Cerus Q3 2026 Earnings Call Transcript

Cerus (NASDAQ:CERS) reported third-quarter financial results on Monday. The transcript from the company’s third-quarter earnings call has been provided below.

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View the webcast at https://edge.media-server.com/mmc/p/uefg6ndj/

Summary

Cerus Corporation reported a 10% increase in product revenue for Q3 2026, driven by strong demand in North America and EMEA, particularly for their INTERCEPT platelet kits and INT200 devices.

The company achieved positive top-line results from the Phase 3 REDIS trial for pathogen reduction technology in red blood cell transfusions, marking a significant milestone in expanding their clinical applications.

Cerus reaffirmed its full-year 2026 revenue guidance of $229 to $231 million, with continued focus on innovation, market expansion, and transitioning its business model for improved gross margins.

Operational highlights include a successful transition to selling IFC kits to blood centers, leading to a sequential increase in sales volume and improved margin profile.

Management expressed confidence in overcoming geopolitical and macroeconomic challenges, emphasizing the resilience of their team and the strength of their financial foundation with 10 consecutive quarters of positive adjusted EBITDA.

Full Transcript

OPERATOR

Good day and thank you for standing by. Welcome to the Cerus Q3 2026 earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 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, Tim Lee, Head of Investor Relations. Please go ahead.

Timothy J. Lee (Head of Investor Relations)

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.cerus.com. With me on the call are Vivek Jayaraman, Cerus President and Chief Executive Officer, Kevin Green, Cerus Chief Financial Officer, and Dr. Nina Mufti, Cerus Senior Vice President, Research and Development.

Cerus issued two press releases this afternoon, one announcing our financial results for the third quarter ended September 30, 2026 and describing the company’s recent business highlights, the other announcing top-line results from our Phase 3 ReTA study. You can access copies of both announcements on the company’s website at www.cerus.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 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 slides 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 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 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’ll 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, Cerus President and Chief Executive Officer.

Vivek Jayaraman (President and Chief Executive Officer)

Thank you, Tim, 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 800,000 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 3 ReDIS 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, and the opportunities ahead. 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 advances. From an operating perspective, we are focused on three 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 three priorities. Furthermore, the 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, are successfully transitioning our ISC business model, and our international rollout of the INT200 Illuminator is exceeding expectations.

With the completion of our Phase 3 REDIS trial, we have built the largest library of clinical evidence in support of pathogen reduction technology and red cell transfusions. Financially, we delivered our 10th consecutive quarter of positive adjusted EBITDA, improved our margins, 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 three pillars in further detail. Worldwide product revenue increased 10% year over year, with US performance leading the way.

We witnessed continued momentum in our ISP 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 INT penetration. North American sales increased 12% and accounted for just over two-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 U.S. hospitals that are recognized in the latest U.S. News & World Report rankings. 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 U.S. While many BCA members were already serious customers, the agreement has created opportunities to deepen those relationships while also allowing us to secure new customers across both platelets and ISV.

Through the first three quarters of the year, revenue growth from BCA member blood centers outpaced overall North American growth. Turning to ISV, hospital demand continues to increase as our value proposition gains traction. Immediate access to fibrinogen and a five-day post-thaw shelf life offer compelling benefits to clinicians, hospital administrators, and most importantly, patients. The longer shelf life can materially reduce waste, while the availability of pre-thawed ISD 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 Biotherapy’s annual meeting, the team from Grady Memorial Hospital, Atlanta, shared their worldwide 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 on site at all times, ready to be issued. Peer-to-peer exchanges are incredibly valuable and help clinicians learn from one another and better understand how ISC can fit into their clinical practice.

We are also evolving our ISC commercial model to support broader patient access 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. Kits carry lower unit prices but offer more attractive gross margins and enable us to leverage the blood centers’ distribution network, which greatly expands our hospital and patient reach.

On a dose-equivalent basis, ISD 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 a strengthening U.S. 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 INT 200 in EMEA have exceeded our expectations and contributed strongly to 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 markets. This afternoon we announced positive top-line results from our Phase 3 REDIS 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 transfusions.

We are grateful to the patients, investigators, blood centers, and Cerus 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 ISD. 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. Let us compare 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 a primary efficacy endpoint and two primary safety endpoints. REDIS 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 REDIS 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 resulted in no clinical impact. The REDIS top-line findings add to the clinical evidence from the STARS, SPARK, and RECIPE 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 REDIS clinical study report. The decision to include the REDIS data into our package was well received by ANSM and will provide more clinical evidence, thereby strengthening our submission. As such, we now expect CE Mark clearance in late 2027.

Pending CE Mark approval, we are planning for a limited market release targeting centers of excellence in Europe. Our initial focus will be 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 U.S., we received preliminary feedback and questions from the FDA on our PMA platelet submission for the INT 200 Illuminator. We believe these questions are addressable, although the scope will require us to gather some additional data. We’ll 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 Green (Vice President Finance and Chief Financial Officer)

Thanks, Vivek, and thank you to those joining us on the call today. On today’s call I’ll be discussing our financial results for the third quarter of 2026 and our expectations for the balance of the year. I’ll start with product revenue. For the third quarter of 2026 we reported product revenue totaling $57.7 million, a 10% increase over Q3 2025. For the first nine months of the year, product revenue increased 14% to $168.8 million compared to the first nine months of 2025. The primary growth drivers during the quarter were increasing demand for IFC 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 IFC business in the U.S., as we mentioned throughout the year, we’ve been converting the business from one in which we sell finished IFC therapeutic to hospitals to a business where we sell kits to blood centers, who will then use our products to produce IFC 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 IFC sales will be in kit form in 2027. IFC product revenue for the third quarter was $5.6 million compared to $3.9 million during the third quarter of 2025. 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 kits. 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 to $231 million. Included in this range is full-year 2026 IFC sales of $23 to $25 million.

I’d 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. Given the conclusion of the FDA contract in 2025 and the wind down of the BARDA 2016 contract, reimbursement for government-related R&D expenses declined year over year to $6.3 million from $7.5 million in Q3 2025. 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 2025. Total operating expenses increased 5% compared to our product revenue growth of 10% as we continue to strive to deliver leverage in the P&L. The increase in total operating expenses was driven by a 10% reduction in R&D expenses reflecting the completion of the REDIS study enrollment, lower development costs on the INT200 following the U.S. PMA submission, and the completion of activities covered under the FDA contract, which concluded in 2025.

Offsetting this were year-over-year reported increases in SG&A due to one-time credits received in 2025 artificially affecting the year-over-year comp. For the third quarter, government-funded R&D expenses accounted for 31% of total R&D spend. As we’ve previously noted, we expect government-funded R&D expenses to increase as a percentage of total R&D spend. Let’s now turn to the bottom line and non-GAAP adjusted EBITDA results for Q3 2026 and 2025. GAAP net loss attributable to Cerus was under a million dollars, 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 of 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 September 30, 2026 were $57.1 million, up close to a million dollars 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’ve not used the shelf since 2021, we believe it’s a matter of good corporate governance to have one 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 Jayaraman (President and Chief Executive Officer)

Thank you, Kevin. Our performance through the first three quarters of 2026 reinforces my confidence in our business. We are driving growth via continued penetration in our core markets globally, are successfully transitioning the IFC 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 REDIS added 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 as we are improving our margins, delivering positive adjusted EBITDA, generating cash flows, and taking clear steps towards becoming GAAP profitable.

What is most important, however, is that each unit of INTERCEPT-treated blood that is produced takes us one step closer to realizing our mission. This quarter our kit sales represented nearly 800,000 doses of transfusible 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 Star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press Star 11 again. Please stand by while we compile our Q&A roster. Our first question will be coming from the line of Josh Jennings of TD Cowen. Your line is open, Josh.

Colin (Analyst)

Hi, this is Colin on for Josh. Thank you, Vivek and Kevin, for taking my questions. Congratulations on the positive REDIS result. 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 Jayaraman (President and Chief Executive Officer)

Hey Colin, thanks for the question and appreciate the positive commentary. We’re certainly excited about REDIS results and 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 as 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’ll 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’re 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 enter into 2027 I think we’ll 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 (Analyst)

Gotcha. That’s 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 2Q. 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’re seeing any distributor choppiness?

Vivek Jayaraman (President and Chief Executive Officer)

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’ve 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 INT200 in international markets. So there are signals that we believe over the mid and long term are encouraging. It’s just a matter of navigating some of these acute issues that we saw sort of manifest in the second and third quarter. And then the other contributing factor that I point to is FX, which certainly the strengthening dollar remains a bit of a headwind.

But ultimately we’re trying to focus on the things over which we have control, and that’s really ensuring that we serve our customers well, that we provide quality product, and we continue to deliver in terms of clinical education and market development. And we saw good progress in international markets this past quarter.

Colin (Analyst)

I appreciate the response. Last one for me before I hop back in queue. I’m 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 centers over the fence who are already considering becoming customers or get new opportunities to come your way?

Vivek Jayaraman (President and Chief Executive Officer)

Yeah, AABB was great. We were in Atlanta. I guess it’s now last month since we turned the calendar to November, but we’re certainly seeing tangible evidence of the BCA agreement, which we mentioned really got underway officially in this calendar year. We’re seeing that agreement bear some real fruit at this point in time, I think. As I’ve 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’d noted, BCA members account for about 50% of blood products distributed nationwide, and that’s where we had the largest room to grow in terms of both platelet and IFC adoption. So there was a lot of good dialogue between blood centers and then also their hospital customers in Atlanta last month. So we’re certainly encouraged and we believe that momentum will continue through ’26 and really for years to come.

Colin (Analyst)

Thank you so much.

Vivek Jayaraman (President and Chief Executive Officer)

Thank you, Colin. Appreciate it.

OPERATOR

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

Mark Basaro (Analyst)

Hey guys, thank you for taking the questions, and I echo the congratulations on the positive Phase 3 REDIS data. My first question is around the—what are your expectations for the ballpark timing of the full data analysis? Is that something that we could perhaps pencil in 1H ’27? Just thinking about upcoming conferences and typical timelines.

Vivek Jayaraman (President and Chief Executive Officer)

Thanks for the question, Mark, and for the positive comment as well. Appreciate it. I think that’s a reasonable expectation around timing. Obviously as we get deeper into the data analysis we’ll learn more, and during that time that information is embargoed so that we can ensure we get the best 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 brush strokes, that timing that you suggest seems in line with what we’re driving towards. We’ll certainly work diligently to get it out as quickly as possible, certainly not compromising quality in the interest of speed. But we’re very excited about the library of evidence we’ve built in support of PR for red cell transfusions.

Mark Basaro (Analyst)

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

Vivek Jayaraman (President and Chief Executive Officer)

Sorry, could you repeat that question, Mark?

Mark Basaro (Analyst)

Yeah, the Phase 3 REDIS, we saw that you had successful on the primary endpoints. I’m asking about the secondary endpoints of the.

Vivek Jayaraman (President and Chief Executive Officer)

Oh, yeah, sorry. Yeah, no, that’s correct. That’s part of the ongoing analysis. We just reported this afternoon top-line results from the primary endpoint as well as the primary safety endpoints. But secondary endpoints and further data analysis will be distributed and published once we finish the complete analysis.

Mark Basaro (Analyst)

Okay, that’s 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 ’27, but 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’re thinking about product revenue in 2027.

Vivek Jayaraman (President and Chief Executive Officer)

Yeah, certainly. And obviously we’ll demur in terms of guidance for ’27 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’s 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, and certainly it’s anyone’s guess as to how some of these events may unfold. But even with those headwinds, we’re seeing continued enthusiastic adoption of the INT200 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’re getting in terms of continued adoption and strong real-world experience gives us long-term confidence. But I think my belief is that the team’s doing a nice job navigating acute headwinds. And while that’s occurring, the U.S. business is really strengthening. So we’re in a good spot, and I think that speaks to the value of a diverse portfolio.

OPERATOR

Great. Thank you, guys. And our next question will come from the line of William Bonello of Craig-Hallum Capital Group. Your line is open, William.

William Bonello (Analyst)

Hey guys, thanks a lot for taking the question. You talked a little bit about the Gen2 device. Can you just explain how that would end up getting incorporated into the FDA process? Would that just be some kind of a modification to the FDA application along the way? Is it something that would have, you know, you get approved on the initial device and you go back afterwards? Just how should we be thinking about that?

Vivek Jayaraman (President and Chief Executive Officer)

I think the latter part of your statement is how you should be thinking about it, Bill. We’re applying for approval on the Gen1 system, and then once we get past design freeze, all of the work on Gen2, we’ll then submit for approval of that system. But it would be a follow-on to a Gen1 device approval.

William Bonello (Analyst)

Okay, that’s helpful. And then just in the past you’ve been talking about what’s been going on with the evaluation in Germany. Any update there?

Vivek Jayaraman (President and Chief Executive Officer)

Yeah, thanks. Great question. So as we had noted in the past, we began the INITIATE clinical trial, which was in partnership with the German Red Crosses. That was to evaluate the INTERCEPT platelet system for platelets in real-world settings in Germany. That study, that post-market study, continues to enroll at a healthy clip, and the feedback we’re getting from customers is quite positive. Separate and independent of that, there has been work at the health policy level in Germany by the P.E.I. to look at what I would describe as something akin to the FDA’s guidance on bacterial 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 INTERCEPT 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 (Analyst)

Okay, that’s great. And then just one more if I could. Flipping back to red blood cell again, just—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. Can you just remind us of sort of how you see this evolving then over time? So fast forward to hopefully a time when you get FDA approval. What are kind of the critical steps that have to happen 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, how are you kind of thinking about that and is there any advance preparation you do on that kind of stuff or just the focus right now solely on the regulatory and the data?

Vivek Jayaraman (President and Chief Executive Officer)

Yeah, very good questions, Bill, and I appreciate it. One thing I want to be explicit about, we certainly 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, 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 and the podium. I think that will facilitate meeting with the FDA and getting clarity on kind of the acute steps between here and approval.

The benefit of developing such a strong body of clinical evidence in support of red cell transfusions, not only with REDIS, but if you think about SPARC and ReCePI, is that we are educating through clinical evidence generation the broader market. And you add to that the fact that now between platelets, plasma, and IFC, there’s well over a decade of experience with pathogen reduction in 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’re attempting to do—and we mentioned that in the context of the limited market release in Europe post CE Mark—is we’ll generate real-world experience with red cells, and that real-world use even in geographies outside of the U.S. I think will be informative and educational as we think about and approach U.S. commercialization. We see that—the question was asked earlier about AABB—we saw that at AABB, where it’s a fairly small industry in terms of influential blood center customers and clinicians.

And so experience that is accrued in one market certainly has influence elsewhere. We’re seeing this, for example, with our IFC rollout, where the more experience and the progress we make in the U.S., we’re getting inbound unsolicited inquiries from international markets about IFC. So I wouldn’t be surprised to see a similar dynamic in play with respect to red cells once we’re in a post-market environment.

William Bonello (Analyst)

Thank you very much. Appreciate it.

OPERATOR

As a reminder, to ask a question, please press star-1-1 on your telephone and wait for your name to be announced. Our next question will come from Gabby Kanter. Your line is open, Gabby.

Gabby Kanter (Analyst)

Hi guys, thanks for the question. I want to double click on IFC demand because it was really impressive. It looked like volumes grew about 80% in the third quarter and 60% year to date. Could you just give some incremental color on what’s behind that acceleration and which customer types are contributing the most?

Vivek Jayaraman (President and Chief Executive Officer)

Certainly, Gabby, thanks for the question. It’s great to have you on the call. You know, 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 IFC 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 U.S. hospitals. So that’s a big underlying driver of our growth. It’s really leveraging a broader SGA network.

In addition to that, as you can probably appreciate, is that with increased customer depth and user experience and leveraging podium and symposium opportunities at a number of not only clinician conferences but blood center conferences, as well as the volume of center experience that’s on the podium, peer to peer dialogue that’s occurring about IFC use and the value it drives 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’s still early days. We have a lot of headroom with respect to growth in this market and so we view IFC as being a meaningful growth driver for the business really, for years to come.

Gabby Kanter (Analyst)

Okay, that’s helpful. And then I have that you guys last estimated IFC share at about 10% last quarter, so just kind of bleeding into that response. Where do you think it can go over the next few years?

Vivek Jayaraman (President and Chief Executive Officer)

We certainly believe that IFC has the ability to become standard of care. You know, that is our aspiration, really, across all of our product categories. And so there’s certainly no reason why, certainly given product performance and clinical enthusiasm, and most importantly, the impact that it has on patients, we believe it 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’s 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.

Gabby Kanter (Analyst)

All right, great. Thanks, guys. And congrats on the positive readout.

Vivek Jayaraman (President and Chief Executive Officer)

Great. Thank you.

Timothy J. Lee (Head of Investor Relations)

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.

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