Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cirrus Corporation second quarter 2022 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. Please be advised that today's conference is being recorded. I will now like to hand the conference over to your speaker, Mr. Matt Notarianni, Senior Director of Investor Relations. Mr. Notarianni, you may begin.

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.cures.com. With me on the call are Obi Greenman, Searson's President and Chief Executive Officer, Kevin Green, Searson's Chief Financial Officer, Vivek Jayaraman, Searson's Chief Operating Officer, Dr. Nina Musti, Sears' Vice President, Development, and Red Blood Cell Program Leader, Dr. Richard Benjamin, Sears' Chief Medical Officer, Carol Moore, Sears' Senior Vice President of Regulatory Affairs and Quality, and Jessica Hanover, Sears' Vice President of Corporate Affairs. Sears issued a press release today announcing our financial results for the second quarter ended June 30, 2022, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.xeris.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 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, and our Form 10-Q for the quarter ended June 30th, 2022, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, We will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to comparable GAAP financial measures, please refer to today's press release. We'll begin today with some opening remarks from Obie. followed by Vivek to discuss some recent business highlights, and Kevin to review our financial results. We will conclude with commentary from Obi with an update on our pipeline and closing remarks. And now, it's my pleasure to introduce Obi Greenman, Sears' President and Chief Executive Officer.

Thank you, Matt, and good afternoon, everyone. Reporting in our second quarter of 2022, I'm proud of the results our team has been able to deliver as we continue to expand patient access to blood components treated with our intercept blood system around the world. The interest level and understanding of the value of pathogen reduction continues to increase. Notably, earlier this summer, we were pleased to work on a study recently published in Transfusion, which concluded that a robust rollout of pathogen reduction for all blood components, such as the intercept blood system, could provide a way to increase donor retention, and improve blood product availability. The strong safety profile and track record the Intercept blood system has in routine use in many regions continues to reinforce the utility of pathogen reduction as a definitive safeguard. Earlier this summer, we eclipsed cumulative kit sales, which translates into more than 12 million Intercept-treated transfusible units of plasma, an increase of 2 million doses in less than a year. The strong revenue growth is expediting our pathway to cash flow breakeven as defined by our non-GAAP-adjusted EBITDA metric that we began providing on our Q1 call. Our rapid growth over the last few years means that we're now selling in a single quarter just slightly less than what we used to sell in an entire year as recently as 2017. It is a remarkable achievement for the company, yet there are significant growth opportunities for us in the quarters and years ahead as we seek to realize our mission of making Intercept the standard of care in transfusion medicine globally. After Vivek and Kevin provide some color on the quarter and how we see the balance of the year shaping up, I will wrap up with comments around some of our important product pipeline development efforts that will help us continue to realize our mission and the upside associated with the full Intercept portfolio for all blood components. We believe we have clearly established our leadership in the U.S. playlet market with North America product sales for the second quarter implying a $100 million annualized run rate. With our ability to continue to grow our presence in playlets in the U.S. and around the globe and create further awareness and increase penetration for intercept fibrinogen complex product in the U.S., we expect to deliver meaningful top line growth from those opportunities. And as we demonstrate this growth and couple it with our financial discipline, we see a clear pathway towards cash flow breakeven, which we believe will afford us the flexibility to self-fund future growth. And there's a marked change from our history of tapping the equity markets, which helped us establish our commercial footprint and funded manufacturing capacity and supply chain activities, all of which have contributed to help us realize our unique position in transfusion medicine and to secure our leadership in the field well into the future. I would now like to turn the call over to Vivek to discuss the second quarter revenue highlights.