All right, I think we've officially turned to afternoon. So good afternoon, everybody. Welcome to the Stephens Investment Conference. I'm Jacob Johnson, the life sciences tools and pharma services analyst here at Stephens. Happy to be joined by the team from Cerus today. We have CFO, Kevin Green, and Head of Tax and Treasury, Scott Seidenberg. Kevin, this will be a fireside chat format. I'll be asking the questions. If anybody has any questions along the way, just feel free, let me know. You can jump in. With that out of the way, Kevin, I'll turn it over to you for any opening comments.
Well, sure. So I thought what I would do, w ell, first of all, let me say thank you for the opportunity to present.
Yes, and thanks for being here.
If I say anything forward-looking, please read our SEC comments, in particular, our risk factors. Well, I thought what I would start with is just a primer of who Cerus is, for those of you that may not be familiar with the story. We are focused in the area of blood safety. And to the extent that I can say so, we are a disruptive technology to testing. So if any of you have donated, typically, you donate whole blood, it gets spun down into components, platelets, plasma, and red cells. And then those are transfused for the therapeutic intervention of the particular patient. We were born out of the HIV crisis, in part, out of UCSF.
One of our founders was head of hematology and out of UC Berkeley, where there was a lab that was developing compounds to cross-link nucleic acid strands. And Larry from UCSF realized that he was transfusing patients with HIV, and realized that blood components by themselves do not require DNA or RNA for their survival and therapeutic function, but every living other organism, virus, bacteria, spirochete, parasite, whatever it may be, requires functioning DNA and RNA for its survival. And so if you could cross-link that, you would have a sterilized blood component. Fairly simple, works really well. They developed the compounds and the technology in conjunction with Baxter. 2006, we reacquired worldwide rights from Baxter. Baxter was getting out of the transfusion therapies business, and we began commercializing the product first in Europe.
We're in 40 countries now around the world. Our guidance would suggest around $160 million of top line. In the U.S. here, we received approval in December of 2014 for platelets and plasma, and we've been commercializing the product, the products in the U.S. since that time. About 65% of platelets transfused in the United States are now INTERCEPT-treated. Our mission is singularly focused on making pathogen reduction the standard of care and ensuring that patients around the world have access to safe blood when they need it. It's taken for granted, if you need a blood transfusion, that it's gonna be safe. It's not always so, unfortunately. And in today's world, with pandemics, I don't think anyone here believes that it's going to subside, that we're not gonna see continued outbreaks.
It's more important than ever to have a solution for not just platelets and plasma, which we currently do, but also that we bring our pipeline product, the red cell program, forward, so that we truly can be a disruptive technology.
Yeah.
We'll stop there, if that's all right.
That's it. All right, thanks for that.
Yeah, yeah. What does, what do you mean by cross-link?
Sure. So we have a small molecule, it's a for platelets and plasma. It's psoralen, and it intercalates with DNA strands, so either double helix or single helix. And when it's exposed to ultraviolet A light, it creates a covalent bond so that it's not able to either express proteins or replicate or split apart and replicate. So I think of it in layman's terms, if you think of a zipper, a kind of a typical double-helix DNA strand.
Just making that they won't replicate?
Correct. That's correct. They're not able to replicate, and they eventually die. Yeah.
Thank you.
Mm-hmm.
Okay. Maybe. So thanks for that background, Kevin. Maybe just first, like, to level set for people.
Uh, yeah.
Maybe, I think the U.S. is probably where we're focused on, but can you talk global, too? But just, can you talk where blood safety stands today? I guess, think particularly around platelets-
Yeah
- and kind of, generally, what are you seeing globally, and then maybe we'll get into what's gone on in the U.S. the last couple of years?
Sure.
Yeah.
So I think when you, when you talk about the blood components, in particular, platelets, you need to think about the interventions by geography-
Yeah
The storage requirements, and then ultimately, the patient population that's receiving these units. For platelets, it's typically hematology/oncology patients.
Mm.
And because of their underlying disease state, they are immunocompromised. Excuse me. They are susceptible to contagions that are in a blood component that they receive, and their platelet counts usually drop significantly, so they need to get topped off with platelets. Platelets are stored at room temperature.
Yeah.
Beyond viral contamination, the concern is of bacterial contamination. And it's just like if you have a glass of milk, and you set it on the table for five days, it's gonna be a little funky at the end of that. And so historically, certain countries do nothing. Some countries do a culture, so they'll take a sample, an aliquot, out of that donated unit. They'll test it for bacteria, and if it's negative, they'll release the unit for transfusion. And that's what had happened in the United States for many years. In 2013, there was a BPAC, a Blood Products Advisory Panel and Ad Com, of the FDA, and it was the first time that they acknowledged, despite culture, they were still seeing an unacceptable number of breakthroughs in septic fatalities.
They decided to implement or to work on a guidance document that would improve platelet safety for bacterial contamination. That was finalized in 2021. It requires an incremental intervention by blood centers for all platelet products. There are 2 classes. There are single-step class and 2-step class. I'm gonna focus on the single-step class. It's a little bit easier. It's 1 step as opposed to 2. That's where Intercept fits in. The 2 options under the single-step class is what's called Large Volume Delayed Sampling and Pathogen Reduction, which is our technology, Intercept.
Large Volume Delayed Sampling, as the name would suggest, which says, "Take a larger sample, hold it for longer, and then test it, and if it's still negative, release it." And then it's aerobic and anaerobic, so it's somewhat much more complicated than historical patterns.
Yeah.
With Pathogen Reduction, you treat it after donation, and you release it.
Yeah.
And so that's those are the really, the predominant interventions in the US that, that happen right now. As I mentioned in my opening remarks, we're about 65% of the market. We expect that to continue to grow, you know, maybe not as fast as from 2021.
Yeah.
till our last published number.
Yeah.
But we continue to expect it to grow, to grow. And then one thing, which we can talk about later, is just expanding from five days, which is our-
Yeah
current shelf life for a treated INTERCEPT product, out to 6 or 7 days.
Yeah. Maybe just first, can we talk about the last 2 years? 'Cause it's actually, it's been impressive, the amount of growth we've seen. That, you know, this guidance comes out, and people have gone away to a nd we saw traction pretty quickly.
Mm-hmm.
So can you talk about that demand trend, and then to your kind of point of, like, it from here, you think it's gonna grow, but it might take some time, like, you know, 65%. Like, what's the natural limit? What's the alternative people are using?
Well, our mission is to make it the standard of care. You could argue that it is, at 65%.
Yeah.
We believe we'd like to see all platelets, but I think realistically, there will always be reservoirs of blood centers and hospitals that, for one reason or another, would prefer to do something else.
Yeah.
I think we need to be realistic about that. With that said, I think there is significant room to grow.
Yeah.
Right now, platelets are in short supply. I don't know if anyone I get called chronically by the blood centers, you know, and, and it's almost daily it seems like, and, and I feel like I'm a pretty good donor-
Yeah
and still it's not enough. So I do think that, underlying interventions and the need for increased utilization of platelets is-
Yeah
is gonna grow. We've seen kinda low single digit, 3%-4% organic growth in the utilization of platelets.
Yeah.
That's probably contrary to what many of you have heard about blood utilization, which, you know, probably in the past five years for red cells, it decreased.
I know.
Not so for platelets. So we think that there is continued organic growth, and then we expect that as we gain access to hospitals and can differentiate INTERCEPT versus Large Volume Delayed Sampling, and then even furthermore, as we increase the INTERCEPT-treated shelf life to beyond five days-
Yeah
that we'll have room to grow in the U.S. Outside of the U.S., there's a lot of area for growth, in particular in Asia-Pacific.
Yeah
Latin America, and still progress to be made in Europe, which was our first commercial territory.
Maybe just coming back to the five-day, I think there's a goal to get to seven days. I think maybe that's a first half 2024 event, if I'm not mistaken.
Yeah.
Can you just talk about what happened there, what, what's going on there, and, and what you need to do to get seven days?
Well, we have seven days in many places around the world, including Canada, which was a catalyst for the Canadian Blood Services to adopt and decide to go to 100%. So that's happening. In the U.S., we need to run another study. I think it's w e've talked about, not so much for next year, we're right now concluding on a five-day, which is a post-marketing requirement. And then once we have that, we'll most likely link a six-, seven-day study to our LED illuminator.
Okay.
Which, for Europe, we expect to submit in 2024, and in the US in 2025. And so there'll be a bit of time, I think, before we have-
Okay
that 6-7-day claim in the U.S. With that said, it's all relative, so a large, you know, large volume delayed sampling, you can go out from date of donation to 7 days, but you have to hold the product for 48 hours.
Yeah.
So you're effectively left with-
The same thing.
the same, that's the same thing.
Yeah.
I do think having seven days in the U.S. makes it a no-brainer for that other 35%.
Yeah, got it. Maybe just quickly on, well, the U.S.- take a step back. U.S. blood market.
Mm-hmm.
Can you just remind us how large the top five players are there? 'Cause it's a pretty top-heavy market.
It is.
How are you doing with yo u know, how are demand trends with those top five customers?
Yeah, so you're absolutely right. It's a very concentrated market. It's actually one of the benefits of the business model, in that you don't need a huge SG&A footprint to service the market. So the top five are about 70% of the market. The American Red Cross is the largest at almost half. And then you've got OneBlood, New York Blood Center, Versiti, Vitalant.
Yeah.
and the Red Cross is about 100% utilization-
Wow
of INTERCEPT. It varies with OneBlood is probably next, and then it scales down from there. The remaining three, outside of OneBlood, you know, by and large, have taken the position that they'll service their hospitals when their hospitals ask.
Yep.
And so it become, you know, and unfortunately, during COVID, gaining access to hospitals is a challenge. And so if they don't know any better, and because platelets are in short supply, they're happy to get a platelet.
Yep.
I think that's changing now, when they realize they can get a fresher unit, like on day 1 rather than day 3, and, you know, they don't have to order CMV Seronegative product, gamma-radiated product. It standardizes their inventory.
Yeah.
And so we do, you know, feel fairly bullish that we'll see continued growth with increased hospital access.
Got it. I guess the follow-up, just on this year, there's been some pressures on the inventory management side-
Mm-hmm
from a large customer.
Mm-hmm.
Can you just walk through what - how much of a headwind that's been this year? And, I guess as we're thinking about 2024, is this something that could recur next year, or does it make for an easy comp?
So, yeah, a couple things. Q1 and Q2 were soft, for sure, for a couple different reasons. One, and we heard about this in, you know, late December or early January, the American Red Cross, which is our largest customer, had decided to pare back the level of inventory that they carried of Intercept, and then they wanted it to burn down their inventory and, you know, make their supply chain, for lack of a better term, more efficient.
Yeah.
In part because of supply chain challenges they've seen with all of their suppliers, not so much for us.
Mm-hmm.
And that had a big impact in Q1 as they burned down, they utilized their existing inventory before they reordered, and so that was more or less flushed through in Q1. In late Q1, Q2, we heard from the FDA that they wanted additional data, stability data on a solvent that's used in the manufacture of a raw material that's used for a component. We have our normal shelf life in Europe, but the FDA wanted freshly manufactured product as of that date to be put up on stability in real time, and that meant that, you know, so they imposed a six-month shelf life on our kits-
Yep
as opposed to the 18 months that we had had. And so that just put pressure on the supply chain, on order patterns, and what we saw in Q2 was a move to smaller but more frequent orders. Customers burned down their inventory levels, and we expect that that now is largely behind us. We're in a more routine order pattern. Back half of the year should be, you know, should show strong growth.
Sure.
We just posted Q3, saw an uptick, and then Q4, you know, we have, well, our guidance would suggest fairly strong growth.
Okay.
We do anticipate submitting for that extended kit shelf life here in Q4, with approval in Q1, to go from either 9 or to potentially 12 months, and then we'll continue to follow up until we get back to our 18-month shelf life.
Gotcha. I mean, so those are things, in theory, you feel like played out this year, but we shouldn't see in 2024?
You know, first half 2023 should be a good comp for first half 2024.
Yeah. Yeah, okay. Yeah. Okay, and then you mentioned Canada and the seven days there. I think that's been a nice growth driver recently. How's that going?
Good. So, Canada, CBS, so in Canada, there's basically 2 customers. There's Canadian Blood Services, which is about 70% of the market, and Héma-Québec. But Canadian Blood Services had been moving towards adopting INTERCEPT. They rolled it out in one of their sites and had committed that if we got a seven-day approval, they would roll out to 100%. We got the seven-day approval, and true to their word, they are rolling out to 100%. So last, I believe, they were at 40% with Vancouver. Next up is Toronto. We expect that they will be at 100% by end-
Yeah
I think by end of year. And at the same time, while not a commercial revenue driver, Héma-Québec, the other 30% is currently in validation. And they're running tests, getting their SOPs written and validating use of INTERCEPT in that region.
Got it. And then, I wanna get to some of the other products, but just kind of another geographic question while we're here. You have a JV to get into China.
Mm-hmm.
Where does this effort stand, and does anything about the current kind of geopolitical environment change your interest in that region?
Well, I'll start, and maybe I'll turn it over to my colleague who interfaces a lot with the JV partner.
Yeah.
You know, it's w e just actually hosted our JV partner here in Nashville a few weeks ago at AABB.
Uh
ironically, and then, had them out in California. What was clear to me, and, and I would say that pathogen reduction for plasma in China is standard, and our partner is the one who has commercialized that.
Right.
It was clear in meeting with them and just seeing body language, which is really hard to get over a Zoom feed at, you know, 10:00 P.M., Pacific Time. That they know what they're doing, they've done it, and that they're very well-connected, and pragmatic.
Yeah.
So that was really helpful for me to just feel, and I think they are very much focused and invested in this.
Mm-hmm.
I'll let Scott speak to it since he interfaces with them quite a bit.
Yeah. I would say the other piece that's happening is they are having really good dialogue with regulators, but there's no, there's no standard path for our product, right? You don't have something comparable, so there's a lot of education. And I believe this week, they're actually having one of those education sessions-
Mm-hmm
to walk through the product, really bring the NMPA up to speed on what's going on through their expert panel.
Mm-hmm.
We'll continue to see next steps from there. So, this is just a wait and see at each step. Quarter by quarter, everything moves along pretty well.
Mm-hmm. Yeah, and then, and the - what Scott's referring to, the NMPA, is obviously we, we have a ton of clinical data, and we've got, I think, 10 million transfusions with the product now, so a pretty solid-
Yeah
body of evidence.
Yeah.
What's in question is whether or not we need to supplement all of that with in-country clinical studies.
Yeah.
Which would be fairly quick relative to what we're used to. But nevertheless, we need to get that answered.
Yeah. That's helpful. Maybe I'll before we move on to other things, I'll maybe pause for any questions. All right, IFC. You know, platelets have been a big growth driver the last couple years. I think as we start kind of thinking about next growth drivers, we'll get to red blood cells, but IFC is kind of the interim one.
Mm-hmm.
I think that was approved in 2020. Can you just first maybe talk about what that product is and what the value proposition is?
So it is a alternative to cryoprecipitate for massive transfusion or massive hemorrhage, rather. Cryoprecipitate, historically, was used for hemophilia, Factor VIII replacement. Not so much anymore, now it's all recombinant Factor VIII, but it's still used to control bleeding. Well, the product itself is a by-product of thawing frozen plasma, and when you do that, you're left with this concentration of clotting proteins, in particular, fibrinogen. And it works, you know, it's very important to administer as early on. There are assays now by Instrumentation Labs and HaeGenetics that would suggest patients should receive more fibrinogen earlier in their treatment to control bleeding.
The challenge with conventional Cryoprecipitate is that it has to be stored frozen, and so if a patient presents to an OR or an ER, the doc's got to call up, well, first of all, issue a massive transfusion protocol, call up the Cryoprecipitate, and it takes about 1 hour and a half to 2 hours, typically, to thaw that and deliver it. Unfortunately, oftentimes, the doc's got to stabilize the patient some way, or shape, or form, or they lose the patient. Once thawed, it's got a 4-hour shelf life before they have to discard it, so discard rates can be upwards of 30%-35% on a fairly expensive product. Our INTERCEPT Fibrinogen Complex is an alternative to that, and it. We piggybacked off of our PMA licensure.
Because we're inactivating viruses and bacteria, ours has a 5-day post-thaw shelf life. So instead of calling up a frozen unit, delivering it, and 2 hours later, hospitals have the option now of having a thawed product readily, more readily available and transfusible, and if they don't use it on that patient, they can use it on the one after that, and the one after that. So we expect that with real-life experience, we're gonna see wastage rates come way down, and you would expect better patient outcomes.
Yeah.
Although, you know, we're just scratching the surface, and we've got to generate that real-world data.
Yeah. So maybe on that, that piece of things, just the initial uptake, I think it's, you know, it's been kind of a modest contributor to the top line-
Yeah
recently. To your point, it seems like there's a real use case for it.
Mm-hmm.
What does it take for that to become larger, and what are you guys doing in terms of your sales strategy right now?
Well, a lot of it is, and we're starting to see the traction now, you know, we launched in COVID. And it's a... We launched, and the business model that we pursued was one where we had five blood centers that would manufacture INTERCEPT-treated INTERCEPT Fibrinogen Complex. We would broker the sale to a hospital, they would manufacture it, drop ship it there. We would invoice-
Yep
hospital collect.
Yep.
The reason we did that is because there are advantages to it, and require marketing and a differentiation.
Yep.
Blood centers are not in that business, right? They're by and large historically selling a commodity, and so you don't necessarily need that skill set. So we wanted to make sure that we could go after the anesthesiologists and the transfusion clinicians and differentiate the product. I mention that because we did launch in COVID, tough time to launch a new product at a hospital, when they're all filled up with COVID patients. Nevertheless, that is subsiding, obviously. You know, once COVID passed, then there was a staffing shortage. I don't think that's yet fully resolved, but we are getting more and more hospital access, which is encouraging. We're also seeing those early adopters increase their utilization.
So it's, you know, a lot of the hospitals would dip their toe in the water, so to speak, try it out for a certain volume, and now that they're gaining experience, they love the product, and they're increasing it, and they become our biggest advocates. And so what we're seeing now is a lot of peer-to-peer dialogue and marketing. We saw that here at AABB just a few weeks ago, and coupled with, you know, more hospital access. I think things are on the right track. It's still a modest contributor, but it is, it is growing. The other piece of it is, as we have more and more experience, we're generating more and more data.
Yeah.
That data has never been available in this market before because the product hasn't existed.
Got it. Maybe just on the last quarter, I think there was some impact due to a delayed sales agreement here. Can you just talk about what happened there?
Yeah. So, large national account, it took a while. I mean, it's just that it's an administrative burden to get the to get everyone agreed on. There are, you know, obviously, competing priorities that you're up against. This particular customer had a number of competing initiatives that we had to get in front of.
Yep.
We expected that we would sign it, you know, early in Q2. That didn't happen-
Yep
until late Q3, Q4. And then, you know, unfortunately, we lost six months of the ability to. You know, it takes time, right? Once you sign the agreement, it's not lights on. You've gotta work through it and operationalize it. So we're—that is well underway. We expect that we'll be seeing now the first orders, but we did lose six months, and it was significant enough where-
Yep
... it caused us to bring guidance down modestly.
Okay. And then just on the—in addition to kind of your own sales effort, I think you've partnered, I think. Is it OneBlood you partnered with on,
Mm-hmm.
Can you just talk about that initiative and, and are there more things like that? Are there other blood centers, I guess, could you partner with on IFC?
Yeah, we-
The one Scott talked about.
We are partnering with them actively.
Yeah.
It depends blood center by blood center, what they're doing. Some of them have actually taken off so much that they're like: "We want to be on our own. We're at a capacity, and we don't have more for you.
Yeah.
Other ones are more than happy to make the product for us. Have them have us help sell it-
Yep
because they just, they don't want to go through the exercise.
Mm-hmm.
Ultimately, a lot of what we're seeing is it's hospital by hospital.
Yeah.
Like, the hospital has the right advocate, they'll move fast.
Yeah.
Some of them just are administratively slow.
Mm-hmm. Contracting takes a while.
Yep.
You know, what we've seen also is hospitals in some cases have a very long-tenured relationship with their local blood center.
Yep.
They don't want to buy product necessarily directly from Cerus. They want to buy it from my blood center that I've got the contract with. We've got to find ways to channel it through their blood center-
Yeah
in order to make it happen.
I mean, with the OneBlood agreement in place, does that at least have like a framework or a model for If they're like: "I want to buy it from my local blood center," you're starting to develop, like a playbook that you can deploy in different places.
We do. We do, yeah. So we've got, you know, we can sell kits to the blood center-
Yeah
to produce IFC. We can sell the finished therapeutic to the hospital.
Yeah.
So yes, we've now figured that out, and have a playbook. But I think to Scott's point, it is still, you know, it's a relationship by relationship on how they operate.
Okay. Red blood cells, the largest component out there.
Yep.
Can we just go back to where that stands from a regulatory perspective in the U.S. and Europe?
Yeah. So you asked about how the technology works, and I said for platelets and plasma, it's actually a photochemical reaction. For red cells, same cross-linking, but red cells, hemoglobin absorbs light, and so rather than trying to shine enough light through it to make that, excuse me, to make that covalent bond, we developed a different compound that does the same thing, but it's the pH of the red cell unit itself that creates the covalent bond. And so that's been longer in development. We have run 2 phase III clinical studies in Europe. We have filed for licensure in Europe. We are in active discussion with. In Europe, there are 2 agencies. There's the notified body, which for us is TÜV, and there is the competent authority, which is a medical, governmental medical body that reviews the API.
We've gone through both of those reviews. We are in the process of, excuse me, answering questions from the competent authority. We expect that we'll have those answered first half, and that we will have that approval decision by end of 2024 in Europe.
Yep.
In the US, we are running 2 phase III clinical studies. One of them just completed enrollment, ReCePI, in cardiovascular surgery patients. We expect that data will read out first half of next year, and RedeS is now enrolling in chronic patients in sickle cell or red cell exchange in sickles. And we expect that that will complete enrollment, ultimately read out in early 2026. We'll begin filing for licensure in 2025. It's a rolling modular submission, so we'll begin filing for that in 2025 and expect that we'll have an approval decision, you know, towards the end of 2026 here in the US.
Yeah, that's helpful. As we think about red blood cells, again, kind of-
Mm-hmm
the largest end market. But can you just discuss the value proposition for Pathogen Reduction for red blood cells versus platelets? Like, why-
Yeah
Why is that?
Where is it on the spectrum?
Yeah, yeah, exactly.
Yeah. So, it kind of fits in between platelets, which, you know, have the most urgent clinical need, and for pathogen reduction in plasma, which is stored frozen.
Yeah.
Red cells are historically refrigerated. Everyone falls in love with the size of the market, so red cells are transfused 10 times the volume of platelets and plasma. And then, obviously, that's really important for us, but I think what really gets me excited is, you know, we've got a platelet product, we've got a plasma product. Those work really well. But if you're a transfusing doc, you're running a blood center, you still gotta do something for red cells, which you're transfusing, you know, by far more than anything else. So as a bug comes along, if you don't have a pathogen reduction technology, you have to do testing. And so having all 3, I think, really does, you know, help define our mission. And so, we'll get that. We expect to have that approval decision in Europe.
We will run a hemovigilance study immediately after, probably about 2 years in Europe, to collect real-time data-
Yeah.
Using the product. We'll most likely start with immunocompromised patients that typically receive gamma radiated red cells. We believe our product is a much better product than a gamma radiated product, and those that are immunocompromised, and sickle cell, and thalassemia patients that are exposed to a lifetime of transfusions from thousands of different donors and are susceptible. So, from that, then we'll move into more standard of care.
Okay.
Excuse me.
Thanks for that. Okay, and then last couple of minutes here. Yep, question. Yep.
What is the math for the blood centers?
Mm-hmm.
What is the math for them when they're trying to value whether they need to have an INTERCEPT?
Well, it depends on what they think they can sell the product for at the, to the hospital. So in the case of platelets, we know that they're. So a platelet unit, a standard plain vanilla platelet, it's about $500 in the US. We know that the, if you, if you, and, and the way we got there is by crosswalking different steps and with P codes and J codes. For an INTERCEPT-treated, they're able to sell it for $650-$700.
The profit, or less or more?
Yeah, so they don't do it giving gamma irradiation. Yeah, I mean, they're buying it from us, so it's y eah.
Yeah.
But the upcharge for them is, you know, is, is fairly significant. It eases their operations. It does - I mean, I would argue it's a better product.
How long did it take to educate what that process was? That transition where-
Yeah.
Well-
Well, what I would say is, cost is always the first objection until you educate, and then it's never brought up again. That's what we've seen historically. We've also seen, once customers adopt, they typically don't change. For red cells, because of the volume and the scale, there will be pricing sensitivity, for sure.
But it's a burden of education for-
It is, and we're all-- we've got a 15-year start, so-
Same customers.
It is, and we'll use the same sales force, calling on the same customers and selling an incremental product. So with that said, you know, to go from 100 per. So there's 300,000 platelet units in France. There's infinitely more red cells, and so the burden on the overall national budget will be very different. And so you'll have to educate, you know, I think, really payers in that case, which is why we're focused on those that are in most critical need at first. So immunocompromised patients, thalassemia patients, and sickle cell patients that really are exposed and really need the product. And then we'll continue to roll it out and do the education.
So it shouldn't be sometimes that you can never get to the whole market.
Well, that's our, you know m aybe not in my lifetime, but, you know, that's our, that's our mission.
Any other questions on red blood cells?
Does it invite more competition now that the market is larger?
Perhaps, but we don't know of anyone developing a technology to compete with us. It's hard. You know, we jokingly say we're a 30-year-old startup, but in many ways, we have a fairly big moat around the business because of the complexity. So we're a drug. We have a small molecule device treating a biologic, and it creates this perfect trifecta of complexity for regulatory, and there are no biosimilars. So anyone that wants to come along and compete is gonna have to develop the compounds, the process, run the clinical studies, and generate real use data, and that, as it turns out, is really hard.
Maybe just the last kind of new product development. You mentioned the new LED Illuminator earlier. Can you just remind us where you stand on that effort?
It's, y eah, so, it is a new device, a new light box, if you will, using LED technology rather than fluorescent bulbs, which is what the existing-
Yep
Illuminator is built on. I'd say the most important thing is that the LED Illuminator appears to be as reliable, if not more reliable, than the existing. And if you're a blood center and you're processing, and you've got 100% of your products running through this process, you need that thing to be running it up.
Yeah.
So we've seen very little downtime. We expect that the new LED Illuminator, it was designed to be as reliable.
Yep.
It uses, again, LED arrays, so there will be less maintenance. You know, the existing light box requires continual calibration and bulb replacement. Won't have to do that as much with a LED illuminator, as we expect. We are in development, and we'll be submitting for approval in Europe-
Yep
In 2024, mid-2024, and in the US in mid-2025.
And then in the last kind of five minutes-ish, Kevin, just gross margins and margins in general, but we'll start on gross margins.
Yeah.
Can you remind us where they are today? Kind of any puts and takes we need to be thinking about from this year.
Mm-hmm
Y ou know, the top line continues to grow, and you put some, I think, manufacturing efforts in place, too. How is that going? Sorry, I touched on that-
No, no worries. No worries. Margins today are mid-50s%. It really is an economies of scale play in finding, you know, sourcing components in lower-cost jurisdictions. As you mentioned, we have a number of those initiatives that are underway. For us, it's also about a nd we take this very seriously, it's about being a good supplier. You know, entire nations' blood supply is reliant on our technology. We, we - you can't go down. We cannot go down. And so redundancy in manufacturing is important. And so those are, those are initiatives that have been underway for, you know, several years, and we will continue to invest in those over the next several years. With that said, we expect margins to continue to improve, you know, without product configuration change, probably in the low 60s%.
The LED Illuminator is very important because it is a foundational component to product configuration change beyond. We expect, you know, while fairly nascent, we expect to continue to iterate on the product, and that margins would move beyond those low 60s% and could get into the low 70s%. Operating margins, with that said, can be fantastic because of the concentration of customers. We don't need a huge SG&A footprint to service the 100 customers in the U.S. And as we have follow-on products-
Mm-hmm
l ike red cells, we'll leverage that same infrastructure to sell. So there's a ton of leverage that we expect to get out of our SG&A investments.
Then just on EBITDA, I think you're nearing EBITDA breakeven. As you turn EBITDA positive and maybe we see cash flow improve, what are the key priorities for that cash flow when we get there?
So we want to take advantage of the business model, the leverage in the SG&A, generate operating cash flow, and then reinvest that. So it will be continued margin expansion.
Yep.
It will be what we call Intercept 2.0, which is a kit configuration change. And then beyond that, we'll see. You know, maybe there will be tuck-ins if we're, you know, hugely lucrative. But we wanna, not trying to get to a point where we're paying out dividends. We want to use that operating cash flow to reinvest, but do so without having to go to external sources for capital. And, you know, we're targeting this quarter, Q4, to hit adjusted EBITDA neutrality, and then with continued growth, we'll manage things appropriately.
What's the unit of capacity for your box?
For manufacturing or for the throughput of a box?
For the manufacturing.
So right now, we don't really have a constraint on manufacturing. So now, I think historically, we manufactured out of one facility in France.
Yes.
and that had a, it says there's an E-beam connection, and that had a capacity limiter. We started sourcing certain components out of different facilities now to take to unburden that. and then ultimately, we'll want more E-beam capacity, but right now there is no real constraint. And we've got, let's say we've got the French facility that's doing full sterilization and packaging and distribution, components from the Dominican Republic, and underway now and probably for the next 2 years, another fully automated standalone facility in Puerto Rico.
That's funded?
Yeah, those are, those are funded, yeah.
Will we see a full quarter without funding?
Yeah. Well, that's a, that's a great question. I don't know that I want to commit publicly to anything because there is chop. But our expectation, my expectation is that we, we will see EBITDA neutrality in a few... You know, a track record, where we're demonstrating that we have the ability to sustain that, without overinvesting.
And that's the most-
Any other questions? All right. Kevin, Scott, thanks for being here.
Yeah. Thank you all.