All right, good afternoon, everybody. For those of you that don't know me by this point, I'll introduce myself: Matt Blackman, one of the medtech analysts here at Stifel, covering largely small and mid-cap names. It's my pleasure to welcome you to this next session with Cerus. We've got President and CEO Obi Greenman to my left, CFO Kevin Green to my far left. They're going to help walk us through the story. We've got a lot of stuff to punch through. I think Obi is going to give us a very quick presentation to level set us, just so everyone's aware of the story, and then we'll dive in. Thank you both for coming. Really appreciate you making the trip out here. Thanks. Turn it over to you. Yeah, thanks, Matt. Appreciate Stifel giving us the opportunity to present Cerus today. I just have like three slides because I thought it'd be helpful, given how niche the transfusion medicine space is, that it's worth getting some kind of grounding in that context. So, making some forward-looking statements, just refer you to our risk factors in 10-K and 10-Q with the SEC, and then Cerus, so the company was really founded to develop solutions to safeguard the blood supply globally. It was started back in the early 1990s with the HIV and hepatitis outbreaks that really impacted the blood supply then and really made safe blood transfusion risky. Obviously, it's improved dramatically over the years with regard to testing, but that doesn't really address future and emerging pathogens like Zika. There's a new virus that has been discussed lately called Oropouche from this vector-borne by mosquitoes that's also in the United States. But other pathogens like monkeypox and clearly COVID was a potentially transfusion-transmitted disease when it happened, and it turned out not to be transfusion-transmitted. But those are the types of concerns that really make the blood supply not as safe as it could be. Cerus has established our INTERCEPT technology as a standard of care in many countries around the world now, including both Canada and the U.S., but also in countries like France and Switzerland, for example. We've been at it for quite some time. The field of transfusion medicine is difficult to transform, but once you do, you have very sort of sticky customers that rely and are dependent upon Cerus to safeguard the transfused blood components in their countries. We're in about 40 countries around the world. So we're still waiting approvals in certain countries and still have a lot of other geographic expansion that we're undertaking, but we're still very much a global company. And lastly, I would say the technology is used around the world, and thousands and thousands of patients get components transfused with our products every day. And so it's obviously a big responsibility that we take very seriously because if for whatever reason we weren't able to supply, the whole blood supply system shuts down. That's how important our technology is. And lastly, we have systems to treat platelets, plasma, red cells, and fibrinogen complex, or cryo. All of them are FDA approved with the exception of red blood cells, which is in phase 3 clinical trials. The total addressable markets that we're targeting for our products globally are north of $7 billion. For the products that are approved, it's north of about $2.5 billion, but that also is a growing market that the demand for blood components grow organically every year, roughly in the sort of mid-single digits. We do expect that the current sales that we're targeting for this year are about $177 million-$179 million. There's a lot of opportunity to grow that business just with the approved products, let alone those that are coming down the pike in our portfolio. As you can see from this slide, we've grown the business meaningfully over the last eight years. A lot of this was driven not just by the safety of transfused blood components and the improvements that Cerus and INTERCEPT technology make, but it's also policy-driven. So a lot of times regulatory authorities like the FDA implement policies like what they recently did to mitigate bacterial contamination in the platelet supply. But that's also done at a national level in other countries like in France and Switzerland. And also it's driven by the economic and operational benefits that our system confers. So these systems have to generate cost savings, and they also have to provide sort of economically pragmatic opportunities for blood centers, meaning they have to be able to increase the price of their components that they're selling to hospitals. And then the last slide I'll show here is just that sort of to highlight for those of you who don't know how blood's collected and processed and then transfused at hospitals. Blood is a foundational element for global healthcare, and it sort of cuts across a lot of different patient populations, whether it's oncology, also maternal hemorrhage and trauma, and also genetic diseases. And so in that context, it's really access to safe blood is critical and is not always available. And even though north of 100 million units of blood are donated and processed and transfused on an annual basis, there's never enough. And you hear that probably if you ever donated blood, there's always a constant need for some crisis that's trying to be addressed. The way that the blood is collected is that the donors come into blood centers typically. And sometimes you can come into a hospital, but they come into blood centers. In the United States, there's roughly 100 blood centers around the U.S. The top five blood centers, including the American Red Cross, represent about 75% of the overall blood supply, and there's a handful of other smaller collectors. A lot of hospitals have their own blood collection centers as well, like Stanford or Mayo Clinic, and then once the blood comes into the blood center after it's been donated, and then donation is also an issue always because you're constantly qualifying a donor, whether they've been traveling or whether there's some other criteria for a donor deferral, so our technology can address some of the donor deferrals as well. But once the blood comes into a blood center, it's then processed into the individual components and then shipped out to the hospitals, and then ultimately, the hospitals transfuse the products to patients. As part of that, you can sort of see there's an inherent fragility of the blood supply globally and even in the United States. And what Cerus really does at the end of the day is sort of help address some of that fragility that relates to blood center logistics and supply, either as it relates to the shelf life of blood components or the safety or donor availability. With that, I'll turn it over to Q&A with you, Matt. Great. That's a great overview. And just a reminder, folks in the audience, it is a fireside chat meant to be interactive. If you have a question, please don't hesitate to raise your hand. I thought maybe we would just, and this is a good segue, a good setup for us to sort of talk about the story. And I think we were going to try to set this conversation up so we can talk about each of the key drivers on the top line and then obviously give Kevin a chance to talk about the profitability outlook as well. So maybe we'll start with the U.S. platelets, which has been the major driver of the business over the last couple of years, very successfully. So over the last couple of years penetrating this market. I saw you mentioned, I think when we first started talking about the U.S. platelet opportunity several years ago, it was like a $150 million opportunity. Today it's $160 million. Now you're talking about $200 million. That mid-single digit growth that you're talking about, can you just talk about the drivers of that? Is that simply just the ramp or the number of cases of chemotherapy, things like what's the key underlying driver there? That's a great question. So it's always we're trying to forecast that, and yet it seems every year it's sort of mid-single digit. And I think it's primarily a function of the evolution of oncology care. So CAR T-cell recipients actually are thrombocytopenic, so they need platelet units. It's also the evolution of trauma care or CV surgery care, where you actually are getting better diagnosis of coagulopathies in the surgical procedure. And a lot of the times they're diagnosing, "Oh, look, there's a platelet deficit in that patient." And there's a whole group of companies that are focused on what's called thromboelastic testing. So essentially, how do you diagnose specific deficits from a bleeding standpoint? And so that leads to an awareness that, "Hey, this patient needs a blood or platelet transfusion." So I think that's inherently what's happening with regard to the sort of mid-single-digit growth in the U.S. Other markets, sometimes you'll see sort of a patient blood management adage, "Oh, look, we can manage to a lower transfusion threshold," but it usually bounces back the following year. And then emerging markets like China, you're seeing double-digit growth just as a function of the evolution of medical care in those countries. Then talk about the structure again. You sort of touched on it, but I think it's really interesting, and we can bring out a little bit more. This is a highly concentrated end market, which is beneficial from a selling standpoint. I think you said 75% now of blood businesses in the top five blood banks. Maybe talk about we've always sort of talked about it in two tiers, sort of it's the Red Cross and then sort of everyone else. Talk about sort of where Red Cross is in terms of platelet adoption and then where you're at with the remaining four, how we should think about that opportunity ahead. Yeah, so I think that the first premise is that there are just not enough platelets in the United States. So I think that governs the hospital demand. So even though we can do a really effective job at creating the demand for our products because of the improved safety versus the alternative in the U.S., which is called large volume delayed sampling, there's just sort of the backdrop to this is that there's just not enough platelets. So in a situation where there are not enough platelets, you'll take whatever you can get. That being said, the Red Cross went to 100% adoption a few years back and really has benefited from that because it streamlines their supply logistics, but also sort of the message that they're committing to their hospital customers. There's another large blood center in Florida called OneBlood. They actually are in North Carolina and Florida and some other states, but they're probably about 85% penetrated. And then the other three large ones are anywhere between sort of 15%-40% penetrated. And some of that's a function of what I said before about the supply. If they're just trying to get the platelets out the door, sometimes they don't want to make the changes required for Intercept to be implemented. And then also it could be economics. "Hey, we're making the same with whatever platelet we give, so we're going to take the most profitable product and move forward." I think that is gradually changing just as a function of the hospital demand and sort of the benefits that our technology confers by making essentially a single SKU. So with our technology, you don't have to worry about irradiation. You don't have to worry about CMV testing. You don't have to worry about Babesia testing or other pathogens. So I think that's a benefit. But ultimately, if you're just in a market environment where we'll take whatever platelet you can get, that demand, if you will, doesn't drive the decision-making, whereas at some point in time, I think it will. Yeah. And is there a catalyst for that? Obviously, the guidelines was the first major catalyst that propelled platelet adoption. Is there anything else out there on the horizon? Obviously, it wouldn't be to the same extent, but something that helps move, helps the inertia of those remaining big boys? A lot of the work, the effort that our deployment team puts into just making sure that the blood centers know that this is easy to manufacture. And so what additional steps can we do to help them in that regard? I think if you just talk to the operations staff at a blood center and compare it to INTERCEPT to large volume delayed sampling, which is just sort of a bacterial culture test, they actually prefer. I mean, this will be even the centers that are low penetrated. They'll publish on this, but then they'll say, "Well, whether it's economics or the input specifications that are required, we're just trying to get the platelets out the door." So I think over time, especially when we launch the new LED illuminator with its ease of use, we'll see that we've really created a foundation for future growth. And then ultimately, what does this mean in the context of hospital demand? Fundamentally, groups like the Red Cross are growing organically as well. Yeah. And what is it you've got multiple initiatives to extend shelf life? What impact could an extended shelf life have on, to the extent there are holdouts out there? Is that a potential nudge in the direction of additional adoption? What Matt's referring to here is just that a shelf life for a platelet in the United States is either five days or seven days. And then you sort of have to talk about what the effective shelf life is, how many days does it actually have on the shelf? In the rest of the world where INTERCEPT's been adopted, you get a seven-day shelf life, and the effective shelf life is actually six to seven days. So it really helps with the supply logistics for platelets. In the United States, we still have a five-day shelf life claim for our product. And the alternative is Large Volume Delayed Sampling, and that's seven days. The effective shelf life is basically the same. But if we were able to get a day six or seven claim, that would have a material impact. The challenge we've had there is just the FDA criteria for that is pretty tight, and we've just missed it historically. We need to go back and do another what's called a recovery and survival test to demonstrate that our product is viable out to seven days. As we speak, certain blood centers actually use and hospitals use variances to extend INTERCEPT platelets out to seven days, but we just need to collect more data and do this additional study. Okay. And Matt, just to carry on, the reason it's an effective shelf life of five days for both Intercept and Large Volume Delayed Sampling is because of a 48-hour hold requirement on the Large Volume Delayed Sampling. Making sure nothing grows. Yeah. And so maybe, Kevin, it's sort of a good way to sort of put a bow on the U.S. How should we think about the trajectory of the platelet franchise from here? Is there a reasonable so we've got underlying market growth in the mid-single digits. You've got some penetration opportunities. Is this a high single digit, low double digit sustainable business over the next several years? Yeah, I think definitely the U.S. platelet business in particular, but also globally, will be the key driver, the primary driver for us over the next few years, and that comes from the under-penetrated accounts in the U.S., but also, as Obi mentioned earlier, there's still a lot of spaces in EMEA and outside of both our core markets in U.S. and EMEA that are going to drive growth that are fairly mature. A lot of those are binary, so it's difficult to predict when, but we've been at this a long time, and so most of them are fairly mature in the overall process and pipeline, and then later, which I'm sure we'll get to, is INTERCEPT Fibrinogen Complex, which we really see as an important kind of mid-term growth driver that's starting to really find its footing. And so it's actually a good segue. I was going to transition to talk about the OUS opportunity and platelets. Obviously, standard of care in multiple large countries. You mentioned some other opportunities out there. You want to just maybe sort of punch through some of the things that are close to the finish line. I know Germany's been there for quite some while across the finish line there, but other key markets, and I know we'll talk about China, APAC in general, a largely untapped opportunity. But how would you think about, and if you want to rank order to them, the key geographies internationally over the next couple of years? Do you want me to? Yeah. I guess, yeah. So it's a great question because clearly it is very binary at the end of the day, and there are very large market opportunities that are at no penetration right now. So as far as size and I guess if you're rank ordering size versus likelihood. Timelines, yeah. I think clearly there's a number of opportunities in EMEA that are developing. I'd say EMEA, I'm sorry, Middle East is a key one just given the size of that opportunity and the amount of investment that's going into healthcare in Saudi and elsewhere. Germany obviously is the largest market in Europe, and we are making progress there. It's just a function of the regulatory process and getting through all the different requirements that each blood center needs to undertake to make the product available. The German market is represented about 40% Red Cross, and the rest is sort of hospital-based blood centers, and so we work with the largest German Red Cross center, and they're in the process of validating INTERCEPT technology for all their sites because they wanted to have it approved across all their sites before they started rolling it out. So we will see, but I think at least it's promising that they're putting in the work, and our team there is working on that. LATAM, and specifically some of the larger countries there, really seems to be looking at this as a way to sort of leapfrog the existing blood safety paradigm that they have there. And there are different things that we have in advanced stages of discussion, and I think that could be really meaningful to the revenue growth for the company in the next several years. And are those single payer systems? Is there like a single, or is it sort of more? Yeah. Obviously, the largest market there is Brazil. It has both public and private hospitals. I think the private hospitals represent maybe about 10% of the platelet supply there, and the rest is sort of a single payer public healthcare system. But they have a certain requirement from the Brazilian government to invest X amount of money every year from their budget in healthcare. And so there's some really interesting opportunities that we've been working on for a while there that may mature faster than we think. And then I don't know if you want to go into APAC. Yeah, let's talk about APAC and China in particular. Yeah, I think we've obviously spent a lot of time investing there. China will be the largest market opportunity for us globally for the foreseeable future. It's just getting into that market. We have an established joint venture partner there who really knows the blood banking field well. They provide, I want to say, 75%-80% of the pathogen inactivation systems for plasma in the country. And so obviously, this is a nice extension to their portfolio. And they just really know the NMPA, or the Chinese regulatory authority, well and helped us navigate that pathway. So we're still optimistic that we'll get some clarity on an approval next year sometime. You're still trying to figure out if you can use data from existing data or if you have to. Is that where we're still at that stage of trying to figure out what the requirements are? It's a little bit nebulous, but it seems like that our rationale for the data so what we're talking about is the clinical data required for an approval in China, and we have both the existing FDA approval and how robust that clinical data set is, but also we actually did a clinical study in Hong Kong several years ago fortuitously, and so we have data out of China, and China, actually, the Hong Kong Red Cross is almost fully adopted with INTERCEPT platelets, so that's a nice sort of pilot study, if you will, to show that the rest of the country can do this. And so once you get through the regulatory, and again, nebulous, we'll see how that plays out. Now, how quickly does the commercial switch turn on there with your partner who's already well established? Yeah, it's about a year process to get reimbursement. You need the approval first, but then it would be really to target sort of the top six-to-ten provincial blood centers and then roll out from there. So that's developing sort of the commercial launch strategy right now. Okay. Let's transition. We've got about 10 minutes left, so I want to touch on IFC or cryoprecipitate. Still very early innings. I think we've all noticed over the last couple of quarters the level of confidence, optimism seems to be building when we hear you guys talk about it. So where are we, I guess, is maybe sort of the first place. Where are we in terms of the launch? And then we can dive in a little bit more. Yeah. So anything in blood banking transfusion medicine takes a while to get some traction because you've got multiple parties that have some stake in the decision-making. So it's the blood centers, you've got the hospital transfusion service, and ultimately you have the clinicians. And trying to coordinate all that sometimes is challenging. And then when you think about it from a manufacturing standpoint, there's also what's called a BLA requirement for blood centers to actually get licensed to ship across state lines. And that usually takes about a year. In our instance, sometimes it took about a year and a half for a variety of reasons we won't get into. So I think we've navigated a lot of that right now. And what we've seen is sort of a very enthusiastic response to the product offering in very large academic medical centers. And so either they have adopted partially, and then that's growing quarter- over- quarter, like Kaiser Healthcare, which has typically been a fairly cautious or conservative group to sell into. And they really see the benefit for this product, and now we're starting to roll that out across all the Kaiser hospitals in California. And then, or it could be, I think, at the latest AABB meeting we had in Houston, Barnes-Jewish out of St. Louis presented on their experience where they sort of went overnight, overnight meaning four months to 100% adoption with IFC to replace their entire cryo inventory. And the reason they did that is they really were trying to not only make fibrinogen much more available more quickly to their clinicians and anesthesiologists, but also they were just trying to improve the ease of use for their blood center staff. You might imagine you're working in a blood center in a hospital, say a blood bank is what they typically call them or transfusion service, and you get an urgent order because, say, a woman's dying from maternal hemorrhage, and you have to activate a Massive Transfusion Protocol. You're getting all these orders for blood components. They're getting lots of blood, red cells, platelets, plasma. And typically, cryo is not even introduced because it takes too long to get there. But the last thing you're trying to do in that environment where you're trying to provide the blood to the OR is to worry about thawing a cryo unit and then making that available. Typically, it takes 60 minutes-90 minutes. And with our product, it's readily available. It's been pre-thawed, and it can be used on that patient or a different patient. So it makes the blood center staff sort of seem like heroes in that they've been able to address an unmet need without incurring any potential cost or delay primarily. And what they presented at the AABB was that they could actually reduce the time to order and time to transfusion dramatically around 50 minutes. And in the context of a surgery case, every minute is around $55-$75. So if they can save 50 minutes, that's a huge cost saver for them. So I think it's just the operational ease of use and the clinical benefit that's driving adoption. I think conceptually, although I guess we haven't seen the clinical data that would bear that out, but it makes sense that the sooner you can get a coagulation agent on board, perhaps the better the outcomes could be at the end of the day, at least conceptually. That seems to make sense. Yeah. I think it sort of is in line with what I've seen before about the improvement of overall coagulation monitoring in hospitals. That test that I told you about before where they're predicting whether they need platelets, they also can predict whether they need fibrinogen or not. That's where the IFC product really has a unique benefit. The wastage rates as well. Yeah. Are you seeing any common thread? And obviously, it's applicable. You've got trauma. You mentioned severe hemorrhaging during childbirth. There's also cardiovascular. Is there a common thread on where it's getting used that you can tell? Anything interesting on that front? Yeah, I think clearly CV surgery is the largest use in CV anesthesiology. OB/GYN, I think it's evolving. I think they just weren't aware that this product's available, so it's not part of the early rounds of MTPs right now. So there's a little bit of an educational component there. Yeah, I think in general, what I get most excited about is just the blood bank staff love it. And so then you're like, you're not trying to push a rock uphill with them because they clearly see a benefit from an ease of use standpoint. And then from a cost standpoint, as Kevin mentioned, the wastage is pretty dramatic. And the blood banks hate wasting blood components because they're such a scarce resource. Makes sense. Let's talk a little bit. We've got a few minutes left. I do want to talk on the Red Cell program in Europe. Just if you could just give us, I guess, it's been a couple of weeks. I can't imagine much has changed, but just an update there in terms of the clinical and regulatory path ahead to get that over the finish line. Yeah. So as I think many of you know, the whole MDR process is difficult to navigate. We did it very successfully with platelets and plasma. And then with red cells, it was a three-plus-year review cycle. At the last minute, we were sort of surprised with a question from our competent authority around the impurity profile in our product, which we believed we had addressed in the Q&A rounds with them around. I should say, you only have a single Q&A round or review cycle. And the reason why we were surprised is that we had sort of a similar question from the FDA historically. And we had provided the same answer to the Dutch competent authority as we did the FDA, assuming that they would, if the FDA is okay with it, then. And they said, "No, we'd like to see additional data, so we're going to give you a negative opinion on this." So where we are right now is this is obviously a delay, but we do believe we have a way to address the question that was raised. We'll address that with TÜV SÜD, and then we'll go out and likely find a different competent authority. Not that we're shopping. It's just more a function of that we have more choices now given that the MDR process is more advanced, so there's less resource constraints on the competent authority selection cycle. I'm not going to have you predict the outcome, but would you hope to, by sometime early next year, have a more sort of visible understanding of what you need to do? Just to help us understand when you think about that. Yeah. Clearly, we're trying to do it as quickly as we can. But I think what we'll probably do, just given the sort of uncertainty around definitive timing, you'll know when you see it. So yeah. But it's clearly something that we think is addressable. The product has an unmet need. And as I think we're going to talk about today, clearly the U.S. government and BARDA sees this unmet need as a function of emerging pathogens and has been very happy with the progress we've made to date. And so we have a way to get through the PMA submission cycle fully funded by BARDA and ultimately the commercial launch. I want to quickly touch on, because I think it's an opportunity that maybe we haven't spent enough time thinking about over the next couple of years. You alluded to it, the LED illuminator that's coming out. Could you just help us understand what the new illuminator is going to do that the old one doesn't? Kevin, to the extent there's a way to frame this opportunity, I'm not asking for specific guidance, but if we think about the installed base out there, you sort of, or maybe it was Obi sort of talked to what that opportunity could look like if you, over the next several years, transition folks to the new product. I think there were both. Yeah. Well, so the new LED illuminator is really foundational for future market penetration. And obviously, the illuminator that we're currently selling is fluorescent bulb-based. That technology has changed. So it gives us and our customers access to more readily available components and dealing with any obsolescence issues. It also should be just as reliable. So one thing that we take a lot of pride in with the existing illuminator is that its uptime is unparalleled. We expect the same from this new platform. It also is easier for the operators to use with less potential for human error. And then, as I said, the new market penetration. Any difference in the margin profile if you're getting? Shouldn't be. It's a little bit early to tell. We have about 700 devices out in the field in the installed base. We've submitted for CE marking for the LED illuminator in Europe, and then we'll follow in the U.S. It will take several years to convert. So we're working through that with the team right now to determine which countries are going to be first, which countries require an in-country approval beyond just a CE mark, and then how quickly we can roll that out to the different markets. But I would expect probably a two to three-year conversion in Europe and probably a little bit less so once we have an approval in the U.S. How old is the installed base that's out there today? It varies, clearly. I mean, some of them, like in Canada, are fairly recently placed. Others in Belgium and in France have been out in the field for a decade or more. So yeah, when you go back to your, particularly those geographies that are 100% penetrated, those might be the ones that are most likely to be sort of early in that cadence. Well, I guess we have 18 seconds to talk about profitability. You're doing a good job on profitability. But if we think about the next sort of phase here to get to sustainably positive and increasingly positive profitability, what are the key levers to drive? Obviously, you've got scale. Gross margin has probably got some room to the upside. How should we think about the key areas for that? Yeah. So obviously, the number one thing is top-line growth, right? So we believe that double-digit growth is very doable for the foreseeable future. And with that, economies of scale. I mean, we produce a disposable set that's manufactured, and we have tiered pricing, but we really are able to get a lot of economies of scale and drive that price down. At the same time, we're probably five years into a number of initiatives with our suppliers to reduce COGS and provide business continuity. So we're producing in France, Dominican Republic, ultimately in Puerto Rico as well. And then beyond that, if you think about the business model, Obi mentioned the concentration of customers, right? 100 of them in the U.S. It's highly, highly leverageable. So we should be able to get increased top-line growth without having to add a lot of incremental SG&A expense. And that's going to be true with follow-on products like red cells or IFC. We're going to continue to leverage the same infrastructure that we currently have and drive that top-line growth. The R&D for the red cell program, for the most part, is government-funded. So we have two BARDA contracts, an FDA contract, and a U.S. Department of Defense contract that help offset any investment in R&D. And so yeah, right now we're at positive adjusted EBITDA, generating operating cash flows. And we expect that as that business continues to grow, we'll be able to get more leverage, both in margin expansion and OpEx leverage. Okay. I think we actually ran over, but not too bad. All right. Well, thank you so much. I really appreciate it. It's always good to see you guys. And. guys. And.