Charles River Laboratories International Inc (CRL) 2015 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by.

Welcome to the Charles River Laboratories third-quarter 2015 earnings call.

(Operator Instructions)

As a reminder, this conference is being recorded.

I would now like to turn the conference over to your first speaker, Ms. Susan Hardy, Corporate Vice President of Investor Relations.

Please go ahead.

Thank you.

Good morning, and welcome to Charles River Laboratories third-quarter 2015 earnings 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 third quarter results and update guidance for 2015.

Following the presentation, Jim, David, and Tom Ackerman, Senior Financial Advisor, will respond to questions.

There's 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 370865.

The replay will be available through November 18.

You may also access and archived version of the webcast on our investors relations website.

I'd like to remind you of our safe harbor.

Any you 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 17 2015, as well as other filings we make with the Securities and Exchange Commission.

During this call we will be primarily discussing 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.

Jim, please go ahead.

Good morning.

I'd like to begin by providing a summary of our outstanding third quarter results before commenting on our business prospects.

We reported revenue of $349.5 million in the third quarter of 2015, a 12.2% increase over the previous year in constant dollars and a 2.9% sequential increase following a strong second quarter.

The acquisitions of ChanTest, Sunrise, and Celsis contributed 3% to year over year revenue growth.

However, safety assessment was the primary driver of the robust third quarter results, outperforming our high expectations.

In addition, many of our businesses reported higher constant currency revenue than in the third quarter of last year.

We were particularly pleased of sales research models increased in every geographic region, except Japan, where Pharma industry consolidation has continued to impact sales.

The operating margin improved by 270 basis points year over year to 20.5%, exceeding our second-quarter record as the highest operating margin we have achieved since 2008.

All business segments reported increased operating margins, driven by either higher revenue or improved operating efficiency, or both.

The most significant increase was in the DSA segment, which gained 590 basis points year over year, including a 270 basis point benefit from Canadian foreign exchange.

Primarily due to higher revenue and operating margins, earnings per share increased almost 20% in the third quarter to a $1.03 from $0.86 in the third quarter of last year.

Third-quarter EPS included a $0.04 gain from limited partnership investments, but even excluding the gain EPS achieved its highest level in our history as a public company.

We were extremely pleased with the third quarter results, which enabled us to raise both our revenue and non-GAAP EPS guidance for the full-year.

We now expect revenue growth to be in the range from 9.5% to 10% in constant currency, and non-GAAP earnings per share in a range from $3.69 to $3.74.

We believe that Charles River is a stronger company today than it has ever been.

We have invested tremendous effort over time to build scalable platforms, both operationally and financially.

To enhance our relationship with clients, and work with them to devise outsourcing solutions, which enable them to increase productivity and efficiency, to create a culture of continuous improvement, in which our employees are open to working in new ways, which improve our efficiency and provide value to clients, and to maintain and enhance our scientific leadership.

We have maintained our focus on early stage drug research, strategically expanding our portfolio to provide clients with the critical capabilities they require to discover and develop new drugs.

We have differentiated ourselves from the competition, and clients appreciate the value we bring to their research efforts and the emphasis we place on individualized service.

We are continuing with our outreach to heads of R&D and other decision-makers at the leading bio pharmaceutical companies, as well as many of the larger biotech companies, to ensure that they recognize our expanded product and service capabilities.

All of these initiatives have positioned us exceptionally well to compete for business now, when global biopharma companies are making the decision to outsource.

Biotech companies are investing in new funding in their pipelines, and academic institutions are working with biopharma companies to discover new drugs.

Third quarter and year to date results demonstrate the effectiveness of our marketing positioning.

We have been gaining market share primarily due to the value of our portfolio and our scientific expertise, but also due to the fact that our competitors are influx.

With some of the process changing hands, we have a unique opportunity to gain market share, and we intend to capitalize on the opportunity.

I would like to provide you with details on the third quarter segment performance, beginning with the RMS segment.

Revenue was $118.5 million, an increase of 2% in constant currency.

We had discussed our expectation for a better second half for the year, which was based primarily on the anniversary of the NCI contract cancellation, and the reduction of a significant GEMS colony by one client.

In addition, we expected to see the decline of research model sales flatten in Europe and Japan.

As anticipated, the services business improved in the third quarter, resulting in revenue just slightly higher than in the third quarter of last year.

Primarily as a result of sales to NCI researchers, research model revenue improved in North America and we were very pleased to see a revenue increase in Europe, as well.

Sales in Japan continue to decline, but when looking at Asia in total, higher revenue in China more than offset the decline in Japan.

China continues to present a significant opportunity for us, as the government and private industry both fund drug research.

Therefore, we are expanding our footprint in China to increase our research model production and provide associated services.

We are watching the market closely, and intend to invest in broader capabilities as market demand requires.

In the third quarter, the RMS operating margin increased by 210 basis points to 27.5%.

The increase in sales, the consolidation of our facilities in Japan, and other efficiency initiatives in both products and services businesses generated a benefit in the third quarter.

We continue to identify opportunities to streamline our RMS operations, and we maintain our belief that an annual RMS operating margin in the high 20% range is achievable and sustainable.

The manufacturing support segment reported revenue of $72.7 million, compared with $62.7 million last year, which represented a growth rate of 23.7% in constant currency.

The acquisitions of Celsis and Sunrise contributed 11.8%.

Organic revenue was also robust, with both EMD and Biologics businesses delivering double-digit growth.

The Biologics business performed very well in the third quarter, delivering strong revenue growth and an improved operating margin.

We have invested, and will continue to invest, in expanding our Biologics portfolio through the development of new assays and additional capabilities, in order to provide a broader testing solution for our clients.

The investment is particularly important now, when the number of biologic drugs in development is increasing, as is demand for testing of bio similars.

Our goal is to be well-positioned to win market share in this expanding opportunity, and we are pleased with the progress we have made to date.

The legacy EMD business again reported growth, about 10%, as the PTS franchise continued to deliver strong sales.

Our strategy to expand the capabilities of the PTS, including the MCS and Nexus, has enabled EMD to increase revenue over time.

We believe that the next-gen PTS, which was launched at the PVA micro conference in October, will continue to support EMD's growth.

Clients have expressed strong interest in the next-gen PTS.

We have already provided quotes for more than 100 systems, and began shipping the first systems last week.

Integration of the Celsis acquisition has proceeded well to date.

As planned, the 90 day critical tasks we have completed, including centralization of operations and initial sales training, and we have moved on to the longer-term tasks.

With the acquisition of Celsis in July, we positioned our EMD business as the only provider that can offer a unique comprehensive solution for rapid quality control testing of both sterile and non-sterile biopharmaceutical and consumer products.

Our portfolio includes both rapid testing for both endotoxin and bioburden, and through our Accugenixs libraries, also provides microbial identification and strain typing.

The extension of our portfolio also expanded our addressable market opportunity to approximately $2 billion, almost twice the current level.

In recognition of the larger market opportunity, and because we wanted the business name to reflect our broad capabilities, we have just re-branded the EMD business.

Announced on November 1, EMD is now microbial solutions.

We believe that our ability to provide a total microbial testing solution to our clients will be a key driver of our goal for the microbial solutions business to continue to deliver low double-digit organic revenue growth for the foreseeable future.

The manufacturing segment's operating margin improved by 40 basis points year over year to 33.4%, in line with our target in the low 30% range.

Leverage from higher sales was significant, and efficiency initiatives undertaken in each of the segment's businesses also contributed to margin increase.

DSA revenue was $158.3 million in the third quarter, a 16.2% increase in constant currency, including 2.5% from the ChanTest acquisition.

The in vivo discovery business reported revenue growth over the prior year, driven primarily by oncology services.

Our early discovery oncology franchise is benefiting from investment in oncology research, and also from market share gains.

The early discovery business continued to be affected by the early termination of large contracts for integrated chemistry programs at the end of last year, but partially offset the loss with new business.

Our acquisition of Argenta, BioFocus, and ChanTest have positioned Charles River as a premier provider of early discovery services, and these new capabilities are resonating with clients.

As we anticipated in our acquisition plans, the strategies we are utilizing to increase client awareness of our broader portfolio are resulting in greater exposure for our early discovery businesses than they were able to gain as independent entities.

We are continuing to hold discussions with numerous biopharma clients and potential clients about playing a larger role in the discovery research efforts, and are optimistic that many of these companies will choose to outsource to us.

As we have noted previously, we believe that outsourcing of discovery services is in the early stages.

We intend to play a leading role in this emerging opportunity, which we believe will be significant.

We were exceptionally pleased to see the safety assessment business report another quarter of double-digit revenue growth over the third quarter of last year, and a 3.7% sequential increase.

All of our facilities reported double-digit year over year revenue growth, resulting from improved client demand.

A 5% increase in pricing and market share gains.

We are clearly taking market share across our client segments, whether a client is a large biopharma wanting to reduce or eliminate internal capacity, or a small biotech with its fortunes tied to a single molecule.

Neither wants to compromise on scientific expertise.

We believe that when those decisions are made, Charles River is the logical choice.

Sales to biotech clients increased in double digits, and were the primary driver of the revenue increase.

I would like to comment on the importance of biotech companies to Charles River.

We have consistently worked with small and emerging biotechs for many years, and some of those initially small companies are among our larger clients.

As a whole, biotech companies have been the most consistent driver of our recent growth, as they invested funding received from both capital markets and from global biopharma, which is increasingly relying on biotech for drug discovery.

Our uniquely focused portfolio and targeted sales strategies have enabled us to successfully penetrate the biotech market.

As a result, over the last two years, biotech companies have represented a larger percentage of our revenue than global biopharma, and we expect that trend to continue.

According to BioWorld, capital markets funding for biotech, which was already robust, strengthened in 2015.

Biotech companies have discovered some of the most impactful drugs on the market, and based on recent breakthroughs, it appears that they have identified promising new therapies for cancer, Alzheimer's, and other complex diseases.

Given the significant amount of funding raised by Biotech companies over the last few years, we believe that even if the capital markets cool, the funds already in hand will support their growth for at least the next fiscal year, and most probably beyond.

Furthermore we would not expect funding from global biopharma to stop, since many of these companies are outsourcing the discovery of new molecules to biotech.

Therefore, we expect that spending by biotech companies will contribute to our revenue growth.

As revenue has increased, our sustained focus on improving efficiency and productivity of the DSA business has led to significant operating margin expansion.

The segment margin increased 590 basis points in the third quarter to 24.2%, from 18.3% last year.

And 260 basis points, sequentially.

The benefit of foreign exchange in Canada contributed 270 basis points to the year over year improvement, but even excluding that benefit, the year over year improvement was significant.

Now operating at near optimal capacity, we are opening additional study rooms in the fourth quarter in Ohio, as planned, and looking forward to the first quarter of next year, when we expect to re-open Charles River Massachusetts.

Situated less than an hour from the Boston Cambridge bio hub, perhaps the most significant concentration of medical research in the world, we believe that the Massachusetts facility is strategically located to support the demand for outsourced services, and to accommodate hands-on research organizations, which want to be closely involved with the CRO partner.

As noted previously, we expect to open 40 study rooms, which is approximately half of the finished capacity at Charles River Massachusetts.

We are diligently marketing the facility, and have already received considerable indications of interest from large biopharma and emerging biotech companies, as well as academic research institutions.

It is our goal to bring this facility online without impacting the 2016 DSA margin.

We believe it's particularly important that we continue to add capacity now, when there is significant opportunity to gain market share.

We have positioned Charles River as the premier early-stage contract research organization, with a unique portfolio and a scientific expertise to partner with all types of clients.

Global biopharma clients, which are making a more significant commitment to outsourcing as they strive to improve operating efficiency and increase pipeline productivity; biotech companies, which have always preferred outsourcing to building infrastructure; and academic institutions, which are partnering with biopharma to monetize innovation and require partners to provide expertise in drug discovery and development.

The outsourcing landscape has changed significantly over the last few years, and now offers us many opportunities to work collaboratively with our clients.

This is the reason that we continue to invest in portfolio expansion, scientific expertise, efficiency initiatives, and our people.

These investments are the basis of our ability to provide a compelling value proposition to our clients.

We intend to continue to identify and acquire businesses and technologies primarily upstream, but also for other growth areas of our business.

Such additions will enhance the role we play in supporting our clients' early-stage drug research processes by providing critical capabilities and expertise, which they do not have in-house or which enable them to eliminate the internal investment.

We believe that continued successful execution of our strategies will enable us to maintain and enhance our position as the leading pure-play early-stage CRO, and allow Charles River to provide value to clients, employees, and shareholders for the long term.

In conclusion, I would like to thank our employees for their exceptional work and commitment, and our shareholders for their support.

At this time, it's my pleasure to introduce David Smith, our new Chief Financial Officer, to give you additional details on the third quarter results.

Thank you, Jim, and good morning.

I'll begin my comments by focusing on our third quarter outperformance and factors that impacted the third quarter results.

Before doing so, may I remind you that I will be speaking primarily to non-GAAP results from continuing operations.

Third quarter results significantly outperformed our prior expectations, due primarily to higher operating income and limited partnership investment gains, which were only partially offset by higher tax rate.

When excluding both acquisitions and foreign exchange, we achieved organic revenue growth of nearly 9%, which is the highest level since the second quarter of 2008.

Double digit organic revenue growth for our safety assessment microbial solutions and biologics businesses drove the increase.

This robust growth, combined with operating margin expansion of 270 basis points, resulted in approximately $0.08 of the third quarter EPS outperformance compared to our prior outlook.

Limited partnership investments contributed $0.04 to EPS growth in the quarter, which was higher than we had previously forecasted.

These benefits were partially offset by a higher tax rate, due primarily to a $0.02 tax effect related to a planned restructuring, with the intention to repay debt.

In total, these factors led to record non-GAAP earnings per share of $1.03, which was significantly above our previous outlook to the low-to-mid $0.90 range.

Foreign exchange rates remained relatively stable in the third quarter, confirming our expectation of a 5% revenue headwind for the year.

The Canadian dollar had the most notable movement during the quarter, as it continued to weaken versus the US dollar.

As I believe you know, the weakening Canadian dollar actually provides a benefit to operating income, and as a result, foreign exchange contributed 270 basis points the DSA operating margin in the third quarter.

That contribution reduces the negative impact of foreign exchange on earnings per share, which is now expected to be only $0.07 in 2015, compared to our July outlook of $0.10.

Foreign exchange was a $0.01 headwind in the third quarter.

I have one additional comment to make regarding foreign exchange.

In the first half of the year, we noted that the operating margin for our manufacturing segment was negatively impacted by 80 basis points, due to foreign exchange.

The reason being that microbial solution products were manufactured in the US and sold internationally.

With the acquisition of Celsis, which manufactures products in Europe, we had reduced a portion of the FX exposure of the operating margin by effectively creating a more natural hedge.

Foreign exchange reduced the manufacturing operating margin by 25 basis points in the third quarter.

Unallocated corporate costs increased $3.7 million, year over year, to $23.6 million in the third quarter, due primarily to higher compensation expense.

These costs were also $1.3 million higher on a sequential basis, but we continue to expect unallocated corporate costs will be approximately be 7% of the revenue for the year.

Net interest expense was $3.7 million in the third quarter, representing an increase of $1.1 million year over year, [and not $0.4 million (sic - negative $0.4 million), sequentially. ]

The year over year increase was primarily due to the incremental interest expense associated with the Celsis acquisition and higher capital lease expense related to a facility buyout, while the sequential increase was driven only by the Celsis acquisition.

Net interest expense is expected to increase slightly in the fourth quarter, due to the inclusion of a full quarter of interest expense related to the Celsis acquisition, resulting in a full year total of approximately $14 million.

The non-GAAP tax rate increased approximately 200 basis points in the third quarter, to 29%, from the prior year rate of 27.1%, and by a similar amount sequentially.

As I mentioned, the increase was primarily driven are the tax impact of a planned restructuring, as well as the geographic mix of earnings.

We expect the fourth quarter tax rate also be elevated because of R&D tax credit legislation enacted last month in Quebec.

As a result, we expect our non-GAAP tax rate for the year to be in the range of 28% to 29%, which is above our previous outlook of 27% to 28%.

I will now provide an update on our cash flow and capital priority.

Free cash flow improved to $77.8 million in the third quarter, compared to $57.4 million last year.

The increase was primarily driven by the strong third quarter operating performance, as well as a year over year improvement in working capital.

Capital expenditures were $10.5 million in the third quarter, bringing the year-to-date position to $35 million.

This is trending slightly below our original expectation for the year, leading us to revise our 2015 CapEx forecast to approximately $65 million from up to $70 million.

Based on two consecutive quarters of strong free cash flow generation, and our revised CapEx forecast, we now expect free cash flow to be between $205 million and $210 million in 2015, which is above our previous range of $195 million to $205 million.

Our capital priorities are unchanged from the investor day update we provided in August.

Our top priority remains strategic acquisition to further enhanced our unique portfolio and drive profitable growth.

We continue to evaluate a number of M&A opportunities, while remaining focused on integrating our recent acquisitions.

We also continued to deploy capital towards stock repurchases and debt repayment.

In the third quarter, we repurchased approximately 242,000 shares of our common stock for $17.9 million, and have $69.7 million available on the current authorization at the end of the third quarter.

Going forward, our goal for stock repurchases remains to offset dilution from stock-option and equity awards, which should result in a diluted share count that is flat to slightly higher than the 47.2 million in the third quarter.

Due to the Celsis acquisition, our total debt balance increased by $82 million during the third quarter to $825 million.

Our goal is to continue to repay debt slightly ahead of scheduled installments, as we remain comfortable with our current pro forma leverage ratio.

As Jim mentioned, we raised our revenue and non-GAAP EPS guidance for 2015.

This revised outlook effectively suggests fourth quarter reported revenue growth of 5% to 7% year over year, or 8% to 10% on a constant-currency basis, and non-GAAP EPS growth of 14% to 20% over the prior year.

These robust growth rates represent a continuation of strong underlying trends that we have experienced for the last two quarters.

We expect fourth quarter reported revenue to be similar to third quarter level, as a full quarter of Celsis will be offset by normal seasonal trends, particularly in the RMS segment.

You may recall that RMS sales volume is typically lighter during vacation and holiday period.

Primarily because of the volume sensitivity of the models business, seasonality has historically caused the RMS segments operating margin to dip below 25% in the fourth quarter, and we expect this will occur in 2015.

Fourth quarter DSA revenue is expected to be similar to the third quarter level, but the growth rate is expected to moderate because we anniversarized the ChanTest acquisition in October.

The safety assessment business also faces a difficult prior-year comparison, because of fourth quarter was the strongest quarter in 2014.

We expect fourth quarter EPS to be below the third quarter level, due to the normal seasonal impact, and also because we are not forecasting limited partnership investment gains in the fourth quarter.

This creates a headwind compared to the $0.04 investment gain in the third quarter of 2015, but we believe this is prudent because we have exceeded our original forecast for these investment gains.

To conclude, we are very pleased with our third-quarter performance and our growth expectations for fourth quarter.

Normalizing for both FX and the investment gains in 2014 and 2015, we remain well-positioned to generate strong EPS growth in 2015 of approximately 12% at the midpoint of our guidance range.

Thank you.

This concludes our comments, the operator will take your questions now.

(Operator Instructions)

Dave Windley, Jefferies.

Hi.

Good morning.

Congrats on the quarter.

I wanted to start the conversation on RMS.

Revenue there, Jim, held up a little better than we were expecting, obviously typical seasonal sequential downtick, but if you mentioned it, I apologize if I missed, but are you seeing each of the geographies progress, or continue to progress, in terms of strengthening or turning around?

Yes, Dave.

We are seeing definitely strengthening in North America.

Some of that sales from our former NCI contract, but it's always been reported in the same segment, and of course we continue to produce those animals.

Europe, as predicted, is strengthening as well.

And we're starting to look at Asia as Asia.

But as we've said, we have seen China, which is high growth mode, offset the continued decline in the Japanese market, which is a smaller, contracting Pharma market.

We are also anniversarying the service issues that caused the downturn, which is the cancellation of the NCI contract, and at least one large GEMS client reduced their colony size.

So sort of looking through that stabilization of the services businesses, which obviously we hope will grow in the future, and definitely a strengthening of the research model business.

We'll gain a little bit about price, but definitely getting some units.

We didn't call it out in this call, but the types of units continued to be, in large measure, immunocompromised animals and inbreds pretty much across the world.

So yes, we are very pleased to see the topline growth and also see the benefits of really focused efficiency initiatives in that business display themselves in improved operating margin.

Super.

So, just to follow up on a piece of that.

It sounds like, if I interpret what you're saying about Asia and Japan in particular, that you are looking at Japan as being less relevant in the scheme of things, because it has shrunk to a small size.

In terms of your growth expectations, the RMS contribution to your overall growth expectations longer-term, can the RMS segment hit the levels that you need it to -- to support your long-term growth expectations if Japan doesn't return to positive territory?

Yes.

That's a fair question.

We don't want to overstate it.

It's one of our geographies, it's always been a small [one].

And not to disparage the market, it's just different.

The clients are primarily local Japanese clients, and there used to be a lot of international clients in Japan.

If you look at the Pharma industry, just haven't seen the growth rates that we see in other parts of the world.

It's been a small, solid part of our RMS business.

Has not been growing -- certainly not has been growing for about three or four years.

Has been entirely the result of infrastructure declines, and not market share of losses in any way.

In fact, there's probably some slight market share gain.

So yes, our long-term goals, which are to have this segment be mid-to-single digit grower on the top line, all in, products and services.

We contemplate this continued level of performance in Japan and a corresponding, meaningful offset by China, which really is a wonderful, high-growth market with great potential.

One that reminds us of perhaps US and Europe, many years ago.

Okay.

Thanks.

I'll drop out.

Tycho Peterson, JPMorgan.

Hey guys.

Congrats on the quarter.

Just one quick question from me on Argenta and BioFocus.

Can you give us some color on the pipeline, there.

You've seen some softness in the second quarter, due to contract terminations and longer timelines.

How is that trending, heading into year end?

As we reported in the last quarter, we had some significant contracts rolloff, sort of unanticipated, earlier than we had thought, which has been causing some softer performance in those acquired companies than we had intended, and certainly that we desire.

I would say that we are experiencing now -- we commented on this in the prepared remarks.

We are experiencing some offsets to that in terms of new work that's come in.

Clearly our sales organization, which has been cross-training and growing, by the way, our discovery services technical sales, and account managers has been growing nicely in the right geographic locales with the right background.

I would say that we have significant amount of activity in that sector, with a host of clients as we move into the back half of the year and hopefully and obviously into next year as well.

Our conclusion of that business is that the sales cycle has been a little longer than we had originally anticipated, to learn it through very complex sales.

So, the amalgamation of the sales force has taken a bit longer, but we are really pleased with the client reaction and the building amount of activity and interest in early orders that we are seeing there.

Got it.

And then, in terms of biotech funding, I know you've disclosed in the past that about 40%-odd of your client base is biotech, and you mentioned some of this in the prepared remarks as well.

Can you help us parse out how much of the biotech's funding spend you have seen is related to capital markets versus global biopharma collaborating with smaller biotech companies?

And how do you see those two pieces of that trending over the next couple of years?

We haven't given specific percentage demarcation between Pharma and biotech in a while.

I think that 40% number is probably an old one.

But, it doesn't really matter.

I think where one starts and the other stops has actually become irrelevant, and a significant amount of the funding -- for sure, the most significant amount of the funding for biotech, who have become the discovery engines for Pharma is coming directly from big Pharma.

We are a bit of a mirror image of what the clients are doing, how they are spending, whether they are -- how their pipelines look, because our business is obviously a composite of so many of them.

We have slightly more sales to Biotech than Pharma.

That's very large biotech companies, that's mid-sized companies.

I would call a mid-sized company one that's got a $5 billion to $10 billion market cap in sales and earnings, and then have a bunch of startup companies, many of whom are virtual.

Almost all of those companies have no internal capabilities, so they are terrific clients for us.

There is a lot of money in the system.

The recent noise, which is more related to some bad actors comments and activities in raising drug pricing is a totally different conversation than how much money has gone into the system.

So you have seen huge amounts of money coming in directly from the capital markets in 2014 and then again in 2015, and much more than that, coming directly from Big Pharma, and as I said a moment ago, you also have a lot of biotech companies generating their own cash flows from their product launches and sales.

We continue to see biotech as a critical element in the drug development pipeline for Big Pharma, for the US, and for the world.

We feel we will continue to benefit from them as a client base, and that there is significant funding for long-term significant investment by them as they continue to not only build their pipelines, but develop them significantly through outsourcing.

Thanks, Jim.

Appreciate the color.

Ross Muken, Evercore ISI

Good morning, and congrats guys on a great quarter.

I just want to expand a little on the prior [caller], I think one of the things we all struggle with is understanding, through the funding cycle of the business, does it have a little bit more sensitivity qualitative to at least more of the virtual biotech?

From a segment perspective, if you can give us a little bit of a sense on which pieces tend to be a little bit more volatile.

Because my guess it's probably smaller than we think, if you could just give us a little color, that would be helpful?

Well, we don't see much volatility, unless you are using volatility to describe churn.

So you have a fair amount of churn with small biotech companies, and by that we mean some of them go bankrupt, some of them get merged.

I was at dinner last night with a bunch of Pharma and biotech guys talking about the Dyax deal that went down yesterday, and there is constant acquisitions.

That's churn, and I don't think that's any sort of weakness in the market conditions at all.

We like our relationships with the virtual companies, because you have a company that is usually well-funded, mostly venture capital funded, not capital markets funded.

By the way, the venture firms have recently replenished at of their funds, so I think they are flush with cash.

And you see companies that are really interested in getting their drug to proof of concept as quickly as possible, with only modest price sensitivity.

We are not seeing a lot of -- we're not seeing any worrisome activity at all.

The churn has always been there.

There are hundreds, if not thousands of clients in the biotech segment.

There are always new ones.

Yes, we of course benefit by robust funding modality, but having said that, it's really subtle, and it's not immediate and it sort of gets smoothed out by the totality of the clients.

So, it is tough to parse it.

If you want a number, really small biotech companies that are sort of virtual and private are well below 5% of our revenue.

I don't think we want to disparage those clients.

I think they have been really strong sources of revenue for us.

As I said a moment ago, I do think that a lot of the dialogue has been about -- has been more about stock prices, and as I've said, a few bad actors or a couple of bad actors that have gotten a lot of press about drug pricing, and not really about the funding that is going to come into the sector, or continue to come into the sector.

We have -- as you know, we have more drugs approved in 2014 than the year before.

We will see where 2015 is shortly.

We have enormous opportunities with immunotherapy, particularly immuno-oncology, and I do think that these small biotech companies, if you talk to the VCs for instance, a vast majority of these companies are in the oncology area.

I would expect funding to continue to be robust.

We would expect that we would continue to work increasingly with more of these companies, and that they would continue to grow and develop and be the bedrock of a lot of modern medicine, but also a lot of our revenue base.

And I guess taking volatility from a different standpoint.

Jim, you have been great acquires of business the last few years, and to the degree that you still have pretty good balance sheet leverage in the next few years, how do you see the recent volatility helping you from a pipeline perspective in terms of M&A?

That is unclear.

The M&A targets have been, for us, really robust I would say for a couple of years.

I think we've done a clear job mapping it out, both internally and explaining it to you folks.

There's a lot of assets out there that are private equity or venture owned that are coming to market or at market.

I think that's sort of happenstance with what we are talking about.

They come to the end of their fund-life, and they seem to be available.

I'm not sure what the relationship is, I just note there are a lot of assets out there.

There aren't a lot of logical strategic acquirers for some of these assets.

I'm sure we'll have competition, but I think less than we used to.

We do see that as a really wonderful opportunity to continue to build out our unique and large portfolio, to make it more robust, but also wider as well as deeper.

I think that will make us a better service provider for our clients.

Great.

Thank you.

Greg Bolan, Avondale Partners

Thanks guys.

While you guys have been busy, congrats.

Just one question here, big picture, Jim.

As you think about the figurative or literal whiteboard, as it relates to big biopharma transitioning from transactional to more kind of full-service or programmatic type partners with Charles River, where are you?

I know that historically, you have said clearly you've had some larger biopharma companies make the move all the way to the right, starting with safety assessment then moving over to discovery.

Some of those are publicly announced, some are not.

But as you think about where we are in the cycle, you kind of alluded to it earlier, that certain biopharma companies -- larger biopharma sponsors are making that move with Charles River, but where would you characterize we are in the cycle?

In the spirit of baseball, maybe what inning or what have you?

That would be very helpful.

Thanks.

I'm going to assume I understood the question, Greg.

(laughter) I thought you were going to ask about strategic deals.

Assuming that you sort of did, let me just comment that, the last time we calculated and reported it, we had 30% of our total revenue associated with strategic deals, which is a terrific thing.

And I would say that for reasons that aren't all that relevant, most of those or many of those have started with the big conversation of safety assessment and moved into these large enterprise agreements that often cut across everything that we do.

Most of the big boys obviously have to do what we do for them internally or buy it externally, and for many of them, it's an opportunity to buy across the board with us and have a great value proposition and have a better strategic and scientific relationship.

If that was at the heart of it, it's working really well.

If you are talking about, maybe you talked about both, if you're talking about selling across the continuum, given our move into discovery and how that's working for these integrated deals, which of course is our dream.

I would say that there's an aggressive dialogue with lots of clients about integrated discovery/chemistry deals with them, which I think we will get, will be relatively commonplace, not to overstate that.

I would say that as we get to understand the molecule really well, assuming it progresses and we get it through an in vitro screen, that when they decide to go into animals, it's likely that we will be the beneficiaries.

I think our goal is that we sign large integrated strategic deals with clients that take us from discovery through safety, and I think that's foreseeable and plausible.

I think it's unlikely they're going to say -- here is my target, make me a drug, and call us in five or six years when you get this through regulator talks.

That won't happen.

How it might happen is, they will say -- here, as we get to certain milestones and the drug moves forward, we will likely do it with you, and here is the structure of the deal and we want to make sure we have access to your space and your best people.

So I think it's fair amount of those are work in progress.

Again, we have this unique portfolio, we're the largest safety assessment player, probably the largest commercial discovery player, with a focus in doing more M&A.

And I think as we have more capabilities to offer them, the deals will be more interesting and more strategic, and more [creative] from a milestone point of view.

And then to go back to where I started, we obviously do hope and believe that a larger percentage of our total revenue will be associated somehow with a strategic relationship with clients, both large and small, across as much of our portfolio as possible.

That obviously provides greater stability in our revenue model and our predictability in terms of guidance to the street.

Thanks, Jim.

Appreciate it.

John Kreger, William Blair.

Thanks very much.

I'm sure you're not done with your strategic planning for 2016.

But, can you talk about some of the key puts and takes that we should be considering as we are remodeling next year?

And one item in particular, given the very strong success you've had in safety assessment, should we be expecting a ramp in capital projects to make sure you've got enough space to take on the new work?

Thanks.

I would love to answer it, particularly for you.

But, we really don't want to give color, and we certainly don't want to begin to be giving guidance for 2016 until we give it in February.

I think, maybe, I'll only comment on the last part of your question, only because we talked about it previously, often.

Which is that we anticipate, and our 2016 plan is getting finished, but it doesn't get locked and loaded until our Board meeting in early December.

So we have another month.

I would say that you should expect CapEx to be around the same level as 2015.

It could be a little higher, I doubt if it will be lower.

It could be.

It will be around the same zip code.

And as you know, we've spent a meaningful amount of money this year in growth, CapEx for growth.

So we certainly would hope -- we certainly -- you should expect, given our growth metrics generally, that we would allocate additional money, CapEx, to growing as well.

And if I start to give color on the rest of your question, I will do what I don't want to do.

So please try to be patient, and wait for our comments in February.

Great.

No problem.

Let me just sneak another one in.

Given all the interest in how biotech behavior might be changing or not, can you just remind us back, let's say in 2001, the last time we had a really severe biotech funding drought, did that impact your businesses to any great extent?

Giving me credit for a much better memory than I have.

(laughter) I am not sure.

I don't think so, because I remember getting the same questions.

The problem is, with the reference at all that the world and the market and the clients was so different, just so different.

And different today, it's different today in a much more positive way.

So in 2001, Pharma basically did everything internally, and the CROs, including us, by the way, we had only been in talks for a year and a half.

So we were really nascent in this.

A little, tiny business.

So we got crumbs.

They really didn't want to do it, and they hadn't done the serious structural work, and a lot of the big deals hadn't happened, A. B, Biotech was probably 20 years into it, but still nascent.

Wasn't nearly the money or the breakthrough.

We get questions like that a lot.

I think it's maybe interesting to you, but I think be careful to relate too much about what happened over a decade ago to what is happening now.

Also, our capability and our scale in talks, talks in particular in discovery, as well, are just so much larger that our ability to do different things and more expensive things for our clients has changed dramatically.

That's helpful.

Thank you.

Robert Jones, Goldman Sachs.

Thanks for the questions, and welcome to David.

Jim, you talked about taking advantage of some of the competitive disruptions.

I was hoping you could dig in a little bit about where we are in those disruptions?

And I assume you are talking about Covance being integrated and then the combination of Harland and Huntington, if there are others, that would be helpful to hear about those, as well?

Just trying to get a sense of where you think the growth from DSA and RMS is coming from, relative to the competitive landscape as it compares to more pure demand for the services within those businesses?

Sure.

I am going to do it without speaking specifically about competitors, but more generally.

We have been taking share from competitors in the research model business actually for some time, and continue to do so.

Particularly in the academic sector, where we have been focusing for a while.

And we are still getting price, and there is still some pure business that's available in the academic sector, in particular.

And we have been able to do that on a worldwide basis, particularly the US and Europe.

And China, it's tough to say what is driving that.

I think most of it is de novo business, its new business that never existed, given the market situation.

In the safety assessment business, not to overstate our importance, but we have been really, really thoughtful, I think, about how we go after competitor business.

And as we have said now for a couple years in these calls in particular, during the downturn we really got in touch with our cost structure, and not only do we continue to run lean, but we really understand our costs exquisitely well.

We would argue better than most of our competitors.

We are able to effectively win business from them, and when we bid against them, win business.

And you can see from the margins, we are able to do that even though we often quote aggressively from a price point of view.

Given the efficiency initiatives and the scale and the capacity utilization and the mix and the price, we have been able to aggressively bid on these deals and dramatically increase our operating margin.

I just think we are better.

I think we are scientifically better; I think we're operationally better, and organizationally better.

We hear it from clients.

I do think that we have clients that are nervous about the noise that they heard last year from our very large competitor that you mentioned, and they are beginning to hear this year from smaller but still large competitors, who are most likely going to be in play this year.

That just makes them nervous.

People don't like the disruption of not knowing who the owner will be, not knowing what the level of investment will be or not be, not knowing who the GM's will be, not knowing whether the study directors will be there.

It just makes them uncomfortable.

We are using all of those things.

The concern that the clients have, the quality of our work, our knowledge of our cost structure and our large infrastructure, and the fact that we are obviously a pure play CRO that actually likes what we are doing and are not private equity or venture owned, and kind of in-play.

To take advantage of business opportunities, as they occur to us.

There is a fair amount of work yet to come outside.

Probably the amount of work that has been outsourced by the large players is probably 50% to maybe 55%, and of course there is also all sorts of new work that is available from the biotech firms.

We do think this is a very interesting inflection point and moment in time that we have now for -- who knows, for a few years.

And we are going to open space thoughtfully, and we are going to hire people thoughtfully but slightly ahead of when we need them, make sure they are well trained, and we are going to go hard for as much business as possible.

I appreciate the comments.

Thanks.

Ricky Goldwasser, Morgan Stanley.

Hi.

Good morning.

And congratulations on a very good quarter.

Couple of question, here.

One is a follow-up on your prior one, in thinking about your comments, right?

The fact that you will introduce some costs and hire people ahead of time, as you open capacity and look to build share.

How should we think about the margin trajectory, when we model?

Margins have shown very, very healthy expansion in the last year.

Should we now assume that this is the new steady state given the different cross-currents that you are discussing?

Ricky, you should assume a few things.

You should assume that this year, we have hired lots of people.

Let me defined lots.

Hundreds of people, in the safety assessment business.

So we are already doing what I said.

We opened new space.

We're hiring hundreds of people, and we are driving margin at the same time.

So we can do both.

So you should not read those comments -- it's a really fair question, but you should not read into the comments that we are going to go and open huge amounts of space and higher lots of people that is going to have a deleterious effect on the margin.

It's a continuation of the same.

We haven't told you what the operating margin is for safety assessment, although we have said it's above our 20% goal, but we haven't told you explicitly what it is.

We are unlikely to tell you.

But what we will tell you is that the margins are well above our corporate target now.

I believe this is -- if it's not the third quarter in a row, the second.

And we have told you that the discovery piece of DSA, most of those companies have been acquired.

Certainly Argenta, BioFocus, ChanTest, have lower operating margins and our goal is to improve those.

So we hope to continue to have an improved operating margin in that segment going forward, what the mix is between discovery and safety, we have no idea.

Of course, we will give clarity on that when we give our 2016 guidance.

Please don't hear growth as having -- potentially having an adverse impact on margin, because it shouldn't be substantially different than the sort of investments we've made this year.

Okay.

And then another follow-up.

You've highlighted how the market is different now, and the [trial] sponsors have changed, kind of reflect your processes.

Earlier this week, we once again heard about the potential for large Pharma consolidation.

Can you just give us some more color and your exposure to this potential consolidation?

And how should we think about potential impact, if there is one?

Tough to say.

This is a rumored deal, but there is obviously been lots of mergers throughout the year.

This one, [occurs] for us, is a very large company buying a relatively small one.

Maybe not price-wise, but in the panoply of large Pharma.

Obviously, they are both clients.

I won't say anything more than that.

This tends to be some modest disruption during this sorting out and integration process.

But you can't really predict that, totally.

It really depends on the complementary nature of the therapeutic areas and the drug pipelines.

I wouldn't expect this one to be very disruptive at all and I would remind you that from a customer concentration point of view, even our largest client accounts for less than 5% of our revenue.

So, we can and will manage this.

Okay.

Very helpful.

Thank you.

Eric Coldwell, Baird.

Okay.

Thanks.

Good morning.

Two questions, first one on research models.

Given over time, more of a mix-shift to higher end models, purpose spread, knockouts, et cetera, and then also the growing demand in the strong biotech financing, client financing globally.

I am just curious if you are at a point now where you can be a little more aggressive with your pricing behavior, as you go into 2016, and maybe give us an update on what you realized on catalog pricing globally in 2015, as well?

And then I have a follow up.

Yes.

It's a bit of an imponderable.

I think the answer is, we probably could.

We probably won't.

We decided, man, it's probably five or six years ago, to be less aggressive with our price increases, so that ceased to be an issue from a competitive market share point of view.

And Eric, I'm specifically, particularly these days thinking about, talking about academia, where there is lots of work.

We have a significant amount revenue from academia, but it's the smallest piece of the three segments.

Big Pharma and biotech, and then academia.

It's a client segment that is pretty price-sensitive.

You may already know that if you take a look at our major strains, we are 5% to 15% more expensive than some of our competitors.

We're at parity with many of our competitors, and in a couple of places, with a couple of strains, lower.

We probably could, but we really are interested in driving share.

It's a very profitable business that we think we can continue to derive profitability without doing what our clients would perceive as inappropriate price increases.

And in any event, we net considerably lower prices than occur in our catalog.

That has a lot to do with the fact that a lot of our big clients are price protected.

We have these big deals with them, either some sort of strategic deal, or at least a deal with research model.

I suspect we won't do anything largely out of the ordinary for pricing, next year.

Okay.

Fair enough.

Let me shift gears to one topic that came up a few minutes ago, which is the notion that perhaps there are some, let's just say assets in play, and the kind of midsize to upper-midsize safety assessment world, on the private side of the market.

Are you in that game?

Are you interested in making acquisitions of these companies, if the books are out there?

Or are you more focused on your organic build outs and reopen [Shrewsbury]?

I'm just trying to get a sense.

You talk a lot about M&A, but would you go back and do kind of a traditional, horizontal deal in safety assessment?

So my surreal answer to that, Eric, since I would've given you a different answer two years ago, is that -- here we are, through three quarters of 2015, with capacity pretty much optimally utilized, with operating margins actually better than we had anticipated, with a lot of efficiency initiatives, with a lot of demand from both large and smaller clients and share gains, and pretty positive view of the demand curve.

We just did our five year plan.

So a demand curve for a while.

And so, I would succinctly said to you a couple years ago, we would never do another deal in the safety assessment space.

Of course, you have to be careful never to say never.

I guess but we would say now, is yes, we are absolutely focused on bringing on new space as we need it.

And opening the former Shrewsbury, which we're calling Massachusetts.

We would be remiss if there were quality assets in the market that are available at a rational price point, that give us geographic reach that we want, service capability that either we don't have, or think we could better us from scale, and access perhaps to some clients that we don't do as well with.

We would be remiss, given the strength of the business, given the strength of our leadership in that field, not to look.

How it comes out?

Whether we do any deals?

Whether they are really for sale, and whether they are affordable?

It's not all that useful to speculate, but we're certainly open to all of our options to thoughtfully and carefully pursue them all.

Okay.

Thanks so much.

Garen Sarafian, Citigroup.

Morning Jim and David, and thanks for taking the questions.

First on China.

[You upsized] your interested in China, and you seem to be doing very well in that market.

But given the volatility of the overall Chinese market, and all the talk of the country transforming itself to a consumer oriented market and such, how does that influence when and how you enter the market?

Do you pause a bit during the transition, do you accelerate down to the market before anything else changes?

Does it even diminish or increase the number of opportunities for M&A in the market?

If you could just comment on that, a little bit.

We made a very careful and relatively small bet in China.

We bought a lab animal production company that had been a licensee of ours.

So, the Charles River name was already in China.

It's a market that is growing very quickly, biotech is really nascent there, the Pharma companies are just beginning to become real companies.

Our competition is principally government-based.

We are very interested in growing our infrastructure, and that would not be through M&A.

Growing our infrastructure through building more space, because it's a really big country.

So we are close to our clients and can compete more effectively that way.

While M&A in China is always a possibility, and we do have some targets that we have been looking at, I would say that you should expect growth to -- A, be principally in research models and services for a while, and principally through investment of our own money and facilities to grow, and reasonably modest.

That's very helpful.

And then just on overall M&A.

I think you are now right around 2.7, 2.8 times leverage.

But it still sounds like you are very enthusiastic to do more acquisitions, even if it's not in China.

With what you're seeing in the pipeline, are you more willing to go above what I thought you had previously stated to be 3 times?

I think we are at about 2.5 times now.

What we have said previously, is for reasons that not necessarily rational, they're more psychological.

We like it below 3 times, 3 turns.

Probably because we where an LBO at one point.

We've also said that we would lever up for a short amount of time.

When we say that, we probably mean a year-ish.

I don't know, 3.5 times, maybe higher, maybe slightly below 4, to do a large strategic accretive deal.

We are quite happy where we are now.

We feel that we are well-financed to do M&A, we are quite interested in doing M&A, there are a lot of targets out there, both in discovery and in some of our other growth businesses, and we feel we have a meaningful amount of headroom to continue to pursue these deals.

Got it.

Thank you very much.

We have time for one final question.

We will go to Tim Evans, Wells Fargo.

Thank you.

I'll be brief.

The pricing in the DSA segment, I think you said was up 5%, and I think that's pretty consistent with what you've seen in prior quarters.

But, is the component of that any different?

In the past you have commented on spot pricing versus change-order activity.

Is the spot pricing, in particular, getting any better?

It gets increasingly harder to tease it out.

We push spot pricing whenever and wherever we can.

There is a lot of complex studies that are -- the inclination is for the clients to change them.

I don't think the mix is changing materially from quarter to quarter, though, but holding steady.

And if I may, you mentioned kind of the penetration rate.

Again, I think you said 50% with Big Pharma.

That is pretty consistent with what have you said in prior years, I believe.

And I just wonder, do you feel like penetration is going up meaningfully for large Pharma, and how much visibility do you have into the true penetration rate for your largest customers?

What I said was, we think about 50% of the safety assessment work has been outsourced.

That's probably a different -- probably the answer to a different question, and a different answer than the one that you're asking.

It's very hard to have visibility, but our goal is to have the majority of the safety assessment work from all of Big Pharma.

I would say that we already have that in the research model business for Big Pharma.

And our goal now is to develop a robust discovery business with as many of the large classic biopharma companies and biotech companies as possible, to get them to outsource more of the very early work.

There is a lot of work just in safety assessment that is still done internally.

There is still a lot of discovery work that is only done internally, or at least most of it is done internally.

And so, there are significant opportunities for them, and clearly major opportunities in most biotech companies who, except for literally a handful, buy most things externally.

Thank you.

That's helpful.

We know there are more callers in the queue, and we will follow up with you later today.

Apologies for not getting to you, but in the interest of time, that concludes our remarks for today.

Thank you for joining us.

This concludes the conference call.

Thank you, ladies and gentlemen, that does conclude the conference for today.

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