Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by. And welcome to the CIRS Corporation third quarter 2021 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 the star, then the one key on your touch-tone telephone. Please be advised that today's conference is being recorded. If you recall operating systems, please press star, then zero. I would now like to hand the conference over to your speaker host today, Sir Matt Milteriani, Senior Director of Investor Relations.

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, 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 third quarter ended September 30, 2021, 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 are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2021 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 activities, 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 the risk factors in our Forms 10-K for the year ended December 31, 2020, and 10-Q for the quarter ended September 30, 2021, 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, a commercial update from Vivek, followed by Kevin to review our financial results. We will conclude with commentary from Obie with an update on our pipeline, recent announcements, and closing remarks. And now, it's my pleasure to introduce Obie Greenman, CIIRS's President and Chief Executive Officer.

Obie Greenman Thank you, Matt, and good afternoon, everyone. Once again, we are excited to share our most recent quarterly results with you all. Before I turn the call over to Vivek and Kevin to cover our third quarter results in more detail, I wanted to provide a few opening comments. 2021 has truly been a breakout year for Cirrus as our annualized product revenue run rate continues to build a momentum we saw in the first half of the year. We continue to achieve major goals in 2021, both commercially and operationally, and I'm excited about the road ahead for the company going into 2022. Since 2014, when the FDA first issued the draft guidance to address bacterial contamination in platelets, we've been focused on making the case that our Intercept blood system is a best-in-class offering to mitigate transfusion-transmitted bacterial infection, while also providing a proactive solution to addressing blood safety and availability in general. We have built a unique and strong position in transfusion medicine, which is a medical field that takes a while to embrace innovation, but when it does, it establishes safety measures that endure. Our Q3 and year-to-date results were driven by U.S. adoption of our Intercept Playlit platform, which enables strong blood center compliance with the FDA guidance that went into effect October 1st. In parallel with the blood center benefits afforded by Intercept, U.S. hospital demand for pathogen-induced platelets continues to build given the logistical benefits of a single inventory of fresher platelets compared to managing inventories of platelets of various ages that are subjected to delayed release due to testing. As you can see from this quarter's results, our business in the U.S. has grown rapidly. With all the work our team has done to get customers ready for the FDA compliance, we believe our current run rate is helping to establish pathogen reduction as a standard of care in the U.S. playlet market, with intercept-treated playlets now representing the majority of playlets produced. Last month at the virtual ABB annual meeting, we were pleased to see our Phase IV Piper study presented as a plenary lecture. Piper represents the largest study of playlet transfusions ever conducted and is the latest in a robust, growing, evidence-based body of real-world data for our technology. With studies like this, combined with over a decade of routine use experience in Europe, we are solidifying the strong safety and efficacy profile for Intercept. We believe such a strong body of evidence will allow us to realize continued growth on a global scale as we help deliver a new standard in transfusion medicine. To that end, cumulative kit sales for Intercept platelets and plasma recently eclipsed 10 million doses globally. It is a remarkable accomplishment in our company's history and a reminder to all of us at Cirrus of the thousands of patients that receive Intercept treated blood components every day. In summary, we are honored to support our blood center customers and their daily efforts to secure the blood supply, and we remain committed to our mission of making the Intercept blood system the global standard of care in transfusion medicine. Following Vivek and Kevin's remarks, I'll return to discuss our pipeline which continues to make good progress and is positioning us for continued growth over the long term. With that, I'll turn it over to Vivek.