Good morning. I'm Josh Jennings from the TD Cowen Medical Devices research team, and we are moving right through the morning block of company presentations and fireside chats on day two of the TD Cowen Healthcare Conference, 46th annual. Amazing. Some longtime participants are in our midst. Executives from Cerus. We have the Chairman, President, CEO, Obi Greenman, and we also I'll just get your title right, Vivek. Vivek Jayaraman, Chief Operating Officer. Just wanna make sure I didn't miss any other titles there. Gentlemen, thank you guys so much for joining the part and participating in the conference again this year. Great to see you in person. I think, Obi, you're gonna do some intro, just slides to build a foundation for a nice fireside chat session after.
Great.
I'll hand it over to you.
Yeah. Thanks a lot, Josh. It's great to be here at the TD Cowen conference again this year. I have a few slides just to orient you about the company, and then we'll go into Q&A with Josh. Just in advance, I wanna refer you to our forward-looking statements that we'll make today and also, if you get a chance to look at the Form 10-K risk factors, that's worth doing. You know, Cerus has a fairly simple mission that we've stayed true to for the last three decades since the company's founding. It's really to make the INTERCEPT Blood System the standard of care globally in transfusion medicine, so you have a definitive safeguard for the blood supply, ensuring both safety and availability.
I think it's been really important to stay true to that singular mission because it's a very large TAM, but it's also fairly complex given the regulatory environment that we operate in and the nature of our customers. Briefly, the way the blood supply is collected globally is you have donors who come into blood centers, like the American Red Cross, for example. It's then processed into individual components, and then the blood centers transport that product to the hospitals and ultimately to the patient and the transfusion physicians. There are four main blood components: platelets, plasma, cryoprecipitate, which is a derivative of plasma, and red blood cells. They can either be collected as whole blood and then processed into individual components, or they can be collected by apheresis as individual components.
Typically, they're all processed at regional blood centers, and that's where our technology has been, you know, globally. It's a very elegant solution to how to inactivate pathogens in the blood supply. Blood components don't have any functioning DNA or RNA. They're anucleated, so red cells are just a bag of hemoglobin, and platelets are cell fragments. Plasma is a bunch of proteins. By targeting nucleic acid in a blood component and cross-linking that nucleic acid with a photochemical we call amotosalen, you inhibit replication, and you kill a wide variety of pathogens, viruses, bacteria, protozoa, and also white blood cells, which is really key, so you don't have to irradiate the components to do that. Over the last 10 years, we've increased our sales 5x.
You see a very steady climb in our overall revenue. We're now selling in over 40 countries. We guided $224 million-$228 million this year. My last slide here is just we are the market leader. There's very little competition globally for our products. We have a first-mover advantage and significant barriers to entry. The INTERCEPT products are now really foundational safety technology for many blood centers around the world. Very large TAMs that we're still working on penetrating. The last thing I'd say is that, you know, I'm really proud of the strong financial foundation the company has. It's really a way to grow the business globally into the future.
With that, I'll turn it over to you, Josh.
Thanks, Obi. I mean, there's, as you've referenced, a lot of growth drivers, many layers of growth in front of Cerus over in 2026 and beyond. Seems as if U.S. platelet share gain opportunity is still in play. You guys are continuing to capture share. The international business has some drivers as well. The core platelet and INTERCEPT platelet and plasma business. You've got a big growth driver in INTERCEPT Fibrinogen Complex that's ramping. Then some pipeline. You also had some regional expansion for both of those businesses. Then you've got INTERCEPT Red Blood Cells in the pipeline, which could be a big game changer from, just looking at the red blood cell transfusion volumes.
Maybe just help us in those buckets in thinking about 2026 guidance and, you know, how all those units are kind of. Any assumptions you can share for those OUS INTERCEPT plates and plasma and IFC. I think you detailed some of that on the call last night, but love to hear more.
Great. Yeah, well, since Vivek is really the architect for our commercial goals globally, I'll let him cover that.
Yeah, sure. I'd be happy to. I think actually, Josh, you laid it out well, so to some degree, my comments will be repetitive to your sort of introduction. If you take the U.S. market, taking a step back in terms of our overall revenue distribution, about 60% of our revenue comes from the U.S., 40% from international markets. The IFC franchise at the moment is solely a U.S. play, but we're categorizing and determining what international markets we may wanna go into in the future. For the time being, that's solely a U.S. business. If you think about our sort of foundational business, it's our platelet franchise and specifically our U.S. platelet franchise. That's currently the standard of care in the U.S.
We estimate that our market share position is roughly mid-60s%, but there's still a pretty significant amount of room to run. We announced at the end of last year that we signed a definitive framework agreement with Blood Centers of America that is a cooperative that represents roughly 50% of the market by volume in the U.S. This provides for us a underlying framework, supply chain network, contracting, a scheme that we can leverage to penetrate 50% of the U.S. market where we would estimate that our share is roughly 30%. We've already seen. It's early days.
We're two months into that agreement and went effective on January 1st, but we're already seeing blood centers who currently don't use INTERCEPT approach us looking to start production and adoption of the technology, blood centers looking to increase their share of INTERCEPT penetration. On the IFC side, we're leveraging their supply chain network basically to integrate our manufacturing partners and expand hospital access. We have many reasons to feel encouraged about the progress we can make there. Internationally, I'll just highlight one area we're excited about. Germany is the single largest market by volume in Western Europe.
If you think about Germany, it's surrounded by countries Austria, Belgium, France, where we're at or very close to 100% share. They just started an INITIATE trial, which is a phase IV post-market, sort of registry study where they're looking at adopting INTERCEPT and its utility in real-world clinical settings. That study will enroll through the balance of 2026. We anticipate, pending, you know, sort of positive results and experience with INTERCEPT, as you can see, some pretty meaningful growth in 2027 and beyond in Germany. We think there are a number of different arrows we have in our quiver in terms of driving sustained growth, not only through the balance of 2026, but through the rest of the decade.
Great. Maybe, Vivek, stop there, and we'll dive into some IFC topics in a minute. Some follow-ups, I think just first on the U.S. and this BCA agreement and partnership seems to be big. I know it's, it seems to be cost efficient just in terms of providing your team, your commercial team with access to some of these non-big five.
Correct. Exactly. Yeah.
... blood center hospitals or excuse me, blood centers. Maybe just talk about, you did some of this last night again on the call, but just, the early traction, if you can build any-
Yeah
... just in terms of signals you're seeing over the first couple months, and then how you are avoiding the spend of to attack that?
Yeah.
... you know, 50% of the market that you there are, you're under-penetrated or underrepresented.
Yeah, I'd be happy to, and Obi, I welcome you to please weigh in, correct me as appropriate. Historically, when we've talked about our approach to commercializing platelets in the U.S., you know, our focus was really allocating our resources to those large concentrated customers. Historically, how we've described the market is there is a big five blood center families that represent roughly 75%, 80% of collections. That's the American Red Cross, OneBlood, New York Blood Center Enterprises, Vitalant, and Versiti. Now, Vitalant, Versiti, and New York Blood Center are BCA members, so it's not as if the BCA contract is exclusive of the big five. It actually incorporates three of those five major customers. Our rationale initially was we have a fairly small SG&A footprint.
You know, this is different than a pharmaceutical or traditional medical device company where sort of, commercialization is largely a feet on the street model, and it's about putting more reps out there. We have a highly leverageable sales and marketing footprint. We said initially what we wanna do is convert the American Red Cross, OneBlood and demonstrate that we can get traction. Now that that's done and they are, existing highly satisfied users, we've got a broader number of blood centers that we need to convert. The BCA framework really provides us with leverage because we can take advantage of their sales and marketing channels, we can take advantage of their overarching contract, we can leverage their supply chain network.
It still allows us to get to really make sure that we're deploying and getting leverage out of our sales channel. In terms of... It's early days, so, you know, I don't wanna put the cart too far in front of the horse, but, you know, we're two full months in, and what we're already seeing, as I mentioned before, is we're seeing blood centers who historically had not adopted INTERCEPT approach our deployment organization to start the process of incorporating our technology into their collections and production process. We recently were invited to the BCA board of directors meeting, which they typically don't invite industry partners to. We presented in front of a collection of 50 of those blood center CEOs, and the enthusiasm and interest in this agreement, I think, was incredibly authentic.
We recently hosted a webinar that had about 150 blood center personnel where our deployment and sales team started talking more specifics about operationalizing our technology. That's both on the platelet and the IFC side. Ultimately, the results and the numbers will tell the tale, but I think there are a number of leading indicators that are cause for genuine enthusiasm on our end.
Excellent. Wanted to ask about the plasma business in the United States 'cause sometimes we just bucket U.S. INTERCEPT business currently as plasma and platelets, ex-IFC. Sorry, wasn't leaving that out.
Yeah.
Important one. Any just updates on where plasma stands and any, I guess, future layers of growth from that franchise?
Yeah. The plasma kit's the sort of foundational component for our IFC business, so it's critically important as you think about.
Yes
an enabler for, you know, arguably our most compelling acute growth driver. Plasma sales themselves have principally been an international dynamic. We have some plasma sales, you know, historically in France and other geographies, Belgium, Spain. We're actually partnering right now with Canadian Blood Services to the north. They're exploring adopting our plasma technology. It's, relatively speaking, more of an international opportunity given the dynamics. In the U.S., it's the foundational component to really launch our IFC platform.
Excellent. There's any channels to kind of leverage that IFC plasma unit to unlock access to different markets? I think we've talked about this in the past, Obi, and I'm not sure if that's a topic to dive into here.
I'll cover it briefly, Vivek, jump in. I mean, we definitely see opportunities ex-U.S. for IFC. You know, the focus right now, just given the size of the U.S. market and sort of the realization that early fibrinogen matters, our focus to date has been almost exclusively on the U.S. We are looking at approvals ex-U.S. and then certain markets where fibrinogen concentrates really haven't penetrated yet, where there's sort of an obvious benefit to IFC over conventional Cryoprecipitated AHF. I guess it'll be through the end of the decade, you'll see more progress in that area.
Great. Sorry, I didn't phrase my question very well. I was trying to get at just any channels within these fractionators where.
Oh
where you're, you know, there's a pipeline action for that INTERCEPT plasma franchise.
Yeah. No, I mean, Josh's question relates to the 100 million liters of plasma that are collected for fractionation globally, and it's, you know, sort of a business that continues to grow at 10% a year for companies like Haemonetics and CSL Behring. Historically, the way that the plasma derivatives have ensured the safety of their products is they have in-process steps like solvent detergent treatment, nanofiltration. We have looked at, you know, the benefits that would be conferred by treating Source Plasma up front, and then you essentially have we have very little impact on IGIV, for example, where some of those other in-process steps have yield losses. It's one of those things where I think it's still gonna take time over the course of the next, let's just say, decade.
As the fractionators look closely at how they move away from Cohn ethanol fractionation, which has been the historic manufacturing process, sort of grandfathered, if you will, into chromatography based fractionation, then they might anticipate, "Okay, well, if we're looking at orthogonal steps, maybe we'd INTERCEPT treat the plasma up front and then have higher yields of IGIV," as they look at sort of evolving from Cohn ethanol fractionation. Sorry, very detailed response to your question, but it's, you know, I think it, you know, the whole concept of blood safety, you know, we do play a unique role in that and that there are other adjacencies that we'll be looking at for sure.
That's an out year kind of pipeline opportunity. Maybe back to the U.S. platelet business. The, you know, 65% share overall, it's a big number and I think you guys have outlined how you can capture more share. I mean, where do you see ultimately share going? I mean, if this BCA initiative is successful in the next two to three years, I mean, American Red Cross, I believe, is at 100%. Some other of the big fives are approaching 100% if they're not there already. Can INTERCEPT platelets account for, you know, 90+% of the U.S. platelet market?
Yeah. I mean, we feel confident we can continue to capture share. I think, we sort of demonstrated that with our results through the course of calendar year 2025. If you look at the BCA agreement and where we can run in the sort of, you know, near to midterm, you know, I can see us getting into the 70+% share environment. We also are pursuing, and this will run in parallel with our INT 200 launch here in the U.S., but we're looking at securing an extended day claim, so getting out to a six, seven-day claim. In that case, you could see, you know, incremental share capture as well.
What, you know, what we're noticing too is you've got a lot of hospitals who are saying, "Hey, we only want pathogen-reduced platelets." There, as you see hospital demand for a uniform as opposed to mixed inventory, that's gonna be another pressure point on the blood center. Depending upon how blood centers contract with their hospitals, they're realizing a profitability bump on pathogen-reduced platelets relative to conventional platelets. There are other factors in the environment that accrue to our benefit, but we certainly think that there's still plenty of room to grow in the U.S. platelet market.
Thanks for that. Maybe transitioning to the international platelet franchise.
Yes
... INTERCEPT platelet franchise. You talked about Germany. Any other geographic expansion opportunities that could come into play in 2026 and maybe thinking out 2027? I mean, China's kind of been on the back burner for a little while. Any updates there? So any ex-China expansion opportunities, and then China.
Yeah. I mean, I'm happy to start, and Obi, I'd welcome you to weigh in. You know, taking a step back and this isn't any particularly unique or noble level insight here, but, you know, we really do try to maintain a diversified portfolio, have sufficient number of market development initiatives that are in varying degrees of maturation such that when they do manifest, they'll all sort of add to being able to drive consistent growth over time. The requirements for us, obviously, to continue to post double-digit growth only increase on an absolute basis given the growth that we've experienced the past 10 years, as Obi outlined in one of the slides.
You know, if I think back to when I joined in 2016 and we were about a $30 million company, okay, finding $3 million-$6 million of incremental growth, while not a slam dunk, was materially easier than now trying to find $30 million-$40 million of incremental growth. We wouldn't be sort of guiding where we are or speaking with the conviction we are currently speaking if we didn't have line of sight into where that could happen. The thing is trying to forecast specifically oftentimes what are binary events, right? A decision that a health policy maker delivers or a regulatory decision is a little bit difficult, but we try to mitigate that by having a number of different options at play.
Some of those include Germany, which we talked about in the past. We've mentioned previously, our joint venture agreement in China. We feel very confident in our joint venture partner, ZBK. We're currently in the process of accumulating data from Chinese blood centers to resubmit our filing there, and we anticipate being on the market, you know, in the next couple of years, and that being a growth driver as we think about, driving towards the end of the decade. Similarly, we have initiatives in play to enter the market in Japan. Brazil is another opportunity for us in the public sector of the market there. We've talked about in the past, one of the big areas for growth for us in 2025 was our business in the Middle East.
They tend to mirror the AABB and U.S. standards for blood banking. Obviously, with what's happening acutely there and some of the geopolitical conflict, we're just keeping a watchful eye. As I mentioned up front, we just want to make sure that we have sufficient initiatives in place across a number of these geographies such that we can, you know, over time, sustain that continued growth. I think to date, we've been demonstrating that.
Yeah. Nothing to add. Yeah.
Just on, you know, this conflict that's ongoing since the weekend in the Middle East. Is, you know, any call-outs just in terms of exposure for the international platelet clients?
I mean, our commercial efforts in the Middle East are almost entirely run via distributors. We have good relationships with those blood centers there. They, you know, at least today, and obviously, no one can really forecast how long and to what level this will create disruption. You know, we maintain close interval communication. They're well-stocked in terms of having product. We'll certainly keep people aware if there are any material changes there. At the moment, no.
Understood.
Yeah.
Wanted to move over to IFC. I think you guys called out a 7% share exiting 2025 and the potential to, you know, increase that share position by 50%. Getting into the double-digit territory. You also made some comments yesterday about on the earnings call. Maybe the market's getting a little bit bigger than earlier assumptions gave it credit for. Maybe start there. How are you guys sizing up the market for as we sit here in early 2026? How do you see the growth of the market from here?
Yeah. again,
Yeah, go for it. Yeah.
Yeah, we sort of just maybe to establish a benchmark, we had talked about the market as maybe a $300 million market roughly in the US. We had said, you know, really as we get into the marketplace, we'll be able to gain greater definition and understanding because one of the big drivers is just clinical appreciation and value of having earlier access to fibrinogen. Really understanding that value and acknowledging that and seeing the market grow is a big function of clinicians even realizing, okay, that's an option for them in their clinical practice. There are other factors that are driving increased interest in this marketplace and overall growth, and one of those is really the large pharmaceutical companies bringing fibrinogen concentrates into the marketplace.
It's a different distribution channel because they sell that into the hospital via the pharmacy. IFC and standard Cryo AHF gets into the hospital via the hospital blood bank. Ultimately, you know, for all intents and purposes, it's going towards the same purpose, which is to, you know, to address acute bleeding. What we're seeing with the IFC product in general is one clinician. Like, our initial hypothesis as to the value, so both the clinical value and then the cost benefit, as evidenced by a reduction in wastage, those things are starting to prove out.
We've Through the course of 2025, I think, you know, at various congresses and in different settings, we've had presentations in places like Vanderbilt, Stanford, University of Florida, all detailing how they've not only been able to better service their clinical partners in different specialties, whether that's high-risk OB, cardiovascular surgery, trauma. They've also seen a material reduction in wastage and the attendant financial benefits that result. That's starting to gain some traction. Similarly, we're hearing that fibrinogen concentrates are starting to get some play as well, which is creating sort of the underlying growth in the market and assumptions as to how large this market could be. From our vantage point, as you mentioned, you know, we're a single-digit share at this point in time, and there's plenty of room to grow.
We feel confident about the outlook for not only sustained double-digit growth but, you know, significantly higher growth than that. It really becomes a matter of leveraging, whether it's a BCA agreement, creating a pass-through to allow ARC accounts to bring on board the product, just making sure we have sufficient channels in place for distribution and then sufficient manufacturing partners in place to produce the finished product. We made great strides in 2025 to build and solidify that foundation. We're pretty excited about that.
The just kit volume growth versus the actual utilization growth is gonna converge and in 2027 those will mirror each other.
Yeah.
as you guys have detailed. This BCA agreement seems to be a big deal for IFC as well. You touched on it already, just in terms of the number of manufacturers, partners that you have at blood centers and the BLAs that are in place going across state lines, it seems like as we move through 2026, just access in the United States for maybe... I mean, so many blood centers is improving, and by 2027 there may be full access. Is that the right way to think about it, just in terms of timing for blood center access to the IFC product?
Yeah, I think that's a good way to think about it. We've been really focused on ensuring that we try to keep supplies, you know, slightly ahead of demand to the extent that we can. I mean, just to jog everyone's memory, 12 months ago we were in a position where we were actually backordered with IFC because demand got out ahead of supply. Right now, we're not in that position, but demand continues to grow. The encouraging thing about this BCA agreement is of our seven current manufacturing partners, six already have a BLA in hand, which enables them to distribute product across the country. That's not a gating item now, and they're all increasing their capacity to produce.
We've had BCA members who aren't current production partners in IFC in the first two months already initiate the process of becoming producers. These things are all very much in play. I mean, it's the sort of thing that you get people started, they get going, they start to see the benefit, and they sort of ramp up. We're very optimistic about how quickly this business can grow, and we think the foundational elements of having the infrastructure in place are only gonna continue to improve.
Thanks for that download. Looking back at 2026 revenue guidance, you know, at the midpoint it's double-digit growth, which is strong. I mean, it seems to us that you have a path to sustained double-digit growth as we move through 2026 into 2027. In 2027 you may have INTERCEPT Red Blood Cells approval, get CE mark, and that could potentially drive an acceleration. I know it'll take some time to launch and get blood centers ramping in various countries. Is that an appropriate outlook? I know you're not giving out your guidance, but it seems like all the pieces are in place for sustained double-digit growth.
I think that the way I would look at it is that through the end of the decade we have a lot of opportunity for double-digit growth with the existing portfolio and the markets that we're addressing, both U.S. and ex-U.S. as Vivek outlined. You know, I think for 2026 this is a milestone rich year for the red cell program, and that we will have clarity, hopefully from ANSM or competent authority in France that, as we mentioned before, has a history of reviewing our submissions for plasma, but just, you know, has obviously, given it's France, has a good understanding of INTERCEPT technology and how we approach things. That's important is the feedback we get that would lead to a CE mark approval in 2027.
We also have outlined that the phase III REDS study, which is the second of the two phase III red cell studies, required for a PMA submission, will read out in Q4 of this year. That'll provide a lot of additional data on just sort of general red cell transfusion, but also specific clinical data on chronic transfusion recipients, including Red Cell Exchange from sickle cell patients, so patients that are getting a lot of red cells over the course of several months, as well as thalassemia patients who are getting transfused on a, you know, three to four week basis as well. I think that data set will be really important, obviously for the PMA submission, but in general for the red cell program and how the transfusion medicine community looks at this.
As you sort of outlined, what we've seen is that you have pretty significant phase III studies that we've done for our programs, ultimately what is required, and we're seeing this now with the INITIATE study in Germany, is additional in-country data, sort of post-approval data that allows the blood centers to understand, like, how this product can be used. We continue to be very excited about the red cell opportunity in the sense that the market segmentation around just replacing the radiation and the damage that radiation does to red cells we don't see with INTERCEPT technology and that it leads to a longer shelf life versus irradiated red cell components. That's about 20% of overall red cell transfusions are irradiated, that's a clear market that we'll target at the time of launch.
Well, I think, this discussion is reconfirming, you know, our assumptions that you guys are well-positioned for 2026 and beyond. We didn't even touch on a number of different growth drivers, including the next generation LED 200 Illuminator and the replacement cycles ongoing in Europe and about to maybe kick off later this year in the United States as well as, you know, your run of EBITDA positive quarters and the profitability profile. We'll have to pick that up at a later date. Thank you guys so much for participating again this year. I think you guys have had a streak, including the virtual sessions during the pandemic of since 2012, so can't thank you enough for joining, participating again, and great to see you in person.
Yeah. Thanks very much, Josh.