Cerus Corporation (CERS) Earnings Call Transcript & Summary

Thank you. Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Sears Corporation's 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 displaying slides that you can follow. You can access the slides from the investment relations website at ir.ceres.com. With me on the call are Vivek Jayaraman, Sears' President and Chief Executive Officer, and Kevin Green, CIRS Chief Financial Officer. CIRS issued a press release today announcing our financial results for the second quarter ended June 30th, 2026, and describing the company's recent business highlights. You can access a copy of this announcement on the company's website at www.siris.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 board-licking statements include those related to our future financial and marketing results, including our 2026 product revenue guidance, our expectations from 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 from clinical trials and regulatory submissions and product launches, product expansion prospects, anticipated impact of our recent debt refinancing and other statements that are not historical facts. These four looking statements involve risk 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 existing 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'll begin today with the vague 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 the vague. And now it's my pleasure to introduce the big Joe Rahman, CSRS President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. We appreciate you joining the call today. At Cirrus, our mission is clear, to expand patient access to save blood around the world. During the second quarter of this year, we made meaningful progress toward that goal. To date, based on kit 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 revenue increased 10% in Q2 compared to the same period last year. This growth was driven by the strong performance of our US ISC 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 US, we estimate market penetration at approximately two-thirds, and we see clear opportunities for continued sharegates and the remaining one-third of the market. In the U.S., our collaboration with Blood Centers of America, or BCA, continues to be a positive contributor to our growth. As a reminder, our BCA contract became effective at the beginning of 2026, and BCA member blood centers now account for more than half of all blood product distributions nationwide. Working closely with BCA, we've expanded education and awareness among its members regarding the benefits of past student 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 IFC businesses. We are actively onboarding new IMC producers and are seeing a pronounced uptick in hospital activations. To further support ISV 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-thought ISB reduced the time to first transfusion by 68% when compared with cryo-AHF and by 18% when compared with fibrinogen concentrate. In cases of uncontrolled bleeding, like maternal hemorrhage and trauma, every second counts. An earlier access to fibrinogen is of tremendous value. As we originally hypothesized, the combination of immediate access to FibroEngine and a five-day post-hoc shelf life is proving valuable to both clinicians and hospital administrators. The longer shelf life 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-AHS and fibrinogen concentrates, 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 concentrates in order to determine which product to adopt. They chose to adopt IFC at 100% based on its immediate availability, five days post-off-shelf life, and lower cost. Nationwide, we estimate that ISC currently holds a market share of approximately 10%. While we are encouraged by the progress to date, that level of penetration highlights a significant growth opportunity that remains for our ISC 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. also making inroads of plasma in a number of markets. In late April, we signed a new multiyear contract with the French Blood Establishment, or EFS. This multiyear 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. Beyond Europe, interest in Intercept continues to grow. At the recently held 39th Annual International Society of Blood Transfusion Meeting in Kuala Lumpur, we saw encouraging engagement from blood centers across the Asia-Pacific region. Currently, Asia represents one of Cirrus' most significant long-term growth opportunities. While we have established customer relationships in markets including Hong Kong and Thailand, our penetration across the broader region remains limited. We believe the opportunity across our current market and product portfolio, combined with expansion into emerging markets, provide access to multiple avenues by which to deliver durable double-digit growth. Turning to our second key priority, advancing innovation, I'm encouraged by the progress we made in the second quarter. New product development and label expansion remain central to expanding the clinical application of our technology. These efforts allow us to expand the pool of patients who can access safer blood and provide the technology platform from which we can support durable long-term growth. Foundational to advancing innovation is the focus on quality. Our blood center customers, hospitals, and ultimately patients depend on us to deliver the highest quality product. To that end, I am pleased to report that we recently completed our Notified Body Recertification Audit with zero nonconformities. This comprehensive assessment of our quality management system is an important component of maintaining our CE and MD-STAT certifications. The result reflects the strength of our quality system and, more importantly, the commitment to quality of our employees and supplier partners worldwide. I would like to thank everyone whose preparation, discipline, and attention to detail contributed to our successful outcome. Maintaining the highest standards of quality is fundamental to our mission and to the trust our customers place in CERA. During the quarter, we also submitted the PMA for the IEP200 for platelets to the U.S. We are excited about the opportunity to bring this technology to customers in the United States. Based on our current expectations, we could receive regulatory approval as early as the first half of 2027, although the timing will ultimately depend on the FDA's review process. Turning to intercept red light cells, we continue to advance our efforts in both the US and Europe. With respect to our US clinical efforts, we remain on track to announce top line results from our phase three reddish trial during the fourth quarter. In addition, we recently expanded our 2024 BARDA contract to advance the development of Intercept RBC, increasing the total potential contract value by nearly $22 million, from approximately $249 million to just over $270 million. These additional funds will be used to support PMA-related activities in the U.S. With respect to our CE mark submission for Red Belt, ANSIM, our competent regulatory authority, continues its review of our application and we expect to receive questions from them later this year. Taken together, our R&D, clinical, and regulatory teams made meaningful strides last quarter to move our innovation portfolio forward. Our third core priority is to enhance our financial strength. During the last quarter, we improved our financial profile, lowered our cost of capital, and increased our strategic flexibility. These efforts strengthen our ability to self-fund market development and product innovation in a financially disciplined manner. We believe that continued execution against these priorities will position SEERs to expand patient access, deliver durable growth, and create long-term shareholder value, all while realizing our mission to increase the safety of the global blood supply. With that, I would now like to turn the call over to Kevin to discuss our second quarter financial results in detail.

Thanks, Vivek, and thank you to those joining us on the call today. We sincerely appreciate your interest in CERIS. Before I get into the Q2 operating results, I'd like to provide some insight into our recently completed debt refinancing, which included a $30 million reduction in our term loan balance, million dollars from our balance sheet and 10 million from the lower cost revolver. While reducing the overall debt load, we expanded the size and borrowing-based flexibility of our revolving lender credit. Given the recent and expected trajectory of our operations and operating cash flows, we believe the new facility is demonstrative of our confidence as we move ahead. As a component of the refinancing, we reduced the interest spread and eliminated many of the smaller fees that were embedded in the previous facility. Just as important, we retained future optionality with up to an additional $30 million of term debt available in $5 million increments. We eliminated prepayment fees after the first year. and retained up to an additional $15 million of capacity on the revolver. As a result of the refinancing, we expect to reduce annual interest expense by up to $3.5 million, further improving our ability to achieve our bottom-line goals. As you saw from today's press release, we continue to experience growing demand for our products and have confidence in our ability to continue driving sustained double-digit growth. As a result, we are raising the low end of our full year 2026 product revenue guidance range and now expect product sales of $229 to $231 million compared to our previous range of $227 to $231 million. In addition, we are raising our full-year IFC revenue guidance to a range of $23 to $25 million, compared to our previous range of $22 to $24 million. The updated guidance represents total year-over-year product revenue growth of 11 to 12 percent compared to 2025 and approximately 40 to 50 percent growth for IFC. Now, for the second quarter results, I'll begin with our product revenue performance. For the second quarter of 2026, product revenue totaled $57.4 million, a 10% increase compared to the second quarter of 2025, when we recognized $800,000 of previously deferred IFC revenue. We saw strong growth across all of our product categories during the quarter. For the first half of 2026, product revenue increased 16% to $111.1 million, compared to $95.7 million recorded during the first half of 2025. By geography, second quarter North American product revenue increased 9% compared to the same period for the prior year. In EMEA, second quarter product revenue increased 10% year-over-year with growth across multiple countries. Favorable foreign currency exchange rates bolstered reported EMEA revenue growth by approximately 2%. In the U.S., reported IFC product revenue, as well as volume demand for the second quarter, increased approximately 20 percent to $6.7 million, compared to $5.6 million during the same period in the prior year. by continuing end market demand. Recall, in the second quarter of 2025, IST sales included approximately $800,000 of deferred revenue from prior periods. Excluding the effect of that prior period revenue recognition, IFC revenue growth would have been approximately 40%, with demand up 43%. Of the total IFC sales shipped, 70% were in kit form. We continue to ship the business to the KIT model and expect that essentially all IFC sales will be in KIT form in 2027. Furthermore, as we see the full shift to kits from a mixed sales model of IST biologics and kits, we expect that we will see a benefit to our gross margins. While the finished biologics carry a higher selling price, the gross margin profile is lower than our corporate average. Switching now to government contract revenue, which, as a reminder, is not included in our revenue guidance. Reimbursement for government-related R&D expenses declined year-over-year to $5.9 million from $7.7 million to Q2 2025. The year-over-year decline was due in large part to the completion of the FDA contract in 2025, as well as the wind-down of the BARDA 2016 contract, and, to a lesser extent, the timing of expenses related to the BARDA 2024 contract. We expect that as we move forward, revenue from the BARDA 2024 contract will increase from Q2 levels. Turning now to gross margin on product sales. Our second quarter product gross margin was 51.4% compared to 55.2% during the prior year. These results are in line with our expectations and prior Q1 commentary. The factors that we previously noted to be headwinds persisted in the quarter, including a year-over-year stronger euro compared to the U.S. dollar and inflationary pressures. We continue to believe 2026 gross margins will be in the low 50s, although we may see some relief towards the end of the year should the impact of these external factors prove less significant than currently expected. Moving down the income statement, in terms of expenses by category, SG&A increased 8% due to slightly higher costs across a variety of functions with no predominant contributing R&D expenses, on the other hand, declined 24%, reflecting lower development costs in the INT200 following the US PMA submission, as well as the reduced work on government-funded related projects during the quarter, namely the completion of the FDA efforts, which concluded in 2025. As a result, government-funded R&D expenses accounted for 27% of total R&D spend. reversal of the trend experienced for the past several quarters. As we look ahead, we expect government-funded R&D expenses to increase as a percentage of total R&D spending, and, as mentioned earlier, we expect a corresponding increase in government contract revenue. Let's now turn to the bottom line and non-GAAP adjusted EBITDA results. For Q2 2026, GAAP net loss attributable to CERES continued to show year-over-year improvement at $2.9 million compared to a net loss of $5.7 million in Q2 of 2025. As an organization, we're committed to achieving GAAP profitability and believe we have line of sight to achieving that objective. On a non-GAAP basis, adjusted EBITDA for the second quarter totaled $3 million, marking our ninth consecutive quarter of posting positive adjusted EBITDA. our third consecutive year of positive adjusted EBITDA results. Turning to cash flows for the quarter, cash used in operations was $2.7 million, driven primarily by increased inventory levels in support of our expected revenue growth. With the increased flexibility of our new revolver, we have offset these operating cash flow investments with advances under the revolver, and we'll look to utilize that facility when appropriate. With that, let me pass it to Vivek for some closing comments. Thank you, Kevin.

Before we open the call for questions, I would like to offer some thoughts as I conclude my first month as CEO. Although I have been at Sturz for nearly a decade, the past month has given me an even broader appreciation for the quality of our team, the value of our technology, and the exciting opportunities in front of us. Solid top line growth, meaningful pipeline progress, and improving financial strength all reinforce my confidence in our business. My conversations with employees, customers, and clinicians only deepen my conviction in our mission and our ability to realize it. talented people, differentiated technology, and a compelling vision. The future is Cirrus' bright and I believe we are uniquely positioned to positively impact global healthcare. Each day, we take important steps towards expanding patient access to safer blood while creating meaningful long-term value for stakeholders. Thank you very much for joining the call today. We are grateful for your continued support.

Operator, please open the call for questions. Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered, you wish to move yourself from the queue, please press star 1-1 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Josh Jennings with TD Cowan. Your line is open.

Hi, good afternoon. Thanks for the questions. Great to see you. Another double-digit revenue growth quarter. Wanted to start with a question on IFC, you know, EXCELLENT PERFORMANCE OFF OF THE MOST CHALLENGING COMP OF THE YEAR ON A REVENUE DOLLAR BASIS. to be helping with the momentum there here in 2026. You described a hospital assessment by a Northeast Center. And I'm just curious, I mean, is that still the common adoption route where individual centers will have to run their own kind of independent, study of IFC or is there more of a blend, especially with BCA in play? I'm just curious on how long you're seeing kind of contracts or agreements take place.

to be put in place here in 2026. Hey Josh, thanks for the question and thanks to you for the kind remarks about the progress. with IFC we're certainly really excited about it as you can imagine there isn't one single pathway in terms of hospital or blood center adoptions the thing that That really does help us now that we're migrating to the kit model as we can take advantage of not only the expanded reach of the blood center sales and marketing team, but also the contracts they have in place across those hospitals to provide blood products. And so we're not in the business of negotiating contracts. directly with the hospital. So that accelerates the process considerably. Most hospitals do not run their own in-house comparison of whether it's ISD versus cryo-AHF or versus fibrinogen concentrate. So it's typically not what we see in those hospitals. was what was encouraging, it was validation to see that when that was done, how ISD compared so favorably and sort of validated some of our original hypotheses in terms of both clinical value and then value to non-clinical decision makers. So we're encouraged by that and we think the continued collaboration with BCA and other blood centers will allow us to do that. us to scale and provide access to ISC even more quickly.