Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by and welcome to the Saris Corporation fourth quarter and full year 2021 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker host today, Mr. Matt Nateriani, 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, 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 fourth quarter and year end of December 31st, 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 in our forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2022 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 31st, 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 some opening remarks from Obie, 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 Obi Greenman, Cirrus' President and Chief Executive Officer.

Thank you, Matt, and good afternoon, everyone. In 2021, Cirrus took a major step forward in realizing our goal to safeguard the global blood supply. Our success in deploying the Intercept blood system for plants in the U.S. built on our solid international foundation of routine use and drove a breakout year for the company. On the last few calls, we've spoken about the momentum the business has seen in the U.S. as blood centers and their hospital customers choose Intercept as their preferred method for complying with the FDA guidance aimed at reducing the risk of bacterial contamination of platelets. We continued to see this trend play out in the fourth quarter and believe we are now the U.S. market leader for platelet bacterial risk mitigation under the FDA required guidance. Last month, we celebrated the company's 30th anniversary. Over the past three decades, Cirrus has embarked on a bold strategy to develop and deploy a technology with a singular focus of safeguarding the global blood supply. Following the devastation of the HIV epidemic at the time of the company's founding, preparedness remains at the core of what we do every day at Cirrus, and we are committed to bringing products to the market that safeguard blood components from known and future threats and that enable sustained blood availability. While we have come a long way with over 10 million intercept doses transfused to date, there remains much opportunity for Cirrus to lead a paradigm shift in transfusion medicine on the way to achieving a new global standard of care. With a continued broad adoption of our technology in the U.S. and globally, we look forward to delivering another year of strong double-digit growth. While we are not providing long-range guidance today, we see significant opportunity to grow our top line meaningfully over the next several years. We expect this growth to come from a combination of extending our leadership in our currently served markets, penetrating untapped geographies like China and commercial success of new products like our intercept fibrinogen complex and later red blood cells. Together with the organic growth of our total addressable markets, or TAMs, The opportunities ahead for Cirrus are significant and enduring. For instance, we have historically estimated the global TAM for intercept planets to be about $1.3 billion, with the U.S. opportunity representing about $150 million of this total market. With overall planet demand growing in the mid-single digits, we expect these TAMs to continue to grow, eclipsing $1.5 billion and $200 million in for the global and U.S. opportunities respectively over the next five to seven years. With Intercept's rapid commercial uptake, we have placed a significant focus on our ability to supply product to our customers across the globe. To fulfill our market leadership role in supporting blood safety and availability, we continue working with our partners to expand manufacturing capacity in multiple facilities to position us to continue to grow the Intercept blood system adoption in 2022, 2023, and well beyond. As Kevin will discuss in more detail shortly, we have planned for this in the near term by building our inventory, which we will utilize during this period to help continue to fulfill customer demand. As we bring additional manufacturing capacity online, the supply and demand balance will become more manageable, and we expect this excess manufacturing capacity will allow us to continue to grow well into the future. For intercept fibrinogen complex, or IFC, 2021 was filled with several market development activities, and we plan to continue to position this product for long-term success. Some of these activities included sales to early adopters in our initial launch dates, Medicare reimbursement secured with a new technology add-on payment, or NTAP, and supporting our blood center production partners to both come online to manufacture IFC units and to also submit biologics license applications, or BLAs. Gulf Coast Regional Blood Center received its BLA approval just before year-end 2021, and more recently, Central California Blood Center also received its BLA approval. As we've been educating the marketplace about this new blood product, the benefits of IFC continue to resonate with blood centers and physicians as they grapple with the challenges associated with conventional cryoprecipitate which has several limitations in its availability for bleeding patients during the critical early phase of resuscitation. IFC addresses several of these limitations by enabling more immediate availability for transfusing physicians and reducing wastage, as conventional cryoprecipitate has a limited post-thaw shelf life of four to six hours. In 2022, we are focused on gathering real-world experience data with our early customers to highlight the benefits of IFC for a variety of patient types. With our nationwide IFC launch commencing, we've also entered into commercial partnerships with Blood Centers of America, or BCA, and OneBlood to further deploy IFC across the US. We believe leveraging our combined sales efforts will provide more of the market with access to IFC as the industry continues to navigate the national shortage of conventional cryoprecipitate. I will now turn it over to Kevin to discuss our results and 2022 guidance in more detail, And then I will return to provide some comments on our pipeline as well as some closing remarks.