Cerus Corporation (CERS) Q3 2026 Earnings Call Transcript

Operator: Good day, and thank you for standing by. Welcome to the Cerus Corp. Q3 26 Earnings Conference Call. At this time, all participants are in a listen-only mode. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker, Timothy J. Lee, Head of Investor Relations. Please go ahead.

Timothy J. Lee: Thank you, and good afternoon. I would 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.cerus.com. With me on the call are Vivek K. Jayaraman, Cerus' president and chief executive officer Kevin D. Green, Cerus' Chief Financial Officer and Dr. Nina Mufti, Cerus' Senior Vice President, Research and Development. Cerus issued 2 press releases this afternoon: 1, announcing our financial results for the third quarter ended September 30, 26, and describing the company's recent business highlights. the other, announcing top line results from our Phase III REDIS study. You can access copies of both announcements on the company's website at www.cerus.com. I would 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 are forward-looking statements. These include statements regarding financial outlook and performance, our business strategy and priorities, expected growth and market opportunities, clinical and regulatory activities, product launches and expansion, and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that can cause actual performance and results to differ materially Please refer to the forward-looking statements slide accompanying today's webcast, today's press releases and risk factors in our Form 10 Q for the quarter ended September 30, 2026, which we will file shortly. For important factors that can cause actual results to differ materially. We undertake no duty or obligation to update our forward-looking. 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 as a supplement to and not a replacement for measures presented in accordance with GAAP. For a 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 is my pleasure to introduce Vivek K. Jayaraman, Cerus' president and chief executive officer.

Vivek K. Jayaraman: Thank you, Timothy, and good afternoon, everyone. We appreciate you joining us today. At Cerus, our mission is clear. To expand patient access to safer blood and establish INTERCEPT as the standard of care for transfused blood components globally. Our third quarter kit sales represent nearly 800 thousand doses of transfusable blood. Each dose represents a step toward improving patient care and enables us to extend the reach of pathogen reduction technology globally. Earlier today, we announced positive top line results from our Phase III REDeS study. This is another important step toward extending our pathogen reduction technology to red blood cell transfusion. Reflecting on my first quarter as CEO, I am more confident than ever in our team, our technology, the opportunities ahead of us. As noted, our mission is to establish INTERCEPT as a standard of care for transfused blood components globally. Realizing this mission requires us to drive sustained growth, deliver meaningful innovation, and build a financially strong business that can self fund ongoing product and technology advancements. From an operating perspective, we are focused on 3 core priorities that support our mission. Delivering sustainable double digit annual growth, advancing clinical and technological innovation, and strengthening our financial foundation. Our third quarter performance reflects meaningful progress across all 3 priorities, Furthermore, our team executed well despite having to deal with a dynamic geopolitical and macroeconomic environment that created some near term headwinds. Taken together, our quarterly performance demonstrates the value of our product and geographic breadth, along with the resilience of our team and their ability to navigate near term obstacles. We are generating strong growth across our core franchises, we are successfully transitioning our ISC business model, and our international rollout of the INT200 Illuminator is exceeding expectations. With the completion of our Phase III REDeS trial, we have built the largest library of clinical evidence in support of pathogen reduction technology in red cell transfusion. Financially, we delivered our 10th consecutive quarter of positive adjusted EBITDA, improved our margin, and generated $3 million in positive cash flow. I am proud of our team's performance this quarter. We will now discuss each of these 3 pillars in further detail. Worldwide product revenue increased 10% year-over-year with US performance leading the way. We have seen continued momentum in our ISC franchise as well as gains in our core platelet franchise that solidly outpaced underlying market growth. International placements of the INT200 illuminator also contributed to growth and helped set the foundation for further kit penetration. North American sales increased 12% and accounted for just over 2-thirds of third quarter product revenue. Intercept for platelets continues to be the standard of care in both the United States and Canada, In fact, INTERCEPT platelets are now used at all leading US hospitals that are recognized in the latest US News and World Report ranking. Our collaboration with Blood Centers of America or BCA is helping broaden adoption. As a reminder, we entered into a nationwide agreement with BCA at the beginning of this year. And BCA member blood centers account for more than half of all blood products distributed in the US. While many BCA members were already Cerus customers, the agreement has created opportunities to deepen those relationships while also allowing us to secure new customers across both platelets and ISC. Through the first 3 quarters of the year, revenue growth from BCA member blood centers outpaced overall North American growth. Turning to ISC. Hospital demand continues to increase as our value proposition gains traction. Immediate access to fibrinogen and a 5-day post-thaw shelf life are compelling benefits to clinicians, hospital administrators, and most importantly, patients. The longer shelf life can materially reduce waste, while the availability of free-thawed ISC can support more timely treatment in critical bleeding situations. Medical education remains important to expanding adoption. At the recent Association for the Advancement of Blood and Biotherapies annual meeting, the team from Grady Memorial Hospital Atlanta shared their real-world experience with the INTERCEPT Blood System including ISC. The team at Grady first adopted ISC in September 2025. Now they keep a unit of ISC thawed at all times ready to be issued. Peer to peer exchanges are incredibly valuable and help clinicians learn from 1 another and better understand how ISC can fit into their clinical practice. We are also evolving our ISC commercial model to support broader patients and more attractive economics. We are migrating from direct hospital sales to distribution via our blood center customers. I am pleased with the progress we made in Q3 with respect to the pronounced mix shift from finished goods to kit sales. Kids carry lower unit prices but offer more attractive gross margin and enables us to leverage the blood center distribution network which greatly expands our hospital and patient reach. On a dose equivalent basis, ISC sales volume increased 7% sequentially. We are seeing continued strong performance in ISC as we approach year end, and are highly confident that our ISC franchise will be a meaningful growth driver for years to come. In EMEA, our commercial organization continues to deliver solid performance in an increasingly challenging environment. Geopolitical conflicts in the Middle East and Russia, along with the strength of the US dollar, created some near term headwinds. We believe these headwinds are transient, and that the underlying opportunity for our international business remains attractive. Unit placements of the INT200 in EMEA have exceeded our expectations and contributed strongly to the third quarter sales. We expect that trend to continue in the fourth quarter, and I appreciate the international team's unwavering focus on customer support. Our second priority, advancing innovation, builds on our commitment to drive clinical and technological advances that improve transfusion medicine. New products and expanded indications can bring INTERCEPT to more patients and increase our addressable market. This afternoon, we announced positive top line results from our Phase III REDeS trial of the INTERCEPT blood system. Completing the study is a significant milestone in advancing our progress to extend the application of our pathogen reduction technology to red cell transfusion. We are grateful to the patients, investigators, blood centers, and Sears colleagues whose commitment made this important study possible. Over the past decade, pathogen reduction has become an integral part of the blood safety toolkit for platelets, plasma, and ISC. We believe extending pathogen reduction to red blood cell transfusions represents an important opportunity to further improve transfusion safety, and expand the reach of our technology. REDeS compared the safety and efficacy of INTERCEPT treated red blood cells with conventional red blood cells in patients requiring acute and long term transfusion support. The study assessed the primary efficacy endpoint and 2 primary safety endpoints. REDeS met its primary efficacy endpoint, demonstrating non inferiority in adjusted hemoglobin increment compared with conventional red blood cells. Adjusted hemoglobin increment is a commonly used measure of RBC transfusion effectiveness. In addition, when evaluating treatment emergent adverse events in the REDeS top line results, including the INTERCEPT RBC-specific antibody seen in the treatment arm, there was no statistically significant difference between the treatment and control arm. The antibodies seen were consistent with prior studies and results in no clinical impact. The REDeS top line findings add to the clinical evidence from the STARS SPARK, and ReCePI trials. We are encouraged by the efficacy results, and will complete the full clinical analysis to further characterize the study's findings over the coming months. With respect to our CE Mark red cell filing, ANSM continues to review our application. We recently held a constructive meeting with ANSM and are preparing responses to the questions they raised. As part of our response, we will include a full REDeS clinical study report. The decision to include the REDeS data into our package was well received by ANSM, and will provide more clinical evidence thereby strengthening our submission. As such, we now expect the CE Mark clearance in late 27. Pending the eMark approval, we are planning for a limited market release targeting centers of excellence in Europe. Our initial focus will be on a small number of leading blood centers with the goal of generating real world experience, which will inform our broader go to market strategy and approach. Turning to the US. We received preliminary feedback and questions from the FDA on our PMA platelet submission for the INT200 illuminator. We believe these questions are addressable, although it still will require us to gather some additional data. We will have more visibility on approval timing once we align with the agency on the scope of these incremental data requirements. Despite the delay, we remain confident in our ability to successfully navigate the regulatory process and bring these technologies to market. In parallel, we will continue to drive ongoing share capture in existing markets and further strengthen the body of real world experience we are gaining with our technology. Our third priority is to strengthen our financial foundation. We made good progress last quarter, and this is enabling us to self-fund investments in both market expansion and product innovation. As we grow, we expect to generate greater leverage from our established commercial infrastructure and improve our overall profitability. Our third quarter results reflect this momentum as evidenced by our improving margin profile, our 10th consecutive quarter of positive adjusted EBITDA, and the generation of meaningful cash flow from operations. We will balance that progress with disciplined investment in the technologies and capabilities that support future growth. Our goal is to build a profitable business that can increasingly fund its own development and expand access to safer blood. With that, I will turn the call over to Kevin to discuss our third quarter financial results in greater detail.

Kevin D. Green: Thanks, Vivek. And thank you to those joining us on the call today. On today's call, I will be discussing our financial results for the third quarter of 26. And our expectations for the balance of the year. I will start with product revenue. For the third quarter of 26, we reported product revenue totaling $57.7 million, a 10% increase over Q3 25. For the first 9 months of the year, product revenue increased 14% to $168.8 million compared to the first 9 months of 2025. The primary growth drivers during the quarter were increasing demand for ISC, and INTERCEPT platelets in the U.S., as well as EMEA placements for our next generation LED based illumination device, the INT200. On a volume basis, North American platelet kit and calculated platelet doses increased 5% year-over-year, Demonstrating we are continuing to take share as we outpace the underlying platelet market growth. By geography, third quarter North American product revenue increased 12% compared to the same period in the prior year. In EMEA, third quarter product revenue, as reported, increased 5% year-over-year, The growth in EMEA shows the resilience and diversity of the business. As we did see some impact from the ongoing conflict between Russia and Ukraine on Russian orders. And separately, deferred orders from the EFS in France, who, as a reminder, is at 100% platelet utilization and who we expect will continue more normalized order patterns going forward. Furthermore, unfavorable foreign currency exchange rates negatively impacted reported EMEA revenue growth by approximately 2%. Switching now to the ISC business in the US. As we mentioned throughout the year, we have been converting the business from 1 in which we sell the finished ISC therapeutic to hospitals. To a business where we sell kits to blood centers, who will then use our products to produce ISC and sell the finished therapeutic to their hospital accounts. As we complete the move to a kit-only model, we expect to see a benefit to our reported gross margins. While the finished biologics carry a higher selling price, the gross margin profile for our kit model is accretive to our consolidated gross margins. Of the total IFC sales shipped during the quarter, 90% were in kit form. And we continue to expect that essentially all ISC sales will be in kit form in 2027. ISC product revenue for the third quarter was $5.6 million compared to $3.9 million during the third quarter of 25. As Vivek mentioned as part of his prepared remarks, we saw a marked sequential increase in the IFC mix shift from finished therapeutic products to kids. Based on our strong year to date commercial execution and conviction in growth projections for the balance of the year, we are reaffirming our full year 2026 product revenue guidance range of $229 million to $231 million Included in this range is full year 2026 IFC sales, of $23 million to $25 million I would now like to switch to government contract revenue which, as a reminder, is not included in our revenue guidance or non GAAP adjusted EBITDA results. With the conclusion of the FDA contract in 2025 and the wind down of the BARDA 2016 contract, reimbursement for government related R and D expenses declined year over year to $6.3 million from $7.5 million in Q3 25. BARDA continues to be an extremely supportive partner for our RBC program, And with the 2024 contract covering many of the activities related to RBC development. The funding from this ongoing contract provided a partial offset to the wind down of the prior contracts. Turning now to gross margin on product sales. Our third quarter product gross margin was 52.4% compared to 53.4% during the prior year and 51.4% during Q2 of this year. These results were in line with our expectations going into the quarter. While foreign exchange rates and inflation continue to pose headwinds to our margins, pricing and product mix namely the continued conversion to IFC kit sales, supported the sequential pickup. For the balance of 2026, we expect to see some relief in Q4, given the recent strengthening of the U. S. Dollar. Moving down the income statement. Total operating expenses for the third quarter totaled $36.2 million compared to $34.4 million for Q3 25. Total operating expenses increased 5% compared to our product revenue growth of 10% as we continue to strive to deliver leverage in the P and L. The increase in total operating expenses, while was driven by a 10% reduction in R and D expenses, reflecting the completion of the REDIS study enrollment lower development costs on the INT200 following the US PMA submission, and the completion of activities covered under the FDA contract which concluded in 2025. Offsetting this were year over year reported SG&A due to onetime credits received in 2025. Artificially affecting the year-over-year comp. For the third quarter, government funded R and D expenses accounted for 31% of total R and D spend. As we have previously noted, we expect government funded R and D expenses to increase as a percentage of total R and D spend. Let's now turn to the bottom line and non GAAP adjusted EBITDA results. For Q3 26 and 2025, GAAP net loss attributable to Cerus was under $1 million, approaching breakeven. On a non GAAP basis, adjusted EBITDA for the third quarter totaled $5.7 million compared to $5 million last year. These results mark our 10th consecutive quarter posting positive adjusted EBITDA. As an organization, we are committed to looking beyond adjusted EBITDA and have line of sight into achieving GAAP profitability. Let's now turn our attention to cash flows for the quarter. Cash generation from operations was $3 million, driven in large part by close management of inventory levels from the first half. These results continue to strengthen our balance sheet. As such, cash, cash equivalents and short term investments as of 09/30/2026, were $57.1 million, up close to $1 million from June 30. Before I turn it back to Vivek, I want to mention that our existing shelf registration statement is scheduled to expire. While we have not used the shelf since 2021, we believe it is a matter of good corporate governance to have 1 in place and as such, we are refreshing it in connection with our third quarter 10-Q filing. With that, let me pass it back to Vivek for some closing comments.

Vivek K. Jayaraman: Thank you, Kevin. Our performance through the first 3 quarters of 2020 reinforces my confidence in our business. We are driving growth via continued penetration in our core market globally, by successfully transitioning the ISC business model while increasing unit volumes and gaining traction internationally with the continued rollout of the INT200. With respect to innovation, the positive top line results from REDES add to the strong library of clinical data we are building in support of red cell pathogen reduction, and reaffirms our commitment to leading the way in terms of investment in scientific research and clinical evidence. Lastly, our financial profile is strengthening, we are improving our margins, delivering positive adjusted EBITDA, generating cash flows, and taking clear steps towards becoming a-- becoming GAAP profitable. What is most important, however, is that each unit of blood that is produced takes us 1 step closer to realizing our mission. This quarter, our kit sales represented nearly 800 thousand doses of transfusable blood components. This means more patients around the world are gaining access to safer blood. We are proud of our progress, but realize that there is much work yet to be done. I am confident that we will continue to deliver against our mission. Thank you for your interest in Cerus and for your continued support as we work diligently to improve the safety of the global blood supply. Operator, please open the call for questions.

Operator: Certainly. As a reminder, to ask a question you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. In the first question will be coming from the line of Joshua Jennings of TD Cowen. Your line is open, Joshua.

Colin: Hi. This is Colin on for Joshua. Thank you, Vivek, and Kevin for taking my questions. Congratulations on the positive REDeS results. It was really encouraging to see. I was hoping you could talk a little bit about the next steps with FDA for Gen 1 RBCs and I know you talked about the clinical process and analysis happening over the coming months. But what are the next steps there after that? And if you have any updates you could share with regard to Gen 2, that would be really helpful. Thank you.

Vivek K. Jayaraman: Hey, Colin. Thanks for the question, and, appreciate the positive commentary. We are certainly excited about the REDeS results, you know, certainly evidence of our commitment to investment in evidence generation. As you noted, next steps include the full data analysis, and that is to support submitting that clinical study report to the FDA is part of the approval process and then also submitting it for publication and presentation on the podium. Once that report is finalized and we submit to the FDA, we will then be able to sit down with them and get a better understanding of timing in terms of the approval process and the pathway forward. In parallel, as you noted, we are working from a device development standpoint. On our Gen 2 system, which we believe will be sort of the main go to market system. We made good progress through the third quarter, and as we end in. enter into 2027, I think we will be able to talk more about the specifics of that system. But right now, the focus is on taking this good top line data, doing the full statistical analysis, and then meeting with the agency to discuss next steps.

Colin: Gotcha. that is that is helpful. And I wanted to spend a minute on international. We saw a little bit of lumpiness come up in the platelet kit growth numbers and the change in the number of treatable platelets kind of similar to Q2. Can you talk about the underlying health of the international markets, kind of what that Russia, Ukraine dynamic impact looks like, and potentially touch on whether you are seeing any distributor choppiness?

Vivek K. Jayaraman: Yeah. Thanks. All great questions, and I think demonstrative of the good insight you have into our business. As we noted, during the call, certainly, the geopolitical climate and some of the tensions in different parts of the world are impacting our business. As I mentioned earlier, we believe that this is transient. The fact is our position in those markets in terms of share and leadership remain strong. We have been working very closely with our distributor partners and with their hospital and blood center customers to do everything we can to ensure continuity of supply so that ultimately patients have access to pathogen treated blood. The underlying impact in terms of long term belief in the technology and the strength of our product remains unchanged, and we saw continued strong adoption of the IT 200 international market. So there is signals that we believe over the mid and long term are encouraging. it is just a matter of navigating some of these acute issues that, we saw sort of manifest in the second and third quarter and then that. The other contributing factor that I would point to is ForEx, which certainly the strengthening dollar remains a bit of a headwind, but ultimately, we are trying to focus on the things over which we have control, and that is really ensuring we serve our customers well, that we provide quality product, and we continue to you know, deliver in terms of clinical education and market development. And we saw good progress in international markets this past quarter.

Colin: I appreciate the response. Last 1 for me before I hop back in queue. I am curious whether your experience at AABB was a bit different this year now that the BCA agreement is on board. Are you hearing about members with firsthand either PR platelet or IFC experience comparing notes, or are there any opportunities with this buzz going on to get centers over the fence who are already considering becoming customers or get new opportunities to come your way?

Vivek K. Jayaraman: Yeah. You know, ABB was great. We were in Atlanta. I guess the now last month since we have turned the calendar to November. But it was certainly, we are seeing tangible evidence of the BCA agreement, which we mentioned really got underway officially listing in this calendar year. We are seeing that agreement bear some real fruit at this point in time. I think as I have mentioned before, peer to peer marketing is arguably the most effective tool in our toolkit. And we saw a number of new BCA centers jump on board both in terms of IFC production and distribution. But then also platelet production and distribution as well. And as we would noted, BCA members account for about 50% of blood products distributed nationwide, and that is where we had the largest room to grow in terms of both platelet and ISC adoption. So there was a lot of good dialogue between blood centers and then also their hospital customers in Atlanta last month. So we are certainly encouraged, and we believe that momentum will continue through 2026 and really for years to come. Thank you so much. Thank you, Colin. Appreciate it.

Operator: And our next question will be coming from the line of Mark Massaro of BTIG. Your line is open, Mark.

Mark Massaro: Hey, guys. Thank you for taking the questions, and I echo the congratulations on the, positive Phase III REDeS data. My first question is around the. What are your expectations for ballpark timing of the full data analysis. Is that something that we could perhaps pencil in the first half of 27 just thinking about upcoming conferences and typical time line. Thanks for the question mark and for the positive comment as well.

Vivek K. Jayaraman: I appreciate it. I think that is a reasonable expectation around timing. Obviously, as we get deeper into the data analysis, we will learn more and during that time, that information is embargoed so that we can ensure we get the best you know, possible audience in terms of clinical publication and ultimately podium presence. And, obviously, we have to submit that information to the various regulatory bodies for their ongoing review and ultimate approval. But I think in broad brushstroke, that timing that you suggest you know, seems in line with what we are driving towards. We will certainly work diligently to get it out as quickly as possible. Certainly not compromising quality in the interest of speed, but we are you know, we are we are very excited about the library of evidence we have built in support of PR for red cell transfusions.

Mark Massaro: Okay. Fantastic. And then as we think about the full study results reporting out, just double checking this. Is it correct that the secondary endpoints have not read out yet? And do you remain blinded to those?

Vivek K. Jayaraman: Sorry. Could you repeat that question, Mark? Yeah. The Phase III REDeS, we saw the we saw that you had successful on the primary endpoints. I am asking about the secondary endpoints of the. Oh, yeah. Sorry. I Yeah. Yeah. No. that is correct. that is part of the ongoing analysis. We just reported this afternoon top line results from the primary endpoint. And as well as the primary safety endpoints with secondary endpoints and further data analysis will be distributed and published once we finish the complete analysis.

Mark Massaro: Okay. that is what I figured. And then, obviously, you put up another strong double digit quarter for product revenue. It might be a little early to talk about 2027, but what I am. What I would like to get at is do you anticipate any potential structural challenges internationally Kevin, feel free to weigh in here as it relates to some of your international business. I would expect continued strong growth from IFC next year as that product remains in early days of penetration. But just wondering if you could just help us frame some of the puts and takes as you are thinking about product revenue in 2027?

Vivek K. Jayaraman: Yeah. Certainly. And, obviously, we will demure in terms of guidance for 2027 at the moment. But if I think about the performance in Q3, as you correctly noted, Mark, The U. S. Business was really the acute source of strength. Not only in IFC, as you mentioned, but also continued share capture for our core platelet business driven principally by continued penetration within BCA members on the heels of that BCA agreement. So that is encouraging across multiple dimensions, and we see continued strength in The U. S. As we continue through Q4 and head into the next calendar year. We noted some transient headwinds internationally certainly, it is anyone's guess of how some of these events may unfold. But even with those headwinds, we are seeing continued enthusiastic adoption of the INT-200. That leads to further opportunities for improved kit penetration and growth. And then we continue to work on strategic market access in larger geographies, that we believe will manifest in terms of meaningful growth opportunities through the balance of this decade. So our overall enthusiasm for the international business and the evidence we are getting in terms of continued adoption and strong real world experience gives us long term confidence. But you know, I think my. My belief is the team's doing a nice job navigating acute headwinds and while that is occurring, The US business is really strengthening. So we are in a good spot, and I think that speaks to the value of diverse portfolio.

Mark Massaro: Great. Thank you, guys.

Operator: And our next question will come from the line of William Bonello of Craig-Hallum Capital Group. Your line is open, William.

William Bonello: Hey, guys. Thanks a lot for taking the question. You talked a little bit about the Gen 2 device. Can you just explain how that would end up getting incorporated into the FDA process? Would that just be a some kind of a modification to the-- to the FDA application along the way? Is it something that would have-- you know, you get approved on the initial device and you would go back afterwards? Just how should we be thinking about that?

Vivek K. Jayaraman: I think the latter part of your statement is how you should be thinking about it, Bill. We would we are applying for approval on the Gen 1 system, and then once we get past you know, design freeze, all of the work on Gen 2, we will then submit for approval of that system, but it would be a follow on to a Gen 1 device approval.

William Bonello: Okay. that is helpful. And then just in the past, you have been talking about what is been going on with the evaluation in Germany. Any update there?

Vivek K. Jayaraman: Yeah. Thanks. it is a great question. So as we had noted in the past, we began the INITIATE clinical trial, which was in partnership with the German Red Cross. That was to evaluate the INTERCEPT plate system for platelets in a real world setting in Germany. That study. That post market study continues to enroll at a healthy clip and the feedback we are getting from customers is quite positive. Separate and independent of that, there has been work at the health policy level in Germany by the PEI to look at what I would describe as something akin to the FDA's guidance on safety for platelets, looking at-- proposing a policy countrywide around how to ensure that platelet transfusions are as safe as possible. And we certainly encourage that evaluation at the health policy level. We believe if that were in fact to go final, that would accrue to our benefit and be favorable in terms of how it is viewed in the German market. But independent of that, the initiate study continues to enroll positively, and we believe Germany will represent a pretty meaningful growth opportunity for INTERCEPT over the course of the rest of this decade. So things in Germany continue to go well.

William Bonello: Okay. that is great. And then just 1 more if I could flipping back to red blood cell. Again, just so you laid out, it was very helpful, both the sort of next steps between here and submitting for publication and submitting something to the FDA and some timeline along with that. Can you just remind us of sort of how you how you see this evolving then over time? So, you know, fast forward to, you know, hopefully, a time when you get FDA approval What are kind of the you know, critical steps that have to happen in the in the marketplace for red blood cell to become a big product You need something like the FDA guidance document, but as it applies to red blood cell, what are you kinda thinking about that? And is there any advanced preparation you do on that kind of stuff, or is this the focus right now solely on the regulatory and the data?

Vivek K. Jayaraman: Yeah. Very good questions, Bill, and I appreciate it. 1 thing I want to be explicit about, we certainly do not engage in any sort of market awareness or development or priming prior to approval. So our acute focus is on getting the clinical study data final. Excuse me. Getting the study data analyzed completely, pulling together that final clinical study report, and then submitting it not only to the FDA, but for publication in the podium. I think that will facilitate meeting with the FDA and getting clarity on their acute steps between here and approval. The benefit of developing such a strong body of clinical evidence in support of red cell transfusions. So not only with REDeS, but if you think about SPARK and ReCePI is that we are educating through clinical evidence generation the broader market in you add to that the fact that now between platelets, plasma, and ISC, there is well over a decade of experience with pathogen reduction and blood transfusions. We think that creates an underlying desire for this product. We certainly get that feedback from customers all over the world. And so what we are attempting to do, and we mentioned that in the context of the limited market release in Europe post-CE Mark is we will generate Real World Experience With Red Cells, and that real-world Use Even In Geographies Outside Of The US, I think will be informative and educational as we think about and approach US commercialization. We see that, the question was asked earlier about AABB. We saw that at AABB where it is a fairly small industry in terms of influential blood center customers and clinicians, and so experiences accrued in 1 market certainly has influence elsewhere. We are seeing this for example, with our IFC rollout where the more experience and the progress we make in The US, we are getting inbound unsolicited inquiries from international markets about IFC. So I would not be surprised to see a similar dynamic in play with respect to red cells once we are in a post market environment.

William Bonello: Thank you very much.

Vivek K. Jayaraman: Appreciate it.

Operator: Our next question will come from Gabby Cantor of Cantor Fitzgerald. Your line is open, Gabby.

Gabby Cantor: Hi, guys. Thanks for the question. I want to double-click on ISC demand because it was really impressive. It looks like volumes grew about 80% in the third quarter and 60% year-to-date. Could you just give some incremental color on what is behind that acceleration?

Vivek K. Jayaraman: And which customer types are contributing the most? Certainly. Gabby, thanks for the question. it is great to have you on the call. As we had indicated heading into calendar year 2026, we officially kicked off our nationwide agreement with Blood Centers of America. They represent over 50% of distributions of blood products nationwide. And a number of BCA member blood centers were already partnering with us as ISC production partners heading into this calendar year. So as part of that agreement, what we are able to do is leverage their resource sharing model transfer those production partners to BCA member agreements, and then gain access to their network of sales and marketing and customer fulfillment professionals to effectively really scale And Expand Our Reach Into US hospitals. So that is a big underlying driver of our growth. it is really leveraging a broader SG&A network. In addition to that, as you can probably appreciate, is that with increased customer depth and user experience and leveraging podium and visibility opportunities, the number of not only clinician conferences, but blood center conferences as well. The volume of real-world experience that on the podium, peer to peer dialogue that is occurring about ISC use and the value derived to patients is really starting to expand, which accrues to our benefit. And then the other piece that we had mentioned is by virtue of transitioning to the kit model, it just allows us to more quickly penetrate accounts again through leveraging their channel and then also offers better economics, for Cerus. And so it was really a combination of all of those factors that contributed, and it is, you know, it is still early days. We have a lot of headroom with respect to growth in this market, and so we view ISC as being a meaningful growth driver for the business really for years to come.

Gabby Cantor: Okay. that is helpful. And then I have here that you guys last estimated, I think, at about 10%. Last quarter. Just kind of leading into that response, where do you think it can go over the next few years?

Vivek K. Jayaraman: We certainly believe that ISC has the ability to become standard of care. You know, that is our aspiration really across all of our product categories. And so there is still no reason why certainly given product performance and clinical enthusiasm and most importantly, the impact that it has on patients. We believe truly can be a lifesaving intervention. So we certainly believe standard of care is something that we can deliver against and it is our goal internally. So that is why I point to the fact that I think this is going to be a material growth driver for the company for years to come. Alright. Great. Thanks, guys. And congrats on the positive REDeS readout. Great. Thank you. Thanks, Gabby.

Operator: And I have no further questions at this time. This concludes today's program. Thank you for participating. You may now disconnect.