Cerus Corporation

Ladies and gentlemen, thank you for standing by and welcome to Cirrus Corporation's third quarter financial results conference call. At this time, all participants are in listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. It is now my pleasure to introduce Investor Relations Director, Tim Lee.

Thank you, Operator. 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 www.serious.com. With me on the call are Obi Greenman, Serious' President and Chief Executive Officer, Vivek Jayaraman, Serious' Chief Operating Officer, Kevin Green, Serious' Chief Financial Officer, and Carol Moore, CIRRS' Senior Vice President of Regulatory Affairs and Quality. CIRRS issued a press release today announcing their financial results for the third quarter ended September 30, 2020, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cirrs.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 2020 financial guidance and goals, operating expenses, anticipated cash use from operations, 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 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 ended September 31, 2019, and our Form 10-Q for the quarter ended September 30, 2020, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we'll begin with opening remarks from Obie, followed by Vivek to provide the commercial update, Kevin to review your financial results, followed by Obi with a development pipeline update and closing remarks. And now, it's my pleasure to introduce Obi Greenman, Cirrus's President and Chief Executive Officer.

Obi Greenman Thank you, Tim, and good afternoon, everyone. We are pleased to report another quarter of record product revenue, totaling $23.6 million, driven by strong commercial execution with gains in both North America and the immediate markets. The robust top line performance in the quarter was complemented by continued progress in our development programs on all fronts. In particular, we are eagerly awaiting the FDA anticipated approval decision on pathogen-reduced cryoprecipitated fibrinogen complex, or PR-cryo, which we think could happen next month. Later in the call, I'll share with you our pre-launch activities in preparation for the anticipated approval for PR-cryo. With a compliance period for the FDA guidance document on bacterial safety of platelets coming to a close in five months, we are seeing increasing adoption of our technology by both blood center and hospital customers in the U.S. As we have previously noted, we think most U.S. blood centers and hospitals will gravitate towards single-step methods, either pathogen inactivation or LVDS, large volume delayed sampling, to comply with the guidance. Our discussions with blood centers and hospitals indicate that rather than the two-step option, the single-step method provides the operational benefits and ease of availability. When comparing Intercept to LVDS, we think our technology offers several advantages such as replacement of gamma radiation, CMV serology, Babesia testing, and Zika virus testing, which gives us conviction in our belief that Intercept will become the standard of care. Vivek will provide additional details on the US platelet market during his prepared remarks. By now, hopefully you have had a chance to review our press release detailing our third quarter results. While the COVID-19 pandemic has had an impact on our business, I continue to be impressed with how the Cirrus team is navigating these challenges in support of our customers and their increasing need to secure the safety of the blood supply. As we head into the winter months, we are seeing a substantial rise in the daily COVID-19 cases and hospitalizations, both here in the US and abroad. This surge could impact the availability of blood donors and staffing at donor centers. In light of the uncertainty as to where and when the COVID-19 surge will peak, we are narrowing our full year 2020 product revenue guidance range from $89 to $93 million to $89 to $91 million. Therefore, the implicit guidance range for Q4 product revenue would represent year-over-year fourth quarter growth between 21% and 30% and solid sales momentum heading into 2021. With that, let me turn the call over to Vivek for a more detailed review of our commercial operations.