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DATE

Thursday, April 30, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

  • President and Chief Executive Officer — Obi Greenman
  • Chief Operating Officer, Incoming President and Chief Executive Officer — Vivek K. Jayaraman
  • Chief Financial Officer — Kevin D. Green

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RISKS

  • Chief Financial Officer Kevin D. Green 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."
  • Ongoing conflict in the Middle East has created logistical complexities that "may impact shipment timing" despite mitigation efforts elsewhere.
  • Full-year government-related research and development reimbursement and associated government contract revenue are expected to decline compared to 2025.

TAKEAWAYS

  • Product revenue -- $53.7 million, a 24% increase, attributed to global platelet franchise performance and rising U.S. INTERCEPT Fibrinogen Complex (IFC) demand.
  • Raised 2026 product revenue guidance -- Management increased full-year product revenue forecast to $227 million-$231 million, reflecting increased confidence in INTERCEPT demand.
  • Raised 2026 IFC revenue guidance -- Full-year IFC revenue guidance increased to $22 million-$24 million, representing an anticipated 30%-40% year-over-year growth.
  • Geographic revenue contribution -- North America contributed approximately 70% of product revenue, with U.S. platelet kit volumes up 69%.
  • EMEA revenues -- Region reported a 28% increase, with an 11% positive impact from foreign currency exchange rates.
  • International contracts -- A multiyear contract renewal with the French blood establishment (EFS) provides greater visibility into anticipated revenue streams.
  • U.S. blood center penetration -- The Blood Centers of America (BCA) group purchasing agreement covered roughly half the U.S. blood supply, driving increased activity and new PR platelet adoption.
  • IFC uptake -- U.S. IFC therapeutic dose equivalents increased about 120%, with revenue up nearly 90% year over year and a continued shift toward kit-based sales.
  • Gross margin -- Reported at 52%, compared to 58.8% previously, with persistent inflation, foreign exchange, and tariffs cited as ongoing headwinds.
  • Operating expenses -- Decreased by 7%, driven by reduced research and development costs and disciplined SG&A management.
  • Non-GAAP adjusted EBITDA -- $4 million, marking the eighth consecutive quarter of positive performance.
  • GAAP net loss -- Net loss attributable to Cerus Corporation (CERS +5.73%) narrowed to $1.6 million.
  • Cash position -- Ended with $80.4 million in cash and equivalents, down from $82.9 million at year-end, primarily due to working capital investments for anticipated revenue growth.
  • INT 200 and INT 100 illuminators -- Continued global INT 200 rollout with international adoption, and a U.S. PMA submission for INT 100 planned this quarter with anticipated 2027 launch.
  • INTERCEPT red blood cells -- The phase 3 RETA study completed enrollment; data readout anticipated in Q4, with CE Mark approval in Europe expected in the first half of 2027 pending ANSM review.

SUMMARY

Cerus Corporation (CERS +5.73%) reported significant commercial progress, with notable growth in both platelets and IFC, prompting management to raise 2026 revenue guidance. International regulatory milestones are planned, including advancement of the INTERCEPT red blood cell program, with key data readouts and regulatory reviews scheduled for the remainder of the year. Strategic initiatives, such as the expansion of BCA agreements and French EFS contract renewals, are expected to enhance forward revenue visibility and geographic reach. Management emphasized ongoing operational discipline and reiterated expectations for positive adjusted EBITDA in 2026, despite persistent headwinds from inflation, tariffs, and currency.

  • Chief Operating Officer Vivek K. Jayaraman stated, "We are already seeing early signs of traction, including increased activity at existing Cerus Corporation customers and new agreements to adopt PR platelets at BCA members who have yet to utilize INTERCEPT."
  • President and Chief Executive Officer Obi Greenman described the U.S. INT 200 PMA submission and phase 3 RETA study readout as anticipated catalysts, with CE Mark approval for INTERCEPT red blood cells expected as early as the first half of 2027 following data review and regulatory audit.
  • Jayaraman highlighted that IFC market penetration remains in the "single-digit share" range, suggesting substantial long-term growth potential beyond current guidance.
  • Development programs funded by Cerus Corporation are trending down as a percentage of total research and development expenses, allowing for leverage and increased emphasis on externally reimbursed initiatives.

INDUSTRY GLOSSARY

  • IFC (INTERCEPT Fibrinogen Complex): Cerus Corporation’s pathogen-reduced cryoprecipitated fibrinogen intended for rapid clinical intervention in bleeding and fibrinogen deficiency.
  • PR platelets: Pathogen-reduced platelets processed using INTERCEPT technology to mitigate transfusion-transmitted infection risk.
  • PMA (Premarket Approval): A regulatory pathway requiring U.S. FDA review and approval for certain medical devices or systems, including INTERCEPT illuminators.
  • BCA (Blood Centers of America): A major U.S. group purchasing organization representing roughly half the country’s blood supply, frequently referenced regarding strategic distribution agreements.
  • ANSM: The French National Agency for Medicines and Health Products Safety, responsible for medical regulatory approvals such as the INTERCEPT red blood cell CE Mark review.
  • RETA study: Phase 3 clinical study of INTERCEPT red blood cells, focused on chronic transfusion indications and required for FDA PMA submission.
  • Therapeutic dose equivalent: A unit of measurement expressing IFC usage in terms consistent with clinical dosing outcomes, used to track adoption and growth trends.

Full Conference Call Transcript

Tim Lee: Thank you, and good afternoon. I would like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cerus Corporation’s president and chief executive officer; Vivek K. Jayaraman, Cerus Corporation’s chief operating officer, incoming president and chief executive officer; and Kevin D. Green, Cerus Corporation’s chief financial officer. Cerus Corporation 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.cirrus.com.

I would like to remind you that some of the statements we will make on this call relate to future events and performance rather than historical facts and are forward-looking statements.

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 ISC; demand expectations with respect to our group purchasing agreement with Blood Centers of America and our multiyear agreement with the French National Blood Service; our potential platelet opportunity in Germany; the anticipated impact of tariffs and ongoing inflationary pressures and related migratory effects on 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 file 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 is my pleasure to introduce Vivek K. Jayaraman, Cerus Corporation’s next president and chief executive officer.

Vivek K. Jayaraman: Thank you, Tim, and good afternoon, everyone. We appreciate you joining us today. At Cerus Corporation, 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 2025. This performance was driven by continued strength in our global platelet franchise and also accelerating demand in our U.S. ISC 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 million to $231 million. In addition, we are raising full-year IFC revenue guidance to $22 million to $24 million. 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 U.S. 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 (treatable doses) increased 69% compared to 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 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 Cerus Corporation 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 mid-term growth. The recently signed multiyear contract with the French blood 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 have seen in 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 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 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.

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 the 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, ISC 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 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 in Cerus Corporation. I will now turn the call over to Kevin to review our financial results in more detail.

Kevin D. Green: Thanks, Vivek. You have just heard Vivek speak to two of our three pillars: growth and innovation. Today, I will focus my comments on our third pillar, financial strength. First quarter financial tables are included in today's press release. As such, I will 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 U.S. 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 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 was 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 nonrecurring 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-fifties 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 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 INT 200 as we approach our planned U.S. PMA submission. Importantly, as you can see from this slide, Cerus Corporation-funded development programs have been trending down as a percent of total R&D expenses. Similar to SG&A, we have been making a concerted effort to generate leverage by focusing relatively more R&D spend on government-reimbursed initiatives compared to those that Cerus Corporation funds. Let us now turn to the bottom line and non-GAAP adjusted EBITDA results.

For Q1 2026, GAAP net loss attributable to Cerus Corporation 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 equivalents of $80.4 million compared to $82.9 million at 2025 year-end. Cash used from operations was $3 million compared to $0.8 million during the same period of the prior year. Cash used during the first quarter was 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 have used that growth to expand patient access to INTERCEPT in new geographies, and to continue investing in our new wave of innovation, including the 200 device and INTERCEPT red blood cells. At the same time, we have 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.

Obi Greenman: 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 Corporation’s president and CEO. As I reflect on fifteen years in this role, and more than thirty 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 inactivation technology from our largest and longest-term blood center customers like the French EFS, Canadian Blood Services, the Swiss Red Cross, OneBlood, especially the American Red Cross, mattered meaningfully over the company's thirty-five-year history.

From the beginning, our vision has been to make INTERCEPT the global standard of care for transfused blood components and to establish Cerus Corporation as a leader in transfusion medicine innovation. When I became CEO fifteen years ago, Cerus Corporation 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, established INTERCEPT as the standard of care in multiple markets, including the U.S., France, and Switzerland, and shipped kits equivalent to treating more than 22 million blood components. That is meaningful progress for Cerus Corporation, and more importantly, it is meaningful progress for patients and health care 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 health care. 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 and the global health care system. Today, Cerus Corporation 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 3 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 3 RECePI 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 Cerus Corporation over the years, you know that transfusion medicine is careful and slow to adopt innovation. One of the defining moments in Cerus Corporation’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 INTERCEPT adoption in the U.S. 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 Cerus Corporation’s 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 Corporation 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 Corporation 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.

Operator: Star 11 on your telephone and wait for your name to be announced. To remove yourself, press star 11 again. One moment for our questions. The first one comes from the line of Josh Jennings with TD Cowen. Please proceed.

Josh Jennings: Hi, good afternoon. Thanks for taking the questions. And congratulations, Obi, on moving into your next chapter. It has been a long, resilient run by you, and you are leaving the company in a position of strength here, looking at these Q1 results and being on the cusp of some RBC approvals globally. We will miss you, but congratulations, Vivek, on your new CEO seat. I would like to start just by asking about guidance. It seems 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 are seeing more upside relative to the outlook at the beginning of the year.

Obi Greenman: Yes. Thanks a lot, Josh, and thanks for the kind comments to start. Vivek, do you want to handle that question?

Vivek K. Jayaraman: Yes, I would be happy to. Josh, echoing Obi’s statements, thanks for the kind words—they are much appreciated. We certainly appreciate your continued interest in our story. The thing that is most encouraging to me about Q1 results is that the strength of the performance is really broad-based, both globally and across product categories. You are right to point out that IFC performed quite well, and that 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 U.S. and the opportunity to have, effectively, a hunting license in roughly half of the U.S. 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 U.S. under the umbrella of the BCA agreement, as well as continued adoption both in growth areas internationally and in some of our core markets where we are seeing a recommitment from customers. There is a lot of enthusiasm coming out of first quarter results and the general qualification of demand in the marketplace.

Josh Jennings: Excellent—great to hear. And maybe, clearly, the BCA agreement is bearing early fruit here and may get stronger over the course of the year. But just within U.S. IFC and BCA blood centers—it sounded like you commented about marked increased demand from BCA blood centers. Any way you could build that out, provide a little bit more detail, and whether you are seeing any new IFC customers coming on, and how that outlook drove the guidance uptick for the IFC franchise?

Vivek K. Jayaraman: Yes, of course. Happy to provide a bit more color there. There are multiple factors at play, as I am sure you can appreciate. The first is we are actively in the process of moving our historical production partners under the BCA agreement, and as we do that, they are able to take advantage of the resource-sharing model that BCA utilizes. So their outlets in terms of potential blood center customers—and ultimately hospital customers—continue to grow. In addition to that, we have had BCA members who were not previously IFC manufacturers reach out to us and initiate the process of beginning IFC manufacturing.

And then, fundamentally, as we have 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. All of those factors come together and effectively create an environment where we are just reaching out to more hospitals, engaging a broader number of clinicians about IFC, and that is all occurring while the data we collect and user experience with the product continue to grow. It has been really encouraging, but still very much early days.

We are proud of the Q1 results and the outlook, but I would remind you that we are still single-digit share in terms of market penetration, so there is a tremendous amount of upside in this market.

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

Obi Greenman: Thanks a lot, Josh. Thank you.

Operator: Our next question comes from the line of William Bonello with Craig-Hallum. Please proceed.

William Bonello: Thanks. Hey, I also wanted to say congratulations to Obi and Vivek. In terms of questions, you gave some timing on the expected regulatory catalysts. I am 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.

Obi Greenman: Yes, thanks for the question, Bill. I presume you are talking about red cells and not the INT 200, which we will be filing for PMA imminently here in the United States.

William Bonello: Talking about both, actually.

Kevin D. Green: Great. Well, I will start with red cells; I will let Vivek cover INT 200 because we are also really excited about that.

Kevin D. Green: For the near term, the milestones through the remainder of the year are clearly very focused on the ANSM review of the red cell program. We are happy to announce this week we actually completed our recertification audit with TUV. That is 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. As far as a pathway to ultimate revenue there, once we have an anticipated approval of the red cell CE Mark, we would move into 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.

That is still a few years out, but the goal right now is to focus on getting that CE Mark so that we can launch the product. Vivek, do you want to cover the INT 200 in the U.S.?

Vivek K. Jayaraman: Sure, I would be happy to. Thanks for the question, Bill. As we indicated earlier, we are moving towards the submission to the U.S. FDA—a PMA submission for the INT 200 device this quarter, so in 2026. We would anticipate a launch in 2027, and I anticipate, similar to what we are experiencing in international markets, that there will be a lot of enthusiasm for that launch. It is clear evidence of our commitment to innovation in this space, which I think differentiates us from a lot of our peers, and it will serve ultimately as the device foundation for the U.S. market.

That is an upcoming catalyst and one that we are very excited about, given the positive receptivity to the illuminator in international markets.

William Bonello: And then, thank you. Just as a follow-up to that, maybe give us some thoughts on the implications in terms of business—whether it is penetration or pricing—or simply this being an enabler of retention in terms of launching that INT 200.

Vivek K. Jayaraman: There is a significant market in the U.S. with respect to our installed base of illuminators, and that will be an area of focus for us. Beyond that, if we think about de novo growth opportunities, as I mentioned earlier in response to Josh's question, there are some 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 illuminators. That will most likely be the INT 200 device.

While we are not providing specific product-level guidance in terms of our device placements, what I can say is it is a significant enabler in terms of serving as the underlying foundation for our business. Beyond that, as we have stated before, the demonstrated investment in innovation and commitment to continuing to advance research and device development in this space positions us very uniquely relative to our industry peers because we continue to invest in R&D and ultimately bring products to market that meet customer needs and enhance their operational efficiency.

We are very much looking forward to introducing that product, and you will hear more about our plans for U.S. commercialization, certainly post-submission of the PMA and then as we approach our launch date.

William Bonello: Sure. Thank you. Appreciate it.

Operator: 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.

Mark Massaro: Hey, guys. Thanks for taking the questions. Obi, it has been great working with you, and congrats as you transition into the chairman role, and Vivek, congrats on your well-deserved promotion to CEO. 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. The 2026 guidance for IFC has been raised to approximately 30% to 40%. I am 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 is probably lumpiness as you roll this out.

But can you walk us through the assumptions as to the delta between the really strong growth at the start of this year and your full-year growth outlook for IFC?

Obi Greenman: Yes, thanks for the question, Mark, and thanks for the comments to start as well. Vivek, do you want to cover that?

Vivek K. Jayaraman: Yes, I would be happy to. Mark, thank you for the kind words about the organizational transition—much appreciated. You are right to point out that the business is a little bit lumpy as we are in this early growth stage, but I want to emphasize our conviction around continued growth and the fact that we are still a single-digit market share player and feel like there is a tremendous amount of headroom. I do not want any of that enthusiasm to be lost as we talk about some of the specifics about the current position itself. I will 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 starting the process of transitioning from a finished therapeutic sale to a kit sale. That transition continues, and we are really driving towards being fully kit sales, ideally by the end of this calendar year—that may bleed a little bit into 2027. We have been talking about unit volume from the standpoint of therapeutic dose equivalents as opposed to revenue growth, and you will see that transition accelerate through the balance of 2026. 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 million to $22 million for the full year now to $22 million to $24 million. Underlying growth remains strong. There will probably be some period-to-period idiosyncrasies given that transition and the nature of our business model. But when we think about blood centers manufacturing IFC and hospital starts—some of the things that we are paying attention to—all of those trend lines are strongly positive. Hopefully that gives you a little bit more color. Certainly happy to answer any more questions about the IFC business as you have them.

Mark Massaro: That is 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 are now getting close. I think you are on the clock. As we put these pieces together, I think you talked about a readout in 2026. Would it be reasonable to think that CE Mark could occur shortly after that readout time period? I am coming in somewhere between either 2027, but I just wanted to get your sense on the timing of CE Mark.

Obi Greenman: Yes, thanks, Mark. I think right now it is probably safe to assume a first half 2027 approval timeline, just given that we do not know what questions the ANSM will ask and the timeline for our responding to those questions. I think that is the timing you should be looking at. We will have a lot more clarity through year-end, and I think specifically, as we think about our Q3 earnings call, not only will there be the phase 3 study readout in that time frame, but also some increased clarity around the ANSM timing. That is the way I think you should think about it.

Mark Massaro: Great. And then, I know this is probably not core to the thesis or anything, but I figured I would ask if you are still planning to pursue regulatory approval for platelets in China, and maybe any update on that process?

Vivek K. Jayaraman: Yes, I would be happy to. Mark, it is 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, ZB, at the upcoming ISCT meeting, which is scheduled to take place in Kuala Lumpur in mid-June. Part of what we are continuing to refine is our strategy to collect in vitro data that is requested in the Chinese market for resubmission to the NMPA. In parallel, our continued channel checks and clinical engagement continue to validate the excitement for, and the need for, pathogen inactivation in that marketplace.

It is probably an opportunity that we will realize in terms of revenue generation towards the latter part of the second half, but it is very much a market opportunity that we are working, in partnership with ZB under our joint venture agreement, to advance.

Mark Massaro: That makes perfect sense. Congrats on the strong quarter, guys.

Operator: 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.