Good day, and thank you for standing by. Welcome to the Certara Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, David Deuchler. Please go ahead..

Good afternoon, everyone. Thank you all for participating in today's conference call. On the call from Certara, we have William Feehery, Chief Executive Officer, and John Gallagher, Chief Financial Officer. Earlier today, Certara released its financial results for the quarter ended September 30, 2024.

A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements, and actual results may differ materially from those expressed or implied in the forward-looking statements.

Please refer to Slide 2 in the accompanying materials for additional information, which you can find on the company's Investor Relations website. In the remarks or responses to questions, management may mention some non-GAAP financial measures.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are available in the most recent earnings release available on the company's website. Please refer to the reconciliation tables in the accompanying materials for additional information.

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 6, 2024. Certara disclaims any obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

And with that, I will turn the call over to William..

Thank you, David. Good afternoon, everyone. Thank you for joining Certara’s third quarter earnings call. John and I will begin with prepared remarks, and then we will take your questions. During the third quarter, Certara continued to benefit from our strategy of investing in the development of biosimulation for global drug development.

Third quarter revenue of $94.8 million increased by 11% compared with last year, while total bookings of $96.1 million increased by 13%.

Among our Tier 1 biopharma customers, we saw stability and some improvement in new business activity versus the second quarter, while bookings from our Tier 3 customers continue to grow on a somewhat improved funding environment and on our increased investment in sales and marketing.

In early October, we closed the Chemaxon transaction, which further expands our biosimulation reach into the preclinical market. We are excited about the prospects of combining core capabilities of Chemaxon software and data with Certara data infrastructure and biosimulation capabilities to create an end-to-end biosimulation platform.

As we expand the serviceable market with Chemaxon, we will look to deepen existing customer relationships and develop new ones. Consistent with the plan outlined in our last earnings call, our biosimulation services achieved higher utilization during the quarter, which drove sequential improvement in our EBITDA margins.

We see several positive indicators of biosimulation demand, particularly that we have a strong pipeline and a very high win rate. However, we have also experienced a lengthened decision-making process among many of our larger customers and have seen more discreet engagements compared with years past.

This backdrop has made us more cautious about predicting second-half growth. Our experience in the regulatory services market has been different. Where we are also achieving higher utilization rates, but market dynamics have been more challenging relative to our expectations earlier this year.

As a result, we are revising our 2024 guidance modestly to reflect the changes that we have seen. Certara has a good regulatory services business with revenues expected to be $50 million to $55 million this year and operating margins that are comparable to a traditional CRO.

However, for some time, the growth profile of this business has diverged from our core biosimulation business and the customer base has less overlap with our course biosimulation business. For these reasons, we have begun a review process to consider the long-term strategic options for the business.

Please understand that we are at the beginning of this review process and we are not going to be making any additional comments until the review is completed during the first half of 2025.

Turning to the biosimulation and data-related businesses at Certara, I'd like to take a moment to highlight the investments we've made over the past 10 months and their importance to our growth strategy. Earlier this year, we announced investments to strengthen our software product suite and broaden our commercial reach.

In research and development, we steadily grew our software team with three key goals in mind.

To accelerate the integration of artificial intelligence and machine learning into existing products, to accelerate the development of new products in the cadence of products updates, and to begin the process of integrating Certara’s software into a more unified platform.

We think of our software business as having three existing pillars, centered around the Simcyp, Phoenix, and Pinnacle 21 products, which are core to our goal of increasing the broader adoption of biosimulation. We have also begun to implement a strategy of uniting these pillars into an overall platform through the introduction of the Certara Cloud.

The initial version of Certara Cloud was launched this year and provides easier access to our software and updates, increases awareness of Certara’s entire platform, and it lowers IT and security cost for customers.

As we move forward, Certara Cloud will further unite our software pillars by integrating data storage and providing workflow and collaboration, which enhance the use of our biosimulation products and services across drug development stages. Our recent acquisition of Chemaxon furthers this strategy.

Chemaxon is a leading software company focused on chemical property calculation, search, research workflow, and in-silico simulation. It brings Certara a complimentary customer base and a close-knit group of employees with a track record of success.

We plan to create a fourth software pillar within Certara by aligning Chemaxon closely with Certara’s D360 product, which is used today by over 6,000 life sciences users in the screening process for drug selection and optimization.

This combination, which will be further tied into our Simcyp and QSP development, will create a very powerful tool for our customers to use biosimulation to select and optimize molecules.

We also intend to fully leverage Certara's other software investments by integrating this combined product offering into Certara Cloud and Certara's AI capabilities.

Now, speaking of Certara's AI capabilities, we have dramatically increased our ability to process data and scientific literature in the wake of the Vyasa transaction, bringing on additional software developers to implement artificial intelligence across our platforms.

Our previously announced launch of CoAuthor into the regulatory writing market is proving successful, with our internal testing indicating the product can generate the majority of a clinical study report and reduce the delivery time to a level that has generated significant customer interest.

We have already begun to generate revenues with the product and we have a healthy sales pipeline. In sales and marketing, we took steps to build out our commercial infrastructure, bringing on global account managers and additional heads across several regions.

Our sales team also grew inorganically as we brought in members from Applied Biomath and Formedix and are now integrating team members from Chemaxon.

By adding experience across a variety of geographies and areas of expertise, we have implemented new best practices and evolved our commercial strategy to focus on large key accounts and on expanding our presence in the biotech market.

This is an important and exciting time for Certara and I want to emphasize how Chemaxon and our 2024 investments tie into our broader strategy. While it's still early days, it is difficult to understate the impact of this year's activities on Certara's ability to drive biosimulation adoption.

On the product and services side, we are bringing technology in-house that expands our serviceable market further into drug discovery via Chemaxon. We've built out a software team that can create and validate models more efficiently using AI technology acquired from Vyasa.

We're integrating our products to form a single platform which will lower the technological requirements required to adopt our software and biosimulation. We are now leveraging investments in our commercial teams to execute an enterprise-style commercial effort to drive cross-selling and software license expansion.

Certara has made big strides toward a broader, more interconnected and user-friendly suite of software products supported by the proper commercial infrastructure to expand our wallet chair among existing and new customers. We believe we are better positioned to drive long-term growth and biosimulation adoption today than we were 10 months ago.

Now I will turn to some of our recent highlights from the third quarter. Mid-August, we launched version 8.5 of Phoenix, introducing several enhancements that reflect feedback from existing users and stakeholders.

Notable new features include integration with the Certara Cloud, reporting enhancements for tables and plotting, and improvements to the precision of the Phoenix NLME population modeling tool. Additionally, towards the end of the quarter, Certara's Simcyp Consortium celebrated its 25th anniversary at the consortium's annual meeting in London.

In conjunction for the first time ever, Simcyp hosted an open day where non-consortium members were given the opportunity to join and connect with industry leaders in the PPPK modeling field. The event was a great success, and we look forward to hosting similar events in the future.

In our services group, one notable highlight in the quarter was our QSP collaboration with Ichnos Glenmark Innovation, or IGI, which was published in Nature Cancer in September. IGI sought Certara's help in optimizing the first-in-human dosing of their candidate, called ISB 2001, as a potential treatment for multiple myeloma.

Our QSP services team developed an innovative model to accelerate the speed at which ISB 2001 was administered to patients, identifying an optimal dose that was significantly greater than the conventional starting dose. The model was accepted by the U.S. FDA and the Australian HREC, meaningfully impacting the opportunity for patients.

We are proud of the team's accomplishments, which highlights the potential efficiencies in patient impact that can result from PPPK and QSP modeling.

As we progress through the fourth quarter, and into 2025, we are focused on uniting our investments in R&D and sales and marketing, the purchase of Chemaxon, and our evolving commercial strategy to drive sustainable growth at Certara.

Through the first 10 months of the year, we have made significant progress on several fronts that have positioned us well to gain wallet share amongst our biopharmaceutical customers. We are entering the earlier stages of development through a well-established software acquisition, and we have continued to invest in our software innovation engine.

With that, I will hand over things to John Gallagher to discuss our financial results in more detail..

Thank you, William. Hello, everyone. Total revenue for the three months ended September 30th, 2024, was $94.8 million, representing year-over-year growth of 11% on a reported basis, and 10% on a constant currency basis.

Software revenue was $35.9 million in the third quarter, which increased 15% over the prior year period on a reported basis, and 14% on a constant currency basis. The growth in the quarter was driven by biosimulation software and Pinnacle 21.

Ratable and subscription revenue accounted for 72% of third-quarter software revenues, up from 68% in the prior year period. Software bookings were $34.8 million in the third quarter, which increased 28% from the prior year period. Trailing 12-month software bookings were $153 million, up 15% year-over-year.

The software net retention rate was 108%, which is consistent with our long-term growth profile. Looking at our software bookings performance by tier, we saw very strong performance in both Tier 1 and Tier 3 customers driven by continued adoption of our software.

Now turning to services revenue, which was $58.9 million in the third quarter, up 9% versus the prior year period on a reported basis, and 8% on a constant currency basis. Our services business continues to recover following a period of cautious spending among our customers.

We were pleased to see improving performance in the Tier 3 customer base continue in the third quarter, while revenue performance among Tier 1 customers also showed some sequential improvement. Technology-driven services bookings in the third quarter were $61.3 million, which increased 6% from the prior year period.

Trailing 12-month services bookings were $266.7 million, down 1% as compared to the prior year. In the quarter, our services bookings performance saw continued divergence between regulatory and biosimulation services.

We were pleased to see an acceleration in our biosimulation services business on a year-over-year basis, as all three tiers of our biopharma customers accelerated their use of biosimulation services.

Conversely, we saw further deterioration and weakness in our regulatory services bookings, which factored into our revenue assumptions for the fourth quarter.

Total cost of revenue for the third quarter of 2024 was $37.2 million, an increase from $35.9 million in the third quarter of 2023, primarily due to a $0.9 million increase in employer-related expenses and a $0.7 million increase in software amortization.

Total operating expenses for the third quarter of 2024 were $55 million, a decrease from $102.5 million in the third quarter of 2023, primarily due to a $47 million decrease in goodwill impairment expense.

Sales and marketing expense increased versus the prior year due to higher employer-related expenses from recent acquisitions and planned investments in our commercial infrastructure, while general and administrative expense was lower due to decrease in change in fair value of contingent considerations.

As we have discussed in prior quarters, we have invested in research and development to accelerate and expand software efforts, where we have seen good initial success. We believe these investments are tracking to our expectations that we will continue to evaluate and invest in good opportunities moving forward.

We have reprioritized some investments in sales and marketing to better align with the realities of our end markets. However, we saw strength across biosimulation bookings performance in the quarter, and we'll continue to support new business opportunities in biosimulation where appropriate.

Adjusted EBITDA for the third quarter of 2024 was $33.1 million, an increase from $28.8 million in the third quarter of 2023. Adjusted EBITDA margin was 35%.

Wrapping up the income statement, net loss for the third quarter of 2024 was $1.4 million, compared to a net loss of $49 million in the third quarter of 2023, when we took a $47 million goodwill impairment in that period.

Reported adjusted net income for the third quarter of 2024 was $20.3 million, compared to $17.1 million for the third quarter of 2023. Diluted loss per share for the third quarter of 2024 was $0.01, compared to a loss of $0.31 per share in the third quarter of 2023, with the variance again related to the goodwill impairment last year.

Adjusted diluted earnings per share from the third quarter of 2024 was $0.13, compared to $0.11 for the third quarter of last year. Moving to the balance sheet, we finished the quarter with $233 million in cash and cash equivalents.

As of September 30th, 2024, we had $296.1 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. As a reminder, we closed the $90 million Chemaxon acquisition in early October, subsequent to the end of the quarter.

We are updating our guidance for the full year 2024 to reflect the impact from the Chemaxon transaction as follows. We expect total revenue in the range of $380 million to $385 million, representing growth of 7% to 9% compared with 2023. Revenue growth excluding Chemaxon is expected to be in the range of 6% to 7% for the year.

We expect adjusted EBITDA in the range of $120 million to $124 million. We expect adjusted EPS in the range of $0.41 to $0.44 per share. Fully diluted shares in the range of $160 million to $162 million, and a tax rate in the range of 25% to 30%. I will now turn the call back over to our CEO, William Feehery, for closing remarks..

Thank you, John. To summarize our message today, we were pleased with the many exciting developments of Certara during the third quarter, and we remain focused on executing our growth and profitability goals in 2024. There's a lot to be excited about at Certara as we advance biosimulation with our innovative technology.

Operator, can you please open the line for questions?.

Thank you. At this time, we will conduct the question-and-answer session. [Operator Instructions] Our first question comes from Jeff Garro from Stephens Inc. Your line is now open..

Yeah, good afternoon. Thanks for taking the question. Maybe we can flush out the demand environment a little bit more.

It sounded like mostly favorable commentary on that end, but I wanted to ask how we should think about the intersection of the current demand environment for biosimulation, the typical end-of-year budget flush activity, and then the myriad Certara-specific go-to-market strategies that you discussed that you've been executing on. Thanks..

Thanks, Jeff. Appreciate the question. It's a good question. So we have traditionally seen a budget flush to some extent by our pharmaceutical customers in the fourth quarter.

Based on our pipeline right now, I would say there will be some degree of that this quarter, but it's always difficult to tell how much, and we didn't count on that in the guidance that we gave you.

We are benefiting, I think, from our increased organization and investment in our commercial team, so that's certainly helping right now, and especially because I think that what we're seeing as far as overall market conditions is probably similar to what a number of other companies reported, that it's a little bit healthier than it was earlier this year.

Biotech funding's modestly up, and I would say Tier 1 customers are looking a little bit better than they were, but it's not a huge change, so I'd say that the change that the performance we're seeing is probably more a result of our investment and sort of just the general uniqueness and demand for bio-simulation..

Excellent, I appreciate that, and maybe just to follow up a little bit.

Could you help us understand how those various Certara Cloud and commercial strategies are translating into different customer interactions? In other words, are you interacting with different buyers, or are you finding it easier to unlock budgets? What's the kind of blocking and tackling that those strategies are yielding? Thanks..

Yeah, thanks, that's a good question, too. So Certara Cloud, it's still, it just was launched earlier this year, but it's acting as kind of the overall platform glue across all of our products, and we've been rolling that out gradually across our products this year. So it does, at the moment, it does a couple of things.

One is it lowers their IT costs because we have a single sign-on to access our products, and it makes our marketing discussions easier because it's easy for us to go into companies and talk about the products that they have and the companies that they don't have, track that and have those conversations. So we are seeing benefits from that.

Hard to say exactly how much, but our software bookings have been healthy, and so I'll say that it's certainly helping on that side.

I think the other piece of it is it's always good to make it easier to implement our products, and using Certara Cloud makes it easier for IT audits and security, the security costs that particularly a lot of our larger customers are concerned about.

So if you can reduce those costs, people are willing to go through the upgrade cycle more frequently than they might otherwise. So these things kind of help us kind of foster overall software growth, but they're helping, right. I mean, what's really driving software growth overall is that we've got unique software primarily focused on biosimulation.

We've been investing a lot in new features, new products, and those things have caused their own demand..

Understood. Thanks for taking the questions..

Thank you..

Thank you. Our next question comes from Max Smock from William Blair. Your line is now open..

Hey, good afternoon, guys. Thanks for taking our questions. Maybe just a few more housekeeping questions on the Chemaxon acquisition or the closing of that acquisition. Based on your guide, I just want to confirm, seems like about $5 million in total revenue here in the fourth quarter.

First, just confirming on that number, and then are you still expecting that to be about 90% software and about 10% services?.

Hi, Max. Yes, $5 million is about the right estimate. So what we had disclosed previously is that it's about a $20 million business. So the $5 million is the right number to cook in, and that's consistent with the non-Chemaxon growth that we had said of 6% to 7% on the guide.

And yes, it's pretty much a software business, so the 90% estimate is the right number to have in..

Okay, that's helpful. Thank you for that. And then we've heard a lot about a broad slowdown in discovery type work. Just wondering if you have any sense, I know it's early days with you all getting your hands on that asset, but just in terms of the outlook for Chemaxon revenue moving forward.

And then on the margin side, can you just remind us how their software and services margin profile compares to kind of your legacy software and services?.

Yeah, so I'll start maybe, and then on the growth profile, so we've said that we expect Chemaxon to be able to grow consistent with how we've been growing our software business. And based on what we've seen so far and the work that we've done, we continue to believe that that's the case.

The margin profile is below that of Certara, but we had said and would continue to say that we expect to be able to exit 2025 with a margin that's consistent with the corporate average Certara margin right now..

Okay. Yeah, and this is Bill, to answer your question about the discovery market. So Chemaxon is kind of a unique company. They have some very sticky products that are regarded by their customers as providing very good value for the price.

So as we've gotten into this, we found that they have a healthy sales pipeline and a number of new products that have been launched totally independent of what we intended to do with this business. So we're pleased with that right now.

But the overall strategy that we're implementing here is to use Chemaxon to answer questions about molecule selection using biosimulation that our customers have been asking us about for years. So Chemaxon fills an important strategic position in the biosimulation story and product suite that we've got as we go forward.

And so we think that beyond what they're doing on their own, that there's going to be a lot of interest in tying this into the rest of Certara's biosimulation..

That's really helpful. Thank you for that, Bill and John. Maybe just one more quick one for me on the regulatory services piece.

And I know it's early in the process there, but could you just remind us, give us some detail on the size of that regulatory services business just to help us frame out what could be the impact of a potential divestiture as you go through your review process here?.

Yeah, Max. So the business is about $50 million to $55 million of revenue. And we said that it would be like pharma services like margins. So think of that in the context of about 20% to 30% is the way to size it..

Got it. Thank you for that, John. Appreciate you taking our question..

Yep. Yep..

Thank you. Our next question comes from Vikram Purohit from Morgan Stanley. Your line is open..

Hi, everyone. This is Morgan on for Vikram. Thank you for taking your question. Wanted to learn a little bit more about the improvements that you're seeing with Tier 1 customers and what has changed from 2Q to 3Q now? Thank you..

So what we saw with Tier 1 is we saw some stability moving from Q2 where we had pressure. And so we saw some improvement there. On the software side of the business, we've continued to see very strong performance across the tiers. On the services side is where we had seen some of the pressure in Q2.

We saw some of that resolve into Q3, most notably on Biosim services, which was then offset by some contraction in the regulatory services Tier 1 performance..

Okay, thank you..

Thank you. Our next question comes from Michael Cherny from Leerink Partners. Your line is now open..

Hi, good evening. This is Ahmed Muhammad on for Mike Cherny. I'm going to ask about the setup for FY’25.

I'm not looking for specific guidance, but given your high degree of visibility on the business, what are you seeing in terms of demand from Tier 1 clients and maybe the smaller biotech customers? Peers have mentioned some disruptions from large pharma customers and like sort of a hesitancy to pull the trigger for smaller projects in the smaller biotech world.

Are you seeing any of that as well? Any color would be helpful. Thanks..

Yeah, thanks for the question. So I think as we went into Q2, we had, there was a lot of restructuring in the pharma industry, particularly in Tier 1s this year, and that probably is. As we're going forward, I would say our sales pipeline is pretty healthy.

We're seeing a lot of projects come through in the second half of the year, but we are seeing a lengthening of time to close those projects. So I guess that gets to your point about a little bit of a hesitancy.

We think that as in past years, we will get some degree of effect of companies that have projects in our pipeline that want to get that done before the end of the year. But like I said earlier, we haven't baked a lot of that into our guidance just to be conservative.

John do you want to?.

Yeah, the only thing I'd add to that is the revision on the guide here takes out a lot of the seasonality that we might normally expect, which does come from Tier 1. So, the end market environment, although we saw stability moving from Q2 into Q3 and some recovery, that's good.

But overall, the end market environment as we exit the year continues to be challenged, and we expect that to continue in the next year..

Great, thank you..

Thank you. [Operator Instructions] Our next question comes from Michael Riskin from BofA. Your line is open..

Hi, thank you for taking the question. This is Avantika on for Mike. Could you provide any additional color on the reallocation of resources from your services business to your software business and how that's driving growth? And then given your software investments, are you seeing conversion from service customers to software? Thank you..

So on the first point there, we've certainly seen for software, our net retention rate has been consistent. In fact, on a year-to-date basis, our NRR is 110. And so we're seeing good renewal and expansion by our customers. Then we're adding new logos, which has taken that up. And then we're getting a boost from M&A as well.

So that the deals that we did last year, that is. So that's part of what's driving consistent performance in software, in addition to, of course, all the products that Bill had mentioned before that we're rolling out, and that's driving the performance.

On the services side, so our services do, as a component of selling software, we are able to sell services. And that's where I mentioned the performance.

When you look at our Biosim services in particular, we saw strong performance in Q3 in Tier 1 and in Tier 3 customers in Biosim services, which was then offset by weak performance in regulatory services. And so that's a part of the story that we wanted to make sure we got out there.

So we are seeing correlation between the strong software performance and Biosim services..

All right, great. Thank you so much..

Thank you. Our next question comes from Kyle Crews from UBS. Your line is now open..

Thank you for taking the questions.

Could you please talk about the uniqueness and demand for Biosimulation that you mentioned earlier? What do you feel is driving kind of the strength and value simulation versus divergence from your regulatory writing business? Is it efforts by regulatory agencies to help promote Biosimulation? Is it increased educational efforts by Certara, such as what you mentioned earlier in opening up the consortium for Simcyp to non-members for educational purposes?.

Yeah, great. Thanks, Kyle. Appreciate the question. Well, I think one of the things that's really driving demand is that we've had a very sustained investment in expanding our Biosimulation product suite, which has driven a lot more capability over the last couple of years. But as we've said before, Biosimulation is favored by the regulatory agencies.

It's becoming more of an accepted technique, and you can see that in submissions of lots and lots of approved drugs today. So, we have the backdrop of that where it's accepted by the regulatory agencies. We have our investment in Biosimulation, which has been going on for a number of years now, and we're planning on continuing that.

So that's making it easier to use the technology and to implement it for specific, for more types of drugs than we could have earlier.

And then I think the other thing that maybe helps us to some extent here is as pharma has gotten a little bit more interested in the cost side of things, that Biosimulation is basically lower cost than going out and running more clinical trials. So it drives more interest in learning about what we offer and how to best use it..

Great, thank you. And then one quick follow-up.

Could you speak to your exposure to small molecule versus large molecule drug development? And any efforts you're making to expand Biosimulation for large molecules?.

Yeah, that's a good question. We've said for a while that our footprint from the standpoint of the types of molecules we look at is a pretty good snapshot of what pharma is working on at any given time. So as biomolecule research has picked up over the last, I don't know, what do you want to say, 10 or 15 years, our percentage has also increased.

Our tools, you don't ask necessarily all the same questions in Biosimulation for small molecules as they do for large molecules, but our tools have features for both and certainly widespread use in both..

Great, thank you..

Thank you. Thank you. [Operator Instructions] Our next question comes from Luke Sergott from Barclays. Your line is open..

Hey guys, sorry, jumping on late here.

So sorry if I repeat anything, but just a quick cleanup on, can you give us the M&A contribution to each segment from the quarter to revenue? And any other bookings there as well?.

Yeah, sure. So the reported total revenue was 11%. The organic was 6%. On software, it was 15 and 10. So you're seeing about 500 basis points, 500 to 600 basis points spread. And on services, the organic was 3%. And when you look at bookings, the organic number on bookings in total was 7% against the reported 13%.

On software, the reported was 28% bookings growth, and that was 25%. So very strong software quarter on bookings across all three tiers, as we had mentioned. And then the organic on services was a minus one..

Okay. That's great. And then I guess just kind of follow up on that from a visibility perspective. I understand that the market is relatively soft here. You're still putting up really good core bookings on that.

So, what's the -- as you're looking at the guide and the cut that you guys just did, like why -- I would expect that given the good bookings trend, you'd have probably a little bit better visibility like, couple maybe a quarter or two ahead.

Is this something that where the, you're getting the bookings, but the burn rate is essentially coming down from those bookings based on longer implementation times and like essentially that these are just function as a push out?.

No, that's -- I wouldn't think about it that way. And instead we had baked in typical seasonality into our original guidance from February and which we had seen historically a pretty significant uptick, particularly related to services and Q4s of every year.

But given the end market volatility that we've discussed on the call today, a lot of that surrounding the regulatory services Tier 1 performance is causing us to really remove that seasonality. And so that's the primary driver around the revision lower..

Okay, great. And then just last one for me, on the regulatory services strategic update, just this has obviously been a business that struggled over the last year. It's starting to kind of pick up here.

Just why now is the -- I understand that now it might be the right time, but thinking about this the portfolio, like why doesn't this fit in with the overall strategy going forward?.

Yeah, look, thanks for the question. Look, we've just done three biosimulation, primarily software focused acquisitions.

So, the biosimulation platform that we have is expanding a lot and that's causing I would say a divergence in both sort of the strategic necessity of staying in the regulatory writing group and also just the businesses, as you pointed out, haven't been operating really on the same cadence for some time.

So, I'd say, the direct answer to your question is, I think what really prompted this is, we've made the last couple of acquisitions has really given us even more mass, critical mass in biosimulation and where we think that's going in the future, which has caused us to think about this..

Got you, got you. Makes sense. Thanks..

Thank you so much. I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program and you may now disconnect..