Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the C-RIS Corporation fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. After this figure's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 101 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 101 again. Please be advised, Today's conference is being recorded. I would now like to hand the conference over to Joel Trujillo, CIRIS's Senior Director of Investor Relations. 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.ciris.com. With me on the call are Obi Greenman, CIRAS's President and Chief Executive Officer, Kevin Green, CIRAS's Chief Financial Officer, Dr. Lawrence Karash, CIRAS's Chief Scientific Officer, Vivek Jayaraman, CIRAS's Chief Operating Officer, and Carol Moore, CIRAS's Senior Vice President of Regulatory Affairs and Quality. CIRAS issued a press release today announcing our financial results for the fourth quarter and year ended December 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 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 10-K for the year ended December 31, 2022, 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 a 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 the best to discuss some recent business highlights and Kevin to review our financial results. We will conclude with commentary from Obie with closing remarks. And now, it's my pleasure to introduce Obi Greenman, Cirrus' President and Chief Executive Officer.

Thank you, Joel, and good afternoon, everyone. In 2022, Cirrus kept up its momentum in progressing on our goal to safeguard the global blood supply, building upon efforts in establishing intercept as a standard of care in multiple geographies, most recently in the U.S. On our last several calls, we have spoken about the momentum the business has seen in the U.S., We continue to see this trend play out in the fourth quarter, the sustained growth of our Intercept platelet business, driven by excellent commercial and operational execution, as we manage the growth with an evolving manufacturing capacity expansion. Our success in deploying the Intercept blood system for platelets in the U.S. drove a record year for the company. The significant growth the company has realized over the past five years is enabling Cirrus to lead a paradigm shift in transfusion medicines. Here is pre-release strong 2022 top line results in January. I'm happy to report that in addition to a robust top line, the company has driven sustained margin expansion, run the business with low cash use from operations over the past several quarters, generated leverage from our SG&A investments, and ended the year with a very strong balance sheet. We remain encouraged by the foundation for growth upon which our core business franchise is built. and expect the few near-term challenges we referenced in our pre-release to moderate as we progress through the remainder of the year. Having established Intercept as a standard of care in many national markets now, we have placed a substantial focus on being a trusted and reliable partner to our customers, with over 13 million Intercept platelet and plasma doses transfused to date. To realize our mission, Cirrus continues to work with its partners to expand manufacturing capacity in multiple facilities, to position itself to continue to grow intercept blood system adoption in 2023 and beyond. We see significant opportunity to grow our top line over the next several years, and now in 2023, we'll have the necessary capacity to realize that growth. This growth is expected to be supported by the extension of our leadership in markets we currently serve, the serving of new geographies such as Canada, China, and Germany, and the commercial success of new products, including our Intershield Fiber Engineering Complex. The opportunities ahead for Cirrus, particularly in the context of the organic growth of the company's total addressable markets, or TAMs, are significant. We expect these TAMs to continue to grow, surpassing $1.5 billion and $200 million for the global and U.S. playbook opportunities, respectfully, over the next five to seven years. driven by mid-single-digit overall playlet demand growth. I would now like to turn the call over to Vivek to discuss the fourth quarter revenue highlights.