James C. Foster
Analyst · Jefferies
Good morning. I'd like to begin by providing a summary of our first quarter results before providing commentary on our business prospects. We reported sales of $286 million in the first quarter of 2012, unchanged from the same period in 2011. The RMS business delivered an exceptionally strong performance in the first quarter. As was the case in the fourth quarter of 2011, both businesses in the segment reported higher year-over-year sales on both a reported and constant currency basis, driving the best quarterly results since the end of 2008 and better than the fourth quarter. The majority of these businesses also reported higher operating margins. The PCS segment was moderately weaker than expected. Although the In-Life business was in line with our expectations, our Biopharmaceutical or BPS business performed significantly less well than expected. The operating margin declined 30 basis points from the first quarter of 2011 but improved 60 basis points sequentially to 17.7%. The increase was due primarily to the RMS margin, which improved on both a year-over-year and a sequential basis to 33.3%. Higher sales volume and process efficiency initiatives were the primary drivers of the improvement. Earnings per diluted share increased 14.8% in the first quarter of 2012 to $0.70 per share from $0.61 in the first quarter of 2011. The increase in earnings per share was driven primarily by the lower number of shares outstanding. We continued to return value to shareholders in the first quarter through our share repurchase plan with the purchase of approximately 348,000 shares for $12.5 million. We are reaffirming our sales and EPS guidance for 2012. Although we have yet to see sustained signs of improvement from our large biopharma client base, we believe that demand for regulated safety assessment continues to remain relatively stable. Furthermore, the growth drivers we discussed on our conference call, Discovery Research Services, GEMS, Insourcing Solutions and In Vitro, are enabling us to generate higher sales. Based on the first quarter sales increase, combined with our ongoing efforts to improve operating efficiency and the benefit of our stock repurchases, we maintain confidence in the guidance we gave on December 14. I'd like to provide some details on the segment performance. In the first quarter, the RMS segment delivered an outstanding performance, the best since 2008. Sales were $183.2 million, 6.5% higher in constant currency than the first quarter of 2011 and approximately 5% higher sequentially when adjusting for the 53rd week. The largest sales contribution came from our In Vitro business followed by our Discovery Research Services business. These are 2 of the businesses which we have identified as growth drivers in 2012. And with double-digit gains for both, they've surpassed our expectations. The In Vitro business delivered an outstanding performance in the first quarter. Sales growth exceeded 10% due primarily to the PTS family of products but also in part to timing. Though perhaps not as high as the first quarter rate, we expect this business to continue to deliver growth in the 10% range in 2012. As has been the case in the last few years, the PCS franchise, including the new multi-cartridge system or MCS, is performing extremely well. As biopharmaceutical companies focus more on efficiency and cost, and the PTS establishes a longer track record in the field, our clients are becoming more open to conversion to the PTS technology. The results are faster, and testing with the PTS requires fewer trained personnel to execute than the older methods do. With the advent of the MCS and the expected launch of the automated MCS at mid-year, we believe we will be able to increase the uptake in manufacturers' central labs and convert a larger portion of the test market to our product. We are the market leader in number of tests performed each year, but to date, have only converted about 10% of tests to the PTS family. We continue to work with clients to facilitate conversion and are very optimistic that the PTS franchise will continue to drive growth. As was the case in the fourth quarter, sales for our Research Model Services businesses, which include Discovery Research Services or DRS, GEMS, RADS and Insourcing Solutions or IS, again gained more than 9%. DRS contributed the fastest growth rate, benefiting both from the expanded preferred provider agreement we signed in the fourth quarter with a major global pharma company and the focus on oncology by many of our clients. We have one of the largest vivo pharmacology franchises in oncology, and because of our expertise, many of our clients choose to utilize our services rather than maintain or expand in-house infrastructure. As the volume of Research Models Services increased, the operating margin also improved, which was one of the drivers in the segment margin increase. Our clients, particularly large pharma, are focusing more attention on discovery in order to eliminate molecules earlier in the drug development process, advancing only the most promising through the pipeline. The growth of our Discovery Research Services is evidence of this trend and confirmation of our thesis that biopharmaceutical companies are increasingly choosing to outsource services which they no longer consider core to their drug discovery and development process. Utilizing our personnel and facilities enables our clients to create flexible drug discovery and development operational models, which are pivotal to their ability to increase efficiency and reduce costs. As a recognized expert in, in vivo biology, we believe we are able to support their efforts in a manner that no other CRO can. Sales of research models increased in the first quarter of 2012 compared to the first quarter of 2011 and were up significantly on a sequential basis. The sequential increase is not surprising given the seasonal softness in the fourth quarter. However, first quarter sales were better than we expected, with Europe and Japan driving growth. As you know, Europe has consistently performed well over the last few years. We continue to believe this is due to 2 factors: the client mix in Europe, which includes more private pharma and government-funded research, and the fact that we believe we are taking market share from our largest competitor. Japan also performed extremely well, in part because of the comparison to the first quarter of last year, which was affected by the earthquake, and in part because of volume increases and market share gains. North America was up slightly as a result of higher sales to mid-tier and academic clients. The RMS operating margin was 33.3% in the first quarter compared to 31.2% in the first quarter of 2011 and 28.8% in the fourth quarter of last year. We were very pleased with this result, which was driven by higher sales volume and the benefit of process efficiency initiatives. The table on Slide 13 summarizes the first quarter sales performance for the RMS segment compared to the first quarter of 2011. On a constant currency basis, research model sales increased 1.4% to $94 million, services increased 9.2% to $56.3 million, and other products increased 19.1% to $32.8 million. I will also point out that Discovery Services in total increased slightly less than 10% of total Charles River sales. About 1/3 of this amount is reflected in RMS and the other 2/3 in PCS. At $108.2 million, PCS sales in the first quarter declined 8.6% from the first quarter of 2011 and 7.6% in constant currency. As I mentioned, this was below our expectations due primarily to the BPS business. This business, which provides cell banking, process development, validation and manufacturing scale-up for biologics, is predominantly comprised of short-term projects with short lead times. We believe that the first quarter decline was due to clients starting off the year slowly as they prioritized projects and allocated new budgets, multiple project delays and low sample volumes related to certain preferred provider agreements. Because sales volume was very low, its impact on the PCS margin was significant. However, we expect the BPS business, which represents approximately 5% of total sales, to improve in the second quarter of 2012 due to the absence of some of the first quarter factors, as well as new business booked. When looking at the In-Life business, first quarter sales were consistent with the third and fourth quarters of 2011 when adjusted for the 53rd week and increased by approximately $1 million from the adjusted fourth quarter. Based on this performance and our outlook for 2012, we continue to believe that overall demand for our in-life services will remain stable, with the expected decline in regulated services partially offset by increasing demand for non-regulated services. The sales mix is still characterized by a greater proportion of shorter-term, non-regulated discovery services. This was expected given the shift in our clients' processes to eliminate molecules early in the drug development process, as well as the expanded preferred provider agreement. Interestingly, non-regulated studies are increasingly becoming more complex, as clients attempt to gain a better understanding of how their molecules perform sooner. The increase in non-regulated studies is visible in our capacity utilization, which improved in the first quarter. In addition, we have begun to see strengthening demand for reproductive toxicology. This is likely due to molecules which are advancing through the clinical trials and are at the stage where they require contemporaneous safety assessment work. The PCS operating margin declined to 8.9% in the first quarter. While clearly not the outcome we wanted, most of the year-over-year sequential decline was due to BPS, which reduced the first quarter margin by approximately 180 basis points. Furthermore, as we mentioned on our February call, the fourth quarter margin benefited from a non-income-based tax adjustment which represented approximately 160 basis points. When adjusting for both of these items, the fourth quarter margin would have been approximately 11.4% and the first quarter margin would have been approximately 10.7% or a decline of approximately 70 basis points. We attribute this decline to the transfer of protocols under the expanded preferred provider agreement. Much of the work which transferred in the fourth quarter went to facilities that had already been providing non-TLC services for the client and were staffed to do so. In the first quarter, the client began transferring more protocols to facilities that had not performed a significant volume of these services, necessitating more start-up costs. We expect these costs to moderate in the second quarter as revenue begins to increase. I'd like to give you a brief update on the status of the expanded preferred provider agreement we signed with a leading global pharma company for its DMPK and in vivo pharmacology work. We have been working collaboratively with the client at every step to ensure a smooth transition of the work. And both we and they are very pleased with our progress to date. As the client becomes increasingly comfortable with our capabilities, together we are identifying more opportunities to expand the services we can provide outside the parameters of the recently added work. As the relationship solidifies, we truly believe that the client is viewing its colleagues at Charles River as critical partners on the same side of the table, not us and them, but one seamless discovery and development team. We are continuing discussions with other large biopharmaceutical clients. We are confident that they are moving towards a shift to a more variable cost model through outsourcing. They recognize that outsourcing will enable them to access scientific expertise on a flexible basis and at a lower cost than they could by maintaining the infrastructure internally. As biopharmaceutical companies limit the number of providers with whom they do business, the opportunities for a top-tier partner like Charles River increase, and we are aggressively pursuing them. We believe that the expanded preferred provider agreement is the template that we can use to assist other clients in their efforts to improve the efficiency and cost-effectiveness of their drug development models. And senior management from our partner has served as a reference for Charles River. I want to take a moment to discuss sales by client type. As you know, we segment our clients into 3 categories: global biopharma, mid-tier biopharma, and together, academic and government. In the first quarter of 2012, we saw growth in the mid-tier and academic sectors, but sales to large biopharma companies declined. Let me start by discussing the large clients. We have seen a continuation of the trends which we have experienced for the last few years. Large biopharmaceutical companies have reduced therapeutic areas, leaned out their pipeline and changed their models to eliminate molecules earlier in the discovery process, investing only in those molecules with the greatest commercial potential. This has led to a significant reduction in the amount of work clients outsource, and in some cases, to retention of work in-house while they make decisions about capacity reduction. In the first quarter, as expected, we saw a continued stabilization in many of these clients. However, a small number continued to steadily reduce the amount of work they outsource. We believe this is a function of their pipeline and the stage of development. We did see some positive sales indicators for the global biopharma segment in the first quarter, including the award of some longer-term regulated studies in both North America and Europe. Consistent with the increased demand for reproductive toxicology, we believe these awards are indicators that some of our large biopharma clients are moving molecules through the clinical development process. The sales force realignment and related allocation of additional resources to the mid-tier and academic sectors is enabling us to enhance our visibility with clients and increase market share in both sectors. We were pleased that sales to our mid-tier biopharma clients increased approximately 5% year-over-year, and were up sequentially when adjusting for the 53rd week. Our focused sales efforts in the mid-tier are resulting in new business, and we intend to maintain our outreach to these clients, many of which are benefiting from funding by large pharma. Sales to the academic sector increased in the high single-digits year-over-year and in the low single-digits on a sequential basis. The powerful combination of our premium products and services at competitive prices has served us very well, particularly at this time when academic and government clients have been spending on basic research tools and services. We continued to believe that the rest of our integrated portfolio, our deep scientific expertise in, in vivo biology, rigorous management of our business, and intensive focus on our 4 key initiatives have enabled and will continue to enable us to manage our performance during this period when our clients are undergoing rapid and extensive change. As they change, it's incumbent upon us to do the same. Throughout this period, we are focused on improving our operational efficiency through the implementation of financial operations and scientific systems, all of which have increased our access to information and enhanced our ability to support our clients. We have added to our capabilities through internal development of new products and services, and hope to further expand our early-stage portfolio through strategic acquisitions. We have strengthened our balance sheet through management of capital and the early payment of debt, reducing our leverage to below 2.75x. We have returned value to shareholders through the cumulative repurchase of 18.5 million shares or 28% of the total outstanding shares when we began the program in August 2010. All of these actions have positioned us extremely well to provide clients with the support they need to achieve their goals of more efficient, cost-effective and productive drug development. At the same time, we believe our actions have positioned the company for profitable growth as demand for our broad portfolio of essential products and services strengthen. In conclusion, I would like to thank our employees for their exceptional work, commitment and resilience, and our shareholders for their support. Now I'll turn the call over to Tom Ackerman.