NASDAQ:CERT Certara Q3 2025 Earnings Report $6.21 -0.10 (-1.54%) As of 11:49 AM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast Certara EPS ResultsActual EPS$0.14Consensus EPS $0.11Beat/MissBeat by +$0.03One Year Ago EPS$0.13Certara Revenue ResultsActual Revenue$104.62 millionExpected Revenue$104.53 millionBeat/MissBeat by +$86.00 thousandYoY Revenue GrowthN/ACertara Announcement DetailsQuarterQ3 2025Date11/6/2025TimeAfter Market ClosesConference Call DateThursday, November 6, 2025Conference Call Time5:00PM ETUpcoming EarningsCertara's Q1 2026 earnings is estimated for Monday, May 11, 2026, based on past reporting schedules, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2026 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Certara Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 6, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Certara narrowed 2025 revenue guidance to $415–$420M (8–9% growth) and raised its adjusted EBITDA margin to around 32% and adjusted EPS to $0.45–$0.47, citing profitability outperformance and share repurchases. Negative Sentiment: Q3 bookings showed weakness—total bookings were $96.6M (+1% Y/Y) while technology-driven services bookings fell ~9%—as several large (Tier 1) pharma customers delayed deals into Q4 and 2026, creating near-term revenue risk. Positive Sentiment: Software remains a growth engine with Q3 software revenue of $43.8M (+22% reported, +6% organic), software bookings +17%, and Chemaxon contributing $5.6M and trending to corporate-average margins. Positive Sentiment: Management highlighted accelerated product innovation—launching Certara IQ, Phoenix Cloud, and Pinnacle 21 Enterprise with embedded AI—and said QSP is the fastest-growing area, which could expand software-led, repeatable revenue. Neutral Sentiment: The strategic review of the regulatory services business is in its final stages with a definitive outcome expected before year-end; the unit is cash-generative but has shown inconsistent performance. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCertara Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good day, and thank you for standing by. Welcome to the Certara Q3 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you need to press Star one one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one one again. 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, Investor Relations. Please go ahead. David DeuchlerHead of Investor Relations at Certara00:00:39Good 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 financial results for the quarter ended September 30, 2025. 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 two 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. David DeuchlerHead of Investor Relations at Certara00:01:17Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are available in the recent earnings press 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 to live broadcast today, November 6, 2025. 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. With that, I will turn the call over to William. William FeeheryCEO at Certara00:01:49Thank you, David, and good afternoon, everyone. Thank you for joining Certara's Q3 earnings call. John and I will begin with prepared remarks, and then we will take your questions. During the Q3, our team continued to execute against our 2025 goals while also positioning Certara for long-term success by investing in our R&D and commercial teams. Q3 revenue of $104.6 million was in line with our expectations, representing 10% reported year-over-year growth. We outperformed internal profitability expectations, delivering adjusted EBITDA of $35.2 million, representing a margin of 34%. Our team remains focused on investing for growth, with R&D up 24% versus the same period a year ago and increasing to 10% of revenue from 9% in the prior year period. On the other hand, Q3 bookings of $96.6 million came in below our expectations, representing growth of 1%. William FeeheryCEO at Certara00:02:54Among our Tier 1 services customers, we observed cautious spending behavior, with some customers pushing deal timelines later into the Q4 and into 2026. Taking this into account, we are narrowing our revenue guidance to $415 million-$420 million, which we believe reflects the most likely range of outcomes for the year based on our performance to date. We have raised our adjusted EBITDA margin guidance to the high end of our previous guidance range and raised our adjusted EPS guidance to reflect a continuation of outperformance against our profitability targets and the impact of share repurchase activity. We continue to see pockets of outperformance throughout our portfolio, including our Simcyp PBPK software and our QSP services. However, some of our customers are still dealing with factors that impact decision-making timelines and R&D allocation decisions. William FeeheryCEO at Certara00:03:51As large pharma customers adjust focus with their R&D programs and now onshoring initiatives that are impacting personnel and resource allocations, we have seen a slowdown in deal completion timelines, particularly in regulatory services and Biosim Services. This slowdown has persisted into the beginning of the Q4, conflicting with historical seasonality trends. We are closely monitoring consumer spending patterns as we begin to plan for 2026. At a high level, we continue to see several positive leading indicators for the biosimulation market and for Certara. Among large pharma customers, the use of Model-informed Drug Development is growing throughout all stages of development. Customers are adopting biosimulation solutions for use in dosing, efficacy, and toxicity analysis, and using the technology earlier as we expand our software capabilities into discovery and preclinical. Among our smaller customers, the adoption of biosimulation is accelerating through the use of our technology-enabled services. William FeeheryCEO at Certara00:04:57As drug developers look to optimize their speed and efficiency, they are often attracted to areas of our business such as QSP, which can help streamline decision-making and trial design in both the preclinical and clinical stages. Since our IPO, we have seen a significant increase in both the number of customers using our products and services as well as the wallet share of Certara within larger organizations. Most of all, we are encouraged by our evolving relationships with key stakeholders and users and customers. Earlier this year, we hosted our second annual Certainty Conference, bringing together hundreds of our users to discuss the future of Model-Informed Drug Development. In early October, we held the same conference in Barcelona with our European user base, and the experience was very productive for all parties. William FeeheryCEO at Certara00:05:48At both events, I had the opportunity to discuss Certara's products with customers, where they provided feedback on our software, suggested new features and functionality, and learned about our new products and long-term vision for the Certara platform. There is tremendous value that can be gained by making more informed decisions earlier in the drug development lifecycle, which is why we are moving into discovery and preclinical. We closed the ChemAxon acquisition a year ago in early October of 2024, which gave Certara an established product suite in discovery with synergistic capabilities relative to Simcyp. In the first 12 months under Certara ownership, ChemAxon has continued to grow and is on track to reach corporate average margins by the end of the year. Elsewhere, our services group has grown preclinical work in QSP, especially since the FDA's guidance promoting the use of new approach methodologies. William FeeheryCEO at Certara00:06:46QSP has grown ahead of the rest of the biosimulation business on a year-to-date basis and is becoming an increasingly important part of our business. Now, turning to our financial performance. In software, bookings of $40.8 million represented growth of 17%. We saw solid bookings performance in Tiers 1 and 3, which were in line with expectations, while Tier 2 was below expectations, which we attribute more to timing than anything. Software revenue of $43.8 million grew 22% on a reported basis and 6% organically, led by strong growth from Simcyp, in addition to $5.6 million of contribution from ChemAxon. In services, bookings of $55.8 million declined 9% on a reported basis. Driven by slowness in the Tier 1 customer base. We have continued to observe cautious decision-making among large pharma customers into the Q4. William FeeheryCEO at Certara00:07:49Services revenue of $60.8 million grew 3% on a reported basis and on an organic basis, led by growth in QSP services. On the innovation front, 2025 has been our most active product development year since our IPO. We've embedded artificial intelligence into both our development processes and our products, accelerating the pace of new model creation following our VIA Science acquisition. We launched several major products this quarter. Pinnacle 21 Enterprise, a cloud-based upgrade improving regulatory data compliance and submission speed. Phoenix Cloud, which transitions our customers from on-premise to Certara Cloud deployment and provides significant upgrades to product functionality, and Certara IQ, our new software for QSP modeling, designed to expand the use of biosimulation across discovery and clinical phases. Early customer feedback on these releases has been excellent, and we're confident they strengthen our long-term software growth engine. William FeeheryCEO at Certara00:08:59Last year, we announced the strategic review of our regulatory services business. To date, we have made significant progress in our evaluation, including dialogue with external parties and significant internal analysis of best practices. As we evaluate our business, we recognize that regulatory writing performance has been inconsistent. Simultaneously, we value the regulatory writing business's ability to generate cash, which we have used to invest in growth and support recent share repurchases. At this point in time, we are in the final stages of our process and intend to share a definitive outcome before the end of 2025. To close, we remain focused on delivering our 2025 plan and entering 2026 well-prepared to capitalize on the opportunities ahead. Although we are seeing some variability in Tier 1 services, we are encouraged by the widespread momentum of biosimulation adoption in drug development. William FeeheryCEO at Certara00:10:01I'll now hand things over to John Gallagher to discuss our financial results in more detail. John GallagherCFO at Certara00:10:08Thank you, William. Hello, everyone. Total revenue for the three months ended September 30, 2025, was $104.6 million, representing year-over-year growth of 10% on a reported basis and on a constant currency basis. Total bookings in the Q4 were $96.6 million, which increased 1% from the prior year period on a reported basis. Trailing 12-month bookings were $471.4 million, increasing 12% on a reported basis. Excluding ChemAxon, total company organic bookings declined 4% compared with the Q3 last year. Software revenue was $43.8 million in the Q4, which increased 22% over the prior year period on a reported basis and 21% on a constant currency basis. Organic growth was 6% in the quarter, driven by strong growth from Simcyp. ChemAxon contributed $5.6 million to our reported revenue, which was in line with our expectations. John GallagherCFO at Certara00:11:16Ratable and subscription revenue accounted for 65% of Q3 software revenues, or 71% excluding ChemAxon, slightly down from 72% in the prior year period. Software bookings were $40.8 million in the Q4, which increased 17% from the prior year period. Q3 bookings included $4.2 million of ChemAxon bookings. Organic software bookings grew 5% versus the prior year. Trailing 12-month software bookings were $187.9 million, up 23% year-over-year. The software net retention rate was 104 in the quarter, consistent with our full-year plan. Looking at our Software Bookings Performance by Tier, we saw strong performance in Tiers 1 and 3, driven by the continued adoption of our software. In Tier 1, we saw some timing-related slowness due to renewals, which we expect to normalize in the Q4. John GallagherCFO at Certara00:12:19Now, turning to services revenue, which was $60.8 million in the Q4, up 3% versus the prior year period on a reported basis and on a constant currency basis. We saw strong performance from our QSP and Simcyp services businesses in the quarter, which was partially offset by softness in the regulatory services. Technology-driven services bookings in the Q4 were $55.8 million, which declined 9% from the prior year period. TTM services bookings were $283.5 million, up 6% as compared to the prior year. During the quarter, we saw softer performance from Tier 1 customers and biosimulation services, driven by spending hesitancy among our largest customers. In regulatory, bookings declined in the double digits, while biosimulation services were down low single digits. Total cost of revenue for the Q4 of 2025 was $39.7 million, an increase from $37.2 million in the Q4 of 2024. John GallagherCFO at Certara00:13:28Primarily due to higher software amortization and consulting expenses, offset by lower employee-related costs. Total operating expenses for the Q4 of 2025 were $61.9 million, an increase from $55 million in the Q4 of 2024, primarily due to higher employee-related costs in sales and marketing and R&D. Adjusted EBITDA for the Q4 of 2025 was $35.2 million, an increase from $33.1 million in the Q4 of 2024. Adjusted EBITDA margin in the quarter was 34%. Wrapping up the income statement, net income for the Q4 of 2025 was $1.5 million, compared to a net loss of $1.4 million in the Q4 of 2024. Reported adjusted net income for the Q4 of 2025 was $22.2 million, compared to $20.3 million for the Q4 of 2024. Diluted earnings per share for the Q4 of 2025 was $0.01, compared to a loss of $0.01 per share in the Q4 of 2024. John GallagherCFO at Certara00:14:46Adjusted diluted earnings per share for the Q4 of 2025 was $0.14. Compared to $0.13 per share in the Q4 of last year. Moving to the balance sheet, we finished the quarter with $172.7 million in cash and cash equivalents. As of September 30, 2025, we had $293.1 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. Subsequent to the end of the quarter, we executed a reprice of our outstanding term loan, which is expected to save $700,000 annually in interest expense beginning in 2026. Earlier this year, our board authorized a $100 million share repurchase program. We have repurchased approximately $41 million of stock during 2025. With year-to-date results in our outlook for the Q4, we are providing the following guidance for 2025. John GallagherCFO at Certara00:15:50We are narrowing the revenue range to $415 million-$420 million, representing 8%-9% growth compared with 2024. We expect ChemAxon to contribute software revenue of $23 million-$25 million. We expect an adjusted EBITDA margin around 32%, which is the high end of our previous guidance range, reflecting outperformance versus our internal profitability expectations to date. We expect adjusted EPS in the range of $0.45-$0.47 per share, fully diluted shares in the range of 160 million-162 million, and a tax rate in the range of 25%-30%. I will now turn the call back over to our CEO, William Feehery, for closing remarks. William FeeheryCEO at Certara00:16:44Thank you, John. To summarize our message today, our team is working diligently to execute our growth and profitability goals despite a mixed operating environment. We are excited to bring several new products to market and look forward to providing further updates on our progress early next year. Operator, can you please open the line for questions? Operator00:17:08Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Michael Cherny from Leerink Partners. Please go ahead. Dan ClarkEquity Research Associate at Leerink Partners00:17:33Great. Thank you. This is Dan Clark on for Mike. Just wanted to ask a little bit on the Tier 1 services revenue or bookings dynamic in the quarter. I guess, one, when did you start to see a slowdown in decision-making timing and of the potential deals that got pushed? Appreciate the color on some of them, hopefully closing in 4Q with the remainder in 2026. How are you kind of thinking about that split at this point? Thank you. John GallagherCFO at Certara00:18:06Yeah. As it relates to the bookings, it was our Tier 1 services customers where we saw delays. What we're seeing is hesitancy, so a slowness in decision-making. A lot of times, we would talk about that as impacting timing and trickling into the next quarter. What we just said in the prepared remarks, though, is that through the month of October, we continued to see some deceleration in Tier 1 services bookings related to these larger customers of ours. As a result of that, we're expecting it to continue in Q4. Operator00:18:53Thank you. One moment for our next question. Our next question comes from David Windley from Jefferies. Please go ahead. David WindleyManaging Director at Jefferies00:19:03Hi. Thanks for taking my question. Hopefully, you can hear me. I'm in the car. I was hoping you could comment or disentangle the gross profit outperformance between mix and perhaps efficiency, productivity. John GallagherCFO at Certara00:19:25Yeah. Thank you, David. Yeah. I mean, on the gross margin line, then. We've certainly seen some productivity, especially compared to last year. You might recall we did some reductions last year on the services side that hit the cost of sales. We're still comping to that in the Q3 of this year. Therefore, some of that productivity is a key component of why the gross profit is accelerating. The other piece of it, of course, is the fact that we're achieving more mix on a software basis. When we're looking, the software business has, of course, a higher gross profit than services. Not only are we getting productivity on the cost of sales side when we look at services, but the mix shift towards software is also a tailwind to the gross profit. David WindleyManaging Director at Jefferies00:20:26Thank you for that. I was going to make my next question, my second question, about your areas of innovation, but it does end up being somewhat related. I think you talked about Certara IQ as your more AI-enabled QSP and Phoenix Cloud launches. It sounds like those have been well received. The comment in the prepared is about QSP being your fastest-growing area. Maybe you could also drill into that because I think today most of QSP is service-driven. You are launching this, what I think sounds like a more technology or software-driven QSP. How do you expect that to evolve? Does that growth in QSP mix kind of reverse the software mix until the technology, the software picks up a little bit more? I am just curious how the QSP feathers into that since you highlighted its growth. Thanks. William FeeheryCEO at Certara00:21:30Yeah. Thanks, David. This is Bill. We are executing the strategy that we set out to do when we acquired Applied BioMath about, whatever it was, about two years ago. Which was to take QSP and to bring a software platform to it. That is Certara IQ, which we launched, as you pointed out. There is a huge demand for QSP. Some of it has to do with the recognition that this type of modeling has been quite useful. Now that the FDA has made its announcement on NAMs and on reducing the number of non-human primates. Some of it has to do with the growth in large molecules, where QSP has been particularly valuable. We are attempting, and I think we will very much succeed with this product, to create a standard product that QSP modelers use. Not just within pharma companies, but also. William FeeheryCEO at Certara00:22:43As they go forward and submit their models for approvals to regulators, there's a big need in the market for this, and there's a big opportunity to make QSP a lot more widespread by improving the efficiency of modeling, which we can do with AI, and providing a platform where our consultants are much more efficient. Providing the same platform so that our pharma customers are using the same platform internally, it can also drive that kind of same efficiency, and we can get work going back and forth. Then finally, this is an opportunity for us to create foundational models, in particular therapeutic or drug modalities, that we can sell over and over again using this software platform. There are multiple ways that this will benefit the company financially as we go forward. There's nothing like it, really, on the QSP market. William FeeheryCEO at Certara00:23:47There's obviously modeling tools out there, but we believe this is a significant advance. It's been well received. We only launched it a couple of weeks ago, so it's a bit early to talk about the financial success, obviously. We expect, as we go into 2026, this will be a success for the company. David WindleyManaging Director at Jefferies00:24:17Thank you. David DeuchlerHead of Investor Relations at Certara00:24:18Thanks for that. All right. Go ahead. That's fine. Go ahead. Operator00:24:23Thank you. One moment for our next question. Our next question comes from Matt Hewitt from Craig Hallum Capital Group. Please go ahead. Matt HewittAnalyst at Craig-Hallum Capital Group00:24:35Good afternoon. Thanks for taking the questions. I apologize. I'm having to hop between a couple of different calls. First off, I recognize that there's some challenges or hesitancy with your Tier 1 customers. I'm just curious if you've heard or seen any change since we got a little bit of clarity on the most favored nation pricing and what that could mean, some clarity on the tariffs and what that impact could be. I mean, we've heard from a few other companies that post some of those initial most favored nation-type contracts or changes that pharma was kind of re-engaging. Is that similar to what you're seeing or any color along those lines? William FeeheryCEO at Certara00:25:15Yeah. Thanks. This is Bill. We have also heard other companies talking about that and heard some discussion among customers. I would say that we're cautiously optimistic. That is a pretty recent development, so we need to see that kind of get out in the marketplace. I think any sign of kind of the macro stability for the Tier 1 customers and what's going on with pricing, I think, would be ultimately good for us and will flow into, hopefully, a better environment as we go into 2026. Matt HewittAnalyst at Craig-Hallum Capital Group00:26:00Got it. Maybe just as a follow-up, and I realize it's still very early, and we haven't even closed out this year yet, but as you're talking to your customers not only about the remainder of fiscal 2025, but as they're starting to think about their budgets for fiscal 2026. Are you getting any sense for where those budgets may be going, any sense for how modeling and simulation kind of fits into those budgetary plans for 2026, recognizing, yes, it's early days, but having gone through this now for a while, I sense you guys might have a feel for, "Okay. If we're hearing this at this stage, that bodes well for the final budgets when they're announced later this year or early next year." Thank you. William FeeheryCEO at Certara00:26:45Yeah. I mean, we obviously only have kind of anecdotes if you're asking a question about the overall industry. I'd say what I can say is I think some of our new products have been very well received. People have talked about making sure that there will be budget for them as they go into 2026. We're getting some sense that the pullback in services is not across the entire industry. We see it in Tier 1s. We're actually doing quite well with Tier 3s with biotechs right now. The Tier 1 seems to be kind of a hesitancy based on the overall macroeconomic environment. I think every time we hear kind of positive signs of stability, things get a little bit more bright for us. We're not, what I've heard, and we're expecting kind of, what do you want to call it? William FeeheryCEO at Certara00:27:46A stabilizing environment, I guess, is the way I'll put it, as we go into 2026, as opposed to kind of where we've seen part of this year where it's been getting a little bit tougher. Matt HewittAnalyst at Craig-Hallum Capital Group00:28:00Okay. That makes sense. Thank you very much. Operator00:28:04Thank you. Our next question comes from Luke Sergott from Barclays. Please go ahead. Luke, you may be on mute. One moment for our next question. Our next question comes from Brennan Smith from TD Cowen. Please go ahead. Luke SergottAnalyst at Barclays00:28:38Great. Thanks, guys, for taking the questions. Actually, just wanted to follow up on some of the earlier questions related to the software business a little bit more. This is, frankly, something we're just asked by investors a fair amount. I guess we're obviously seeing pharma and some of those Tier 1 customers invest a lot more internally in some of their own kind of AI-plus capabilities. I guess, do you kind of feel that's net-net headwinds, tailwinds, maybe a wash to where you guys come out? Just trying to understand to what extent, as they build out those capabilities, they turn to you all to help make sure that those internal processes are ramping as they should. Is it kind of an or rather than an and within their budgets, just based on your conversations? Thanks, guys. William FeeheryCEO at Certara00:29:20Yeah. Thanks for the question. What we've seen happen with AI has been tremendous. This is starting more than a year ago, tremendous excitement and willingness to try things in pharma, but somewhat of a hesitancy to commit to enterprise sales until they understood the full implications of putting AI in terms of data security and how the products will be used, sort of the, let's call it the quality controls that you have to put in around AI and some of these uses. We saw a lot of, in the beginning, they were really great marketing opportunities, but slow to sell. As we've gotten through 2025, we've seen somewhat of a pickup in actual sales of the pure AI products. All of our products that we've recently launched, well, let's say Phoenix and Certara IQ have embedded AI in them, and that's been quite well received. William FeeheryCEO at Certara00:30:30I think we're seeing a bit more willingness to move faster, to put these things in as you deploy them across the enterprise. You're asking a somewhat different question also around, as pharma, considering building our core products using AI internally versus buying them from us. The core modeling technologies we have are really quite specialized. That doesn't tend to be a real option. You can see that with our software, which is still growing quite nicely, and we expect will continue to be strong as we go into 2026. Luke SergottAnalyst at Barclays00:31:19Got it. Thanks, guys. Operator00:31:22Thank you. Our next question comes from Joe Vruwink from Baird. Please go ahead. Joe VruwinkDirector at Baird00:31:31Hi, John. Thanks for taking my questions. Just to go back a couple of questions ago, you mentioned the prospect of stabilized environments for 2026. What do you think stabilized means for Certara growth potential at this point? I just ask because the last three years have obviously seen a lot of macro turbulence. Organic growth has averaged 3-4% over that stretch of time. Is stabilized supportive of mid to high single-digit growth and robust gets you back to the double digits? Or any way directionally just appreciating kind of what the company has been through over recent history? John GallagherCFO at Certara00:32:15Yeah. Hi, Joe. As it relates to us calling it stabilized, then really what we're saying is we see continued performance on the software side, which has been playing out according to plan this year. Year-to-date software looking to be 7% on a TPM basis. We're seeing 6% year-to-date, 7% TPM, and then 6% organic software this year. We're adding the product that Bill was talking about, of course, too. Those are the positives. The headwind to all that is what we're seeing in services right now. We saw it. You can see it in the Q3 results, but you can also see it. We saw it in October. That's why we were indicating that. John GallagherCFO at Certara00:33:13As we look toward the end of the year this year, we're not really expecting to see the same level of seasonality that we've seen over prior years. That is going to provide a bit lower of a jumping-off point as it relates to services. Services is likely to be in the low single digits as we approach next year as a result of that. Software going well, playing out according to plan. We've got new products. Services is the spot that we're keeping our eye on as we finish 2026. Joe VruwinkDirector at Baird00:33:49Okay. That's helpful, Color. Thank you. Just to go back to David's question on gross margin, as I look at the mix of software sales this year, a lot of the incremental growth has come from higher license sales as opposed to subscriptions. And that might be ChemAxon related, but in case it's not. Is that a beneficial margin mix to year-to-date results? Or. How to think of that versus a higher proportion of, I guess, ratable subscription revenue? John GallagherCFO at Certara00:34:22Yeah. You've got that straight, Joe. Bringing in ChemAxon, ChemAxon is predominantly license-based, at least right now. Whenever we're recognizing revenue there, we're getting all of it at once. That combined with Phoenix achievement on revenue this year is what's helping the gross margin, if you will, from that perspective, while at the same time is reducing the proportion of ratable that we have. That's why I like to cite it, not just what the ratable portion of software is, but even excluding ChemAxon is a better comp to the prior year. Joe VruwinkDirector at Baird00:35:06Okay. Great. Thank you very much. Operator00:35:10Thank you. Our next question comes from Kyle Kruesi from UBS. Please go ahead. Kyle KruesiAnalyst at UBS00:35:16Hey. Thank you for taking our questions. You mentioned that customers were adopting model-informed drug development for use in toxicity and dosing analysis. CDER, earlier in October here, announced that you could use essentially Pharmacokinetic analysis to replace some animal testing for first-in-human dosing. Can you elaborate a bit more on that point that you made earlier in the call? Thank you. William FeeheryCEO at Certara00:35:38Yeah. One of the significant uses around QSP has been in these two areas. First-in-human dosing has been a particular area of interest in pharma for modeling. It does not sound like the biggest problem. When you really think about it, the initial dose that gets tried in a phase one trial really defines the range that will be used for all trials later. If the doses that are tried are outside the effective or the safe range, they are kind of wasted. That has been recognized by a lot of companies in the pharmaceutical industry, and it has been good to see that the regulators are paying attention and are encouraging it as well. That has been one of the reasons for the uptake in modeling services like QSP that we have seen. Kyle KruesiAnalyst at UBS00:36:52Great. Thank you for that. Can you speak briefly on your exposure to biologics or small molecule drugs at this point with your software offerings? Thank you. William FeeheryCEO at Certara00:37:03We have exposure to both. We always said, and I believe this has not changed, that our exposure is pretty similar to what the pharmaceutical industry as a whole is working on at any given point. The questions that get asked in modeling between small molecules and large molecules are often somewhat different. For example, small molecules, there can be more formulation questions and absorption questions. In large molecules, there are often more questions around things like dosing and immunological responses and things like that. However, we have products targeted for both. We have quite healthy and active businesses for both technologies and even other technologies that maybe do not even quite fit this kind of definition. For example, we have products focused on radioligands and peptides, things like that. I think we are pretty well covered in terms of our exposure. William FeeheryCEO at Certara00:38:22Our investment in the technology to kind of serve both of these. Kyle KruesiAnalyst at UBS00:38:28Great. Thank you. Operator00:38:31Thank you. Our next question comes from Max Smock from William Blair. Please go ahead. Max SmockAnalyst at William Blair00:38:39Hey, guys. Good afternoon. Thanks for taking our questions here. John, maybe I just wanted to follow up on some of your earlier commentary around services bookings, particularly in Q4. I think you mentioned you have not seen much improvement or did not see much improvement in October. Just kind of looking back historically, you typically see a 30-40% sequential increase in bookings in Q4. Can you just kind of frame out, given the volatility quarter to quarter here, how you are thinking about just kind of the range of outcomes on the services bookings in Q4, just to give us some more color around what organic growth in that segment can look like in 2026? John GallagherCFO at Certara00:39:12Yeah. Hi, Max. So we do still expect from Q3 into Q4 a sequential increase, but not to the same magnitude that we've seen historically. Historically, you've seen a book-to-bill in Q4 that's 1.3-1.4, and we don't anticipate that being the case given what we've seen through October. Max SmockAnalyst at William Blair00:39:36Yeah. Thank you for that. That's helpful. Maybe just one on the margin side. Really nice performance in the quarter. I know in the past you talked about maybe pulling back on some of your investments if the macro environment got a little bit more challenging. Just want to make sure that that wasn't a factor that contributed to the beat on margins in the third quarter here. As we're thinking out in 2026, can you just talk about how you're kind of prioritizing the opportunity that you have here to continue to advance or invest in your pipeline versus prioritizing margin expansion? Just your initial thoughts on how we should be thinking about margins moving forward. John GallagherCFO at Certara00:40:12Yeah. Yeah. Definitely not pulling back on the investments. You can see that reflected in the 24% growth in R&D year on year. We are continuing to make those investments. Good discipline across the rest of the P&L. We talked a little bit about gross profit, but if you exclude ChemAxon from the expense lines, you'd see that they are in line or lower than growing at the rate of sale. I'd say, yes, making the investments, absolutely. You can most notably see that reflected in the R&D line as you would expect. There is more investment to come as we look at next year. We have been pleased with our ability to navigate both making those investments in software development while also preserving our margin. Max SmockAnalyst at William Blair00:41:03Got it. Thanks again for taking our questions. Operator00:41:07Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. Our next question comes from John Park from Morgan Stanley. Please go ahead. John ParkAnalyst at Morgan Stanley00:41:25Hey, guys. Thank you for taking my question. I was wondering, I know you guys talked about Tier 1 and some of the macros that they're facing. I was wondering if you could talk to Tier 2 and Tier 3, acknowledging that they make up a smaller portion of the revenue, but is it any different in terms of some of the macro headwinds that Tier 1s are facing? Thank you. John GallagherCFO at Certara00:41:47Yeah. That's a bright spot for us, actually. Tier 3, both Tier 2 and tier 3 services, have had good growth throughout the year. In fact, in Q3, we saw double-digit growth in bios and services Tier 3. This has been a partial offset to the headwinds that we've been describing in Tier 1. The positive growth and momentum that we have in Tier 2 and most notably in Tier 3. John ParkAnalyst at Morgan Stanley00:42:20Great. And just as a follow-up, I know. You guys work with the FDA. I was wondering if there was any type of waterfall implications with the government shutdown regarding, for FDA or any of the agencies that you guys work with. William FeeheryCEO at Certara00:42:37Yeah. Thanks for the question. I guess the question revolves around how long it lasts. I think most people in the pharmaceutical industry believe that this will resolve itself at some point. That point will be less, and then it causes serious issues if it goes on for a really long time, and we have a big slowdown in drug approvals or something. That's one thing, but I don't think that that's really what people believe. There's a little bit of slowdown in terms of any kind of contracting with the government. We don't expect that will have a significant effect on the year. John ParkAnalyst at Morgan Stanley00:43:30Great. Thank you. Operator00:43:33Thank you. I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesJohn GallagherCFOWilliam FeeheryCEODavid DeuchlerHead of Investor RelationsAnalystsDavid WindleyManaging Director at JefferiesJohn ParkAnalyst at Morgan StanleyMatt HewittAnalyst at Craig-Hallum Capital GroupKyle KruesiAnalyst at UBSMax SmockAnalyst at William BlairJoe VruwinkDirector at BairdLuke SergottAnalyst at BarclaysDan ClarkEquity Research Associate at Leerink PartnersPowered by Earnings DocumentsSlide DeckEarnings Release(8-K)Quarterly Report(10-Q) Certara Earnings Headlines8 Best Healthcare AI Stocks to Buy According to AnalystsMay 5 at 2:55 PM | insidermonkey.comCertara (CERT) Sells Regulatory and Medical Writing Business for Up to $135MMay 5 at 7:50 AM | insidermonkey.comI was right about SpaceXJeff Brown predicted Bitcoin before it climbed as high as 52,400%, Tesla before 2,150%, and Nvidia before 32,000%. Now he says SpaceX is shaping up to be the biggest IPO of the decade - and three key milestones just confirmed it. In the past 21 days: SpaceX crossed 10,000 active satellites, Elon filed confidential IPO paperwork with the SEC, and another rocket launched 25 more satellites. Two-thirds of every satellite in orbit now belongs to one company. The public filing could drop any day.May 8 at 1:00 AM | Brownstone Research (Ad)Certara (CERT) Projected to Post Quarterly Earnings on MondayMay 4, 2026 | americanbankingnews.comCertara, Inc. (NASDAQ:CERT) Given Consensus Recommendation of "Hold" by BrokeragesMay 3, 2026 | americanbankingnews.comAI in Predictive Toxicology Research Report 2026 Featuring Certara, Schrodinger, Instem, Simulations Plus, Lhasa, Chemaxon - Global Forecast to 2030 and 2035April 29, 2026 | finance.yahoo.comSee More Certara Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Certara? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Certara and other key companies, straight to your email. Email Address About CertaraCertara (NASDAQ:CERT) is a biosimulation software and services company that partners with pharmaceutical, biotechnology and medical device developers to accelerate drug discovery, development and regulatory approval. The company’s platform integrates quantitative pharmacology, real-world evidence, artificial intelligence and machine learning to model and simulate drug behavior across a range of therapeutic areas and patient populations. By applying these mechanistic and data-driven approaches, Certara helps its clients predict clinical outcomes, optimize dosing strategies and streamline decision-making throughout the product lifecycle. The company’s offerings are divided into software tools and consulting services. Its software suite includes Phoenix WinNonlin for population pharmacokinetics and pharmacodynamics analysis, the Simcyp Simulator for physiologically based pharmacokinetic (PBPK) modeling, and the Cognigen clinical pharmacology services platform. On the services side, Certara provides regulatory strategy support, model-informed drug development (MIDD) consulting, real-world data analytics and bespoke simulation projects. These capabilities enable sponsors to address regulatory requirements, design efficient clinical trials and generate compelling evidence for product safety and efficacy. Founded in 1993 as Pharsight and later rebranded Certara in 2014, the company has grown through organic innovation and strategic acquisitions to establish a global footprint. Headquartered in Princeton, New Jersey, Certara maintains offices and development centers across North America, Europe and the Asia Pacific region. The firm is led by a management team with deep expertise in pharmacometrics, regulatory science and technology innovation, supporting a diverse client base that ranges from emerging biotech firms to large multinational pharmaceutical companies.View Certara ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Hims & Hers Earnings Preview: The Novo Nordisk Shift Puts GLP-1 Strategy in FocusDutch Bros Q1 Earnings: The Newest Starbucks Rival Faces Its First Big Reality Checkonsemi Stock Dips After Earnings: Why the Dip Is BuyableMonolithic Power Systems: AI Stock Beat, Raised and Upgraded Post-EarningsNVIDIA’s China Connection: Investor Risks With Earnings Ahead5 Mega-Cap Stocks That Beat Q1 2026 Earnings and Are Still ClimbingBig-Tech Earnings: Google and Meta's Results Support Broadcom's Outlook Upcoming Earnings Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Good day, and thank you for standing by. Welcome to the Certara Q3 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you need to press Star one one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one one again. 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, Investor Relations. Please go ahead. David DeuchlerHead of Investor Relations at Certara00:00:39Good 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 financial results for the quarter ended September 30, 2025. 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 two 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. David DeuchlerHead of Investor Relations at Certara00:01:17Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are available in the recent earnings press 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 to live broadcast today, November 6, 2025. 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. With that, I will turn the call over to William. William FeeheryCEO at Certara00:01:49Thank you, David, and good afternoon, everyone. Thank you for joining Certara's Q3 earnings call. John and I will begin with prepared remarks, and then we will take your questions. During the Q3, our team continued to execute against our 2025 goals while also positioning Certara for long-term success by investing in our R&D and commercial teams. Q3 revenue of $104.6 million was in line with our expectations, representing 10% reported year-over-year growth. We outperformed internal profitability expectations, delivering adjusted EBITDA of $35.2 million, representing a margin of 34%. Our team remains focused on investing for growth, with R&D up 24% versus the same period a year ago and increasing to 10% of revenue from 9% in the prior year period. On the other hand, Q3 bookings of $96.6 million came in below our expectations, representing growth of 1%. William FeeheryCEO at Certara00:02:54Among our Tier 1 services customers, we observed cautious spending behavior, with some customers pushing deal timelines later into the Q4 and into 2026. Taking this into account, we are narrowing our revenue guidance to $415 million-$420 million, which we believe reflects the most likely range of outcomes for the year based on our performance to date. We have raised our adjusted EBITDA margin guidance to the high end of our previous guidance range and raised our adjusted EPS guidance to reflect a continuation of outperformance against our profitability targets and the impact of share repurchase activity. We continue to see pockets of outperformance throughout our portfolio, including our Simcyp PBPK software and our QSP services. However, some of our customers are still dealing with factors that impact decision-making timelines and R&D allocation decisions. William FeeheryCEO at Certara00:03:51As large pharma customers adjust focus with their R&D programs and now onshoring initiatives that are impacting personnel and resource allocations, we have seen a slowdown in deal completion timelines, particularly in regulatory services and Biosim Services. This slowdown has persisted into the beginning of the Q4, conflicting with historical seasonality trends. We are closely monitoring consumer spending patterns as we begin to plan for 2026. At a high level, we continue to see several positive leading indicators for the biosimulation market and for Certara. Among large pharma customers, the use of Model-informed Drug Development is growing throughout all stages of development. Customers are adopting biosimulation solutions for use in dosing, efficacy, and toxicity analysis, and using the technology earlier as we expand our software capabilities into discovery and preclinical. Among our smaller customers, the adoption of biosimulation is accelerating through the use of our technology-enabled services. William FeeheryCEO at Certara00:04:57As drug developers look to optimize their speed and efficiency, they are often attracted to areas of our business such as QSP, which can help streamline decision-making and trial design in both the preclinical and clinical stages. Since our IPO, we have seen a significant increase in both the number of customers using our products and services as well as the wallet share of Certara within larger organizations. Most of all, we are encouraged by our evolving relationships with key stakeholders and users and customers. Earlier this year, we hosted our second annual Certainty Conference, bringing together hundreds of our users to discuss the future of Model-Informed Drug Development. In early October, we held the same conference in Barcelona with our European user base, and the experience was very productive for all parties. William FeeheryCEO at Certara00:05:48At both events, I had the opportunity to discuss Certara's products with customers, where they provided feedback on our software, suggested new features and functionality, and learned about our new products and long-term vision for the Certara platform. There is tremendous value that can be gained by making more informed decisions earlier in the drug development lifecycle, which is why we are moving into discovery and preclinical. We closed the ChemAxon acquisition a year ago in early October of 2024, which gave Certara an established product suite in discovery with synergistic capabilities relative to Simcyp. In the first 12 months under Certara ownership, ChemAxon has continued to grow and is on track to reach corporate average margins by the end of the year. Elsewhere, our services group has grown preclinical work in QSP, especially since the FDA's guidance promoting the use of new approach methodologies. William FeeheryCEO at Certara00:06:46QSP has grown ahead of the rest of the biosimulation business on a year-to-date basis and is becoming an increasingly important part of our business. Now, turning to our financial performance. In software, bookings of $40.8 million represented growth of 17%. We saw solid bookings performance in Tiers 1 and 3, which were in line with expectations, while Tier 2 was below expectations, which we attribute more to timing than anything. Software revenue of $43.8 million grew 22% on a reported basis and 6% organically, led by strong growth from Simcyp, in addition to $5.6 million of contribution from ChemAxon. In services, bookings of $55.8 million declined 9% on a reported basis. Driven by slowness in the Tier 1 customer base. We have continued to observe cautious decision-making among large pharma customers into the Q4. William FeeheryCEO at Certara00:07:49Services revenue of $60.8 million grew 3% on a reported basis and on an organic basis, led by growth in QSP services. On the innovation front, 2025 has been our most active product development year since our IPO. We've embedded artificial intelligence into both our development processes and our products, accelerating the pace of new model creation following our VIA Science acquisition. We launched several major products this quarter. Pinnacle 21 Enterprise, a cloud-based upgrade improving regulatory data compliance and submission speed. Phoenix Cloud, which transitions our customers from on-premise to Certara Cloud deployment and provides significant upgrades to product functionality, and Certara IQ, our new software for QSP modeling, designed to expand the use of biosimulation across discovery and clinical phases. Early customer feedback on these releases has been excellent, and we're confident they strengthen our long-term software growth engine. William FeeheryCEO at Certara00:08:59Last year, we announced the strategic review of our regulatory services business. To date, we have made significant progress in our evaluation, including dialogue with external parties and significant internal analysis of best practices. As we evaluate our business, we recognize that regulatory writing performance has been inconsistent. Simultaneously, we value the regulatory writing business's ability to generate cash, which we have used to invest in growth and support recent share repurchases. At this point in time, we are in the final stages of our process and intend to share a definitive outcome before the end of 2025. To close, we remain focused on delivering our 2025 plan and entering 2026 well-prepared to capitalize on the opportunities ahead. Although we are seeing some variability in Tier 1 services, we are encouraged by the widespread momentum of biosimulation adoption in drug development. William FeeheryCEO at Certara00:10:01I'll now hand things over to John Gallagher to discuss our financial results in more detail. John GallagherCFO at Certara00:10:08Thank you, William. Hello, everyone. Total revenue for the three months ended September 30, 2025, was $104.6 million, representing year-over-year growth of 10% on a reported basis and on a constant currency basis. Total bookings in the Q4 were $96.6 million, which increased 1% from the prior year period on a reported basis. Trailing 12-month bookings were $471.4 million, increasing 12% on a reported basis. Excluding ChemAxon, total company organic bookings declined 4% compared with the Q3 last year. Software revenue was $43.8 million in the Q4, which increased 22% over the prior year period on a reported basis and 21% on a constant currency basis. Organic growth was 6% in the quarter, driven by strong growth from Simcyp. ChemAxon contributed $5.6 million to our reported revenue, which was in line with our expectations. John GallagherCFO at Certara00:11:16Ratable and subscription revenue accounted for 65% of Q3 software revenues, or 71% excluding ChemAxon, slightly down from 72% in the prior year period. Software bookings were $40.8 million in the Q4, which increased 17% from the prior year period. Q3 bookings included $4.2 million of ChemAxon bookings. Organic software bookings grew 5% versus the prior year. Trailing 12-month software bookings were $187.9 million, up 23% year-over-year. The software net retention rate was 104 in the quarter, consistent with our full-year plan. Looking at our Software Bookings Performance by Tier, we saw strong performance in Tiers 1 and 3, driven by the continued adoption of our software. In Tier 1, we saw some timing-related slowness due to renewals, which we expect to normalize in the Q4. John GallagherCFO at Certara00:12:19Now, turning to services revenue, which was $60.8 million in the Q4, up 3% versus the prior year period on a reported basis and on a constant currency basis. We saw strong performance from our QSP and Simcyp services businesses in the quarter, which was partially offset by softness in the regulatory services. Technology-driven services bookings in the Q4 were $55.8 million, which declined 9% from the prior year period. TTM services bookings were $283.5 million, up 6% as compared to the prior year. During the quarter, we saw softer performance from Tier 1 customers and biosimulation services, driven by spending hesitancy among our largest customers. In regulatory, bookings declined in the double digits, while biosimulation services were down low single digits. Total cost of revenue for the Q4 of 2025 was $39.7 million, an increase from $37.2 million in the Q4 of 2024. John GallagherCFO at Certara00:13:28Primarily due to higher software amortization and consulting expenses, offset by lower employee-related costs. Total operating expenses for the Q4 of 2025 were $61.9 million, an increase from $55 million in the Q4 of 2024, primarily due to higher employee-related costs in sales and marketing and R&D. Adjusted EBITDA for the Q4 of 2025 was $35.2 million, an increase from $33.1 million in the Q4 of 2024. Adjusted EBITDA margin in the quarter was 34%. Wrapping up the income statement, net income for the Q4 of 2025 was $1.5 million, compared to a net loss of $1.4 million in the Q4 of 2024. Reported adjusted net income for the Q4 of 2025 was $22.2 million, compared to $20.3 million for the Q4 of 2024. Diluted earnings per share for the Q4 of 2025 was $0.01, compared to a loss of $0.01 per share in the Q4 of 2024. John GallagherCFO at Certara00:14:46Adjusted diluted earnings per share for the Q4 of 2025 was $0.14. Compared to $0.13 per share in the Q4 of last year. Moving to the balance sheet, we finished the quarter with $172.7 million in cash and cash equivalents. As of September 30, 2025, we had $293.1 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. Subsequent to the end of the quarter, we executed a reprice of our outstanding term loan, which is expected to save $700,000 annually in interest expense beginning in 2026. Earlier this year, our board authorized a $100 million share repurchase program. We have repurchased approximately $41 million of stock during 2025. With year-to-date results in our outlook for the Q4, we are providing the following guidance for 2025. John GallagherCFO at Certara00:15:50We are narrowing the revenue range to $415 million-$420 million, representing 8%-9% growth compared with 2024. We expect ChemAxon to contribute software revenue of $23 million-$25 million. We expect an adjusted EBITDA margin around 32%, which is the high end of our previous guidance range, reflecting outperformance versus our internal profitability expectations to date. We expect adjusted EPS in the range of $0.45-$0.47 per share, fully diluted shares in the range of 160 million-162 million, and a tax rate in the range of 25%-30%. I will now turn the call back over to our CEO, William Feehery, for closing remarks. William FeeheryCEO at Certara00:16:44Thank you, John. To summarize our message today, our team is working diligently to execute our growth and profitability goals despite a mixed operating environment. We are excited to bring several new products to market and look forward to providing further updates on our progress early next year. Operator, can you please open the line for questions? Operator00:17:08Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Michael Cherny from Leerink Partners. Please go ahead. Dan ClarkEquity Research Associate at Leerink Partners00:17:33Great. Thank you. This is Dan Clark on for Mike. Just wanted to ask a little bit on the Tier 1 services revenue or bookings dynamic in the quarter. I guess, one, when did you start to see a slowdown in decision-making timing and of the potential deals that got pushed? Appreciate the color on some of them, hopefully closing in 4Q with the remainder in 2026. How are you kind of thinking about that split at this point? Thank you. John GallagherCFO at Certara00:18:06Yeah. As it relates to the bookings, it was our Tier 1 services customers where we saw delays. What we're seeing is hesitancy, so a slowness in decision-making. A lot of times, we would talk about that as impacting timing and trickling into the next quarter. What we just said in the prepared remarks, though, is that through the month of October, we continued to see some deceleration in Tier 1 services bookings related to these larger customers of ours. As a result of that, we're expecting it to continue in Q4. Operator00:18:53Thank you. One moment for our next question. Our next question comes from David Windley from Jefferies. Please go ahead. David WindleyManaging Director at Jefferies00:19:03Hi. Thanks for taking my question. Hopefully, you can hear me. I'm in the car. I was hoping you could comment or disentangle the gross profit outperformance between mix and perhaps efficiency, productivity. John GallagherCFO at Certara00:19:25Yeah. Thank you, David. Yeah. I mean, on the gross margin line, then. We've certainly seen some productivity, especially compared to last year. You might recall we did some reductions last year on the services side that hit the cost of sales. We're still comping to that in the Q3 of this year. Therefore, some of that productivity is a key component of why the gross profit is accelerating. The other piece of it, of course, is the fact that we're achieving more mix on a software basis. When we're looking, the software business has, of course, a higher gross profit than services. Not only are we getting productivity on the cost of sales side when we look at services, but the mix shift towards software is also a tailwind to the gross profit. David WindleyManaging Director at Jefferies00:20:26Thank you for that. I was going to make my next question, my second question, about your areas of innovation, but it does end up being somewhat related. I think you talked about Certara IQ as your more AI-enabled QSP and Phoenix Cloud launches. It sounds like those have been well received. The comment in the prepared is about QSP being your fastest-growing area. Maybe you could also drill into that because I think today most of QSP is service-driven. You are launching this, what I think sounds like a more technology or software-driven QSP. How do you expect that to evolve? Does that growth in QSP mix kind of reverse the software mix until the technology, the software picks up a little bit more? I am just curious how the QSP feathers into that since you highlighted its growth. Thanks. William FeeheryCEO at Certara00:21:30Yeah. Thanks, David. This is Bill. We are executing the strategy that we set out to do when we acquired Applied BioMath about, whatever it was, about two years ago. Which was to take QSP and to bring a software platform to it. That is Certara IQ, which we launched, as you pointed out. There is a huge demand for QSP. Some of it has to do with the recognition that this type of modeling has been quite useful. Now that the FDA has made its announcement on NAMs and on reducing the number of non-human primates. Some of it has to do with the growth in large molecules, where QSP has been particularly valuable. We are attempting, and I think we will very much succeed with this product, to create a standard product that QSP modelers use. Not just within pharma companies, but also. William FeeheryCEO at Certara00:22:43As they go forward and submit their models for approvals to regulators, there's a big need in the market for this, and there's a big opportunity to make QSP a lot more widespread by improving the efficiency of modeling, which we can do with AI, and providing a platform where our consultants are much more efficient. Providing the same platform so that our pharma customers are using the same platform internally, it can also drive that kind of same efficiency, and we can get work going back and forth. Then finally, this is an opportunity for us to create foundational models, in particular therapeutic or drug modalities, that we can sell over and over again using this software platform. There are multiple ways that this will benefit the company financially as we go forward. There's nothing like it, really, on the QSP market. William FeeheryCEO at Certara00:23:47There's obviously modeling tools out there, but we believe this is a significant advance. It's been well received. We only launched it a couple of weeks ago, so it's a bit early to talk about the financial success, obviously. We expect, as we go into 2026, this will be a success for the company. David WindleyManaging Director at Jefferies00:24:17Thank you. David DeuchlerHead of Investor Relations at Certara00:24:18Thanks for that. All right. Go ahead. That's fine. Go ahead. Operator00:24:23Thank you. One moment for our next question. Our next question comes from Matt Hewitt from Craig Hallum Capital Group. Please go ahead. Matt HewittAnalyst at Craig-Hallum Capital Group00:24:35Good afternoon. Thanks for taking the questions. I apologize. I'm having to hop between a couple of different calls. First off, I recognize that there's some challenges or hesitancy with your Tier 1 customers. I'm just curious if you've heard or seen any change since we got a little bit of clarity on the most favored nation pricing and what that could mean, some clarity on the tariffs and what that impact could be. I mean, we've heard from a few other companies that post some of those initial most favored nation-type contracts or changes that pharma was kind of re-engaging. Is that similar to what you're seeing or any color along those lines? William FeeheryCEO at Certara00:25:15Yeah. Thanks. This is Bill. We have also heard other companies talking about that and heard some discussion among customers. I would say that we're cautiously optimistic. That is a pretty recent development, so we need to see that kind of get out in the marketplace. I think any sign of kind of the macro stability for the Tier 1 customers and what's going on with pricing, I think, would be ultimately good for us and will flow into, hopefully, a better environment as we go into 2026. Matt HewittAnalyst at Craig-Hallum Capital Group00:26:00Got it. Maybe just as a follow-up, and I realize it's still very early, and we haven't even closed out this year yet, but as you're talking to your customers not only about the remainder of fiscal 2025, but as they're starting to think about their budgets for fiscal 2026. Are you getting any sense for where those budgets may be going, any sense for how modeling and simulation kind of fits into those budgetary plans for 2026, recognizing, yes, it's early days, but having gone through this now for a while, I sense you guys might have a feel for, "Okay. If we're hearing this at this stage, that bodes well for the final budgets when they're announced later this year or early next year." Thank you. William FeeheryCEO at Certara00:26:45Yeah. I mean, we obviously only have kind of anecdotes if you're asking a question about the overall industry. I'd say what I can say is I think some of our new products have been very well received. People have talked about making sure that there will be budget for them as they go into 2026. We're getting some sense that the pullback in services is not across the entire industry. We see it in Tier 1s. We're actually doing quite well with Tier 3s with biotechs right now. The Tier 1 seems to be kind of a hesitancy based on the overall macroeconomic environment. I think every time we hear kind of positive signs of stability, things get a little bit more bright for us. We're not, what I've heard, and we're expecting kind of, what do you want to call it? William FeeheryCEO at Certara00:27:46A stabilizing environment, I guess, is the way I'll put it, as we go into 2026, as opposed to kind of where we've seen part of this year where it's been getting a little bit tougher. Matt HewittAnalyst at Craig-Hallum Capital Group00:28:00Okay. That makes sense. Thank you very much. Operator00:28:04Thank you. Our next question comes from Luke Sergott from Barclays. Please go ahead. Luke, you may be on mute. One moment for our next question. Our next question comes from Brennan Smith from TD Cowen. Please go ahead. Luke SergottAnalyst at Barclays00:28:38Great. Thanks, guys, for taking the questions. Actually, just wanted to follow up on some of the earlier questions related to the software business a little bit more. This is, frankly, something we're just asked by investors a fair amount. I guess we're obviously seeing pharma and some of those Tier 1 customers invest a lot more internally in some of their own kind of AI-plus capabilities. I guess, do you kind of feel that's net-net headwinds, tailwinds, maybe a wash to where you guys come out? Just trying to understand to what extent, as they build out those capabilities, they turn to you all to help make sure that those internal processes are ramping as they should. Is it kind of an or rather than an and within their budgets, just based on your conversations? Thanks, guys. William FeeheryCEO at Certara00:29:20Yeah. Thanks for the question. What we've seen happen with AI has been tremendous. This is starting more than a year ago, tremendous excitement and willingness to try things in pharma, but somewhat of a hesitancy to commit to enterprise sales until they understood the full implications of putting AI in terms of data security and how the products will be used, sort of the, let's call it the quality controls that you have to put in around AI and some of these uses. We saw a lot of, in the beginning, they were really great marketing opportunities, but slow to sell. As we've gotten through 2025, we've seen somewhat of a pickup in actual sales of the pure AI products. All of our products that we've recently launched, well, let's say Phoenix and Certara IQ have embedded AI in them, and that's been quite well received. William FeeheryCEO at Certara00:30:30I think we're seeing a bit more willingness to move faster, to put these things in as you deploy them across the enterprise. You're asking a somewhat different question also around, as pharma, considering building our core products using AI internally versus buying them from us. The core modeling technologies we have are really quite specialized. That doesn't tend to be a real option. You can see that with our software, which is still growing quite nicely, and we expect will continue to be strong as we go into 2026. Luke SergottAnalyst at Barclays00:31:19Got it. Thanks, guys. Operator00:31:22Thank you. Our next question comes from Joe Vruwink from Baird. Please go ahead. Joe VruwinkDirector at Baird00:31:31Hi, John. Thanks for taking my questions. Just to go back a couple of questions ago, you mentioned the prospect of stabilized environments for 2026. What do you think stabilized means for Certara growth potential at this point? I just ask because the last three years have obviously seen a lot of macro turbulence. Organic growth has averaged 3-4% over that stretch of time. Is stabilized supportive of mid to high single-digit growth and robust gets you back to the double digits? Or any way directionally just appreciating kind of what the company has been through over recent history? John GallagherCFO at Certara00:32:15Yeah. Hi, Joe. As it relates to us calling it stabilized, then really what we're saying is we see continued performance on the software side, which has been playing out according to plan this year. Year-to-date software looking to be 7% on a TPM basis. We're seeing 6% year-to-date, 7% TPM, and then 6% organic software this year. We're adding the product that Bill was talking about, of course, too. Those are the positives. The headwind to all that is what we're seeing in services right now. We saw it. You can see it in the Q3 results, but you can also see it. We saw it in October. That's why we were indicating that. John GallagherCFO at Certara00:33:13As we look toward the end of the year this year, we're not really expecting to see the same level of seasonality that we've seen over prior years. That is going to provide a bit lower of a jumping-off point as it relates to services. Services is likely to be in the low single digits as we approach next year as a result of that. Software going well, playing out according to plan. We've got new products. Services is the spot that we're keeping our eye on as we finish 2026. Joe VruwinkDirector at Baird00:33:49Okay. That's helpful, Color. Thank you. Just to go back to David's question on gross margin, as I look at the mix of software sales this year, a lot of the incremental growth has come from higher license sales as opposed to subscriptions. And that might be ChemAxon related, but in case it's not. Is that a beneficial margin mix to year-to-date results? Or. How to think of that versus a higher proportion of, I guess, ratable subscription revenue? John GallagherCFO at Certara00:34:22Yeah. You've got that straight, Joe. Bringing in ChemAxon, ChemAxon is predominantly license-based, at least right now. Whenever we're recognizing revenue there, we're getting all of it at once. That combined with Phoenix achievement on revenue this year is what's helping the gross margin, if you will, from that perspective, while at the same time is reducing the proportion of ratable that we have. That's why I like to cite it, not just what the ratable portion of software is, but even excluding ChemAxon is a better comp to the prior year. Joe VruwinkDirector at Baird00:35:06Okay. Great. Thank you very much. Operator00:35:10Thank you. Our next question comes from Kyle Kruesi from UBS. Please go ahead. Kyle KruesiAnalyst at UBS00:35:16Hey. Thank you for taking our questions. You mentioned that customers were adopting model-informed drug development for use in toxicity and dosing analysis. CDER, earlier in October here, announced that you could use essentially Pharmacokinetic analysis to replace some animal testing for first-in-human dosing. Can you elaborate a bit more on that point that you made earlier in the call? Thank you. William FeeheryCEO at Certara00:35:38Yeah. One of the significant uses around QSP has been in these two areas. First-in-human dosing has been a particular area of interest in pharma for modeling. It does not sound like the biggest problem. When you really think about it, the initial dose that gets tried in a phase one trial really defines the range that will be used for all trials later. If the doses that are tried are outside the effective or the safe range, they are kind of wasted. That has been recognized by a lot of companies in the pharmaceutical industry, and it has been good to see that the regulators are paying attention and are encouraging it as well. That has been one of the reasons for the uptake in modeling services like QSP that we have seen. Kyle KruesiAnalyst at UBS00:36:52Great. Thank you for that. Can you speak briefly on your exposure to biologics or small molecule drugs at this point with your software offerings? Thank you. William FeeheryCEO at Certara00:37:03We have exposure to both. We always said, and I believe this has not changed, that our exposure is pretty similar to what the pharmaceutical industry as a whole is working on at any given point. The questions that get asked in modeling between small molecules and large molecules are often somewhat different. For example, small molecules, there can be more formulation questions and absorption questions. In large molecules, there are often more questions around things like dosing and immunological responses and things like that. However, we have products targeted for both. We have quite healthy and active businesses for both technologies and even other technologies that maybe do not even quite fit this kind of definition. For example, we have products focused on radioligands and peptides, things like that. I think we are pretty well covered in terms of our exposure. William FeeheryCEO at Certara00:38:22Our investment in the technology to kind of serve both of these. Kyle KruesiAnalyst at UBS00:38:28Great. Thank you. Operator00:38:31Thank you. Our next question comes from Max Smock from William Blair. Please go ahead. Max SmockAnalyst at William Blair00:38:39Hey, guys. Good afternoon. Thanks for taking our questions here. John, maybe I just wanted to follow up on some of your earlier commentary around services bookings, particularly in Q4. I think you mentioned you have not seen much improvement or did not see much improvement in October. Just kind of looking back historically, you typically see a 30-40% sequential increase in bookings in Q4. Can you just kind of frame out, given the volatility quarter to quarter here, how you are thinking about just kind of the range of outcomes on the services bookings in Q4, just to give us some more color around what organic growth in that segment can look like in 2026? John GallagherCFO at Certara00:39:12Yeah. Hi, Max. So we do still expect from Q3 into Q4 a sequential increase, but not to the same magnitude that we've seen historically. Historically, you've seen a book-to-bill in Q4 that's 1.3-1.4, and we don't anticipate that being the case given what we've seen through October. Max SmockAnalyst at William Blair00:39:36Yeah. Thank you for that. That's helpful. Maybe just one on the margin side. Really nice performance in the quarter. I know in the past you talked about maybe pulling back on some of your investments if the macro environment got a little bit more challenging. Just want to make sure that that wasn't a factor that contributed to the beat on margins in the third quarter here. As we're thinking out in 2026, can you just talk about how you're kind of prioritizing the opportunity that you have here to continue to advance or invest in your pipeline versus prioritizing margin expansion? Just your initial thoughts on how we should be thinking about margins moving forward. John GallagherCFO at Certara00:40:12Yeah. Yeah. Definitely not pulling back on the investments. You can see that reflected in the 24% growth in R&D year on year. We are continuing to make those investments. Good discipline across the rest of the P&L. We talked a little bit about gross profit, but if you exclude ChemAxon from the expense lines, you'd see that they are in line or lower than growing at the rate of sale. I'd say, yes, making the investments, absolutely. You can most notably see that reflected in the R&D line as you would expect. There is more investment to come as we look at next year. We have been pleased with our ability to navigate both making those investments in software development while also preserving our margin. Max SmockAnalyst at William Blair00:41:03Got it. Thanks again for taking our questions. Operator00:41:07Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. Our next question comes from John Park from Morgan Stanley. Please go ahead. John ParkAnalyst at Morgan Stanley00:41:25Hey, guys. Thank you for taking my question. I was wondering, I know you guys talked about Tier 1 and some of the macros that they're facing. I was wondering if you could talk to Tier 2 and Tier 3, acknowledging that they make up a smaller portion of the revenue, but is it any different in terms of some of the macro headwinds that Tier 1s are facing? Thank you. John GallagherCFO at Certara00:41:47Yeah. That's a bright spot for us, actually. Tier 3, both Tier 2 and tier 3 services, have had good growth throughout the year. In fact, in Q3, we saw double-digit growth in bios and services Tier 3. This has been a partial offset to the headwinds that we've been describing in Tier 1. The positive growth and momentum that we have in Tier 2 and most notably in Tier 3. John ParkAnalyst at Morgan Stanley00:42:20Great. And just as a follow-up, I know. You guys work with the FDA. I was wondering if there was any type of waterfall implications with the government shutdown regarding, for FDA or any of the agencies that you guys work with. William FeeheryCEO at Certara00:42:37Yeah. Thanks for the question. I guess the question revolves around how long it lasts. I think most people in the pharmaceutical industry believe that this will resolve itself at some point. That point will be less, and then it causes serious issues if it goes on for a really long time, and we have a big slowdown in drug approvals or something. That's one thing, but I don't think that that's really what people believe. There's a little bit of slowdown in terms of any kind of contracting with the government. We don't expect that will have a significant effect on the year. John ParkAnalyst at Morgan Stanley00:43:30Great. Thank you. Operator00:43:33Thank you. I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesJohn GallagherCFOWilliam FeeheryCEODavid DeuchlerHead of Investor RelationsAnalystsDavid WindleyManaging Director at JefferiesJohn ParkAnalyst at Morgan StanleyMatt HewittAnalyst at Craig-Hallum Capital GroupKyle KruesiAnalyst at UBSMax SmockAnalyst at William BlairJoe VruwinkDirector at BairdLuke SergottAnalyst at BarclaysDan ClarkEquity Research Associate at Leerink PartnersPowered by