Good day, and thank you for standing by. Welcome to the Certara First Quarter 2022 Earnings Conference Call. [Operator instructions] Please be advised that today's conference may be recorded. [Operator instructions] I would now like to hand the conference over to your host today, David Deuchler. Please go ahead..

Good afternoon, everyone. Thank you all for participating in today's conference call. On the call from Certara, we have William Feehery, Chief Executive Officer; and Andrew Schemick, Chief Financial Officer. Earlier today, Certara released financial results for the quarter ended March 31, 2022.

The 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 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 1, 2022.

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 our remarks through responses to questions, management may mention some non-GAAP financial measures.

Reconciliations of adjusted EBITDA, adjusted net income, and adjusted EPS to the directly comparable GAAP measures are available in the recent earnings press release, which is available on the company's website. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 5, 2022.

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 pleased with how the Certara business performed in the first quarter of 2022 as we executed on our strategic and financial goals.

We continue to grow our position as a global leader in biosimulation. We reported strong first quarter revenue of $81.6 million, growing 22% year-over-year, including Pinnacle 21.

Software revenue was $29.2 million, growing 33% year-over-year with a 92% renewal rate, driven by double-digit growth in our core Simcyp and Phoenix licenses and the impact from Pinnacle 21. Pinnacle 21 continues to meet our expectations.

Technology-driven services revenue was $52.4 million, representing 17% growth compared with the first quarter of last year. We are pleased with the sequential improvement in our technology-driven services business.

As expected, and discussed on our fourth quarter call, we saw some impact from the omicron variant in January and several regulatory services projects continue to be delayed. We remain focused on navigating through the delays in our clients' clinical trials to better manage the conversion of our bookings to revenue and regulatory services.

We effectively managed through issues related to COVID and the business exited the first quarter at more normalized levels of employee and client availability as well as project activity. Looking forward to the remainder of the year, we expect the positive momentum in the business to continue.

Booking trends in both software and technology-driven services remain very strong, and we continue to add new customers. We continue to experience healthy double-digit growth in new customers over last year. As such, we remain well-positioned to achieve our 2022 financial guidance. Now moving on to other recent highlights.

Our Simcyp COVID-19 vaccine model continues to get recognized for its contributions to combating the pandemic and improving the patient outcomes. A few weeks ago, we were honored to receive a Thomas Edison Award in the therapeutic impact category.

Winning an Edison award is one of the highest accolades the company can receive for the successful launch of a game-changing new product or service. Results from our COVID-19 vaccine model have been submitted to global regulatory agencies, including the FDA, to support clinical trial designs.

Our clients and we are currently using the COVID-19 vaccine model to optimize dosing for special populations, such as the elderly and children. The FDA continues to support expanded use cases of biosimulation, to help advance the safety and efficacy of medicines.

On our last earnings call, we highlighted our first quarter announcement that the FDA recently licensed our immunogenicity simulator to be used in the valuation of biologics. Immunity reactions can be a major problem in biologics and can lead to reduced effectiveness and/or adverse events.

Our simulator helps guide improved study design to drive better clinical outcomes. In February, the FDA released draft guidance, providing recommendations for incorporating clinically relevant information into the labeling of products having immunogenicity assessments. We think that this is a growth area within the R&D pipeline at customers.

Additionally, as I've mentioned, the FDA's Project Optimus is an initiative to reform the dose optimization and selection paradigm in oncology drug development. There was a dosing workshop just this week held by the FDA that we contributed to.

This is a positive development for the use of biosimulation regarding dose finding and optimizing clinical study design. We continue to invest in capabilities that are strategically aligned with regulatory guidance. Innovation and growth are driven by the people at Certara.

We remain committed to growing, retaining, and developing talent at Certara, and we have invested in additional professional development programs to support these goals. Our culture, people, and commitment to innovation and customer partnerships continue to make Certara an employer of choice.

We continue to invest in our global team of experts across the organization, and we're well-positioned to capitalize on the opportunities ahead. We started the year with a higher level of investment, particularly in software R&D and sales.

Specifically, we are investing to expand the use cases of our Simcyp Simulator and also advancing R&D initiatives to support Pinnacle 21 enterprise software development. This elevated level of investment did pressure our reported adjusted EBITDA margins in the quarter, as Andy will discuss in a minute.

But I remain confident in our ability to deliver on our EBITDA guidance for the year. A few weeks ago, Certara issued its inaugural ESG report, which can be found on our Investor Relations website.

This report relates our commitment to understanding, managing, and monitoring our ESG impact to support sustainable growth, and we are pleased to share it with our stakeholders.

In summary, I'm pleased with the performance of the company in the first quarter and our continued dedication to advance global adoption of our software and technology-driven services. We remain on track to achieve our revenue and adjusted EBITDA goals for the remainder of the year.

I will now turn it over to our CFO, Andrew Schemick, to discuss first quarter financial results in more detail..

Sales and marketing expenses were $6.1 million, compared to $3.8 million for the first quarter of 2021. This increase is primarily due to the aggressive hiring that we successfully executed during the last two quarters in our commercial organization. R&D expenses were $7.5 million, compared to $4.7 million for the first quarter of 2021.

The increase in R&D expenses was primarily due to people and investments made to support software development. G&A expenses were $18.3 million, compared to $16.6 million for the first quarter of 2021. The increase was primarily due to operational headcount, medical, and other benefit expenses.

Additionally, the company incurred $0.9 million increase in professional and consulting costs associated with the financial audits and SOX implementation. The increases were partially offset by a reduction of $1 million in acquisition-related costs.

Intangible asset amortization was $10.1 million, compared to $9.5 million in the first quarter of 2021, increasing due to amortization costs from acquired assets. Depreciation expense was $0.5 million, compared to $0.6 million last year. And continuing down the P&L, other expenses include interest expense, and miscellaneous income.

Interest expense was $3.2 million, compared to $3.9 million for the first quarter of 2021 due to lower interest rates on the term loan and interest swap. Miscellaneous income was $0.8 million due to foreign currency gains from re-measurement accounting at one of our foreign subsidiaries that maintains the U.S. dollar bank account.

Income tax expense was $1.5 million, compared to $0.5 million in the prior year due to a 41% effective tax rate, compared to 33% last year. Net income for the first quarter of 2022 was $2.2 million, compared to a net income of $1.1 million in the first quarter of 2021.

Diluted earnings per share for the first quarter 2022 was $0.01, as compared to $0.01 in the first quarter of 2021. Adjusted EBITDA for the first quarter of 2022 was $27.7 million, compared to $23.9 million for the first quarter of 2021, representing 16% growth.

As William mentioned, we accelerated operating investments in the first quarter, resulting in adjusted EBITDA margin of 34%. Despite this performance in the quarter, we remain on track to deliver our adjusted EBITDA margin target of 36% for the full year.

Adjusted net income for the first quarter of 2022 was $16.9 million, compared to $14.4 million for the first quarter of 2021. Adjusted diluted earnings per share for the first quarter of 2022 was $0.11, compared to $0.09 for the first quarter of 2021.

Now moving to the balance sheet, we ended the quarter with $184.3 million of cash and cash equivalents. As of March 31, 2022, we had $294.3 million of net outstanding borrowings on our term loan and full availability under our revolving credit facility.

We are reiterating our full year guidance issued during the fourth quarter call, with the exception of an update to our year-end fully diluted shares.

Revenues in the range of $350 million to $360 million, adjusted EBITDA in the range of $127 million to $131 million, adjusted EPS in the range of $0.48 to $0.53 per share, fully diluted shares in the range of $159 million to $161 million, a GAAP tax rate in the range of 40% to 45% and a cash tax rate in the range of 20% to 25%. Thank you.

Now we will open up the line for questions. Operator, please open the line for questions..

Thank you. [Operator instructions] And our first question comes from the line of Dave Windley with Jefferies. Your line is open. Please go ahead..

Hi. Thanks for taking my questions. Good afternoon. I was thinking, looking back to this time last year, when your customer count was about 1,650 and now over 2,000. So you've added about 350 customers in the last year. And then the last two quarters, I've seen your bookings really step up.

So I wondered if perhaps those threats were inter rolled in [ph], and you could talk about the progress you're making with that new customer base where they are engaging and how quickly they are expanding?.

Yes. Hi, David. It's Andrew. We've seen in the metrics, particularly coming out of Q1 with the higher customer count, strong growth rates in the clients with greater than $100,000, and we've seen growth in the number of clients and also a growth in the dollar amount with those clients. So that's kind of driving the growth.

We've also seen strength with our largest accounts, accounts greater than $1 million. So I think the newer clients are coming on board, and they're progressing into that greater than $100,000 nicely. But we're also seeing strong growth with the larger clients greater than $1 million..

And in terms of the products that they're starting with or with which they are engaging in contracts, are there any themes there? Is it kind of same old, same old in biosim, or are you seeing other avenues of customer engagement?.

At this point, it's primarily driven by biosim, particularly Phoenix and biosim services. We're also getting introduced to new customers through Pinnacle 21..

Okay. And then maybe just on the guidance, the margin point that you made and still comfortable with EBITDA margin guidance for the year, how should we think about the higher investment in 1Q tapering off? Or is it level through the year and your revenue grows into that? Just help us with cadence that gets you to the 36 by the end of the year..

Yes. The way that – just to clarify that, so the first quarter margin, the bridge from 34% to the target, about half of that was accounting costs primarily associated with higher-than-expected costs for the integrated audit and the completing the SOX implementation.

The other half was growing headcount, particularly in light of the strong performance in bookings Q4, Q1 and what we can see in the pipeline. In terms of the margin progression for the year, essentially, what I'm seeing right now is a – we'll take the onetime half of those costs, the onetime cost out of the first quarter and the second quarter.

We'll see some improvement quarter-over-quarter, Q1 to Q2 and then kind of in excess of target in the back half of the year to get back to the 36%..

Okay, great. Thank you..

Thank you. And our next question comes from the line of Michael Ryskin with Bank of America. Your line is open. Please go ahead..

Hi. Great. This is Wolf Chanoff on for Mike. Thanks for taking the questions.

I know you've spoken to this a little bit, but I was wondering if you'd give us some more color on how successful you've been in recapturing the service revenue shortfall from 4Q, and how we should be thinking of kind of modeling that dynamic as it plays out through the rest of the year? Thanks..

Thank you, Michael. This is William Feehery here. As you know, at the end of last year, we saw a lengthening in trying to start certain services projects, particularly in regulatory. You saw that continue in the month of December and January. But then as we went through the quarter, we saw a month-to-month improvement each month through the quarter.

So what I'd say is we haven't quite gotten back to the point where all the delays have been removed. There are still some projects that are delayed, waiting on – largely waiting on clinical data to be completed. But there has been – basically, we're marching in the right direction, and we've made up a lot of the graph in the first quarter..

Great. Thank you much. And then just kind of higher-level one. Can you give us some color on the early cross-selling opportunities you've been able to realize with the Pinnacle deal, maybe some particular products or just, yes, anything you can speak to in that area? Thanks..

Yeah. Thanks. So Pinnacle 21 has opened up a lot of opportunities for us. I think immediately, we found a lot of cross-selling opportunities between Pinnacle 21, and our integral data repository product. So data repository that ties into a data validation product, they kind of go nicely together.

So we think there's some opportunities as we go forward there. We've also seen tie-ins between Pinnacle 21 and some of our services business. We've been able to add on to some of our services projects by adding – by basically offering data validation using Pinnacle two projects. They managed to make some larger.

We've managed to open up some new customers as well for Pinnacle 21. So I think there will be more to come as we go forward, but I think we're off to a pretty good start with Pinnacle 21..

Great. Thank you..

Thank you. And our next question comes from the line of Vikram Purohit with Morgan Stanley. Your line is open. Please go ahead..

Great. Thanks for taking my question. So I had a broad one on your biosimulation TAM. I noticed that in your current corporate presentation, you broke out the TAM by software versus services. And then within each of these segments, you have a further breakout between drug discovery and drug development.

So the two questions I had here are, first, if you could just walk us through a bit of what's feeding this high-level build for the biosimulation TAM? And then secondly, which of the specific areas of the opportunities you laid out here, you think Certara has the most opportunity to grow and moving forward over the next couple of years, especially now that Pinnacle 21 is fully within the Certara umbrella?.

Sure. Thanks, Vikram. The information we put on the corporate, we're just always trying to update the research we've done on the size of the market. A lot of people have been in the last few years, the biosimulation market has been growing and maybe got defined in a lot of investors' minds.

So we wanted to provide the latest thinking we had on the different sizes and break it down. In terms of where Certara is playing, the bulk of our biosimulation expertise in revenue has been on the development side. So typically particularly with Simcyp, companies get involved during clinical or during the design of clinical trials.

And so our services kind of mirror that as well. But we've also moved some of our software to earlier stage.

So we have Pinnacle 21, which largely comes in at the end of clinical when you submit to the FDA, but is increasingly being used during the clinical phase and during the preclinical phase as companies are collecting data and want to hold that data as a certain standard.

And then we have other software which we either have or have been developing, which have pushed our reach earlier stage into preclinical and even a little bit in the discovery, for example, we acquired a piece of software a while ago called SEND Explorer, which is kind of like a data visualization product during the preclinical phase.

We have D360, which is primarily used during the discovery phase. So I think over the time and as we go forward overall – over time, the company is interested in extending the reach of biosimulation earlier stage in the discovery, but the reality today is probably 60%, 70% of our business is really tied to the development phase.

Hopefully, that helps..

Very helpful. Thank you..

Thank you. And our next question comes from the line of Justin Lin with William Blair. Your line is open. Please go ahead..

Hi. Good afternoon. Congrats on the quarter. First of all, I think you said your software bookings was up 34%, but excluding Pinnacle 21, it was up 5%.

First of all, I want to clarify I heard that right? And second, I guess, how did that compare to your expectations?.

You did hear that right. Typically, we look at bookings over a trailing 12-month period. And software bookings ex Pinnacle 21 trailing 12 months is 13%.

The factors that drive us to look at it over a longer time horizon is that we have client renewals that tend to shift from quarter-to-quarter, sometimes early, sometimes late, they don't have an impact on revenue recognition.

We also saw some disproportionate impact on FX in terms of the software bookings, given kind of the nature where our products are developed around the world. So that impacted that bookings line. We didn't adjust for that from a constant currency basis. And then we had sale last year that was essentially delivered this year through services arrangement.

So when I normalize for those, the quarter was, I think, about 10% in terms of kind of software bookings and looking at the quarter and looking at the TTM, I would call that things were healthy and is what we were expecting..

Got it. That's helpful.

I guess, can you remind us what your capital deployment priorities are as the rising rate environment affected your thinking on M&A or investments in general at all?.

From my perspective, we're still evaluate M&A opportunities. We're open to that, given the current environment could be – it's a good time to be – have a strong balance sheet, take advantage of opportunities. So I would say this has been a relatively fast-moving event. We haven't changed our capital deployment strategies..

Okay. And just last one for me.

Can you talk about the opportunities you see in cell and gene therapy specifically? Are you happy with your expertise in this area at the moment? Or are there additional investments needed whether toward expanding our software capability or hiring the right people?.

Yes. Thanks. This is William. A lot of our cell and gene therapy work is done by our quantitative systems pharmacology group, which has been one of our faster growing areas. A lot of the work in cell and gene therapy is just for orphan drugs that just tends to be what's in the pipeline.

And that tends to lend itself to the type of modeling and dosing work that Certara is known for to deliver. So I guess, to answer your question, I feel very good about the group we have and the offering we have, but our ambitions are much larger. So we think that QSP, in general, will be a growth.

We know for a fact it will be a growing part of the pharma market going forward as a lot of companies adding, a lot of pharma companies adding to their groups in that area, and there's a lot of beef for it. So we are planning to continue to invest in growing that group as we go forward.

And we're also thinking about how best to tie that to our software offerings. We already tying a lot to our Simcyp offering. But there's other opportunities to kind of create specialized software in QSP that we're also thinking about or pursuing..

That's very helpful. Thank you very much..

Thank you. And our next question comes from the line of Jacob Putman with Barclays. Your line is open, please go ahead..

Hey, guys, thanks for the question.

Can you talk about your ability to pass on pricing and how many of your contracts allow pricing scalers, given that they're long term for the life of the program?.

Yes. I can start and then Andrew can chime in here. Most of our contracts are for one year or less. We do occasionally because customers ask for it enter into longer-term contracts and particularly in the current environment, we're very sensitive to making sure that there's appropriate price increases in any contract that goes out.

We're aware that we're in an inflationary environment right now just as every other company is. And we have the ability to – we believe we have the ability to basically offset inflation with pricing and maintain our margins..

Great. That's helpful.

And how about any other offsets to rising costs?.

Well, there's always efficiencies to be gained in any company, in particular, in Certara, we're growing quite rapidly, and that's enabling us to make investments in – basically, in company infrastructure that leads to efficiencies that offset some of that.

We've been investing heavily, for example, in our sales and marketing group basically since we went public, we said we would do that. What that lets us do, for example, is free up our scientists from having to sell, and they can write more software or go to more project work, which, for example, leads to one sort of efficiency..

Great. Thank you so much. That’s helpful..

Thanks..

Thank you. [Operator instructions] And our next question comes from the line of Vikram Kesavabhotla with Baird. Your line is open. Please go ahead..

Yes, thank you for taking the question. I think on the last call, you talked about the fact you saw some increased attrition in the workforce toward the end of the year. It sounded like that has started to normalize toward the start of the year.

Wondering if you can just give us an update there and talk about what turnover has looked like in the organization so far this year and what your expectations are for managing headcount through the balance of this year?.

Yes, Vikram. Thanks for the question. You're right. We did see an uptick in attrition at the end of last year. Fortunately, we saw that drop down to a more normalized level in the first quarter. I think we're making sure we keep up with market in terms of wages, and we're maintaining our margins.

But the uptick, I guess, we saw, I think, there were a lot of disruptions in the last – at the end of last year due to COVID or people's perception of COVID and things like that, that have kind of worked their way through people's perception of their careers.

I think Certara has got a tremendous backlog of really interesting work right now, which helps to attract people. And we've been investing in training, and we've been bringing in some really great colleagues here.

So I think all that's been reflected in the fact we've seen much more normalized attrition as we went in to – as we went through the first quarter..

Okay, thanks. And then I guess from a higher level, can you just remind us of the visibility that you have into the revenue guidance range at this point in the year? I think historically, you've talked about the approach that you've taken to the building guidance based on your bookings performance.

Just wondering if there's been any updates to that approach.

And I guess at this point of the year, where do you think some of the key areas of variability could come from in the revenue performance?.

Yes, so we've used the same methodology in terms of forward visibility. I think we have high confidence in the guidance for this year. In light of the Q1 performance, the bookings for the last two quarters, the TTM bookings as well as the pipeline looking forward for bookings.

The variability from the perspective of predicting the revenues at the end of the year today versus the actuals primarily rely around opportunities that we don't have visibility into right now. So we do that kind of bottoms up build to get to the revenue forecast.

And I think the offset to that is just variability in client timelines and client drug development program successes..

All right. Thank you..

Thank you. And I'm showing no further questions at this time. And I would like to turn the conference back over to William Feehery for any further remarks..

Yes. Thank you all for joining us. I think the overall message I would say is that after our – where we were in the fourth quarter, we saw significant improvement in Q1. We're very happy to see very strong bookings.

We saw month-over-month improvement throughout all three months in the quarter, and we're feeling quite confident as we look forward to the rest of the year. So look forward to updating everybody in future quarters. Thank you very much..