Cerus Corporation (CERS) Earnings Call Transcript & Summary

Well, good morning, everyone. My name is Obi Greenman, and I am the CEO of Cerus. I'm here with my colleague, Kevin Green, who is the CFO of Cerus in the back room there. I just want to thank Goldman Sachs for the opportunity to present our company Cerus today. Before I start, I will want to acknowledge the forward-looking statements that I'll be making today and I encourage you all to read the SEC Form 10-Q and 10-K risk factors, just to be aware of all the things that are happening at Cerus. And then I also will be using a number of non-GAAP financial measures throughout the presentation. So Cerus is a company that's been around for about 3 decades now, and we're focused exclusively on safeguarding the global blood supply. The mission that we have is really clear and that is to make INTERCEPT the standard of care for transfused blood components around the world. We've already met that goal in a number of countries right now in the United States, France, Switzerland, Belgium, and Canada. INTERCEPT is the standard of care for platelet transfusion. So the majority of platelets in those countries, if not all, are treated with INTERCEPT technology. The pathogen -- we are the pathogen activation market leader with over 20 years of commercializing these products in the market with global sales in more than 40 countries, and cumulative kit sales now represent more than 20 million INTERCEPT-treated doses to patients for platelets and plasma. So that means that every day, thousands of patients receive our technology, which is really sort of uncommon when you think about the impact that we have on global health care. And lastly, the INTERCEPT technology has been developed to treat each of the transfused blood components. So I'll go into this a little bit later, but whole blood is typically broken down to individual components for specific patient populations. Platelets are one of them, plasma, red cells and INTERCEPT fibrinogen complex. Sometimes that's also called cryoprecipitate and it's a derivative of plasma, and we'll talk about that a little bit later. But our technology has been developed to treat all 4 of those components. So before I give you sort of an overview of the global impact we're having on health care, the markets we serve and the patients that are transfused with INTERCEPT treated components, I thought I would discuss why Cerus is such a unique opportunity at this point in time after many, many years of effort and sort of maybe what the investment thesis for you all might be. So we are the clear market leader in pathogen reduction technologies for transfused blood components, and we have significant barriers to entry as a result of our first-mover advantage and the superior technology that we have. So we really don't have a lot of competition in many of the markets around the world. We also have a repeat orders with long-standing customer base that it's a recurring revenue model. And so if you think about how we grow our business, every year, we have an established base business of the recurring revenue from our existing large transfusion service in blood centers. And then we add to that, either as a function of new products or new geographies, our new customers within the country. The customer base is very concentrated. So that allows for a lot of leverage in the business model and specifically the SG&A investments that we've made to date. And so what that means is that we already have established sales forces in Europe and the United States. And as we add new products or new customers, we really don't need to add to that. So there's a lot of compelling leverage in the business model there. And this has all led to a sort of strong and improving financial profile for the company. We're well positioned to deliver sustained revenue growth through the end of the decade as a function of the products that we currently have approved as well as an additional product that we'll talk about later, the INTERCEPT red cell program that we hope to get approved hopefully in Europe next year. We also have improving margins and demonstrated leverage in the operating model. We've achieved positive non-GAAP adjusted EBITDA for 2024, and we're committed to doing that for 2025 as well. And we also have a strong cash position as a function of that. So the markets that we're targeting are significant around the world. The TAMs for the existing licensed products, platelets, plasma and fibrinogen complex represent about $2.5 billion globally. And putting that in the context, we will -- our current revenue guidance for 2025 is $194 million to $200 million. So we're sub-10% penetrated of that overall market opportunity. In addition to that, there's organic growth in the platelet market, typically 3% to 5% annually. And so we believe that by 2030, the overall TAM for the platelet opportunity will be at least $1.5 billion, specifically with large growth in the transfusion platelet market in places like China. And lastly, the red cell market opportunity, as you can see here, that's the largest TAM. It's roughly $5 billion globally, and that's why it's such an important product for us to get approved and start selling commercially. Over the last 8 years, we've had about 20% CAGR. So good growth. As you can sort of see here, there's been sort of inflection points in the 2018 and 2021 time frames. Those were a function of France adoption and then subsequently, the U.S. adoption of the INTERCEPT platelet technology. We're guiding $194 million to $200 million for this year. And this is the first year also that we broke out guidance for our IFC or INTERCEPT fibrinogen complex of $12 million to $15 million. That product was launched during COVID and is really starting to accelerate, and we'll get into that a little bit later. For those of you who don't know anything about the transfusion medicine market, I'll just provide a brief summary on the unmet need and why a proactive protection of the blood supply and ensuring availability is so compelling. I think roughly 1 in every 3 people will get a transfusion in their lifetime and yet only 3% of people actually donate blood. And so that leads, as you might imagine, to a fairly tenuous supply chain. Typically, blood donors come into a blood center and donate their whole blood or they can be hooked up to a machine to collect individual components. Those -- that blood is then processed at the blood center into the individual components and then shipped to the hospital blood bank and then that is then distributed within the hospital to either the OR or inpatient wards, ICU, et cetera. And the 4 components I mentioned before, platelets, plasma, cryoprecipitate and red cells are derived from whole blood. And then each of those components have their individual indications. So typically, platelets are transfused to hem/onc patients that are thrombocytopenic. That's the majority of platelet use, although it's also used in major surgical procedures and in trauma. Plasma is used also in major surgical procedures to treat bleeding primarily, but also can be used in liver disease. And then cryoprecipitate, which is basically just a concentrated version of plasma to improve the concentration of fibrinogen is used a lot in maternal hemorrhage, cardiovascular surgery and trauma. And lastly, red cells, which you're probably most familiar with, deliver oxygen that's used to treat acute anemia in the surgical setting or trauma setting, but it's also used in the chronic transfusion setting for diseases like sickle cell disease, thalassemia and MDS or certain oncology patients. And as you can see below, there's different shelf life for each of these products. And so that just leads to, again, a difficult logistical challenge for blood centers and hospitals to manage their inventory of products and then get them -- get those products to the patients in a timely manner. One of the biggest problems that's happened in transfusion medicine over the last 3 decades are infections. And I think many of you -- I certainly lived through the HIV and hepatitis transmission issues in the '80s and '90s. At that time, I was with Baxter Healthcare and worked in the hemophilia space and a lot of patients were getting transmitted -- getting HIV transmission via their blood component products. And that's why I went to Cerus in 1995, where the founders had established Cerus to try and address the sterilization of blood components, if you will. But what this slide shows is that over the course of 3 decades, there's now multiple tests for just 11 agents. And every new emerging pathogen like Zika or chikungunya or others. You're all very familiar with COVID creates a challenge to the blood supply. Fortunately, COVID was not transfusion transmitted. That would have really created chaos. But as you remember, in 2020, '21, it was just very challenging to get up diagnostic tests to be able to diagnose the disease, let alone to have one with sufficient sensitivity and specificity for COVID in a blood component if it had been transfusion transmitted. Ultimately, what I'm suggesting here is that the testing solution really isn't sustainable for the long term. And you'll see there's also multiple tests for a single pathogen here. This slide just sort of shows you the variety of different bugs that could be in blood. If you live in the Northeast, there's a lot of tick-borne Babesia that's a problem. If you travel to Central America or Africa, you have concerns around malaria. And then there's sort of recurring arboviral threats like Zika and dengue and other things that if you live in this part of the country or in Puerto Rico that there are concerns about that. So what that does is it shuts down the donor availability. And if only 3% of the population is donating, it creates challenges of availability, which our technology essentially prevents. Specifically in platelets, platelets are stored at room temperature for 5 to 7 days after they're collected. And that leads -- and that's to maintain their viability and maintain the count increments after transfusion. But what that does is it leads to potential growth of bacteria in those components. So when you do a venipuncture to draw the component, oftentimes, there's like a skin plug in that needle and that skin plug can be contaminated with bacteria. And so every year, there are septic transfusion fatalities. And a lot of the countries, including the United States, the INTERCEPT system was adopted to sterilize platelet components to try and prevent transmission of bacteria septic transfusion reactions. This is just a design or a layout of our kit and the process. And I'll briefly walk you through it so you have an understanding of how our process works in blood banks around the world. This system is in use in places like Tahiti to the United States, so small large blood centers and has really been easy for the blood centers to use. So this disposable set is the majority of our revenue. As you can see, there's a red pouch on the left that contains the photochemical compound that's used to treat the component. And you sterile connect the plasma platelet unit onto that set in step 1 there. And then by gravity, it flows through the amotosalen pouch, the photochemical into the illumination bag. That's then placed in -- this is our new LED illumination device that I'll talk about in a bit, but it's a new platform for us that really makes it a lot easier to use. That's illuminated for about 3 to 5 minutes, and then it goes through a compound absorption step, again, by gravity into the final storage bag. This overall process takes about 10 minutes in total. And each one of those illuminators can process between 4 and 6 units in that 10-minute time frame. So though it looks manual and most of the blood banking operations are manual, it is actually relatively efficient for blood center operators to process the components they need on a daily basis. The mechanism of action for the photochemical is pretty straightforward. It's a psoralen derivative and what it does is it targets the nucleic acid in a transfused or in pathogens that would be in a transfused blood component. So viruses, gram-negative and gram-positive bacteria, spirochete like syphilis, protozoa like malaria, or donor leukocytes, so white cells from the donor, all can be inactivated with our technology. And what it does is it essentially cross-links the nucleic acid and prevents the replication. So pretty straightforward. We get very robust log and activations with this technology. Now I'd like to move on to the IFC product briefly, just to talk about a product that, again, we launched during COVID and now is really getting a lot of reception from the major academic hospitals in the United States. The main message here is that this is all about time. And so if you have a bleeding patient, every minute matters. If you miss the window to treat these patients early, you will see exsanguination and deaths associated with major bleeding events. It turns out that trauma is actually the #1 cause of death for adults under the age of 45 and 40% of those patients die from exsanguination or bleeding. And that -- those deaths typically happen within 1.5 hours of the event happening, either admission to the hospital or if it's a woman during childbirth bleeding that you really need to get on top of it. And as a function of that, there are now massive transfusion protocols that have been implemented and mandated in many states, but also many major Level 1, Level 2 hospitals to try and address major bleeding events. And this is a somewhat complicated slide, but I'll just briefly walk you through it. Typically, these massive transfusion protocols involve rounds of blood components getting to the OR. So they come in a cooler. You have 1 platelet, 6 plasma, 6 red cells, and they just keep coming as long as the patient is bleeding or unless they die. And you can see here with the survival graph here that typically within 1.5 hours, you pass the 50% survival rate if you keep bleeding. What's interesting here, though, is that the cryo AHF product, that's cryoprecipitate -- it's the product that I mentioned before is rich in fibrinogen. It typically doesn't get to the patient until round 3 because you have to thought and then figure out how to get it from the hospital blood bank to the OR and that can take typically as long as like 60 to 90 minutes. And what I'll talk about in a second is what we're focused on is how do you allow cryoprecipitate to be used much earlier and thereby prevent the need for future blood component use because you can stop the bleeding of the fibrinogen concentrate early, you essentially save the patient's life. So what we decided to do with the INTERCEPT fibrinogen complex was to use the INTERCEPT technology to sterilize cryoprecipitate, also help standardize it. And then establish a thawed shelf life for 5 days in the blood bank, hospital blood bank. So once they thaw this product, it can be put on the shelf for 5 days. And if it's not used on one patient, it can be used on another, it can be shipped around. And what it does is this really frees up the hospital blood bank when they have stat orders for like what I was talking about there previously with the massive transfusion protocols. This 5-day thaw shelf-life is very different, obviously, than cryo AHF that typically has a 4- to 6-hour shelf life. And so what you see is cryo AHF, conventional cryo AHF can have anywhere from a 20% to 30% wastage rate in a hospital, which is really -- it sort of impedes its use as well. So not only thrown it out, but the hospital blood banks and physicians are reluctant to order it because they don't want to throw it out. And so our technology, the IFC product overcomes that. And lastly, fibrinogen concentrates are coming to the U.S. market from the major plasma manufacturers, plasma derivatives manufacturers, but they still have about a 20-minute reconstitution time and also have a 4- to 8-hour expiration date after they've been reconstituted. So now that the technology is in routine use around many major academic centers in the United States, we're starting to see great case studies come out on, hey, does this impact turnaround time? And we can see at places like Stanford and Kaiser that they can get the product, our IFC product to the OR within 10 minutes. That's just remarkable. So it sort of frees up the anesthesiology staff to think about other things, and they know they have something that they can get on top of the bleeding event if they need to. And then as I mentioned previously, the impact on waste has just been dramatic at these major academic hospitals like UCSF and Weill Cornell here in New York. And that really also drives sort of the economics and considerations. One of the things we've also noticed that Barnes-Jewish, one of the larger academic hospitals in the country, is that they really see a reduction in OR time. And so obviously, that has a value as well. And then this just sort of shows you that we're still early days with this product. I mentioned previously, we're $12 million to $15 million in guidance for 2025. We think the overall market opportunity in the United States is north of $300 million. So there's a lot of room to grow. And right now, we're only in 47 institutions, not even 100% of those thus far, but it does represent about 40% of the U.S. News World report best hospitals in the United States. And the increasing number of publications and presentations is really helping further the momentum for this product. Now I'll move briefly on to INTERCEPT red blood cells to give you an update on that. This is a program that's been under development for more than a decade. During the Zika epidemic, in the 2016 time frame, U.S. Biomedical Advanced Research and Development Agency, or BARDA, provided us with funding for this program, the late-stage clinical development, north of now $400 million. So they've really gotten behind this program. We've completed a lot of Phase III studies, both in U.S. and Europe, most recently, the ReCePI study, which I'll elaborate on in a few slides following. And we're nearing completion of enrollment for the RedeS study in the United States. And I won't really talk about it, but that's required for the ultimate PMA submission with the FDA. So the ReCePI study, I thought it would be important just to highlight this data as it came out last year when we completed the study. In discussions with the FDA, we were looking at what the endpoints might be to show that INTERCEPT red cells have the same ability to treat anemia in an acute setting, and these are in complex cardiovascular surgery patients as conventional red cells. And surprisingly, there's not a lot of easy endpoints for that. So the FDA pointed us to a paper and said, we really think that you should consider acute kidney injury as a surrogate for tissue oxygenation. And certainly it was a challenging study to enroll, but the design of the study was looking at a non-inferiority design relative to conventional red cells with the AKI endpoint, and we enrolled more than 300 patients. The results of the study were promising. I'll show you those in a second. But one of the things we noticed early on when we were looking at the data, which we found surprising was we actually transfused fewer red cells than conventional in the study and less hemoglobin. So we don't really know why that is. This graph just shows you the amount of hemoglobin in each unit. So there's obviously a lot of variability unit to unit and everyone has different hemoglobin levels in their blood. But in general, you can see that we actually transfused fewer red cells. And then the hemoglobin increment really showed no difference in post-surgery patients, the hemoglobin levels between test and control, even though we use fewer red cells and less hemoglobin. So that was also a great study outcome because if this had been different than this, people would have said, "Oh, there's something wrong with INTERCEPT red cells". And then lastly, the AKI endpoint, which was defined as the change in serum creatinine from baseline within 48 hours of the surgery, you saw that we really hit the endpoint head on, and there's really no uncertainty here. And then lastly, obviously, concerns around are there any safety adverse events. We didn't see any. The only thing that popped up was that we did see 5 antibodies to treated red cells. So the process generates a modification of the red cell membrane that ultimately falls off. But there were 5 patients developed antibodies to the treated red cells, but there were no clinical sequelae associated with it. So there was no hemolysis, no increased transfusion reactions. So this is obviously an area that we'll continue to investigate in our RedeS study and future rollout of the product in Europe. But just to highlight that this was something that popped up. And then lastly, I wanted to talk a little bit more about the INT200. This was a product that we've developed over the course of the last 5 years with a lot of feedback from our customers. It really is an intuitive design with simplified handling as we rolled this product out after the CE Mark early this year, and now we've had subsequent approvals in both France and Switzerland earlier than expected. The big concern always is when you're rolling out a new product like this to customers that are using the product in routine use every day, they can't go down. And so you really are trying to build something that's very reliable. And we've got about 750 devices around the world placed right now in countries from Russia to the U.S. to Brazil. So we're gradually replacing the earlier device with this new device. But what we're seeing so far is this thing is rock solid. The customers love it. It's a lot easier throughput, and it's just so intuitive that you can actually train anyone in this room in 5 minutes how to use it. So that's been great where we have a planned PMA submission to the FDA during probably mid-2026. So a few other slides here. I just wanted to have one slide on the Q1 '25 financial results. And this slide sort of says it all in that we've now had 4 quarters of adjusted EBITDA positivity. We are committed to doing that for the full year 2025. And having been in a cash-consuming company for multiple decades now, it's nice to finally be at a point where we can chart our own destiny. And then closing remarks, just where do we go from here? So we have the INTERCEPT Blood System for Platelets and Plasma that we really want to extend our leadership position, not only in our current markets and capture additional market share in the United States. We're currently about 65% penetrated in the U.S., so there's more room to grow there. About 70% penetrated in Canada. So the Hema-Quebec Blood Service is evaluating the technology as well. But there are other big markets like China, Brazil, Saudi Arabia, Germany that are also well on their way. The INTERCEPT fibrinogen complex, we believe, really will be a driver for revenue growth through the end of the decade. And the focus right now is to continue to develop the real-world outcomes data, penetrate across the U.S. and ultimately target OUS opportunities. And lastly, we talked about the red cell opportunity and really with the goal of getting the product approved in Europe in 2026 and completing the RedeS study so that we can look to filing a PMA in the United States. And with that, are there any questions? Thank you all for joining this morning. Appreciate it.