All right, we'll go ahead and get started. Good morning, everybody. Thanks for being here. Welcome to the Jefferies 2023 Global Healthcare Conference. I'm Brandon Couillard. I cover the life science tools and diagnostics sector here at the firm. Before we get started, I hope everyone in the audience is enjoying the conference. If you learned something from this fireside chat, and I hope you do, or you've just had a great one-on-one meeting, when you get back to your desk, we'd appreciate your support in the II poll. It means more than you know. So, with that out of the way, great to have Waters here and CEO Udit Batra joining us. Great to see you.
Thank you, Brandon.
Maybe to jump in, Udit, we'd love to get your view as far as, you know, kind of what's happening as far as instrumentation demand in your business and in the market broadly. How would you characterize that between LC and mass spec? What's your visibility look like? And any nuances, you know, in terms of end markets or geographies?
Sure. That's fascinating. Great to see you, Brandon. And there was a straw poll going on before we started that this would be the first, second, or third question that would come up. So, see, we're true to form instruments. So, I think I'll start by saying, if you are looking at Waters as an investment, I would urge you to look at instrument growth rate over a longer period of time. Because if you're looking at it quarter on quarter, you'll go crazy, right? And I'm the CEO for the last three years, and I can tell you the quarter on quarter trends are nerve-wracking if you pay a lot of attention to them. But over the long term, instruments grow predictably at 5%.
And the growth is driven by the volume of prescriptions and phase III starts, if you just think of pharma as the key customer segment. And as you think of instruments growth rate, so 5% over the long term, and it fluctuates around that, and we can get into that in a second, but around 5% growth rate, 50-60, so 58-60% gross margin, very low SG&A. It's a replacement business. It's a really darn good business if you continue to replace instruments. It's driven by really three factors. Number one is the prescriptions and phase III starts, which have not changed, right? So, which have in fact increased if you just look at prescription data for our customers. Second, it's dependent upon execution, especially instrument replacement cadence, and it's dependent upon innovation. It's dependent upon pricing.
All three of those factors at this point in time, I would argue, especially for Waters, look better than they have historically. So, that's the second piece. The first causative factor is, hey, what are the leading indicators? The second is, what is Waters doing in that business? And the third, as you look forward, is, are you seeing any dramatic changes in the regulatory factors? And none of that is happening. So, over the long term, we expect the growth to be 5+ %. That's what we've seen over the historic period. Now, I think there's a lot of discussion on the fluctuations, right? And when you look at the fluctuations, there's not a lot of data that can help you guide what's going to happen quarter on quarter or in the future, but there are sort of correlations with macroeconomic events.
There are three periods where there's a significant amount of fluctuation. There's been a significant amount of fluctuation in instrument growth: 2008 and 2009, 2011 and 2012, and 2019, 2020-ish period. In two out of those three time frames, there are conflating factors that don't let you truly understand the correlation between macroeconomics and instrument growth rate. In 2008 and 2009, there was pharma consolidation taking place, right? So, that was superimposed on the economic slowdown. In 2019 and 2020, especially in 2019, Waters was going through a difficult period commercially, right? So, you have to extract those two and say, well, if I want to compare only a macroeconomic driver, then you'd have to say, okay, 2011 and 2012 were purely macroeconomic. 2008 and 2009 had one conflating factor. 2019, 2020 had another.
What you realize is there's usually, even if you take all that into account, there's usually two quarters of steeper declines around a macroeconomic issue. By steeper, I mean high single digits to low double digit decline, and largely on the LC side, and then surrounding it, you see other quarters sort of flattish or up or down, and don't ask me exactly how that lasts. There's a small tail, but two-ish quarters of steeper decline. Now, that's as analytical as we can get with all the assumptions, and again, I'll come back to where I started. If you're investing in Waters and you're thinking about investing in Waters longer term, the business grows roughly 5%, and the fundamental drivers and the execution is better than it's ever been, so I think that's as much as I would tell you about instruments.
I appreciate all that detail and historical perspective.
Thank you.
Maybe if we just look in terms of, you know, so you've assumed that instruments are down again in the second quarter. You've been, I think, a little more constructive as far as your view on mid to large pharma budgets and the back half, I think implying that some instrument growth in the second half. You speak to, I guess, the source of that confidence and maybe any change in those conversations or signals in the last month?
Three factors. I'll start where I ended. One, prescription rates and phase three starts, especially for novel modalities and large molecules, if anything, are trending up, right? So, that's not a headwind at all. Second, our personal conversations that I've had with senior leaders in pharma, my colleagues have had, and senior leaders in pharma all told us about 30 conversations we've had across different people, across different organizations. And there is no cancellation of orders. If anything, there's a bit of delay, right? And the third thing, and this is the most important that gives me confidence, historically, if you just look at Waters' business, 54% of our business is in the second half of the year. 46% is in the first half of the year. We're just reverting back to the mean prior to the pandemic.
So, if 2019 and before, you would have seen 54% of the business in the second half, 46% in the first half, and that is consistent with what we're seeing now. And the last piece is Q1 is the quarter that fluctuates the most, right? So, it's the smallest quarter for Waters. And historically, also, you'll see that this is the quarter that fluctuates the most for us. And we're seeing something that's no different. So, nothing makes me believe that this is a dramatically new trend. It is something that has happened all along. And conversations reveal that. And if anything, the fundamental demand drivers are very robust.
One of your closest competitors in this space has kind of talked about this 12-1 8-month, you know, let's say, cycle or recovery process. In your case, you had a lot of low-hanging fruit, right? That maybe others didn't have the same benefit from. How does that sort of reconcile, you know, those two things?
No, the fruit's hanging low depending upon how much you jump, right? So, let's just put that out there first. But that said, look, there are others in the industry who have forgotten more about LC and mass spec, and I know who you're talking about, a friend of mine, than I have learned in the last two to three years, okay? I'll preface that by saying, by starting by that statement. But that said, I mean, go back to the analytical data that I was talking about earlier, 2008 and 2009, 2011 and 2012, and 2019 and 2020. And what you find is two quarters of steep decline sort of meandering around that flattish or a bit higher, a bit lower, depending upon which period you picked. And the three are not comparable, right?
So, there's not a lot of data that you can use and say, hey, I have a causation. It's a correlation, which is flawed. So, it's very difficult to come up with a robust argument of what's happening. Other than saying, hey, look at the fundamental drivers. The fundamental drivers are the same. They're in fact better. Look at the execution. The execution's better. And yes, we were jumping a bit higher. Depending upon where the fruit was, we were jumping, we've started to jump a bit higher. Yes, the execution's better. The innovation is way better, right? So, we're seeing a lot of, we've seen a lot of new products come in for Waters. The pricing is better than it's been historically. So, none of those factors make me believe that this should last for too long.
Maybe switching gears, as I'm sure you're happy to do. You recently closed on the Wyatt transaction. Waters has never, I don't think, really done a big acquisition. Just touch on what that adds to the portfolio. I'd be curious also as well as to what extent did that business also see an elevated instrument demand period that may be going the other way right now?
That's both a good question. So, Waters Wyatt is about 80% focused on large molecules, right? And one of the fundamental drivers for the acquisition was to increase our weight in faster-growing markets and build our portfolio in bioanalytical characterization, right? So, 40% of the pharma pipeline is large molecules and novel modalities. The characterization techniques for those large molecules are still not to the point where they can all make it into QA/QC in high-volume applications, which is what we have for small molecules. And there is a significant unmet need there, right? And so, we're working with our customers to do that, to bring these sophisticated techniques downstream. And one of the techniques that was furthest downstream was multi-angle light scattering. In fact, I was at a conference two days ago, and there were several regulators in the audience.
There was a lot of our customers in the audience. And I think the talk prior to this one, I caught the tail end of it, was focused on cell and gene therapy for one of the large pharma players. These are exquisitely difficult molecules to characterize. If you find a technique that allows you, for instance, to examine the amount of filled AAV caps, these are viral vectors that are used to transfect cells for cell and gene therapy, if you can find a technique that allows you to characterize these molecules in line as opposed to in QA/QC, you jump on it. And that's what Wyatt's multi-angle light scattering instrument is able to do. It allows us to not only identify the process conditions, but isolate the fractions of full capsids in line.
I showed this data two days ago at a conference, and we had a lot of discussion with the regulators on how to bring that data and use it to file for AAV. Stay tuned. I mean, it's a terrific, I just wanted to give you that example. It's a terrific technology that has made it very far downstream. Now, to your question on the fraction of business that is exposed to different customer segments, 80% of Wyatt's business is large molecules. Out of that, about 80-ish% is large biotech and pharma. 20-ish% was pre-commercial biotech. In pre-commercial biotech, largely in the cell and gene therapy space, which has not seen any slowdown. That business, we've said, will grow low double digit. Historically, it's grown close to 20%. You'd say, well, there's a bit of caution there. Yes, I mean, it's an acquisition.
It's an integration, as you rightly mentioned. It's an acquisition for Waters, over, after a long period of time. But nothing makes us believe at this stage that it's going to slow down.
The 20% earlier stage biotech, but because it's mostly cell and gene therapy and those customers are well capitalized.
Very well capitalized. So, no slowdown in order velocities that we've seen so far.
Bigger picture, I mean, what is your appetite to do additional M&A? And are there certain milestones you want to achieve with Wyatt? You want to keep the organization laser-focused on that asset before you do something else? And what else would you be interested in adding to?
It's a good question, Brandon, right? So, I would say three priorities, right? And when you just think of the period that we're going through, right? So, new management team, commercial turnaround, new products, heavy focus on execution, and all sort of the macroeconomic challenges that we're facing, right? So, there are three priorities. Number one is to do focus on things that you can control, meaning, hey, continue to execute well commercially, continue to invest in innovation, ensure that the acquisition of Wyatt goes extremely well, right? And that's the number one priority. Second, you want to make sure that the teams are healthy and focused. I mean, there's a lot of turbulence out there. You want to make sure the teams are healthy and focused and they're taking care of their families and their health. And the last piece is to put it all in perspective, future M&A.
I mean, our capital allocation priorities don't change, right? I mean, there's a time period that will go through with the integration, but the capital allocation priorities don't change. We're still focused on growth. First, organic growth, making sure that we invest enough in our pipeline with a battery of new products. Then M&A, and especially in the areas that we've outlined, bioanalytical characterization, right? Like I mentioned, UV and mass spec allow you to characterize the chemistry. With light scattering, we'd start looking at the physics. 70%-80% of the characterization of many large molecules occurs with these three techniques. 20%-25% is still pending, and there are some other techniques that we think we want to bring into the armamentarium. So, that is an M&A priority. We want to have more of the workflow in the bioanalytical space. That's an M&A priority.
We think there are small things we can do in the LC-MS clinical space, in the battery space. So, the priorities we've outlined in the past, right? And we will stick with those. So, the capital allocation starts with internal investment, second with M&A, and then third, of course, when the time is right, we will resume our share buybacks.
You've had, you know, quite a bit of new product introduction, certainly since you came into the company. You talk about just the legs that are left there, and you still have, you introduced a lot of things in ASMS. It'd be great if you could touch on the relative importance of those as well as the Alliance iS, the new Alliance iS system.
So, it's across the portfolio. This might take very long, so I'll be quick with this, right? So, it's across the portfolio and very fortunate. And as for somebody who's come from the scientific roots and used these instruments, I mean, this makes me the most excited, right? So, with the mass spec portfolio, starting with your question at ASMS, I mean, again, Waters' mass spec portfolio is the broadest in the industry, and now I would argue is one of the freshest. You start with high-res mass spec. There we have our Select Series Cyclic IMS instrument that's started to gain a lot of traction for examining shapes of molecules in addition to their sizes. The Select Series MRT platform at ASMS, we introduced an even higher speed version while maintaining the highest resolution that's possible for high-resolution mass specs.
As you go downstream and you start looking at other unmet needs for testing and identification of molecules at a very low abundance, this is PFAS testing or in clinical settings. Our Xevo TQ Absolute is the most sensitive instrument in the industry, and we showed enhancement both for the clinical setting as well as for PFAS. Then finally, we expanded our collaboration with Sartorius to not just analyze large molecules upstream, but also downstream. So, that's the ASMS picture, and there was a lot of detail. I said, I'll go through this fast, happy to answer questions down the line. If you go to our workhorse, LC instruments, the most interesting innovation over a decade has come through with the Alliance iS in this space.
This is basically the value proposition for this instrument is to reduce human errors by 40% when you submit data to regulators, right? So, this is an instrument that has a lot of interest from our customers. It's in the largest individual segment for Waters as far as instruments are concerned. So, we expect a lot from that particular instrument. And then finally, if you move into the TA side, we have introduced several new products that are targeted towards characterizing batteries and especially looking at parasitic reactions and early signatures of runaway reactions in battery testing. For informatics, you'll see a lot more news coming through. We've introduced several products on that front as well, but I'll stop here so you can see the whole portfolio is renewed. And the contribution, what is most important to keep in mind is the contribution is still very much ahead of us.
I don't know if there's an easy way to sort of articulate it, but are those incremental, I guess, upgrades or enhancements, or are they more, you know, I guess, step change?
I think the Alliance iS is step change, right? It's been over a decade since a new platform was introduced for high-volume testing of small molecules, right? And customers have a lot of challenge if the wrong vial or the wrong column or the wrong data is accidentally submitted to the regulators. There's a lot of change requests that one has to do, right? And 40% of the errors occur due to those reasons. The Alliance iS, with its enhanced software, with its ability to detect any sort of errors before the experiment starts, reduces that dramatically. So, that's a step change, right? We expect that to make a huge difference for our QC customers. The Xevo TQ Absolute is by far the most sensitive instrument to detect PFAS.
There are 40 molecules that the EPA has outlined that we need to detect in water, in food, and now in human and animal tissues. And that number will continue to rise, but they want to keep increasing the sensitivity of measurements. And the Xevo TQ Absolute can detect molecules at the part per quadrillion level. So, this is a pretty significant advancement as well. And those are just two examples of unmet needs that are significant and instruments that have been developed over a decade to meet those. And these are not things that happen overnight, right? So, it takes a long time to enhance the capability in these areas.
Just quickly on PFAS and failures, not a day that goes by when there's not a headline that I see on that issue. What's your assessment of the TAM size there and how fast is that market growing?
You know, best estimate is $200 million-$250 million, and it changes every day because what's happening is not only are people interested in testing drinking water, they're interested in testing food, they're interested in testing tissue in fish, in other types of meats.
It's everywhere.
It's everywhere, right? And not only are we changing the types of matrices that we're testing, we're changing the levels and the number of PFAS molecules. PFAS is not one molecule, right? There were 40 different ones that the FDA has said different chains. So, think of it as a carbon chain. For those of you who are chemists, will understand. So, carbon, carbon, carbon chains. You have one fluorine, two fluorines, five fluorines, 20 fluorines. You can have very complex molecules. And they don't have to be linear chains. They can be branched chains. So, the EPA is continuing to increase the number and types of fluorocarbons that they want tested in different matrices. And that's increasing the TAM also quite dramatically.
We'd love to get your latest view on what's going on in China. You did call that out, I think, as a source of weakness. It's been a little bit different commentary, I guess, from everybody. Maybe yours seemed more isolated to a smaller subset of customers. Is that right, and how are you thinking about China for the balance?
Yeah. I mean, I think our focus was largely on the pharma segment, right? So but if you just take a step back and look at what we've said about China, we had initially going into the year said, look, things will recover faster right after the lockdowns are done and people recover from COVID. That, unfortunately, was not the case, and I think several others have commented on that, so we've seen that. But if you look at the full year, instead of growing high single digits to low double digits, we're saying China is going to be flat to low single digits, right, and this is three different inputs. Academic and government grew 80+ % for the first quarter, so please don't expect that to repeat in Q2 and through Q4. That'll definitely slow down.
The year will end up likely high single digits to low double digits. Industrial is mid single digits, so assume a slight slowdown given the comps for the balance of the year, so assume low to mid single digits, and pharma will be declining, at least as far as we can see today, and that's our largest segment in China, and pharma is broken up into three parts. CDMOs, we think the CDMOs segment will remain under pressure in China, and we've sort of said, look, that piece of the business will not recover. If anything, the volume will go for contract manufacturing into Singapore or into the U.S. The emerging biotech or the pre-commercial biotech in China completely halted. That was 20% of the business of many of our customers. That has completely halted, and we don't expect that to come back for the balance of the year.
So, I hope that gives you a bit more color on what the assumptions are behind our China projections.
Generative AI tools have been an increasing focus of Jefferies' research platform. It's also a big investor topic. Where are you applying those tools in your business? And how do you see them being applied in the life sciences industry in the future?
It's a fantastic tool, right? I'll give you two examples. One, we are taking with clear firewalls all our internal data and ingesting it into different types of AI tools. So, we've hired a company to sort of take all our data. So, all the queries, for instance, if I have questions on what happened to instruments in Q4 of 2004 and what happened in China exactly at that time, I can get that by typing in a sentence as opposed to having an analyst go and do that analysis, which is a relief for a lot of people. But that's just a case in point, but there are many other predictive ways that you can use it. Second, for our customers, the Alliance iS, in fact, has a machine learning algorithm.
Just to sort of embellish on this a little bit, one of the advantages of the Alliance iS is that if you have any instrument on Empower in your network, it can get connected to the Alliance iS. And you can look at the utilization historically and look at the independent factors that impact it and predict what's going to happen in the future. So, not just a point in time, but also what happened historically and what drove the different utilization and demand. And it's a fantastic step forward. But the iS is one area where we've applied it.
Unfortunately, we're out of time, so I'll leave it there. Thanks so much for being here, everyone. Y'all have a great day.
Thanks.