Cerus Corporation

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Cirrus Corporation third quarter 2024 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. I would like to hand the conference over to Jessica Hanover. Dr. Hanover, 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.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' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President. Cirrus issued a press release today announcing our financial results for the third quarter ended September 30, 2024, 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 2024 product revenue guidance, our expectations for operating cash flows and non-GAAP-adjusted EBITDA performance and our expected expense levels, expected future growth and our growth trajectory, our product supply expectations and ability to meet customer demand, the potential value of and anticipated activity to be funded under our new BARDA agreement, planned regulatory submissions and product launches, product expansion prospects, 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, in our slide presentation, and under risk factors in our Form 10-Q for the quarter ended September 30th, 2024, 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 and the slide presentation available on our website. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review our financial results and expectations for the rest of 2024, and lastly, closing remarks from Obie. And now, it's my pleasure to introduce Obie Greenman, Sears' President and Chief Executive Officer.

Thank you, Jessica, and good afternoon, everyone. I would like to open the call with a review of our strong quarterly performance on both commercial and financial fronts. as well as our increasingly positive outlook for the full year 2024. Our North American platelet business drove our Q3 product revenue result, and our Intercept Fiber Engine Complex, or IFC, business in the U.S. is gaining momentum at the same time that we are increasing supply capacity for the product. Vivek will provide additional color in his remarks. With this trajectory, we are raising our product revenue guidance to account for the positive trends in both these business segments. We are also executing on the financial measures that we have been targeting for the full year, both on the bottom line as well as operating cash flows, as you will hear from Kevin shortly. With the growing scale of our business, the leverage of our business model, and the discipline around our operating expenses, we've been able to consistently deliver against our quarterly financial targets. At a high level, and on the heels of the annual meeting of the Association for the Advancement of Blood and Biotherapies, or ABB, earlier this month, it is gratifying to see how pathogen inactivation has become increasingly ubiquitous across the transfusion services in the U.S. and in multiple geographies, from blood centers that manufacture pathogen-inactivated components to the hospital clinicians who transfuse them. And sitting in the plenary session at the Houston Convention Center with thousands of AABB meeting participants, listening to the presentation of the positive recipe Phase III clinical trial data was truly a rewarding experience. The further acknowledgment from the recent up to $248 million BARDA contract designed to see the Intercept RBC program through potential regulatory approval and product launch only added to the collective enthusiasm from our blood center customers for the recipe data. Meanwhile, the need for pathogen inactivation is ongoing. Since our last quarterly call when we noted the rise in dengue transmission in the U.S. and Europe, multiple U.S. public health officials have released notifications regarding the rise in the incidence of two emerging arthropod-borne viruses, Eastern Equine Encephalitis Virus, or EEEV, and Oropush Virus, or OROV. Together, EEEV and travel-related OROV cases have been reported in 12 states and U.S. territories to date. CDC and FDA recommend donor referrals for those recently diagnosed with these viruses, reminding our community that the potential exists for the disruption of our local blood supplies. And while there remains no evidence of transfusion transmission to date, the similarities of Orov to the Zika virus epidemic and the new evidence of vertical transmission argue that precaution and preparedness are warranted. On the development front, as we announced earlier this month, In Europe, we are closely collaborating with our notified body, TUV-SUD, to define our strategy for a potential new and enhanced CE mark submission for intercept red blood cells, or RBCs. As we noted before, while we are disappointed that our intercept RBC filing was not approved by our competent authority, we are closely assessing the potential to include data from both Recipe and Redis clinical trials in a future filing with the intent to seek a broader patient indication for the product candidate. In the US, we are moving full speed ahead after extending our partnership with BARDA, which is designed to fund further development, regulatory activities, and ultimately anticipated commercial readiness initiatives for intercept RBCs. We have also recently completed our regulatory submission to TUV for our LED illuminator in Europe, marking the next step in our effort to make this next generation technology platform available to our customers in that geography. Based upon extensive feedback from our customers, we believe that this new platform is eagerly awaited and will provide multiple benefits for the production of intercept-treated playouts and plasma in routine. With that, I will now turn the call over to Vivek to discuss our commercial results and progress for the third quarter of 2024, as well as our outlook for the last three months of the year.