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Stephens 26th Annual Investment Conference | NASH2024

Nov 21, 2024

Jeff Garro
Healthcare IT Analyst, Stephens

All right. Good morning, everyone. I'm Jeff Garro, the Healthcare IT Analyst here at Stephens, and pleased to have the team from Certara here with us this morning: William Feehery, CEO, and John Gallagher, CFO. So thanks for joining us, guys. Appreciate it.

William Feehery
CEO, Certara

Thanks, Jeff. Great. See you.

Jeff Garro
Healthcare IT Analyst, Stephens

We'll just kick right into the questions and want to start with a macro perspective. It's a question we've been asking everyone this week with a little bit different flavor depending on the end markets. Want to see if you have any perspective you could relay from clients or that you guys have internally from Certara on how we should think about the new administration, potential leadership changes at the FDA. Maybe a more helpful way to frame it is, if you have any detail you can provide on how far removed biosimulation and the similar work that you do is removed from policies that could be influenced by a political appointee.

William Feehery
CEO, Certara

Okay. Thanks for the question, I guess. So I think it's obviously the subject of lots of customer discussions, but I think a lot of it really translates to it's a level of uncertainty that hangs over the industry right now. You're in an industry where people make long-term bets, so uncertainty doesn't help. But nobody really. There's kind of a range of what they say and what they may do, so it's anybody's guess right now. Our view of this is, well, number one, I think there isn't any direct impact to healthcare software companies that we can see or to biosimulation. So if you want to look at vaccines, for example, it's a very small, really tiny portion of our revenues coming directly from vaccines.

If you look at what they've said kind of strategically is they want to hold pharma's feet to the fire to become more efficient, and that actually kind of fits along with our overall message. As far as the other part, I think our business is pretty healthy right now. We have a good third quarter. We have a good pipeline right now. We haven't seen any kind of a shift in anything after the election. I think most of it, from our perspective, is just people talking and being nervous, but waiting for a little bit more information on what the policy is, and then people will align around it. I would say we're watching the same as everybody else, but we're not really expecting any direct impacts on Certara.

Jeff Garro
Healthcare IT Analyst, Stephens

Makes sense. I appreciate that. Then maybe more broadly on the end market, want to check in and ask what macro indicators you guys are following most closely and see as most impactful on Certara's business. And even maybe more importantly, what your sales teams on the ground are hearing in their regular interactions with the purchasers and end users of your biosimulation software and services.

William Feehery
CEO, Certara

So from a macro perspective, what drives Certara is pharma R&D spending. And I guess you could argue it's a lagging measure, but NDA submissions is a pretty good indication of success in pharma, right? So those submissions have been down a little bit over the last year. And obviously, a lot of pharma companies have been pulling back. That's not news to anybody, I'm sure, who's followed the industry. We've got a pretty healthy pipeline coming into the second half of the year. We've said that before. We have seen an increase in time to close deals. Not that we're losing deals, but it feels like particularly a lot of big pharma has more process and signatures required. And so what used to take X number of weeks now takes longer than that to close. But we haven't seen an increase in really the competitive situation.

And the pipeline has grown pretty nicely. So one thing you do there when things are closing more slowly is you work on increasing your pipeline. I think we've done that pretty successfully. So I think coming into the third quarter, we had, I think, a decent level of bookings. I think we had the ability to close more, and some of the stuff rolled over. So that's kind of my point about length to close. But going to the fourth quarter, pipeline's expanded, and I think we're feeling reasonably confident as we go forward here. Any comment you want to add?

John Gallagher
CFO, Certara

Yeah. I think the only thing I'd add to that is, like Bill said, I mean, the Q3 bookings were pretty good and software very strong, which was good, but services bookings were growing as well. And then as it relates to the fourth quarter, we did, given the uncertainty that we were just describing, then we did revise out the typical seasonality out of our expectations in Q4. And so as we look at it, we're happy to see that the pipeline is strong. But given some of the elongation of the decision-making cycle and some of the cautiousness, we decided to take that out of Q4, and that would really be upside if it played out.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. I appreciate that. Maybe just to double-click a little bit further there and appreciate the remarks about evolving the expectations to remove seasonality, but would appreciate any further comments on your views on your clients' budgets and how it relates to typical year-end budget flush and whether any of the elongation that you've seen from reaching an agreement to a final contract relates to just kind of tactical management of the budget process as we roll from one year into the next year by your clients?

William Feehery
CEO, Certara

Well, I mean, there's kind of always a budget flush in pharma, right? This year, we decided we would be more conservative because it felt like the market's softer than it was. So let's not. Maybe some year, it'll be less. But it's part of the nature of things. I think there's two things that goes on. People are trying to spend their budgets. And then over time, we tend to have lots of renewals that happen in the fourth quarter. And that kind of increases over time. I would say right now, Certara is benefiting on the software side from investments we started making a couple of years ago in new products and accelerating the cadence of new version launches with new features. So that's giving us the ability, in the case of our existing products, to charge for those features.

And then we've got new products coming along as well. And on top of that, we've acquired some software companies over the last couple of years, which were all good companies when we bought them, but we've had the opportunity to integrate them and to invest in them. So I think that kind of is going separately from whatever the underlying market is because we've got new things, new products out there that are drawing customer interest. On the services side, we're still growing mid-single digits outside of our regulatory business. We're not giving up price or anything like that. But the overall level of activity in the industry has been depressed compared with a couple of years ago.

That's kind of, I'd say we're still growing, but not quite at the rate we were a couple of years ago and probably not at really the steady-state rate that you'll see as we come out of this.

Jeff Garro
Healthcare IT Analyst, Stephens

Appreciate that. And thinking back to those various comments on the end market, anything you'd want to call out in nuances by customer tier, does any of that apply more or less to large pharma versus your more emerging biotech customers?

William Feehery
CEO, Certara

Yeah. A lot of those dynamics we're describing are generally in the Tier 1, so budget flush activity is generally a Tier 1 customer services kind of activity, and so that's where we're seeing the cautiousness. On the Tier 3s, so the biotech, the performance there has been good. On the back of pretty good capital markets and funding environment for biotechs, then we've seen that benefit our Tier 3 business during the year. I think we're still cautious because those capital markets can be lumpy, and so to the extent that funding isn't as available, we also think that that could whipsaw some there, but we've been very pleased with the performance on Tier 3s, and that continued into our Q3, so a lot of what we're describing are dynamics that are isolated to Tier 1 services customers.

John Gallagher
CFO, Certara

Yeah. And I'd like to just emphasize one thing. So we talk a lot about this budget flush thing. But the reality is our fourth quarter bookings is always the highest book, right? It's kind of just the way our business has worked for years. And so pharma does this. There's structural reasons why we do lots of renewals in the fourth quarter. We signaled a little bit of caution this year because the market is softer. That caution may or may not really have been necessary. But it's not like a cliffhanger where we're sitting on like, "Are they going to do it or are they not going to do it?" There's certainly going to be a bigger fourth quarter of bookings this year, just like every other year, just where our business runs.

William Feehery
CEO, Certara

We had counted on that as we laid out our guidance for the year and everything else, so.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Appreciate that. Maybe we'll dive a little bit deeper into the software business. Want to ask about Certara Cloud, your common SaaS platform for software applications. And if you could give us an update on how progress is for general uptake of that by clients and then what that has meant to date and in the future on your cross-selling efforts.

William Feehery
CEO, Certara

Yeah. Okay. So for those who are familiar, Certara Cloud is our overall platform strategy for how we're pulling together all of this biosimulation software that we have in Certara. We do have quite a number of products that stretch across every phase of pharma development. And so one of the complications we have here is we're selling not the problems that pharma is solving in each phase of development, they're all different, right? And so you need different tools. But yet, there is a linkage across this. The data flows, obviously, from discovery all the way through clinical to approval and to post-approval. And at a high level, you want to use biosimulation and modeling and analytics tools across the chain. So we've got four platforms that kind of naturally occur, four software platforms that are sort of naturally growing by themselves.

We have our Simcyp platform, Pinnacle 21, Phoenix, and now we just bought a discovery platform in Chemaxon. Certara Cloud is our overall strategy to pull that together into a coherent platform that stretches that someone in pharma can say, "Okay, I can apply this across a drug as it's moving through all the phases." It has three phases of what we're doing. One of them is to—this is where we are now. We're centralizing all of the things you can leverage across all of our software. There's one authentication platform. There's a—and kind of the first stage of it is pull together the common pieces of it and then cut the IT costs of our customers who are worried about auditing and security and validation costs, right, because we can have all that in one place. We've been rolling that out.

I actually don't remember the number, but we have thousands of customers, largely because what's happening right now is if you buy our product, you wind up on Certara Cloud. So there's not really a choice. That's just where our products are going. The second phase of this is going to be to integrate the data model between our products. So as data flows across the pharma development cycle, it will be stored in a standardized way and accessible to all of our products. And then we're also uniting the workflow between the pairs of our products that make sense as there's a handoff. Those things will be launching in 2025 and 2026, but they'll further extend it.

So I think we're making pretty good progress about this overall idea of having one platform in pharma, but we also have to be aware that it's a complicated situation what our customers are actually doing with the software in different parts of pharma. And obviously, we're not going to go throw out all our software and rewrite it into one thing. So you got to take steps to get there.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Maybe to follow up a little bit on the next steps there, the unified data infrastructure and workflow tools. That sounds kind of like the bread and butter of what Pinnacle 21 has done. But maybe that's oversimplifying things. But would love if you could explain why or why not that might be a big lift or a small lift for the company to take those next steps.

William Feehery
CEO, Certara

No, I think it's a natural fit. I mean, a lot of our products need these features anyway. But specifically in Pinnacle 21, the product we bought was used to validate clinical data that went to the FDA. And it's a great tool for that. It's almost the only tool for that. So it's a great product, but at some point, you kind of have all the business that's going to the FDA. What we've done is we've taken that product and we've said, "Wow, that's a great tool." But particularly big pharma companies, all pharma companies hire CROs. They hire labs.

When you do those contracts, you say, "Okay, I want you to go collect some data for me, and I want you to deliver that data to me in some format." And Pinnacle 21 is a great platform to do that because we can say, "Okay, you gave me the data. Is it the right format? Is it correct?" All those types of things. So we've added to Pinnacle 21 a product we call Data Exchange that lets that happen. And that's been one of the reasons why Pinnacle 21 has been growing the same way it has. And then the next stage on that has been around looking at the metadata across pharma.

It sounds complicated, but really what pharma wants to do is they want to define a data standard, and they want to enforce it across all of their CROs and all of their labs where they're collecting data so they don't have to keep revalidating and renormalizing data. So we're investing in that heavily, and that's drawing a lot of attention. But maybe this is where you're going with the question, Jeff, but what Pinnacle 21 is turning into is this platform where sort of immense amounts of clinical data is flowing through that system in a normalized way, and we can tap into that with our other tools that need that data. So everything kind of fits together here in Certara.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Excellent. Exciting next steps. Maybe to translate a little bit of this discussion into the financials, I want to hit on software net revenue retention. I describe it as good, about 108% year to date within the kind of historical range of strong results from Certara on this front. What kind of needs to happen from here for it to get to great, to the 114% kind of last couple of years high watermark that you guys have achieved in at least one quarter?

John Gallagher
CFO, Certara

Right. Yeah. So I mean, we were at 114% in Q1. Q4 and Q1 tend to be our high software revenue quarters just based on customer preference for renewal timing and bookings timing. And what you saw last quarter, it was 108%. So actually, on a year-to-date basis, it's 110%. And as you look back over history, then it kind of averages out on an annual basis at about 110%. So I'd say that when you look at the performance of the software business, meaning revenues have been consistently coming in in sort of the low to mid-teens. And that's a combination of this net revenue retention rate, which is our core customers renewing, expanding. You add price in there.

And then on top of that, you're adding new logos to get to the growth rate, as well as contribution from M&A is really what's getting us to the mid-teens rate. So I'd say that the performance we've seen this year, again, year to date, 110% is about in line with our historical expectations on NRR.

Jeff Garro
Healthcare IT Analyst, Stephens

Got it. Appreciate that. And maybe to probe on a different software growth initiative, and whether it's related to Chemaxon, I know it's relatively early post-close there or other parts of your portfolio. Could you update us on your progress of trying to do more work for your clients in discovery, preclinical, or earlier clinical trial work?

William Feehery
CEO, Certara

So sorry, you're talking about how does Chemaxon fit into other parts of our work?

Jeff Garro
Healthcare IT Analyst, Stephens

Yeah. Just thinking that Chemaxon is part of the effort to get more exposure, more revenue from the discovery part of the.

William Feehery
CEO, Certara

Yeah. So, Chemaxon, we've said for people have asked us for a long time, "What other parts of biosimulation do you think you need to invest in?" We've always talked a lot about the discovery area has been kind of an opportunity for us. The reasons it's been an opportunity is because prior to Chemaxon, most of our business starts in the preclinical phase. It doesn't start with the biggest dollars, but that's where we capture customers. Strategically, if they've chosen the wrong molecule or optimized the wrong molecule, there's nothing much you can really do at that point other than tell them to stop. We've had this vision that if we could get in earlier, it would have two. The benefit to the customers is we would have more influence about what molecule they chose.

And then for the company, we've seen this trend that the earlier we can catch a drug program, basically the more benefit we can have, and frankly, the more revenues we can pull out of it. So moving earlier is, even though discovery numbers are smaller for drugs, it's good for intake. The vision we have with Chemaxon is that we can provide something that can't be done right now. So right now, discovery scientists are looking at what drug matches a specific biological target. What we can do is we can integrate that with Simcyp. So as one of the screening criteria, we can say, "How would this molecule that you're thinking about likely fare when it gets into a clinical trial with a big population of people?" No one does that right now.

And so that's an additional kind of criterion that would ideally let you pick a molecule, a better pick as you're in the discovery phase. So that's what we want to do. That's going to take us well into 2026 to put in place. 2025, we bought a company, which is a great software company. It's growing kind of at the same rate as our software, but it's less profitable. So it's an opportunity, and we've said over the course of the year, we'll get the profitability up to our level. And then there's opportunities, but there's a whole suite of products there in discovery that we can integrate in various ways.

So there's a lot of sort of like the plan we have in 2025, which is we're going to come out with a company that we will be very happy with the price we paid just based on the EBITDA margin that it has. And then as we go into 2026, we'll have integrated this with Simcyp, and we'll have a bigger product play. And then along the line, obviously, we've got a whole set of customers now in discovery that we didn't have that we can leverage. So there's kind of multiple angles to this thing for the company.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Maybe we'll follow up a little bit there on the go-to-market strategy to unlock more of those customer types, those end-user types and parts of phase of the clinical research process. I know you guys have experimented some with free software trials with the light versions of software offerings that you've had. So curious on an update on what's working, what's not from a go-to-market perspective to unlock more of the market?

William Feehery
CEO, Certara

The key, I think, is really to integrate the products as much as possible. So you're right. We do have different models of our software. And Pinnacle 21 has sort of like a freemium model. There's a community version that we don't charge for, and smaller companies take advantage of that. And then when you get bigger, then you upgrade to the enterprise version, which is definitely not free. Simcyp, I wouldn't say we've experimented. We very much have a strategy of launching smaller versions that are more targeted to certain earlier stage groups in pharma. And the reason to do that is because, as I said, data flows through the development cycle. And so we're helping our customers sort of standardize on a platform and avoid the cost and the time of basically taking data out of one type of software and moving it into another.

So I think there's various models we've tried. And I'm not sure that there's kind of one answer here. There's kind of different things going on in each sub-market that's kind of led to those strategies. But overall, you can see from the growth rate we've got. I think we've got a pretty healthy software business.

Jeff Garro
Healthcare IT Analyst, Stephens

Makes sense. And another software-related question. You alluded to the investment in innovation and execution against that to deliver new features and functionalities across a wide portfolio of software products. So I want to ask about both what products are having the most success capturing incremental market share from new customers, and then part of releasing new features and functions every year related to your ability to charge annual price increases. So we'd love to get an update on client reaction and how much they value those incremental features and are willing to pay for it accordingly.

William Feehery
CEO, Certara

Yeah. So our four biggest, well, let's leave Chemaxon on the side because we just acquired it. So our three software platforms, they're all growing. We have kind of a baseline level of investment that we need to make in them because they have a launch cadence. It's either every six months or every year. And I kind of think about that in terms of we get a price increase that compensates us for doing that R&D and for the additional features that we have. Sometimes it goes beyond that. Simcyp often has spinoff products where you get new products or new parts where we charge separately, right, for example. And then we think separately from that, "Okay, from an R&D perspective, what can we do that's different?" Right? So what new products will we launch that are kind of not just within the normal cadence of software?

Those are obviously not price increases. They were doing market research. We were trying to think about how fast can we get there, what will the market size, how fast will it grow, what will the pricing be? A classic example of that right now is we've launched a product called CoAuthor, which is an AI regulatory writing tool. We launched it this summer. We've gotten a tremendous amount of interest from both biotechs and big pharma. It takes out half of the work to write a regulatory submission or something like that. It's a pretty good tool. Now, that's not a price increase. They were kind of guesstimating a market for which we don't really have past data, but that's part of the launch cycle. I mean, I'm just illustrating a little bit of the last couple of years.

We started out five years ago, maybe 20% software or 80% services. We're more like 40% software and headed higher than that right now, and the way that's happened has been very deliberate investment in the software. There's a tremendous amount of opportunity to continue to invest in these products, and Simcyp alone has been a very steady grower over the years because even though it's a 25-year-old product that something called Simcyp got launched 25 years ago, there's so much white space in terms of areas in pharma that no one's gotten around to even modeling where there is nothing you can buy, and as we move into them, we've just been playing that every year, and obviously, it takes a long time, but we've been investing a long time, so every year, more of them are coming out.

I think there's even in our older what we call our older tools, there's a lot of opportunity to kind of continue to grow. A lot of our strategic decision internally is sort of really around how fast we want to invest, right? Some of that has to do with a certain expectation that we've set to our investors around EBITDA margin, which is important because we're a profitable company. Some of it has to do with just the ability to absorb large increases and then organizationally, there's only so much you can do based on the opportunities you have, right? We've been increasing that over the last couple of years and just starting to see the results of that.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Appreciate that. It's probably a helpful segue into some more questions on the services business. And you referenced the opportunity. And one of the gating factors that we've seen to capture more of that opportunity is regulatory acceptance because your clients are a little hesitant to move forward with using biosimulation unless they know that regulators are ultimately going to be interested in that type of work. So we'd like to hear from you guys on some of the work you're doing to increase regulatory acceptance of biosimulation.

William Feehery
CEO, Certara

Well, so that actually is kind of how the whole business works. So no one in this industry wants to do anything the regulators won't support. But the fact is the regulators have been very supportive of biosimulation, very interested and very involved in biosimulation over the years. And so the FDA is one of the, if you look at number of licenses, it probably has. It's one of the largest clients. It's not the largest client by any means in terms of dollars, but in terms of the number of licenses that they have, it's huge, right? So it's very widely used there. They're very interested in additional uses of biosimulation. We recently had the, so I mentioned that Simcyp is 25 years old. So we had a kind of like the consortium had a big meeting in London this year.

And the FDA flew in specifically to go give a talk about Simcyp and their use of Simcyp and biosimulation. So it's kind of a situation where there's some synergy between what they want and what we're doing. So we spend a lot of time basically I mean, and this is a highly regulated area, so nothing happens quickly. But if you have a long enough pipeline of new areas that biosimulation is going into, every year, more and more are being approved. And so that's what's been benefiting us. So I don't really see that changing. And maybe back to your first question, I don't really think that anything the administration's likely to do is going to change that general trend just because it's kind of driven by the science of drug development.

And other tools, the FDA is important, but largely, they're not going to hand anybody a monopoly, but you certainly want to make sure you have a tool that they're willing to use and accepting and that kind of stuff. And that's kind of the way the rest of our business works.

Jeff Garro
Healthcare IT Analyst, Stephens

Understood. Maybe we have a slightly different side of that coin is asking what you're doing with customers to increase adoption of specific use cases. What are your product sales and delivery teams all doing to work together to take one success and translate it into an opportunity, a growth opportunity across the entire customer base?

William Feehery
CEO, Certara

Yeah, it's a great question. So it's one of the reasons why it's great to have software and we kind of have to have software and services in the same company. But a lot of the services are we get hired in services and biosimulation for a couple of reasons. So one of them is because a lot of our customers want the expert who wrote the models to help them out, right? So that makes sense. But a lot of the other reasons are they want something that we don't have in our software. They want it extended. They want it customized. They want to do something cutting edge. And so those are sort of the inspiration for new features for the software. Somebody does something, and then you say, "Okay, well, that's interesting.

“How do we roll that out across the industry?” And that was a little bit of our impetus for why we bought Chemaxon. Because what I described around how we can integrate Simcyp clinical predictions in discovery, we've seen some of our customers hire us to actually start to put that together. “Well, that's interesting. It's a good idea. We have 1,800 customers. How do we start to think about putting that in software so we can roll that out across the whole world?” But there's many other examples. I mean, there's teams in Certara that are working on all the neurodrugs and Alzheimer's and extending those models. There's teams, obviously, as you would expect, there's teams working on weight loss types of drugs and extending those stuff.

Some of it has to do with what are our customers pulling us into and then how do you extend it? Some of it is, as we look forward, we can kind of see certain trends and we sometimes try to get ahead of it. For example, we've done a lot in CAR-T over the years. We've done a lot. A lot of the cell therapy companies aren't really that big yet, but in terms of modeling, we've done lots and lots of work with them in developing those types of tools, for example.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Very interesting. John, maybe a kind of more modeling type question, but also fundamental to the business. I was hoping you could, and we talked kind of at length about the demand environment in bookings, but I was hoping you could speak to bookings to revenue conversion and how we should think about those trends year to date versus last year, and probably a good opportunity as well to talk about project cancellations and the normal course of business and how that might differ than what investors have seen from some of the CROs.

John Gallagher
CFO, Certara

Yeah, thanks, Jeff. So bookings to revenue conversion has been quite strong this year, in fact, stronger than we've seen in the past. And when we constructed the guidance at the beginning of the year, one of the keys around that was working through some of the bookings backlog that we'd had from the previous year. And so during the course of this year, we have been doing that. And in fact, when you saw us take some cost actions at the very end of Q2, that was to boost the utilization on our services team, which really was to further accelerate the actions of having the bookings to revenue convert. So you are correct. We have seen acceleration there. The utilization of the teams is high now that we've taken some of those specific actions. And we're expecting to continue to see that conversion be strong in this environment.

And then the second part of your question was the.

Jeff Garro
Healthcare IT Analyst, Stephens

Cancellations as well.

John Gallagher
CFO, Certara

Oh, yes, on the cancellations. Yeah. So the cancellations, we haven't seen anything unusual there. So we've talked a lot about the elongation of the decision-making cycle to get into a booking. And we have seen some slowness in progress on projects once they're in, but we haven't seen any notable increase of cancellations. So that's a good news piece of what we're seeing in the services backlog. And that's also what's helped enable us to be able to work off of that backlog to have a high conversion rate to revenue this year.

Jeff Garro
Healthcare IT Analyst, Stephens

Understood. Appreciate that. I want to ask about the regulatory business. And I know you're not planning on giving interim updates on the strategic review for that regulatory business, but was hoping you could provide some detail on what the growth and margin profile of the business would look like if we pro-forma that regulatory business out of the financials. And then also just for clarity, if you could help us understand the overlap between CoAuthor software product that you touched on earlier and the medical writing business within regulatory services.

John Gallagher
CFO, Certara

Right. So yeah, on the growth profile, well, first, we sized the business for the first time to be able to give some transparency into not only what the size is, but to your question also, what is the performance in the business, so the regulatory services business is $50 million-$55 million of revenue for us, just to reiterate what we had said before, which represents about 15% of the total company's revenue. From a growth perspective, it's not met our growth expectations, and in fact, had contracted on a year-over-year basis, and you kind of see that come out when we had disclosed that services bookings on Q3, excluding reg, were actually 13%, so that provided some clarity that biosim services, underlying bookings, excluding reg, were really quite strong, and we wanted everybody to be able to have a window into that performance.

From a profitability perspective, we said that the reg business has a CRO-like EBITDA margin that would be in the 20s. It's actually quite richer than that, but anywhere in the range of 20%-30%, depending on when you look at this business on its own, what you put into it. And so that profitability profile, we think, is pretty attractive for a regulatory business. So overall, when you look at the potential, again, we're still in the early stages of reviewing this strategically. But if you were to think about the Certara business, excluding regulatory, then it would be accretive to both the top line and to the bottom line.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. Excellent. Appreciate that. Maybe a good opportunity to pause and see if there are any questions from the audience. All right. We'll keep firing away. I want to dive into profit margins a little bit. And last quarter, EBITDA margins up over 600 basis points year over year to nearly 35%, so closer to some of your historical performance. And as you referenced, driven primarily by cost actions taken in the second quarter. So I think great to see that kind of commitment to margins play out. You also appropriately, I think, set expectations around some of the moving pieces going forward. So maybe you can provide a little more detail on how expenses from the Chemaxon deal that closed October 1st layer in, as well as the continued investments in innovation that you guys have talked about.

John Gallagher
CFO, Certara

Yeah, thanks, Jeff. So yeah, I mean, look, as we were finishing the first half of the year, we noted that the margin wasn't coming in where we were expecting it to, based on the guide that we had on the EBITDA margin being between 31%-33%. We were coming in below that. That was driven largely by some excess capacity on a sustained basis that we were seeing in the services business that ultimately we decided to take that out. So we did that. As you said, we saw the benefit of those actions come in in Q3, and we would expect that to flow through into Q4, so that was all good news. We did that intentionally. That does show the commitment to the margin profile that we said would be 31%-33% on the year.

Now, as we look forward, I think what you're saying is correct. We shouldn't necessarily expect the margin in Q4 to be the jump-off point for next year. And there's a few reasons for that. One is, on a seasonal basis, the margin from Q4 into Q1 always steps down. And there's a reason for that as you re-rack personnel costs in a new year. But compounding that typical seasonal stepdown is also the fact that we're going to continue to focus on investments in software, which includes investments in continuing to integrate and roll out AI across our product portfolio. And then on top of that, too, we have a Chemaxon business.

As you noted, Jeff, when we bring that in, it's going to provide a dilutive effect, most notable in the first half of the year as we work through the integration, because the commitment that we had said at the time that we closed the transaction was that we would get Chemaxon margins up to Certara corporate average by the time we exited 2025, and so during the course of the year, that will have what I call sort of a modest dilutive effect on the margin as we work through the integration, but overall, we're very excited about our performance and the margin that we saw in Q3 and that we're anticipating into Q4.

Then, for the very important reasons of integrating a new acquisition as well as investments to continue to make in our software business that's going to sustain the high growth that we've had there, is going to play out in the margin next year.

Jeff Garro
Healthcare IT Analyst, Stephens

Understood. Maybe follow up a little bit more on gross margins, which have been reaching all-time highs. Not too surprising given the emphasis on software and related favorable mix shift there. But I was hoping you could speak to any drivers independent of mix that we should think about for gross margins going forward.

John Gallagher
CFO, Certara

Yeah. Yeah, Jeff, you're right. It's really two things. One is the mix. And so our software business has been growing strongly. That's shifting the mix from services towards software. In addition to that, we're making acquisitions in the software space. That's also shifting the mix towards software, which does have higher gross margins, as you know. But in addition to that, too, is one of the points that I just mentioned earlier, which is we also took actions in the services business where we saw overcapacity. We did make changes there that increased utilization, which also are increasing the gross margin. So it's really the two things together. We see a mix shift towards software that's improving the gross margin. And then we've specifically made changes to boost utilization, and it's also boosting our gross margin on the services side.

Jeff Garro
Healthcare IT Analyst, Stephens

Oh, great. That helps on that front. We'll transition a little bit to a different main longstanding topic we have time for. I want to ask about capital deployment, whether you could give us an update on your priorities there, including appetite for further M&A and whether with the stock at somewhat depressed levels, whether a buyback starts to enter the thinking there?

John Gallagher
CFO, Certara

Yeah. So for cap deployment, we're always thinking through a menu of options for capital allocation. And M&A has been at the top of our list, as you've seen through our actions. And we've been an acquisitive company, and those have paid off very well for us. We would continue. We have a strong balance sheet. We have cash on the balance sheet. We have very low leverage. So our ability to execute on M&A is certainly there. And we continue to look at the landscape. But we also are aware of where the share price is. And so other cap deployment opportunities are on our radar as well. And that's an ongoing discussion that we have as a team. But I'd say all of those, we evaluate all capital allocation opportunities on a regular basis. And we're considering those now like we always did.

Jeff Garro
Healthcare IT Analyst, Stephens

Excellent. I appreciate that. I guess the one follow-up there would be on potential future M&A. Any priorities that you'd spell out other than software continues to be an emphasis? I'd point out that Chemaxon is one of many existing or previously existing D360 partners. There's other parts of the ecosystem there. It seems like it could be a jumping-off point for a broader platform for that part of the research process. But maybe D360 plus Chemaxon really gives you what you need for the foreseeable future.

William Feehery
CEO, Certara

Yeah. Look, we've just bought three companies in the last year. So I'm perfectly happy just sitting back and getting these right and doing them. Now, M&A is not, the way we do it is not totally in our control in terms of timing, right? So really, there's a lot of things out there. You look at them and when they become available at the right price and the right motivations of the team, sometimes you have to move. And so that's been the advantage. But to your point, we do look at strategically in terms of what's interesting. And so what's interesting to the company, one is what you said, which is there's more in it. We've looked at Discovery a long time. It's a very fragmented software area.

And there are potentially other things we could do as we integrate Chemaxon to figure that out. The other one that's kind of obvious in the company is we have a very small business in post-approval, commercial. In biosimulation, it doesn't stop at approval. People are interested in not just whether I will get approval, but how will the drug hold up really on the market? And so we haven't really done a whole lot in that area, but that's another if you kind of play out the overall strategy over time, that's another thing that we'll have to think about. And then I think there's always people that have interesting ideas kind of within our core market. We've launched a series of smaller products targeted towards preclinical simulations of predicting toxicology, things like that. So those are the kind of things that just ordinary course of business.

If someone has something that's cheaper, then you can build it yourself and think about it, right? but I mean, I'm not signaling I'm not trying to do M&A right now, and like I said, we've got a fair amount of integration to get right here right now, so.

Jeff Garro
Healthcare IT Analyst, Stephens

Thanks, guys. I appreciate that. I think that's all we have time for today. Thank you again for your time, guys. I really appreciate it.

William Feehery
CEO, Certara

Thanks, Jeff.

Jeff Garro
Healthcare IT Analyst, Stephens

All right. Thank you.

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