William Feehery
Analyst · Jefferies. You may begin
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. I'm very pleased with how the Certara business performed in the second quarter of 2021 as we continue to successfully execute on our strategic and financial plans. In the quarter, we continue to grow our position as a global leader in biosimulation by delivering strong financial results. Revenue in the second quarter grew 15% compared with the second quarter of 2020 as we achieved another record quarter of revenue. Adjusted EBITDA grew 1% compared with the second quarter of 2020. Adjusted EBITDA growth was impacted by higher profitability in 2020 due to reduced SG&A spending during the height of the COVID pandemic, in addition to increased public company costs in 2021, which did not exist same time last year. Bookings growth in the quarter continued both in software and in services, with software bookings up 8% year-over-year and services bookings up 7% year-over-year. Because there are quarter-to-quarter fluctuations in our bookings, we believe looking at trailing 12-month bookings growth is a more accurate way to evaluate our business development activity. Total company trailing 12-month bookings is up 26% year-over-year. Overall, we are pleased with our year-to-date performance, which is ahead of the expectations earlier in the year. In keeping with our goal to expand the use cases of biosimulation and grow adoption of our end-to-end platform, earlier today, we were thrilled to announce the acquisition of Pinnacle 21, the largest acquisition in our history, for $310 million in cash and stock. Pinnacle 21 is a privately held company with industry-leading data standardization software for pharmaceutical clinical data. Their SaaS-based solutions are used for managing compliance to the CDISC standards and increasing preclinical and clinical data quality. CDISC, also known as the Clinical Data Interchange Standards Consortium, has developed a set of global data standards for regulatory submissions. Compliance to these standards is required for regulatory submissions to the U.S. FDA and Japan's Pharmaceuticals and Medical Devices Agencies, so that these agencies can efficiently make sense of the data they received and evaluated during the review process. The CDISC standards are also the preferred standards for electronic data submissions in China. Pinnacle's software is used by the FDA and the PMDA to validate all incoming submissions data. This acquisition is an ideal fit for Certara on many levels. First, Pinnacle 21's proprietary validation software perfectly complements our biosimulation and regulatory software. Global regulatory submissions require consistent and compliant data sets to minimize costly delays. Additionally, data standardization advances scientific research as data is collected and combined from increasingly more and more diverse sources and then organized and analyzed with biosimulation and other methods. Second, Certara's drug development consultancy and regulatory sciences teams will be able to expand our data standardization and CDISC compliance service offerings powered by Pinnacle 21's software, as we are already collaborating with our clients on gathering, integrating, analyzing and preparing data. And last, but certainly not least, the culture fit is remarkable, as we are both passionate about driving innovation and efficiencies throughout the drug development life cycle using technology. Working together, we will integrate and expand features and tools to accelerate life-saving therapies to patients. Pinnacle 21 has achieved incredible milestones with a top-notch team of software developers and CDISC experts that has built user-friendly software to help biopharmaceutical companies deal with complex data standards. Their Pinnacle 21 community open source software is used by more than 1,000 organizations and helps remove barriers to entry and promote innovation, especially among smaller biopharma companies and start-ups, while adhering to the complex data standards that can be daunting and consume significant time and resources. This broad user base also creates a robust community of engaged data scientists and biostatisticians who provide feedback that fuels the development of new features. As companies become familiar with the significant benefits that Pinnacle 21's tools deliver, many find it valuable to upgrade to the enterprise version so that they get the most value from their data, ensure compliance to the standards and minimize the risk of regulatory delays. Pinnacle 21 has more than 130 enterprise customers, including 22 of the top 25 biopharmaceutical companies by R&D spend as well as the FDA and the PMDA. They have rapidly grown the number of customers with annual customer value in excess of $100,000 from 19 customers in 2018 to 44 in 2020. When we close, Pinnacle 21 will be immediately accretive to Certara's revenue growth and adjusted EBITDA. We expect the acquisition to close in early fourth quarter. As we've discussed in the past, we continually seek the right technology, people and capabilities to increase the depth and breadth of our end-to-end platform, which is what we believe Pinnacle 21 will do. Andrew will discuss the financial details and the implications of Pinnacle 21 in a few minutes. Turning back to Certara's overall business. Our proven track record of innovation continued in the second quarter as we announced the launch of our new versions of our immunogenicity and immuno-oncology simulators. These software platforms help address challenges in the discovery and development of biologics in combination cancer therapies. Immunogenicity is a key challenge for developing biologics, which now comprise almost 40% of the global biopharmaceutical R&D pipeline. Researchers use our immunogenicity simulator to understand immunogenicity, which is the ability of a therapeutic to trigger an unwanted immune response. The immunogenicity simulator uses in vitro data, drug data and clinical data, if there's any available, to extrapolate into virtual patient populations and predict outcomes. At the June FDA workshop on immunogenicity, thought leaders at Certara and our customers presented case examples of our simulator in action, including how it helped to advance COVID vaccine development. Regarding COVID vaccines, we're proud that our vaccine simulator accurately predicted that eight weeks was the optimal timing between first and second doses of COVID-19 vaccines. The PITCH study, conducted at Oxford University in the United Kingdom, confirmed Certara's vaccine simulator prediction which was released six months ago back in February. This further validates the predictive power of our biosimulation software to address critical questions, including predicting which dosing regimens potentially work best before heading into clinical trials. In immuno-oncology, the sheer number of possible therapy combinations requires a robust quantitative framework to integrate the complex and dynamic factors that influence efficacy. Challenges around this complexity have led to the selection of suboptimal combinations. Our immuno-oncology simulator uses virtual patients to test many different therapy combinations to determine the optimal regimen of therapies and dosing. Version 3.0 of the immuno-oncology simulator vastly expands the number of targets and cell types and also test combinations of chemotherapy and radiotherapy. The immuno-oncology simulator has correctly predicted therapeutic outcomes with the use of drugs in various cancer types, including solid tumors and blood cancers. Turning to services. Our technology-enabled services business continues to grow well in excess of our stated long-term goal, driven by the expansion of our work with existing customers and the growth of partnerships with new biotechnology customers. Our services offerings, powered by our proprietary technologies, are highly differentiated and profitable. We are incredibly proud of our team of scientists and experts who are well known in the industry as thought leaders at the forefront of biosimulation, regulatory science and market access. Certara also continues to add to our expert team worldwide with more than 975 employees currently growing 5% year-to-date. Our turnover remains low relative to the industry and we are generally viewed as an employer of choice within the biosimulation industry. More than 60% of our new hires in the second quarter were scientists and subject matter experts. Over the past few months, Certara's board of directors welcomed three new members: Dr. Carol Gallagher, Nancy Killefer and Cynthia Collins. Each of these new board members brings a wealth of knowledge and extensive corporate board and leadership experience that will be invaluable to Certara as we expand our business. In addition, as we announced last week, Mubadala Investment Company invested approximately $250 million in Certara through a direct purchase on August 2 of more than 9.61 million shares from existing institutional shareholders of Certara, including a stakeholder affiliated with EQT. EQT remains a significant and important shareholder in Certara. We are excited to welcome Mubadala and recognize its investment as a vote of confidence in our people, strategy and financial performance. Looking forward to the second half of the year, we will host a Business Overview Day for the analyst and investor community, where we will dive deeper into the business and Certara's end markets. Please mark your calendars for the afternoon of December 15 in New York City for this event. In summary, Certara had a strong second quarter. We announced a strategic acquisition today and we are focused on continuing to deliver against our strategic and financial objectives. I will now turn it over to our CFO Andrew, to discuss the financial details of our acquisition and the financial results for the second quarter.