Good day and thank you for standing by. Welcome to the Certara First Quarter 2021 First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there'll be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

[Operator Instructions] I would now like to hand the conference over to your speaker today, David Deuchler Investor Relations. Please go ahead..

Good afternoon everyone. Thank you all for participating in today's conference call. On the call from Certara we have, William Feehery, Chief Executive Officer; and Andrew Schemick, Chief Financial Officer. Earlier today, Certara released financial results for the quarter ended March 31, 2021.

A copy of the press release is available on the company's website.

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements contained in this call, that relate to expectations or predictions of future events, results or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements, due to a variety of factors.

For a list and description of risks and uncertainties associated with Certara's business, please refer to the Risk Factors section of our Form 10-K filed with the Securities and Exchange Commission on March 15, 2021.

We urge you to consider these factors and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance. Also, in their remarks or responses to questions, management may mention some non-GAAP financial measures.

Reconciliations of adjusted EBITDA, adjusted net income, adjusted EPS and certain other 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.

The conference call contains time-sensitive information and is accurate only as of the live broadcast today May 6, 2021. Certara disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

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

Thank you, David. Good afternoon everyone. Thank you for joining Certara's first quarter earnings call. Andrew and I will start with prepared remarks and then, we will take questions. I am very pleased with how the Certara business performed overall in the first quarter of 2021, our first full quarter as a public company.

While we are turning the corner on this pandemic in some regions, COVID-19 continues to impact many lives around the world. I am deeply proud of how our Certara team has remained focused on our customers, developing innovative ways to further the adoption of our end-to-end platform to accelerate medicines to patients.

In this quarter, we continued to strengthen our position as a global leader in biosimulation, by delivering strong financial results and executing against our well-defined strategic plan. Revenue in the first quarter grew 16%, compared with the first quarter of 2020, achieving another record quarter of revenue.

Adjusted EBITDA grew 20% in the first quarter of 2021, compared with the first quarter of 2020. We saw very robust customer demand during the quarter across both software and services, demonstrated by year-over-year total company bookings growth of 34%.

In the first quarter of 2021, we expanded our global footprint with revenue growth of 31% in Europe and 69% in Asia Pacific, fueled by our continued momentum in China in both, software and tech-enabled services. Our team, based in our new Shanghai office, is excited to participate in the Drug Information Association's conference later this month.

In Japan, the Pharmaceutical and Medical Devices Agency renewed more than 50 licenses of our Phoenix platform and Simcyp simulator. The majority of our new employees in the first quarter are based in Europe and Asia to support our strong worldwide expansion. The needs of our customers continue to drive our passion for innovation in biosimulation.

We were excited to announce version 20 of our Simcyp simulator in the quarter. This latest version expands the use cases of biosimulation, with new and enhanced models for maternal health, such as assessing drug performance during pregnancy and lactation. It also automates the assessment of virtual bioequivalence to obtain biowaivers.

This is a key advancement in the modernization of drug development. Scientists at the FDA recently published a manuscript, illustrating the FDA's approval of a complex generic using the Simcyp simulator to achieve virtual bioequivalence, instead of a comparative clinical study in patients.

Furthermore, we surpassed 80 novel drugs approved by the FDA that had drug labels informed by the Simcyp simulator. For these new therapies, our simulator was used to address critical decisions regarding dosing, safety and guidance for use for special populations.

Another major update to the Simcyp platform is the newly expanded biologics module the Simcyp Biologics Simulator, which is now available to be licensed as stand-alone software.

With upgraded capabilities in protein development, we can further help our customers address dosing and safety questions, using virtual patients in an important area of research, where our customers are accelerating investment.

This information and conclusions generated by the Simcyp Biologics Simulator optimize dosing regimens and predict biologic behavior in special populations, such as children, the elderly or patients with comorbidities.

The Simcyp simulator is having a growing impact in biologics, following a path similar to small molecules, where the use of mechanistic biosimulation is now well established.

We believe the go-to-market strategy of licensing the Simcyp Biologics Simulator outside of the consortium, potentially opens up new customers and markets for biosimulation in software and tech-enabled services.

Earlier this week, we announced another new software, called Secondary Intelligence, which is the only software of its kind that predicts off-target safety issues, earlier and faster. Safety issues contributed 25% of drug program failures.

And some of these safety issues arise from secondary pharmacology, which is the activity of a drug that is not related to its desired therapeutic target.

With this software, safety pharmacologists and toxicologists can automate, streamline and standardize secondary pharmacology analysis and increase confidence in go, no go decisions, in which compounds are decided to move forward, adjust or discontinue.

The introduction of this software plants the seeds of innovation for future longer term growth allowing us to tap into new markets. Turning over to services. Our technology enabled services business continues to experience elevated growth due to the expansion of our work with existing customers and the acquisition of new biotechnology customers.

Our services offering powered by our proprietary technologies is highly differentiated and profitable. The majority of Certara's services business incorporates the use of biosimulation software throughout the drug discovery and development continuing.

We are incredibly proud of our team of scientists who are well-known in the industry as thought leaders and at the forefront of the science and technology of biosimulation. Our solid total company performance supports our view that 2021 remains very well on track relative to our plan.

The impressive total company growth in bookings is driven by demand across all customer types and is reflective of higher levels of activity at our customers as we begin to make our way out of the pandemic.

The first quarter is typically when many of our customers are making major budget decisions on their strategic programs and we're proud that we're often their first choice as their biosimulation partner. Our remarkable achievements this quarter were the result of hard work by our dedicated and talented Certara colleagues.

We continue to add to our expert team worldwide, increasing our employee base by more than 5% in the quarter. Approximately 75% of our new hires this quarter were scientists and subject matter experts and many of the remaining hires were business developers. Our turnover remains very low.

As I mentioned earlier while we are starting to recover from the pandemic in some parts of the world others are continuing a fierce battle with this disease. Our colleagues in India are especially in our thoughts and we continue to provide support to our global team through these challenging times.

In summary, Certara is widely recognized as one of the largest and leading biosimulation companies in the world with relationships across more than 1,650 customers at the end of 2020. We are enthusiastic about the continued success of our customers, a good number of whom had drugs approved at the FDA during the first quarter.

These customers use Certara's end-to-end platform in their development programs, covering a wide range of therapeutic areas such as autoimmune diseases, infectious diseases and oncology. Today Certara is involved with thousands of programs annually throughout all stages of discovery and development across a very diverse and expanding customer base.

We are dedicated to innovating and delivering high-quality science-backed results for our customers. And our opportunities are expanding every day. I’ll now turn the call over to our CFO, Andrew to discuss our financial results for the first quarter..

Thank you William. Hello, everyone. As mentioned earlier, total revenue for the three months ended March 31 2021 was $66.7 million, representing year-over-year growth of 16%. Software revenue was $21.9 million, which increased 8% over the prior year period as a result of strong first quarter bookings and renewal rates.

Software bookings were $21.9 million, which increased 22% from the prior year period and the aggregate renewal rate was 92%. We continue to see strong demand for our biosimulation software products. Services revenue was $44.8 million, which increased 21% over the prior year period.

The growth in services revenue was also driven by strong demand for our biosimulation solutions. The overall growth rate in services was very robust despite some lingering effects of clinical trial delays from last year, which may impact the timing of project start-ups for regulatory science engagements.

The installed base of Certara customers continue to see the value of our highly technical consulting business, which has led to continued success of our land and expand strategy. This can be seen in services bookings of 60 million, which increased 39% from the prior year period.

Total cost of revenue for the first quarter of 2021 was $26 million, an increase from $22.2 million in the first quarter of 2020, primarily due to a $2.3 million increase in employee-related costs and a $0.8 million increase in stock-based compensation costs, partially offset by decreases in travel related costs and retention expenses.

Total operating expenses for the first quarter of 2021 were $35.1 million, an increase from $27.3 million in the first quarter of 2020, primarily due to a $3.9 million increase in stock-based compensation expenses, $1.4 million increase in employee related costs and $1 million of ongoing public company costs.

The remaining increases were due to increases in secondary offering costs and acquisition related costs. The components of operating expenses are as follows. Sales and marketing expenses were $3.8 million compared to $2.9 million for the first quarter of 2020.

The increase was primarily due to $0.5 million increase in employee related costs and $0.4 million increase in stock-based compensation expenses, partly offset by lower travel. R&D expenses were $4.7 million compared to $2.9 million for the first quarter of 2020.

The increase was primarily due to $0.5 million increase in employee related costs, $0.6 million reduction in capitalized research and development and $0.4 million increase in stock-based compensation expenses. G&A expenses were $16.6 million compared to $11.5 million for the first quarter of 2020.

The increase was primarily due to a $3.1 million increase in stock-based compensation expenses, $1 million in ongoing public company costs and $2.3 million of transaction and M&A expenses, which were partially offset by lower costs in a number of other line items. Intangible asset amortization was $9.5 million for the first quarter.

And depreciation and amortization expense was $0.6 million during the period. There were no significant changes in either line item. Continuing down the P&L, interest expense during the first quarter was $3.9 million compared to $6.9 million for the first quarter of 2021.

The reduction in interest expense is due to the repayment of our holdco loan in the fourth quarter of last year. Our income tax expense was $0.5 million, resulting in an effective tax rate of 33% for the first quarter. The expense for the quarter was primarily due to the tax effects of U.S.

pre-tax income, the impact of non-deductible items, the effects of tax elections made for U.K. earnings, and the relative mix of domestic and international earnings. Net income for the first quarter of 2021 was $1.1 million, compared to a net income of $1 million in the first quarter of 2020.

The increase in revenues as well as the, decrease in the provision for income taxes were offset by increases in cost of revenues and operating expenses of which $4.6 million was stock compensation expense. Diluted earnings per share for the first quarter of 2021, was $0.01 compared to $0.01 for the first quarter of 2020.

Adjusted EBITDA for the first quarter of 2021 was $23.9 million, compared to $19.9 million for the first quarter of 2020. Despite having measurable public company expenses that we did not have last year, we delivered an adjusted EBITDA margin expansion. Ongoing direct public company expenses were in excess of $1 million in the quarter.

Adjusted net income for the first quarter of 2021 was $9.5 million, compared to $2.1 million for the first quarter of 2020. Adjusted diluted earnings per share for the first quarter, was $0.06 compared to $0.02 for the first quarter of 2020. Now moving to the balance sheet, we ended the quarter with $273 million of cash and cash equivalents.

One timing difference that I'd like to point out is that, we paid our annual bonuses to employees in the first quarter this year, compared to the second quarter last year. Our total debt outstanding was $298.4 million, net of deferred financing fees of $4.9 million, as of March 31st 2021.

The current debt structure does not include any significant maturity, until 2024. Regarding the financial outlook, we are updating our previously reported guidance for full year 2021 revenue, adjusted EBITDA and effective annual tax rate.

Revenues to be in the range of $277 million to $285 million, adjusted EBITDA to be in the range of $100 million to $102 million, adjusted EPS to be in the range of $0.20 to $0.24 per share, the cash tax rate to be in the range of 25% to 30%, a slight revision to our effective tax rate guidance to be between 40% and 45%, and fully diluted shares to range between 153 million and 155 million at year-end.

Thank you. Now I'll turn it back to our CEO, William Feehery..

Thank you, Andrew. In summary, Certara had a successful start to our year and our first full quarter, as a public company. Our Certara team continues to focus on our commitments to customers. And deliver strong growth for our shareholders. We believe that, our end-to-end platform is well positioned to continue benefiting from solid market trends.

We expect to capture a larger share of overall biopharmaceutical R&D spend, as we continue to innovate acquire and add new solutions to our end-to-end platform. At this point, we'll open the call for questions.

Operator, can you open-up the lines?.

[Operator Instructions] Our first question comes from the line of Luke Sergott from Barclays. Your line is now open..

Hey guys. Just a couple of -- just a quick one here on guidance, so I'm just trying to get a sense of you had a really strong bookings quarter. Things seem to be opening up. And a decent beat on the top line. So, on a modest guidance raise, is this just -- as we think about conservatism, I know you have 85% visibility into your business.

Is there something with those bookings that they're going to flow through later on, most likely 2022, or just how to think about that from -- as things seem to be opening up it seems like we should be expecting a little bit more..

Yeah. Thanks Luke.

And Andrew, why don't you take that?.

Okay, sure. So the year-over-year growth rates have been stronger than we had anticipated. I would say that, in terms of conservatism, given we're a new public company, those bookings results make us very comfortable with our guidance, but we'd like to see another quarter or two before making any adjustments. We'll certainly reassess it at that time.

The way that I look at this is not just in a quarter, but also looking back in the trailing 12 months. And on a trailing 12 months basis, the bookings growth was a little bit over 20%, 22% which is highly supportive of achieving the mid-to-high teen's revenue growth.

And with another quarter of activity, I would be in a better position to assess the guidance..

All right. That's fair. Yeah, I fully get that.

And so, when I think about the margin trajectory here and the pacing through the year, between services and the software piece, any dynamic that you want to call out and from a modeling perspective?.

So we talked about it briefly, last call. So the first quarter and the fourth quarter are high quarters for software bookings, given the renewal cycles in software. The services we expect to kind of grow sequentially throughout the year, given the kind of profile of the bookings that are coming in.

Historically, if you kind of normalize for one-time items or movements about, 49% of the EBITDA is generated in the first half of the year, 51% in the second half of the year. The margin trajectory will pace with the revenue growth. So targeting that kind of mid-teens revenue growth with the -- maintaining our EBITDA margin outlook..

Okay, great. If I could sneak one last one in on the Shanghai office, I know you guys are opening that one.

Where are you on that being on? And when can, we start expecting more of a meaningful contribution from that area?.

Hi. Thanks Luke. The office is open. It opened at the very end of last year. And we started hiring then. So we have a small but growing team there. And so, as you'd expect we've got some growing to do, as we go forward.

We do have a nicely growing business in Asia Pacific and in China, partly due to the fact that we get some sales that were coming in even before we opened that office. So I think it's a good sign for the future, but we've got some building to do as we go through the year here. And we hire people..

Yeah. It sounds great. Thanks a lot. I leave it there. See you forward..

Thanks a lot, Luke..

Thank you. Our next question comes from the line of Dave Windley from Jefferies. Your line is now open..

Hi. Good afternoon. Thanks for taking my questions. William, I wanted to ask around the biologics simulator description that you gave.

And my curiosity is, whether you as a management team, have visibility into either how your clients are applying your software between biologics and small molecule and applications? Or if you could comment perhaps on how this expanded biologics simulator opens up new market to you? Just trying to get an understanding of how that could accelerate growth in the biologics side..

Yes. So, if you go way back, Simcyp started focused on small molecules. And we've been adding functionality related to biologics over the last, I don't know, five years or so. So in some ways the latest release is a culmination of that. And it's not the final state, so we'll continue to innovate. We are doing a lot of work in biologics today.

Quite a lot of our customers are working on biologics. There are somewhat different questions that get asked around biologics versus small molecules, which is why the software is different. What we've announced is that, we've decided to make the biologics module a stand-alone module.

Because we have some customers that work on both small molecule and biologics, but there's a large group of customers that are only working on biologics. So it, sort of, lets us address them a little bit and more straightforward way with that product..

Got it. That's helpful. Thank you. And then, I guess, kind of similar questions about the Secondary Intelligence product that you announced this week. It sounds like that's very unique in the market newly launched.

Is that something that you expect to have rapid uptake? Or is that something that you need to kind of seed the market and make your customers familiar with? How would you expect that to evolve? And do you expect that your clients, maybe on both of these, are they likely to license software from you on these or engage you through tech-enabled service to get at these capabilities, predominantly?.

Yes, great question. No. Great. Thanks for that question. So we believe that the Secondary Intelligence product is the only software we're aware of, of its kind that predicts. And what it does is, it predicts safety issues that are derived from secondary pharmacology. So this would be the action of a drug on targets that were sort of unintended.

So there isn't an existing market for this. We are -- to your point, I think, we're creating the market. And we're out there announcing this, so that we're starting to get customer feedback over the next six to 12 months. What we've announced right now is the first version of the product. We have about, let's say, about a dozen receptors right now.

By this summer, we'll have more than 40 in the product. And I think that as we add more and more we're going to find that there's a fairly large group of safety pharmacologists and toxicologists at drug companies and we'll find this to be a very useful product. But as a new category, we do need to go out and do our introduction and demonstrate it.

So that's what we're kicking off right now..

Got it. And then, the -- you think clients will license the software or engage in services or….

I'm sorry. I apologize. Yes, sorry, I didn't get to your whole question. The answer is both. You can license the software and we will also provide service through tech-enabled services as well. It depends on -- as I think we've said in previous calls, it really depends on the client.

Larger clients with internal groups, a lot of times they prefer to license the software directly. And other ones prefer to use our services groups to do the work, to basically use our software and do the work for them. So both of them are valid, I guess, you call it, delivery mechanisms for the technology to our customers..

Got it. I’ll leave it at that. Thank you very much..

Thank you, David..

Thank you. Our next question comes from the line of Michael Ryskin from Bank of America. Your line is now open..

Hey, guys. Thanks for taking the question. Andrew or William, first one would be on -- I think in your prepared remarks you had an interesting comment in there on clinical trial delays from last year and sort of the lingering impact on the services business.

I was wondering if you could expand on that a little bit, sort of, how should we think about that impacting the business as we go through the rest of the year.

Are you sort of hinting that, that could be a nice little tailwind, as some of those delays work their way through the system and sort of we go back to operating in normal, specifically, on the tech-enabled services side of things? I was wondering if you could clarify that a little bit. .

Yes, it's a great question. As we pointed out, the market is somewhat disrupted due to COVID and the fact that there were delays in clinical trials in 2020, for parts of 2020, that are still working their way through the drug development cycle and have resulted in delays to certain projects that we have.

We haven't lost any projects, but we have seen, in some cases that, projects are delayed as they're waiting for their data to come in. As you point out, that will mean -- that has some implications around the potential that we'll have multiple projects catching up with us in the later part of the year.

But the post -- I don't know if it's fair to call it a post-COVID situation. But as we come out of COVID, we're in kind of a unique situation and want to keep an eye on that..

Okay. All right. That's fair. And then, a follow-up on the last couple of questions on some of the new product introduction, Secondary Intelligence, the new Simcyp nodule.

I'm wondering, how should we think about the cadence of new software introductions or new solutions going forward? Is this a couple of new launches a year, a couple of new launches a quarter? And are these more sort of complementary to the business, or is there any -- or should we should anticipate any material introductions on their own sort of as a complementary package? So how do you think about expanding the portfolio?.

Yeah. I think it would be a challenge for any software company to do a couple of products a quarter. So I guess you should think more around a couple of a year is something that I think we could be proud of. These products are I think extensions of our existing business, but pretty sophisticated extensions.

Particularly the Secondary Intelligence product we're very excited about that moves us into really what we think will be an entirely new market and a new way to help our customers out. But at the same time, it is an extension of a logical extension of what we've been doing in Simcyp.

And there'll -- how do I put it? You should expect there'll be others as we go forward..

Okay. And then one last one, one last quick one for me. Andrew, I think you mentioned a 5% increase to head count in the quarter.

Is that just sort of early in the year bump up, or are you anticipating sort of a similar cadence through the rest of the year? How do you think about SG&A and sort of head count additions as we go forward?.

Yeah I think that's a similar -- I think the best way to look is similar cadence for the rest of the year..

Okay. Great. Thanks..

Thank you. [Operator Instructions] Our next question comes from the line of John Kreger from William Blair. Your line is now open..

Thanks guys. I have a couple of questions about mix. I think in the past, you've talked about your revenue mix being mainly in clinical with much smaller chunks in discovery preclinical and post market.

Assuming I've got that right, if you look at your recent bookings, are you seeing any shift in that mix, or should we expect that to be fairly typical? What I'm getting at is sort of where are you seeing the biggest changes in how clients are using your software?.

Andrew, do you want to address that question?.

Sure I can start. The mix is consistent with the previously discussed mix. No changes there. .

Great. Thanks, Andrew.

And maybe a similar one how about mix between large and small clients? Is that fairly stable, or are you seeing any change?.

What we see -- I mean -- I can answer that. What we're seeing is growth in both areas. We're seeing growth in more of the mid-teens in large clients and higher growth rates and uptick with the small clients. We had a record number of new logos in the first quarter..

All right. Thanks. And then maybe one more, Bill.

Can you just talk a little bit about how you guys have played a role in COVID work? Should we view that as at all a material contributor if you think back to the last couple of quarters? And therefore, would you expect it to be a headwind or a tailwind as you move through 2021?.

Yeah. Thanks, John. The way I think about this is that the business was really resilient throughout COVID. So I'm really proud that we were able to continue serving our clients without really skipping a beat. We did work on I forget what we have said last year, more than 30 COVID projects last year.

But a lot of that had to do with the customers moved to work on COVID and we moved with them. And then when they move back to work on other things we're moving back with them. So from a financial standpoint, we don't believe this that it will really be a significant event.

Obviously, the operations of the company we worked on somewhat different projects last year. And we're managing the disruptions that to some extent happened in the pharmaceutical pipeline as we go into the first quarter. But we have a very diverse and broad business across pharma.

And so that kind of lets -- it basically makes us pretty stable throughout the whole things. I wouldn't expect it to be either really a headwind or a tailwind as we go into this year. .

Okay. Thank you..

Thank you. At this time, I am showing no further questions. I would like to turn the call back over to William Feehery, CEO for closing remarks..

I wanted to thank everybody for joining us. This was our first quarter as a public company. I believe that Certara performed very well. I'm very proud of our team. The team set out with a very good solid plan. I believe we've delivered on that throughout the quarter. And I think we are quite well set up as we go forward for the rest of the year.

We'll look forward to updating everybody in the coming quarters. Thank you very much. And with that, I think we can wrap up tonight. Thank you..

This concludes today's conference call. Thanks for participating. You may now disconnect..