William Feehery
Analyst · Barclays. Please go ahead
Thank you, David. Good afternoon, everyone. Thank you for joining Certara's fourth quarter and full-year earnings call. Andrew and I will start with prepared remarks and then we will take questions. 2021 was a milestone year for Certara. It was our first full-year as a public company and we made progress on a number of key priorities and initiatives. We are very excited about the opportunities ahead and as we continue delivering on our mission to accelerate the drug development process with our proprietary biosimulation software, technologies and services. At Certara our strategy is to transform the drug R&D process with our end-to-end platform powered by innovative technology and our global team of leading experts. We not only speed up the process, but also help to advance safety and efficacy of drugs for millions of patients worldwide. For the full-year, we reported total revenue of $286 million, growing 17% year-over-year including Pinnacle 21 and 15% excluding Pinnacle 21's contribution in the fourth quarter. 2021 revenue growth was in the double-digits in every region of the world. Fourth quarter total company revenue was $75.3 million, growing 17% versus the same period a year ago. Pinnacle 21 contributed $6.1 million in the quarter. Excluding Pinnacle 21, revenue was $69.2 million, growing 7% compared with the same period a year ago. Excluding Pinnacle 21 fourth quarter software revenue was in line with expectations, growing 13% compared with the fourth quarter of 2020, but technology driven services came in below our expectations, growing 6% compared with the fourth quarter of 2020. Our technology driven services performance in the fourth quarter was driven by two issues, both of which impacted the timing of work being executed. First, as we commented in our third quarter earnings call in November, we have been experiencing variability in the timing of our regulatory services projects due to COVID related delays. We did not have cancellations and our bookings and regulatory services projects continue to be strong. As you recall, in Q3 2021, we experienced significant growth, 28% year-over-year in technology driven services due to the recognition of delayed regulatory services projects. In Q4, the COVID related slowdown in closing out clinical trials impacted timing of projects and revenue recognition in regulatory, which resulted in a shortfall in Q4 in services. In the back half of the year, technology driven services revenue grew 16% year-over-year and we expect it to continue growing in the mid-teens in 2022. We expect these delays will moderate in 2022 and we will recapture most of this regulatory services revenue over the course of the year. We continue to work hard to manage consistent conversion of our bookings billings to smooth out our revenue recognition throughout the year. Second, the surge in COVID-19 cases resulting from the Omicron variant reduce the capacity of our employees and clients in the back half of the fourth quarter. We believe that these are transitory factors that we are well equipped to manage in 2022. As we look forward to the coming year, we remain optimistic about activity returning to more normal levels as the year progresses with conferences coming back and more people back in the office. Turning to software, we were pleased with our performance during the fourth quarter, which grew 46% including Pinnacle 21 and 13% excluding Pinnacle 21. The growth was driven by a 96% software renewal rate and strong demand for our proprietary biosimulation software our Phoenix and Simcyp platforms and Pinnacle 21 also delivered according to our expectations. As we mentioned at our December Investor Day, we see a number of compelling opportunities ahead for Certara in software and we've increased our investment to support those R&D activities in 2022. Specifically, we're focused on expanding the use cases of our Simcyp Simulator, which continues to grow in adoption to reduce or waive drug-drug interaction and bio-equivalent studies as well as support better dosing for special patient populations. Looking to 2022, we expect strong momentum in software to continue and we believe the transitory headwinds experienced in regulatory services projects during the fourth quarter will subside over the course of the year. Bookings trends in both software and technology driven services remain strong. Fourth quarter bookings grew 30% year-over-year and trailing 12 month bookings grew 18% over the prior period, including the contribution from Pinnacle 21. As such, we remain well positioned to achieve our long-term financial and strategic plans. Moving to performance for the year. In 2021, we drove strong growth in new customers and we now serve more than 2,000 customers, including more than 350 additional software end customers who engage with us through our distributors in Asia Pacific. Our land and expand strategy has also delivered solid growth among existing customers. We ended the year with 299 customers with annual contract value of more than $100,000, representing growth of 15% year-over-year. The integration of Pinnacle 21 into our software group was an important focus in the fourth quarter. We are now beginning to execute on the promise of the compelling opportunities identified when we acquired Pinnacle 21. In December, we released the latest version of the Pinnacle 21 enterprise software, which offers immense value to experts in biostatistics and biometrics in ensuring that submissions to regulatory agencies comply with data standards requirements. The feature-rich release proactively supports the new Define-XML 2.1 data standards. This is the first of many growth milestones we expect to emerge from the Pinnacle 21 platform. Updating Certara software remains a top priority for our team and we continue to innovate during the fourth quarter with the release of Simcyp Simulator Version 21 and D360 Scientific Informatics Software Version 21.5. The latest update to the Simcyp Simulator aligns with recent regulatory guidances and it includes other updates to support customers development priorities including additions to the compound library to facilitate drug-drug interaction analysis and updates to our renal and hepatic impaired population models. The latest version of D360 software increases efficiency in analyzing and guiding the design of small molecule drugs and biologics. We remain very encouraged by the growing pipeline and opportunity for our software to advance discovery research. During the quarter we announced that the FDA has renewed and expanded licenses of Certara's biosimulation software with more than 400 user licenses of Simcyp and Phoenix platforms across 12 divisions and offices. The FDA also recently licensed our Immunogenicity Simulator for the first time to research and evaluate immunogenicity and regulatory submissions for biologics. Immunogenicity or the tenancy of protein-based therapeutics to trigger an immune response is a major problem in drug development. Our Immunogenicity Simulator predicts the immunogenicity incidence of therapeutics could guide dosing and study design for better clinical outcomes for patients. It continues to be a privilege for us to provide software that global regulatory agencies can rely on to inform their reviews of regulatory submissions. 2021 was also the eighth consecutive year that Certara's customers received 90% of the novel drug approvals by the FDA excluding diagnostic products. The Simcyp Simulator is used in 13 of these approvals to inform a drug label. We are excited by the recent launch of the FDA's Project Optimus initiative, which aims to reform the dose optimization and dose selection paradigm in oncology drug development. This is important for drug developers and patients because the current approach of maximum tolerated dose may lead to selection of a dose that provides more toxicity without additional efficacy. Certara is well positioned to address these upcoming changes in dose finding and the evolving regulatory landscape with our extensive experience in oncology as well as dose optimization trial design, regulatory strategy and submissions. As outlined in our strategy, we continue to invest in the business and add to our expert team worldwide. For the end of the year, we experienced an increase in attrition due to a variety of factors. Our attrition was fairly low in 2020. So now we're getting back to more normal levels of attrition that we had experienced pre-COVID. We continue to prioritize adding top talent and in 2021 we hired leading scientists and subject matter experts to support our ongoing growth. We ended the year with approximately 1100 employees, including more than 350 employees with doctorate degrees. Certara culture and commitment to innovation and customer partnerships continue to attract top talent in a competitive hiring environment. We remain focused on making Certara the employer of choice in the industry. In summary, I'm pleased with the performance of the company in 2021, delivering double-digit growth in software and services, advancing the adoption of biosimulation and acquiring and integrating Pinnacle 21. While revenue from our regulatory services business in the fourth quarter did not meet our expectations, our bookings growth and our momentum remain strong. I am confident in our Certara team to execute our plan. I will now turn this over to our CFO, Andrew Schemick to discuss the fourth quarter and full-year financial results in more detail.