All right. Well, good morning and welcome. Elizabeth Garcia, UBS Life Science Tools and Diagnostics Analyst. I'm joined today by my co-coverage, John Sourbeer, as well as Jim Hippel, the CFO of Bio-Techne, and David Clair, the IR. Well, thank you guys so much for making the trip out.
Thanks for having us.
Really appreciate it. Let's just start off, let's set up the discussion. Let's maybe get high level, Jim, and background with the earnings. Obviously, you just reported the end of your fiscal 2023. Can you kind of walk through the variables that you're monitoring and thinking about as you're thinking about how fiscal 2024 can maybe shake out and the growth outlook, particularly maybe thinking also about the second half, obviously, you know?
Sure.
interesting times, so.
Yep. Yeah. I'll maybe first try to characterize how we think about our fiscal year 2023. I mean, if you listen to our earnings call, we kind of use this terminology that we came up with, having the way the, the COVID halo that we've experienced the last couple of years, followed by the COVID hangover, as we call it, this, this past year, right? You know, for I think all the life science tools companies, whether they were directly involved with COVID testing or COVID vaccine manufacturing or what have you, they all saw a COVID halo lift from indirectly from all the additional money that was flowing into the space because of the COVID pandemic, and that money being reinvested back in R&D and accelerating programs and taking on new, you know, newer programs that were further down the pipeline.
There was this COVID halo effect across, I believe, the entire tool space, and that included us. You know, in, in retrospect, maybe you didn't see it at the time, but in retrospect, it was clearly the case. Now with obviously, and thank goodness, you know, the pandemic hopefully behind us and, you know, the vaccines and the testing obviously very much moderated now, that money is, there's less of it, especially in the biotech space, especially. Clearly, I think there's three main . This isn't just for us, this is the whole industry, right? There's really three main areas where this COVID hangover manifests itself. The first one being the lower biotech spending, lower R&D budgets, but lower relative to what? Lower relative to you know, to calendar year 2021 and 2022?
Yes, of course, but still pretty healthy relative to pre-pandemic levels, right? I call it that's what we call more of a normalization, but nonetheless, a major headwind when comparing to the last two years, right? That's the first major dynamic. The second way it may mainly manifests itself is in destocking, and you're hearing that from everybody in the space as well. I think luckily for us, destocking is less of an issue, but still a material bit, but less of an issue because we're not as heavy into the downstream manufacturing, bioprocessing areas where I think that stocking and now destocking took place the most. We're mostly in research, but we do have a segment of our customer base.
It's really only, you know, a dozen customers or so, but, but important customers and the other life science tools companies just like ourselves, who buy our products, namely our antibodies, as a key ingredient into their assays or whatever, you know, their tool that they're providing commercially to researchers. We refer to them as OEM customers, but we also refer to them as licensing supply customers. They behave differently than the one, call it the run-of-the-mill researcher. A run-of-the-mill researcher isn't going to be stocking their products up because they buy what they need when they need it, and they know it's going to be available the next day. If you're a manufacturer and you're having a supply chain crunch that occurred during COVID, you're buying up everything you can because you're afraid it won't be there, regardless of past history.
That's what happened with these handful or so customers of ours, life science peers, customers of ours. We started to see it happening because many of these customers, we also get royalties off their products, and we get to audit their end-unit sales as part of that agreement. The royalties were continuing to increase, the end-unit sales were continuing to increase, but all of a sudden, you know, the purchases of our product just kind of stopped. We also know because of our supply agreements with them, they can't swap us out with anybody else. It became very apparent when we went back and looked that, hey, during the COVID, the supply chain crisis, they were overbuying.
At the time, we thought they were anticipating even higher growth, but clearly they were overbuying on purpose because they were concerned about supply. Now in the downdraft, they're winding down those inventories. We're seeing customers that didn't buy anything all year from us, but at least had these handful. For us, it was about a 2% headwind to our overall growth for the back half of the year. I know a lot of the other companies, peer companies, are seeing a lot bigger impact than that because of they played more downstream. Nonetheless, that's the second key theme. The third key theme of the COVID hangover is, of course, China.
I think China, from a geographic perspective, regional perspective, has been hit the most, with variability and ups and downs, and more downs than ups with regard to the whole COVID pandemic and now even the COVID hangover that, that followed. I think similar to other companies, you know, I, I, the overall Chinese economy is, is, is struggling right now with the aftermath of, of COVID. But within the life science, life sciences space, I think both in the short and longer term, it's actually less impacted than maybe other areas because it's such, it's still such a critical area for the Chinese government from a long-term thinking perspective.
Their healthcare is still, relatively speaking, very, very far behind the West, and they know it is, and they've been very public about wanting to continue to invest there heavily to increase the healthcare of their people. The long term, I think, is still a great picture and story for us. Similar to the destocking situation, maybe here, a lot of our peer companies in China, they, they played more heavily in the downstream activities of bioprocessing, CDMOs. CDMOs in China that actually do most of the business for American customers, by the way, and those are the ones that are pulling out of China or cutting off programs in China. Again, I think they're suffering really bad right now as a result of that, our peer companies who, who supply those customers. Our customer base is different.
We're more heavily bent towards research, and the research that's being done is by, you know, largely research institutions that are you know, hospitals, government-owned or government at least funded in some sort. Don't have the same destocking issues that you might have in China. Their customers aren't U.S. companies; their customers are Chinese researchers. It's more of a China for China play. That all being said, we're not seeing the very seared, severe declines that some of our peers are seeing. What did surprise us in China, because, you know, of course, you had to shut the rolling shutdowns in the first half of the year, and when people aren't in their labs, they're not buying our product.
You had in January, December, January, everyone got sick, and they lifted the quarantines, and so literally there was no one in the labs even doing any work. We saw in the second half of our Q3, so call it the late February, March timeframe, it just came roaring back because everyone came back from the Chinese New Year. They were healthy, they were getting ready, wanting to get back to their research, and we were seeing over 50% growth, which is why we said on our earnings call, we think China could have a 40% quarter. We were hedging it a bit even, right? About halfway through the quarter, call it, you know, mid-May into June, it just kind of fell off a cliff again.
There hasn't really been any we've found that talks about this publicly, but everyone who's in the industry there in China understands this, that the Chinese government funding cycle is usually in the April, May timeframe. It just didn't happen. Without any real announcement as to why, it just didn't happen. So it's believed it's being postponed because of the overall general economic malaise that's going on there. You know, whether they're trying to, you know, increase their coffers after all the spending they did on testing and quarantines and things of that sort. It's not a matter, we believe, of yes. I t's a matter of when that comes back, and when it comes back, it'll be really strong. That's been a headwind for us, like it has been for other companies all year in fiscal year 2023.
When we exited Q3 of this quarter going into Q4, we, you know, China was roaring back, so we thought that would be a nice tailwind for us as we got into 2024, and that no longer looks to be the case. In fact, it could be even yet a headwind. We could actually have , at least for the first half of fiscal year 2024, not as good of a year, or even maybe a worse year than we even had in fiscal year 2023 for China. The other parts of the business are continuing. The headwinds are starting to go away. Like the destocking, for example, that major piece for us.
We know from these handful of customers, there's still probably some inventory to get through here in Q1 and Q2, but we think the headwind will be maybe half of what it was the last two quarters. By the time we get to our second half of fiscal year 2024, we believe that they'll have to start buying from us again. Their, their inventory levels will just be too low. That could turn into a slight tailwind for us. Then, kind of going back to China, just to finish off that story. I mean, right now, what we're hopeful for is that, you know, if you look at China, when they outside of their regular funding schedule, when do they put stimulus back in the economy or in life sciences?
For life sciences, it tends to happen either sometime after the summer vacations, like in October timeframe, when academics come back to work, or more often than not, it happens after the Chinese New Year when everyone's on vacation, and they come back to work. You know, we're hopeful that that's the worst-case scenario, that the pause is not until then. That would mean at least our last quarter of the year, if not our last half of the year, we'll come back strong in China. But we can't predict that. We just don't know.
Oh, yeah, China.
China, destocking, and back to the biotech where I started with biotech funding. Biotech funding for us, I mean, it's been growing, just not growing at the rate it has been. Even though we know their budgets are smaller, we're still growing. Now, not like we were, but we believe we're taking share, so that, that's good. It's been very stable for us. We think that stable growth will continue. You know, it remains to be seen whether, you know, how much, when, when the biotech increases will start to happen again. We think we'll continue to take share and grow at that same rate we have been for fiscal year 2023, in the fiscal year 2024. For it to improve in the biotech space, we need to see their budget start to increase again.
You know, there's some green shoots out there, but our base case right now is it doesn't improve, at least not until the back half of this, call it the first half of calendar year 2024.
Okay.
Long-word answer, but that's kind of how we saw the dynamics play out in 2023. Bottom line for 2024 is, aside from China not getting worse, possibly getting better, China worse in the first half, potentially way better in the second half, but we'll see.
Great. Really great color. Just sticking on the theme of China, since we've been talking about it already, can you just kind of level us up with the higher instrument mix that you kind of have in your China business? How that impacts the region and how you think about the growth there?
Well, the reason why we think the first half for us in China will be slightly worse than what it had was for fiscal year 2023, because in fiscal year 2023, much of the impact for us in China was people not getting in the labs, not, you know, the all quarantines and so forth. If they can get into the labs, even five days a quarter, it's enough time for them to place an order on instruments. Whereas with consumables, they got to be at the lab. Every day they're not at the lab, they're not buying our consumables. Our consumables was, was actually more severely impacted by the fiscal year 2023 ups and downs, and our instruments less so.
We think with what's happening there now, it's a bit of a flip, because people are at work, but they are going to the labs. They're just doing very basic research with the funds they have, and as long as they're in their lab, they're buying our reagents. What they are holding off on are the, are the instrument purchases. That is where the kind of the flip is going to be. Because instruments, for us, you look at the instruments and the consumables those instruments pull through, globally, it's around 20% of our business, but in China, it's around 50% of our business. Because of the higher concentration of the mix of instruments in China, we think this next six months will have a more severe impact on us than it did in fiscal year 2023.
Great. All right, let's talk about pharma. Can you maybe kind of talk to us a little bit about your exposures, and just kind of remind us, how you think about, like, large or small mole kind of pharma exposures? You know, obviously, you've talked about the green shoots. Kind of, Just dive a little bit more into conversations with customers, and the puts and takes there that you're having, and kind of how you're thinking about that.
Yeah. We don't think about pharma in terms of small molecule or large molecule. Quite frankly, we kind of play along that whole space. I mean, which kind of gets to, you know, we participate in whatever modality pharma is, is working on, which gets to cell and gene therapy, because we believe that's the next very large modality for healthcare, particularly around oncology and regenerative medicine. And, you know, and so we're participating very strongly there, obviously, and it's a big growth, growth opportunity for us. I t's not that. For us, where our goal is to help pharma along wherever path they're going on, and be there to enable them in whatever modality that the science takes them on.
Pharma has been very strong for us throughout the COVID period. They've been strong for us throughout the COVID hangover period. You know, we won't see any signs yet of pharma, like, dramatically slowing down, but we're not overly concerned about it, because even, even where pharma might, Some pharma is prioritizing, they've announced they're prioritizing making certain cuts here or there, they're still focusing their efforts heavily in cell and gene therapy. That's where we've been positioning ourselves to win for the last five years and laying track there. I think we're seeing that pay off, because we grew over 20% for the year and nearly 30% for the quarter within our cell and gene therapy portfolio, in a year when budgets are supposedly contracting, at least in biotech.
All right. Let's, yeah, let's move over to cell and gene therapy, because obviously an area of interest, for you. I guess, let's start with kind of broadly, kind of how you're thinking about the growth trajectory for cell and gene. You know, you have the Wilson Wolf acquisition, and how do you dimension kind of the opportunity set for Bio-Techne, and how it's positioned? Obviously, cell therapies, you've mentioned quite a number of times, i t'd be great to kind of get how you're thinking about this market.
Yeah. You mentioned the small molecule, large molecule. I think if there's one opportunity this company missed, you know, 20 years ago, was w e could have gotten more entrenched into the supply of the actual clinicals and manufacturing in those, in those drug modalities. Because, you know, at the end of the day, we are a protein and antibody maker. Again, this management team wasn't here 20 years ago, so we didn't make those decisions, but we're looking back on it with a lost opportunity. The beautiful part about life sciences is it's always evolving. There's always a new modality. Now it's cell and gene therapy. This is why we see this as the next opportunity for us. To truly scale, you got to get beyond just pure research.
I think what allows for a potential for that within cell and gene therapy for companies like ours, more so maybe than in the past, is that these therapies aren't necessarily, maybe it's good the terminology, they're not in vitro. They're, you know, the tools, the proteins, the media, the growing up of cells, is all done outside the body, and so it doesn't have the same regulatory oversight, so to speak, or thresholds as it was with in vitro. It still needs the GMP and all that, but it allows, it gives the pharma companies more confidence to call, outsource that out more, because it's not their core capability.
They don't have to have as much control over it, because it doesn't have the same regulatory, you know, hassle, so to speak. Again, that's why, I think it feeds right into our wheelhouse on the reagent side, with regards to what's needed to, you know, grow up these cells, and the media and the proteins. It's what we do. With the Wilson Wolf, we believe, you know, quite firmly that they have the best-in-class bioreactor to actually, where all this magic happens in this container. First and foremost, in my mind, why it's the best and will be the leader, is because it's scalable. It all gets back to being scalable.
This modality for these therapies, to become something more than just a niche thing for that person who has nothing else left to do but die, for it to scale, it's got to become, it's got to become less expensive. Even less expensive, because you can make the argument that chemo is more expensive than even these expensive therapies. It's got to be producible in high quantities. With the methodologies that have been out there so far today, they're just not scalable. When you have to tie a patient up to an instrument for three weeks in an ICU, what have you, it's not scalable.
So that has been our whole strategy around cell and gene therapy, is how do we come up with a solution with partners and now buy- buying companies, that enable a solution that you can produce this in scale for thousands and thousands of patients, in a very, you know, quick turnaround time period? That's what the Wilson Wolf bioreactor helps, you know, the key piece of that scalability.
Great. Well, you know, since you're mentioning scale, let's talk about the GMP facility. You know, I think you've significantly expanded kind of what you think that facility is capable of producing in terms of annual revenue.
Yeah. Now we just got to fill it up.
Let's talk a little bit about how kind of you went from, it was like sub $150 million kind of target to now potentially, you know, maybe reaching $1 billion. It would be great to kind of understand the learnings there.
Yeah, we're learning as we go. We never, we never had a reason to produce proteins at this kind of scale. We're a world leader in producing proteins. You know, traditionally, we put research, which is like a beaker the size of that cup, right? That's actually, that's your quantity. The truth is, I think our team's just the world's best in making proteins, but they've never done it the scale. They did their algorithms to try to figure out what they thought the yield might be at certain scale, but they never had really actually done it and put it in practice. They were, I think, conservative, and rightfully so, in terms of their initial estimates, and scientists tend to be conservative anyway, right?
I think they're even shocked themselves with regards to the massive yield. Every time they do a run, the yield improvements they're receiving. The bottom line, it's definitely a tweak in the process for making it in that massive liter containers from, as opposed to milliliter test tubes or what have you. The amount of yield that they're able to attain, it still is extremely high quality, has been even surprising for them. As we learning every run of the manufacturing process, they learn more and more how to get more yield out of the process. It seems like every six months, that number keeps going up.
To your point, now, it's up to, I think, depending on the mix of proteins, because some proteins yield, higher yield than others, but it could be as much as $1 billion that we get out of factory, w hich, you know, I would say it'll last a very long time because, you know, I want to fill that factory, you know, five years. I don't think that's going to happen.
Can you just remind us how much you spent building the facility?
Yeah, all in, it was around $55 million, something like that.
Okay.
Yeah.
Sure.
You know, honestly, from an ROI perspective, that investment, internal investments usually are your best investments anyway, but to put that in perspective for you, I mean, I don't know, three, four years ago, I think we were doing, like, $5 million a year of GMP proteins out of our existing RUO facility, you know, and now the run rate is near 50.
Okay.
The margin's like, you know, 90% contribution margin, so $55 million was a pretty meager investment for what that will be in the future.
Certainly. All right. I guess kind of maybe just circling, I'll do one more, and then I'm sure John will have some spatial questions. Just academic, it's your second-largest end market, just so that we're kind of rounding out behind pharma. How should we think about, you know, you did talk a little bit about China, but current dynamics across geographies, how you're feeling a bout that market and growth and, you know, how you're feeling about the funding environment?
I mean, we feel good about academic. because it doesn't have that whole, you know, the manufacturing downstream potential, it hasn't been our major emphasis. We've been emphasizing more and more towards the biopharma side, but academic, all research still starts there, then it goes to biotech, then it goes to pharma, so you got to have a foothold in academic. You know, what's interesting is even during the double-digit increases in NIH budgets that occurred through the COVID pandemic, and in our space, because we monitor all of our peers, no one was bragging about massive growth in academic. It's about a mid-single digit growth, kind of, and that's kind of where we were, right?
Now there's all this, you know, concern and discussion around what if budgets go down or flat, you know, which they could. Congress always starts out low and then usually ends up giving some increase, but nonetheless, not the increases we've seen in the past. I can't prove this, you know, what's interesting, this past quarter was the best academic quarter we've had in, throughout the whole COVID period, in the U.S. It's been strong in Europe now for several quarters, actually almost the whole year, because of the Horizon program going on there, and that still has a ways to go, which is great. In the U.S., we had the best quarter, this most recent quarter, and that's when all this concern around funding is, is happening.
It seems kind of, like, you know, illogical. I have a theory, and it's my theory only, really, but it's that, you know, at the end of the day, yes, NIH budgets were increased dramatically during COVID. Why? To fight COVID. That's not where we play. We don't play strongly in infectious diseases. As long as those budgets don't decrease by double digits year-over-year, and they stay at, at that relative level, where's that money going to be spent in the future? It's probably not on COVID. It's going to be redirected back in the spaces where it traditionally went, like oncology, neurology, things where we do play very strong. Maybe we're starting to see the start of that now already. I don't know.
The bottom line, we've always said this, NIH funding levels have not always been a very good barometer of how our actual academic business. It's much more important where that funding is being spent on, or what it's being spent on, than the absolute level. Clearly, higher levels overall raise the water for everybody, and lower levels can lower it, but for us, it's more important on where that money is being spent.
Great. John, I'm sure you have some questions.
Sure. Yeah, maybe wanted to start off on the spatial market. I think you kind of framed it as maybe 15%-20% industry growth, getting to maybe a $2 billion TAM. If you look at some of the companies, the imagers out there, even some of the other consulting reports, you may be pointing to higher growth. I guess, where, where do you see where you play in the market? Just maybe start there, just high-level overview of the spatial market.
Maybe we're just being conservative, I mean, to some extent, right? I mean, because I think we came out early in the early days of ACD saying 20%-30%, and it's been growing closer to 15%-20% for us. It's like anything else. When you have a nascent market that's brand new and emerging, it has fits and starts and, you know, gaining wide, broader acceptance.
I would say this, and we'll hear more about this on investor day because we're building up that story right now as we speak, so I'm not going to quantitate it right now, but that was a key reason for our Lunaphore acquisition, was to truly enable the kind of higher growth rates that we think we should expect from our spatial franchise. We think we should actually not grow as fast, but faster than the actual spatial franchise, given our technology. But the biggest limiting factor, I believe, as well as our ACD franchise has done, our RNAscope franchise has done, what the biggest, innate, as such, the biggest headwind, if you want to say, to even more accelerated growth, has been the lack of automation.
It's a very slow process, particularly if you want to do more than , you know, one target, a 100% manual. This Lunaphore platform, I mean, it's like a night and day comparison in terms of the speed. We think that really will be a huge, huge impetus to , accelerating our growth from here.
I think, if I could just add one thing, we, we actually play in the translational space. A lot of the other players out there are on the, the discovery side.
Yeah.
Slightly different.
Well, that's a great point, Dave, because that, one of our views is that the accelerated growth is still yet to come. Because we're downstream from all that discovery, and it has to start there before it gets into the translational. If the growth is starting to really take off on the discovery side, to me, that's a very good sign of what's to come for the translational, where we play.
Thanks. You know, you mentioned the Lunaphore acquisition. You know, I think previously, you know, Bio-Techne has had partnerships with multiple other, like Akoya out there. You, you just talked, I think, you know, the Akoya partnership, there was press release earlier this week , you know, that ended now with the acquisition. I guess, can you just talk about maybe the change in strategy now that you've brought in a platform here?
Yeah. I wouldn't say it's necessarily a change in strategy. We still want to be able to be used on as many different instruments as, as, as possible. It really gets down to what's the right tool for the right job. There is no instrument that does, is the end all, be all for every application that you may want to use, say, RNAscope. What, with regards to Akoya specifically, the Lunaphore instrument that, you know, we, we're partnering with them as well. The reality is we hadn't with both Akoya and with Lunaphore, we actually started later with Lunaphore. We found them later. We still hadn't perfected our RNAscope for use, you know, so that it works as well on the instrument as it does on, on a manual basis. We're still working on that.
When we found Lunaphore, and not only, you know, quickly reached the level of sophistication we did with Akoya, but even surpassed it in a very short period of time, you know, we have a very, very high level confidence that Lunaphore instrument will work the best with our RNAscope application. Frankly, the right tool for the right job is very close for Akoya as it is for Lunaphore. You know, we kind of had to pick one to put our resources on. We didn't, you know, we couldn't put resources around on both. Then when we bought Lunaphore, that made that choice even more obvious.
T hat's the dynamics. That's a slight difference between, say, Akoya and any other partnerships we may have with other instrument makers, is Akoya was just very, very close to being the job, the right job for the right tool as Lunaphore, but we think Lunaphore is the better tool. Other instruments have applications for ACD, too, but maybe different applications.
Appreciate it. I'll turn it back to Eliza.
Great. All right, I guess let's talk a little bit about the other piece that kind of you guys have been highlighting, which is with the biopsy. I, you know, I guess you guys have been kind of one of the companies that have really talked about exosomes and kind of the value there. Maybe, you know, and you have the ExoTRU platform. Can you just talk a little bit at first about kind of how you approached it in thinking about exosomes kind of versus like maybe ctDNA, and what kind of led you to, to the strategy that you've adopted?
Well, even high level than that, you know, going back to the early days of Chuck's tenure here, I mean, we talked about that, hey, we want to really scale this company and exponentially grow it. We got to be more than just pure, pure research, right? Where do you go? You go, more downstream into the biopharma, you know, drug, you know, clinicals and manufacturing kind of prop way. From a assay perspective, you go more downstream into an assay. Every diagnostic in a day is an assay. So you go, you get out of research and go more downstream into the clinic, and ultimately you have a diagnostic. So that was kind of two. With our assay franchise, the path was, let's go downstream closer to the patient, where there's more scale.
With our core reagents, it was, let's go closer to the manufacturing process of making drugs. That's kind of the big, big picture. We're doing that with cell and gene therapy and biopharma. Now with diagnostics, it was more about, okay, if we're going to go down that path, we've always said we're not a commodity-based company. That's why we pride ourselves on being differentiated, having high profitability as a result of that. We're not going to go with a me-too product or head-to-head with someone who's already well established. It's got to be something that's new to the world. We knew liquid biopsy was kind of, you take the next generation where diagnostics are going, similar to cell and gene therapy is for drug therapies.
You know, we were looking at all these different cell-free DNA and circulating tumor cell players, and this and that, and there was nothing that jumped off us, that really felt like we they had it truly figured out. You know, as maybe simple serendipity, we found this company, Exosome, and, we must have worked with them for over a year and a half, really understand their technology. Just at the end of the day, our top scientist said, this is the one. This is the technology that can truly, truly win. Now we can get into all what's happened between now and the regulatory and anything else, that we were probably a little bit unprepared for, that we learned a lot on going forward.
But to this day, nothing has changed from whatever it was five years ago, or four or five years ago, when we bought them, with regards to the fundamental technology we still believe is absolutely the most superior. Simplistically, from my layman's perspective, how I understand that and why that is, is because when it comes to using exosomes as a modality for finding biomarkers, there's just many, many more of them. I'd say, I mean, like, exponentially more of them in your in your bodily fluids than there are, say, cell-free DNA or circulating tumor cells.
They're easier to find. Once you find them, they're easier to interrogate, because they haven't been eaten up by, you know, enzymes and things like that, that are also floating around in y our fluids, because they're protected by that exosome, I call it bubble, but that cell. You know, once you do interrogate them, and you find the biomarker you're looking for, you have a much better probability of understanding precisely what organ or what part of the body that, that came from, because that protective bubble, as I call it, that's around the DNA and RNA, is, is, is essentially made from the same protein as the originating cell. You get a leg up there as well.
Those three things alone, you would argue, are good enough to say, h ey, the exosome is the right technology. There's actually one more factor that to me, it blows it all away, and that gets back to early detection. Why is it a better modality for early detection? Because exosomes are released from a cell from the time it's born, all through its life, and then as it's dying, as it's dying. Whereas cell-free DNA are excreted from dying cells. By just by pure biology, by looking for your biomarkers within your exosomes, you're going to find whatever you're looking for sooner and allow for the chance for earlier detection.
Great. I know I next mentioned ExoTRU, and we'll get to that, but ExoDx Prostate.
Yep.
I think you've gotten past 100,000 tests at this point?
Yeah.
How are you thinking about the adoption curve going forward, indication, expansion, kind of, can you kind of frame for us how you're thinking about the growth opportunity here?
Just with the test we have now, the upside is still, I mean, we've barely even touched, scratched the surface. To put that in perspective for you, we have maybe 15% of all urologists that actually even know about our test and have tried it once. There's still an 85% market to go after there. As importantly, of the 15% of the urologists that have used it at least once, we monitor how often they're using them, and then, you know, t he rate of adoption, and they're actually into their practice and their workflow. Like anything else, it goes up over time as they get more comfortable with it, and they understand how to use it in their diagnosis. The average is around six tests per doctor per quarter, so six tests per doctor per quarter.
Our doctors who've been with us, you know, for a couple, at least a couple years, many of them are up to over 25 tests per quarter. There's a 4x to 5x increase in just utilization from our existing, on average, from our existing base, not to mention the 85% we haven't even gone after. We're just, just still scratching the surface. The story is very much resonating. I think we know one of the key things was it when, when the test was originally launched, it was launched as a way to prevent biopsies, which was a great marketing message for the patient, but it's not. The patient doesn't have control over prescribing the test, the doctor does.
We've done a lot of studies, there's been a lot of publications on this, where we've proved out that there's so many patients who are advised by their doctor to get a biopsy and never show up for it because it's so invasive and, you know, on and on and on. They just don't, they don't even show up for it. There's a lot of good studies out there that show that I think it's something like 60% more patients will return for their biopsy, recommended biopsy, if they have t he Exo test, tell them they have a higher, a high EPI score. It's actually now a tool that to get patients who should have the test to take the test, and that's really resonating with doctors now.
They understand it's not just about taking business away from them, but to truly help them make the right decisions for the patients, while at the same time actually, you know, helping them make some money at it, too, in terms of getting the right patients in for , you know, the right procedures. That's helped a ton. Of course, we got all the NCCN guidelines now through Medicare, so we can actually now have recurring tests now. It, it's meant to be a monitoring test anyway, so we can now have repeat tests. Then getting back to the core of the test itself, it's not reliant on anything else. It's a standalone test, meaning, so it's much more scientifically pure. It doesn't have, like, PSA as a part of the test.
More importantly, for the patient, there's nothing about it that's, you know, invasive. Like, there's a few a couple of that are out there that we know are basically taking share from you. You require DREs and things like that. The other piece of this is that you can take the test from home. You can.
Okay.
In fact, I think almost half our tests now are being done from home. If the doctor prescribes it, before we had the take-home kit, it was a pain because it has to be the first draw of the day, so you had to reschedule another appointment to come in, and patients wouldn't show up for their second appointment. Now, the doctor can just give them the kit, they can go home, pee in a cup, send it in, and it's done. That has helped the uptake a lot in terms of getting, you know, the patients to follow through with it.
Interesting. I guess, how do you guys disclose kind of the adoption with the at-home versus kind of the increase that you're seeing by having that optionality?
It's hard to say how much, but the fact that at-home has gone from zero to, like, nearly 50%.
Okay.
it definitely helps. There's no question.
What about ExoTRU and the transplant monitoring platform? Can you talk a little bit about your strategy? You've got a partnership.
Yep.
And kind of obviously, this test is a little bit different than I think maybe some other ones, right? It's urine-based. Maybe just kind of walk us through and then kind of your strategy as well, and how you're thinking about attacking, tackling this market?
It is urine-based, and so, you know, these transplant centers, there's only a few of them, and so if patients live far away, they would have to drive hundreds of miles, perhaps, to, to have a test done in a traditional way, which they actually take a biopsy. You just got a brand-new kidney, now you're going to take a piece out of it? I mean, it doesn't make sense, right? If you have a, a non-invasive way, such as urine, to do that, not only does it not damage the new kidney, but it can be done from hundreds of miles away and, and mailed in or what have you.
Just like I explained, the exosome platform, the test has demonstrated it's got earlier detection of something going wrong, but also is able to decipher what is truly, or better, a better job of deciphering what is truly something going on with the kidney that's related to the transplant itself, versus something else that could be causing the inflammation or what have you. It just does a better job overall, doing the job of what it's supposed to do, which is the kidney working or not working, as opposed to false alarms and things like that.
Obviously, the Thermo team evaluated quite heavily, and they believe so, which is believe in it as well, which is why they've taken on the cost of taking it through the trials and so forth, and they have the channel for it. I think the ExoTRU is a good example of what one of our three key strategies are with exosome, and that is for new-to-the-world tests for new indications, our strategy will be to partner with those that already have an existing channel. Because, you know, it's expensive, as we know from diagnostic companies, to build up channels of sales teams and marketing, everything else, for all these different types of doctors.
That's when most diagnostic companies lose a lot of money, because they try to do that. We're not gonna try to do that, and I think our technology's, it speaks for itself. The ExoTRU deal was a good way to show that, hey, everyone else believes in this, too. We had three or four companies all bidding to have access to this. Thermo just happened to be the one that won. The technology, I think, is becoming more and more proven and accepted, and so we'll partner with every new indication we have for those who already have made the investments on the commercial side. Of course, our strategy with our urology practice, that will continue, since we've already built that up.
To the extent there's any new indications or new next-generation prostate tests that are more rule in, as opposed to rule out, we already have that channel built out for that. Then the third strategy around exosome is really to leverage our Asuragen acquisition. Asuragen does the... what's the word again?
Carrier screening.
Thank you, carrier screening. The it carrier screens, also some oncology screening within the lab, reference labs and hospitals. Doing quite well as a standalone company, by the way, and great management team. They're now running exosome. They've added a third leg to the strategy, which is take those tests that already exist in the market that are used for monitoring post-cancer treatment, to make sure there's not a reoccurrence, whether it's in lung or other. We know the exosome technology is superior to the other technologies out there for early detection and more accurate detection. Let's just roll out new tests that use that technology.
The coverage will be easier to get, because you just gotta show that it's equivalent or better, and the channel is already there with the Asuragen channel into th e hospitals and to the reference labs. And so that's kind of a third-prong strategy of how to get exosome tests to market faster and cheaper.
Great. All right, one more portfolio one, and then... MauriceFlex, the instrument.
Yeah.
You know, you talked about last quarter, traction gaining. Can you kind of, well, A, just remind us kind of exactly why you would use Maurice Flex, and then, you know, who the earlier adopters have been, and what customer set this is, and where you've been seeing kind of the traction?
Yeah. Yeah, it's a little bit above all my technical wheelhouse, to be honest with you. I know that in identifying the purity, identity of a given protein from a QC process, there's a downstream analysis that's also that uses mass spec f or further analysis of that. It's really about, you know, where in that particular workflow, where Maurice is more upstream in that process, and mass spec is kind of at the back end, downstream. A step in between that, which is often used by ion exchange, is to, you know, fractionalize these proteins, so that t hey're more readable, I guess, by the mass spec. That's what this Maurice instrument is, adding that capability, so that then you no longer have to go from this step to that step before you get to mass spec. You can just go right from the Maurice into the mass spec, essentially.
You're actually taking out the LC component of the kind?
For certain applications, yes.
Okay. What customer group have you seen the most traction, or has it been pretty broad?
Well, first of all, it's brand new. The uptake of any new biologic instrument, so we had the iCE and the Maurice, and now MauriceFlex, it's, you know. In just a quarter, it's had the fastest uptake in one quarter of any instrument we have. That, I think there's generally a lot of excitement about it, yeah.
Great. All right, since we have you here, maybe we will end with a financial question and your 40% operating margin target.
Yeah.
You know, obviously, profitability, one of the highest in the industry. Can you talk us through kind of the puts and takes to getting to that number, and how you think about kind of getting there in a couple of years?
Yeah.
Great to kind of-
Well, I have our investor day in a couple of weeks, and we're gonna talk about targets. We're gonna talk about what our targets were, how we see them today, and then talk about new targets in the future. I'll get in more details then. But, you know, honestly, from an ROI, I'd say is this. I t's that things that I think we're all very proud of is, you look back. I'm gonna talk about the revenue growth first, and I'll talk about the margins. You go back to fiscal year 2020, which was just before the COVID really hit hard.
Looked at, at the size of our business then versus the size of our business today, it's almost all been organic because we've done very few acquisitions during the COVID period, and the ones we've done have been small. Our business is over 50% bigger than it was just three years ago. I think why we're so proud of that is because, perhaps unlike other companies who were also a lot bigger, but now are shrinking, we're not shrinking. We're still growing. My point is that growth has been very sticky. This has become our new baseline, whereas everyone else seeing in the industry, see, we wanna talk about a non-COVID baseline versus a COVID baseline, et cetera. We're not doing that. We don't have to.
We're extremely proud of that, and it gives you a sense of coming off a year of COVID hangover and still having a business that's 50% bigger than it was three years ago and still growing on top of that, why we're so excited about the future going forward. From a profitability perspective, and I went back and looked, three years ago, our margins were in the low 30s, and they were 36% or so this, this past year. You know, we add 100 basis points every year on top of that, and, and that's despite some acquisitions we made, which, you know, we did NanoString, which was hit by 100 basis points.
FX, over the same time period, has been a big headwind to our margins, and we still have been able to expand margins by 300 basis points in three years with those headwinds. I think it gives you a sense of just how scalable our margins are with volume growth. Now we'll see that perhaps detract a bit now with the new acquisitions we made with Lunaphore. My point is that everything we've, everything we organically and inorganically, it's all about profit, profitable growth. That is what's core to us. Really, how fast we get to 40% depends more on our internal investment decisions, not because we have to do something drastically different to get there.
We'll make the right call to manage that absolute short-term margin profile with long-term growth prospects every year. It's not like we have 40% plastered all over our walls, and we're, you know, doing everything we can to get there, because honestly, we proved, we proved during COVID, it was actually two quarters in COVID, we hit 40% because we weren't traveling, as an example. We, we could hit 40% tomorrow if we wanted to, but there's obviously a strong balance between that and investing for the future. Our teams still have way more ideas than we, than we are willing to give them money for, to invest and grow this company. That's exciting.
Yes. really good preview, hopefully, to the analyst day.
Yeah.
I really appreciate you guys coming. Thanks so much. Really good conversation.
Yeah. Thank you so much.
Thank you.
You're welcome. All right.