Susan E. Hardy - Charles River Laboratories International, Inc. James C. Foster - Charles River Laboratories International, Inc. David R. Smith - Charles River Laboratories International, Inc..

Ross Muken - Evercore Group LLC Jack Meehan - Barclays Capital, Inc. Robert Patrick Jones - Goldman Sachs & Co. Michael Ryskin - Bank of America Merrill Lynch Eric W. Coldwell - Robert W. Baird & Co., Inc. David Howard Windley - Jefferies LLC Greg Bolan - Avondale Partners LLC Steven Reiman - JPMorgan Securities LLC Mark Rosenblum - Morgan Stanley & Co.

LLC Erin Wright - Credit Suisse Securities (USA) LLC George R. Hill - Deutsche Bank Securities, Inc. Jon Kaufman - William Blair & Co. LLC Garen Sarafian - Citigroup Global Markets, Inc..

Ladies and gentlemen, thank you for standing by. Welcome to the Charles River Laboratories Fourth Quarter Earnings and 2017 Guidance Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will be given at that time. As a reminder, this conference is being recorded.

I'd now like to turn the conference over to Susan Hardy, Corporate Vice President of Investor Relations. Please go ahead..

Thank you. Good morning, and welcome to Charles River Laboratories' fourth quarter 2016 earnings and 2017 guidance conference call and webcast.

This morning, Jim Foster, Chairman, President and Chief Executive Officer; and David Smith, Executive Vice President and Chief Financial Officer, will comment on our fourth quarter and full-year results and guidance for 2017. Following the presentation, they will respond to questions.

There is a slide presentation associated with today's remarks, which is posted on the Investor Relations section of our website at ir.criver.com. A replay of this call will be available beginning at noon today and can be accessed by calling 800-475-6701. The international access number is 320-365-3844. The access code in either case is 416045.

The replay will be available through February 28. You may also access an archived version of the webcast on our Investor Relations website. I'd like to remind you of our Safe Harbor.

Any remarks that we may make about future expectations, plans and prospects for the company constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by any forward-looking statements as a result of various important factors, including but not limited to those discussed in our Annual Report on Form 10-K, which was filed on February 12, 2016, as well as other filings we make with the Securities and Exchange Commission.

During this call, we will be primarily discussing results from continuing operations and non-GAAP financial measures.

We believe that these non-GAAP financial measures help investors to gain a meaningful understanding of our core operating results and future prospects, consistent with the manner in which management measures and forecasts the company's performance.

The non-GAAP financial measures are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP.

In accordance with Regulation G, you can find the comparable GAAP measures and reconciliations to those GAAP measures on the Investor Relations section of our website through the Financial Information link. I'll now turn the call over to Jim Foster..

Good morning. I'm very pleased to say that 2016 was an important year for Charles River's strategic growth. Investments we've made enhanced our position as a trusted scientific partner by pharmaceutical and biotechnology companies, academic institutions and government and non-governmental organizations worldwide.

With the acquisitions of the WIL Research, Blue Stream and Agilux, we continue to expand our unique portfolio of central products and services, which support the discovery and early development to new therapies for the treatment of disease. We made significant progress on our efficiency initiatives, exceeding the targets we set.

We continued to invest in our scientific capabilities, and in the necessary staff to ensure that we could meet the needs of our clients and support our future growth.

The success of our efforts was evident not only in our outstanding financial performance, but also in the fact that we worked on approximately 70% of the drugs approved by the FDA in 2016, a significant increase from 55% for the previous two years.

That is an accomplishment few CROs can claim, and we believe is a testament to the value that many of our clients place on our contributions to their research efforts. Let me give you highlights on our fourth quarter and full-year performance. We reported revenue of $466.8 million in the fourth quarter of 2016, a 31.9% increase.

Organic growth was 8.3%, with all our businesses except Early Discovery contributing, and we continued to make progress on our plan to improve the Early Discovery performance.

Each of our client segments, Global Accounts, Biotech and Other, and Academic and Government, generated higher revenue with biotechnology clients again contributing a double-digit increase. The operating margin was 19.2%, a decrease of 150 basis points year-over-year.

However, you should recall that the fourth quarter of 2015 included a one-time benefit from the Quebec tax change. When adjusting for that benefit, there's only a 50-basis-point decline, which was due primarily to higher corporate costs. We were very pleased with the margin improvement in the RMS and Manufacturing segments and with the DSA margin.

Although the DSA margin declined year-over-year, it exceeded our long-term target as a result of higher revenue and efficiency initiatives. Earnings per share were $1.21 in the fourth quarter, an increase of 21% from $1 in the fourth quarter of 2015.

The improvement was due primarily to higher revenue and operating income, in part as a result of the WIL acquisition. In 2016, revenue was $1.68 billion, a reported growth rate of 23.3%, and an organic growth rate of 7.7%, in the range of our long-term high-single-digit target.

The operating margin was 19.2%, only 20 basis points below 2015, but a 10-basis-point improvement when adjusting for the Quebec tax change in 2015. Earnings per share were $4.56, a 21.3% increase over the prior year.

When adjusting for gains on our venture capital investments, which were $0.13 in 2016 compared to $0.05 in 2015, the earnings per share growth rate was just slightly lower at 19.4%.

We believe that our strong performance in 2016 thoroughly demonstrates that we've worked very hard to achieve the strongest portfolio that we've ever had, with the ability to support clients from target discovery through 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 2017. Demand for our products and services is robust, and we continue to gain market share, which supports our expectation for organic growth in a range from 7% to 8.5%.

Non-GAAP earnings per share are expected to be in a range from $5 to $5.10, which represents an increase of nearly 11% at the midpoint and meets our goal of earnings growth at a higher rate than revenue growth.

You should bear in mind that our guidance includes a gain of $0.04 from venture capital investments, which is $0.09 less than the gain included in 2016 earnings per share. And foreign exchange is another $0.10 headwind for 2017 earnings.

As we announced in our earnings release this morning, we divested our CDMO business worth $75 million on February 10. The CDMO business was not optimized within our portfolio at its current scale, so we were very pleased to place this high quality business in a more synergistic parent.

We plan to redeploy the capital in our long-term growth priorities – opportunities. For 2017, the divestiture reduces reported revenue growth by approximately 1% as a minimal effect an organic revenue growth and a negligible effect on non-GAAP earnings per share.

I'd like to provide you with the details on the fourth quarter segment performance, beginning with the RMS segment. Revenue was $124.7 million, an increase of 5.7% on an organic basis. This was a very strong performance, driven both by sales of research models and research model services. Sales of models in the U.S. and China were robust.

In both regions, we continued to see increased demand for inbred research models, which we believe are the models of choice for translational research. And we also gained market share in the U.S. and China as clients made the decision that at a comparable price, Charles River provides a superior product and better service and support.

In Research Model Services, both the GEMS and RADS businesses delivered strong performances. We offer clients the ability to outsource services to a strong scientific partner, which is a more flexible and cost-efficient alternative than maintaining capabilities in-house.

Revenue growth was driven by new contracts, extensions of existing contracts, and for RADS, in part by special projects, which we do not expect to reoccur in 2017.

In the fourth quarter, the RMS operating margin increased by 190 basis points to 27.3%, with leverage from higher revenue and the benefit of systems-related efficiency initiatives driving the improvement.

We continue to identify opportunities to streamline our RMS operations, particularly through the automation of manual processes and the implementation of systems to improve data availability and accuracy. As a result, we maintain our belief that an annual RMS operating margin in the high-20% range is sustainable.

The Manufacturing Support segment finished a very strong year with an outstanding fourth quarter performance. Revenue was $100.3 million, representing growth of 12.9% on an organic basis, driven by the Microbial Solutions and Biologics businesses.

Microbial Solutions was the primary driver of the increase, reporting revenue growth in the mid-teens on an organic basis. Our continuous product innovation has expanded the applications for the PTS, whether as a result of higher throughput from the MCS and Nexus or improved connectivity from the nexgen.

Client conversion to our rapid endotoxin testing systems in 2016 drove higher cartridge sales, which was primarily evident in the fourth quarter. When I spoke to you last February, I said that execution of our sales strategies for both the sterile and non-sterile markets would be a key component of revenue growth in 2016.

The sales organization was extensively trained on selling the broader Microbial Solutions portfolio, and I'm pleased to say that in 2016, our targeted sales strategies did generate synergies.

The advantages of using both an endotoxin and bioburden testing system from the same provider who also offers microbial identification are resonating with clients.

We are optimistic that our ability to provide a total microbial testing solution to our clients will be a driver of our goal for Microbial Solutions to continue to deliver at least low double-digit organic revenue growth for the foreseeable future.

The Biologics business reported another very strong performance in the fourth quarter, delivering robust revenue growth.

Our continued investment in expanding our Biologics portfolio, most recently with the acquisition of Blue Stream, has enabled us to provide a comprehensive portfolio of both bioanalytical and biosafety testing services, with the ability to support biologic and biosimilar development from discovery through clinical phases and commercial manufacturing.

This has increased the value proposition for our clients. And as demand for our services grows, we have added capacity, especially in the U.S. We believe that the services our Biologics business provides are particularly important now, when the number of biologic drugs in development is increasing.

Our goal is to be well-positioned to capitalize on this expanding opportunity, which we believe will support our growth in the coming years. The Manufacturing segment's fourth quarter operating margin was 34.2%, a 40-basis-point increase over the prior year.

The improvement was driven primarily by the Microbial Solutions business, which benefited both from increased volume and efficiency initiatives. DSA revenue in the fourth quarter was $241.7 million, a 7.9% increase on an organic basis.

The legacy Safety Assessment business was the primary growth driver, reporting a low double-digit revenue increase over the fourth quarter of 2015. As expected, studies had been delayed from the third quarter to the fourth quarter, and those were initiated, and demand for our Safety Assessment services was robust.

We continued to attract new business on the basis of our strong portfolio, scientific expertise and flexible and customized working relationships, all of which were strengthened by the acquisition of WIL last April.

During the integration process, we have focused on leveraging the best practices of both Charles River and WIL, which has enhanced our ability to support our clients' goal of improved efficiency and effectiveness of their early-stage drug research efforts. Occupancy continued at near optimal levels.

And as we have done for the last three years, we plan to open an appropriate number of study rooms in 2017 in order to accommodate the persistent demand. The Discovery Services business performed better than our expectations in the fourth quarter, including Agilux, which also exceeded our expectations.

Although organic revenue was still below last year as a result of the Early Discovery business, we believe that the realignment of our sales strategies will enable us to generate growth over time, as the Early Discovery outsourcing market evolves. The Discovery business is a small, but extremely strategic one.

Having Discovery capabilities enables us to engage with clients early in the research process and continue to move downstream with them through non-clinical development. DSA margin was 23.8% in the fourth quarter of 2016, a decline of 330 basis points year-over-year.

However, as I noted earlier, the fourth quarter of 2015 included a significant benefit from the Quebec tax change. When adjusting for that benefit, the margin in the fourth quarter of 2015 would have been approximately 24.8%.

The 100-basis-point year-over-year decline was primarily due to the fact that WIL's operating margin was below the segment average. We did make very good progress on WIL synergies this year, achieving an operating margin above 20% in the fourth quarter.

I remind you that our margin progress may not be linear, but WIL's fourth quarter performance supports our expectation that WIL's operating margin will be consistently at or above 20% by the end of 2017.

As we continue to broaden our unique portfolio and enhance our scientific expertise, we are enhancing the value we can provide in support of our clients' early-stage drug research efforts.

This was demonstrated in 2016 by the fact that each of our client segments, Global Accounts, Biotech and Other, and Academic and Government contributed to our revenue growth.

As has been the case in recent years, the most significant contribution came from our Biotech and Other segment, which in addition to virtual, small and mid-sized biotech companies, includes small pharmaceutical, agricultural, chemical and veterinary medicine companies as well as CROs.

This client segment represents approximately 50% of our revenue, with biotech companies accounting for approximately 60% of that percentage. It's not surprising that biotech companies were the primary driver of our revenue growth in the fourth quarter and for the full year.

A significant number of new therapies, which are being discovered, are coming from biotech. And because of the potential cure for disease that these therapies represent, biotechs have support from large biopharma, venture capital funds, and the capital markets.

We've spoken previously about our belief that biotechs have at least three years to cash on hand, which was likely reinforced by funding from all three sources in 2016. Funding for biotechs from the capital markets was $86 billion in 2016, second only to the record-breaking $109 billion in 2015.

Furthermore, most biotech companies do not invest in infrastructure, preferring a more flexible and cost-efficient structure, which enables them to move drugs through the pipeline more effectively.

Many of these clients prefer to work with Charles River because of the breadth of our portfolio, which enables them to work with one partner across the early-stage drug research process and also because of our focus on scientific expertise.

Clients, particularly those with limited in-house infrastructure, want a strong scientific partner who can assist them in making the critical go and no-go decisions as to which drugs have the greatest potential and should progress through the development pipeline.

The acquisitions we made in 2015 and 2016, particularly WIL, with its predominantly small to mid-sized biotech client base, effectively diversified our client concentration. As a result, we now have no single client that accounts for more than 3% of our revenue compared to 5% in previous years.

Offering our unique portfolio, world-class scientific expertise, and best-in-class client service at an effective price has been the cornerstone of our value proposition for clients and is clearly resonated with them. Our organic growth rate was 7.7% in 2016, and the range for 2017 is 7% to 8.5%.

As our clients increase their use of outsourcing and choose to partner with Charles River, we want to ensure that we can meet their current needs and anticipate their future requirements. Clients continually tell us that our staff's commitment to exceptional client service and our scientific expertise are what differentiate us as a partner of choice.

Given our rapid growth over the last few years and our expectation for its continuation, our ongoing efforts to identify and hire the best scientific and operational personnel are a key priority in order to maintain and enhance our position as the CRO of choice.

We need to ensure that our management team is strong and we are appropriately staffed and that all staff are extraordinarily well trained to deliver the exceptional service for which Charles River is known and respected. This is a critical component of the effective execution of our business strategy and the foundation of our future growth.

We intend to continue to assess opportunities to broaden our early-stage portfolio with strategic acquisitions and in-house development, to increase our scientific capabilities and therapeutic area expertise, and to invest in efficiency and productivity initiatives.

By leveraging the investments we have made, and new ones we intend to make, we will continue to differentiate Charles River as the CRO partner of choice for early-stage drug research. We are very enthusiastic about the opportunities available to us in 2017 and are working harder to capitalize on them.

All of our efforts to date have been focused on positioning Charles River as the premier early-stage contract research organization with a unique portfolio and the scientific expertise to partner with all types of clients.

Global biopharma companies, which are increasingly making a more significant commitment to outsourcing as they strive to improve operating efficiency and then increase pipeline productivity. Biotech companies and non-governmental organizations, which have always preferred outsourcing to building infrastructure.

And academic institutions, which are working with biopharma to monetize innovation and require partners to provide expertise in drug discovery and development. We believe that our clients are searching for the right partners to support them by taking on a broader role within their organizations, and Charles River intends to be that partner.

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 2017 guidance..

Acquisitions are expected to add 5% to 6% to revenue growth, primarily driven by the revenue contribution from WIL in the first quarter. The divestiture of the CDMO business is expected to reduce reported revenue growth by approximately 1%. Foreign exchange is expected to reduce revenue growth by approximately 2% to 2.5%.

I will discuss foreign exchange in greater detail shortly, including the impact of the earnings per share. And the 53rd week, which was required in 2016 to align with the December 31 calendar year-end, will reduce reported revenue growth by approximately 1.5%.

From a segment perspective, the 2017 organic revenue growth drivers in each of our business segments are also expected to be very similar to those last year. RMS growth should continue to be driven by the services business as well as robust demand for research models in China, resulting in organic growth in the low- to mid-single digits.

We expect the DSA segment to deliver low-double digit organic growth, reflecting a continuation of strong client demand from Safety Assessment and In Vivo Discovery businesses. The Manufacturing segment is expected to generate organic growth of approximately 10%, driven by both the Microbial Solutions and Biologics businesses.

We expect realized price increases to contribute approximately 3% to consolidated revenue growth in 2017 with the increases from most of our businesses to be relatively similar to last year. On a reported basis, revenue for the RMS segments is expected to decline slightly, primarily due to the headwinds from the 53rd week and foreign exchange.

The DSA segment is expected to be in the mid- to high-teens, reflecting the contribution from the 2016 acquisitions of WIL and Agilux. And Manufacturing segment is expected to be in the low- to mid-single digits, primarily due to the impact of the CDMO divestiture.

In addition to revenue growth, we expect operating margin expansion to be a meaningful driver to earnings growth this year. We are anticipating the 2017 non-GAAP operating margin to be at or near our long-term target of greater than 20%.

This represents an increase of up to 100 basis points, driven by margin improvement in each of our three segments and corporate expenses, which will moderate as a percentage of revenue.

Margin expansion will be driven by leverage from higher sales volume and our efficiency initiatives, including continued progress on the acquisition synergies related to WIL.

Over time, our efficiency program has become more sophisticated, evolving from pure cost reduction to improving processes, to leveraging IT and automation, and to optimizing capacity to generate savings. Both the realized benefits in 2016 and our expectations for 2017 exceed the outlook that we provided at our Investor Day last August.

We achieved incremental savings of approximately $54 million in 2016, a significant step up from $38 million in 2015 due to expanding the scope of the program and because of the synergies from the WIL acquisition.

This year, we expect to generate a benefit of at least $55 million through projects focused on many of the same areas – processes, automation and utilization, but we also continue to enhance the program to encompass new areas, such as our customer-facing strategies and employee retention.

Unallocated corporate expenses in 2016 were higher than our November outlook, primarily because of the fourth quarter increase in performance-based compensation costs related to our financial outperformance in 2016.

Corporate costs will moderate from 7.5% of revenue in 2016 to approximately 7% of revenue in 2017, which will contribute to the operating margin improvement. We intend to continue to make investments in our people, processes and systems, which will generate efficiency and productivity benefits.

As mentioned, we are pleased with this year's low-double digit earnings growth outlook, particularly because we are offsetting some fairly significant headwinds this year, the largest of which are foreign exchange and venture capital investments. We also expect interest expense to increase in 2017, due in part to the rising interest rate environment.

Adjusting for these items, earnings per share growth rate would meaningfully exceed revenue growth in 2017, which is consistent with our long-term financial target.

Foreign exchange has become a more significant headwind for 2017 as a result of the weakening of most foreign currencies towards the end of last year, especially the British pound following the Brexit vote. Foreign currency translation is expected to reduce reported revenue growth by 2% to 2.5% and earnings per share by approximately $0.10.

Our foreign currency exposure in the UK and Canada will somewhat mitigate the negative impact of earnings per share, but we still expect a meaningful headwind this year. You may recall that in the UK and Canada, we invoiced less than half of our revenue in the local currency, but incur nearly all of our costs in that currency.

We have provided an updated revenue breakdown by currency for 2016 on slide 39 in our presentation. Consistent with our guidance in recent years, we have forecast venture capital investment gains of $0.04 in 2017, which is the expected return on invested capital that we believe we should generate on these investments.

However, this represents a $0.09 headwind to 2017 earnings per share when compared to the $0.13 of investment gains realized last year.

We remain pleased with our two-pronged strategy for our venture capital investments, which is to generate attractive investment returns and to have preferred access to a growing number of emerging biotech companies in the VC portfolios.

In 2016, revenue generated from these portfolio companies increased significantly year-over-year to nearly $90 million as a result of expanded relationships with our existing portfolio of companies, new VC relationships and the addition of WIL.

Net interest expense is expected to be in the range of $29 million to $31 million in 2017 compared to $25.4 million in 2016. The increase is the result of our assumption that LIBOR rates will continue to gradually increase in 2017 as well as an additional quarter of interest expense related to the WIL acquisition.

We expect to continue to repay debt in 2017, which will partially offset the effect of higher interest rates. This year's non-GAAP tax rate is expected to be in the range of 28% to 29%, similar or slightly favorable to the 29% rate last year. Our tax guidance does not include the impact of any potential U.S. tax reform initiatives.

We expect an estimated tax benefit from the adoption of the new FASB rule, ASU 2016-09, on the accounting treatment of excess tax benefits on stock compensation, but believe it will be partially offset by costs associated with tax planning initiatives.

We also expect upward pressure on the effective tax rate related to geographic earnings mix and a tax law change in a European jurisdiction. Free cash flow in 2016 was $245 million, an increase of $20 million from $225 million in 2015.

The $20 million increase reflects our focus on working capital and cash management, which have offset significant cash charges related to the WIL acquisition and integration last year. In 2017, we expect free cash flow to be in the range of $265 million to $275 million. This year, capital expenditures are expected to total $75 million to $85 million.

The increase from $55 million last year will be driven primarily by new projects to support growth. We plan to build a new RMS facility in the Shanghai area, in order to expand our geographic presence in the high growth China market.

We will continue to modestly increase capacity in our Safety Assessment business, as we have done in recent years, and we will also continue to invest in projects to enhance the automation and efficiency of our businesses through IT investments. Following the acquisition of WIL, our capital priorities were focused on debt repayment.

We successfully reduced our pro forma leverage ratio from 3.4 times following the WIL acquisition to 2.7 times at year end. We had $1.21 billion in total debt outstanding at year end after repaying over $200 million in debt following the WIL acquisition.

With our leverage ratio well within our targeted range, we expect that top priority for 2017 capital deployment will be strategic acquisitions. Our M&A pipeline is robust with numerous opportunities to enhance or expand our scientific capabilities and supplement our organic growth.

The net proceeds from the CDMO divestiture, which are expected to total approximately $65 million after cash tax expense will provide additional capital to invest in growth opportunities.

In addition to M&A, we expect to continue to repay debt and also resume stock repurchases with the purpose of offsetting dilution from option exercises and equity awards, and maintaining our share count at approximately 48 million diluted shares outstanding. Before I discuss our outlook for the first quarter, I will recap our 2017 financial guidance.

We expect organic revenue growth of 7% to 8.5%, which is similar to the 7.7 percentage level achieved last year and a consolidated operating margin at or near 20% or up to 100 basis points higher than 19.2% last year. We expect unallocated corporate costs to be approximately 7% of revenue, slightly lower than the 2016 level.

Interest expense to be higher than 2016 in the range of $29 million to $31 million and the tax rate similar to 2016 in the range of 28% to 29%. Earnings per share is expected to increase at a low double digit rate to a range of $5 per share to $5.10 per share.

Free cash flow is expected to increase to $265 million to $275 million and CapEx is expected to be in the range of $75 million to $85 million. In the first quarter of 2017, we expect year-over-year revenue growth to be in the mid-20% range on a reported basis.

First quarter revenue growth will be driven by the contribution from acquisitions, primarily WIL, and continued robust organic growth consistent with our guidance range for the year. The operating margin is expected to be similar to the first quarter of 2016 and earnings per share is expected to increase at a mid- to high-teens high growth.

This outlook represents a sequential decline from fourth quarter level, which is in line with historical trends.

The primary drivers of the sequential decline this year are the headwinds from the 53rd week, the divestiture of the CDMO business and normal seasonal order activity at the beginning of a new year, primarily in the DSA and Manufacturing segments.

You may recall that there is typically lighter Safety Assessment study activity in January and February, as clients' programs are prioritized for the year. And for Microbial Solutions, some clients utilize available funds in December to purchase consumables ahead of price increases at the beginning of the year.

To conclude, we are very pleased with our continued progress in 2016. We believe that our investments to support future growth, our culture of continuous improvement, and our mission to deliver even greater value to our clients are the driving forces behind our position as the leading full service early-stage CRO.

We are now keenly focused on building upon this leadership position to achieve our financial targets and enhance shareholder value in 2017 and beyond. Thank you..

That concludes our comments. The operator will take your questions now..

Thank you. And our first question will go to Ross Muken with Evercore ISI. Please go ahead..

Good morning, guys, and congrats. So, maybe as we think about the cadence into FY 2017, it seems like the business obviously is growing at quite a good clip and you're continuing to invest to continue to foster that growth.

I guess, when you think about the number one or two priorities on the investment side in terms of where we should be focused for maybe even either continuation in elevated level or an acceleration in the business, where should we be looking at that? And then, how do you balance that against obviously the desire to show operating margin expansion next year, which obviously seems key to the earnings growth trajectory, ex the noise on some of the other moving parts?.

Well, on the CapEx side, we're going to be investing in capacity for pre-clinical business in multiple sides as we indicated, and we have a major initiative in China to provide more capacity to service the fastest growing market that we have there.

From a sort of an operating P&L point of view, we need to invest in our staff and our benefits and in IT initiatives to continue to support a more complex business.

And we're confident, as we said, that we'll be able to do all of that, particularly P&L side, and continues to drive sufficient amount – significant amount of efficiency and pricing and mix, so we'll be able to improve our operating margins by about 100 basis points.

So we feel really good – that's obviously been a long-term goal of us to be at 20% all-in, and we're optimistic that we will be able to get there..

And maybe on DSA, I mean, there was some skepticism after 3Q as we saw a little bit of a pause in Discovery Services but not the traditional business, but it obviously seems like things bounced back, as you had expected in 4Q. On a client basis, strength appeared to be pretty broad.

I mean, I guess, versus your expectations, how are you looking at the different segments in terms of how they paced and how they're, again, jumping off into 2017 and where do you think, if we're going to see any surprise up or down, you're likely to see that in DSA from a customer segment perspective?.

As we said during our third quarter call, and I said there was still some skepticism even though we said, that business is now linear, and we were quite confident we would deliver low-double digit organic growth rate, which we did, and we also guided to during that fourth quarter, which we did.

So we weren't concerned at all by anything that happened in the third quarter. We also did call out the fact that the Early Discovery business had been performing less well than we had anticipated, but that we had taken great strides in restructuring the operations and the sales efforts there, and it's actually going really well.

And the non-early development piece of discovery is going well also. From a client demand point of view, biotech continues to disproportionately drive our top-line in a significant fashion.

We just have a plethora of new clients and expanding relationships with current clients and of course many of the biotech companies are getting drugs to market and have been well financed both from the capital markets and big pharma.

We're also continuing to see pretty significant infrastructure reductions by a few of the large drug companies who still have significant amounts of infrastructure and, let's say, safety assessment. And we're beginning to get some really good traction from NGOs and academic institutions.

So, it's hard to see which if any of those client bases would deliver us a negative surprise, which I think is where you phrased or I guess what could be an opportunity or a headwind.

I think, it's more likely that we continue to see the sort of significant demand sort of driven by the new innovation for the biotech companies who become the discovery engines to big pharma.

So, we're really organizing ourselves to have enough capacity, have the right people ready and trained, and be able to interface with these clients in a flexible, nimble fashion, which we have been able to do, and I think our ability to continue to respond that way should be able to ensure that we can meet that demand..

Very helpful. Thanks, Jim..

Sure..

And we'll go to the line of Jack Meehan with Barclays. Please go ahead..

Hi, thanks. Good morning. I wanted to start with RMS and get your thoughts on growth into 2017.

And just any changes there, talk about the traction in China and some of the investments you're making would be great?.

Yeah. So, we continue to see China as the principal growth engine for RMS growth. It's growing disproportionately fast to other geographic locales with very good operating margins I might add. It's a very large market, which is sort of underserviced right now by everyone. We're building facilities, hiring staff as quickly as we can.

We remain a sort of only and premier commercial provider in that locale, and we're quite confident that that will continue – we'll continue to see those growth rates. We saw pretty good growth in the U.S. and Europe as well, taking some share – significant sales of inbred models, which are used extensively in translational research.

And we'll continue to get some price maybe a couple of percent net all-in for RMS across all geographic locales. We're also confident that the service piece is particularly the GEMS piece, the Genetically Engineered Models and Services piece, where those products are particularly important for discovery research, should continue to perform well.

So, again, we're sort of guiding to our longer term targets of low- to mid-single digits. We certainly hope we can deliver mid, but we want to continue to put multiple quarters together to demonstrate that. But we feel good about the demand. We feel very good about the competitive posture.

It's quite strong and we have always been able to get a bit of price as I said, there's also continued mix enrichments in the research model business as we get more high-value animal models..

Great, thanks. And then, just want a follow-up on the pricing changes contemplated in guidance, I caught the 3%, but what's embedded within Safety Assessment? And then, David, I think, you mentioned some purchasing ahead of some of the price increases, just any thoughts on trying to quantify that? Thank you..

So, in terms of price, we've called out that collectively we think we will get 3% for the total business. I guess, the way to look at the pricing is, very similar cadence that saw in 2015 and 2016, so we called that out in the past. We're not expecting a significant shift in the way that the pricing pans out during the course of 2017.

And in terms of your second question, in Microbial, we did see some customers take the opportunity to buy in December ahead of price increases. That's not necessarily unusual. It's sort of a quick pattern that we see in Microbial..

Great. Thank you..

We'll go to the line of Robert Jones with Goldman Sachs. Please go ahead..

Great. Thanks. Jim, just wanted to go back to the Biotech and Other segment. You mentioned 50% of revenue now coming from this cohort, the segment clearly has been a key driver now for the past few years. Just curious on your view of where we are in this particular innovation cycle.

And then, other than cash on hand, are there other metrics that you monitor that give you confidence that this group can support the continued strength you've seen?.

Probably the best monitoring metric for us is the fact that we are dealing literally with several thousand clients in that segment, and some international cadre of clients, albeit predominantly North American because that's where most of biotech is, but we feel that foreign clients as well.

There are so many data points and so much consistency of demand across this client base. So we would see very early and we would see multiple indications from clients, so there were some level of concern on their part whether it's related to funding assuming that was their concern or some problem with pipelines or some kind of scientific logjam.

And we – not only we're not hearing any of that, we're hearing sort of the antithesis of that, which is clients continuously asking us, do you have enough space? Do you have enough people? Can you accommodate my work? How long do I have to wait to start a study? How much are you sort of backed up? I'm really concerned about getting in the queue.

So, we have a high degree of confidence that these companies are extremely well-financed, because there's a lot of money in their bank accounts and on the balance sheets and the capital markets. Big pharma will pick up the slack for sure, assuming there is any slack, and we don't think there's going to be any.

By the way, 2016 was a great year of investment and innovation. And then, I guess, secondarily, our confidence stems from the enormous amount of scientific innovation that we're seeing.

I have been with a client last night, he's a CEO of an oncology company that has a whole new way to attack cancers and has a drug filed and looks like there's a probability of success.

So we're seeing all the immunos, particularly immuno-oncology coming to fruition and monoclonal antibodies coming to fruition and gene-editing and other technologies that are very promising. So, tied to comprehended scenario where either the capital markets or big pharma doesn't fund those technologies.

It's hard to believe that any of these biotech companies will set up internal infrastructure. As the guy said to me last night, why would we ever do that? So they just won't, it's not our opinion, that's just a fact.

So, as long as the companies are well financed and the science is robust, we think the work will continue to be available, and our job is to be able to accommodate it but also to do the work really well. And we're quite confident in our ability to do both of those..

So, Jim, actually my quick follow-up you kind of touched on was just around capacity, given the strength seen this past year and in the quarter and implied in guidance.

Where are you today with capacity relative to demand?.

Yeah, so we feel good about our capacity. It's kind of just where we would want it. I would say that we are capacity and safety assessment is well utilized, meaning that we're very efficient and we're generating very good margins.

By the same token, we have added and we'll continue to add relatively modest amounts of space at multiple sites, the largest amounts of space that we obviously have added is reopening Massachusetts. There are 80 rooms there, of which 40 we have opened. It gives us enough capacity to accommodate the demand that we anticipate.

If the demand is actually higher than we anticipate, we could always put into service the other 80 rooms in Massachusetts. We would have to hire the staff obviously, but there's no meaningful capital drop or construction required.

So, we like this sort of equilibrium point that we have with clients planning better, waiting a bit, I was hiring the people slightly ahead of where we need them and getting the space ready slightly ahead of where we need that as well, so we think we're very much in balance..

Got it. Thank you..

Sure..

Thank you. Our next question will go to Derik de Bruin with Bank of America..

Hi. It's actually Mike Ryskin on for Derik. Thanks for having us. Congrats on the quarter. And just following up exactly on the question you're talking about, about Shrewsbury, the Charles River Mass site, so are we to understand that that's pretty much up to speed as far as you wanted to be.

You said you have 80 rooms opened and the rest of the facility is ready to go. And then, following off that question, just a broader discussion of CapEx to expand overall capacity.

The spending you're doing for the RMS facility in China and other sites, when will that CapEx start to pay-off? When will those facilities be ready? Is that later in 2017 or out in 2018 and beyond?.

So, the China facility is going to be paying off or generating revenue in 2018. So that's the answer to that one, take a while to build that..

Okay..

Shrewsbury facility is well underway. We have a significant staff there. We have a management team that's going to assemble predominantly from other Charles River sites. So, we have extremely experienced people.

We have been doing a meaningful amount of work for clients, I would say, principally on the East Coast and predominantly in Cambridge, Massachusetts area, like non-GLP work, BM/PK work (53:01), some laboratory-based services and some work in our Biologics segment. We are hard at work in getting ourselves GLP-ready.

We have several prominent clients, both large pharma and biotech who are working with us to help us ensure that we launch this GLP capability when we are absolutely ready. So, we're moving forward with the process as anticipated in some time this year.

We will be GLP-ready when we believe that's the case where we sort of get the stamp of approval from our clients. So, proximity is obviously going to be very beneficial and powerful for local clients. We think the quality of the work will be great.

And as I said earlier, we have a little bit of play in terms of capacity because 80 rooms were built out but we're only opening 40 rooms, but we could open the other 40 rooms relatively quickly as demand intensifies. That's pretty much a certainty that those 80 rooms will be opened.

The question is when, and we're standing by to see what the demand is..

Got it. And then, on the capital deployment side, you talked a little bit about the deal pipeline and the opportunities for 2017.

Is there any particular area where you're seeing opportunities, and can you comment overall on valuation from what you're seeing out as you're shopping around for that?.

Without getting too specific, we are looking seriously at multiple areas for acquisitions in the business segments where we have the highest growth rates. So, we are looking very much, say, in Discovery, perhaps in Safety, there are service aspects of the RMS business that are attractive as well, and there are some geographic opportunities for us.

So, it's pretty broad gauge in terms of the type of businesses that we're looking at. We would prefer to buy businesses, the size of WIL or at least the size of Argenta and BioFocus. Business of that size are available, but they are – you are far between, most businesses are smaller. And I would say that valuations are full but fair.

We are often competing with private equity firms and less often competing with strategic buyers, so we have greater synergy opportunities..

Great. Thank you so much..

Thank you. And as a reminder, we ask that you limit yourself to one question. And we'll go to Eric Coldwell with Baird. Please go ahead..

Thanks very much. I might break the rules and ask two. So, first off, Avian, last quarter you mentioned an impairment coming in the fourth quarter. You said it would cost $0.02 to $0.03 and dampen Manufacturing segment operating margins. I see no mention of it anywhere..

So, it did dampen by the $0.02 that we mentioned, and that is included in the number..

So you put up these results with that included, it did have....

Correct. Correct..

Okay. Better than expected. All right. My second question, sorry, the divestiture of the CDMO, frankly I applaud the decision, I'd like the price tag. It does seem a little bit of a change versus the tone when you first talked about the WIL acquisition done relatively quickly.

I guess, the question is, did you always expect to divest it or was there just a little bit of a learning process? Was this an opportunistic sell, because the buyer came to you or were you fully marketed, and just would love a little more background on the thought process there?.

I'd love to give you some background, Eric. So, I would say that it was a small piece that came with the deal, certainly was in the raison d'être of doing it, right. So, we bought that business for its large safety assessment capability, and there we were with the CDMO.

As we said at the time that we did the transaction, it's a space that we have talked about for years and had some interest in because it obviously has a strategic fit. We wanted to test the waters by living it. I'm not sure it was the best test. It's a small but high quality asset, but a small one.

We did do a – that was standing there relatively short timeframe, we did do an exhaustive study with a highly well-known consulting firm to study the marketplace. And we concluded that while it did fit, it was a very crowded field with 600 players, many of whom were multi-billion-dollar companies.

And in order to stay and play, we would have to do some very large M&A. And even then, it looked as if there was very little pull-through for or from our other services.

And I guess that second part is really what sort of iced it for us, that why would we make significant investment in a business that's related but quite different without having at the robust part of the portfolio.

So, it actually became very clear to us that it was not something that we wanted to bulk up and there's lots of companies that would be happy with that asset. We did have a process. We have lots of bidders, and we are, as you said, very pleased with the price..

Well, I think it was a very good decision. So I applaud it. Thanks, guys. Good work this quarter..

Thanks, Eric..

And we'll go to the line of Dave Windley with Jefferies. Please go ahead..

Hi. Thanks for taking my question. Just the $0.02, I agree with Eric, I had heard that you were shopping that business, and so not surprised by the sale, but think it's a good decision, good price tag. So, thank for that. Wanted to clarify on the fourth quarter.

I guess, first of all, David, the geography of this charge, does the $0.02 to $0.03 flow through the margin in Manufacturing Support or is it perhaps part of the elevated corporate overhead number? And then beyond that, the comments about kind of operational investments, I guess I'm wondering how much of that was perhaps pulled forward into the fourth quarter because the revenue was so strong, just kind of timing and gating some of those investments?.

So, in terms of the where did the Avian charge get placed, it's in manufacturing, because obviously it's to do with Avian. I'm not quite clear when you're talking about the operational investment and hence....

Well, through the prepared remarks, there were several comments about investing in the business to support growth. My sense is that some of that may have shown up in corporate overhead. You mentioned incentive comp.

I guess, what I'm digging for there is – was the inventive comp kind of a full $7 million-or-so delta relative to the expectation or was there also some, say, accelerated investment in the corporate overhead number as well?.

Right. So, I understand where you're coming from. So, there are some – to be frank, there are some one-off charges that we're taking in corporate in Q4. So, the main bulk of the increase in corporate overheads is to do with the compensation, but there was some other charges..

Can you put a number on the charges?.

Not really..

Okay. All right. Just thought, I'll try. Thank you..

We'll go to the line of Greg Bolan with Avondale Partners. Please go ahead..

Thanks, guys.

So, I wanted to ask with regards to, I think, you had mentioned, David, similar price increases expected in 2017 than what occurred in 2016, and is there any, I guess, color that you might want to provide around the dropping margin on those price increases? Will the dropping margins look or feel any different than they did in 2016? Thanks..

I'm not quite sure that I agree that there was a drop in margins. Let me....

Not drop – sorry, drop-through or incremental margins on the price increases?.

So, you've seen the margin improvement that we've called out. If you look at the full year, the 130 basis points increase in margin for the research – sorry, RMS. DSA is flat, when we take out the Quebec tax charge. And also, remember, we had WIL in that. And then, the Manufacturing segment is up by 120 basis points.

So, you've seen margin accretion in all three of our segments, some of that of course, is to do with price, but some of that is to do with the efficiency initiatives.

So, when we move into 2017, you should expect to see similar sort of guidance taking place in that, we got – we expect to get similar type of price in 2017 as we saw in 2016, you've heard about our efficiency initiatives, we will continue to drive those.

And so, I think we've called out on a number of occasions, we push all of our units to get margin accretion year-on-year, and 2016 demonstrates we achieve that..

Great. Thanks, guys..

And we'll go to the line of Tycho Peterson with JPMorgan. Please go ahead..

Hey, guys. It's Steve here on for Tycho. Thanks for taking my question. Most of my questions have been answered. Just sort of a quick follow-up on Charles River Massachusetts. You mentioned being GLP-ready soon.

Should we expect the overall mix of GLP work across the network to increase in 2017? And then, can you remind us how the pricing of GLP work compares to non-GLP work? Thanks..

So, you said that a little bit fast, but I think the answer is that, we're working to get this facility GLP-ready. We haven't said exactly when it will be ready, because it will be ready when we deem that we are prepared to do GLP work, so sometime later in the year. Pricing really depends on the nature of the GLP work.

I mean, some of the non-GLP work has wonderful margins, different aspects of safety have different margin levels. So, what we're aiming for is to utilize our capacity well to service this gigantic market that we have primarily in Cambridge, Massachusetts.

And we find with our clients that all things being equal, clients always prefer proximity, they always would prefer to spend time with the study directors and talk about the design of the studies and the endpoints and the conclusions.

So, we're quite anxious to get this facility open for GLP purposes, but clients are constantly going through there, doing audits. Clients are familiar with the facility and the staff. They put non-GLP work in there, just to enhance that familiarity, and we're anxious and looking forward to being able to open it..

Got it. Thanks..

So we'll go to the line of Ricky Goldwasser with Morgan Stanley. Please go ahead..

Hey, guys. It's Mark Rosenblum on for Ricky. I just had a one quick one on potential impact of tax changes.

Would you guys expect to benefit from a border tax adjustment, and do you have any preliminary sense of the quantity of that benefit?.

So, well, clearly our tax advisors are very busy at the moment. We feel the changes that are taking place, and we sat down with our advisors and we've been through literally line-by-line each initiative by each initiative, some of them are more meaningful than others.

But for instance, the corporate Fed income tax change and that the territorial taxes, which encourage more IP and R&D spending in the USA, there's the border adjustment tax that you're talking about, which I'll come back to in a second. There's also the one-time mandatory tax on foreign earnings. Those are the big full ticket items that impact on us.

Net-net, when you look at them in the round, there was a meaningful benefit for us. At this stage, what I would say is, in terms of your specific question, the potential on the border adjustment tax, that got puts and takes in it when you get into the weeds and that's broadly somewhat neutral, we think, at this stage.

It might swing slightly one way or the other. So, we haven't put it into our guidance, of course. I do know that I think Trump mentioned last week that he felt that things were way ahead of schedule, and that in the next two weeks to three weeks, there should be a meaningful announcement.

So we might see that it's broadly meaningful benefit net-net, impacting partly in 2017..

Okay. Thanks. That's very helpful..

We will go to the line of Erin Wright with Credit Suisse. Please go ahead..

Great. Thanks. Can you speak to the underlying growth trends at WIL versus the legacy segment and the quarterly progression of those trends kind of going into 2017, and how we should think about like the progression of WIL synergies and how is just the integration process going? Thanks..

You should think of the top line demand for WIL being essentially the same as legacy business, servicing essentially the same markets, albeit primarily smaller clients, but very healthy growth rate there. The integration process has gone and continues to go extraordinarily well from all vantage points.

We exceeded our expectations for the integration and for that asset. We hit 20% operating margins in the fourth quarter, which we had guided to accomplish by the end of 2017, and we're well ahead of our EPS target to that asset as well..

Okay, great. And then, you mentioned some nice project wins in RMS, but what were some of the – or what was the nature of some of the special projects that you mentioned won't recur in 2017? Thanks..

We had a significant amount of work for a very large client having to do with a new facility that gave us a concentrated amount to work for that client. So, the client will continue to be a client, but the nature of that work is unlikely to continue at that level..

Great. Thank you..

And we'll go to the line of George Hill with Deutsche Bank. Please go ahead..

Good morning, guys, and thanks for taking the question. I think most of my questions have been answered.

I think, Jim, I'd start with, you're seeing, I guess, I don't even want to call it the first signs of weakness or tough comps, it's probably more like tougher comps in the fund-raising environment with some money in 2016 being down a little bit from the money raised in 2015. I guess, you talked about the three years' visibility.

I guess, when do you start to worry that the tougher comps or the slowdown in the early stage fund-raising environment starts to impact just – I want to call it just the year-over-year comps sort of growth as a business, not necessarily the health of the business?.

We continue to believe that the fund-raising environment has been extremely robust. We don't think 2016 was a poor fund-raising year, it was a very good one. 2015 was unusually high, but 2016 was higher than 2013 and higher than 2014.

The strength of the biotech industry, the individual companies, their technologies, quality of the therapies continues to be stronger and stronger all the time. So, we don't begin to worry at any point until we hear from our clients some concern about not having enough money to generate their pipelines or not being happy with their pipelines.

And as I said earlier, we literally have sort of a universe of several thousand clients that we're not hearing any of that from any of them. So, we're not actually – the whole conversation that we endured for all of 2016 which started at the JPMorgan meeting about the sort of alleged slowdown, I think was totally overblown with actually no substance.

It was slower than 2015, but so what. So, we do think that the client base is extremely well funded, and we should continue to see strong demand from them..

Okay. And if I could sneak in a quick follow-up. I don't know if there're any stats you could give us, just underlying strength of the business year-over-year, increase in RFPs or RFIs, would love just kind of any other quantitative factors you can give us around revenue visibility? Thanks..

Yeah, I mean, all that we can say is that the request for proposals continues to be quite strong across our entire client base..

Thank you..

And we'll go to the line of Jon Kaufman with William Blair. Please go ahead..

Hi, guys. Good morning, and thank you for taking the questions. Just a quick one here. So the Early Discovery business was the only business in the quarter that didn't report organic growth.

So, I know you mentioned making great strides in this area, but do you think your current capabilities position you where you want to be in terms of closing these longer-term sales pitches to clients or are there other capabilities within Discovery you feel would help you?.

Yes, good question. No, we like our portfolio a lot, some of this has to do with doing a better job accessing clients and telling the story about integrated services we can provide from multiple sites across multiple streams of service. We're doing that much better, and we are signing a meaningful number of contracts with meaningful companies.

We have a bit of a gap in our revenue stream as two big projects rolled off from two very large companies, and we're actually just working to fill that. Yeah, I think the portfolio could continue to be broadened and larger both – with new therapeutic areas and beefing up ones that we are in.

We are continuing to look carefully there, but we have a very high science In Vivo and In Vitro capability, and we do think that the enhanced sales effort, the sophistication of the people selling many of whom have PhDs and just having sufficient time to tell the story, because it's still a relatively new business for us, is beginning to bear fruit.

We actually performed better in that business in the fourth quarter than we had anticipated. So, we remain optimistic about its stability and its eventual growth opportunity..

Okay, great. Thank you..

And our final question, we'll go to Garen Sarafian with Citigroup. Please go ahead..

Hi, guys. Thanks for squeezing me in. So, just want to focus quickly on the RMS comments that you had made. In the prepared remarks, there was a comment about building an RMS facility in China and you emphasized the demand there, but I know in the past, you guys have been very deliberate and thoughtful on how you approach that market.

And also, one of the Q&A comments, Jim, you had made a comment about opportunities to expand geographies to M&A in RMS, so just trying to put those two together.

How did you guys go about thinking the build versus buy approach was the way to go right now and how are you guys thinking of it, just in – I guess, upcoming quarters and near-term years, relative to what's going on in the market?.

Our original foray into China was an acquisition of a pre-existing company. Even though it's a licensee of us, we bought the vast majority of it and bought a bit more recently.

So that was a very efficient way to get a foothold in China with some name recognition put on together with the company that we bought, but that's a Beijing-based operational while we're selling beyond Beijing, and obviously the Shanghai market is substantial, and it's a long train and truck ride.

So, there's really necessity for us to be close to the Shanghai market to take advantage of that. We feel this is a better way to do that to define an acquisition close back, we haven't seen any that we like.

There are other parts of China, which is a very large country with small cities with 10 million people in them, so it is highly likely that this will be the first build from scratch of other facilities that we will build in the future.

I suppose, we'll continue to look at M&A opportunities, but we know the universe of potential sellers, they are well-enough for me to say that's unlikely. We think we can keep up with the demand to that in a highest quality fashion. We would build their facilities and we could buy. And so, this is an important strategic move for us to service that..

And now under the build-out taking, and is there any way to size the size of the facility, I guess, what it adds to your current capability in terms of just size?.

I mean, it's going to take most of 2017. It's a meaningful size facility, which will allow us to support that marketplace..

Okay, great. Thank you..

Thank you. And I'll turn it back to the speakers for closing comments..

Thank you for joining us this morning. We look forward to seeing you at the Leerink Healthcare Conference on Thursday or at Raymond James or Barclays in March. This concludes this conference call. Thank you..

Thank you. Ladies and gentlemen, that does conclude your conference for today. Thank you for your participation and for using AT&T Executive Teleconference. You may now disconnect..