James Foster
Analyst · William Blair. Please go ahead
Thank you. Good morning. As the COVID-19 pandemic continues to pressure the global economy and adversely affect so many lives, medical innovation has never been more critical. The biomedical research community is rising to this challenge, resulting in an unprecedented level of investment, and Charles River has never been so essential to our diverse and growing client base. Not only are we continuing to work on a wide range of drugs across multiple therapeutic areas, utilizing our unmatched suite of early-stage solutions, but we are also helping clients develop drugs to find treatments for, and ultimately, prevent COVID-19. As anticipated, we experienced challenges related to COVID-19 in the second quarter, principally in the RMS segment. However, the resilience of our business model has enabled us to weather these challenges extremely well. This resilience is demonstrated by our second quarter financial performance, which widely exceeded our expectations. The outperformance was due in part to the tireless efforts of our dedicated staff; the effectiveness of our comprehensive business continuity plans that enabled us to keep our operating sites open and adequately staffed; and the global scale, broad scientific capabilities and flexible outsourcing solutions of our unique early-stage portfolio on which clients are increasingly relying to move their programs forward in the face of disruptions or delays at their own sites. We also benefited from persistent client demand across many of our businesses, driven by robust biotech funding and continued innovation that is generating scientific breakthroughs across multiple therapeutic areas, including for COVID-19 therapeutics. Before I provide more details on our second quarter results, I want to update you on the impact that COVID-19 has had on the company. I'd like to start by thanking our employees around the globe for their hard work and unwavering commitment. It's because of your extraordinary efforts that we have kept all of our operating sites open and continue to serve our clients throughout the pandemic. Because of your dedication to our mission, our clients are making progress on their critical research. We believe that providing continued support to clients during the pandemic is leading to more outsourcing opportunities for Charles River. Clients, large and small, are outsourcing work to us that they previously performed internally or outsourced to others because working with one large scientific partner like Charles River enables them to implement a more flexible and efficient R&D solution over the longer term and helps them navigate the evolving COVID-19 situation in the nearer term. We are principally seeing the benefit of this outsourcing in our Discovery, Safety Assessment, biologics and GEMS businesses. As we continue to perform these services, we believe clients will become accustomed to our faster turnaround times, superior science and cost effectiveness and therefore, we believe we will retain a meaningful amount of this incremental work. We are also experiencing favorable trends across most of our businesses, including through July. In the RMS segment, which was most affected by COVID-19, academic clients are opening their facilities more quickly than anticipated around the world, particularly in Europe and Asia. And the services businesses continue to perform well. HemaCare's donor clinic reopened, and the business has largely returned to full operations. The DSA segment continues to experience strong demand, with high proposal in booking volumes and only a small impact associated with COVID-19. In the manufacturing segment, microbial did face some headwinds, but the biologics business continued to perform exceptionally well with significant demand, especially for cell and gene therapy products projects and, to a lesser extent, COVID-19-related activities. I'll now provide additional details on our second quarter results. We reported revenue of $682.6 million in the second quarter of 2020, a 3.8% increase over last year. Organic revenue growth of 1.4% exceeded our prior outlook of mid-single digit decline because client demand has been resilient, and the impact of COVID-19 has been less severe than originally anticipated. COVID-19 had a meaningful impact on the RMS segment, including RMS revenue by approximately $35 million in the second quarter. However, the impact of the DSA and manufacturing segments was quite small with both reporting healthy organic growth rates of 6.2% and 8%, respectively. The operating margin was 17.3%, a decrease of 120 basis points year-over-year. The decline principally reflects the significant margin decline in the RMS segment as a result of the lower sales volume and the fixed cost nature of the business. However, we were quite pleased that both the DSA and manufacturing segments reported meaningful operating margin expansion in the second quarter, reflecting the operating leverage in these businesses, as well as the benefit of operating efficiencies, including temporary cost reduction initiatives in response to COVID-19. Earnings per share were $1.58 in the second quarter, a decrease of 3.1% from $1.63 last year, widely exceeding our prior expectation of a 20% to 30% decline. Overall, we were pleased to be able to generate earnings per share nearly unchanged from last year, which demonstrates the resilience of our business and our continuity planning during this global crisis. Based on the better-than-expected second quarter performance and our expectation that COVID-19 will be less of a headwind than originally anticipated, we are increasing our revenue growth and non-GAAP earnings per share guidance for 2020. We now expect organic revenue growth in a range of 4% to 5.5% or 175 basis point increase at midpoint. Non-GAAP earnings per share are expected to be between $7.05 and $7.35, which represents a $0.275 increase at midpoint and a 5% to 9% year-over-year growth. The revenue loss from COVID-19 is now expected to be approximately $100 million, which is below our previous range of $135 million to $215 million. We believe that we are beyond the worst of the COVID-19-related headwinds, but we understand that there may still be additional challenges ahead. We are assessing the situation on an ongoing basis, and we'll be diligent about addressing any new challenges just as we did in the second quarter. Our guidance assumes that there will be additional recovery in client demand in the third quarter, principally in the research models business. David will provide an update on the assumptions that are included in our revised outlook shortly. I'd like to provide you with additional details on our second quarter segment performance beginning with the RMS segment. RMS revenue in the second quarter was $116.5 million, a decrease of 18.4% on an organic basis. As I mentioned earlier, COVID-19 reduced the second quarter RMS revenue by approximately $35 million, which was favorable to our initial expectation as clients began to gradually resume activities at their research sites earlier than anticipated, particularly in Europe and Asia. On our last earnings call, we anticipated that demand for research models would improve in the third quarter as biopharmaceutical clients resume more normal research activities, and we expected that academic demand will begin to rebound by the fall. However, this return-to-work process began in the second quarter with clients in Europe and Japan returning in the middle of the quarter in North America North American clients beginning the process in June. Academic clients showed the most significant improvement by the end of the quarter as these clients were most adversely affected when institutions began closing abruptly in the first quarter. Overall, these reopening activities resulted in a significant improvement in client ordering trends in June. We expect these favorable trends will continue in the coming months but believe it will take time for volumes in our research models’ business to return to pre-COVID-19 levels. For 2020, we expect RMS revenue to decline at a mid to high single digit rate organically, which is a notable improvement from our prior outlook of at least a 10% decline. The research model services businesses continued to perform very well in the second quarter, experiencing very little impact from COVID-19. We believe the strong performance reflects the value our clients see in outsourcing these critical services to us or in the case of insourcing solutions, or IS, the efficiency of using our people or capacity to manage their research needs. As I mentioned last quarter, we are seeing evidence that some GEMS clients, who previously managed their model colonies in-house, have opted to outsource this work to us due to COVID-19 restrictions at their own sites. We continue to anticipate that much of this GEMS work will remain outsourced after the COVID-19 crisis subsides. After a strong first quarter, HemaCare was negatively affected by a two-month closure of its donor clinic, which reopened in mid-May, as well as reduced cell therapy development activities at its clients' sites due to stay-at-home orders and associated disruptions caused by COVID-19. Similar to our research models business, client demand improved meaningfully in June, and we continue to believe that beyond 2020, HemaCare will grow in excess of 30% annually as more clients start their cell therapy discovery programs at Charles River and remain with us through discovery, early stage development and the manufacturing support process. Today, we also announced a signing of an agreement to acquire Cellero for approximately $38 million, which will complement HemaCare by enhancing our supply of critical biomaterials including a wide range of human-derived primary cell types to further support discovery, development and manufacture of cell therapies. The acquisition will expand our access to high-quality human-derived cellular products with Cellero's donor sites in both the Eastern and Western United States. Cellero will enable us to provide a more comprehensive cell therapy solution, allowing clients to work with us through the cell therapy development and manufacturing process, which will accelerate their speed to market and enhance client retention. Following the acquisition of Cellero, we expect to continue to generate revenue growth for human-derived cellular products, including HemaCare, of at least 30% annually over the next five years, beginning in 2021. The transaction's expected to close in August. The RMS operating margin declined from 25.5% last year to 9.1% in the second quarter, driven almost exclusively by the impact of COVID-19. The segment operating margin benefited from the temporary cost reduction initiatives that we implemented, but due to the fixed cost nature of the business, these savings could not offset the sharp short-term decline in research model volumes. We believe the RMS operating margin will improve meaningfully in the third quarter as research model volumes continue to increase. DSA revenue was $442.6 million in the second quarter, a 6.2% increase in an organic basis over the second quarter of 2019. There was a much smaller impact from COVID-19-related study slippage and product project delays than we originally expected due to strong demand across the Discovery and Safety Assessment businesses, as well as our efforts to ensure both business and resource continuity. Biotechnology clients was a primary driver of DSA revenue growth, which is not surprising, given the capital available to fund scientific innovation and the industry's focus on finding a cure for COVID-19. The Discovery Services business had another excellent quarter of broad-based growth, particularly in Early Discovery and oncology services. In May, we commented on indications from a small number of discovery clients that they would slow the initiation of new programs because of COVID-19. There was only a very limited impact in the second quarter as we believe our integrated discovery portfolio, scientific expertise and track record for delivering clinical candidates encourage clients to move their programs forward by partnering with us to overcome challenges at their own sites. With continued strength in bookings, we do not foresee any change in the robust business environment for our Discovery Services in the second half of the year. Safety Assessment business performed well with sustained growth in study volume. As we mentioned at our investor conference in June, proposal activity and bookings continue to be strong throughout the second quarter. We believe both biotechnology clients and large biopharmaceutical companies are compensating for reduced on-site activities with increased outsourcing of their IND-enabling safety programs. We believe our integrated early stage portfolio spanning target identification through nonclinical development uniquely positions us to enable clients to work with one trusted partner to ensure business continuity amidst the challenges of the COVID-19 crisis. We believe this has and will continue to be will continue to translate into additional outsourcing opportunities as we collaborate with our clients to navigate today's challenges as well as those that arise in the future. Given the limited impact of COVID-19 today and our expectation that the robust outsourcing trends will persist in the second half of the year, we now expect DSA revenue to increase at a high single-digit rate in 2020, which is effectively the same as our original outlook before the spread of COVID-19. The DSA operating margin improved 210 basis points year-over-year in the second quarter to 23.2% with improvement in both Discovery and Safety Assessment businesses, greater operating leverage on the healthy revenue growth as well as the benefits of operating efficiencies drove improvement. Revenue for the manufacturing support segment was $123.5 million or an 8% increase on an organic basis over the second quarter of last year. The Biologics Testing Solutions and Avian businesses had excellent quarters. However, the revenue growth rate in the Microbial Solutions business was constrained by COVID-19. For the year, we continue to expect organic growth in the high single-digit range for the manufacturing segment. Microbial Solutions was affected by reduced client activity and delayed instrument installations in the quarter as certain client sites were inaccessible due to COVID-19. This was a challenge but one that we expect to overcome as more of these clients allow access to the sites and activity at these sites accelerates, which is already beginning to occur. In addition, we are serving our clients via remote instrument installations. As a result, we expect the Microbial Solutions growth rate will improve in the second half of the year. Overall, we continue to firmly believe that our ability to provide clients with a comprehensive, rapid and efficient microbial testing solution as well as the quality and accuracy of our testing platform are key differentiators from the competition, which will lead clients to continue to choose Charles River for their critical quality control testing requirements. The biologics business reported another exceptional quarter. Revenue growth was driven in part by the sustained rapid increase in the number of biologics in development, as well as new opportunities such as cell and gene therapies and COVID-19 therapeutics that continue to propel market growth. We believe the biologics market opportunity is expanding at a low double-digit rate annually, which is why we continue to modestly add capacity to accommodate demand. Revenue growth was also driven by our successful efforts to gain new business. Clients see the value of our extensive portfolio of services to support the safe manufacture of biologics, and we will continue to enhance our abilities to support clients by developing new services such as additional assays for cell and gene therapy. The Manufacturing segment's second quarter operating margin was 37.4%, a 650 basis point increase year-over-year. The significant improvement was related to enhanced operating efficiency in the Microbial Solutions business, primarily from process improvements and operating leverage from higher revenue in both the biologics and Avian businesses. In biologics, the elimination of duplicate costs related to last year's transition to our new Pennsylvania facility also drove the improved operating margin. The demand for our leading portfolio of early-stage and Manufacturing Support solutions remains robust. Biotech funding levels continue to increase and are expected to reach record levels again in 2020. And biotech IPO activity is accelerating. FDA drug approvals remain healthy. Fewer clients have delayed or canceled work due to COVID-19 than we anticipated just three months ago. Clients are essentially business-as-usual across most of the company as they emphasize investment in their preclinical pipelines to move their programs forward. We believe this underlying strength in our markets and the resilience of our business model have enabled us to withstand the challenges of the COVID-19 pandemic better than many other companies to date. Because of our strength and stability, we feel confident in our ability to move forward with the execution of our M&A strategy, albeit cautiously. Today's announcement of the Cellero acquisition is consistent with that strategy. It's imperative that we continue to expand our portfolio of essential products and services to enhance our ability to comprehensively support our clients' drug research efforts. Strategic acquisitions have always been our preferred use of capital. And after a pause in the second quarter, we are continuing to evaluate new opportunities using our disciplined and mindful approach. There continues to be an abundance of M&A candidates available, and we will evaluate a number of opportunities, including unique research tools, discovery capabilities and manufacturing support activities. We will also increasingly employ our strategic partnership strategy to stay current with new technologies and modalities and add innovative capabilities and cutting-edge technologies with limited upfront risk. We continue to closely monitor the risk that COVID-19 poses to human health as well as to our clients' operations and our own. The crisis is far from over globally, particularly in the U.S. and there will likely be a prolonged recovery until the world returns to some semblance of normalcy. But as I mentioned earlier, we will continue to assess the situation and be diligent about addressing any new challenges. We believe Charles River has weathered the challenges of the COVID-19 pandemic better than many other companies to date because of our clients' increased reliance on our outsourcing across a wide range of therapeutic areas, resilient biotech funding and as always, the efforts of our dedicated staff. As a result, we are confident in our ability to operate in the current environment and execute our strategy. We fully anticipate this new normal environment will be with us for the rest of the year and likely well into next year, if not beyond. But we believe the worst is behind us. Barring any widespread changes in the COVID-19 recovery, we believe that our two year financial targets of high single-digit organic revenue growth and a 20% operating margin in 2021 remain intact. Before I hand the call over to David, I'd like to update you on some of our social initiatives to support our people as well as the communities in which we operate. COVID-19 has affected us all, and it's our responsibility to be good corporate citizens and to lead by example. Our immediate priority was to address the needs of our employees and fully support them during these challenging times through initiatives like enhanced workplace safety measures where necessary, flexible work hours and scheduling and other forms of assistance as needed. Beyond the immediate COVID-19 priorities, we are firmly committed to the need for equality in our world. We will not stand for racism, inequality, discrimination or harassment of any kind at Charles River and are dedicated to supporting those values in our communities. It's more important than ever to support each other. We have a culture that celebrates and supports our differences. And we realized it's more important than ever to support each other in our communities through a posture of respect, listening, learning and empathy. At Charles River, this is our obligation and part of our core values. As part of our commitment, we launched a $2 million charitable donation campaign in the second quarter aimed at supporting our local communities through a range of initiatives and organizations that promote equality and social justice and support local food banks, first responders, youth and family organizations, STEM education and scientific causes. As a company and a corporate citizen, I want us to be able to reflect on this extraordinary period and be proud of our contribution to life-saving medicines, be proud of how we treated each other, and be proud of how we supported our communities. In conclusion, I'd like to thank our clients and shareholders for their support and once again, our employees for their commitment to our mission. Now I'll ask David to give you additional details on our second quarter results and updated 2020 guidance.