Jim Foster
Analyst · Barclays. Please go ahead
Good morning. I’m very pleased to speak with you today about the conclusion of an excellent year for Charles River and our expectations for 2019 and the continued expansion of our leading early-stage portfolio to support our long-term growth objectives. We are extremely pleased to report a second consecutive quarter with organic revenue growth about 10% and also to have achieved an operating margin consistent with our long-term target above 20% in the fourth quarter. As we previously mentioned, we believe that the pace of demand of our essential products and services accelerated during the second half of the year which positions us extremely well into 2019. We believe that our strong financial performance in 2018 was driven by two factors; robust industry fundamentals and the actions we’ve taken to enhance our position as the leading early-stage CRO. Let me begin with an overview of our industry. We continue to operate in a robust business environment that is showing no signs of slowing, which gives us excellent growth potential. Biotech funding remains strong. 2018 replaced 2017 as the second strongest year on record, with funding increasing 8% to $81 billion. The FDA approved 59 drugs in 2018, a record number and nearly tripled the approvals from a decade ago. Because of our unique early stage portfolio, extensive scientific expertise and client centered approach we worked on 85% of the approved drugs. We are proud that our pharmaceutical clients continue to choose to partner with us as they recognize the value that we provide. Even at this level of success, our addressable market of at least $15 billion provides a long runway for growth. In today’s robust business environment, we will continue to invest in our business both through internal initiatives, technology licensing deals and strategic acquisitions in order to enhance the scientific capabilities that we offer our clients. Before I discuss our performance and guidance, I’d like to share further details on our announcement in a separate press release this morning that we signed a binding offer to acquire Citoxlab for approximately $510 million subject to certain adjustments. We believe this proposed acquisition would further strengthen our business and enhance our ability to achieve our long term growth goals. The proposed transaction is subject to labor consultations and regulatory requirements, as discussed in more detail in the press release. Upon completion of the labor consultations, we expect the Citoxlab shareholders will enter into a definitive purchase agreement. With operations in Europe and North America, Citoxlab is a premier, non-clinical contract research organization, providing a broad suite of early stage services for biopharmaceutical, agriculture and industrial chemical, and medical device companies worldwide. Citoxlab would enhance Charles Rivers capabilities and regulated safety assessment, non-regulated discovery and medical device testing services. Like WIL and MPI, the proposed acquisition of Citoxlab would further strengthen our position as the leading global early stage CRL by expanding our scientific portfolio and geographic footprint, enhancing our ability to partner with clients across the drug discovery and development continuum, and also by driving profitable revenue growth in the immediate non-GAAP earnings per share accretion. Now let me give you the highlights of our fourth quarter and full year performance. We reported revenues of $601.5 million in the fourth quarter of 2018, an increase of 25.7% on a reported basis. Robust client demand across all three business segments drove organic revenue growth of 11.4%. The DSA and manufacturing segments continued to report low double-digit organic growth. The RMS segment’s organic growth rate improved to 8%, driven primarily by the contribution from our NIAID contract that commenced last September. For 2018, revenue was $2.27 billion with a reported growth rate of 22% and an organic growth rate of 8.7%. This is the highest annual organic growth rate that the company has achieved since 2007, which is a testament to the strength of client demand and in particular our focus on enhancing our position as a partner of choice for our clients early stage research and manufacturing support efforts, and further distinguishing ourselves from the competition. From a client perspective, biotech clients were our fastest growing client segment in both the quarter and the year. The operating margin was 28.3% in the fourth quarter, an increase of 60 basis points year-over-year. Margin improvement in the DSA segment drove the fourth quarter increase and we also benefited from leverage on corporate costs. We are very pleased that we are beginning to see the benefits of the investments we are making to accommodate client demand and build a more scalable infrastructure. From strategic hiring and employee engagement initiatives to the expansion of our capacity and scientific capabilities, we’ve worked diligently to make investments that will enable us to forge stronger relationships with our clients and create a more efficient operating model. Primarily as a result of his investments, the 2018 full year operating margin declined 50 basis points to 18.8%, however, we believe we are well-positioned to achieve modest operating margin improvement in 2019 and beyond. Earnings per share were $1.49 in the fourth quarter, an increase of 6.4% from $1.40 in the fourth quarter of last year. For the full year, earnings per share was $6 03, a 14.4% increase over the prior year. We exceeded our prior guidance range of $5.87 to $5.97 due primarily to a higher than expected revenue and operating margin improvement in the fourth quarter, as well as a lower tax rate. Consistent with our prior estimate, we recorded a $0.10 loss from our venture capital investments in the fourth quarter, and a $0.23 gain for the year. Adjusted to exclude Venture capital investment, earnings per share increased by 25.2% for the fourth quarter, and 16.2% for the year, including the contribution from MPI. We believe that our strong performance in 2018 thoroughly demonstrates what we worked very hard to achieve and continue to enhance the strongest portfolio that we’ve ever had with the ability to support clients from target discovery to non-clinical development, deep client relationships, and the successful execution of our strategy to position Charles River as the early stage research partner of choice. We are very enthusiastic about the outlook for 2019. As demonstrated by the strong finish to 2018, we believe the current business trends support our view that robust client demand will continue in 2019. We also believe that our investments to support growth and enhance our scientific capabilities, including the proposed acquisition of Citoxlab position us extremely well to capitalize on new business opportunities in 2019. Excluding Citoxlab, we expect organic revenue growth of 8% to 9.5% and non-GAAP earnings per share in a range of $6.25 to $6.40 or an increase of 8% to 10% year-over-year when adjusted for Venture capital investments. And when including Citoxlab, the non-GAAP earnings per share range is expected to increase to $6.40 to $6.55 a growth rate of 10% to 13% on the same adjusted basis. I’d like to provide you with additional details on our fourth quarter segment performance and our expectations for 2019, beginning with the DSA segment results. DSA revenue in the fourth quarter was $358.2 million, a 12.9% increase on our organic basis, driven by both the discovery and safety assessment businesses. For the full year, DSA organic growth was 10.4%. Client demand remained robust through the year end, positioning us extremely well for the start of this year and to achieve high single digit organic revenue growth in 2019. We believe that the higher DSA growth rate in 2018 and our outlook for 2019 shows their clients both large and small are increasingly choosing to partner with Charles River due to our science, our broad and early stage portfolio and our flexible relationships that enable clients to work with us for a study or project or an entire therapeutic program. Robust biotech funding continued to fuel demand from our biotech clients, and revenue to global biopharmaceutical clients also increased. Our safety assessment business continued to perform extremely well, capacity remained well utilized in 2018, study mix improved over the course of a year as we anticipated, and pricing increased. All of our in-life safety assessment facilities reported higher revenue for the year and MPI continued to exceed our expectation. Proposal volume, bookings and backlog also remained very strong through year-end, which gives us confidence that we are positioned for a strong start in 2019. The discovery business had another excellent quarter and a strong year. Our efforts over the past several years to build scientific expertise for the discovery of novel therapeutics to create targeted sales strategies and to harmonize the discovery portfolio have resonated with our clients. We are attracting new business ranging from single projects to larger integrated programs that encompass multiple businesses. Our outlook for 2019 is encouraging with an expectation for broad based demand for our suite of early discovery, oncology CNS and bio-analytical services. To achieve our goals in 2019 and beyond, we will continue to strengthen our portfolio, by expanding our scale, our science and our innovative technologies. We plan to accomplish this through acquisitions like Brains On-Line in 2017 and KWS BioTest in 2018 last year, and also through alliances to add cutting edge technologies to our discovery toolkit. We believe these initiatives will help to accelerate our client’s drug discovery programs and further differentiate ourselves from the competition. Recently, we added through two alliances. In October, we entered into an exclusive partnership with Distributed Bio to enhance our large molecule discovery capabilities. And last month, we formed a strategic alliance with Atomwise to add artificial intelligence or AI drug discovery capabilities. AI is a cutting-edge, emerging tool and discovery that allows scientists to quickly screen compounds and predict whether a small molecule will bind to a target protein of interest. We also opened the largest site in the South San Francisco biohub at the beginning of this year. This site offers a range of discovery capabilities, enabling us to generate new West Coast business opportunities by providing clinical services proximate to the fast-growing biotech client base. Whether through acquisition, internal investment or alliance, we intend to continue to enhance our position as the premier, single-source provider for a broad portfolio of discovery services. The DSA operating margin was 23.2% for the fourth quarter, 140 basis points above the fourth quarter of 2017. The increase was driven by both the discovery and safety assessment businesses reflecting the benefit of robust topline growth and the normalization of the safety assessment study mix over the course of the year as we had anticipated. We also believe, we have enhanced the scalability of our DSA business with well-thought-out investments in staffing and capacity, and by focusing on our organizational speed and responsiveness. As a result of these investments, we believe that the DSA segment will be the primary driver of the expected modest margin improvement for the company in 2019. For 2018, the DSA operating margin declined 40 basis points to 21.7% primarily reflecting the 30 basis point headwind from our compensation structure adjustment last year, to enhance employee recruitment and retention. We believe, we are well-positioned exceptionally well to provide the support, which our clients require to expedite the drug research efforts, by focusing on expanding our global scale and enhancing our scientific expertise through acquisitions like WIL, MPI, Brains On-Line, KWS BioTest, and Citoxlab in a few months, or strategic alliances like Distributed Bio and Atomwise and by improving our operating efficiency and by providing a more seamless and flexible client experience, we have created a unique, nimble, early stage CRO that can meet our clients extensive needs. This is especially important now on global biopharma companies are increasingly reliant on CRO and small and mid-sized biotech companies, which have always relied on external resources are benefiting from a robust funding environment. In our view, it will continue to be a significant demand for outsourced services for both biotech and pharma companies, and we intend to maintain and expand our position as their partner of choice. For that reason, we are very pleased to express our intent to acquire Citoxlabs at this time. Citoxlab is a strong, strategic fit with both a complementary service offering and geographic footprint. Citoxlab provides a bright suite of early stage services, that would expand our existing capabilities in general and specialties tox, including reproductive toxicology and ocular services as well as ecotoxicology. The proposed acquisition would also double our revenue for preclinical medical device testing services, which has an addressable market opportunity approaching $1 billion. I would also, it would also add Non-GLP discovery solutions, ranging from traditional DMPK to innovative drug transporter and drug-to-drug interaction research and genomics research services. In addition to its strong scientific capabilities Citoxlab would enhance our presence in Europe, particularly in Eastern Europe. The company has nine operating sites in six countries generating approximately 60% of revenue from its European operations and the remainder from North America. Citoxlab has a diverse client base of biopharmaceutical, agriculture and industrial chemical and medical device companies worldwide. Specifically, the proposed acquisition would further expand our small and mid-sized biotechnology client base, which is our fastest growing client segment. From a financial perspective, the proposed acquisition would also deliver compelling benefits, which would generate value for shareholders in which we consider fundamental to any acquisition we do. Citoxlab would be immediately accretive to non-GAAP EPS and would meet or exceed our ROIC hurdle rate within three to four years, and it would enhance our opportunities for organic growth. Following the completion of the Labor consultation and subject to entry into the definitive purchase agreement, as well as regulatory approval and customary closing conditions, we expect to close the acquisition in the second quarter of 2019, but slightly later than MPI or WIL, which closed early in April. On that basis, the acquisition is expected to contribute $115 million to $130 million to our consolidated revenue, and add approximately $0.15 to non-GAAP earnings per share in 2019. We expect greater benefits in 2020, with Citoxlab contributing approximately $200 million to consolidated revenue and non-GAAP earnings per share accretion of at least $0.35. Consistent with the long term target for our DSA segment, Citoxlab is expected to grow at high single digit rate organically as it has recently. As we did with MPI and WIL acquisitions, we will be ready to implement a comprehensive integration on day one. We have appointed two senior operational leaders to manage the integration in North -- in Europe and North America respectively to help ensure a smooth transition. Citoxlab would further solidify our leading position in the $4 billion to $5 billion outsourced safety assessment market, and our business would have the scientific expertise in global scale that was our goal when we entered the market in 1999. Following the proposed Citoxlab acquisition, we believe our safety assessment portfolio would have the ability to fully support our long term organic growth aspirations for this business. As a result, we expect future M&A within the safety assessment business to be centered around niche players, with specific expertise rather than scale. M&A remains a top priority of our growth strategy, and while smaller acquisitions will be evaluated in 2019, we will use this year to primarily focus on the integration of Citoxlab and repaying debt. Over the longer term, we intend to remain acquisitive to enhance the scientific capabilities and scale of our other businesses. Upon closing of the proposed Citoxlab transaction, we will have invested over $2.5 billion in acquisitions, since 2012 which have collectively achieved returns that exceeded our cost of capital to-date. The largest of these WIL and MPI have performed exceptionally well as part of the Charles River family, and we believe that Citoxlab will be no different. The success of our M&A strategy and integration planning is a result of an excellent team, which includes representatives from operations, corporate support functions, senior management and our Corporate Development Group, which provides direction and dedicated integration resources. Joe LaPlume has led our Corporate Development team since 2011 and his oversight has elevated our acquisition planning and execution. I’m pleased to announce that Joe was recently promoted to Executive Vice President of Corporate Development & Strategy in recognition of his outstanding leadership. RMS revenue in the fourth quarter was $128.5 million, an increase of 8.1% on our organic basis. The Insourcing Solutions contract with NIAID, which commenced in September, contributed slightly more than 300 basis points of the increase. As mentioned in November, the profitability of these staffing contracts is typically significantly lower than our RMS segment’s operating margin. The NIAID contract was the primary reason that the RMS non-GAAP operating margin decreased by 80 basis points to 25.1% in the fourth quarter. Adjusting for the NIAID impact and headwinds from the compensation structure adjustment, the RMS operating margin would have increased slightly in the fourth quarter. Excluding the NIAID contribution, RMS organic revenue growth was similar to the third quarter level. For the year, RMS organic revenue growth was 3.7%. Growth for both the quarter and the year driven by demand for research models in China and higher revenue for the GEMS and Insourcing Solutions businesses. Looking ahead, we continue to believe that the RMS segment will grow in line with its long-term target in the low-single digits but the benefit from the NIAID contract is expected to push RMS growth to mid-single digit rate in 2019. Our business in China reported another year of double-digit revenue growth, an accomplishment that – it has maintained annually since the business was acquired in 2013. In China, we continue to add capacity in Shanghai to support the robust market demand and win new business in this important geographic region. To support our expected future growth, we intend to continue to invest in Beijing and Shanghai and expand into other large research hubs in the country. The services businesses also continue to be a source of growth. GEMS is benefiting from our clients’ use of CRISPR and other technologies to create genetically modified models faster and more cost effectively as these complex research models provide scientists with targeted data in their research. Aside from the NIAID contract, the Insourcing Solutions business also performed well, because of client interest in our flexible solutions to address their vivarium management and related research needs. I’d also like to note that the U.S. government shutdown did not have any impact on our business as most of our contracts are for essential services The manufacturing support segment finished another strong year with a superb fourth quarter performance. Revenue for the quarter was $114.9 million with growth of 11.4% on an organic basis, driven by the Microbial Solutions and Biologics businesses, the organic revenue growth for the year was 10.9% to support our expectation that low-double-digit growth will continue over the longer term we continue to invest in these businesses and expand our product and service offerings. As it has throughout the year, our Microbial Solutions business reported strong revenue growth. Growth was driven primarily by demand for our Endosafe testing systems and cartridges and Accugenix microbial identification services. We believe that our ability to provide clients with a total microbial testing solution will be a fundamental driver of Microbial Solutions’ ability to continue to deliver low-double-digit organic revenue growth. There is an abundance of new opportunities to support growth by converting clients to our efficient testing platform and driving greater adoption with existing clients. We are continuing to invest in the Microbial Solutions business to advance its product and service offerings, technological interface, and footprint. The Biologics business also reported strong revenue growth in the fourth quarter and for the full year. The increasing number of biologics in development represents a significant market opportunity for our Biologics business and we have been successful at gaining business because of our extensive portfolio of services to support the manufacture of biologics. We are continuing to invest in capacity expansions to accommodate robust client demand and believe that this is essential to achieving our goal for low-double-digit revenue growth over the longer term. We continue to make progress with our plans to open a new facility in Pennsylvania, as well as other smaller expansions globally. The construction of Pennsylvania facility is complete and we expect to begin generating revenue in the second half of this year as we transition operations to the new site. We are incurring redundant costs during this transition, which is expected to pressure the manufacturing segment’s operating margin until the transition to the new facility is complete. Due to the leverage from strong revenue growth, the manufacturing support segments’ operating margin was 37.4% in the fourth quarter compared to the prior year the operating margin declined by 20 basis points in the quarter, and by 130 basis points to 34.2% for the full year effectively in line with our long-term target in the mid-30% range despite costs associated with capacity expansions. As I said earlier, we are operating in a robust business environment with excellent growth potential to continue to successfully execute a strategy to position Charles River as our leading early-stage CRO it's essential that we continue to make investments in our scientific capabilities through both M&A and internal development, expand capacity at staff and exploit our digital enterprise to provide critical data for both internal and client use. We will do so mindfully promoting a more efficient and scalable organization that focuses on speed and responsiveness as we meet our client's individual needs, with the goal to reduce the development timeline by an additional year. By focusing intently on our strategy, we have become a trusted scientific partner for pharmaceutical and biotechnology companies, academic institutions and government and non-governmental organization worldwide. We have demonstrated the value we can provide to client and believe that this has and will continue to enable us to deliver greater value to shareholders. In conclusion, I’d like to thank our employees for their exceptional work and commitment and our shareholders for their support. Now, I’d like David Smith to give you additional details on our financial performance and 2019 guidance.