Cerus Corporation

Good day and thank you for standing by. Welcome to Xerox Corporation second quarter 2023 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. To ask a question during the session, you will need to press star 11 on your telephone. You will hear a message advising your hand is raised. To withdraw the question, simply press star 11 again. Please be advised, that today's conference is being recorded. I would now like to turn the call over to Jessica Hanover, Vice President of Corporate Affairs.

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, and Kevin Green, Cirrus's Chief Financial Officer. Cirrus issued a press release today announcing our financial results for the third quarter ended September 30, 2023, 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 related 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 updated 2023 product revenue guidance, our Q4 adjusted EBITDA commitment, and our expected expense, inventory, and margin profiles, expected future growth and our growth trajectory, expected future product sales, the availability and related timing of data from clinical trials, and other statements that are not historical facts. These forward-looking statements involve risks and uncertainties 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, and our form 10-Q for the quarter ended September 30, 2023, 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 reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures, please refer to today's press release. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, Kevin to review our financial results and expectations for the rest of 2023, and Obie with closing remarks. And now it's my pleasure to introduce Obie Greenman, Cirrus' president and chief executive officer.

Thank you, Jessica, and good afternoon, everyone. I would like to provide some commentary about the progress we are continuing to make this year both on the commercial front and in the pipeline. During the third quarter, we reached and surpassed the 15 million mark for sales of trans-usable doses for Intercept kits since our initial launch of the system. I'm very proud of this important milestone, particularly with respect to the global patient impact this figure represents and the thousands of patients in countries around the world that receive Intercept treated components every day. Importantly, as we cross this 15 million kit sales milestone, We are also approaching a milestone of adjusted EBITDA breakeven in this quarter, even as we invest in the geographic expansion of our business and our R&D pipeline to sustain our growth long term. Indeed, we are pleased to report that our top line performance stabilized in Q3, returning to the levels of Q3 2022 and showing growth from the prior quarter. We expect to see our growth trajectory accelerate into the double digits as we exit 2023 and move into 2024. Three weeks ago, I and many colleagues and customers attended our industry's top conference, the AABB Annual Meeting in Nashville, the first time it has been held in person since 2019, and notably since the FDA guidance for bacterial safety went into effect now two years ago. I was particularly struck by the pervasive and positive sentiment around pathogen reduction. The Intercept blood system for platelets has clearly been established as an essential tool for safeguarding the blood supply here in the U.S. Meeting sessions covering IFC were also well attended with standing room only audiences, and overall awareness and interest in the product was very high. The Sunday morning oral session scheduled by ABB meeting organizers, transfusion medicine leaders from both UT Southwestern and Stanford Medical Centers highlighted the realized benefits of IFC adoption in their practice. In particular, IFC enabled streamlined operations, significantly reduced wastage, and much faster availability for patient transfusion. These centers have assessed the time from physician order to delivery since the implementation of IFC, demonstrating marked improvements in the range of 50 to 70%. Moreover, like Intercept Play has before, IFC now allows hospital transfusion services to strengthen their collaboration with their hospital clinicians to improve patient care. While historically, the hospital blood bank may have had to say no given the challenges of providing conventional cryo, now they can say yes to a demanding physician with a bleeding patient, particularly when every minute counts. Given growing interest in partnerships with blood centers for IFC, we continue to believe this product and its compelling value proposition will be meaningful to our growth trajectory. Moving on to our pipeline, and in particular the Intercept Red Blood Cell, or RBC program, In Q3, as planned, we completed an enrollment in the BARDA-funded Phase 3 recipe trial in cardiovascular surgery patients. 321 patients were transfused and are available in the study. We continue to anticipate database lock and an initial top-line data readout from this trial in Q1 of 2024. Our second Phase 3 trial, REDIS, continues to enroll as expected as well. Recently, the study's Data Safety Monitoring Board or DFMB met and expressed no safety concerns regarding the study to date and recommended continued enrollment. This study's enrollment is now focused on the chronic transfusion patient population, encompassing sickle cell and thalassemia patients, in addition to oncology patients with anemia. At the most recent investigators meeting for the RETA study, held prior to the ADB annual meeting, there was enthusiasm for completing this last phase of the study in a timely way, which is now possible with the full support of the program by BARDA. I would like now to turn the call over to the bank to discuss the third quarter commercial highlights and the outlook for the remainder of the year.