Certara, Inc. (CERT) Earnings Call Transcript & Summary
June 4, 2021
Earnings Call Speaker Segments
David Windley
analystGood morning. Thank you for joining our Jefferies Virtual Global Healthcare Conference here on the last day on Friday, June 4. We appreciate your persisting with us and attending our conference. Appreciate your attention and interest. Here to present, I'm Dave Windley with Jefferies Healthcare Equity Research. I cover drug development, supply chain type areas, clinical research organizations, contract manufacturing and clinical technology as well. And in that last category is a relatively new company to the public domain, Certara. The management team here to talk to us today, William Feehery, the company's CEO; and Andy Schemick, the company's So welcome to you guys, and thank you for joining us this morning. We appreciate you being at our conference.
David Windley
analystWilliam, I want to start off with kind of a broad question, just to kind of lay some groundwork around the biosimulation area that Certara -- in which Certara focuses. Biosimulation has a couple of decades at least of history. But my sense is that it is becoming increasingly sophisticated and perhaps increasingly intensively used in clinical trials, And so maybe you could give us kind of a quick historical perspective and what brings Certara to the stage that it is today.
William Feehery
executiveGreat. Great question, David, and probably a good opportunity to kind of introduce biosimulation to people that might be not as familiar with it. It started about -- for us, about 20 years ago. There was a belief in pharmaceutical -- in the pharmaceutical industry that there's a lot that's known about biology and what today is called systems biology. So how are biological processes in the body and in the organs of the body interacting and how will they interact with the drug. So there was a desire to move beyond kind of what we call the traditional pharmaceutical process, which is valid, but it's expensive in which you do a lot of clinical trials, and eventually, you'll come with an updated approve in a -- in a clinical setting, whether a drug should be approved or not. But the reality is a lot is known about the science, and we could model that. And before we start those trials, the idea was that we could take into account all that was known and we can make some decisions from that. So we -- the history here is that about 20 years ago, a number of big pharmaceutical companies came together in what was called the Simcyp Consortium. Their view was, I guess, at the time that to put together the software was more than any one of them wanted to kind of take on by themselves. And they worked together on a pre-competitive basis in this consortium to create what is now the Simcyp software, which has gone on to become what Certara is today with some other products and capabilities added on. And what this enables the pharmaceutical industry to do is to model what happens in -- not only just in one body when a dose of a drug is given, so where the drug goes, how it's metabolized, how it's excreted, how it's acting on the drug target. But it also allows them to model what happens on lots of different variations in human populations. So we can look at people that are older, younger, differences by weight, differences by sex, differences by genotype. And so what you can do with this is you can run what we call a virtual clinical trial. So before you start your clinical trial, you use biosimulation to make some -- to get some ideas based on the known science, what's likely to happen when you go out in the big population of a clinical trial. And by doing that, you can be a lot smarter about designing your clinical trial. It could be faster, it could be smaller, it could be more likely to succeed, all of which is really big money for pharma and has really drawn the attention. So I'm giving you a long answer to this question, but if we kind of flash forward 20 years where we are today, the software has been used in over 80 approved drugs so far that we've counted. Over the last 5 years or so, over 90% of drugs that have been approved, novel drugs that have been approved by the FDA have used this. So it's become a much more -- it's become an accepted part of the pharmaceutical development. We still have lots of white space, lots of different therapeutic areas we can expand into. But this is -- it's an exciting area and it's an exciting tool to kind of improve the overall efficiency of pharmaceutical development.
David Windley
analystThat's very helpful. I want to key in and ask a follow-up on the white space point that you made, is -- I believe that your primary user is a clinical pharmacologists or a pharmacometrician, is the type of person that has the brainpower to understand how to do this modeling and use the modeling. Is the intensity of use of the software or the range across clinical trials expanding? You mentioned therapeutic areas. But if I were to pick a therapeutic area, and think 10 years ago, 5 years ago and today, is it now being used, say, Phase I, II and III where, historically, it would have only been used kind of around the Phase I area? Are there expansions along that axis as well?
William Feehery
executiveYes. So our revenue base has been, for some time, concentrated on actually the clinical phase. We're about -- today, we're about 60% of our revenue in clinical phase. Now we do work earlier phase with companies, but those projects tend to be smaller, so that's kind of reflected in the revenue. And so that's been kind of the case all the time because the kind of the core problem we're trying to solve has to do with how do you design your trial to be more efficient. And that problem is kind of the biggest when you get into the later stage. And we -- the software, as you pointed out, is a pretty sophisticated model. You can use it to add certain -- different questions, depending on the particulars of that drug and what phase it's in, right. For a very -- we often get involved in fairly late-stage questions. For example, there's a lot of use of this technology in working on drug-drug interactions, which is kind of a study that you typically do fairly late stage after you're pretty sure your drug is likely to be approved. We work a lot on things like pediatric translational studies, we're going to take the adult clinical trial data, and we're going to figure out what the dose is and what the treatment regime is going to be in the pediatric regime. So it's not just kind of a phase -- a discovery or Phase I type of thing. To your question about therapeutic areas, we've tried to match with the pharmaceutical industries in. We tend to We tend to go where our customers are interested in. So we've done a lot of work in oncology and in rare diseases, kind of like the pharmaceutical industry does today. We've been making a lot of investments recently in things like cell and gene therapy, which kind of matches a little bit where we see it, a lot of investment going in the future. But there's still plenty of open areas, depending on what investments are going to be made in the pharmaceutical industry that we can tie this to.
David Windley
analystSure, sure. So moving to a little more kind of focus on current, your bookings in the first quarter, kind of consistent with the overall environment or maybe even better than the overall kind of drug development environment being very robust. Your bookings were up 34%, a little bit more heavily weighted toward your services side and your tech-enabled services side of your business. Can you talk about the mix of demand that you're seeing by software versus services? And then also maybe talk about how that is feathering in across biosimulation versus regulatory versus your market access segment?
William Feehery
executiveYes. It's a great question. Maybe I'll let our CFO take a stab at that one.
Andrew Schemick
executiveA moment in the sun. Yes, the bookings were strong in the first quarter. They've been strong for the last 3 quarters. The strength has been across the board, but we did note a particular strength in the biosimulation software, as well as biosimulation services, so accept exceptional growth rates in those areas. What we're not -- what we did see kind of counterbalancing that was some delays in project startups on the regulatory side in the first quarter, attributed to non-COVID clinical trial delays and database locks that are the starting point for launching a lot of that business. But generally speaking, it was healthy across the board on the bookings line. And then revenue conversion. We did see some impact on the regulatory side, but very strong underlying growth rates on biosimulation.
David Windley
analystGot it. And then sorry...
William Feehery
executiveWell, I'd say just to that point, I'll add, we've seen a very healthy uptick in bookings and business from the biotech sector. We do see a tendency in the biotech sector to buy more of our tech-enabled services than our software, and that has to do with the fact that a lot of these companies don't want to put in these big groups of pharmacometricians that are needed to kind of install and run the software. So they will use our tech-enabled services groups to run our software. We run it and do the project for them. So that's kind of reflected in some of the bookings and the revenues we're seeing. But we're seeing pretty strong growth, I think, across pretty much all the sectors of pharma right now.
David Windley
analystGot it. Okay. How would you describe, if you can, how that demand is continuing into 2Q? Would you say steady, or are you even seeing acceleration? I know in a lot of the pharma outsourcing space, 1Q is kind of a seasonally slower start to the year, so maybe you would naturally see some lift in 2Q. But how is that looking as you progress through the quarter?
William Feehery
executiveAndy, you want to take that one?
Andrew Schemick
executiveYes. So we're seeing that, I would say a steady trend.
David Windley
analystVery good. The update that you gave on the first quarter call, your revenue guidance was maintained. Your EBITDA was up a little bit. And with that backdrop of bookings that we just talked about certainly suggests a pretty strong backdrop. I think your posture was that you wanted early company to the public markets, wanted to maintain some level of conservatism. But maybe you could give us a sense for how the visibility of the business is building up underneath that guidance, and what triggers you're looking for that would give you the comfort to improve your outlook?
William Feehery
executiveYes. I can start here, and then I think Andy should comment on some of how we do our forecasting. But you're correct. We are focused on showing that we have a good reputation of saying what we're going to do, and then doing it, so -- in terms of our forecast. We saw strong bookings in the first quarter. Our forecast is -- I'll let Andy talk a little bit about it, but we look kind of in the -- we try to do our forecast based on our past history and past data. And so if that trend continues, we would think about changing the forecast. But maybe, Andy, you want to comment on that?
Andrew Schemick
executiveCertainly, the -- given the bookings performance in the first quarter, the visibility overall increased, which is why we kind of moved up the bottom of the range. I did -- I mentioned earlier, but I'll reiterate, we saw some lengthening and project start-up time on the regulatory side. I'd like to see that come back. We had a strong bookings quarter there. But from a revenue perspective, the conversion was slower than historical on non-COVID regulatory work. The key thing we look at is our bookings, the majority of our bookings convert to revenues in 12 months or less. So I tend to look at the quarter, but I also look at the trailing 12 months. On a trailing 12-month basis, the bookings growth was a little over 20%. And given about a 3% to 5% factor for cancellations or delays in that number kind of points us to that mid- to high teens range. Another quarter of strong bookings would certainly significantly increase the visibility.
David Windley
analystAnd then maybe while we're on that -- thanks, Andy. And while we're on that subject, one of the questions that does come up is the strength in bookings on the services side and the shift in mix towards services is a lower -- relatively lower margin line -- high margin as services go, but lower margin than your software. What are some of the efficiency initiatives or mitigating factors that allows you to maintain margin in the face of that mix shift headwind?
William Feehery
executiveWell, the first thing I'd say is, although we did not -- right now, we don't break out the EBITDA margin by segments. Our services EBITDA margin is quite high. Obviously, software has a higher gross margin than services, but software has R&D and a different selling model that has to be accounted for. So when you get down to the EBITDA line, there -- they're a lot closer than you think. And I'd point out that even though services grew a little bit faster than software, our EBITDA margin actually expanded in that time, which kind of reflects that. Now to your question about efficiencies, the company -- we came from the history, we were small for quite some time, and we've -- as biosimulation has been accepted, we've been growing rapidly. That's given us a lot of opportunities for -- to implement efficiencies so far and we've got more in the future. So a couple of the things were going on. One is we're investing a lot more money in sales and marketing and business development. It's pretty common for, I think, companies after an IPO. But in our case, we want to make sure that we've got a high profile in the industry with our customers and also in the market for talent, which we're always on a hunt for. We are kind of professionalizing the internal organization of the company. We've invested a lot in the infrastructure in terms of our IT systems. So we've got one IT stack, where we're able to track drugs as we find them early in their development phase, and we know where they are as they're moving on and we can bring the right product, service and person to that as they move through development. We are expanding our training and our professional development, which kind of allows us to bring in people a little bit more junior in their career path, and we can -- we've got a good -- that expands our ability to bring people in and to kind of serve our clients in a more cost-effective way. And there's more to be done on that as we go forward and as we get bigger. There's a lot of operational efficiencies we can gain as we continue on our growth journey here.
David Windley
analystGot it. So let's pivot a little bit and talk about new products. In the last quarter call, you talked about some investments in your biologics simulator. I think you also kind of announced the rollout or the launch of the secondary intelligence product. Maybe you could describe how those complement your existing base of capabilities and what has been the initial customer reaction to those.
William Feehery
executiveYes. That's a great question. So These products have been under development for some time. We're pleased to kind of get them out there and talk about some new things in the quarter. We've obviously been working on with biologics for a long time, and the simulator software has been advanced and modified for that for years now. With the Simcyp biologics product, what we've done is we've kind of recognized that there are these 2 -- we've seen these 2 segments. One is big pharma that likes to buy software from us. The other one is the small biotechs that might like to buy a tech-enabled service, where we run the software for them. There's also a group in the middle of companies that aren't big pharma, but they might have come from pharma. They want the software. And so what we've done is we've made a tailored version of the software for that segment, where it's a little bit more cost-effective, and it's a relevant subset of the features of the full thing that would attract that segment. So kind of expanding our reach in different segments of the pharmaceutical market. When -- what we call our new secondary intelligence product is something different. It's a completely new product. And that one, what we're doing is we're using our kind of core simulation technology. But rather than talk about the target that the drug is aimed at, what we're doing is we're looking at all of the, what are called the secondary pharmacological targets that a drug might also hit that you don't intend to. So that's what leads to side effects. And if we can provide some information early on about what side effects a drug might have, I think -- we believe that, that could be quite valuable to the industry, and it's kind of a unique software offering, I think, it depends if this is -- we believe it's the first of a kind. This opens up kind of the world of the toxicologists and the safety pharmacologists as kind of an expanded market for Certara. And we have several kind of like you do in software, we've got multiple versions of -- we've got a pipeline of multiple improved versions coming out. So the first version, I think we had around 15 secondary targets in the software. By the summer, we expect to have over 40, and we're to keep going on there and just making it more and more relevant to that market segment and the questions they take. But we're very excited about it, but it will take some time to -- for people to understand what it is and hopefully start using it. But I think we've gotten a pretty good market reception compared with what we had expected so far.
David Windley
analystExcellent. That's encouraging. So to follow up on this, at the top of your answer, you talked about this product having been in development for some time. Given that biosimulation is new, Certara is new to us as public investors. Can you just drill in a little bit more to product cycle? How long does it take to develop a product like that? It sounds like you've got some versions teed up to bring out. And then when you think about adoption rate, what's that curve look -- what does the product cycle in the market look like until it gets to some state of maturity?
William Feehery
executiveRight, right. Great question. It's not always kind of a consistent answer, depending on what the product in the market is. In that particular case, to make that happen, we needed to hire some people that -- it wasn't just that we repurposed our technology, but we needed to get some of the experts in the industry who understood the problems and the uses that we can take into and have that kind of dream on, on really what is a brand-new product for them. I believe that we started that years ago, more or less. And so that's maybe not a perfect answer, but a lot of these -- it's difficult to start a completely new product in less than about 2 years or so in our history. Now of course, We put out significant new features every year. We've been doing that for the last 20 years, and we've got an entire infrastructure buildup around continuing to do that. But to some extent, it takes a slightly different group and a different investment to kind of put out something totally new. So what we'd like to do is to see our regular advancement of our core products that the industry depends on, continue to march along every -- and most of them, it's every year. Occasionally, it's a little bit more frequent than that. And then if we can get out let's say, 1 or 2 really new products every year, I think we would be -- we will be doing pretty well.
David Windley
analystExcellent. So -- and on that front, the other area that I've heard you put some emphasis against is QSP or -- and specifically some disease-specific consortia that you're standing up. How much importance should we put on those? How significant are those in terms of their market opportunity?
William Feehery
executiveYes. So if you go into the scientific literature in the pharmacology areas, and I'm not suggesting you do that, but if you go to the one of the conferences, I mean, QSP is all that's talked about. This is where all the attention is going, it's where all the excitement is going. And so -- and the reason is because we're taking the kind of the core biosimulation idea. But QSP, to some extent, is really narrowing down on what's going on in the biology of that specific disease target. And so it extends the -- it extends the concept quite considerably, although it does also focus it down as we have to focus much more narrowly on disease targets. We've set out to build a significant QSP group. We talked about some of the growth, which has been very impressive. And it's enabling us to tackle new therapeutic areas. So one of the very exciting areas that QSP lets us get into is in cell and gene therapy. There's a lot -- obviously, there's not that many approved cell and gene therapy products, but there's a big pipeline in the pharmaceutical industry. And for a lot of them, there are difficult questions about dosing, given that you can really only dose the patient one time in their, maybe in their lifetime with that drug. And the dose may vary by individual patient characteristics. So developing those models has been very important for the development of some of these things, and we believe could lead to a nice position for us as we continue there in the future. And all of this is leveraging the software and the kind of the body of scientific knowledge that we've incorporated in all of the existing biosimulation market. So just a very exciting extension into the kind of the new therapeutic areas that the pharma is going on and our ability to kind of provide more resolution and more detail in the questions they're asking.
David Windley
analystExcellent. And we're basically out of time. But just to follow up on that last, that body of information point that you made, is that proprietary to Certara, that body of information? Or does Certara, by virtue of its size, have an advantage in terms of the accumulated body of information that it has?
William Feehery
executiveYes. A lot of the information we have is the sort of the accumulated known science that has been developed. However, developing these models is a tough one because you -- every individual, little step has to be validated against data. It takes a long time, and we have a conservative industry that wants to know the models are accurate before they base big decisions on them. And so a lot of -- one of the big advantages that we talk about for Certara in the industry is that we've got 20 years of every year pushing this forward, validating and proving that these models are accurate, convincing both the regulators and the pharmaceutical industry that they would make big decisions based on them. And that's a significant competitive moat that's maybe even better than having like one great big patent or something like that.
David Windley
analystExcellent. I appreciate your answers. As I said, I think we're out of time. I'm more informed than I was 30 minutes ago, though. So thank you very much. Appreciate your attendance and the audience's attention. I wish you all great afternoon and great weekend.
William Feehery
executiveThank you very much. We really enjoyed it, David.
David Windley
analystYes. Thank you. Good to see you.
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