Certara, Inc.

Good day, and thank you for standing by. Welcome to the Sitara Second Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David Dyker. Please go ahead.

Good afternoon, everyone.

Thank you all for participating in today's conference call. On the call from Sartara, we have William Ferry, Chief Executive Officer, and John Gallagher, Chief Financial Officer. Earlier today, Sartara released financial results for the quarter ended June 30th, 2023. A copy of the press release is available on the company's website. Before we begin, I would like to remind you 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 their 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 recent earnings press release available on the company's website. For additional information, please refer to the reconciliation tables in the accompanying materials. This conference call contains time-sensitive information and is accurate only as of the live broadcast date today, August 9th, 2023. Stratara disclaims any obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

And with that, I will turn the call over to William. Thank you, David. Good afternoon, everyone.

and thank you for joining Sitara's second quarter 2023 earnings call. John and I will start with prepared remarks, and then we will take your questions. In the second quarter, we delivered software revenue of $33.7 million, growing 17% versus last year, and services revenue of $56.7 million, representing 5% growth versus last year. Total company revenue results were $90.5 million, representing 9% growth compared with the second quarter last year. Second quarter software bookings were $35.7 million, and services bookings were $50.2 million. The results this quarter were disappointing and primarily resulted from cautious spending among smaller biotech customers who primarily buy our services, as well as a slow recovery in our regulatory business. While we are not satisfied with this quarter's results, and they have led us to restate our outlook for 2023 based on current market dynamics, we believe the fundamental health of the pharmaceutical development market and the increasing acceptance of biosimulation technology provide an excellent opportunity for us to continue to invest in the growth of Sertara. During the second quarter, our software business continued to perform well. as we expand our deep relationships with customers and drove new product introductions. Our customer base continues to renew at a high rate, with an ARR of 93% and a net retention rate of 112%. On top of the strong renewals, we are generating demand with our newer products, which include SimCit Discovery, Send Explorer, and new Pinnacle 21 modules. Customer interest in biosimulation software remains strong, And during the quarter, we passed a milestone of 300 approved drugs with label claims that directly reference SimCit. During Q1, we acquired Viasa, an artificial intelligence software company, which has given us the opportunity to extend AI capabilities across several of our existing products. We call it Sertara.ai. We have rapidly enhanced the development plans for many of our software products with this new AI capability, and Sotara.ai is already beginning to generate customer traction. The situation during the quarter in our services business was very different. Challenges in growing our regulatory business have persisted longer than we anticipated, and during the quarter, we saw an unexpected slowdown in services bookings, primarily from our smaller biotechs clients. but also including a handful of large pharma customers who were reevaluating their portfolios. As biotech companies expanded over the last several years, we successfully supported many of them with biosimulation services, but their funding situation has become much more tight. Although services bookings slowed rapidly, our services revenue continued to grow during the quarter based on the strength of our backlog. Keep in mind that we are typically actively working on 800 to 1,000 services projects in any given month, so we have a broad footprint across the drug development market. We have seen recent month-over-month improvements in services bookings, but we remain cautious in our near-term outlook based on these market disruptions. We are not satisfied with our performance in services during the quarter. I believe the long-term health of the pharma industry and interest in Surtara's biosimulation technology indicates that we can do better. Following an internal review of our performance and the current market situation, we are making some changes to help Surtara grow to the next level. The first major change is that we are combining our services groups, including both our regulatory group and our integrated drug development groups, into one unified services business with one management team led by Dr. Patrick Smith. By doing this, we can take advantage of operational synergies and scale benefits of having a single services organization with over 700 people, and we can more effectively offer the full array of Certara capabilities to our customers' projects. The second major change we are announcing is that we are creating a single integrated sales force that will combine the several specialized sales groups we currently have in Certara. I have asked Leif Peterson to become the Chief Commercial Officer, and all sales resources across Sartara, including both software and services, will report to him. This change will enable Sartara to bring the right offering at the right time to the right customers, to offer combined software and services projects, to become more efficient in our deployment of resources, and to provide strategic focus on key accounts. Because our confidence in the long-term health of our market and the underlying demand for biosimulation remains very high, we are continuing with our investments in new products which can further benefit this market. The addition of AI technology into our portfolio has led to a transformation of many of our product plans as we race to incorporate the technology in our existing products. The first product that we enhanced was D360, which now has AI models for analysis and prediction of new drug discovery targets. This product is already in the hands of customers who have provided positive feedback. Another early example is our Codex clinical trial outcomes database, which now includes a state-of-the-art AI-powered interface for performing meta-analysis and comparison on new drugs. We are moving very quickly with generative AI technology, and have conducted a full review of our existing product plans to incorporate transformational features and upgrades across Sertara's platform. More to come as we launch new versions and upgrades. As we proceed to the remainder of the year, our focus is on three priorities. We are actively assessing our existing backlog of projects to accelerate projects that were previously delayed and to identify further opportunities to serve those customers. We are uniting our sales force into one organization and investing in marketing to increase our new bookings. And we are making important investments in new products that will continue to accelerate the impact of biosimulation as the pharma industry continues to invest in development. So Tara has an excellent position in an important technology that will continue to be adopted by the pharmaceutical industry and an impressive team of people who are committed to invest and grow our company. Unpredictable market dynamics have led to some softness this quarter, and we have evaluated the situation and are reacting accordingly. But we also continue to see a very bright future with the opportunity to make biosimulation even more important to drug development than it is today. I'm confident in our ability to execute on our revised plan and excited about our long-term commitment to expand the use of biosimulation worldwide. With that, I will now turn the call over to John Gallagher to go over our financial results. Thank you, William. Hello, everyone. Total revenue for the three months ended June 30th, 2023 was $90.5 million, representing year-over-year growth of 9% on a reported basis and 10% on a constant currency basis. Software revenue was $33.7 million in the second quarter, which increased 17% over the prior year period on a reported basis and 18% on a constant currency basis. Growth in the quarter was driven by biosimulation software and Pinnacle 21. Rattable and subscription revenue accounted for 57% of second quarter software revenues. We are pleased with the year-to-date performance in software, which is growing as expected. Software bookings were $35.7 million in the second quarter, which increased 17% from the prior year period. Trailing 12-month software booking for $131.3 million, which increased 16% as compared to the prior year. As William mentioned earlier, Sertara's total bookings in the quarter were challenged by evolving dynamics surrounding customer spending. With that said, software bookings have maintained strength and grown at or ahead of historical levels. The software aggregate renewal rate was 93% in the second quarter, which is in line with our plan. Services revenue was $56.7 million in the second quarter, which increased 5% versus the prior year period on a recorded basis and on a constant currency basis. Services bookings in the second quarter were $50.2 million, which decreased 28% from the prior year period. Trailing 12-month services bookings were $267.5 million, which decreased 5% as compared to the prior year. Our services bookings were significantly impacted by the dynamic William described earlier. In reviewing the underlying drivers of services performance, We see continued weakness in regulatory as the primary source of our lower full-year outlook. We had previously anticipated a low single-digit revenue growth outlook, and we are now looking at a decline in the regulatory business. Booking's conversion to revenue has also elongated versus historical trends of customers' delayed execution on previously booked projects. Regulatory has been a headwind to our revenue and bookings growth so far in 2023, which we expect to continue for the remainder of the year. The pipeline of opportunities in regulatory remains active, but the timing of revenue and bookings has been very hard to predict. Outside of regulatory, weak services bookings were seen among Tier 3 customers, which we define as having up to $100 million in revenue. and includes non-revenue generating companies. Bookings acquisition in this tier has been more challenging as a result of macro-related concerns and could potentially be related to temporary cash conservation efforts. Our Tier 1 services bookings, which are bookings from those customers with revenue above $5 billion, have not been immune from macroeconomic uncertainty as well, and their spend appears conservative and less urgent. Our commercial team remains highly engaged with our customers, and our customers remain highly engaged with Sertara as well. Total cost of revenue for the second quarter of 2023 was $36.2 million, an increase from $35.2 million in the second quarter of 2022, primarily due to employee costs related to BioSIM services billable headcount growth. Total operating expenses for the second quarter of 23 were $41.2 million, a decrease from $43.4 million in the second quarter of 22. The components of operating expenses are as follows. Sales and marketing expenses were $8.1 million compared to $7.1 million in the second quarter of 22. This increase is primarily due to employee costs related to expanding the sales and marketing team. R&D expenses were $7.9 million compared to $7.7 million for the second quarter of 2022. R&D expenses were up primarily due to employee-related costs for software development. G&A expenses were $14.2 million compared to $17.8 million for the second quarter of 2022. The decrease was primarily due to lower stock-based compensation. Intangible asset amortization was up to $10.6 million compared to $10.4 million in the second quarter of 2022. Depreciation and amortization expense was $400,000, which is flat to prior year. Continuing down the P&L, interest expense was $5.7 million compared to interest expense of $3.9 million for the second quarter of 2022. due to higher interest expense relating to our floating rate term loan. As a reminder, we have about 78% of our debt fixed at 6.38% and roughly 22% floating at LIBOR plus 350. Miscellaneous income was $1 million compared to $2.5 million for the second quarter of 2022. Income tax expense was $3.7 million compared to $3.4 million for the second quarter of 2022. Net income for the second quarter of 23 was $4.7 million compared to a loss of $600,000 in the second quarter of 22. Reported adjusted EBITDA was $32.4 million compared to $28 million in the second quarter of 2022. representing 16% growth. Adjusted EBITDA margin was 35.8% in the second quarter of 2023. Reported adjusted net income for the second quarter of 2023 was $18.4 million compared to $14.6 million for the second quarter of 2022. Diluted earnings per share for the second quarter was 3 cents as compared to zero in the second quarter of 2022. Adjusted diluted earnings per share for the second quarter of 2023 was 12 cents compared to 9 cents in the second quarter last year. Now moving to the balance sheet, we ended the quarter with $245.2 million of cash and cash equivalents. As of June 30th, 2023, we had $289.1 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. Turning to guidance for the full year, we are adjusting our 2023 guidance to reflect evolving bookings acquisitions so far this year. We now expect total revenues between $345 to $360 million, representing year-over-year growth of 3% to 7%. We expect software revenue to grow at the rate of our historical target. Biotimulation services revenue is expected to grow in the low double digits for the year, while regulatory services revenue is expected to decline from 2022. We are committed to maintaining our mid-30s adjusted EBITDA margin performance despite lower expectations for revenue. We now expect adjusted EBITDA in the range of $120 to $128 million. We expect adjusted EPS in the range of 44 to 48 cents per share. fully diluted shares in the range of 159 to 162 million, and a tax rate in the range of 25 to 30%. We also wanted to provide some context on our expectations for bookings performance for the remainder of 2023. We now expect 2023 bookings to be down low single digits as compared to 2022. As William highlighted, our conversations with customers about biosimulation continue at a strong pace and implementing Sercaro's biosimulation remains a priority for customers. As we work to execute on a more integrated commercial strategy and focus on pipeline conversion with our customers, we will look to improve our revenue and bookings performance. I will now turn the call back over to William Fiery for closing remarks. Thank you, John. To summarize our message today, we are operating in a challenging environment that has evolved throughout 2023. We believe this experience to be transitory and are taking a more balanced view of the second half of the year. I'm encouraged by the continued high level of performance from our team and the innovation that is coming out of Sertara. We have reasons to be optimistic about the changes we are making in the commercial organization, but timing with such changes is a little tricky to forecast. Our medium and long-term view on the biosimulation industry and the value of Sitara's end-to-end products and services to our customers remains as compelling as ever. We're confident that Sitara is well-positioned for growth and profitability over time as a global leader in biosimulation. We will now open the line for questions. Operator, can you please open the line?

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Your first question comes from David Windley of Jefferies. Please go ahead.

Hi. Good afternoon. Thanks for taking my question. I wanted to first start on kind of the bookings revenue cycle. Did you talk about your typical cycle time from booking to revenue? Just thinking about, you know, how should, I mean, you're giving us updated guidance, admittedly, but how should we think about the lower bookings feathering to revenue over the next, you know, maybe two or even quarters thing?

Yeah. Hi, David. It's John. Um, yeah, as far as, so as you mentioned, you know, we, we've re guided here and the way that we look at our bookings coming in is we're looking at the pipeline, uh, and then conversion of the pipeline into bookings. And then ultimately the bookings conversion, uh, into revenue. And what you've seen here is, uh, some slowness in our tier three customers. As you'd expect, and you'd kind of expect that to be the case, given the biotech funding environment that we're in at the moment. And so what that's doing is that's slowing both the pipeline as well as the booking conversion to revenue. But compounding that is with our tier one customers, we're seeing some slow. So that's IE, that's the large pharma. We're seeing some slowness, not, and mind you, not cancellations of projects. but some slowness on the services side as they've taken more time, delayed projects, even administrative tasks like getting a contract assigned have taken longer in this environment. And so our updated guidance reflects what we've seen both in Q2 and what we forecast going forward related to the slowness there. As it relates to you know, what the visibility is and the timing of that, then for software, and you saw the strength of our software business, both bookings and revenue growing 17%, so we're very pleased with the strength in that business. And that's a key proof point in the biosimulation adoption and use case as it continues. The visibility for software is good with, you know, both SAS, RADable, in addition to annual renewal licenses, then the visibility is good. As it relates to the services side of the business, then the cycle time is a bit shorter there, which I think is where your question was going. All that being said, we do have a strong backlog from previous bookings, and we're very focused on converting that backlog to revenues in the second half of this year.

Thanks for that, John. So maybe to try to pin you down just a little bit more, in thinking about the applied guidance for the second half of the year, do you expect that to be fairly level third quarter to fourth quarter, or third quarter still a little higher because it is still living for bookings from last year, and then fourth quarter drops off more? Just trying to triangulate on cadence.

Yeah, so if you look at the second half of the year, then the primary driver for having the second half decelerate is really the regulatory business, where we've seen weakness there in the tier three and on large deals that historically have come in that we haven't seen as many this year. As it relates to the second half and sort of the cadence of it, It's really two different stories. On bookings, we expect Q3 bookings, you know, here we are, it's August. Q3 bookings, we're expecting to be sort of in line with what we saw at Q2. As we look on to Q4, we are expecting an uptick in Q4, and we've seen that historically. There's, you know, we see the software business continuing strength. We see BioSim services. being able to make some improvements from what we saw at Q2. And then, importantly, in the reg business, historically, we have seen larger deals come in during Q4. And so, for that reason, we see bookings sort of about the same in Q3 and then an uptick in Q4. As it relates to revenue, we expect the quarters of revenue to be similar in the back half of the year.

Got it. Helpful. Thank you. More on the pricing environment. I'm wondering, kind of pricing vis-a-vis inflation, really, and wondering if demand is a little more cautious at the moment, if that puts some pressure on passing through normal price increases, and then on the flip side, maybe you're not hiring that much, but from a labor perspective,

environment the related cost environment standpoint has that settled down uh to the point where you don't need to push through as much inflationary price increase thanks yeah on on pricing um you know we're we are seeking to be competitive here we do have as it relates to services we have large deals that we have visibility to in the pipeline um and obviously we have a very keen focus on converting those to bookings and ultimately to revenue. And we seek to be competitive and want to win those deals. So I think that goes to price a bit on that question.

Okay. Okay. I'll leave it at that. Thank you very much.

Thank you. One moment for our next question.

Your next question comes from Luke surrogate of Barclays. Please go ahead.

Hi, this is Salem on for Luke. Um, thanks for the question. So, uh, just to start us off, what's your level of communication with customers and what's kind of giving you that confidence that these are pushouts versus lost business to, um, the macro, so to speak. And then, um, how, how long is that process between speaking to the customer and then. eventually having them come on with a booking. And then lastly, the biotech funding environment has obviously been talked about for the past few quarters. In fact, some other companies are starting to see green shoots within that customer base. I'm just wondering now why this is coming up for you guys and what you're kind of thinking about. you know, why this is coming up now versus, you know, a few quarters ago with the rest of the industry.

Yeah, maybe I'll take the last one first.

So as far as, you know, why are we seeing Tier 3 pressure? I think the way to think about that is the Tier 3 customer weakness is not surprising to your point. I mean, one way that we look at it is the funding of some of those biotechs and the pressure they have on them has increased certainly over time. And we generally work with them on later stage drug development projects. And therefore, it might hit us a little bit later. I think more importantly, though, I think what's happening is it's the compounding effect of some weakness in Tier 3 compounded by some of the weakness that I talked about in Tier 1. And when you take those two things together, there's no offset there, and that's really what you saw in the results at Q2. The conversations with customers, as I mentioned before, our visibility into the pipeline is actually really good for some large transactions in both BioSim services as well as in the reg business. But, you know, we need to convert those. And what is the time? I think the time varies quite a bit based on whether it's a big or a small contract. But I can tell you that sort of the total cycle time for projects and services is shorter than the sales cycle in software.

And I'd say, Luke, Bill, but, you know, it's an interesting question about why it hit us later than some other

Others have reported, but, you know, the fact is that based on published data, the funding that's gone into non-public biotechs, not just the early stage ones, the later stages down, you know, 20, 30% year over year.

And we saw that, you know, come through in the behavior of that segment of our customers' quarter.

Awesome. That's helpful. And then one last one, what is your guide right now contemplating at the low end? Is this a scenario where things kind of worsen or just any other color around that would be helpful? Thanks.

Yeah, the low end of the guide, to your point, it is if a couple of things would have to happen that worsen. And that would be if we saw the regulatory business, which as we said in the remarks, we do expect to contract on a year-over-year basis. But if that business was to decline more, and also if BioSim services saw additional weakness, that would put you at the lower end. So that's the way to think about it.

Awesome. That's all from me. Thank you.

Thank you.

One moment for our next question. Your next question comes from Vikram Potohit of Morgan Stanley.

Please go ahead.

Hi, good afternoon. Thanks for taking our questions. So we had two. One, on the services business, you talked quite a bit about the impact of Tier 3 clients and Tier 1 clients being impacted as well. But any color you can provide on the relative impact contribution from those two client sets and your expectations on how likely each category of clients are to end up either canceling projects or simply just pushing out projects into 2024 that they would have wanted to do in 2023. So that's question one. And then secondly, just wanted to see if you could talk a bit more about the Salesforce consolidation and how you think that might help the business overall kind of on a point of sale basis. Thank you.

Yeah, sure. So on the services side and how we're looking at that, as you said, I mentioned the Tier 3s, which is not totally surprising. I think the Tier 1 space, that's really what was creeping in and compounding that during Q2. As far as the size of it, Tier 1s are representative of more than half of our revenue. So I guess the way to think about that is you know, a small delay or some small timing can have a larger dollar impact than what you would expect in Tier 3 because the Tier 3 businesses, from a sizing perspective, Tier 1s, like I said, are more than 50%. Tier 3s are, you know, maybe about 30% of the business. And so, you know, we could aggregate more of those to have a similar impact. As far as... Timing on projects. The timing, we don't see timing flipping into 2024. That's not really the issue here. I think what we're finding is that deals in the pipeline that we want to get signed and have them become bookings, seeing some delays, even just administrative delays in getting them signed. Well, once they are bookings, especially on the services side, turning them into revenue is typically a one to two quarter kind of exercise. we are not at this moment suggesting or thinking that, you know, project timing is slipping into 2024.

Yeah, and then Vic, I'll take the second question. This is Bill. You asked about Salesforce consolidation. So Sartara from its beginning is a software and a services company, and they are in fact tied together.

We believe that we can basically gain both operational synergy, you know, synergies and also price our offer, you know, package our offerings better by bringing the Salesforce together.

I mean, a lot of cases, our services involve our software or, you know, a lot of our software clients could become services customers.

We don't feel like we fully taken advantage of that in the past.

I think there's more to go there. So we think that by bringing this together and having a company-wide sales force, we'll have, you know, a better ability to serve those customers and, you know, just better efficiency in terms of how we treat, like, for example, our key accounts.

Understood. Thanks very much.

Thank you. One minute for our next question.

Our next question comes from Jeff Garrow of Stevens, Incorporated. Please go ahead.

Yeah, good afternoon, and thanks for taking the question. I want to ask about the work you referenced on analyzing the health of the backlog. You've given several comments on kind of cancellations versus delays, but just curious what assessment that you've come to after looking into that a little bit more and your ability to influence client behavior where you see a clear ROI on projects that are under contract but not underway generating revenue yet.

Yeah, Jeff, as far as the reference to the backlog, then what we've seen with the services piece of the business is we had put up significant bookings over previous quarters, and our conversion of the backlog historically has been quite good. And so although we see the bookings weakness here, and we've spent a lot of time discussing what that looks like, the backlog for biosim services in particular, more so than regulatory, is large and that's something that's actionable by us, especially looking at our utilization as something that, you know, is going to help us achieve the guidance that we just laid out. So, we do, the reason why we brought that up is that, you know, we wanted to make sure we noted that, you know, previous bookings are still something that, is something that we're able to work through as an organization. It's something that we're focused on in addition to generating the pipeline and the bookings.

Got it. That helps.

And then another question, maybe to dive a little bit deeper on the regulatory business and some of the pressures there. You know, you described regulatory as kind of a category, but I think there are a few different product lines within that. So the extent that you could distinguish between some of the larger projects versus more regular course of business regulatory work and what might be closer to your biosimulation work versus more generic medical writing, as well as the market access piece would be helpful. And if you could comment on your ability to compete with CROs for regulatory work, in an environment where demand seems to be a little bit softer.

Yeah, Jeff, I mean, it's a competitive space, as you know, in a large market. And one of the challenges that we're seeing in that business is, historically, we have been able to get, you know, I'll call it several large deals or bookings done in any given year. By large, we're saying, you know, basically more than a million dollars. This year, we haven't seen that. Although, as I mentioned earlier, we do have visibility in the pipeline to some of those. So, that gives us, you know, encouragement that, you know, we've got to focus, we've got to be competitive. And historically, we have turned turns some of those into bookings in Q4, which historically has been our heaviest quarter for some of those larger deals in the reg business.

Yeah, and I would say also the reason we have this business is not to be competitive with CROs on medical writing. So we have a high-end, onshore, tech-enabled business that appeals to a certain segment. We believe we can price competitively when we need to, but the point of the business has been to go after work that we get because of our biosimulation business. And that is one of the key reasons why we want to combine the sales forces here so that we're taking advantage of all those opportunities to their fullest extent.

Understood. Thanks again.

Thank you. Thank you. Thank you. One moment for our next question, please.

Your next question comes from Kyle Cruz of Credit Suzy Financial Services.

Please go ahead.

Thank you for taking the questions. Looking specifically at software bookings growth, when you look at the 16% trailing 12-month bookings growth within software, it appears that the prior year trailing 12-month bookings would have one quarter without pinnacle 21 bookings in them as compared to the current year, which would have the full year worth of acquisition bookings, like the full year bookings from that acquisition. Could you please frame the impact of how having one additional quarter of pinnacle 21 bookings impacts the 60% year-over-year trailing 12-month bookings growth, and maybe provide some broader color on how to look at software bookings growth going forward?

Yeah, thanks for your question. So yeah, we've been very pleased with the strength of the software business. We've talked a lot about services here for good reason. But as you pointed out, both trailing 12-month bookings for software, and then also for the quarter, we grew 16% and 17% respectively. And then revenue grew 17% also. So that's really, if you look at it, that's ahead of our expectations and we're pleased with the strength there. The Pinnacle 21 business, you mentioned that was an acquisition we did back in 2021 and it's continued to perform well. It's been a good transaction and a great business to add to the portfolio and its growth has continued. As far as impact on the growth rate, we annualized Pinnacle 21 So, I think what I'd point you toward is looking at both the current trailing 12 months as well as the current performance in the quarter on both bookings and revenue as a key indicator on software. And as we look forward, I think the last part of your question was, you know, how do we think about software going forward? And, you know, we expect the strength that we saw in software to continue. for the remainder of the year. And we've got good line of sight there, both on a ratable or SAS type business, as well as annual license renewals. And again, we think that's a key indicator that the value proposition around biosimulation remains firmly intact. So despite the fact that we do have some, what we would consider to be sort of transitory near-term disruptions in the business, mainly centered in reg and services, software is a good indicator that biosimulation as, you know, both as products and the services that go with it remain a key item for our customers to look at in lowering the cost and shortening the timeframe for drug development.

Thank you.

Thank you. One moment for our next question.

Your next question comes from Max Mock of William Blair. Please go ahead.

Hey, good afternoon. Thanks for taking our questions. Just following up on bookings here in the back half of the year, you mentioned on a consolidated basis bookings expected to be down low single digits this year. Can you just help us think through what that incorporates for bookings within each segment? And then, more importantly, I know it may be a little early for next year, but what does bookings being down low single digits this year portend for revenue growth next year? Should we expect kind of more low single digits, or could you actually see that maybe step back up to the low teens range that you've outlined as kind of the target moving forward? Thank you.

Yeah. Thanks, Max. The way to think about bookings for the second half is you do see some deceleration there, and that is mainly centered on the regulatory business and the lower bookings that we're experiencing. So, we do think, as I just mentioned, the software business should continue on pace. We would anticipate that biosim services, we begin to get some recovery moving into, on the performance moving into Q4. And the reg business is where we've got some softness. And we're expecting that to continue into the back half. As far as what does that mean for 2024, you know, we're not, we're not able to guide 2024, but the way to think about it is, you know, the strength in the software business is, you know, we would anticipate will continue, and that's what we expect for that to continue. I think to get back to a spot where we'd want to be on higher growth in 2024, you know, we need some help from the biotech funding environment. We need the tier threes to return to spending, and then what we mentioned on some of the slowness and R&D spend in the Tier 1s for that to alleviate, and then you end up in a higher growth scenario there. One thing I'd mention is that we do believe that over the long term, Sertara would return to a mid-teens grower. And we believe that because of what we were saying earlier, on the adoption and the runway for adoption for biosimulation. And so that's certainly not a comment around 2024, but we think that over the long term, then biosimulation as a process and the products and services associated with it have the opportunity. The market is there. We are a leader in that market, and our ability to grow within that market certainly remains intact.

Understood. Thank you. Maybe just a quick cleanup one before my final one.

On the split between biosimulation and regulatory, I think in the past you said about 70% biosimulation. I wonder if there's any update to just how to think about the mix from a services perspective as well as the mix within each individual segment in terms of software versus services would be really helpful.

Yeah, so we've said that the reg business Um, well, we said historically, it's about 2025% of the business. And, um, actually, even in 2023, we, we still expect it to be in that range. It might be at the lower end of that range. Um, and the mix between software and services, you know, at least in recent history has been. 65%, 35% on a revenue achievement basis services software. And that mix will shift a bit based on this current guidance. Think of it in the range of about 200 basis points or so towards software.

Got it. Okay. And then maybe just a quick one for me. Just anything you can provide around the type of work that's being held up in regulatory. We've heard a lot this quarter about a shift towards later stage trials. And it seems like that would actually kind of play into your regulatory business. So I guess just anything you can help us or you can provide to help us understand like why those programs are just not moving forward. I guess I'm just struggling to understand the rationale for a small biotech in particular, maybe hold off on filing for regulatory approval and understanding kind of like the thought process behind that actual decision.

Yeah, I mean, you know, it's a competitive space too. So You know, what we're doing is, you know, and we mentioned the pipeline visibility for REG. We do see some larger size deals that are in the pipeline. And I think what the management team is focused on is converting those to bookings. But it is a competitive space. And whether it be small biotechs or some of the larger customers there. We have had a track record of being able to get some of those larger deals in, but we haven't seen that yet in 2023. So we're very, very focused on the pipeline as we see it right now. So kind of to your point, it's not like the business, yes, has the business as a whole slowed. Yeah, I think we do think that's the case. But, you know, it's not a complete lack of business, and I think that's to your point, and we're competing for it. Great. Thank you.

Thank you. One moment for our next question. Your next question comes from Gaurav Gopartu of Brennenberg Capital Markets.

Please go ahead.

Hey, guys. Just two quick ones from me. How are new additions from larger biopharma software users looking year over year? And is software this quarter being driven largely by those tier one customers expanding software use?

It's not entirely driven by, I mean, big pharma is a piece of it, but not entirely. I'd point you to new logos. So, you know, that's a metric that we sometimes talk about in our, you know, our new logos on the quarter were 134, which is sequentially is a good spot. But I think overall the way to think about it is we're seeing strength in Tier 1 on software for biosimulation.

we and we see a little bit of slowness in in the tier three there but overall a lot of that business is centered on on our top customers as we've said before got it and then just one more from me uh what software solutions have you seen larger existing customers typically expanding uh their software into are there any in particular that you're seeing trends in yeah we've seen um

Expansion in Pinnacle 21 in particular, we're still having a very good uptake in our Phoenix suite as well.

And in the core biosimulation SIMSIP, there's also been some additions as well. So it was pretty healthy in kind of the core offerings. Those are the three biggest product lines that we have as a company, and so we saw expansions in all three of them.

And on SimCiv Discovery, have you seen any updates since it's been relatively recently released, or is that Tier 3 weakness kind of impacting that pickup?

Well, we have seen – yes, it's relatively recent.

We have seen some nice pickup in that.

Probably it's also been affected by the Tier 3 weakness in terms of, I think, you know, We probably would have seen more, but it's hard to estimate that. But, you know, it's off to a good start.

It expands the reach of SimCiv to a different audience, which is important.

And I think there'll be more to come as we go forward in the next couple of quarters. Awesome. Thanks, guys.

Thank you. One minute for our last question. Your last question comes from Joe Verwink of BARD.

Please go ahead.

Great. Thanks for squeezing me in. I just wanted to start on the topic of AI and Wondering on the opportunity, not just from an application standpoint, but also the integration of data and different data sources. It would seem like Sertara, just given some of the foundational elements you have, would maybe be in a unique position to commercialize a data model and a data offering of what the industry is going to need. I wonder how you think about kind of the product roadmap and what might be first out of the gates as you look to address the AI opportunity?

Yeah, thanks, Joe. You're right. So, like a lot of companies, we've been rapidly assessing what AI can do, but we were fortunate in that we acquired Viasa at exactly the right time. We got a good team, and we got it in their layer product. We have a very interesting opportunity for data integration exactly like what you're talking about.

so uh just you know keep in mind we've owned them for uh you know just a few months uh and so we've had the opportunity to go through our product portfolio first step was to look at you know what can we add in our existing product portfolio and we you know in a few months we've we've added to uh a couple of our products d360 and and our codex uh database that's a that's a good good early indication, but certainly not our full ambition or really what we've got in the pipeline.

As you look forward, though, it's exactly what you talked about. There's an opportunity to look across the vast amounts of data that not only exists publicly, but that many of our clients have internally in their proprietary databases and integrate them

and either train the models or use that in AI products. So, we're very much focused on that. It's really quite energized our software development team here as we're at the forefront of figuring this out. And I think as you go forward, you know, you'll see more and more of that in what we talk about in our products.

Okay, that's helpful. And then just a question on kind of the connection between biosim services and software. And I guess this is more directed at some of the changes you saw in the tier one customer segment. But is there ever a leading indicator between the two where services utilization and seeing downward adjustments there is a precursor for changing in software demand? Or maybe a different spin on the question, can your software get to a point, and obviously you've invested in user interface and making things more user-friendly, can it ever get so self-serve that maybe the need for services is ultimately lesser?

Yeah, great question. But I think that the situation is that Software is pretty complex. Obviously, we want to make it easier to use with better user interfaces like you're talking about so we can expand the number of people. But what we see is that as the software expands its user base, we actually kick up many more services projects. It gets used to answer a lot of different questions. People want to extend the software. They want to change the models.

A lot of times it goes back the other way as well in terms of services projects give us good ideas for features that we extend the software. So, there's sort of this interesting ecosystem between the two.

It would be, I mean, it would be great for pharma and we wouldn't say no if our software got so good that we could just eliminate services altogether. But the reality is that, you know, pharma is working on so many drugs with just so much different

complexities in terms of the science that's going into them, that there's always opportunities there to add on services.

And I think our clients really value not just that we're software providers, but we've got a pretty impressive group of people who have, you know, numerous drug development, you know, successful drugs under their belt from before they came to Sertara.

And at Sertara, you know, they're seeing hundreds of drug development projects you know, every month. And so that's valuable to our clients as well as they bring our services in. So I think what we saw in the quarter is, you know, I would be more alarmed if the software dropped because that would probably indicate more of a permanent shift in the amount of money going into pharma development. You know, services can go up and down a little bit based on, you know, how, you know, how funding comes in and how cautious people are in spending and how distracted they are. But as long as we have that software base there, we've got a good opportunity to continue to grow the services group as well.

Okay. Thank you very much.

Thank you. I would now like to turn it over to William Fury for closing remarks.

Thank you very much, everybody. So we obviously are not happy with the performance we turned in in the second quarter on bookings.

We still feel with a lot of data that there's plenty more growth ahead for Sitara to bring biosimulation to the pharmaceutical industry. We are investing heavily, not slowing down at all because of this, the further development of our software. We're very excited about the potential to incorporate AI in BIOS simulation and what that's going to do to expand. And we believe that as we come out of the next couple of quarters, this softness in service will reverse itself. So I look forward to talking to you in the next quarter and hopefully giving you a better update in terms of where we stand in terms of bookings. Thank you very much and good evening.

Thank you for your participation in today's conference.

This does conclude the program. You may now disconnect. Thank you. you Thank you. Thank you.

Good day, and thank you for standing by. Welcome to the Sitara Second Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David Dyker. Please go ahead.

Good afternoon, everyone.

Thank you all for participating in today's conference call. On the call from Sartara, we have William Ferry, Chief Executive Officer, and John Gallagher, Chief Financial Officer. Earlier today, Sartara released financial results for the quarter ended June 30th, 2023. A copy of the press release is available on the company's website. Before we begin, I would like to remind you 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 their 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 recent earnings press release available on the company's website. For additional information, please refer to the reconciliation tables in the accompanying materials. This conference call contains time-sensitive information and is accurate only as of the live broadcast date today, August 9th, 2023. Stratara disclaims any obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

And with that, I will turn the call over to William. Thank you, David. Good afternoon, everyone.

and thank you for joining Sitara's second quarter 2023 earnings call. John and I will start with prepared remarks, and then we will take your questions. In the second quarter, we delivered software revenue of $33.7 million, growing 17% versus last year, and services revenue of $56.7 million, representing 5% growth versus last year. Total company revenue results were $90.5 million, representing 9% growth compared with the second quarter last year. Second quarter software bookings were $35.7 million, and services bookings were $50.2 million. The results this quarter were disappointing and primarily resulted from cautious spending among smaller biotech customers who primarily buy our services, as well as a slow recovery in our regulatory business. While we are not satisfied with this quarter's results and they have led us to restate our outlook for 2023 based on current market dynamics, we believe the fundamental health of the pharmaceutical development market and the increasing acceptance of biosimulation technology provide an excellent opportunity for us to continue to invest in the growth of Sertara. During the second quarter, our software business continued to perform well. as we expand our deep relationships with customers and drove new product introductions. Our customer base continues to renew at a high rate, with an ARR of 93% and a net retention rate of 112%. On top of the strong renewals, we are generating demand with our newer products, which include SimCit Discovery, Send Explorer, and new Pinnacle 21 modules. Customer interest in biosimulation software remains strong, And during the quarter, we passed a milestone of 300 approved drugs with label claims that directly reference SimCit. During Q1, we acquired Viasa, an artificial intelligence software company, which has given us the opportunity to extend AI capabilities across several of our existing products. We call it Sertara.AI. We have rapidly enhanced the development plans for many of our software products with this new AI capability, and Sotara.ai is already beginning to generate customer traction. The situation during the quarter in our services business was very different. Challenges in growing our regulatory business have persisted longer than we anticipated, and during the quarter, we saw an unexpected slowdown in services bookings, primarily from our smaller biotechs clients. but also including a handful of large pharma customers who were reevaluating their portfolios. As biotech companies expanded over the last several years, we successfully supported many of them with biosimulation services, but their funding situation has become much more tight. Although services bookings slowed rapidly, our services revenue continued to grow during the quarter based on the strength of our backlog. Keep in mind that we are typically actively working on 800 to 1,000 services projects in any given month, so we have a broad footprint across the drug development market. We have seen recent month-over-month improvements in services bookings, but we remain cautious in our near-term outlook based on these market disruptions. We are not satisfied with our performance in services during the quarter. I believe the long-term health of the pharma industry and interest in Sertara's biosimulation technology indicates that we can do better. Following an internal review of our performance and the current market situation, we are making some changes to help Sertara grow to the next level. The first major change is that we are combining our services groups, including both our regulatory group and our integrated drug development groups, into one unified services business with one management team led by Dr. Patrick Smith. By doing this, we can take advantage of operational synergies and scale benefits of having a single services organization with over 700 people, and we can more effectively offer the full array of Certara capabilities to our customers' projects. The second major change we are announcing is that we are creating a single integrated sales force that will combine the several specialized sales groups we currently have in Certara. I have asked Life Peterson to become the chief commercial officer, and all sales resources across Sartara, including both software and services, will report to him. This change will enable Sartara to bring the right offering at the right time to the right customers, to offer combined software and services projects, to become more efficient in our deployment resources, and to provide strategic focus on key accounts. Because our confidence in the long-term health of our market and the underlying demand for biosimulation remains very high, we are continuing with our investments in new products which can further benefit this market. The addition of AI technology into our portfolio has led to a transformation of many of our product plans as we race to incorporate the technology in our existing products. The first product that we enhanced was D360, which now has AI models for analysis and prediction of new drug discovery targets. This product is already in the hands of customers who have provided positive feedback. Another early example is our Codex clinical trial outcomes database, which now includes a state-of-the-art AI-powered interface for performing meta-analysis and comparison on new drugs. We are moving very quickly with generative AI technology, and have conducted a full review of our existing product plans to incorporate transformational features and upgrades across Sertara's platform. More to come as we launch new versions and upgrades. As we proceed to the remainder of the year, our focus is on three priorities. We are actively assessing our existing backlog of projects to accelerate projects that were previously delayed and to identify further opportunities to serve those customers. We are uniting our sales force into one organization and investing in marketing to increase our new bookings. And we are making important investments in new products that will continue to accelerate the impact of biosimulation as the pharma industry continues to invest in development. So Tara has an excellent position in an important technology that will continue to be adopted by the pharmaceutical industry and an impressive team of people who are committed to invest and grow our company. Unpredictable market dynamics have led to some softness this quarter, and we have evaluated the situation and are reacting accordingly. But we also continue to see a very bright future with the opportunity to make biosimulation even more important to drug development than it is today. I'm confident in our ability to execute on our revised plan and excited about our long-term commitment to expand the use of biosimulation worldwide. With that, I will now turn the call over to John Gallagher to go over our financial results. Thank you, William. Hello, everyone. Total revenue for the three-month end of June 30, 2023, was $90.5 million, representing year-over-year growth of 9% on a reported basis and 10% on a constant currency basis. Software revenue was $33.7 million in the second quarter, which increased 17% over the prior year period on a reported basis and 18% on a constant currency basis. Growth in the quarter was driven by biosimulation software and Pinnacle 21. Rattable and subscription revenue accounted for 57% of second quarter software revenues. We are pleased with the year-to-date performance in software, which is growing as expected. Software bookings were $35.7 million in the second quarter, which increased 17% from the prior year period. Trailing 12 months software booking for $131.3 million, which increased 16% as compared to the prior year. As William mentioned earlier, Sertara's total bookings in the quarter were challenged by evolving dynamics surrounding customer spending. With that said, software bookings have maintained strength and grown at or ahead of historical levels. The software aggregate renewal rate was 93% in the second quarter, which is in line with our plan. Services revenue was $56.7 million in the second quarter, which increased 5% versus the prior year period on a recorded basis and on a constant currency basis. Services bookings in the second quarter were $50.2 million, which decreased 28% from the prior year period. Trailing 12-month services bookings were $267.5 million, which decreased 5% as compared to the prior year. Our services bookings were significantly impacted by the dynamic William described earlier. In reviewing the underlying drivers of services performance, We see continued weakness in regulatory as the primary source of our lower full-year outlook. We had previously anticipated a low single-digit revenue growth outlook, and we are now looking at a decline in the regulatory business. Booking's conversion to revenue has also elongated versus historical trends of customers' delayed execution on previously booked projects. Regulatory has been a headwind to our revenue and bookings growth so far in 2023, which we expect to continue for the remainder of the year. The pipeline of opportunities in regulatory remains active, but the timing of revenue and bookings has been very hard to predict. Outside of regulatory, week services bookings were seen among Tier 3 customers, which we define as having up to $100 million in revenue. and includes non-revenue generating companies. Bookings acquisition in this tier has been more challenging as a result of macro-related concerns and could potentially be related to temporary cash conservation efforts. Our Tier 1 services bookings, which are bookings from those customers with revenue above $5 billion, have not been immune from macroeconomic uncertainty as well, and their spend appears conservative and less urgent. Our commercial team remains highly engaged with our customers, and our customers remain highly engaged with Sertara as well. Total cost of revenue for the second quarter of 2023 was $36.2 million, an increase from $35.2 million in the second quarter of 2022, primarily due to employee costs related to BioSIM services billable headcount growth. Total operating expenses for the second quarter of 23 were $41.2 million, a decrease from $43.4 million in the second quarter of 22. The components of operating expenses are as follows. Sales and marketing expenses were $8.1 million compared to $7.1 million in the second quarter of 22. This increase is primarily due to employee costs related to expanding the sales and marketing team. R&D expenses were $7.9 million compared to $7.7 million for the second quarter of 2022. R&D expenses were up primarily due to employee-related costs for software development. G&A expenses were $14.2 million compared to $17.8 million for the second quarter of 2022. The decrease was primarily due to lower stock-based compensation. Intangible asset amortization was up to $10.6 million compared to $10.4 million in the second quarter of 2022. Depreciation in amortization expense was $400,000, which is flat to prior year. Continuing down the P&L, interest expense was $5.7 million compared to interest expense of $3.9 million for the second quarter of 2022. due to higher interest expense relating to our floating rate term loan. As a reminder, we have about 78% of our debt fixed at 6.38% and roughly 22% floating at LIBOR plus 350. Miscellaneous income was $1 million compared to $2.5 million for the second quarter of 2022. Income tax expense was $3.7 million compared to $3.4 million for the second quarter of 2022. Net income for the second quarter of 23 was $4.7 million compared to a loss of $600,000 in the second quarter of 22. Reported adjusted EBITDA was $32.4 million compared to $28 million in the second quarter of 2022. representing 16% growth. Adjusted EBITDA margin was 35.8% in the second quarter of 2023. Reported adjusted net income for the second quarter of 2023 was $18.4 million compared to $14.6 million for the second quarter of 2022. Diluted earnings per share for the second quarter was 3 cents as compared to zero in the second quarter of 2022. Adjusted diluted earnings per share for the second quarter of 2023 was $0.12 compared to $0.09 in the second quarter last year. Now moving to the balance sheet, we ended the quarter with $245.2 million of cash and cash equivalents. As of June 30, 2023, we had $289.1 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. Turning to guidance for the full year, we are adjusting our 2023 guidance to reflect evolving bookings acquisitions so far this year. We now expect total revenues between $345 to $360 million, representing year-over-year growth of 3% to 7%. We expect software revenue to grow at the rate of our historical target. Biotimulation services revenue is expected to grow in the low double digits for the year, while regulatory services revenue is expected to decline from 2022. We are committed to maintaining our mid-30s adjusted EBITDA margin performance despite lower expectations for revenue. We now expect adjusted EBITDA in the range of $120 to $128 million. We expect adjusted EPS in the range of 44 to 48 cents per share. fully diluted shares in the range of 159 to 162 million, and a tax rate in the range of 25 to 30%. We also wanted to provide some context on our expectations for bookings performance for the remainder of 2023. We now expect 2023 bookings to be down low single digits as compared to 2022. As William highlighted, our conversations with customers about biosimulation continue at a strong pace and implementing Sercaro's biosimulation remains a priority for customers. As we work to execute on a more integrated commercial strategy and focus on pipeline conversion with our customers, we will look to improve our revenue and bookings performance. I will now turn the call back over to William Fury for closing remarks. Thank you, John. To summarize our message today, we are operating in a challenging environment that has evolved throughout 2023. We believe this experience to be transitory and are taking a more balanced view of the second half of the year. I'm encouraged by the continued high level of performance from our team and the innovation that is coming out of Sertara. We have reasons to be optimistic about the changes we are making in the commercial organization, but timing with such changes is a little tricky to forecast. Our medium and long-term view on the biosimulation industry and the value of Sitara's end-to-end products and services to our customers remains as compelling as ever. We are confident that Sitara is well-positioned for growth and profitability over time as a global leader in biosimulation. We will now open the line for questions. Operator, can you please open the line?

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Your first question comes from David Windley of Jefferies. Please go ahead.

Hi. Good afternoon. Thanks for taking my question. I wanted to first start on kind of the bookings revenue cycle. Did you talk about your typical cycle time from booking to revenue? Just thinking about, you know, how should, I mean, you're giving us updated guidance admittedly, but how should we think about the lower bookings feathering to revenue over the next, you know, maybe two or even quarters thing?

Yeah, hi David, it's John. Yeah, as far as, so as you mentioned, you know, we've re-guided here and the way that we look at our bookings coming in is we're looking at the pipeline and then conversion of the pipeline into bookings and then ultimately the bookings conversion into revenue. And what you've seen here is some slowness in our tier three customers. As you'd expect, and you'd kind of expect that to be the case, given the biotech funding environment that we're in at the moment. And so what that's doing is that's slowing both the pipeline as well as the booking conversion to revenue. But compounding that is with our tier one customers, we're seeing some slow. So that's IE, that's the large pharma. We're seeing some slowness, not, and mind you, not cancellations of projects. but some slowness on the services side as they've taken more time, delayed projects, even administrative tasks like getting a contract assigned have taken longer in this environment. And so our updated guidance reflects what we've seen both in Q2 and what we forecast going forward related to the slowness there. As it relates to you know, what the visibility is and the timing of that, then for software, and you saw the strength of our software business, both bookings and revenue growing 17%. So we're very pleased with the strength in that business. And that's a key proof point in the biosimulation adoption and use case as it continues. The visibility for software is good with, you know, both SAS, RADable, revenue in addition to annual renewal licenses, then the visibility is good. As it relates to the services side of the business, then the cycle time is a bit shorter there, which I think is where your question was going. All that being said, we do have a strong backlog from previous bookings, and we're very focused on converting that backlog to revenues in the second half of this year.

Thanks for that, John. So maybe to try to pin you down just a little bit more, in thinking about the applied guidance for the second half of the year, do you expect that to be fairly level third quarter to fourth quarter, or third quarter still a little higher because it is still living for bookings from last year, and then fourth quarter drops off more? Just trying to triangulate on cadence.

Yeah, so if you look at the second half of the year, then the primary driver for having the second half decelerate is really the regulatory business, where we've seen weakness there in the tier three and on large deals that historically have come in that we haven't seen as many this year. As it relates to the second half and sort of the cadence of it, It's really two different stories. On bookings, we expect Q3 bookings, you know, here we are, it's August. Q3 bookings, we're expecting to be sort of in line with what we saw at Q2. As we look on to Q4, we are expecting an uptick in Q4, and we've seen that historically. There's, you know, we see the software business continuing strength. We see biosim services. being able to make some improvements from what we saw at Q2. And then, importantly, in the reg business, historically, we have seen larger deals come in during Q4. And so, for that reason, we see bookings sort of about the same in Q3 and then an uptick in Q4. As it relates to revenue, we expect the quarters of revenue to be similar in the back half of the year.

Got it. Helpful. Thank you. More on the pricing environment. I'm wondering, kind of pricing vis-a-vis inflation, really, and wondering if demand is a little more cautious at the moment, if that puts some pressure on passing through normal price increases, and then on the flip side, maybe you're not hiring that much, but from a labor perspective,

environment the related cost environment standpoint has that settled down uh to the point where you don't need to push through as much inflationary price increase thanks yeah on on pricing um you know we're we are seeking to be competitive here we do have as it relates to services we have large deals that we have visibility to in the pipeline um and obviously we have a very keen focus on converting those to bookings and ultimately to revenue. And we seek to be competitive and want to win those deals. So I think that goes to price a bit on that question.

Okay. Okay. I'll leave it at that. Thank you very much.

Thank you. One moment for our next question.

Your next question comes from Luke surrogate of Barclays. Please go ahead.

Hi, this is Salem on for Luke. Um, thanks for the question. So, uh, just to start us off, what's your level of communication with customers and what's kind of giving you that confidence that these are pushouts versus lost business to, um, the macro, so to speak. And then, um, how, how long is that process between speaking to the customer and then. eventually having them come on with a booking. And then lastly, the biotech funding environment has obviously been talked about for the past few quarters. In fact, some other companies are starting to see green shoots within that customer base. I'm just wondering now why this is coming up for you guys and what you're kind of thinking about. you know, why this is coming up now versus, you know, a few quarters ago with the rest of the industry.

Yeah, maybe I'll take the last one first.

So as far as, you know, why are we seeing Tier 3 pressure? I think the way to think about that is the Tier 3 customer weakness is not surprising to your point. I mean, one way that we look at it is the funding of some of those biotechs and the pressure they have on them has increased certainly over time. And we generally work with them on later stage drug development projects. And therefore, it might hit us a little bit later. I think more importantly, though, I think what's happening is it's the compounding effect of some weakness in Tier 3 compounded by some of the weakness that I talked about in Tier 1. And when you take those two things together, there's no offset there, and that's really what you saw in the results at Q2. The conversations with customers, as I mentioned before, our visibility into the pipeline is actually really good for some large transactions in both BioSim services as well as in the reg business. But, you know, we need to convert those. And what is the time? I think the time varies quite a bit based on whether it's a big or a small contract. But I can tell you that sort of the total cycle time for projects and services is shorter than the sales cycle in software.

And I'd say, Luke, this is Bill, but, you know, it's an interesting question about why it hit us later than some other

Others have reported, but, you know, the fact is that based on published data, the funding that's gone to not public biotechs, not just the early stage ones, the later stages down, you know, 20, 30% year over year.

And we saw that, you know, come through in the behavior of that segment of our customers this quarter. Awesome. That's helpful.

And then one last one, what is your guide right now contemplating at the low end? Is this a scenario where things kind of worsen or just any other color around that would be helpful? Thanks.

Yeah, the low end of the guide, to your point, it is if a couple of things would have to happen that worsen. And that would be if we saw the regulatory business, which, as we said in the remarks, we do expect to contract on a year-over-year basis. But if that business was to decline more, and also if BioSim services saw additional weakness, that would put you at the lower end. So that's the way to think about it.

Awesome. That's all for me. Thank you.

Thank you.

One moment for our next question. Your next question comes from Vikram Potohit of Morgan Stanley.

Please go ahead.

Hi, good afternoon. Thanks for taking our questions. So we had two. One, on the services business, you talked quite a bit about the impact of tier three clients and tier one clients being impacted as well. But any color you can provide on the relative impact contribution from those two client sets and your expectations on how likely each category of clients are to end up either canceling projects or simply just pushing out projects into 2024 that they would have wanted to do in 2023. So that's question one. And then secondly, just wanted to see if you could talk a bit more about the sales force consolidation and how you think that might help the business overall kind of on a point of sale basis. Thank you.

Yeah, sure. So, on the services side and how we're looking at that, as you said, I mentioned the Tier 3s, which is not totally surprising. I think the Tier 1 space, that's really what was creeping in and compounding that during Q2. As far as the size of it, Tier 1s are representative of more than half of our revenue. So, I guess the way to think about that is you know, a small delay or some small timing can have a larger dollar impact than what you would expect in Tier 3 because the Tier 3 business, just from a sizing perspective, Tier 1s, like I said, are more than 50%. Tier 3s are, you know, maybe about 30% of the business. And so, you know, we could aggregate more of those to have a similar impact. As far as... Timing on projects. The timing, we don't see timing flipping into 2024. That's not really the issue here. I think what we're finding is that deals in the pipeline that we want to get signed and have them become bookings, seeing some delays, even just administrative delays in getting them signed. Well, once they are bookings, especially on the services side, turning them into revenue is typically a one to two quarter kind of exercise. We are not at this moment suggesting or thinking that, you know, project timing is slipping into 2024.

Yes, and I'll take the second question. This is Bill. You asked about Salesforce consolidation. So Sartara from its beginning is a software and a services company, and they are, in fact, tied together.

We believe that we can basically gain both operational synergy, you know, synergies and also price our offer, you know, package our offerings better by bringing the sales force together. I mean, a lot of cases, our services involve our software or, you know, a lot of our software clients could become services customers. We don't feel like we've fully

taken advantage of that in the past. I think there's more to go there. So we think that by bringing this together and having a company-wide sales force, we'll have, you know, a better ability to serve those customers and, you know, just better efficiency in terms of how we treat, like, for example, our key accounts.

Understood. Thanks very much.

Thank you. One minute for our next question.

Our next question comes from Jeff Garrow of Stevens, Incorporated. Please go ahead.

yeah good afternoon and thanks for taking the question want to ask about the the work you referenced on analyzing the the health of the backlog they've you've given several comments on kind of cancellations versus delays but just curious what. assessment that you've come to after looking into that a little bit more and your ability to influence client behavior where you see a clear ROI on projects that are under contract but not underway generating revenue yet?

Yeah, Jeff.

Yeah, as far as the reference to the backlog, then, you know, what we've seen with the services piece of the business is we had put up significant bookings over previous quarters, and our conversion of the backlog historically has been quite good. And so, although we see the bookings weakness here, and, you know, we spend a lot of time discussing what that looks like, the backlog for biosim services in particular, more so than regulatory, is large and that's something that that's actionable by us, especially looking at our utilization as something that, you know, is going to help us achieve the guidance that we just laid out. So we do – the reason why we brought that up is that, you know, we wanted to make sure we noted that, you know, previous bookings are still something that is something that we're able to work through as an organization. It's something that we're focused on in addition to generating the pipeline and the bookings.

Got it. That helps.

And then another question, maybe to dive a little bit deeper on the regulatory business and some of the pressures there. You know, you described regulatory as kind of a category, but I think there are a few different product lines within that. So the extent that you could distinguish between some of the larger projects versus more regular course of business regulatory work and what might be closer to your biosimulation work versus more generic medical writing, as well as the market access piece would be helpful. And if you could comment on your ability to compete with CROs for regulatory work in an environment where demand seems to be a little bit softer.

Yeah, Jeff, I mean, it's a competitive space, as you know, and a large market. And one of the challenges that we're seeing in that business is historically, we have been able to get, you know, I'll call it several large deals or bookings done in any given year. By large, we're saying, you know, basically more than a million dollars. This year, we haven't seen that. Although, as I mentioned earlier, we do have visibility in the pipeline to some of those. So that gives us you know, encouragement that, you know, we've got to focus, we've got to be competitive, and historically we have turned some of those into bookings in Q4, which historically has been our heaviest quarter for some of those larger deals in the reg business.

Yeah, and I would say also the reason we have this business is not to be competitive with CROs on medical writing.

So we have a

high-end, onshore, tech-enabled business that appeals to a certain segment. We believe we can price competitively when we need to, but the point of the business has been to go after work that we get because of our biosimulation business.

And that is one of the key reasons why we want to combine the sales forces here so that we're taking advantage of all those opportunities to their fullest extent.

Understood. Thanks again.

Thank you. Thank you. One moment for our next question, please.

Your next question comes from Kyle Cruz of Credit Suisse Financial Services.

Please go ahead.

Thank you for taking the questions. Looking specifically at software bookings growth, when you look at the 16% trailing 12-month bookings growth within software, it appears that the prior year trailing 12-month bookings would have one quarter without Pinnacle 21 bookings in them as compared to the current year, which would have the full year worth of acquisition bookings, like the full year bookings from that acquisition. Could you please frame the impact of how having one additional quarter of Pinnacle 21 bookings impacts the 60% year-over-year trailing 12-month bookings growth?

maybe provide some broader color on how to look at software bookings growth going forward yeah thanks for your question so um yeah we've we've been very uh pleased with the strength of the software business we've talked a lot about services here for good reason um but as you pointed out you know both trailing 12-month bookings for software and then also for the quarter uh we grew We grew 16% and 17% respectively. And then revenue grew 17% also. So that's really, if you look at it, that's the head of our expectations. And we're pleased with the strength there. The Pinnacle 21 business, you mentioned that was an acquisition we did back in 2021. And it's continued to perform well. It's been a good transaction and a great business. to add to the portfolio, and its growth has continued. As far as impact on the growth rate, you know, we annualized Pinnacle 21, so I think what I'd point you toward is looking at both the current trailing 12 months as well as the current performance in the quarter on both bookings and revenue as a key indicator on software. And as we look forward, I think the last part of your question was you know, how do we think about software going forward? And, you know, we expect the strength that we saw in software to continue and for the remainder of the year. And we've got good line of sight there, both on a RADable or SAS type business, as well as annual license renewals. And again, we think that's a key indicator that the value proposition around biosimulation remains firmly intact. So despite the fact that we do have some, what we would consider to be sort of transitory near-term disruptions in the business, mainly centered in reg and services, software is a good indicator that biosimulation as, you know, both as products and the services that go with it remain a key item for our customers to look at in lowering the cost and shortening the timeframe for drug development.

Thank you.

Thank you. One moment for our next question.

Your next question comes from Max Mock of William Blair. Please go ahead.

Hey, good afternoon. Thanks for taking our questions. Just following up on bookings here in the back half of the year, you mentioned on a consolidated basis bookings expected to be down low single digits this year. Can you just help us think through what that incorporates for bookings within each segment? And then more importantly, I know it may be a little early for next year, but what does bookings being down low single digits this year portend for revenue growth next year? Should we expect kind of more low single digits, or could you actually see that maybe step back up to the low teens range that you've outlined as kind of the target moving forward? Thank you.

Yeah. Thanks, Max. The way to think about bookings for the second half, is you do see some deceleration there, and that is mainly centered on the regulatory business and the lower bookings that we're experiencing. So we do think, as I just mentioned, the software business should continue on pace. We would anticipate that biosim services, we begin to get some recovery moving into, on the performance moving into Q4. And the reg business is where we've got some softness. And we're expecting that to continue into the back half. As far as what does that mean for 2024, you know, we're not, we're not able to guide 2024, but the way to think about it is, you know, the strength in software business is, you know, we would anticipate will continue, and that's what we expect for that to continue. I think to get back to a spot where we'd want to be on higher growth in 2024, you know, we need some help from the biotech funding environment. We need the tier threes to return to spending, and then what we mentioned on some of the slowness and R&D spend in the Tier 1s for that to alleviate, and then you end up in a higher growth scenario there. One thing I'd mention is that we do believe that over the long term, Sertara would return to a mid-teens grower. And we believe that because of what we were saying earlier on the adoption and the runway for adoption for biosimulation. And so that's certainly not a comment around 2024, but we think that over the long term, then biosimulation as a process and the products and services associated with it have the opportunity. The market is there. We are a leader in that market, and our ability to grow within that market certainly remains intact.

Understood. Thank you. Maybe just a quick cleanup one before my final one.

On the split between biosimulation and regulatory, I think in the past you said about 70% biosimulation. I wonder if there's any update to just how to think about the mix from a services perspective, as well as the mix within each individual segment in terms of software versus services would be really helpful.

Yeah. So, we've said that the reg business Um, well, we said historically, it's about 2025% of the business. And, um, actually, even in 2023, we, we still expect it to be in that range. It might be at the lower end of that range. Um, and the mix between software and services, you know, at least in recent history has been. 65%, 35% on a revenue achievement basis, services software. And that mix will shift a bit based on this current guidance. Think of it in the range of about 200 basis points or so towards software.

Got it. Okay. And then maybe just a quick one for me. Just anything you can provide around the type of work that's being held up in regulatory. We've heard a lot this quarter about a shift towards later stage trials, and it seems like that would actually kind of play into your regulatory business. So I guess just anything you can help us or you can provide to help us understand like why those programs are just not moving forward. I guess I'm just struggling to understand the rationale for a small biotech in particular, maybe hold off on filing for regulatory approval and understanding kind of like the thought process behind that actual decision.

Yeah, I mean, you know, it's a competitive space too. So You know, what we're doing is, you know, and we mentioned the pipeline visibility for REG. We do see some larger size deals that are in the pipeline. And I think what the management team is focused on is converting those to bookings. But it is a competitive space. And whether it be small biotechs or some of the larger customers there. We have had a track record of being able to get some of those larger deals in, but we haven't seen that yet in 2023. So we're very, very focused on the pipeline as we see it right now. So kind of to your point, it's not like the business, yes, has the business as a whole slowed. Yeah, I think we do think that's the case. but it's not a complete lack of business, and I think that's to your point, and we're competing for it. Great. Thank you.

Thank you. One moment for our next question. Your next question comes from Gaurav Gopartu of Brennenberg Capital Markets.

Please go ahead.

Hey, guys. Just two quick ones for me. How are new additions from larger biopharma software users looking year over year? And is software this quarter being driven largely by those tier one customers expanding software use?

It's not entirely driven by, I mean, big pharma is a piece of it, but not entirely. I'd point you to new logos. So, you know, that's a metric that we sometimes talk about in our, you know, our new logos on the quarter were 134, which is sequentially is a good spot. But I think overall the way to think about it is we're seeing strength in Tier 1 on software for biosimulation. And we see a little bit of slowness in the tier three there, but overall, a lot of that business is centered on our top customers, as we've said before.

Got it. And then just one more from me. What software solutions have you seen larger existing customers typically expanding their software into? Are there any in particular that you're seeing trends in?

Yeah, we've seen... Expansion in Pinnacle 21 in particular, we're still having a very good uptake in our Phoenix suite as well.

And in the core biosimulation SIMSIP, there's also been some additions as well. So it was pretty healthy in kind of the core offerings. Those are the three biggest product lines that we have as a company, and so we saw expansions in all three of them.

And on SimCiv Discovery, have you seen any updates since it's been relatively recently released, or is that Tier 3 weakness kind of impacting that pickup?

Well, we have seen it. Yes, it's relatively recent.

We have seen some nice pickup in that.

Probably it's also been affected by the Tier 3 weakness in terms of, I think, you know, We probably would have seen more, but it's hard to estimate that. But, you know, it's off to a good start.

It expands the reach of SimCiv to a different audience, which is important.

And I think there'll be more to come as we go forward in the next couple of quarters.

Awesome. Thanks, guys.

Thank you. One minute for our last question. Your last question comes from Joe Verwink of BARD.

Please go ahead.

Great. Thanks for squeezing me in. I just wanted to start on the topic of AI and Wondering on the opportunity, not just from an application standpoint, but also the integration of data and different data sources. It would seem like Sertara, just given some of the foundational elements you have, would maybe be in a unique position to commercialize a data model and a data offering of what the industry is going to need. I wonder how you think about kind of the product roadmap and what might be first out of the gates as you look to address the AI opportunity?

Yeah, thanks, Joe. You're right. So, like a lot of companies, we've been rapidly assessing what AI can do, but we were fortunate in that we acquired Viasa at exactly the right time. We got a good team, and we got it in their layer product. We have a very interesting opportunity for data integration, exactly like what you're talking about.

so uh just you know keep in mind we've owned them for uh you know just a few months uh and so we've had the opportunity to go through our product portfolio first step was to look at you know what can we add in our existing product portfolio and we you know in a few months we've we've added to uh a couple of our products d360 and and our codex uh database that's a good good early indication, but certainly not our full ambition or really what we've got in the pipeline.

As you look forward, though, it's exactly what you talked about. There's an opportunity to look across the vast amounts of data that not only exists publicly, but that many of our clients have internally in their proprietary databases and integrate them

and either train the models or use that in AI products. So, we're very much focused on that. It's really quite energized our software development team here as we're at the forefront of figuring this out. And I think as you go forward, you know, you'll see more and more of that in what we talk about in our products.

Okay, that's helpful. And then just a question on kind of the connection between BIOSIM services and software. And I guess this is more directed at some of the changes you saw in the tier one customer segment. But is there ever a leading indicator between the two where services utilization and seeing downward adjustments there is a precursor for changing in software demand? Or maybe a different spin on the question, can your software get to a point, and obviously you've invested in user interface and making things more user-friendly, can it ever get so self-serve that maybe the need for services is ultimately lesser?

Yeah, great question. But I think that the situation is that Software is pretty complex. Obviously, we want to make it easier to use with better user interfaces like you're talking about so we can expand the number of people. But what we see is that as the software expands its user base, we actually kick up many more services projects. It gets used to answer a lot of different questions. People want to extend the software. They want to change the models.

A lot of times it goes back the other way as well in terms of services projects give us good ideas for features and we extend the software. So, there's sort of this interesting ecosystem between the two.

It would be, I mean, it would be great for pharma and we wouldn't say no if our software got so good that we could just eliminate services altogether. But the reality is that, you know, pharma is working on so many drugs with just so much different

complexities in terms of the science that's going into them, that there's always opportunities there to add on services.

And I think our clients really valued not just that we're software providers, but we've got a pretty impressive group of people who have, you know, numerous drug development, you know, successful drugs under their belt from before they came to Sertara.

And at Sertara, you know, they're seeing hundreds of drug development projects you know, every month. And so that's valuable to our clients as well as they bring our services in. So I think what we saw in the quarter is, you know, I would be more alarmed if the software dropped because that would probably indicate more of a permanent shift in the amount of money going into pharma development. You know, services can go up and down a little bit based on, you know, how, you know, how funding comes in and how cautious people are in spending and how distracted they are. But as long as we have that software base there, we've got a good opportunity to continue to grow the services group as well.

Okay. Thank you very much.

Thank you.

I would now like to turn it over to William Fury for closing remarks.

Thank you very much, everybody. So we obviously are not happy with the performance we turned in in the second quarter on bookings.

We still feel with a lot of data that there's plenty more growth ahead for Sitara to bring biosimulation to the pharmaceutical industry. We are investing heavily, not slowing down at all because of this, the further development of our software. We're very excited about the potential to incorporate AI in BIOS simulation and what that's going to do to expand. And we believe that as we come out of the next couple of quarters, this softness in service will reverse itself. So I look forward to talking to you in the next quarter and hopefully giving you a better update in terms of where we stand in terms of bookings. Thank you very much and good evening.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.