Cerus Corporation

Good day and thank you for standing by. Welcome to the CEROS Corporation first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate, you will need to press star 1 1 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please see advice that today's conference is being recorded. Now it's my pleasure to hand the conference over to Tim Lee, Head of Investor Relations. Please proceed.

Thank you and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cirrus' President and Chief Executive Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer and incoming President and Chief Executive Officer, and Kevin Green, Cirrus' Chief Financial Officer. Cirrus issued a press release today announcing their financial results for the first quarter ended March 31st, 2026, the company's recent business highlights and outlook. You can access a copy of this announcement on the company's website at www.cirrus.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 our forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2026 product revenue guidance and our expectations for product gross margin non-GAAP adjusted EBITDA performance, P&L leverage, and our government-reimbursed R&D expenses and corresponding revenue. Expected future growth, the potential for us to achieve GAAP profitability, the availability and related timing of data from clinical trials, our mission to establish Intercept as a global standard of care, anticipated regulatory submissions and milestones, commercial expansion prospects, projected market opportunities for the Intercept blood system, including for IFC demand expectations with respect to our group purchasing agreement with Blood Centers of America and our multi-year agreement with the French National Blood Service, our potential platelet opportunity in Germany, the anticipated impact of tariffs and ongoing inflationary pressures, and related mitigatory effects of our business and other statements that are not historical facts. These forward-looking statements involve risk and uncertainties that can 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 end of March 31st, 2026, which we will follow shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP-adjusted EBITDA, which is a non-GAAP financial measure. Non-GAAP-adjusted EBITDA should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For reconciliation of non-GAAP-adjusted EBITDA, the net loss attributable to Sears Corporation, the most comparable GAAP financial measure 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 opening remarks from Vivek, followed by Kevin to review our financial results, and lastly, closing remarks from Obi. And now, it's my pleasure to introduce Vivek Jayaraman, Cirrus' next President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. We appreciate you joining us today. At Cirrus, our mission is clear, to expand access to safe blood for patients around the world. As we enter 2026, we are focused on delivering against that mission while executing on three core priorities, driving sustainable double-digit growth, advancing innovation, and strengthening our financial foundation. Our first quarter results reflect disciplined progress across each of these areas and reinforce our confidence in the path ahead. 2026 is off to a great start, with strong first quarter results and increasing confidence in our sales outlook for the full year. In the first quarter, product revenue, which reflects our core commercial business, was $53.7 million, up 24% compared to the first quarter of 2025. This performance was driven by continued strength in our global platelet franchise and also accelerating demand in our U.S. IFC business. Based on our better-than-expected start to the year, as well as our growing conviction in the underlying demand for intercepts, we are raising our full-year 2026 product revenue guidance to $227 to $231 million. In addition, we are raising full-year IFC revenue guidance to $22 to $24 million. This updated guidance represents total year-over-year product revenue growth of 10 to 12 percent compared to 2025, and approximately 30 to 40% for IFC. From a top line perspective, North America accounted for nearly 70% of first quarter product revenue as our U.S. platelet franchise continues to serve as a foundation of our overall business. We are deeply grateful to our key customer partners like the American Red Cross who continue to place their trust in Intercept. First quarter North American platelet volumes and treatable doses increased six and 9% respectively when compared to the first quarter of 2025. This gain outpaced the overall historical market growth rate. Looking forward, we anticipate further platelet penetration as we continue to expand adoption among blood centers and hospitals. A key enabler of this growth is our group purchasing agreement with Blood Centers of America, whose members represent approximately half of the U.S. blood supply. Since the agreement took effect on January 1st, we have been focused on execution, educating members through targeted engagement, supporting implementation, and expanding both existing and new customer relationships. We are already seeing early signs of traction, including increased activity at existing Cirrus customers and new agreements to adopt PR platelets at BCA members who have yet to utilize Intercept. Internationally, our RMA business delivered another strong quarter, led by performance in France and Belgium. We continue to view the region as an important contributor to both near and midterm growth. The recently signed multi-year contract with the French Flood Establishment, or EFS, enhances visibility into our forward outlook. We are deeply grateful to EFS for their continued trust in Intercept. France was the first country of scale to fully adopt Intercept to safeguard their platelet supply and this contract renewal is a strong confirmation of the value they've seen intercept. In Germany, progress on the initiate study continues to build the clinical and operational foundation for broader adoption over time. While we remain encouraged by the global opportunity, we are also navigating near-term challenges in certain regions. In the Middle East, ongoing conflict has created logistical complexities that may impact shipment timing. That said, We are actively managing the situation and believe that potential disruptions can be mitigated by strength in other parts of the business. Importantly, we remain confident in our long-term growth prospects in that region, and these near-term challenges were considered when deciding to increase our product revenue guidance for the full year. Innovation remains central to how we expand access to safe blood and drive long-term growth. A key example is the continued successful rollout of our next generation I&T 200 Illuminator across international markets, where we are seeing encouraging adoption and operational performance. Domestically, we are on track to submit our PMA for the I&T 100 to the U.S. FDA this quarter, which represents an important milestone in bringing this technology to the U.S. market. Innovation is also evident in our U.S. ISD franchise, where demand continues to increase, supported by a growing number of blood centers manufacturing IFC, deeper utilization within hospitals, and increasing awareness of its clinical and logistical advantages, particularly the highly valuable combination of immediate availability of fibrinogen alongside five-day post-thaw shelf life. As with our platelet franchise, we are seeing a marked increase in IFC engagement and adoption from BCA member blood centers under our new agreement. As a result, IFC demand in the first quarter, measured by therapeutic dose equivalent, increased approximately 120% year-over-year, with revenue growth approaching 90%. We are seeing a continued shift towards kit-based sales, which supports both operational efficiency and long-term margin expansion. Taken together, these results reflect a business that is executing with focus, expanding access to safe blood, delivering sustainable double-digit growth, advancing innovation, and strengthening our financial profile. While there is much work to be done, we are encouraged by the progress we are making and confident in the opportunities ahead. At the end of the day, the most important point to note is that we were able to meaningfully expand access to Safer Blood in the first quarter of 2026. Thank you for your continued interest and service. I'll now turn the call over to Kevin to review our financial results in more detail.

Thanks, Vivek. You just heard Vivek speak to two of our three pillars, growth and innovation. Today, I'll focus my comments on our third pillar, financial strength. First quarter financial tables are included in today's press release. As such, I'll focus most of my comments on key takeaways and insights. In addition to the 24% product revenue growth that Vivek mentioned, Total revenue, which includes government contract revenue, increased 23% compared to the prior year results. By geography, product revenue growth was broad-based, with both North America and EMEA reporting year-over-year gains of 20% or more. In EMEA, demand for our platelet product was the primary contributor, driven by both increased kit volumes and pricing discipline. As reported, EMEA revenues grew by 28%. Of that reported growth, favorable foreign currency exchange rates benefited EMEA revenue by approximately 11%. On a consolidated basis, FX provided a benefit of approximately 3% when compared to Q1 2025. In North America, growth was led by higher US IFC sales, as well as increased demand for platelet kits in both the U.S. and in Canada. Speaking to IFC, which at this point is exclusively a U.S. product, first quarter revenue was $5.7 million compared to $3 million during the first quarter of 2025. Switching now to government contract revenue, reimbursement for government-related R&D expenses increased year over year. As I noted on our Q4 earnings call, we still expect full-year government-related R&D expenses and the corresponding reimbursement, which we recognize as government contract revenue, to taper this year compared to 2025. Turning away from the top line to gross margin, our first quarter gross margin was 52%, compared to 58.8%. Recall that first quarter 2025 margin is an unusually tough comp and was artificially high by approximately 2% due to a one-time true-up from the capitalization of inventoriable charges and the non-recurring release of previously accounted for favorable variances. With that said, The factors that we forecast to be headwinds in Q1 have proven to be slightly less impactful than we originally predicted. Nevertheless, these headwinds have been persistent, and we expect that to be the case for the remainder of the year. These reference headwinds include inflationary pressures with shipping and fuel costs expected to persist, the impact of foreign currency exchange rates, and the ongoing tariffs. Given the current trends, We continue to believe 2026 gross margin will be in the low 50s range, although we may see some relief should our assumptions on external factors prove conservative. Moving down the income statement, operating expenses for the first quarter declined 7 percent compared to the first quarter of 2025. One of our key areas of focus supporting financial strength is disciplined control of operating expenses while growing revenue. To that end, SG&A expenses were largely consistent with the prior year, reflecting our ongoing focus to drive revenue growth without the need for proportional incremental investments in SG&A. R&D expenses declined year over year due in part to lower development costs of the INT200 as we approach our planned US PMA submission. Importantly, as you can see from this slide, CSRS-funded development programs have been trending down as a percentage of total R&D expenses. Similar to SG&A, we've been making a concerted effort to generate leverage by focusing relatively more R&D spend on government-reimbursed initiatives compared to those that CSRS funds. Let's now turn to the bottom line in non-GAAP-adjusted EBITDA results. For Q1 2026, GAAP net loss attributable to SARIS continued to show year-over-year improvement to a modest level of $1.6 million. As an organization, we are committed to not just growing non-GAAP adjusted EBITDA, but achieving GAAP profitability. On a non-GAAP basis, adjusted EBITDA for the first quarter totaled $4 million and marked our eighth consecutive quarter of posting positive adjusted EBITDA. we continue to match the strong commercial results with disciplined expense management and deliver the inherent leverage in our business. Looking ahead, for the balance of 2026, we expect to deliver our third consecutive year of positive adjusted EBITDA results. Turning to the balance sheet and associated cash flows, we ended the first quarter with cash in equivalence of $80.4 million compared to $82.9 million at the end of 2025. Cash used from operations was $3 million compared to $800,000 during the same period of the prior year. Cash used during the first quarter was primarily tied to working capital investments, specifically increased inventory levels in support of the expected revenue growth as suggested by our increased guidance. With all of this said, this progress has resulted in a stronger business. Since 2019, product revenue has grown at a compound annual rate of 18%. We've used that growth to expand patient access to Intercept through new geographies and to continue investing in a new wave of innovation, including Intercept Red Vigin Complex, the new INT200 device, and Intercept Red blood cells. At the same time, we've managed the business with discipline. Since 2019, operating expenses have increased by less than 3% annually, demonstrating the operating leverage in our business as we continue to scale. As a result, net loss has narrowed meaningfully during the period from 2019 to now, and our adjusted EBITDA has consistently grown over the last few years. Accordingly, we have line of sight into GAAP profitability. With that, let me turn it over to Obi for his closing comments.

Thank you, Kevin, and good afternoon, everyone. I want to thank all of you for joining us today for what will be my final earnings call as Cirrus's president and CEO. As I reflect on 15 years in this role and more than 30 years with the company, I do so with deep gratitude to our shareholders, to our blood center partners, to our employees, and to the clinicians and patients who have believed in our mission. The advocacy for our pathogen and activation technology from our largest and longest-term blood center customers, like the French EFS, Canadian Blood Services, the Swiss Red Cross, OneBlood, and especially the American Red Cross, mattered meaningfully over the company's 35-year-old history. From the beginning, our vision has been to make Intercept the global standard of care for transfused blood components and to establish Cirrus as a leader in transfusion medicine innovation. When I became CEO 15 years ago, Cirrus was still in the early stages of translating that vision into broad clinical and commercial impact. Earlier, in 2006, when we took back the global commercial rights intercept from Baxter and built our European organization to commercialize the platform in Europe and beyond, The clinical experience with Intercept amounted to fewer than 10,000 platelet units transfused. Today, Intercept is available in more than 40 countries. We have secured four FDA PMA approvals in the United States, established Intercept as the standard of care in multiple markets, including the U.S., France, and Switzerland, and shift kits equivalent to treating more than 22 million blood components. That is meaningful progress for Cirrus, and more importantly, it's meaningful progress for patients and healthcare systems around the world. And yet, the underlying need remains as compelling as ever. Safe and available blood is one of the fundamental requirements of modern healthcare. Patients undergoing cancer treatment, trauma care, complex surgery, childbirth, and chronic transfusion support all depend on blood products that are both safe and ready when needed. That is the mission we share with our blood center customers every day. It is also why our work has impact far beyond our company. Advances in blood safety and availability strengthen care delivery across the global healthcare system. Today, Cirrus is better positioned than at any point in our history to help meet that need. We have built a global commercial footprint, a maturing intercept portfolio designed to address all major transfused blood components, and an organization with the experience and discipline to execute. While we have made meaningful strides towards making Intercept the global standard of care, I believe the opportunity ahead remains substantial. That is especially true as we advance the Intercept Red Blood Cell Program. 2026 is an important year for the RBC program, with major regulatory and clinical milestones ahead in the second half. The Phase III RETA study, which includes the broader chronic transfusion experience required for an FDA PMA, has completed enrollment and is expected to read out in the fourth quarter. As a reminder, the RBC program previously met its primary endpoint in the Phase III RECIPE study, and the acute transfusion data from that study were included in the CE-MARC submission, which is now under a French ANSM competent authority review for potential approval in Europe. We believe intercept red cells remains one of the most important opportunities in blood safety, and success there could materially expand both our clinical impact and our long-term growth potential. For those of you who have followed Cirrus over the years, you know that transfusion medicine is careful and slow to adopt innovation. One of the defining moments in Cirrus's history was the FDA's 2019 guidance on reducing the risk of transfusion transmitted bacterial infections, with an implementation deadline in October 2021. That guidance helped accelerate intercepted adoption in the U.S. and influenced many other markets that looked to the FDA as an important benchmark. It was a reminder that durable change in the field is possible and that when regulatory standards evolve, the impact on patient care can be significant. We have built a strong foundation that supports an enduring company, a clear mission differentiated technology, deep customer relationships, global regulatory and commercial capabilities, and a pipeline with meaningful growth drivers still ahead. That foundation is what gives me such confidence in Cirrus' future. Over the last three decades, we have built an exceptional team united by the opportunity to protect the blood supply and help ensure that life-saving transfusions are available for patients when they are needed most. For many of us, this mission has always been personal. We remember the devastating impact that HIV and hepatitis had on the blood supply in the 1980s and 1990s, and we were determined to help create a different future, one in which transfusion transmitted infections would pose far less risk in the face of new pandemic threats, and blood centers and hospitals would be better equipped to serve patients safely and reliably given the positive impact of Intercept on blood donor deferrals. It has been the privilege of my career to help build Cirrus into a lasting, purpose-driven company, and I am very pleased to pass the baton to Vivek. He is a bold, team-first leader who will build on the strong foundation we have established, continue advancing our patient-first mission, and lead Cirrus through its next phase of growth, innovation, and value creation for all stakeholders. With that, let me turn the call over to the operator for questions.

Thank you so much. And as a reminder, to ask a question, press star 1-1 on your telephone and wait for your name to be announced. To remove yourself, press star 1-1 again. One moment for our questions. The first one comes from the line of Josh Jennings with TD Cowan. Please proceed.

Good afternoon. Thanks for taking the questions and congratulations, Obi, on moving into your next chapter. It's been a long, resilient run by you and leaving the company in a position of strength here, looking at these one key results and being on the cusp of some RBC approvals globally. We'll miss you, but congratulations, Vivek, on your new CEO seat. I'd like to start just with... Just asking about guidance, it seems like the uptick is or looks like the uptick is being driven mostly by IFC strength, but also by intercept platelet strength. Maybe just talk about the outlook for the U.S. intercept platelet franchise versus the OUS intercept platelet franchise and where you're seeing more upside relative to the outlook at the beginning of the year.

Yeah, thanks a lot, Josh, and thanks for the kind comments to start. Vivek, do you want to handle that question?

Yeah, I'd be happy to. Josh, echoing Obi's statement, thanks for the kind words. They're much appreciated, and certainly appreciate your continued interest in our story. You know, the thing that's most encouraging to me about Q1 results is that the strength of the performance is really broad-based, both globally and across product category. You're right to point out that ISD performed quite well and is a significant part of our revised upward guidance. But as you also correctly pointed out, platelets is a big component of that as well. If you recall late last year and earlier this calendar year, we pointed to the BCA agreement in the US and the opportunity to have effectively a hunting license in about half of the US market where relatively speaking, our platelets were under penetrated we saw good progress in the first quarter in that section of the market but we also saw strength with platelets internationally as evidenced by what kevin spoke to in terms of strengthen our emea organization and then we also highlighted the renewed contract with the ess so as we think about the outlook for the balance of the year We see continued solid platelet growth in both geographies, continued expansion in the U.S. under the umbrella of the BCA agreement, as well as continued adoption both in growth areas internationally, but then also in some of our core markets where we're seeing a recommitment for customers. So really there's a lot of enthusiasm coming out of first quarter results and the general qualification of demand in the marketplace.

Excellent. Great to hear. And maybe just clearly the BCA agreement is bearing early fruit here. That may get stronger over the course of the year. But just within USIFC and BCA blood centers, I think you commented, Vivek, about marked increased demand from BCA blood centers. Any way you could just build out, provide a little bit more detail in whether you're seeing any new IFC customers coming on and how that outlook drove the guidance uptake for the IFC franchise. Thanks for taking the questions.

Yeah, of course. Yeah, certainly happy to provide a bit more color there. There are multiple factors at play, Josh, that I'm sure you can appreciate. The first is we're actively in the process of moving our historical production partners under the BCA agreement. And as we do that, they're able to take advantage of the resource sharing model that BCA utilizes. So there are outlets in terms of potential both blood center customers, but ultimately hospital customers continue to grow. In addition to that, we've had BCA members who weren't previously IFC manufacturers reach out to us and initiate the process of beginning ISD manufacturing. And then fundamentally, as we've talked about previously, as we transition from selling the finished therapeutic to the kits to blood centers, that enables us to leverage and partner with the sales and marketing channels of the blood centers, thereby significantly expanding our reach and our ability to engage with more hospitals. So all of those factors come together and effectively create an environment where we're just reaching out to more hospitals, engaging a broader number of clinicians about IFC, and that's all occurring while the data we collect and the user experience on the product continues to grow. So it's been really encouraging, but still very much early days. We're proud of the Q1 results and the outlook that, you know, remind you that we're still a single-digit share in terms of market penetration. So there's a tremendous amount outside in this market.

Outstanding. Thanks for the incremental detail, and congratulations on a strong start to the year.

Thanks a lot, Josh.

Thank you. Our next question comes from the line of Bill Bonello with Craig Hallam. Please proceed.

Thanks. I also wanted to say congratulations to Obi and Vivek. In terms of questions, you gave some timing on the expected regulatory catalyst. I'm wondering if you could maybe give us some sense of the timeline from the events that you talked about today until we reach revenue generation and maybe some of the key milestones along that pathway to commercialization.

Yeah, thanks for the question, Bill. I presume you're talking about red cells and not the INT200, which we'll be filing for PMA imminently here in the United States.

Talking about them both.

Okay, great. Well, I'll start with red cells and I'll let Vivek cover INT200 because we're also really excited about that. For the near term, the milestones through the remainder of the year, we clearly are very focused on the ANSM review of the Red Salt Program, and we're happy to announce that this week we actually completed our recertification audit with TUV, so that's exciting. But we have two additional milestones for the CE mark. One is the ANSM review, and then ultimately an audit of the manufacturing facility. And then as far as a pathway to ultimate revenue there, we, you know, would, you know, once we have an anticipated approval of the Red Cell C mark, we'd move into sort of an early launch of that product with an iteration of the device, you know, to ultimately improve the overall scale-up and operational efficiency of processing Red Cells. So that's still, you know, a few years out, but, you know, the goal right now is to just focus on getting that CE mark so that we can launch the product. Malik, do you want to cover the INT200 in the U.S.?

Sure, I'd be happy to. Thanks for the question, Bill. So as we indicated earlier, you know, we're moving towards a submission to the USDA, so CMA submission for the INT200 device this quarter, so in the second quarter of 2026. We would anticipate a launch in the first half of 27, and I anticipate, similar to what we're experiencing in international markets, that there'll be a lot of enthusiasm for that launch. It's clear evidence of our commitment to innovation in this space, which I think differentiates us from a lot of our peers, and it'll serve ultimately as the device foundation for the US market. You know, that is an upcoming catalyst and one that we're very excited about, given the positive receptivity to the Illuminator and international markets.

And then, thank you. Just as a follow-up to that, maybe just give us, you know, some thoughts on sort of the implications in terms of business, whether it's, you know, penetration or, you pricing or you know simply this being an enabler of um retention in terms of of launching that uh that int 200. so there's a significant market in the us with respect to um just in our installed base of illuminators and you know that'll be an area of focus

for us there. But beyond that, if we think about de novo growth opportunities, as I mentioned earlier in response to Josh's question, you know, there are still customers in the U.S. who have yet to begin their journey with us in terms of adoption of the intercept technology. And part of that process will be equipping them with a liminator that will be the most likely the IAT 200 device. So there, you know, while we're not providing specific product level guidance in terms of our device placement. What I can say is a significant enlabeler in terms of serving as the underlying foundation for our business. Beyond that too, as we think about, as we stated before, the sort of demonstrated investment in innovation and commitment to continuing to advance research and device development in this space, we're positioned very uniquely relative to our industry peers in this area because we continue to invest in R&D research and ultimately bring products to market that meet customer needs and enhance their operational efficiency. So we're very much looking forward to introducing that product, and you'll hear more about our plans for U.S. commercialization certainly post-submission of the PMA and then as we approach our launch date.

Sure. Thank you. Appreciate it.

Thank you, and as a reminder, if you do have a question, simply press star 11 to get in the queue. Our next question is from Mark Massaro with BTIG. Please proceed.

Hey, guys. Thanks for taking the questions. Obi, it's been great working with you, and congrats as you transition into the chairman role, and Vivek, congrats on your well-deserved promotion to CEO. All right, so moving into the business, you know, I wanted to get a better sense on the guidance because, you know, when I look at the IFC business, you know, you grew 90% in Q1 here. The 2026 guidance for IFC has been raised to approximately 30% to 40%. So I'm just trying to get a sense. about the seasonality of this business. It looks like in Q3 last year, it was down sequentially. I recognize there's probably lumpiness as you roll this out, but can you just walk us through the assumptions as to, you know, just the delta between the really strong growth to start this year and, you know, your full year growth outlook for IFC?

Yeah, thanks for the question, Mark, and thanks for the comments to start as well. Vivek, you want to cover that?

Yeah, I'd be happy to. Mark, thank you for the kind words about the org transition. Much appreciated. You're right to point out that the business is a little bit lumpy as we're in this early growth stage. But I just want to emphasize that our conviction around continued growth and the fact that, you know, it's still we're a single digit market share. player and feel like there's a tremendous amount of headroom. I don't want any of that enthusiasm to be lost as we talk about some of the specifics about the current position itself. I'll remind you that a year ago, there were some anomalies in terms of our posted results. If you recall, we deferred from an accounting standpoint, some revenue recognition to the second quarter as we were sort of starting the process of transitioning from a finished therapeutic sale to a kit sale. That transition continues and really we're driving towards being fully kit sales ideally by the end of this calendar year. That may bleed a little bit into 2027. So we've been talking about really unit volume from the standpoint of therapeutic dose equivalence as opposed to the revenue growth. And so you'll see that current transition, you'll see that transition accelerate through the balance of 2026. And that was part of what factored into the guidance for the full year. Obviously, we took it up pretty significantly from original guidance of 20 to 22 million for the full year now to 22 to 24. So underlying growth remains strong. There'll probably be some period to period idiosyncrasies just given that transition in the nature of our business model. But as we think about blood centers manufacturing IFC, hospital start, some of the things that now we're paying attention to, all of those trend lines are pretty strongly positive. So hopefully that could be a little bit more color, certainly halfway to answer any more questions about the IFC business as you have them.

Yeah, that's really helpful. Maybe switching gears to red blood cells. I think I heard you talk about, you know, the transition to ANSM. and it seems like we're now getting close. I think you're on the clock. As we put these pieces together, I think you talked about a readout in Q4 of 26. Would it be reasonable to think that CE Mark could occur shortly after, you know, the readout time period? I'm sort of coming in somewhere between now either late Q4 or first half of 27, but I just wanted to get your sense on the timing of CE, Mark.

Yeah, thanks, Mark. So, I think right now it's probably safe to assume that it's being a first half 2027 approval timeline, just given that we don't know what questions ANSM will ask and, you know, the timeline for our responding to those questions. So, I think that's That's the time that you should be looking at. I think we'll have a lot more clarity through the year end, and I think specifically as we think about our Q3 earnings call, not only will there be the Phase 3 Reddit study readout in that time frame, but also some increased clarity around the ANSM timing. So that's the way I think you should think about it.

Okay, great. And then I know probably not core to the thesis or anything, but I figured I would ask, you know, if you're still planning to pursue regulatory approval for platelets in China and maybe any update on that process.

Yeah, thanks, Mark. Yeah, Blake, do you want to cover that?

Yeah, I'd be happy to. So, Mark, it's a great question. We absolutely continue to be excited about the opportunity in the China market. We will be meeting with our joint venture partner, ZBK, at the upcoming ISBT meeting, which is scheduled to take place in Kuala Lumpur in mid-June. And so part of what we're continuing to refine is our strategy to collect in vitro data that's requested in the Chinese market for resubmission to the NMPA. But in parallel with our continued channel checks and clinical engagements, it sort of continues to validate the excitement for and the need for patent activation in that marketplace. So it's probably, you know, an opportunity that we'll realize in terms of revenue generation towards the latter part of this decade, but it's very much a market opportunity that we're working in partnership with BBK under our joint venture agreement to advance.

Yep, that makes perfect sense. Congrats on the strong quarter, guys. Yeah, thanks, Mark.

Thank you. And ladies and gentlemen, this will conclude our Q&A session and conference for today. Thank you all for participating. You may now disconnect.