Cerus Corporation

Ladies and gentlemen, thank you for standing by, and welcome to the SARIS Corporation's fourth quarter and full year 2020 financial results 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 then 1 on your telephone. It is now my pleasure to introduce the SARIS management team. Please go ahead.

Thank you, and good afternoon. I'd like to begin by introducing myself. My name is Matt Notoriani, and I am Cirrus' Senior Director of Investor Relations. 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 Jay Araman, Cirrus' Chief Operating Officer, Kevin Green, Cirrus' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President of Regulatory Affairs and Quality. Cirrus issued a press release today announcing our financial results for the fourth quarter ended December 31, 2020, 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 2021 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 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, 2020. 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 opening remarks from Obie, followed by Vivek to provide the commercial update, Kevin to review our financial results, followed by Obie, who will comment on some recent announcements, provide a pipeline update, and make some closing remarks. And now, it's my pleasure to introduce Obie Greenman, Cirrus' President and Chief Executive Officer.

Thank you, Matt, and good afternoon, everyone. Right now, hopefully you've had a chance to review our press release detailing our fourth quarter and full year 2020 results. It goes without saying that the 2020 was a year filled with many challenges, but it turned out to be a significant year of progress for Cirrus. In the face of a global pandemic that stretched the capabilities of healthcare systems everywhere, our dedicated team rose to the challenge continued to make progress on multiple fronts. Our goal remains to establish Intercept as the standard of care in transfusion medicine for safeguarding the global blood supply against pandemic and other threats. As I think about the COVID-19 pandemic, I'm reminded that the company was founded largely as a result of another global health emergency in our history, HIV. In those early days, our founders recognized that threats could emerge and influence medicine in unexpected ways. Fast forward to today, we are seeing this play out in real time, and I'm proud that Cirrus is at the forefront of pandemic preparedness. As evidenced by our 2020 results, our team has been tirelessly working to commercialize the system with the goal of protecting the global blood supply from potential threats, including those that are not yet known. It was not always easy to accomplish so much of this work virtually, but I'm grateful to our employees for their dedication, our partners for their commitment to our shared goals, and our customers for their unending commitment to the safety of the blood supply for patients around the world. While the challenges we face did not end as we turned this calendar forward, there's much to look forward to as we head into 2021. As the experts anticipated, COVID-19 cases, hospitalizations, and deaths surge during the winter months and remain elevated. While we do not expect COVID-19 and its associated disruptions to abate anytime soon, we at Cirrus remain focused on continuing the momentum we generated on multiple fronts during 2020. Before we look ahead, I'm pleased to report our results for the fourth quarter and full year. As you saw in January, we announced record fourth quarter and full year 2020 product revenues with year over year growth of 35% and 23% respectively. Demand for Intercept continues to grow despite the COVID-19 crisis. Earlier this year, we provided a first look at our product revenue guidance for 2021, which at this time we continue to expect will be in the range of $106 to $110 million. This range reflects year over year growth of between 15 to 20% from our full year 2020 results. During the quarter and in response to the ongoing disruption blood centers have seen as a result of COVID-19, the FDA announced a delay in the compliance deadline for its platelet safety guidance. Previously, you will recall the deadline was set for April 1st, 2021. As a result of the change, the new compliance deadline is now October 1st, 2021. Both this change in deadline as well as the ongoing impact of COVID-19 were factors that we contemplated and included when we put together our 2021 plan. While we do not plan to provide quarterly guidance, what we will say about the new timeline for compliance is that we expect continual momentum throughout the year as our existing customers increase their overall production of intercept-treated platelets and as new blood centers come online in order to be compliant by the new deadline. Our discussions with blood centers and hospitals suggest that this new deadline provides additional time to increase production capacity of intercept platelets in order to meet strong hospital demand. We continue to hear that the preference of our U.S. blood center and hospital customers will be to implement single-step methods in order to comply with FDA guidance using intercept and or LVDS, large volume delayed sampling. The extension of the deadline does not change our expectation that Intercept will become the standard of care in the U.S., given the numerous advantages it has versus the other options for compliance with the FDA guidance. Vivek will provide additional details on the U.S. play that market during his remarks. During the fourth quarter, we announced FDA approval for our pathogen-reduced cryoprecipitated fibrinogen complex product, or PR-Cryo-FC for short. While it remains very early days for PR Cryo FC, we are excited to be bringing to market a product that addresses a currently unmet need and has the potential to help stabilize bleeding events for hundreds of thousands of patients. With the formation of the Cirrus Therapeutics business, this product puts us in front of a new set of customers, and our therapeutics team is focused on building out these relationships. To date, we are pleased to see that the value proposition for PR Cryo FC resonates well with hospital clinicians who value immediate access to a hemostatic therapeutic for controlling and treating hemorrhage in trauma and surgical patient populations. With the current shortage of conventional cryo across the U.S. and the production advantages conferred by our PR Cryo FC product label, we believe we have a unique opportunity to increase not only ease of access but also overall availability once we are able to realize nationwide distribution of the product post-BLA approvals. Our focus launch targeting level one and two trauma centers in four key states this year will cover about 25% of the U.S. volume of serious trauma cases. As the year progresses, we look forward to sharing insights on the commercial reception as well as expectations for the timing of a nationwide rollout in 2022. On the reimbursement front, our new technology add-on payment, or NTAP, application is currently under review by the Centers for Medicare and Medicaid Services, with a decision still expected later this year. With that, let me turn the call over to Vivek for a more detailed review of our commercial operations.