James Foster
Analyst · JP Morgan
Good morning. In the first quarter, we saw a continuation of the robust business trends that we experienced throughout the second half of last year. Organic revenue growth for each of the three segments was at/or above our long-term targets. We attribute this performance to the success of our ongoing efforts to enhance our position as the leading early-stage CRO as well as the strong industry fundamentals, including biotech funding. Overall, we believe our first quarter performance supports our solid outlook for the year. By continuing to invest in our portfolio, our people and our infrastructure, we believe we are maintaining and enhancing our leading position among early-stage CROs and our ability to support our clients' diverse research needs. The acquisition of Citoxlab, which was completed on April 29, is another step forward in our strategy and will enable us to deliver incremental value to clients. The success of our strategy was validated by the fact that we worked on 85% of the FDA-approved drugs in 2018 and have discovered 80 novel molecules for our clients. Before providing further details on our first quarter performance and the Citoxlab acquisition, I will briefly comment on the cybersecurity incident that we disclosed last week. On April 30, we notified clients of unauthorized access into portions of our information systems after recently determining that some client data was copied. This incident did not disrupt our day-to-day operations and was not a malware or ransomware attack. Further details on this incident can be found in our 8-K filing and on our website. We have reached out to affected clients, which represents approximately 1% of our total number of clients. The client response has been appropriately measured to date, yet most were understanding. I was struck by the collaborative nature of many of our client interactions. In several cases, the client offered to lend their own expertise or assistance in our remediation efforts, which we truly appreciate. Other clients have requested additional discussions with our teams, often scientist-to-scientist or CIO-to-CIO. We will continue to work closely with our clients to address their questions and concerns. While it's too early to determine whether there will be any revenue impact from this incident, we believe it would be minimal. In addition, the cost to fully remediate this matter are not expected to be material based on our preliminary estimates, and we believe that potential revenue and cost impact can be accommodated within our current guidance range for 2019. I will now provide highlights of our first quarter performance. We recorded revenue of $604.6 million in the first quarter of 2019, a 22.4% increase over last year. Organic revenue growth at 10.8% was broad-based across our portfolio and was above the 10% level for the third consecutive quarter. From a client perspective, biotech clients were their primary contributors to our first quarter revenue growth as they continue to benefit from a robust funding environment. The operating margin was 16.3%, a decrease of 50 basis points year-over-year. The decline was primarily driven by the RMS and Manufacturing segments, which I will provide further details on shortly, as well as the adjustment to our compensation structure that we implemented on July 1 of last year. Earnings per share were $1.40 in the first quarter, an increase of 8.5% from $1.29 in the first quarter of last year. Strong revenue growth was partially offset by the operating margin decline, resulting in earnings per share that were in line with our prior outlook. As a reminder, venture capital investment gains are now excluded from non-GAAP results in both periods as well as from future guidance. Based on the first quarter performance and our outlook for the remainder of the year, we are reaffirming our revenue growth and non-GAAP earnings per share guidance for 2019, including Citoxlab. We continue to expect robust organic revenue growth in a range of 8% to 9.5% and non-GAAP earnings per share of $6.40 to $6.55, including Citoxlab. This represents earnings per share year-over-year growth of 10% to 13% from $5.80 reported in 2018 when excluding venture-capital investment gains. I'd like to provide you with details on the first quarter segment performance, beginning with the DSA segment. Revenue was $354.2 million in the first quarter, an 11.2% increase on an organic basis over the first quarter of 2019, driven by broad-based demand for both Safety Assessment and Discovery Services. The Safety Assessment business continued to perform exceptionally well in the first quarter, highlighted by strong demand from biotech clients and increased pricing. Bookings and proposal activity also remained strong, reinforcing our outlook for high single-digit organic growth in the DSA segment for the year. Last week's acquisition of Citoxlab helps us extend our leadership position in the Safety Assessment market by enhancing our presence in Continental Europe and North America and by strengthening our existing capabilities in general and specialty toxicology, agrochemical and preclinical medical device testing and niche discovery services, including drug transporter and drug-drug interaction research. Our efforts to build our global scale and enhance our scientific capabilities through internal investments and the acquisitions of WIL, MPI and now Citoxlab have enabled us to become our clients' partner of choice for early-stage drug research. We are pleased to welcome the exceptional team at Citoxlab to Charles River family and look forward to working together to help our clients discover and develop new drugs for the patients who need them. Citoxlab's complementary service offering and geographic footprint are an excellent strategic fit and will enable us to enhance the support we can provide for our clients' early-stage research efforts. The addition of Citoxlab's talented staff, extensive scientific capabilities and client-centric approach solidifies our leading position in the outsourced safety assessment market at a time when we believe there is and will continue to be significant client demand for these outsourced services. We believe that the team at Citoxlab is enthusiastic about working with their Charles River colleagues. The collaboration of our respective scientific teams, the implementation of best practices and the synergies between the early-stage services offered by Charles River and Citoxlab will represent a significant growth opportunity for the combined organization. As we did with the MPI and WIL acquisitions, we had a comprehensive integration plan ready to implement on day 1. To ensure a smooth transition, we have assigned 2 senior operational leaders, 1 from Charles River and 1 from Citoxlab, to manage the integration in Europe and North America. Through our integration efforts, we expect to generate operational synergies of $8 million to $10 million within 2 years, which we believe will drive Citoxlab's operating margin above the 20% level from its current mid-teens operating margin. As we noted when we announced the acquisition, we expect Citoxlab will contribute $115 million to $130 million to our consolidated revenue and add approximately $0.15 to non-GAAP earnings per share in 2019. As our global safety assessment footprint has expanded, we are now at least 50% larger than the nearest competitor. It has become increasingly important that we ensure a seamless client experience across all of our sites and encourage clients who work across multiple sites. This offers clients access to much broader capabilities than they might have at a single site and reduces lead times to start studies. It also benefits from our operating efficiency through shared resources and optimized capacity utilization. We have and continue to work very hard to standardize and harmonize best practices and processes across our Safety Assessment network, and we intend to do the same with Citoxlab as the integration now begins in earnest. Our initiatives to enhance client mobility will also drive Discovery clients with integrated programs to work broadly with us across the entire early-stage spectrum and into Safety Assessment. The Discovery business had another good quarter led by strong demand for oncology and early discovery services. Our clients' ability to work with a single-source partner to support the discovery of their novel cancer therapeutics, coupled with a significant investment in this area of drug research, is driving demand for our oncology capabilities. Demand for our early discovery services also continues to improve as clients partner with us for a single project or for their larger integrated discovery programs. Our efforts to strengthen our portfolio by expanding our scale, our science and our innovative technologies continue to resonate with clients as they increasingly view Charles River as their scientific partner who can support their efforts to identify new drug targets and discovering novel therapeutics. As we did with our Safety Assessment business, we intend to continue to build our Discovery portfolio so that clients can outsource complex discovery projects to us rather than maintain or try to develop in-house capabilities. Our recent alliances with Distributed Bio to enhance our large molecule discovery capabilities and Atomwise to add artificial intelligence or AI drug discovery capabilities, are part of the expansion of our Discovery portfolio. The DSA operating margin was unchanged year-over-year at 18.6%. Leverage from the robust DSA revenue growth was primarily offset by the compensation structure adjustment. Similar to last year, we expect the DSA operating margin to rebound above the 20% level starting in the second quarter. RMS revenue was $137.2 million, an increase of 5.4% on an organic basis over the first quarter of '18. The primary drivers of RMS revenue growth continued to be strong revenue growth for Research Model Services and robust demand for research models in China. From a services perspective, the Insourcing Solutions contract with NIAID, which commenced last September, contributed slightly more than 300 basis points to the revenue increase. Aside from the benefits from the NIAID contract, the Insourcing Solutions business continued to perform very well as clients took advantage of our flexible solutions for their vivarium management and related research needs. We can support our clients through a variety of working arrangements, including providing staff and expertise to manage the vivarium at a client site, to provide a flexible vivarium space at a Charles River site supported by our staff. The latter option is our CRADL initiative, or Charles River Accelerator and Development Labs, which has become an increasingly popular solution to provide both small and large biopharmaceutical clients with turnkey research capacity in the Boston/Cambridge biohub. Utilizing CRADL allows clients to invest in the research programs instead of their infrastructure. Our GEMS business also continues to benefit from our clients' use of CRISPR and other technologies to create genetically modified models faster and more cost-effectively. Clients come to us because we have the expertise to help them derive and maintain their proprietary model colonies, which play an increasingly critical role as drug research becomes more complex with a shift to oncology, rare disease and cell and gene therapies. Excluding the NIAID contribution, RMS organic revenue growth was consistent with our long-term target in the low single digits. As we often point out, demand for our products and services is now linear, which was reflected in our first quarter performance of the research models businesses in North America, Europe and Japan. Similar to last year, research model sales to large biopharmaceutical clients started slowly. Large biopharma's ongoing efforts to reduce internal infrastructure and externalize research by outsourcing to CROs like Charles River and by partnering with biotech companies and academic institutions also contributed to softer demand from this client base. Not surprisingly, we saw an increase in demand for research models from both biotech and academia in the first quarter. In China, our research models business continued to grow at double-digit rates. China represents less than 10% of total RMS revenue but offers a significant opportunity for growth. We intend to continue to expand capacity in China to support robust client demand and drive future growth. In the first quarter, the RMS operating margin decreased 170 basis points to 28.1%. Most of the decline was driven by 3 known headwinds: the lower-margin NIAID contract, the compensation structure adjustment and the MPI intercompany sales, for which the revenue and profitability are now recognized in the DSA segment. The year-over-year effect of these factors will be anniversaried during the second half of the year. The remainder of the first quarter margin decline was primarily attributable to the lower sales volume for research models outside of China. A large bio -- as large biopharmaceutical clients continue to reduce internal infrastructure and the mix of the RMS business shifts toward services, it's vitally important that we remain focused on initiatives to enhance operating efficiency in order to sustain the RMS operating margin. In the first quarter, these efficiency initiatives included the decision to consolidate a small RMS site in Southern California by the end of this year and transition operations to an existing larger California site. Revenue for the Manufacturing Support segment was $113.2 million, a 17.2% increase on an organic basis over the first quarter last year. The increase was driven by double-digit revenue growth in both the Microbial Solutions and Biologics Testing Solutions businesses. Microbial Solutions had an excellent quarter. Our advantage as the only provider who can offer a comprehensive solution for rapid quality control testing continues to resonate with our clients, which was demonstrated by robust demand across our Endosafe testing systems and cartridges, core reagents, Accugenix microbial identification services and Celsis bioburden solutions. Sales of Celsis products benefited from a large stocking order from our strategic partner in certain nonpharma markets. Even adjusting for this order, Microbial Solutions growth was well above the 10% level. The Biologics business also reported strong growth in the first quarter. A number of biologic drugs in development as well as the efforts we made to position the Biologics business as a premier provider for these critical services have led to a rapid increase in demand for our services. To accommodate this demand, we are adding capacity. The new Pennsylvania facility, the largest of our Biologics expansion projects, continues to progress well, and the transition is expected to be completed by the end of the year. In order to ensure that the transition is seamless for our clients, we are operating 2 facilities as we transfer services to the new site. This is creating duplicate costs during the transition, however, these costs are expected to moderate over the course of the year. The Manufacturing segment's first quarter operating margin was 31%, a 90 basis point decrease year-over-year. The decline was primarily related to the ongoing capacity expansion in the Biologics business, which reduced the segment operating margin by 80 basis points. The first quarter margin in the Manufacturing segment is typically the lowest point of the year as a result of the seasonal impact of lower sample volume in the Biologics business after the holiday period. Our unwavering focus on our strategy has enabled us to enhance our position as the leading early-stage CRO. We have differentiated ourselves from the competition through our science, our broad early-stage portfolio and the flexible relationships that we can offer clients. With the acquisition of Citoxlab, we continued to expand our global scale and unique portfolio of essential products and services, which support the discovery and early development of new therapies for the treatment of disease. Acquisitions remain a vital component of our growth strategy as we endeavor to further enhance the scientific expertise, global scale or innovative technologies that we can offer clients across all 3 of our business segments. Investing in our scientific capabilities and in the necessary staff and resources will help us ensure that we can meet the needs of our clients and support our current and future growth. Investments that we continued to make have enhanced our position as a scientific partner of choice for pharmaceutical and biotechnology companies, academic institutions and government and nongovernmental organizations worldwide. The success of our efforts was evident in our first quarter financial performance and is further demonstrated by the fact that we remain confident in our outlook for the year of 8% to 9.5% organic revenue growth and a non-GAAP earnings per share of $6.40 to $6.55. In conclusion, I'd like to thank our clients and shareholders for their support and our employees for their continued exceptional work and commitment. Now David Smith will give you additional details on our first quarter results and 2019 guidance.