platelet business in the U.S. and globally, We are making solid progress with our nationwide launch of intercept fibrinogen complex, or IFC, across the U.S. We have a robust funnel of accounts we look forward to bringing online through 2022 and into 2023. And we are just beginning to realize the leverage of our combined direct-to-hospital and blood center sales channels. As we know well from our prior product launches, bringing a new product into hospital transfusion services and changing clinical practice is a significant undertaking. But we are benefiting from the strong clinical interest around the opportunity to improve the patient treatment paradigm through the early administration of a fibrinogen-enriched product without delay, while also reducing frequent conventional blood product wastage. Hospitals that have adopted IFC are quickly seeing numerous benefits compared to conventional cryoprecipitate. Perhaps the most compelling example is at the University of Florida Shands Hospital, where IFC has now been included in the first round of the institution's massive transfusion protocol, and wastage rates have been reduced from over 20% to less than 0.5%. With an estimated demand for fibrinogen expected to grow in the mid-teens over the next five years, we are excited to be rolling out IFC across the country at a time when the awareness around early fibrinogen delivery is growing, both as a function of improved coagulation monitoring and lower transfusion thresholds. I would now like to hand the call over to Vivek to provide some updates about two of our partners, the American Red Cross and Fresenius Cabi.