Greetings, and welcome to the Simulations Plus Third Quarter Fiscal 2025 Financial Results Conference Call. As a reminder, this conference call is being recorded. It is now my pleasure to introduce Lisa Fortuna from Financial Profiles. Ms. Fortuna, please go ahead.

Good afternoon, everyone. Welcome to the Simulations Plus Third Quarter Fiscal 2025 Financial Results Conference Call. With me today are Shawn O'Connor, Chief Executive Officer; and Will Frederick, Chief Financial Officer of Simulations Plus. Please note that we updated our quarterly earnings presentation, which will serve as a supplement to today's prepared remarks. You can access the presentation on our Investor Relations website at www.simulations-plus.com. After management's commentary, we will open the call for questions. As a reminder, the information discussed today may include forward-looking statements that involve risks and uncertainties. Words like believe, expect and anticipate refer to our best estimates as of this call, and actual future results could differ significantly from these statements. Further information on the company's risk factors is contained in the company's quarterly and annual reports and filed with the Securities and Exchange Commission. 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 and on the company's website. Please refer to the reconciliation tables and the accompanying materials for additional information. With that, I'll turn the call over to Shawn O'Connor. Please go ahead.

Thank you, Lisa. Good afternoon, everyone, and thank you for joining our Third Quarter Fiscal 2025 Conference Call. Third quarter revenue came in slightly above our preliminary range communicated in June. Final results showed revenue growth of 10% to $20.4 million, including a $2.4 million contribution from the Pro-ficiency acquisition. On an organic basis, revenue declined 4%, primarily due to lower QSP/QST software revenue and a decrease in our biosimulation services revenue. Diluted EPS loss was $3.35, which included a $77.2 million charge, noncash impairment expense related to prior acquisitions, compared to $0.15 last year. Adjusted diluted EPS was $0.45 compared to $0.27 last year. Adjusted EBITDA was $7.4 million or 37% of revenue, compared to $5.6 million or 30% of revenue last year. A year ago, we acquired Pro-ficiency to expand our capabilities into the clinical operations space to leverage our science and technology capabilities and the use of predictive analytics to support our clients' ability to better manage a critical contributor to clinical trial failures. The acquisition doubled our TAM and positions us well for future growth in clinical operations, where the opportunity to improve outcomes with better use of predictive technologies is recognized as an important area of potential improvement in drug development. The Pro-ficiency training platform and Medical Communication services have been significantly impacted by market headwinds that disrupted clinical trial initiations and tightened commercialization budgets. These are similar in nature to the headwinds encountered in our biosimulation market. As a result, our outlook for these revenue sources for fiscal year '25 and into fiscal year '26 decreased. And we took what we believe was a prudent and conservative step to align the book value of these assets to their near-term market value. We are deeply committed to our clinical operations and Medical Communications businesses and…

Thank you, Shawn. To recap our third quarter performance, total revenue increased 10% to $20.4 million, including a $2.4 million contribution from the Pro-ficiency acquisition. Software revenue increased 6%, representing 62% of total revenue; and Services revenue increased 17%, representing 38% of total revenue. Turning to the Software revenue contribution from our products for the quarter. GastroPlus was 56%, ADMET Predictor was 20%, MonolixSuite was 17%, Pro-ficiency was 3% and QSP/QST products were 4%. For the trailing 12 months, GastroPlus was 48%, MonolixSuite was 20%, ADMET Predictor was 17%, Pro-ficiency was 9% and QSP/QST products were 6%. The trailing 12-month software revenue for Pro-ficiency only includes revenue since the acquisition in June 2024. During the quarter, our Software customer renewal rate was 84% based on fees and 71% based on accounts. Average software revenue per customer for the quarter was $96,000, down slightly both sequentially and compared to last year. On a trailing 12-month basis, our Software customer renewal rate was 89% based on fees and 78% based on accounts, slightly lower than last fiscal year. Average revenue per customer increased to $101,000 from $95,000 on a trailing 12-month basis. Shifting to our Services revenue contribution by solution for the quarter, PK/PD services were 38%, Med Comm services were 26%, QSP/QST services were 19% and PBPK services were 18%. On a trailing 12-month basis, PK/PD services were 37%, QSP/QST services were 24%, Med Comm services were 22% and PBPK services were 17%. Again, the trailing 12-month Med Comm services revenue only includes revenue since the acquisition of Pro-ficiency last June. Total Services projects worked on during the quarter were 202 and year-end backlog increased to $20.7 million from $19.6 million last year. Total gross margin for the quarter was 64%, with Software gross margin of 80% and Services gross margin…

Thank you, Will. We faced new challenges in the third quarter, which recalibrated our outlook for the balance of fiscal '25. At the same time, we remain optimistic about the long-term prospects for biosimulation growth and the use of AI predictive analytics in clinical operations. Our positive long-term outlook is underpinned by growing demand for more efficient drug development, an area where our platforms and solutions deliver clear value. The regulatory environment is also increasingly supportive of in silico methods as demonstrated by the FDA's recently announced road map to reduce animal testing through the adoption of new approach methodologies. Additionally, the FDA Commissioner has publicly endorsed the use of AI in drug development, highlighting its potential to enhance both speed and efficiency without sacrificing safety and efficacy. Just this week, the NIH announced that the biomedical agency would no longer award funding to new grant proposals solely relying on animal testing. Since it remains unclear when the market will stabilize, we believe that we have taken necessary actions that will allow us to operate effectively and efficiently to serve our clients until the market dynamics improve. As in prior years, we will provide our fiscal 2026 outlook when we report fourth quarter results. Assuming current market conditions persist in the near term, we generally anticipate modest improvement in fiscal 2026 compared to fiscal 2025. We anticipate exiting fiscal year '25 with relatively flat organic revenue growth, with Software revenue growth in the 5% to 9% range and Services revenue decline in the 9% to 13% range. Between now and when we provide fiscal year '26 guidance, we will have the benefit of understanding the ongoing impact of market headwinds as well as input from clients as they undertake their calendar year budgeting cycles. Looking to the future, Simulations Plus…

[Operator Instructions] And our first question comes from the line of Scott Schoenhaus with KeyBanc Capital Markets.

So I guess my first question is on the implied fourth quarter -- fiscal fourth quarter margin guide. It comes down steeply from the margins you just posted, and you talked about your efficiencies and streamlining the operations to get to those margins this quarter. What is driving that margin erosion next quarter?

The reorganization and the actions we took in terms of our expense structure, Scott, primarily did not impact the third quarter. They impact the business on a go-forward basis. As we had communicated, they represented an annual cost savings of $4 million and that starts to kick in, in the fourth quarter, really impacts our next fiscal year. Our challenge in terms of the fourth quarter margins really is embracing the revenue step down on the top line. And while we're making our expense structure more efficient, fourth quarter revenues impact those margins and bring us down to that guidance in the mid- to high 20s in terms of EBITDA -- adjusted EBITDA.

And then on the renewal rates on the Software side, stepping down from 93% to 84% on the fees and 86% to 71% on the accounts. And I think you talked in your prepared remarks about, mostly this was driven by GastroPlus, the site closures from certain accounts. Can you just provide more color here? It seems like a pretty big drop off. And what historically have you seen that floor for renewal rates? Are we -- is there more risk for renewal rates to fall even further from here?

Yes. Our renewal rates, as we've said previously, historically, the renewal rate is impacted primarily by consolidations, site closures, combinations of our clients that result in reduction of the renewal size and that certainly was the case in the third quarter. A consolidation, both with regard to a GastroPlus client and as well a Monolix client impacted those renewal rates for those two products. I don't see others on the horizon of great significance, but consolidations are occurring in our client base. And as they have contributed historically, I'm sure they will in the future. I don't know that our experience here in the third quarter is indicative. And we've maintained historical rates in that 90% to 95% renewal rate on fees, which I expect we will, in the long term, maintain.

The next question comes from the line of Matt Hewitt with Craig-Hallum Capital Group.

Maybe first up, regarding the April 10 guidance from the FDA, my sense was initially that there was a little bit of a pause, that your customers kind of pulled back a little bit, trying to understand what the new guidance was, how it impacted their business and their clinical trials and whatnot. Are you starting to see that come back as those customers become more comfortable with what the guidance calls for? And are you anticipating that things could start to pick up as we exit this calendar year and get into fiscal '26 for you guys?

Yes. Thanks, Matt. First, I'd say that the announcement by the FDA with regard to use of NAMs, alternative methodologies and replacements of animal testing is one component of the drug development process, and that taking place in the early preclinical translational activities with our clients, our products and services serve the full development cycle. And so the announcement is, a, very specific to a certain area of drug development; and b, never underestimate the time it takes for these objective stating goals to be translated down into actionable steps. We certainly -- it is topic high on the list of all of our conversations today with clients that are in that phase of development with some of their programs. But action is still at that stage of waiting for clarity from the FDA and their stated process of putting together guidelines and interacting with the industry in their development. And that's a process that will take some time. Certainly, it is an indicator of momentum in terms of the use of modeling and simulation there at that stage of development and broadly wind in the sails of the use of modeling and simulation. It's where future drug development will go and become more dependent upon in silico techniques. But measuring it right now in a quarter-to-quarter basis impact on revenue is probably too quick in your anticipation of its impact. Certainly, a long-term impact. Modeling and simulation continues to grow over the years through its continued adoption of not only existing applications, but the creation of new applications like this will be over the long term that increase the ways in which modeling and simulation is used in the full drug development process. So great news, certainly a topic of conversation that's quite prevalent, a lot of momentum in terms of modeling and simulation. Patience required in terms of seeing its impact on top line revenue.

Got it. And then maybe a different way of kind of looking at this, but you listed off a number of different headwinds that you're facing, the funding environment, customer consolidation, site closures. As you look at those, what do you think has been the biggest headwind recently? And what's it going to take for that to kind of ease so that you could maybe start to get back to double-digit growth, particularly on the Software side?

Yes, the million-dollar question. I wouldn't point to any single factor. It's really the plethora of uncertainties that exist that cause clients to be cautious in their investment decisions, their spending decisions. And I think we got to see a shortening of the list of all those items that are on that list that contribute to, hey, let's slow play and let's wait and see a little bit. It's -- each of them has their impact with specific clients, specific programs. It's the length of that list that I think is really impactful right now. As we look at our business today, we've taken some actions to gain some efficiencies, rightsize our expense run rates and not anticipate a significant uptick in the market characteristics in the near term. We'll poise and be ready if they do, but our view right now is let's optimize performance in this environment and work and be ready to step up when the market does turn to down the road.

The next question comes from the line of Max Smock with William Blair.

Great. It's Christine Rains on for Max Smock. So just to start with, circling back on the previous question on 4Q EBITDA margin expectations. Just hoping to get a bit more clarity here. So at the midpoint of your guide, it seems like revenue is dropping off around $4 million sequentially, but your adjusted EBITDA step down is roughly $6.5 million, even though I think you're expecting around $1 million of savings from cost cuts. So maybe it would be helpful to get a breakdown of your expectations for COGS and OpEx spend as a percentage of revenue to help us get a handle on drivers for your margin guide for this year? And then how you expect both to trend in 2026, given your recent cost-cutting efforts?

Yes. I'll provide an answer at a high level, and then, Will, I certainly invite you to jump in. The revenue drop in the fourth quarter at an environment, even with a RIF and a reduction, our expense load generally is linear. And while that's impacted by some of the efficiencies, fourth quarter is also a quarter in which a lot of marketing activity takes place, a number of our conferences -- key conferences, industry conferences occur in that quarter. And so the combination of revenue step down and expense while muted, there are expense drivers that come into the fourth quarter. We started out the year looking to try and step up. Our original guidance was pointed towards getting close to and stepping up to the 31% to 33% range. With a significant drop in revenue, some expense reduction is taking place, but that still is going to fall through and leads to a reduction on EBITDA guidance. Will, I don't know if you have anything to add to that?

Yes, I'd say that pretty much characterizes expectation that with a revenue drop, but largely fixed costs for us on the personnel side, although we will see some cost reductions as a result of the layoffs in May. We've also got amortization costs with intangibles that we don't expect to see a significant drop off in the cost of revenues or the operating expenses compared to, say, where we were in Q1, but with a lower revenue number that will flow down to both, that EBITDA margin as well as the adjusted diluted earnings per share.

Got it. That makes sense. And then when do you think is a good time line more reasonable to get back to kind of your initial guide range of low 30% for EBITDA?

Check in with us when we announce our fourth quarter results. Cautiously outlook over the fourth quarter here. We'll take into consideration what we learned in terms of change of those headwinds and/or discussions with our clients as they enter their budgetary cycles and that will help formulate, certainly, our expectations long term in a market that is allowing us to grow top line revenues at historical rates. Our long-term expectation of being able to achieve 35% adjusted EBITDA is unchanged, question is to how quickly we can get to that point given the market conditions. That's the open question right now.

Got it. That makes sense. Just one more clarification question for us. So it looks like your guide is calling for a step up sequentially in 4Q for Services on the top line, but significant like around 20% sequential decline for Software sales. So just hoping you can help us understand this dynamic, and it seems like your commentary in your prepared remarks was more focused on Services pressure, and I mean Software has been relatively resilient up until now and seems like expected going forward based on your commentary to be in 2026 more, resilient.

Yes. I don't know that our commentary implies that profile in terms of the fourth quarter Software versus Services. The impact on revenue decline in our guidance as it relates to fourth quarter is driven significantly by the Service side. Our Software business is -- anticipated that we'll continue to grow in the 5% to 9% time -- or level for fiscal year '25. And it's the Service side that is down 9% to 13% anticipated for the year. So I think our fourth quarter is impacted primarily by Services.

Got it. That makes sense. I think I was just applying the percentage breakdown that you had for your revenue by Software and Services and maybe I was reading a little bit too much into that, but that clarity is helpful.

The next question comes from the line of David Larsen with BTIG.

Can you please remind us what the organic year-over-year revenue growth was in total and then also for Software and then also for Service, please?

For which period, Dave?

For the quarter, the organic growth rate for total revenue, Software revenue, Service revenue, please?

Will, do you have that?

Yes, I can jump in there. So total was just for the quarter, down 3%; Software was up 2%; and Services were down 13%.

Okay. That's very helpful. And then when I look at the number of adds for GastroPlus in the quarter, it actually looked pretty good to me. I think you added 12 new customers for Gastro. That's relatively high over the past 2 years. And your -- I think Gastro revenue growth, we're estimating around 6% year-over-year growth for the quarter. That's fairly high relative to the past 5 quarters. I mean, correct me if I'm wrong, but it seems like the Gastro business was doing fairly well, but Monolix maybe came under a little bit of pressure. Is there a difference in like the kinds of clients you're serving between the two? Can you just sort of like why would one grow nicely, but the other would not? Gastro looks pretty good, Monolix under pressure.

A couple of things. Let me unpack the question a little bit. Our Software revenue generally has contributed 80% renewals, 10% upsells, 10% new clients, round numbers on a quarterly basis. And as you point to, yes, our upsells, new clients, that continues to flow pretty well. Those tend to be -- those new clients tend to be introductory clients starting with a small footprint, so smaller dollar value clients. Upsells were good. It's in that renewal side where a couple of consolidations, acquisition activity in our client base impacted us. The GastroPlus and Monolix, yes, Monolix on this quarter, in the third quarter got impacted by one of those consolidations but is growing very nicely. It's our fastest-growing product, up in the high teens, is on a 12-month -- trailing 12-month basis will be in that ballpark for the year and expectations continue to be strong there. The dynamics of the two products are a little bit different in that Monolix is -- Monolix and GastroPlus are sold to two different user bases. And so common clients, but two different user groups within our clients. Monolix has the benefit as well as not only chasing those upsells and new logos, but is also taking market share away from the primary product in that space, NONMEM. And so that is contributing to its higher growth rate compared to the other software platforms, ADMET Predictor and GastroPlus. All of those applications are growing quite nicely. We're in the high 5% to 9% range for the year and reflects the fact that, for the most part, there's no sort of cost-constrained pullback in spending on the software side. We'd anticipate that in better times that they'll be growing their departments more rapidly, and therefore, add to and contribute to Software revenue growth that has historically been in 10% to 15% range historically. They're not growing their groups, but they're not to dismantling. That dismantling, if anything, comes from consolidation when clients combine and are acquired. So hopefully, that helps, Dave.

It does. And then on the Service side, what was -- how did bookings do? I think backlog -- correct me if I'm wrong, but I think backlog was actually up 6% year-over-year? How are bookings themselves in the quarter on a year-over-year basis?

Yes, a couple of comments there. One, backlog is up year-over-year. We've got backlog that's sourced in the Med Communications business that was not a component, 0 contributor, if you will, a year ago at the end of the third quarter. So the backlog increase in part is due to Med Communications, the acquired business. Secondly, part of the issue has been the delays. We have backlog accounts that their contractual start date -- anticipated start date of that project and whatnot gets deferred. And that certainly was -- the number of delays was on an uptick in the third quarter. So those delayed accounts, at some point, if they've been delayed or we get information that tells us otherwise, we'll pull those accounts out of backlog, but we're seeing a prolonged time to initiation of projects out of the backlog accounts.

Okay. Last one for me. Obviously, the broader S&P 500 pulled way back on Liberation Day, and it has since come back up, which I kind of view as the tariff relief rally. Between the end of May, the close of the quarter, and today, which is mid-July, have your salespeople sensed any improvement in the buying activity of your clients? Or is it all still completely sort of cautious in nature? Because I mean, it seems to me like it's possible that maybe there was a slowdown in April and May during Liberation Day, but now we're in mid-July, the S&P is at an all-time high, the funding environment likely has improved, has there been any discussion of any improvement at all? Or are we still sort of in a very cautiously sort of careful slow environment?

Yes. I mean we're talking about a short window of time, April and May, we're in July. So a few months, a short window of time to see movement. No, I'd say that the environment continues to be cautious, and we're entering summer months, which tends to slow down activity for annual reasons. And while the S&P has picked up, I don't know that the S&P is an indicator of communication between our sales force and decision-making necessarily at our client level. Yes, I think these things have a shock value when they get announced and maybe an exaggerated slowdown that dissipates even though the issue, be it tariffs or whatever, doesn't go away. The shock value goes away, and things start opening up. We're certainly out there executing diligently in the marketplace to find those accounts that may have been pausing and are ready to move forward now. But I'd say it's too short of a window of time to draw any conclusions just yet.

The next question comes from the line of Constantine Davides with Citizens.

Yes. Can you just expand on the -- you called out a Services cancellation that had a $2 million, I think you used the word or words near-term impact. So was that all in the third quarter? Or was this something that you'd contemplated in terms of hitting fourth quarter as well?

Yes. Constantine, it was a single client with contracted services covering two drug programs, which from a contract basis were anticipated to begin contribution to the third quarter with a more significant contribution to the fourth quarter. And both of those programs had bad readouts. The client canceled the contracts, canceled their programs, and, in fact, laid off 95% of their staff. So very impactful scenario. Its impact was the majority of it in the fourth quarter, with some impact in the third quarter as well.

Got it. And then, Shawn, you alluded to a number of AI initiatives, new product initiatives, some of the cloud initiatives as well. And you look at R&D expense and it's running well below $10 million a year. And I know you're not giving guidance for next year, but I guess as you think generally about sort of the AI cycle we're in, which is going to be multiyear, the FDA initiatives around animal testing, should we just start to think about more R&D investment over the next several years relative to where you've been? Just wondering if you can give us a little color on that.

Yes. Opportunities abound, and we're very excited about what is both the near-term hopper in terms of our GastroPlus release anticipated late summer with some pretty impactful AI functionality to be delivered to the marketplace. And beyond that into next fiscal year, both the extension of that into our other platforms and the opportunities for its ongoing development more broadly. So opportunity abound. Does that mean increased R&D expenditure next year? Hey, we're committed in balancing both, previous questions, in terms of getting our adjusted EBITDA back up into 30-plus, into a longer-term expectation of 35% and opportunities to spend more in R&D, and we will cautiously balance those two opportunities as we move forward. The productivity on the AI side of the R&D team is high. It's been complemented with the technology that underlies the Pro-ficiency platform, which provided us -- has provided us an accelerated ability to deliver utilizing that technology to support the cloud platform and delivery of AI functionality into GastroPlus and subsequently down the road, ADMET Predictor and Monolix as well. So pretty exciting times on the technology side. How that impacts R&D, it will be a balancing act between EBITDA improvements and the needs on the R&D side.

The next question comes from the line of Jeff Garro with Stephens Inc.

Maybe a couple of follow-ups for me on the AI topic. I want to ask if we should expect product development, product release pacing in line with historical product releases and adding new features and capabilities with regular updates? Or will it be more discrete on the AI front? And then I also wanted to ask about any gross margin implications we should think about with AI and with some of the cost related to usage there? Do you move to a more transactional model?

Yes. I mean I'll work backwards. Impact on margins, we are -- a couple of things, both on the revenue line and on the cost side. On the revenue side, we're looking at pricing configurations for this increased functionality and how we can optimize both the expansion in upsells and new clients, but also a step-up in terms of renewal improvements. So there should be some contribution there on the expense side. Really, the banner is on the service side, where AI capabilities in our operational group can lend to improvements in terms of the cost to perform projects, and anticipate we'll see some opportunity there. The pricing structure, are we going to move to a more transactional sort of perspective, not on the near-term horizon. Our clients really are not demanding that. We may provide some of these solutions in a situation that is more transactionally based, but a movement to a transaction-based SaaS model is still deep in the horizon for our customers, and that's really driven by their desires at this point in time. I hope that answers your question, Jeff.

Yes. And then the first part of it was around pacing of releases, kind of regular updates or more discrete?

Yes. I think -- yes and no. Our ability to deliver more frequent updates is certainly a driver in terms of our new product and technology organization. Our clients operate in a regulatory environment. And their desire is primarily to not be updating frequently. So the base application, GastroPlus or Monolix, its -- releases on an annual basis, fits their need and their investment desires on updating inside their IT operations. To the extent that we provide some of these in the cloud that are more accessible outside their SOP environment, we may be able to deliver those more quickly paced during the course of the year and intend to be able to do so. Whether our clients will be able to in their environment and their IT infrastructure and costs and planning capabilities, whether they'll adopt them more rapidly or not, we'll see. We certainly give them the opportunity to.

Understood. I appreciate that. And then I wanted to hit Pro-ficiency and see if you had any updated financial expectations for FY '25? And any color you might be able to provide on the large Pro-ficiency engagement that was expected to start in the back half of the year that you had discussed last quarter.

Yes, that engagement was in the Medical Communications side of the business, and that has proceeded. It was impacted a little bit, delayed in part on the commercialization side by the client, not canceled, but delayed, but that project has initiated. Overall, as we indicated in our guidance, $9 million to $12 million contribution from both the Pro-ficiency platform and the Med Communications business, certainly down from our expectations at the beginning of the year, but again driven by the same factors, headwinds in terms of slow start-up clinical trials and cost-constrained environment.

This concludes the question-and-answer session. And I'll turn the call back to Shawn O'Connor for closing remarks.

Thanks again, everyone, for joining our call and your interest in Sim Plus. In the next few months, we'll be attending some important industry events including the Controlled Release Society annual meeting, which started today, and the American Chemical Society National Meeting in August. For the financial community, we'll be attending the KeyBanc Annual Technology Leadership Forum in August and the Wells Fargo 2025 Healthcare Conference and the Morgan Stanley Annual Global Healthcare Conference, both in September. Hope to see many of you there. I appreciate you joining the call, and look forward to talking to you again and updating you at the end of the fourth quarter. Take care, everyone.

This concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation.