Earnings Call Transcript - CERT Q2 2022

Operator, Operator

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 Andy Schemick, Chief Financial Officer. Earlier today Certara released financial results for the quarter ended June 30, 2022. 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 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, adjusted EPS and constant currency revenue to most directly comparable GAAP measures are available in the recent earnings 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, August 9, 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.

William Feehery, CEO

Thank you, David. Good afternoon, everyone. Thank you for joining Certara's second quarter earnings call. Andrew and I will start with prepared remarks and then we will take questions. In the second quarter, Certara delivered significant growth in bookings, and the biosimulation software and services business achieved mid-teens growth in revenue, despite headwinds from foreign exchange rates. Our performance in regulatory services, which comprises less than 25% of our business, did not meet expectations due to ongoing delays and recent regulatory decisions regarding China-only clinical trial data. Our operating cash flow growth, which was not impacted significantly by foreign exchange rates, continues to be strong. We reported second quarter revenue of $82.8 million, growing 18% year-over-year on a reported basis and 21% on a constant currency basis including Pinnacle 21. As you know, Certara operates a global business with employees and customers located in many different countries around the world. This global footprint has many advantages; however, during periods of foreign currency volatility, our reported revenue growth figures may be impacted. As a result, we have decided to disclose our second quarter financial results on both a reported basis and a constant currency basis to help you better understand the underlying trends in the business, which remain healthy. Reported software revenue was $28.7 million, growing 48% year-over-year on a constant currency basis, with a 92% aggregate renewal rate. These results were in line with our expectations and driven by mid-teens growth in our core Simcyp and Phoenix biosimulation software businesses as well as the contribution from Pinnacle 21. Demand for biosimulation continues to be strong, with customer interest in new applications growing at a very healthy rate. We are committed to expanding the role of biosimulation to meet the needs of researchers with innovation and expansion of our software offerings. In June, we launched our new Simcyp Discovery Simulator, which applies biosimulation earlier in discovery and development. Simcyp Discovery advances lead optimization, first-in-human dose prediction, and early formulation development. We are excited to help identify and progress the most promising new drug candidates for further investigation. In addition, we released new versions of our immunogenicity, immuno-oncology, and Vaccine Simulators to help predict how drugs work and to address key questions in the development of novel biologic therapies. The latest versions of these simulators help our customers tackle the toughest challenges in drug discovery and development. We also recently announced an initiative to develop a biosimulation platform for CAR T-cell therapies with Memorial Sloan Kettering. We are excited to be collaborating in the MSK innovation hub and look forward to developing a biosimulation model that will help researchers, practitioners, and ultimately patients with personalized therapies. Pinnacle 21 continues to meet our expectations. Last week, we introduced an updated version of Pinnacle 21 enterprise with a new data exchange module. The majority of pharmaceutical companies are grappling with four or more primary data sources in clinical trials. Data Exchange is a data management solution that streamlines the process of ingesting clinical trial data from external sources. This solution ensures data integrity and regulatory compliance while empowering sponsors to maintain executive oversight to drive objective decisions. Turning to technology-driven services, we delivered revenue of $54 million, representing a 10% growth on a constant currency basis compared with the second quarter of last year. Within technology-driven services, biosimulation services revenue continues to show robust growth in the high teens on a constant currency basis. We expect continued strength in biosimulation services in the second half of 2022 and into 2023. The industry has clearly shown an interest in expanding the use of biosimulation with strong growth in bookings and new customers. As demand for biosimulation services continues to grow, we are investing in our team to expand existing customer relationships as well as establish new relationships. In our regulatory services business, we have experienced more volatility this year than planned. Our customers continue to experience delays in projects, and our business in China has been impacted by recent regulatory decisions causing Chinese customers to reassess their US strategy. As a result, performance in the regulatory business was below plan in the second quarter, and we are taking a more conservative outlook on this business for the remainder of the year. We believe in the strategic value of the regulatory business, which generates very healthy cash flow and remain committed to supporting our clients. With our revised outlook, regulatory services and the negative impact from foreign exchange rates, we are adjusting our revenue guidance for the full year to $325 million to $335 million, reflecting an approximate $10 million reduction due to foreign exchange and $15 million related to the performance in regulatory services. Andrew will provide more details to the guidance shortly. Overall, we continue to see industry trends moving in the right direction to drive growth in the adoption of biosimulation and Pinnacle 21. We see opportunities to expand our software and services offerings throughout the entire drug development cycle as well as into new modalities and disease areas. I am confident our Certara team will capitalize on these opportunities as we continue to deliver on our mission. I'll now turn it over to our CFO, Andrew Schemick, to discuss second quarter financial results in more detail.

Andy Schemick, CFO

Thank you, William. Hello everyone. Total reported revenue for the three months ended June 30, 2022 was $82.8 million, representing year-over-year growth of 21% on a constant currency basis and 18% on a reported basis. Excluding Pinnacle 21, constant currency second quarter revenue growth was 11%. As a reminder, the largest non-US dollar currency exposures are the British pound, euro, and yen, and the majority of the foreign currency translation impacts biosimulation software and services. We remain well positioned with trailing 12 months bookings coming in at $393.5 million, up approximately 25% year-over-year on a reported basis and excluding Pinnacle 21, up 17%. We continue to look at trailing 12 months bookings as a basis for forward 12-month revenue. Reported software revenue was $28.7 million in the second quarter, which increased 48% over the prior year period on a constant currency basis and 43% on a reported basis. Excluding $6.5 million in Pinnacle 21 software revenue contribution, year-over-year growth was 16% on a constant currency basis. The growth in this quarter excluding Pinnacle 21 was driven by our biosimulation software Simcyp and Phoenix, which grew approximately 15% compared to the same period a year ago despite the foreign exchange headwinds. Software bookings were $30.5 million in the second quarter, which increased 57% from the prior year period. Pinnacle 21 contributed $8.6 million to software bookings in the second quarter. So the 2Q year-over-year software bookings growth excluding Pinnacle 21 was 13%. Trailing 12-month software bookings were $113.1 million, up 44% year-over-year, and up 14% excluding Pinnacle 21. Software aggregate renewal rate was 92% in the second quarter, and net retention rate was 139%, or 107% excluding Pinnacle 21. Reported services revenue was $54 million in the second quarter, which increased 10% over the prior year period on a constant currency basis and 8% on a reported basis. As William mentioned, biosimulation services revenue growth was in the high teens on a constant currency basis. Regulatory services growth was flat, and we're no longer forecasting it to grow at historical rates for the remainder of this year. Technology-driven services bookings in the second quarter were $69.7 million, which increased 25% from the prior year period. TTM services bookings were $280.4 million, which increased 19% as compared to the prior year. Regulatory services booking growth is trending in the low single digits, and we're forecasting a longer conversion of bookings to revenue in this business due to elongated customer cycles. Total cost of revenue for the second quarter of 2022 was $35.2 million, an increase from $27.5 million in the second quarter of 2021, primarily due to a $4.2 million increase in employee-related costs due to billable headcount growth, $1.7 million increase in intangible asset amortization, a $1.2 million increase in stock-based compensation expense, and a $0.5 million increase in cost of licenses. Total operating expenses for the second quarter of 2022 were $43.4 million, an increase from $37.3 million in the second quarter of 2021. The components of operating expenses are as follows; sales and marketing expenses were $7.1 million compared to $4.6 million for the second quarter of 2021. This increase is primarily due to $1.6 million in employee expenses due to the expansion of the sales force, $0.5 million increase in marketing and travel costs and miscellaneous sales and marketing operations costs. R&D expenses were $7.7 million, compared to $4.6 million for the second quarter of 2021. The increase in R&D expenses was primarily due to R&D expense from acquisitions, and software R&D headcount investments. G&A expenses were $17.8 million, compared to $18 million for the second quarter of 2021. The decrease was primarily due to a $1.1 million decrease in transaction and M&A costs, a $0.6 million decrease in stock-based compensation, offset by $1 million of investment in headcount, and $0.6 million in higher professional services costs primarily related to accounting and stock implementation. Intangible asset amortization was $10.4 million compared to $9.5 million in the second quarter of 2021, increasing due to amortization costs from acquired intangible assets. Depreciation expense was $0.4 million, compared to $0.6 million last year due to a decrease in depreciation for furniture and equipment. Continuing down the P&L, interest expense was $3.9 million compared to $6.3 million for the second quarter of 2021 due to slightly higher interest expense offset by the reclassification of our interest rate swap to an effective hedge. Miscellaneous income was $2.5 million compared to a loss of $0.3 million in the second quarter of 2021 due to foreign currency gains of $2.7 million. Income tax expense was $3.4 million as compared to $1.5 million in the prior year due to the relative mix of domestic and international earnings and the impact of pre-IPO stock compensation expense, which is not deductible for corporate income tax purposes. We expect the rate to come down in the back half of the year. Net loss for the second quarter of 2022 was $0.6 million compared to a net loss of $2.9 million in the second quarter of 2021. Diluted earnings per share for the second quarter of 2022 was $0.00 as compared to a loss of $0.02 in the second quarter of 2021. Reported adjusted EBITDA for the second quarter of 2022 was $28 million, compared to $25.5 million for the second quarter of 2021, representing 9% growth. Reported adjusted net income for the second quarter of 2022 was $14.6 million, compared to $11.8 million for the second quarter of 2021. Adjusted diluted earnings per share for the second quarter of 2022 was $0.09, compared to $0.07 for the second quarter of 2021. Now, moving to the balance sheet. We ended the quarter with $194.8 million of cash and cash equivalents. As of June 30, 2022, we had $299 million of outstanding borrowings under our term loan and full availability under our revolving credit facility. Turning to guidance; we are adjusting our full year guidance due to foreign exchange rates and slow recovery in the regulatory services market. We are lowering our revenue forecast by approximately $10 million due to foreign exchange headwinds and $15 million due to the performance and outlook of the regulatory services business. Our updated forecast for the full year of 2022 is as follows: Revenue in the range of $325 million to $335 million, adjusted EBITDA in the range of $112 million to $117 million, adjusted EPS in the range of $0.43 to $0.48 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 cash tax rate in the range of 20% to 25%. I would like to point out that due to capital planning, the approximate $10 million of foreign exchange headwind we have forecasted flows through to a minor impact on reported adjusted EBITDA and virtually no impact to reported adjusted EPS. Lastly, as we look towards the second half of the year, it's worth highlighting that we have a particularly challenging third quarter comparison in reported technology-driven services revenue due to the change in outlook in regulatory services. As a result, we anticipate reported revenue growth in technology-driven services to be in the low single digits for the third quarter before returning to mid-teens growth in the fourth quarter.

William Feehery, CEO

Thank you, Andrew. In summary, we remain focused on our commitments to customers and delivering strong results for our shareholders as we continue to grow as a global leader in biosimulation. We will now open the line for questions. Operator, can you please open up the line.

Dave Windley, Analyst

I wanted to understand a little bit more on the regulatory services. It's been a little bit choppy for you at different times in the last year plus. I guess, first question there would be what visibility – what communication level and visibility do you have with your clients to kind of understand in real time what the anticipated project end dates and delivery of databases to you for your start of these projects? If you could just kind of help us understand how tight is your visibility there?

William Feehery, CEO

Yeah. Thanks, David. It varies by client. A number – many times, what we find is that the clients are still working that out themselves sometimes when they book with us. So there can be some discrepancies. But generally, we have been in touch with all of our clients in our backlog talking with them about when they expect to start the projects we currently have booked. And we have seen a slowdown in the number of – sorry, we've just sort of seen a slowdown in some of the projects starting. That started last year which I think is what you referred to during the pandemic and it's continued a little bit. I would say generally, we have about 60% visibility at any given time. We said that in the past. Anything you'll add?

Andy Schemick, CFO

That just relates specifically to the reg services, projects on hand. We would have firm visibility into start dates about 60% the other 40%, we’re in dialogue with the customers, today.

Dave Windley, Analyst

Got it. And that 60% visibility on the next four quarters. And you mentioned that's specifically related to regulatory matters?

Andy Schemick, CFO

That's regulatory specifically. That relates only to the total work available to work on and that gives us 60% visibility if it gives us basically 100% coverage to what's in the guidance here.

Dave Windley, Analyst

Okay. Okay. Maybe on the product side, you mentioned Discovery Simulator, new versions of Simcyp Phoenix, enterprise version of Pinnacle 21? And then I'd also throw in, you had carved out biologics simulator and we're beginning to sell that on more of a stand-alone basis. I guess I'd be interested in how that biologic simulator is taking hold in the market? What kind of receptivity you're getting there? And then Pinnacle 21 being a late last year acquisition, looks like it's tracking pretty well. What opportunities do you see for that to inflect a little bit? Thanks.

William Feehery, CEO

Yes, we launched two new products this quarter. One of them is the Simcyp Discovery Simulator, aimed at the early stages of discovery and preclinical processes. Historically, Simcyp has generated most of its revenue in the clinical phase and beyond, so this launch has been successful. We already have paying customers for this product, and it's experiencing good growth. Regarding biologics, customer interest in that area has been steadily increasing, although we haven't disclosed specific numbers for that product. As for Pinnacle 21, I'll let Andy provide details shortly, but we recently launched Pinnacle 21 Data Exchange, which was in development before we acquired the company. It has already made early sales this year, and we anticipate continued growth as it gets incorporated into budgets for next year. Andy, would you like to share thoughts on the growth of Pinnacle 21 in relation to expectations?

Andy Schemick, CFO

Pinnacle 21 is, pleased to say tracking in line with our guidance, from the beginning of the year. So we did about $13 million year-to-date $7 million in the second quarter, 95% SaaS and we've seen some uptake on the new product launch there. So we're feeling that that's performing well relative to our expectations.

Joy Zhang, Analyst

Thanks for taking the question. I want to revisit one of your comments in the prepared remarks about Chinese customers reassessing their strategy. Is that a headwind only for the regulatory business, or could that eventually become a bigger headwind in other parts of your business as well?

Andy Schemick, CFO

I could start Bill. That's specifically addressing a headwind in our regulatory business. We started to see some, we call export work helping Chinese companies with global submissions last year. And based on some FDA feedback in the current pipeline, that work's not materializing this year but we're continuing to add resources on the biosimulation front. And believe that the opportunity to use biosimulation with regards to some of the concerns about the lack of diversity in the population of the submissions could create some new entry points for us in discussions with clients.

Joy Zhang, Analyst

Got it. That's helpful. Maybe a question on the QSP side, I know you touched on this a little bit. But I just wanted to get an update on in terms of large molecule modeling, what is possible to do now? And what are some of the areas for future innovation?

William Feehery, CEO

On QSP, we are developing models to understand how a drug interacts with its target system. Some of the work we've invested in QSP and received from our clients involves areas like cell and gene therapy. We recently announced a collaboration with Memorial Sloan Kettering, which is intended to enhance our models for CAR-T therapies. Additionally, we've conducted significant research on modeling the immune system, leading to the creation of our Vaccine Simulator. This tool was utilized by some companies that launched vaccines during the pandemic. I hope this gives you a better idea of our activities in this area.

Joy Zhang, Analyst

Yeah. No. That’s super helpful. Thank you.

Jeff Garro, Analyst

Hi. Good afternoon. Thanks for taking my questions. I want to follow up on the regulatory services outlook. And just was hoping you could comment more on whether any headwinds there are being caused by capacity with the regulatory agencies themselves or just various reasons causing delays from clients?

William Feehery, CEO

No, we're not seeing this as a specific issue caused by regulatory agencies. What we're observing in the regulatory business appears to be due to several factors. Firstly, we were working with some Chinese clients who were establishing their business as they entered the U.S. market and that process with the FDA has experienced some delays this year. Secondly, some of the Tier 2 and Tier 3 clients have pulled back to conserve cash, leading to a slowdown. Lastly, as we mentioned in previous quarters, the pandemic caused a delay in completing studies. Our work typically starts only after a 100% database lock, and we've noticed that the completion of studies has slowed down, extending the backlog significantly compared to historical trends.

Jeff Garro, Analyst

Got it. Very helpful there and then maybe to follow up a little bit on the funding environment, we saw the strong bookings number in the quarter. But wanted to ask more about your business given some of the discussion from the CROs around kind of the pros and cons of a long sales cycle and the various steps before a project gets into their backlog and is marked as a net new win. I was hoping you could discuss the typical length of your sales cycle and whether any elements of that have changed over the last six months?

William Feehery, CEO

Our sales cycle generally spans a couple of quarters for most of the company. I don’t see a significant difference between biosimulation and regulatory in this regard. One distinction in software sales is that we receive a lot of renewals, especially in the first quarter, which we've mentioned before. From what I'm observing in our regulatory business, it seems to align with what some of the CROs are experiencing. However, we begin work only after the study is fully completed and the database is locked, while CROs are compensated throughout the entire study. I don’t believe what we’re reporting is vastly different from market observations. Overall, we are experiencing strong bookings on the biosimulation front, and the issues affecting regulatory in China across different tiers don't seem to impact biosimulation. We are seeing considerable customer interest and bookings for both software and services in biosimulation.

Andy Schemick, CFO

Yes, I would just add specifically in Q2 in terms of the bookings mix ex-Pinnacle 21, we saw 2% growth on the regulatory side and 42% growth on the biosim side, and similar trend when I look at it on a TTM basis as well.

Jeff Garro, Analyst

Great. Then one last follow-up there. It sounds very positive in terms of the client activity and the overall end market, but specifically asked is the pipeline growing roughly in line with the bookings growth that you've printed year-to-date?

Andy Schemick, CFO

The pipeline remains healthy, especially in the biosim area. One factor influencing our guidance is the absence of a major submission project, which we usually have every one to two years in the several million dollar range. Therefore, I can say that the biosim pipeline is in good shape, and we expect continued strong performance in bookings. However, it's important to note that we had two large deals last year that were planned for booking then but are instead being recorded in the first half of this year. I anticipate that, in line with historical patterns, we will see a decline in bookings in Q3 followed by a rebound in Q4, which is usually our largest quarter.

Dave Windley, Analyst

Many questions in the queue. I'd like to revisit margin. Your adjusted EBITDA margin was lower in the second quarter. I assume this is at least partly due to revenue being lower than expected. Could you provide some explanation or insights into the factors affecting your adjusted EBITDA margin for the quarter? Also, does your regulatory services business align with your current outlook for that segment, or are there necessary adjustments in the cost structure?

William Feehery, CEO

All right, Andy do you want to take the first part?

Andy Schemick, CFO

The business is generally sized appropriately, and we are exploring opportunities for the latter half of the year. The main opportunity lies in the hiring rate, which is expected to be slower than in the past due to revenue growth projections for regulatory purposes. Looking at the margins, I assess them on a product basis, focusing on the contributions from software and services. Year-over-year, we are essentially flat in contributions. We did see a decline in regulatory but that was counterbalanced by higher margins elsewhere. Overall, there was no significant change, and we benefitted from a favorable mix due to stronger software. The margin impact stems from lower revenues affected by certain corporate investments, which are divided into three main areas: rising audit and SOX costs, the development of commercial office space, and the expansion of the recruiting and HR team.

Dave Windley, Analyst

Okay. In the second half, it seems you're at the midpoint for your full year adjusted EBITDA margin, which is slightly lower than what you've reported so far this year. Should we anticipate that the third quarter will resemble the second quarter, considering your comments on revenue, and then see a jump in the fourth quarter, or will it be more consistent throughout the second half? Could you clarify the cadence for us, please?

Andy Schemick, CFO

Yes. So, it's a little bit more even through the back half. I'm not quite sure what you're looking at. We can talk offline, but I think I've got about 35.5% for Q3 and Q4.

Dave Windley, Analyst

Got it, okay.

Andy Schemick, CFO

Could be a little just towards Q4, yes.

William Feehery, CEO

Thank you all for joining. To summarize the quarter, we have a strong biosimulation business with impressive bookings and ongoing investments demonstrated by our new products. We are optimistic about this area. Our Regulatory business has grown less than expected due to the factors we've discussed, but we remain supportive of it as it has good margins and generates substantial cash flow, making it an important part of our operations. However, it is small compared to the larger market, and there is potential for growth through simulation. Overall, we are excited about the future and have many positive developments on the horizon for the company. We look forward to speaking with you next quarter. Thank you.

Operator, Operator

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