All right, great. Good morning. We'll go ahead and get started. Welcome to the Wells Fargo Healthcare Conference. I'm Brandon Couillard. I cover life science tools and diagnostics here at the firm. Thrilled to have Bio-Techne with us back at the conference this year. And joining us for this conversation, CEO Kim Kelderman. Kim, thanks for being here.
Thank you, Brandon. Thanks for having us.
Maybe to kick off, it'd be good to just start with a recap of your fiscal forecast and kind of walk through what played out differently, perhaps relative to your initial expectations, and what would you kind of pick out as, I guess, some of the key themes and takeaways?
Yeah, fourth quarter came in in line with our expectations, 3% organic growth. We had kind of mentioned low single digits, so on the high end. And it was actually a quarter that definitely got carried by certain end markets. Pharma, large pharma end markets had performed very strongly in Q3, and so they did in Q4, which is the double-digit performance. Low single-digit performance from the biotech area. And yeah, from a product line point of view, very strong performance in the proteomic analytical instrumentation. They had their third quarter in the black growing, and the instrumentation had been growing back into double digits in Q4. So that was very strong. We had a little bit of a headwind in academics, counterbalanced by some tailwind academics Europe. And then in spatial biology, most exposed to academic headwinds as well as in biotech headwinds.
There was a little bit of a pullback, and we also had some issues installing new instruments in the Middle East during the quarter, so that was a little bit of the downside for the quarter. A positive surprise, if you ask about surprises, is definitely that China came in double digits, but during our earnings call, we want to be clear that we don't believe that China is at double-digit growth levels just yet. That was, in our mind, mostly based on some pull-ins from customers trying to avoid tariffs because the moratorium was going to expire, and therefore, we were quite happy with double digits in China, but we believe that the status is more a kind of flattish and accelerating growth going forward, but not yet in double digits.
I want to start with China. Maybe we'll just pick up there. You did say low double digits in the fourth quarter. How much of that was pulled forward, and what do you kind of see as the base underlying market right now? And over kind of the long term, what would your expectation be for China growth?
Yeah, as I mentioned, I don't think it's yet at double-digit growth. That was more or less a pull forward. We do believe it has stabilized. We expect a stabilization to take place during our last fiscal year. But it was a little delayed. I think the tariffs created a little bit of turbulence for the Chinese economy and the Chinese situation. However, life sciences have kind of bottomed out, and I feel the China for China business is stable and reset. However, there is some positive momentum from the China for the rest of the world biotech activities, where out-licensing and investment from the rest of the world has stepped up. And I think that will create a positive momentum for that region in life science technologies.
Therefore, I feel that we have a good reason to believe that instead of just pure flat and pure reset, that the growth will continue to accelerate smoothly.
I think your China business skews more heavily toward capital equipment. Correct me if I'm wrong there. And then to what extent have you seen any stimulus benefit from instrument orders?
Yeah, in Q4, not too much. It was more the pull forward related to the tariffs. But in Q3, we had a little bit of stimulus. Most of the stimulus for this last fiscal year were really related to upgrading existing equipment. And we are not a company that has a whole bunch of upgrading high-end equipment installed base there. For us, it's typically an expansion of capacity rather than an upgrade cycle. So we've had some benefit from funding rounds, but not a whole lot. Not that you would think that we're very funding related. To the mix, it used to be 50/50 if it comes to instruments versus consumables. But over the last year, where this business kind of has reset, that mixture has fell more in line with how the rest of the world looks at the biotech consumables mix.
Maybe shifting gears over to biopharma as a whole. You did say it was up high single digits in the fourth quarter and the year. I mean, that's really the high end of the group, right? Just unpack what's driving that growth in terms of applications, pharma versus biotech, regionally. Any detail that would kind of help us understand how you're performing better than most tools peers in that market?
Yeah, thanks for noticing that. We certainly are. Several product lines are doing really well in pharma, and one of them is obviously the cell therapy product line. We had a 20% quarter for Q4, 30% growth for the whole year in cell therapy. We feel that that is an end market with quite some momentum and very promising pipeline. For large pharma also, we've been able to, of course, have instrumentation with the right ISO certification to play in the pharma markets more downstream. Our biologics platform, Maurice and MauriceFlex, are participating in QA/QC setups for bio production. Our Western blot line of Leo, which is a very high throughput Western blot machine, fully automated, very much tailored for the large pharma customer, found fantastic traction as well.
So overall, from a reagents point of view, as well as an instrumentation point of view, we have enabled pharma customers to not only do their research, but also be able to take these technologies into the more regulated phases of their research going into translational and eventually production.
Maybe rounding out pharma, I mean, tariffs, MFN, clearly on top of investors' minds. I think you were one of the only companies and one of the first to kind of say back in, call it May, June, that you did see some slowdown when these policies sort of first started to be talked about. To what extent is it coming up in your customer conversations? I mean, high single digit growth in the fourth quarter wouldn't suggest there's a lot of impact. But what are you hearing from customers as far as they're holding back spending given that uncertainty?
Yeah, so we have not really heard from customers like we're holding back spending. But for us, it was really at the time of the earnings call, an assumption like, listen, is it prudent to look at two things? One is you have two quarters of double-digit growth in pharma, but you also have the rhetoric of possibly 200%-250% tariffs on pharmaceuticals, MFN rhetoric. And then on top of that, I think just days before earnings call, the president had notified 18 CEOs through a letter that he had these plans. And so for us, it was just the best thing to do is assume that they're going to let go of the throttle a little bit and become more careful. And that was the assumption.
Now, how it will play out, we'll have to see during the quarter, and we'll be reporting on that in our next earnings call.
Shifting gears over to A&G, you gave an update on the last quarter that your direct NIH exposure is kind of low single digits now. Impressively, that market was only down low singles in the fourth quarter, hardly a disaster. Just kind of unpack what you're seeing geographically and what you expect from this end market as we move through the rest of kind of the calendar year.
Yeah, academic has been, of course, since February relatively volatile. I'll break it down. 21% of Bio-Techne's revenue comes from academic globally, right? 12% of that is in the U.S., 9% of that is Europe. In the U.S., we feel that institutions that have NIH exposure and that eventually could influence our revenue, that is low single digits exposure. So that's true. We've seen that instruments had a tough time in academics, so they're definitely holding back on CapEx. But overall, the volumes in reagents have held up pretty nicely and are flat or better. And you combine those two, yes, U.S. was down single digits, mid-single digits. Europe was up mid-single digits. And therefore, overall, globally, the academic end markets was neutral for us. We have, of course, high hopes that the U.S. will continue to figure out how to stabilize the funding environment.
We're very happy with the direction it's taking with looking at neurological diseases and oncology, etc. Our product lines are very nicely aligned with that, more so than with infectious diseases. So the direction it's heading is favorable for us. And then if you look at European funding for academics, the rhetoric there is that it will increase with the new Horizon funding for Europe and that they're thinking about substantial increases. So that could actually accelerate some of the activity levels for us in Europe.
Shifting gears over to some of the SBUs. Starting with GMP proteins, I think that business is up over 20%, or I think north of 30% for the full year, maybe 20% in the fourth quarter. What do you think's driving that strong demand for the products there? How sustainable is that? And how tied is that business to biotech? Anything competitively that you call out?
This is a cell therapy business?
The GMP proteins.
GMP proteins, yes. So GMP proteins is part of our cell therapy. Cell therapy is about $80 million or so run rate. GMP proteins of that is $60 million. It's the main ingredient. Yes, it's grown 20% in Q4. It had a strong year with 30% overall growth, but it's lumpy. We had quarters where it was 40%-60%, and I always wanted to make sure that people do not pencil those in as standard rates going forward. And the lumpiness is basically related to some customers that go into the later stage clinical trials, where you typically buy your reagents for the whole clinical trial, and therefore those are multi-million dollar orders. And that makes the business a little lumpier. What you do is try to continue to grow your funnel of customers. So we're right now at 550 customers. 85 of those are in clinical trials.
A handful of them are in the later stage clinical trials, and unfortunately, but at some point we have now zero commercial customers, but that will continue to go up with the number of shots on goal that we have. A little bit later in their life cycle is the Wilson Wolf, which is a company we own 20% of. We will own a full 100% of Wilson Wolf in about 28 months, so it's pretty soon. They have 800 customers started off earlier. And at the end of the day, they also have six of them in commercial, right? And they play in 45% of all clinical studies globally, so very strong footprint.
And we are really keen on further collaborating with that organization, which will become ours, because our GMP reagents, our GMP small molecules all fit really nicely together with this G-Rex, which is basically a small bioreactor to grow your cells. And that way, we can have a very scalable, very affordable bioreactor that helps people produce their cell therapies. And we can link our very high margin reagents, the GMP reagents, directly to it. And that will create a real nice pull through.
How much of the Wilson Wolf business is commercial or late stage? And just help me understand how sustainable the margins are in that business. I mean, even those margins are just remarkable. And once you acquire it, is that durable?
Yeah. So the overall revenue sits at $80 million-$85 million right now. And the last year, the last fiscal year, they grew about 20%. So very much in line with what we are seeing, and that makes sense. And their margins sit north of 70% EBITDA margins right now. We believe that we have to put some controls in place and some other processes that will probably drop it by about 10 percentage points. But our expectation is that we can run it around 60%. And we're very excited about it. Again, there's the pull through, but we've also found that through the Wilson Wolf and through our newly launched ProPaks, which are basically little bags with cytokines and GMP proteins that link directly to the G-Rex.
That way, there are fewer operator mistakes, but also a much reduced risk of contamination, which some of the cell therapy setups struggle with. So the closed system setup that we can provide will really help customers to scale and have high yields. And we think we're pretty unique in that setup and will be a dominant player in the cell therapy setup.
I want to touch on the core reagents business, up low singles in the quarter. Talk about some of the dynamics there. How much of that business is tied to A&G? Are you seeing some benefit from integrated consumables and instrument offerings? And how much pricing power do you have in that segment?
The core reagents, of course, is the origins of the company, right? For 49 years, we've been building our core reagents. A little bit over 50% of our revenue is still coming from these core reagents, and it's a very interesting setup because we have 6,000 proteins and almost 1,000 antibodies, so it takes quite a while to create a portfolio like that, and you have to have all these flavors to really play, so that is a strong position. In the meantime, we've continued to innovate, so you'll see and notice that we have launched about eight AI-designed or aided designs of proteins with hyperactivity or more heat stability, and designing those was a pleasure because now it's not really a natural component. Therefore, you can patent it, and therefore, you can help your customers be way more efficient and effective, so innovation was one.
Our go-to-market is second, so we have a very consultative selling sales force that helps you up to speed with true know-how, and as I said, consultative selling, meaning they help you design your experiments. Once you know which proteins and antibodies you like, you can order them very easily because we have a relationship with Thermo Fisher Scientific, so our products are available on the Fisher website, and that's for ease of ordering, and then we also have a newly established licensing team where if you would like to use our components in your products, then you deal with the licensing team, licensing and commercial supply, basically an OEM relationship, which we now have a very transparent setup and templates for people to have an easier time using our ingredients in the non-RUO setup, but in products, and that's been doing really well.
And then last but not least, some of the roles we're playing in fast and growing markets such as organoids and immunology in general have been really positive waves for this core business as well. So we're quite enthusiastic about the core business itself. We have made sure that the customers can take these RUO reagents into GMP setups. So we have created a stepping stone ladder, if you will, for people that want to take it further. That will, of course, typically mean a price bump. So imagine there's a 100% price for RUO, then you would pay 150 or so for GMP version. Then we have a price step if you want to have higher activity through the AI-designed products. So you would sit at 180%. And no doubt, we will launch at some point GMP versions of these AI-designed ingredients.
And then you can go up to like 2x of a normal price. But then it's very tightly linked to added additional value you give a customer. And therefore, I feel there's a really nice stepping stone, a similar ladder, if you will, for our core portfolio to also command further price.
That's great color. Maybe shifting gears to proteomic analytics. I mean, on the last call, you've talked about seeing traction in expanding use cases for different instrument lines, including Simple Western and viral vector QA/QC. Can you just talk about the opportunity across the portfolio and maybe how much runway there is, particularly in cell and gene therapy?
Yeah, we are very pleased with the performance of our three platforms in the proteomics analysis. Obviously, proteomics are here to stay. Proteomics analysis is truly taking off. Our solutions are easy to use. They also compete typically with the manual forms. So you have the ELISAs as well as the Western blotting processes that we have been able to automate. So not only is therefore your efficiency and your labor costs, your efficiency increase, your labor costs reduced, your consistency in your results, but also many more results that are quantifiable rather than analog. All of it, in general, very, very good. On average, our market share in those three platforms sits at 15%. The highest market share we enjoy in the biologics, which sits close to 20% market share, and growing rapidly. So we have substantial market share.
We have substantial advantages of our instruments to continue to drive our win-loss rate, so we make sure we win more deals than we lose, and then, of course, at the end of the day, very competitive instruments that also pull through our core reagents, so real nice win-win setup.
You mentioned the recent launch of the high-throughput Simple Western, the Leo. What does that add to the portfolio? And just talk about initial reception, maybe relative to expectations and demand profile?
Yeah. Leo is an instrument we launched two and a half quarters ago. Really a perfect story because it was designed for and not by. The specs were set by pharma, and we designed it specifically for large pharma. The project was on time, on budget, and then it hit all our launch expectations from volumes. It's four times higher priced than the previous generation. Also, the throughput is four times higher, but you do get a lot more information around your sample. So there is, again, some value for the customer. Turnaround time is much faster. And now we also have a higher-priced instrument that has four times the pull through of the previous generation. So all around, a real nice new product introduction. MauriceFlex is a new generation on the Maurice Biologics side. There we have added the fractionation capabilities.
Fractionation basically enables you to take some of your sample or portion of your sample and then feed it into your mass spec. Something customers really like as a capability, and we made sure that it also links nicely to some of the laboratory systems. In this case, we talked about the compatibility of the instrument with Waters and Agilent, which is also something that customers value and works really well.
Maybe shifting gears over to spatial for a moment. You really play more in the mid-plex range. There's a number of high-plex players out there. Just talk about competitive positioning. and then what markets or use applications are kind of driving growth for Lunaphore?
Yeah. Yeah, there are really well-established players in the early stages, like the research stages of spatial biology, where you look at few precious samples and you get thousands of data points for you to understand where your thesis could be going. Once you have a certain set of markers that you're interested in and you would like to run some more samples, that's really when you get into the translational space. That's where we feel that we're the best player, and we are the best player because our instrument is fully automated, so you don't have to have any manual interactions during the workflow. You can run four samples at the same time, and you can run them fully multi-omics. That means you can utilize 24 of our RNA targets, and we have 80,000 in a database, but you could design any target that you really want.
And then we have a very nice portfolio, fast-growing portfolio of antibodies that you could use for your protein detection. And in the meantime, if you then want to go further downstream and even higher volumes, but maybe even fewer Plexes, we have really good relationships with the Leica instrumentation as well as the Ventana instrumentation, where you can run higher volumes and fewer markers. And so we basically scoop up the higher volume market there as well. And then that's to be tracked by 10% of our revenues or so in spatial coming from clinical accounts. And it's really good to see that the technology can hold its ground also there in the clinical setting.
Of course, we worked really hard for many years to build the right of technologies, but also to have the right quality systems in place to allow these technologies to play in the clinical markets.
I want to touch on the ExosomeDx divestiture just for a moment. What kind of led to that decision? You bought the business seven years ago. It had been kind of growing nicely, and are there other portfolio changes that you're kind of assessing beyond this one-off divestiture?
No, it was truly the first full year as a CEO. You want to look at the portfolio of products. We've done 19 acquisitions over the last 10 years, and some are great, some are not as good, or sometimes you do an acquisition where you really like the main product, but there are some skunk work products that are around, and in a time of run, run, run, you don't get to clean up, and this was a good phase to clean up, two reasons. The end markets were a little bit quieter, as well as first year's new CEO. You want to take a look at this, so we did a full 360 of our product portfolio and sorted through different lenses, strategic alignment, we looked at financial performance and future growth, EBITDA entitlements.
We felt that the Atlanta Biologicals, it was a fetal bovine serum. We divested that mid-year, which is an animal-derived product, which is more of a commodity that you sell through channels. So this is not really our play. It didn't pull through any of our core reagents, so not the symbiotic relation with the core portfolio, and therefore not a perfect strategic fit. And then Exosome Dx, yes, we really liked Exosome interrogation. So we kept the capability of doing so in kitted products. But owning a specialty sales force, very capable group of people selling into doctors, urologists in this case, and not having the synergy with pulling through any of our other products into that end market was just really hard for us to scale and get the entitlement on the bottom line.
There are companies focused on having the CLIA setup and running CLIA laboratories. Therefore, we felt that it was a great test. Customers, urologists, and patients deserve these fantastic results, but that we were not the rightful owner to scale it. That's why we divested it. It will have an immediate positive benefit on the bottom line of basis points. It will, of course, free up some mind space to fill in the gaps with other acquisitions, not necessarily in the DGS segment, but in general for management to continue on the path of very good and healthy acquisitions.
In terms of the guide, you're kind of the first to sort of guide for the next fiscal year, right? You kind of talked about a scenario where, look, core is going to be low single digits for the time being. Just kind of talk about what went into that assumption. And in the first half of the year, you do lap a tough comp in 2Q. So is low single digits the right starting point just when we think about the first half of the year?
Yeah. It's in contrast to last fiscal year, right, where we said, like, listen, the first quarter will be low single digits, and then we will step up every quarter a little bit because we saw biotech funding getting better. We saw pharma getting over the IRA reshuffle, and we saw China stabilizing and possibly improving. So there we had kind of a 2%, 4%, 6%, 8% growth setup. And instead, we delivered 4% and then 9% in Q1, Q2 of this last fiscal year. So we are accelerating much faster than we expected or more in line with what we hoped for. This year, however, we said, like, listen, there's NIH turbulence as we know. There's some hopefully more clarification along that way that will clarify things. But on our last earnings call, we didn't have a clear view on when and how this was going to get resolved.
There were the pharma tariffs that we just talked about. I've got a lot going on. And biotech funding doesn't look super healthy. In fact, it was negative 40% for the first five months of the year. Now, fortunately, June, July has gotten a little bit better, but that's only two months out of seven, right? So we didn't see clear accelerators. And therefore, we want to take it easy and say, listen, we have done the Exosome divestment . We will definitely deliver on the bottom line. So we'll give you a full-year view on the bottom line, which is we will have 100 basis points improvement. On the top line, under similar conditions, expect a low single-digit environment. And there might be some lumpiness just because we compare against four and nine and then six and three quarters.
So of course, the comparables will start playing a little bit of an effect on it. But overall, we're managing a company, unless there are positive changes, to a low single-digit environment and making sure that we can still deliver on the bottom line.
Maybe don't assume low single digits each quarter per se, given sort of variable comps. But for, I guess, next few quarters, I guess on average, kind of low single-digit assumption would be kind of the baseline floor.
Right. Yep. That's the baseline for us.
Got it. What needs to change macro-wise by end market geography to get back to mid to high single digits? What needs to go your way?
So I think the risk around, and the largest market that we address, is our large pharma is 30% of our revenues. If it is indeed true that it stabilizes with the 15% level currently on the table for Europe and then a Most Favored Nation only related to generics, I think that will be good enough for large pharma to continue the trajectory they were on, and that will be very important to us. Biotech, 20% of our revenues. I think some sort of improvement in overall funding. Right now, we have a certain portion of the biotech customers that are well-funded, and they are closer to commercialization or closer to an exit, and they're after the races, and they keep the biotech results in the low single digits. But there's also biotech companies that are really spreading out the butter.
They're funding to not make as much progress, but more to stay alive. And if those guys could get some funding and then actually start increasing their activity level, that would be definitely a booster that we would need on the biotech side to then also boost into the double digits. And then I think a reset in NIH is already in the making, and that will be eventually a new baseline and will grow from there. So that is more a yeah, that's more going to run its course, and we're not as worried about that over time.
I want to touch on margins for a minute. You guided the year up 100 basis points. The Exosome divestiture gives you 200 basis points at tail end, and you talked about exiting the year up 200 basis points.
Correct.
So, maybe more detail you kind of want to go into. But how should we think about just phasing through the year of margin expansion? And I guess level of confidence that you can get to your five-year target, I think it was north of 35% OPM.
Yeah. Yeah, remind me of that one. And then I'll answer in the same order as you the question. To understand the margin profile, yes, 200 basis points basically coming from Exosome Dx. Why will you not see a full 200 basis points in our bottom line? It's because we kind of want to make sure that in this period, even if markets are not humming just yet, we want to make sure that we invest even more so than our normal budgets in some of that money into our areas where we know we are having great success. We talked about organoids being a wave where it totally makes sense to have better models that are more related to humans, give you better data. It totally makes sense to get out of animal models.
We think organoids are here to stay, and it's all about growing cells in a certain direction, a certain way. And that's really what we do and we're really good at. So why not throw some money after that? The protein sciences segment is doing really well. There are other detectors that we can build in there. And those are investments up and above the normal R&D budget. So we wanted to make sure we double down on where we can accelerate and then therefore increase our re-acceleration speed, if you will. There's a little bit of seasonality in the year. So you know that our Q1, Q2 are basically the summer months and the holiday season. That's typically lower volumes. Therefore, you will see flattish margins and then accelerating the second half of the year because that's when the volumes come in.
Also, a real contributor to that dynamic is that the beginning of our fiscal year is when we do our merit increases, and that's our biggest cost center in the company, which is basically compensation for the Bio-Techne team. And that happens right at the first month of the fiscal year. So you see our cost coming up at the beginning of the year when volumes are a little down, but then the dynamics throughout the year gives us the exit speed of 200 basis points increase.
And then long term, the only business line that right now is weighing somewhat and keeping us from being 35 or higher is the Lunaphore business, which is the earlier stage spatial biology instrument where you still have a big R&D team, you have manufacturing that you are ramping, and you have a direct sales force, which results in a very high cost while you're in the launching process, right? The nice thing is we're very committed to that market. It's the best instrument, so we're winning in the market, and the instrument has a tremendous pull-through. Right now, we're sitting at $45,000 per instrument per year, but it will double because we pull through the RNAscope reagents from our ACD business, and we will pull through antibodies from our core business.
So we are fully committed to that business and know that it has the entitlement to have the margins that we as a company are striving for, so overall, there's no doubt in my mind we'll get back to the 35 plus.
Very good. Fortunately, we're out of time. I'll have to leave it there. Thanks so much for being here. Y'all have a great day.
Thank you, Brandon. Thank you.