Good day and thank you for standing by. Welcome to the Cerus 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 11 on your telephone. You will then hear a message advising your hand is raised to withdraw your question. Please press Star 11 again. Please be advised 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.cerus.com. With me on the call are Obi Greenman, Cerus President and Chief Executive Officer, Vivek Jayaraman, Cerus Chief Operating Officer and incoming President and Chief Executive Officer, and Kevin Green, Cerus Chief Financial Officer. Cerus issued a press release today announcing our financial results for the first quarter ended March 31, 2026, the Company's recent business highlights and outlook. You can access a copy of this announcement on the company's website at www.cerus.com. I'd like to remind you that some of the statements we'll make on this call relate to future events and performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include those related to our future financial 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 risks 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 ended March 31, 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 a reconciliation of non-GAAP adjusted EBITDA to net loss attributable to Cerus 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, Cerus's next 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 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 US IFC business. Based on our better than expected start to the year as well as our growing conviction in the underlying demand for Intercept, we are raising our full year 2026 product revenue guidance to 227 to 231 million dollars. In addition, we are raising full year IFC revenue guidance to 22 to 24 million dollars. This updated guidance represents total year over year product revenue growth of 10 to 12% 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 US platelet franchise continued 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 kit volumes and treatable doses increased 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 US blood supply. Since the agreement took effect on January 1, 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 EMEA 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 Blood Establishment, or efs, enhances visibility into our forward outlook. We are deeply grateful to EFS (Établissement Français du Sang) 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 Safeblood and drive long term growth. A key example is the continued successful rollout of Our next generation Int 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 Int 100 to the USFDA this quarter which represents an important milestone in bringing this technology to the US Market. Innovation is also evident in our US IFC 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 5 day post op 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 equivalents 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 the 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 accessibility to save her blood in the first quarter of 2026. Thank you for your continued interest in Cirrus. 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 US and in Canada. Speaking to IFC, which at this point is exclusively a US 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 and D expenses increased year over year. As I noted on our Q4 earnings call, we still expect full year government related R and 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 referenced 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% 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 SGA. R&D expenses declined year over year due in part to lower development costs of the Int 200 as we approach our planned US PMA submission. Importantly, as you can see from this slide, cirrus funded development programs have been trending down as a percentage of total R and D expenses. Similar to sga, we've been making a concerted effort to generate leverage by focusing relatively more R and D spend on government reimbursed initiatives compared to those that SARIS funds. Let's now turn to the bottom line and 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 and 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 new geographies and to continue investing in our new wave of innovation including Intercept Fibrinogen 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 Cerus 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 (Établissement Français du Sang), 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 Cerus as a leader in transfusion medicine innovation. When I became CEO 15 years ago, Cerus 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 to 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. Establish Intercept as the standard of care in multiple markets including the us, France and Switzerland, and Ship kits equivalent to treating more than 22 million blood components. That is meaningful progress for Seris 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, Cerus 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 three RETIS 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 three recipe study and the acute transfusion data from that study were included in the CE Mark submission, which is now under 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 SERES over the years, you know that transfusion medicine is careful and slow to adopt innovation. One of the defining moments in SERIS 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 intercept adoption in the US and influenced many other markets that look 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 SERIS 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 Cerus 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 Cerus 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.

Hi, 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 you're leaving the company in a position of strength here. Looking at these 1Q 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 looks like the uptick is being driven mostly by IFC strength, but also by Intercept platelet strength.

Vic, you want to handle that question? Yeah, I'd be happy to. Josh, echoing Obi's statements. 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 portfolio is really broad based, both globally and across product category. You're right to point out that IFC 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, PR platelets were underpenetrated. 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 strength in our EMEA organization. And then we also highlighted the renewed contract with the efs. 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 US 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 increase demand from BCA blood centers and any way you could just build out, provide a little bit more detail and whether you're seeing new IFC customers coming on and how that outlook drove the guidance uptick 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, as 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 their outlets in terms of potential both blood center customers, but ultimately hospital customers, continues 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 IFC 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 user experience, the product continues to grow. So it's been really encouraging, but still very much early days. I mean, we're proud of the Q1 results and the outlook, but I'll remind you that we're still single digit share in terms of market penetration. So there's a tremendous amount of upside in this market.

Talking, talking about them both. Okay, great. Well, I'll start with red cells and I'll let Vivek cover Int 200 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 Cell 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, once we have anticipated approval of the Red Cell CE mark, we'd move into sort of an early launch of that product with an iteration of the device to ultimately improve the overall scale up and operational efficiency of processing red cells. So that's still a few years out, but the goal right now is to just focus on getting that CE mark

so that we can launch the product. Vivek, you want to cover the INT200 in the US? Sure, I'd be happy to. Thanks for the question, Bill. So as we indicated earlier, we're moving towards a submission to the US FDA, so PMA submission for the INT200 device this quarter. So in the second quarter of 2026, we would anticipate a launch in 1H27. 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. So, 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.

So there's a significant market in the US with respect to just 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, there are still customers in the US 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 illuminator that will be Most likely the INT200 device. So while we're not providing specific product level guidance in terms of our device placement, what I can say it's a significant enabler 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 and D research and ultimately bring products to market that meet customer needs and enhance their operational efficiency. So. So we're very much looking forward to introducing that product. And you'll hear more about our plans for US commercialization, certainly post submission of the pma and then as we approach our launch date.

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. I wanted to get a better sense on the guidance because when I look at the IFC business, 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 just the delta between the really strong growth to start this year and 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 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 result. 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 you know, 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 well 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, you know, 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 we're paying attention to, all of those trend lines are pretty strongly positive. So hopefully that gives you a little bit more color. Certainly happy to answer any more questions about the IFC business. Did you have them?

Yeah, that's really helpful. Maybe switching gears to red blood cells. I think I heard you talk about 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 the readout time period? So I'm sort of coming in somewhere between 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 the timeline for our responding to those questions. So I think that's the timeline 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 Redis study readout in that timeframe, but also some increased clarity or around the ANSM timing. So that's the way I think you should think about it.

Yeah. 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. In fact, we will be meeting with our joint venture partner, Zhong Baicheng (ZBK) at the upcoming International Society of Blood Transfusion (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 engagement, it sort of continues to validate the excitement for and the need for pathogen activation in that marketplace. So it's probably 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 ZBK under our joint venture agreement to advance.

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