Cerus Corporation

Ladies and gentlemen, thank you for standing by and welcome to the Cirrus Corporation's first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. It is now my pleasure to turn to introduce Matt Notoriani, 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.cirrus.com. With me on the call are Obi Greenman, Cirrus's President and Chief Executive Officer, Vivek Jayaraman, Cirrus's Chief Operating Officer, Kevin Green, Cirrus's Chief Financial Officer, Carol Moore, Cirrus's Senior Vice President of Regulatory Affairs and Quality, and Jessica Hanover, Cirrus's Vice President of Corporate Affairs. Cirrus issued a press release today announcing our financial results for the first quarter ended March 31st, 2021. and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.serious.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 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 the risk factors in our Forms 10-K for the year ended December 31, 2020, and 10-Q for the quarter ended March 31, 2021, 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, and Kevin to review our financial results. We will conclude with commentary from Obie regarding recent announcements and update on our pipeline and closing remarks. And now, it's my pleasure to introduce Obie Greenman, Cirrus's President and Chief Executive Officer.

Thank you, Matt, and good afternoon, everyone. I'm pleased to report our Q1 results which I hope you've had a chance to review from our earnings release earlier today. Before Vivek and Kevin discuss some of our commercial and financial updates for the quarter in greater detail, I'd like to make a few remarks about the business and how we are thinking about the balance of the year. As you can see from our results, we are off to a strong start in 2021, building on the momentum our business had exiting 2020. Intercept platelet adoption in the U.S. continued to be the driving force behind our revenue growth during the first quarter of 2021. With the FDA compliance deadline five months away, we were pleased to see customers moving in many cases more quickly than we had anticipated to ramp up production capabilities to provide intercept platelets to hospital customers across the country. On the therapeutics front, our commercial team responsible for our intercept fibrinogen complex product is making good progress at hospitals ahead of our first sales, and we will share more details with you later on this call. Our US commercial team is executing well to support blood centers across the country as they prepare for compliance with the FDA guidance later this year, and Vivek will provide more perspective in his prepared remarks. Looking a little more closely at the Q1 product revenue, I am proud to report that we are able to continue a pattern of consistent year-over-year product revenue growth that goes back multiple years now. Moving to our full-year product revenue guidance, the momentum we saw in the market at the start of 2021 has been strong, and as a result, we are raising our 2021 product revenue guidance to a higher range of $110 to $114 million, representing year-over-year growth of between 20% and 24%. from our full year 2020 results. While, as usual, we are not providing quarterly guidance, we continue to expect the momentum of hospital adoption to build each quarter over the course of this year. We talk often about the global opportunity for Intercept being close to $7 billion, which includes opportunities in geographies where Intercept is not yet approved and pipeline opportunities like Intercept red blood cells. When considering our current portfolio of licensed products alone, we believe the near-term opportunity for our business is very significant in and of itself at about $1.4 billion. There remains a lot of commercial upside to penetrate in the current total addressable markets for intercept platelets, plasma, and fibrinogen complex. In addition, with the organic growth of these end markets, our geographic expansion into Asia Pacific and Latin America, and ultimately product line extensions, We continue to believe they're a significant runway for future revenue growth. Before I turn the call over to Vivek for the commercial update, I would like to highlight a few updates for Intercept Fibrogen Complex, or IFC. First, last week we were very pleased to see that CMS released its preliminary decision to approve IFC for a new technology add-on payment, or NTAP. This is another step forward in the early days of our commercialization of IFC, and CMS's provision of NTAPs for breakthrough technologies like IFC will help providers and their Medicare patients gain access early. We anticipate that CMS's final decision will be released in August ahead of the start of their fiscal year and the effective date for new NTAPs on October 1st, 2021. Additionally, I want to share some of the sales and marketing materials our team has developed and reviewed with the FDA to use in the field that underscores the benefits of Intercept Fibrinogen Complex. With a focus on improving timely access to clotting factors, including fibrinogen, and correspondingly outcomes for critically bleeding patients, we are preparing for a nationwide launch once our production partners receive BLA approval, anticipated sometime next year. Some of the key messages for Intercept Fibrinogen Complex that resonate with prospective hospital customers include its more immediate availability as well as its five-day post-thaw shelf life, which has the potential to meaningfully reduce the challenging wastage rates associated with the product exploration for conventional cryoprecipitate. We're looking forward to getting this product to physicians and patients to enable better management of critical bleeding events. With that, let me turn the call over to Vivek for a more detailed review of our commercial operations.