Cerus Corporation

Ladies and gentlemen, thank you for standing by. Welcome to the Sears Corporation second quarter 2026 earnings conference call. Please be advised today's conference is being recorded. I would like to hand the conference over to Tim Lee, Sears Head of Investor Relations. Tim, 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 explaining 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 Vivek Jayaraman, Cirrus' President and Chief Executive Officer, and Kevin Green, Cirrus' Chief Financial Officer. Cirrus issued a press release today announcing our financial results for the second quarter ended June 30, 2026, and describing the company's recent business highlights. You can access a copy of this announcement on the company's website at www.serious.com. I'd like to remind you that some of the statements we'll 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 offering results, including our 2026 product revenue guidance, our expectations for gross margins, Non-GAAP adjusted EBITDA performance and our expected expense levels, as well as our commitment to achieving GAAP profitability, expected future growth in our growth trajectory and market opportunities, our expectations that we will deliver P&L leverage in 2026, the availability and related timing of data and clinical trials, planned regulatory submissions and product launches, product expansion prospects, The anticipated impact of our recent debt refinancing and other statements that are not historical fact. 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 June 30, 2026, which will follow shortly. We undertake no duty or obligation to update our four linking 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 to the extent reasonably available, Please refer to today's press release and the slide presentation available on our website. We will begin today with Vivek providing a business update and corporate highlights, followed by Kevin to review our financial results and expectations for the rest of 2026, and lastly, closing remarks from Vivek. And now, it's my pleasure to introduce Vivek Jayaraman, Sirius' President and Chief Executive Officer.

Thank you Tim, and good afternoon everyone. We appreciate you joining the call today. At Spirits, our mission is clear, to expand patient access to safe blood around the world. During the second quarter of this year, we made meaningful progress toward that goal. To date, based on sick sales, nearly 24 million transfusible doses have been produced worldwide. While we are proud of this progress, The fact remains that far too many patients still lack consistent access to safe blood. To realize our mission, we are focused on three core priorities, delivering sustainable double-digit growth, advancing innovation, and strengthening our financial foundation. I'm pleased to report that our second quarter results demonstrate solid progress across each of these priorities. With respect to growth, worldwide product This growth was driven by the strong performance of our U.S. IFP franchise along with continued strength in our core business globally. North American sales accounted for approximately two-thirds of second quarter product revenue. As previously noted, Intercept for Platelets is the standard of care in both the United States and Canada. In the U.S., we estimate market penetration at approximately two-thirds Thank you for joining us. We've expanded education and awareness among its members regarding the benefits of past unit inactivation. As a result, we are seeing a meaningful increase in engagement and receptivity to our technology, and this is resulting in new customers for both our platelet and ISP businesses. We are actively onboarding new ISP producers and are seeing a pronounced uptick in hospital activations. To further support ISP and drive awareness, We continue to invest in clinical evidence generation and medical education. For example, at the recently held Society for Obstetric Anesthesia and Perinatology meeting in Montreal, Dr. Jonathan Tucci of Vanderbilt University Medical Center presented data evaluating the use of ISB in the treatment of postpartum hemorrhage. In his analysis, Dr. Tucci noted that pre-thawed ISB reduced the time to first transfusion by 68% Thank you for joining us. The longer shufflet can materially reduce wastage, while immediate availability can support more timely treatment in critical bleeding situations. We believe these attributes position IFC favorably relative to both traditional Cryo-Agea and Fibrinogen concentrate, and we are beginning to see that value proposition gain traction in the market. As an example, we recently learned that a major academic hospital in the Northeast conducted a direct comparison of ISD and fibrinogen concentrate in order to determine which products to adopt. It shows to adopt ISD at 100% based on its immediate availability, five-day post-sale shelf life, and lower cost. Nationwide, we estimate that ISD currently holds a market share of approximately 10%. While we are encouraged by the progress to date, that level of penetration highlights the significant growth opportunity that remains for our ISV business. Turning to our efforts abroad, there is positive momentum across our business in EMEA. This is driven by the continued positive rollout of our next generation INT200 illumination device and further penetration of our core platelet franchise. We are also making inroads of plasma in a number of markets. In late April, we signed a new multi-year contract with a French blood establishment, or EFS. This multi-year agreement provides greater visibility into our medium-term revenue outlook and represents an important validation from one of the world's most respected blood services.