Steve Cutler
Analyst · Baird. Please ask your question
Thank you, Brendan, and good day, everyone. 2021 was an outstanding year for ICON. Over the course of the year, we completed a transformational acquisition, doubling scale of the organization, and creating a world leading health care intelligence and clinical research organization. Our employees expertly navigated the challenges of the ongoing pandemic, deploying innovative solutions to ensure clinical trials were able to continue and patients received life-saving treatments despite continued impact to site and patient and access. We delivered on our mission to accelerate the development of customers ' drugs and devices by providing support on 30 new drug approvals in 2021 in areas such as liver disease, schizophrenia, a range of cancers, and, of course, infectious disease. I'm incredibly proud of the role the ICON team has played in the fight against COVID and the development of these critical vaccines and therapies. The overall environment in clinical development throughout 2021 was robust as biopharma development spending continued to grow, and biotech funding activity was near the record levels seen in 2020. Scientific advancements in areas such as mRNA techniques in vaccines, and cell and gene therapies present new opportunities to develop novel drugs that could have a major impact on potential treatments for a variety of diseases. Customers are increasingly turning to CROs as partners, not just providers, to aid in the development of these complex, groundbreaking therapies. RFP volume continue to be strong through the year, increasing low double-digits on a year-over-year basis for the quarter and full year 2021. While biotech funding levels were down from a record year in 2020, we have not seen this negatively affect overall demand in the small Biopharma customer segment. In fact, in quarter four, we saw a particular strength in RFP activity in the small and mid-sized Biopharma segments, as strong cash positions continue to drive demand for best-in-class development. We were very pleased to see our top 25 customer concentration decrease sequentially in the fourth quarter, as well as from a full-year perspective, attributable to the new ICON combination. At a high level, our overall customer mix is well balanced with approximately half of revenue attributable to large Biopharma, and 45% attributable to small and mid-sized Biopharma companies. Within this segment, companies that have less than $100 million in annual R&D spend represented a mid-teen percentage of our overall revenue in 2021. This percentage will vary on a quarterly basis, and I would add that we haven't seen any issues or concerns related to cash collections, or rising bad debts in this customer subset. Our engagement with customers on a strategic level has continued to show positive progress. ICON 's offering of integrated and innovative solutions appeals to Biopharma customers, large and small, and across different modalities of development from functional to full-service. Our success in creating enduring customers -- strategic customer partnerships with strong delivery for our customers, has led to further opportunity to expand the existing relationships, as well as open the door to new partnerships. As new ICON, we can be even more of a strategic partner to our customers. With the unique resources, world-class talent, and differentiated solutions we offer. I'm delighted to report that we secured an agreement with a large pharma partner during the quarter, expanding our existing relationship across a number of services and further validating the strategic merits of the new ICON organization. During the quarter, ICON increased net business wins to a record $2.38 billion, delivering a quarterly book-to-bill of $1.26 billion and growing our backlog to $19.1 billion, an increase of approximately 3% over quarter 3, 2021, and approximately 10% year-over-year on a combined company basis. We believe our backlog is a robust figure based on contracted and awarded work, with a conservative but realistic assessment of associated pass-through costs. New award activity was strong across several operating segments. On a combined Company basis, full-year 2021 revenue and adjusted EBITDA increased an impressive 25% year-over-year, hitting the midpoint of our guidance ranges for revenue and adjusted EPS for the year. Our backlog burn for the quarter remained over 10%. Cash collection efforts continued to be strong, with a DSO of 31 days down from 57 days on a comparable basis from December 31, 2020. As a result, I'm happy to report that these efforts allowed us to make a $500 million payment on our term loan B facility at the end of the year, reducing our leverage to 3.4 times adjusted EBITDA, including synergies exiting 2021. This puts us on track to exit 2022 with a leverage ratio of approximately 2.5 times adjusted EBITDA. We're pleased with the progress already made on our cost and revenue synergy goals. As announced earlier this year, we expect to reach a run rate of approximately 50% of our $150 million cost synergy target, or $75 million exiting this year. From our revenue synergy perspective, our target of a $100 million by 2024 remains unchanged. Our cross-sell award activity has been strong, particularly in awards for central and specialty labs, the Accellacare site network imaging, and early phase services. Our integration process continues well with notable achievements, in the first six months as a combined organization. We have completed over 30 facility integrations across our sites, unifying our workforce, and ensuring an efficient footprint across our organization as the pandemic restrictions start to ease. Our technology and systems integration activity and planning is well underway, with a priority focus on enterprise-level systems in order to enable a uniform, unified, and engaged employee experience as soon as possible. Our global business support services model has started organization-wide implementation in areas such as finance, IT, and other administrative functions. In addition, we have rolled out our new brand campaign, highlighting the shared values of new ICON, and reflecting the best of both from the organizations we have brought together. The priorities we set out at the start of the integration remain unchanged; delivering on time and budget for our customers, and ensuring a positive employee experience. To that end, we have increased our investments in internal initiatives to improve retention and attract the industry's best talent as we strive to become the employer of choice in the CRO industry. Indeed, we were pleased to be the only CRO included in the Forbes America's best large employers list for 2022. As the labor market continues to be highly competitive, we recognize the importance of continuing to invest in our employees and provide support in areas such as career development and training programs. With the increased scale of new ICON, we are excited by the expanded and diverse career opportunities that are available for our entire employee population. As the COVID-19 pandemic continues on, we see areas of opportunity amidst the challenges that inevitably will remain. Alongside our Biopharma partners, ICON has played a key role in the ongoing development of COVID vaccines and therapies. We rose to the challenge of executing clinical trials in record timelines, starting up sites and recruiting patients with increased efficiency. As site network was at the heart of many of these critical vaccine trials, displaying the strategic benefits, we can bring through our owned and partnered sites in the Accellacare network. It's all the peak of revenues related to COVID programs, occurring in the first half of 2021. As expected, the level of COVID world decreased further in quarter four to mid-single-digits as a percentage of total revenue as large vaccine trials gradually wide down and therapies made up a larger proportion of our contracted work. End of quarter four, are backlog from COVID-related projects decreased further, representing approximately 5% of total backlog, which is down slightly from the end of the third quarter. Our expectation is that revenue attributable to COVID -related vaccines and therapies, will represent less than 5% of total revenue in 2022. This assumes we do not see a need for further large scale trials on new variants. We saw increase from continued resilience from site and staff through the Q4, despite the emergence of the omicron variant. Although approximately 15% of sites remain restricted in some capacity due to COVID across the globe, a similar level to Q3. Innovation is valued in our industry and by our customers more than ever, as impacts from the global pandemic continue to be felt, and have necessitated a change in how we can best execute clinical trials. We're seeing solutions such as remote and risk-based monitoring deployed on the majority of clinical trial programs, and the number of hybrid drove initiated have increased significantly over the course of the last few years. Our innovation priorities that I'm going to have focused on providing enhanced solutions, that address core customer needs. Faster access to diverse pricing groups and more efficient clinical development. As customers seek novel solutions, we have continued to invest in unique partnerships and expanded offerings to further our position as a leader in helping to transform clinical development. During the quarter, we announced an expansion of our Accellacare site network, entering the new partnerships with six research sites across four countries. These new site partnerships further our strategy, of increasing the reach and capabilities of our site network, as well as expanding our therapeutic depth and expertise in the areas of CNS and immune diseases. With the addition of these new partnerships, our site network now stands at over 100 active locations across eight countries with access to over 9 million patients globally. This broad reach and increased resource has enabled us to realize increased efficiencies for our customers ' trials, including faster patient recruitment and Study Startup at ICON sites, versus industry averages. In addition to the site network, we have made significant investments in our digital health platform, one of the key components of our Decentralized Clinical Trial offering. Now branded the ICON Digital Platform, or IDP, this platform builds upon our already strong pacing pricing mobile application and its integrated other key applications, such as e-consent, wearables data capture, and tele -health capabilities. One of our critical differentiators, is our ability to integrate operational and functional expertise into our digital platform, allowing for customization and enhancements based on customer needs and our firsthand trial experience, while also providing a compelling, one-stop service that avoids the need to contract third-parties, thereby improving accountability while reducing risk and timelines for customers. Our role as a leader in successful decentralized trial execution was evidenced with a presentation of the chief heart failure trial results in Q4 in conjunction with the 2021 American Heart Association Conference. This is the only published positive, fully decentralized drop that we have seen in the industry. This large randomized trial required a significant amount of innovative planning, design, implementation, and unique services to execute. This trial integrated several components of our DCT offering. The mobile health platform, including a smartphone app to enroll participants and collect data, direct-to-patient drug and device logistics. A virtual coordinating center and wearable components. In addition to showing improvement in patient retention rights, trial results confirmed a dramatic increase in patient diversity, more than four times better than industry averages. I applaud the new ICON, saying that ran this program, alongside a key pharma partner, successfully implementing a new model of development in the middle of a global pandemic and enrolling patients with heart failure, which is one of the most challenging disease entities to treat. This is a great example of our innovative strategy in action, providing solutions to support patients and creating the opportunity for a more diverse patient population to participate in clinical research. In addition to increasing patient diversity and inclusion in clinical trials, we have seen trials including decentralized components recognize other benefits, such as reduced data variability and more timely data capture with the utilization of digital health technologies and wearables. By leveraging our extensive resources, technology, and product development expertise, ICON is well positioned to partner with our customers to provide insights on their hybrid and de -centralize designs are likely to work well for sites and patients, and just as importantly, in what protocols they are unlikely to be successful. Deploying decentralized solutions is not a one-size-fits-all approach, and every study needs to be evaluated by an experienced team to properly conduct this analysis. As this market continues to evolve, we see a consistent from our customers to find new ways of solving complex issues in their development programs. I know we can. we pride ourselves on our ability to take on our customers’ challenges as our own. We are committed to our investments innovation through talent, technologies, data, and analytics, as well as with noble partnerships, such as those with Deep Lens and Veradigm announced earlier this year to disrupt traditional product development. We're excited by the opportunity in front of us to create a new paradigm for bringing clinical research for patients, and believe in the value of bringing shareholders, sites, customers, end purchase. With the strong performance in the fourth quarter and positive momentum coming into this year, we are reiterating our 2022 financial guidance of revenue in the range of $7.77 billion to $8.05 billion, representing growth of 42% to 47% over full-year 2021 revenue. And adjusted earnings per share guidance in the range of $11.55 million to $11.95 million, up 20% to 24% over full year 2021 adjusted earnings per share. As we look beyond 2022, we continue to expect to deliver on the mid-term to long-term financial projections we announced a year ago, revenue growth in the mid to high single digits on a combined company basis, and adjusted EBITDA growth in the low teens, and EPS growth in the mid to high teens. We're looking forward to sharing more of our longer-term projections at our in-person Analyst Day which will be held on St. Patrick's Day, March 17, 2022, at our site in Blue Bell, Pennsylvania. The event will be webcast from fleets of several members of ICON's leadership team, highlighting our strategic focus areas, including innovation and technology. Finally, I'm thrilled that our team's excellent performance in 2021 has resulted in several industry awards, including Scrip's best CRO award. And additionally, as mentioned previously, ICON was the only CRO to be recognized in Forbes, America's Best Large Employers list for 2022. Before moving to Q&A, I'd like to recognize and thank sincerely, all of the 38,000 ICON employees across the globe for their commitment and tireless efforts in the quarter and throughout 2021. We look forward to continued success in 2022 as we build the world's leading health care intelligence organization and help shape the future of drug development. Operator, we're now ready for questions.