Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Linda Tharby - Becton, Dickinson & Co..

Rick Wise - Stifel, Nicolaus & Co., Inc. David Ryan Lewis - Morgan Stanley & Co. LLC Lawrence S. Keusch - Raymond James & Associates, Inc. Brian D. Weinstein - William Blair & Co. LLC Vijay Kumar - Evercore ISI Derik De Bruin - Bank of America Merrill Lynch Jonathan Groberg - UBS Securities LLC Justin Jordan - Jefferies International Ltd. Robbie J.

Marcus - JPMorgan Securities LLC William R. Quirk - Piper Jaffray & Co. Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Ravi Misra - Leerink Partners LLC Kristen Stewart - Deutsche Bank Securities, Inc..

Hello, and welcome to BD's Third Fiscal Quarter 2016 Earnings Call. At the request of BD, today's call is being recorded.

It will be available for replay through August 11, 2016 on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 44231624.

I would like to inform all parties that your lines have been placed on a listen-only mode until the question-and-answer segment. Beginning this call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin..

Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com.

During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings.

We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website.

As a reminder, we annualized the acquisition of CareFusion in March. And as such, our third quarter results reflect the new BD in both the current and prior-year period.

In addition, comparable prior-year revenues are adjusted to exclude sales related to the terminated agreement with CareFusion for the sale of Fisher & Paykel's respiratory care products. The fiscal year 2016 comparable revenue guidance provided today will also exclude the year-over-year impact of this contract termination.

The impact to the bottom line is not material and is included in our EPS guidance. Comparable organic revenues are adjusted to further exclude the impact of non-annualized acquisitions and closed divestitures.

Details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliation to GAAP measures in the financial schedules, in our press release or the appendix of the Investor Relations slides.

At this time, we would like to announce some leadership changes, which will take place on October 1. Jerry Hurwitz, Executive Vice President of HR and Chief Human Resources Officer, has announced his intention to retire from the company. We thank Jerry for his many contributions and his 24 years of service to BD.

We are also very pleased to announce that Linda Tharby will be our next Executive Vice President of HR and Chief Human Resources Officer, effective with Jerry's retirement. We are confident that Linda's drive for performance, combined with her strong strategic agility and passion for people development, will make her well suited to lead HR.

Linda's appointment helps the company meet a unique business need and enables Linda to gain personal development on the functional leadership side. We are also pleased to announce that Alberto Mas, currently the Worldwide President of Diagnostic Systems, will succeed Linda as Executive Vice President and President of the Life Sciences segment.

Having served as president of three major business units during his 24-year career at BD, Alberto is uniquely positioned for this next step.

Since assuming his position of Worldwide President of Diagnostic Systems in 2013, Alberto has focused the business on reinventing the lab through automation and standardization and advancing our position in molecular diagnostics through differentiated assays.

We are confident that both of these leaders will make major contributions to our future success as we build a bigger, better, bolder BD. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President.

Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Linda Tharby in her current role as Executive Vice President and President of the Life Sciences segment.

It is now my pleasure to turn the call over to Vince..

Thank you, Monique, and good morning, everyone. Before we discuss the company's performance in the quarter, I would like to comment briefly on the organizational changes Monique just mentioned.

Over the past several years, we have continued to strengthen our leadership team through a diversity of experiences and perspectives to form a global team that helps ensure our future success and the continued development of our senior leaders.

Our leadership team is designed to support the company's strategy and increased focus on growth, as we develop more impactful solutions for our customers. We're extremely pleased to announce Linda and Alberto's new roles, as they help lead the company through our next phase of growth. Now, turning to slide four and the company's results.

We're pleased with our third quarter growth profile. Performance from both the Medical and Life Sciences segments contributed to solid organic revenue growth that was in line with our expectations. Our results this quarter continue to highlight our consistent performance and the benefit of our diverse portfolio.

We continue to drive strong underlying margin expansion through the achievement of synergies, operational efficiencies and continuous improvement. We're also increasing our R&D investment in key strategic opportunities and expect to fully utilize the benefit of the medical device tax suspension.

As we've shared with you, we have a robust pipeline and look forward to sharing new opportunities with you in the near future. Looking ahead, I feel good about the business and our performance year-to-date gives us confidence in our full year outlook. Moving to slide five.

I will review our third quarter revenue and EPS results, which I will speak to on a currency neutral basis. Total company organic revenues grew 4%, in line with our expectations. Adjusted EPS of $2.35 was ahead of our expectations.

As I just mentioned, this was driven by strong operating performance, which enables us to invest incremental dollars in R&D. Chris will provide more details on this later in his remarks Now, I'd like to turn things over to Chris for a more detailed discussion of our third quarter financial performance and our updated fiscal year 2016 guidance..

Thanks, Vince, and good morning, everyone. As Vince just mentioned, the breadth and geographic diversity of our portfolio contributed to solid third quarter results. Total third quarter revenues of $3.2 billion grew 4% on a comparable organic basis. This was in line with the growth expectations we had outlined on last quarter's earnings call.

As a reminder, the second fiscal quarter had benefited by about 50 basis points from the timing of revenues, which occurred earlier than originally anticipated. In turn, this negatively impacted the third quarter by about 50 basis points. I'll discuss this further as I take you through the business results.

BD Medical third quarter revenues increased 3%, reflecting strong performance in Medication Management Solutions and Diabetes Care units and solid growth in the Medication and Procedural Solutions unit.

As anticipated, performance in the Pharmaceutical Systems and Respiratory Solutions units were negatively impacted, in part, by customer ordering patterns and the timing of capital placements. These items occurred earlier than originally anticipated, benefiting the second fiscal quarter as communicated on last quarter's earnings call.

Medication and Procedural Solutions growth was 2.1%, which reflects strength in infusion therapy and safety-engineered products, but was negatively impacted by the divestiture of our Spine business and a tough comparison to the prior year.

Medication Management Solutions revenues grew 6.2%, driven by strong dispensing capital installations with our Pyxis platform. We also saw solid growth in the infusion business. Growth in Diabetes Care was 6.6%, driven by pen needles and a favorable comparison to the prior year.

Pharmaceutical Systems growth of 1.5% reflects strong growth in SAIS and safety-engineered products, partially offset by the aforementioned timing of customer orders. Respiratory Solutions revenues decreased 3.3%, reflecting the aforementioned timing of capital placements.

Respiratory Solutions had a negative impact of 60 basis points to the third quarter organic growth. Excluding the Respiratory Solutions business, total company organic growth was 4.6%. BD Life Sciences third quarter revenues increased 6%, primarily driven by strong growth in the Preanalytical Systems and Diagnostic Systems units.

Preanalytical Systems growth of 6.6% was driven by international markets and safety-engineered products in the U.S. Diagnostic Systems growth of 9.5% was the result of strong growth in microbiology, led by the timing of BD Kiestra installations, as well as continued strength in blood culture and growth in BD MAX.

Biosciences revenues grew 1.2% in the third quarter. We are seeing additional pressure in Africa related to our clinical HIV business, and we continue to monitor this situation. In the U.S., Biosciences had double-digit growth, driven by sales of research instruments. In addition, we experienced strong sales in research reagents globally.

Growth was partially offset by funding delays, primarily in Western Europe and Japan. Moving to slide eight. I'll walk you through our geographic revenues for the third quarter on a currency neutral basis. U.S. revenues increased 3.4%, reflecting strength in both the Medical and Life Sciences segments.

BD Medical's performance reflects strength in dispensing capital installations, which includes the benefit of a large customer installation, as well as strong performance in infusion systems, which include a double-digit growth in our disposables business. SAIS and safety-engineered products also contributed to growth in the quarter.

BD Life Sciences growth in the U.S. reflects continued strength in our research business in Biosciences, led by the recently-launched FACSymphony and FACSCelesta instruments and a growing research reagent and Sirigen dye portfolio, including our new OptiBuild platform for customized reagents.

Diagnostic Systems was driven by strong growth in molecular, including BD MAX; and growth in core blood culture. Preanalytical Systems also had solid performance across all core platforms during the quarter. Moving on to international, revenues grew 4.6%.

This is below our normal growth rate and primarily reflects some unfavorable timing events within the Medical segment. The Medical segment grew 2.6%. This reflects strength in China and sales of safety-engineered products and strong dispensing installations and Medication Management Solutions.

This growth was partially offset by the timing events in Pharmaceutical Systems and Respiratory Solutions and softness in the Middle East, as we expected. The Life Sciences segment grew 8.1%. Preanalytical Systems growth was very strong across all regions, primarily due to continued expansion of safety-engineered products.

Diagnostic Systems had strong growth in Western Europe, driven by Kiestra installations in the quarter. Overall strength in core microbiology and cervical cancer-related sales also contributed to growth in Diagnostic Systems. The Biosciences business was negatively impacted by the aforementioned declines in the HIV business and funding delays.

Now, turning to slide nine, developed markets revenues grew 3.7%, and emerging markets revenues grew 5.2%. The third quarter growth rate in emerging markets reflects solid growth in China and Latin America, partially offset by declines in the Middle East and Africa, as communicated on last quarter's earnings call.

The Middle East and Africa had a negative impact of approximately 400 basis points. Excluding these regions, emerging markets grew approximately 9% in the quarter. China growth for the third quarter was 9.5%. Revenue growth across the Medical and Life Sciences segments was driven by continued strong demand for consumables.

For the total year, we continue to expect China to grow in the low-double digit range. We now anticipate total emerging markets to grow in the mid-single digit range. We expect that, as we exit fiscal year 2016, these headwinds in the Middle East and Africa will largely be behind us.

It's important to note that we anticipate emerging markets growth of high-single digits as we move forward. Moving to global safety on slide 10. Currency neutral sales increased 8.9%. Safety revenues in the U.S. grew 5.3% and international sales grew 13.9%, currency neutral, driven by strength in Asia-Pacific and Europe.

Safety revenues grew 19.6% in emerging markets. Medical safety sales grew 9.6%, driven by a range of safety-engineered products including safety catheters and strength in Pharmaceutical Systems. The benefits from E.U. safety legislation continued to aid growth in the quarter.

Life Sciences safety sales, which are driven by our Preanalytical Systems unit, grew 7.6% in the quarter. Slide 11 recaps the third quarter income statement and highlights our currency neutral results. As I mentioned a few moments ago, revenues grew 4% on a comparable organic currency neutral basis. Pricing was slightly positive in the quarter.

Gross profit improved 6.3%. I'll provide more color on gross profit on the next slide, when we look at the underlying performance and the impact of currency. SSG&A as a percentage of revenues was 22.7%. We're very pleased with the leverage we're getting, which includes the benefit of cost synergy capture.

The suspension of the medical device tax also had a positive impact on SSG&A. So, as we've previously communicated, we intend to reinvest the savings in R&D, which you're beginning to see on the R&D line. R&D as a percentage of revenues was 6.5%.

We continue to invest in new products and innovation and expect to incrementally reinvest approximately $25 million of the medical device tax in the fourth quarter. As a result, we expect R&D as a percentage of revenues in the fourth quarter to be above our full year guidance range.

This brings our total year R&D dollars as a percentage of revenue closer to 6.5%. Operating income grew 12.8%, reflecting strong P&L leverage. Our tax rate declined 350 basis points to 21.3%, which is in line with our full year expectations of 21% to 22%.

As Vince discussed earlier, adjusted earnings per share were $2.35, which is a 19.5% increase versus the prior year. This reflects our solid growth profile, strong underlying margin expansion and our lower tax rate. I'd also like to highlight that, year-to-date, we have driven very strong earnings growth of 33.9%.

Slide 12 illustrates our gross profit and operating margin for the third quarter. Foreign currency had an unfavorable impact of about 50 basis points on our gross profit margin in the quarter.

On a performance basis, strong gross margin expansion of 160 basis points was primarily driven by operational performance and continuous improvement initiatives and, to a lesser extent, from favorable raw material prices.

Strong operating margin performance of 210 basis points was primarily driven by gross margin expansion, combined with the achievement of operational efficiencies and the positive impact of cost synergies. These contributions were partially offset by increased R&D expenses we incurred following the medical device tax suspension.

Foreign currency had an unfavorable impact of 60 basis points on operating margin in the quarter. Year-to-date, we have driven approximately 280 basis points of underlying operating margin expansion.

This strong performance gives us the ability to raise our guidance for the year to a range of 200 basis points to 210 basis points of underlying operating margin expansion. Moving on to slide 14. To ensure consistency and clarity, I'd like to provide more color on revenue growth guidance.

Last quarter, we noted there was approximately a 50 basis point benefit from the timing of revenues that occurred earlier than we anticipated. We expected that timing to bring down the third quarter growth rate a bit, and we had guided this quarter to be below our revenue growth range for the total year.

The key to understanding our second half revenue growth trajectory is to focus on the absolute dollars we're achieving this year versus last year. We are up against a tough comparison this quarter because, in terms of absolute dollars, that was our highest quarter last year.

As you model out the total fiscal year, we have been steadily improving sequential revenue dollars every quarter. While our year-to-date performance implies a revenue growth rate of about 7% in the fourth quarter, you will see that, in terms of absolute dollars, it's reasonable and achievable as illustrated on slide 14. Moving on to slide 15.

We are maintaining our adjusted EPS guidance range of $8.50 to $8.57. Our strong performance in the third quarter and our full year outlook give us the confidence to raise our currency neutral adjusted EPS guidance for fiscal 2016 by 1 percentage point to a range of $9.08 to $9.15, while increasing our investment in R&D.

Offsetting this increased performance are incremental currency headwinds of approximately 1 percentage point that have resulted from the U.S. dollar strengthening relative to the euro and other currencies since we provided guidance in May. We remain extremely pleased with our performance and our ability to execute and deliver on our commitments.

Turning to slide 16. I'd like to walk through additional elements of our guidance for the full fiscal year 2016. We continue to expect growth of 4.5% to 5% in BD Medical. Due to the aforementioned challenges in Africa in our Biosciences business, we now expect revenues in BD Life Sciences to grow between 3.5% and 4%.

This brings total BD to the bottom end of our revenue growth guidance range of 4.5% to 5% for the total year.

On a reported basis, revenue growth for the total year is expected to be between 21% and 21.5%, which reflects a currency headwind of about 350 basis points, which is an incremental 50 basis point headwind compared to our prior guidance of about 300 basis points of currency headwinds.

Based on our current view of the environment, we continue to expect pricing to be flat to slightly positive for the year. Our guidance assumes a euro-to-dollar exchange rate of $1.11 for the rest of the year. We see some remaining FX headwinds over the fourth quarter, as non-euro currencies are also expected to be unfavorable year-over-year.

Before I turn the call back over to Vince, I'd like to note that, in June, we continued to deleverage as we paid down a $750 million debt maturity associated with the CareFusion acquisition.

At the end of the third quarter, our leverage ratio was 3.4 times and we remain on track to achieve our commitment of 3 times gross debt leverage within 24 months of close or March of 2017. Now, I'd like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio..

Thank you, Chris. Moving on to slide 18. I will walk through our updates on product innovation, strategic and business initiatives and partnerships and collaborations. Starting with new product innovation. Within our Medical business, we reached over 100 hospitals with Alaris infusion pump interoperability.

Bi-directional interoperability to a hospital's electronic medical records improves patient safety and care by reducing manual input of data and programming errors, while also improving staff efficiency. Within our Life Science business, we are seeing strong performance from our recently-launched research instruments, FACSymphony and FACSCelesta.

In addition, to complement the portfolio, we recently introduced the unique, mid-level cell sorter, the FACSMelody, which has received positive customer feedback. The FACSMelody will have a full scale commercial launch in the fourth quarter.

All of these instruments are complemented by our Sirigen dyes and recently-launched OptiBuild-customized reagents. In the area of women's health, we have continued to make good progress. We have already submitted our vaginitis and GC/CT assays and are now in the process of submitting our HPV assay to the FDA for approval.

This assay is designed to provide physicians access to broader, high-risk HPV genotype information beyond types 16 and 18 to guide informed treatment decisions for their patients. This is an important milestone for the company and is complementary to our current portfolio.

As part of our menu extension on BD MAX, we have completed an agreement with Check-Points BD, a Netherlands-based company, which is focused on the development of rapid molecular tests for the detection of carbapenem-resistant organisms. Check-Points currently has a CE-marked product optimized for the BD MAX that incorporates our open system reagents.

Within strategic and business initiatives, we're pleased with the progress towards the creation of the Respiratory Solutions joint venture and remain on track to close late in fiscal year 2016 or early in fiscal 2017. As we told you last quarter, we have also continued to make good progress with our CareFusion product registration process.

We remain on track with our plans to achieve revenue synergies and continue to expect them to begin to materialize in fiscal year 2017 in our Medication and Procedural Solutions business.

And in the areas of partnerships and collaborations, we recently completed an in-depth launch planning meeting with Medtronic to integrate our commercial plans and operations, as we anticipate the launch of our insulin infusion set. We remain on track for broad commercial release in early fiscal year 2017.

As you can see, we are executing on our strategy and continue to have strong opportunities to drive growth and innovation. We look forward to updating you further at our Analyst Day in New York City in November. Moving on to our business update on slide 19. We continued to make progress with our cost synergy capture.

Our G&A functional transformation continued in the third quarter. We're making progress, expanding and leveraging global shared services and centers of excellence. We also continued to focus on implementing lean and efficient end-to-end processes with our corporate functions.

During the quarter, we also announced plans to close two plants as we made progress with our footprint optimization. We continue to expect the majority of manufacturing-related synergies to be achieved in the latter part of our deal horizon.

We remain on track to achieve our FY 2016 cost synergies and continue to expect $325 million to $350 million in total cost synergies related to the CareFusion acquisition as we exit fiscal year 2018. Turning to operating margin expansion.

The consistent solid performance of our businesses, combined with operating efficiencies, cost leveraging and cost synergy capture, is driving continued underlying operating margin expansion.

In addition to the 100 basis points of operating margin expansion we achieved last year, we expect another 200 basis points to 210 basis points of expansion this fiscal year. Now, I'd like to reiterate the key messages from our presentation today. First, this was a solid third quarter.

Both segments performed well, and our results highlight the benefit of our diverse portfolio, both from a product and geographic standpoint. Second, we are delivering strong operating performance.

Also, with respect to our operating efficiencies, cost leverage and cost synergy capture are generating significant operating margin improvement, as evidenced by our increased guidance for the total year. Also, we have many exciting opportunities in the pipeline, and we are incrementally investing in R&D to fund those strategic opportunities.

Finally, we are confident in our outlook for the full fiscal year. We remain very optimistic about BD's prospects for the future and our ability to continue to deliver strong returns to shareholders over time. Thank you. We will now open the call to questions..

The floor is now open for your questions. [Operator Instruction] Thank you. Your first question comes from the line of Rick Wise with Stifel..

Good morning, Vince. Good morning, everybody..

Good morning, Rick..

I guess, I'll start off with the operating margin expansion. I mean, you really are generating extraordinary margin expansion this year for multiple reasons. Maybe, just stepping back, how much – actually, I'll start it differently. Becton has consistently, for a long time, every year, done a good job of expanding margins and reducing costs.

But this kind of performance we've seen in fiscal 2015 and 2016, how do we think about the next few years? What are the opportunities that are remaining? And, I mean, do you have a lot more to go in terms of consolidating plant manufacturing? Just give us some larger perspective to think about the future..

Sure, Rick. I'll take that. It's Chris. Thanks. Yeah, we're really happy with the margins that we're driving. Operating margins this year will be 200 basis points to 210 basis points up, and I'll remind you that that's on top of 100 basis points last year. And so, it's good continuous improvement, and that's coming from two things.

Obviously, the synergies are helping us on the operating margins, SSG&A and that type of thing. But we're also seeing very good performance on the gross profit line, and a lot of that is really coming from continuous improvement-type initiatives that we've had in place. So, we feel good about that.

And the good news is that that continues going forward, particularly on the synergy piece, so you would expect to see – on top of the normal 40 basis points to 50 basis points that we drive every year, you would expect to see an incremental 40 basis points to 50 basis points just coming from the natural synergies that you get over the life of the deal horizon.

On top of that, you would also think about the fact that, with the Respiratory going away and with that joint venture, you'll get a benefit on margins as well because, as we've mentioned, the Respiratory margins really were headwinds to the overall margin.

So, we feel good about the margin profile going out into the future over the next couple of years..

And you were asking about manufacturing, and what I was trying to indicate in my remarks – this is Vince, Rick, is that the manufacturing piece of the synergies in the $325 million to $350 million really starts to hit towards the back end, and we've been giving that timeframe of, kind of, late 2017 into 2018.

So, we're really early on in kind of the footprint adjustment. We did mention the two plants, but there's a lot more work to be done, but I feel very good about the way the team has this organized. Tom and I have met with them, and I think we really have a solid plan..

Great. And just as a follow-up. Just thinking about two growth drivers, maybe you can give us some more color. You talked about the 50 CareFusion products registered, 25 more on track. Maybe talk about the growth implications there and where you're investing in R&D and how we think about that potentially being incremental growth driver as well.

Thank you..

we've been doing very well with Kiestra. We see enhancements that we can make to Kiestra. We know that the market is going to like these. And so, this is an opportunity to accelerate that work that would have taken us another year or two to get to.

On the Medication Management side, what I would tell you is that where we're spending is core to that Medication Management strategy. We saw it as a great opportunity, and there was an opportunity to get some technology at the same time. So, we're a little opportunistic to do this in the fourth quarter. It made all the sense in the world.

So, right down the middle of what we're doing is the way to think about that, Rick. So, I'll turn that over to Tom..

Sure..

Hey, Rick. This is Tom. And just to answer your question on revenue synergies, we continue to make good progress on our new product registrations. As you said, last quarter, we shared that we had gained regulatory approval for more than 50 products in over 20 countries and we had another 25 registrations submitted and awaiting approval.

And since then, over the last quarter, we've gained a number of new approvals. We've gained – we've actually submitted a number of additional registrations. And so, as we shared before, we're on track with our expectations to begin seeing the initial signs of some of those synergies coming through in FY 2017.

And as we shared in the past, we expect those initial synergies to show up in our consumable Medication Management business, which is MPS..

Thanks for your questions, Rick..

Your next question comes from the line of David Lewis with Morgan Stanley..

Good morning..

Just two quick questions, guys. I guess, the first thing for Chris. I'm thinking about 2016, Chris. And so, obviously, the underlying earnings growth this year has been extremely strong. It sets up more of a difficult comparison for 2017.

So, I know it's early, but I wonder if you're willing to comment on sort of the comfort with consensus next year, which is sort of low-double digits, sort of low-teens and some of the factors that get you that comfort, if you're willing to provide it. And then, just maybe for – a second one for Chris. Just the capital deployment priorities.

You mentioned deleveraging here into this year, into next year. How are we thinking about capital priorities? Maybe it's also a question for Vince in terms of future M&A, share repurchase activity or further deleverage. Thanks..

Great. David, thanks for those questions. Absolutely, as I think through fiscal year 2017, I would take you back to our normal model, which is mid-single digits, 5 percentage on the top and 10 percentage on the bottom. On top of that, you get a couple of hundred basis points coming from the synergies that we've talked about.

And then, I think you just have to take into consideration – and I'm not sure everybody's model shows this yet, the $0.10 to $0.14 that come from the Respiratory dilution. So, that gets you to a number that is clearly in the low-double digits, as you said. So, I have a lot of confidence in that.

What I'd also point to though is the variables of the headwinds and tailwinds, which generally come from FX and pension, and it's too early to call either of those. And we'll certainly give more guidance on that in November as we provide specific guidance. But right now, neither one of those seem too bad.

If FX stayed where it is, it'd be pretty neutral. Pension right now with interest rates are probably a slight negative, but that could change between now and September when it gets measured. So, bottom line is we're really feeling good about that.

On to your second question, in terms of capital allocation, you see that we are making great progress towards our 3 times leverage. We're already down to 3.4 times. So, we're well on our way. So, thinking about the second half of next year, we will certainly be in a position where we can – our cash flow is good.

We'll be in a position to start on redirecting some of that cash away from debt pay-down and back to the more traditional capital allocation methods that we have. I think what you could expect us to do is go back to a similar model that we had pre CareFusion acquisition, where we look at tuck-in acquisitions.

We make sure we're invested in the business, clearly, first. We have always been increasing our dividend, and we continue to increase the dividend, obviously, as we did the CareFusion transaction and we've been increasing 10%. But because the bottom line is growing more than 10%, the payout ratios come down.

So, I think we've got to bring that more in the line and do a little bit of catch-up there. And then, obviously, that still leaves a lot of cash leftover. We would rather not have that build-up on the balance sheet. And so, we would likely go back to some share buybacks. Having said that, I intend to go through that in November. We do have some time.

I'm actually thinking of getting all of your input between now and March to let us know what you think. And so, I'd encourage that. And as you know, we've been already beginning that kind of dialogue. And so, the good news is I think we have a lot of cash and some positive things that we can do in terms of allocating that.

So, that's a way to think about it..

And, David, we haven't changed our philosophy on M&A. We're going to be very strategically driven, number one. We're not size driven or – it's really about what is the strategy and how does that create shareholder value. And so, just as you've seen us do that in the past, that's the way we're going to approach it in the future.

Thanks for your questions, David..

Your next question comes from the line of Larry Keusch with Raymond James..

Well, hi. Good morning..

Good morning, Larry..

Two questions for you. I'm wondering if you could perhaps help us think a little bit about the agenda, if you will, for the November Analyst Meeting, just on a high level, just trying to figure out what you guys are thinking about covering there..

Well, we have a lot of new things in the pipeline. We've integrated a lot of things, but I don't think you've had the opportunity that the market hasn't had the opportunity to really see. And so, we're thinking that we have to cover both segments for you. We have to get into in-depth on Medication Management, kind of, across the care continuum for you.

We really haven't had that in-depth discussion. And so, that will be a major focus. And then, on the Life Science side, we have a lot to talk about in the core businesses and then the ramp-up of things such as genomics. So, we're going to make sure that you really understand these things.

We know that we're a little difficult to understand because there's so much to cover. So, we're going to try to be concise about it. And then, hopefully, we can give you a little sense of the capabilities we have been building at the same time to drive this new wave of innovation. So, those are what we're really looking at.

And then, around the same time, as Chris talked to you, we're going to focus on capital allocation. Maybe not in that meeting, but as we do the earnings call. So, those are the big things that we want to talk to you about..

Your next question comes from the line of Brian Weinstein with William Blair..

Hi, guys. Thanks for taking the question..

Good morning, Brian..

So, a question on Africa, Middle East, the headwinds that you have there. Can you describe some of that in more detail? In Africa, specifically, you said you're monitoring the CD4 and viral load situation there.

But what can you actually do proactively there? And how meaningful of a headwind is this for you, guys, right now?.

Sure. So, Linda can address that question..

Hi, Brian. It's Linda here. So, as we discussed on our last call, the decline in the Africa HIV business is largely associated with, now, the regional health systems in Africa starting to implement the HIV viral load testing based on WHO guidelines. So, what we are seeing is two things occurring.

Number one is tenders that have been previously issued, the amount of volume against those tenders, we're seeing come down, and then the actual tenders themselves being cancelled. So, the impact on our quarter was roughly 200 basis points. And as we exit 2016, we believe that the headwinds are largely behind us.

The size of this business in Africa now, think of as being under the – around the $30 million range..

And, Linda, the 200 basis points you were talking about was on....

Yeah, the 200....

Life Sciences....

Was on the Biosciences growth within the....

Biosciences growth..

Yeah. And on Life Science, as you saw, we took the guidance down. That was reflective of what was happening in Africa, and that was about 50 basis points – talking about a $20 million kind of hit. And that – we see that as largely behind us. So, we don't carry that going into next year, and it's behind us..

Yeah..

Your next question comes from the line of Vijay Kumar with Evercore ISI..

Congrats on the nice quarter..

Thanks, Vijay..

Maybe just one housekeeping question on – I know, on the last call, you guys spoke about the comp metrics, the triggers for comp being changed from the June to September fiscal end. I'm just wondering, how is that, as we're modeling 4Q, right, because it looks like the EPS guidance is a little light relative to what the Street is modeling.

Is this just because of how this comp moved from 3Q to 4Q (42:04) the Street was modeling?.

Yeah, I know, Vijay, so you're pointing to slide 14 and I think we gave that to give you a sense that the revenue growth in the quarter just increases a little bit in the fourth quarter, but the growth rate is significantly different and that's all about last year.

So, if you remember last quarter, I mentioned this, this time, we thought we'd actually give you a chart that kind of demonstrates it because I think, if you really study that chart, you can see that the growth rate is moving around, but the dollars have nice, sequential increases every quarter.

And so, that gives us the confidence that we can achieve that in the fourth quarter. To your point on EPS, it's really all about the fact that we let the over-performance in the third quarter, we let half of that flow through and then the other half is what we're investing. If you do the math on that investment of R&D, that's about $25 million.

That takes you up close to 7.5% of revenue in the fourth quarter. And so, that's the other half of the overachievement in the third quarter that we're going spend. And when you think about that, it's really – we couldn't really spend it in the second quarter. We just couldn't get the programs in place fast enough.

We've spent the fair share in the third quarter at 6.5% of revenue, so we started getting some traction on reinvesting in medical devices there and fourth quarter is really a catch-up. So, when you look at how much we're spending this year on R&D related to medical device tax, it's the entire amount of the medical device tax that we get in benefit.

So, think about that more as a catch-up. Now, in addition to that, on EPS, we talked about headwinds from FX and that's certainly the other piece of it. We get a little bit of a headwind from the euro going from $1.13 down to $1.11, but the bigger portion is the other currencies.

And those other currencies are – there's really three that are driving that impact. The Yuan in China has significantly weakened against the dollar since May, about 3% weakness. The Mexican peso has weakened about 6% versus the dollar. And obviously, the British pound, we all know, from Brexit, impacted by about 9% from our May call.

And those are the three that are driving the preponderance of the headwinds on FX in the fourth quarter. Thanks very much..

Your next question comes from the line of Derik De Bruin with Bank of America..

Good morning, Derik..

Good morning. So, I've got one housekeeping question and just a broader one. The housekeeping question is what's the overall impact of the Spine divestiture? Can you give us a run rate? And then, the follow-up on that is – and since you mentioned BREXIT, I guess, you talked about some weakness in Eastern Europe.

Can you just, sort of, elaborate on what you're seeing in those market trends and sort of how do we think about the impact to the – some of the uncertainty in Europe going forward? Thanks..

Okay. So, I'll take the first piece. The Spine business is about a $25 million business. So, that should help you in terms of getting the sense of the size that..

And then, for Brexit, we don't see any significant impact to the business. It's very difficult to say exactly how this is going to play out. It's going to take years to play out. No one knows exactly which model they are going to follow.

But I think the UK business for us is around $250 million, but we expect the NHS is going to continue to buy product to support the country. So, we don't see a big impact..

Your next question comes from the line of Jon Groberg with UBS..

Great. Thanks a million, and congratulations. So, just an end market question for you, Vince or whoever you want to hand it off to.

One, can you just give us an update on China on kind of where you are in terms of some of those inventory issues that you called out earlier in the year and just what you're seeing generally in China? And then, in the U.S., I think a lot of people are a little bit perplexed, given what you see hospitals are reporting and MLR ratios.

Can you maybe just talk about what you're seeing from a utilization standpoint in the U.S.? Thanks..

Yeah. Well, starting on China, we had a strong quarter in China. So, we think those inventory issues are behind us. And so, we're not seeing a lot of change in the environment from quarter-to-quarter.

What we did see was a little bit of strengthening on the Life Science side of things and some of the tenders that we had seen postponed are starting, so it gives us a little bit more confidence on that side, but we continued to see strong performance on the Medical side of the business, consistent with what we've been saying.

So, pretty stable there and optimistic as we look towards next year.

And then, what was the second piece that you were asking about?.

(47:26) U.S..

U.S.? So, U.S. utilization seems to be stable to maybe up a tick. I can't give you any real specific data on that. But just in talking to the organization, the U.S. organization, we're feeling quite good. That's the clinical market I'm talking about. The U.S. research market is doing quite well and you saw that, of course, in the Bioscience business..

Your next question comes from the line of Brandon Couillard with Jefferies..

Hi. Good morning. It's Justin in for Brandon..

Good morning..

Good morning..

Could you just provide some color surrounding the strength in emerging market safety? And how much longer can the segment grow in the double digits?.

We think we still have a long runway there in the emerging markets, and Tom can give you a little bit of color. But a lot of what we saw of this in core products was the catheter area. But, Tom, maybe you want to talk about China and where they are. In Brazil and Latin America, they're real drivers for this..

Sure. Hi, Justin This is Tom. So, as Chris had mentioned, specific to the Medical segment, we grew 9.6% in the quarter. As Vince just alluded to, safety catheters were a major contributor to that growth, particularly in Europe and China. Within the U.S., we saw growth in the third quarter really driven by safety connectors on our infusion set.

I know you didn't specifically ask about Europe. It's a common question as well. And so, we do see safety continuing to also perform well in Europe. Compliance with the regulation is continuing, and it's the major driver of that safety growth.

We've shared in the past that we really see stronger conversion in the infusion therapy and still more of infusion therapy as well as blood collection with less conversion in injection. So, that's more room to go there.

And overall, as you think about it, in terms of what we still have ahead, we're still in the middle innings in European safety conversions, let's say, in that start of the fifth..

Yeah, and earlier in emerging markets..

And earlier in emerging....

(49:31) just starting in the first and second inning in emerging markets..

Yeah..

Your next question comes from the line of Michael Weinstein with JPMorgan..

Great. This is Robbie Marcus in for Mike. I just wanted....

Hi, Robbie..

To follow up – oh, hey. I just wanted to follow up on the fiscal year 2017 outlook, maybe focusing on revenue growth.

So, with some of the upcoming launches, like infusion set early next year and some of the early CareFusion approvals in China, are you expecting the top line to accelerate next year and how should we be thinking of that? And if not, what are maybe some of the other puts and takes we should be considering?.

Sure. Let me take a shot at that, Robbie. Yes, we do expect acceleration next year from where we are in 2016. And what contributes to that is we begin to see some acceleration in terms of revenue synergies from CareFusion. Think about that in tens of basis points. You'll also get a lift from Respiratory going away.

And to size that, the impact of Respiratory this year for the full year and it's choppy, as we said, it was about 60 basis points in the third quarter. But over the course of the whole year, it's worth about 10 basis points. And so, you get a little bit of a lift from that naturally, and we feel good about the rest of business.

As we talked about emerging markets, we see getting back to the high-single digits kind of range, which is really where we were this year, if you exclude the issues in the Middle East, which was both Africa and in Saudi Arabia, which we talked about on the last call.

And so, we feel good about that, and developed markets are continuing to do very nicely. So, we feel really good about our revenue guidance for next year.

We'll clearly give you a lot more details as we get into the November call and give you a little bit more about the specific products that we have in the pipeline and the Analyst Meeting in November..

And the only other thing I would add is, as we think about it, Saudi Arabia, we're expecting it to be stable. Going forward, we don't expect any major change there. And then, on the Life Sciences side, as we talked about the situation in Africa, we think it's going to stabilize as well, too. So, that's how we're thinking about it..

Your next question comes from the line of Bill Quirk with Piper Jaffray..

Great. Thanks. Good morning, everybody..

Good morning..

Good morning..

So, I guess, two questions, guys. First off, at AACC this week, you had a new Vacutainer. I was hoping you could maybe elaborate a little bit on that in terms of, I guess, some price specifications, kind of, what that could possibly do incrementally for margin structure, et cetera.

And then, also, just want to highlight on the microbiology comment that you made. I would be curious as to, kind of, what you're seeing bigger picture there. There does appear to be, I guess, more interest in the category from an investment standpoint than a lot in both domestic as well as European hospitals. Thanks..

Okay.

Linda?.

All right. So, thanks so much. Yes, the technology you're referring to in PAS is called a Barricor technology. So, if you think about blood collection, we created a blood collection tube with our gel about 25-plus years ago. So, this is the next generation. It uses no gel. It's a mechanical separator. So, we're really looking forward.

If you think about what this drives for the lab, it really drives so much higher quality, cleaner sample. Just think about all the breakdowns due to the gel in the clinical diagnostic systems, think about that going away and then just driving better workflow efficiency and lower cost. So, we've now rolled that product out outside of the U.S.

We're seeing a lot of activity in terms of numbers of accounts that are validating this. So, the validation cycles will take some time, so really start to see the impact of this in 2017. And then, we expect our U.S. launch to occur in 2016. So, really excited about that one. Moving on to microbiology.

Broadly, of course, we saw a lot of share gains over the course of the last year in our BACTEC. But if we think about what we're trying to do in the microbiology lab, it's really about our Kiestra system and doing two things. So, the first thing we've done with Kiestra acquisition a few years back is really focus on the full automation.

So, moving that plate right from the start of streaking that plate right through to IDAST. Kiestra links all of those systems completely together. And then, over the course of the last year, we worked on our Infostratus (54:29) program, which will now drive informatics around that platform.

And of course, the first thing that we will do on that informatics side is launch our Veritor Plus, which is our flu. It will be the next-generation Veritor for us, which will link in to that system which will launch in Q4 of this year. So, hopefully, that gives you a good picture about on the PAS side. We're really excited about the innovation.

I talked about the tube side. We also have innovation on the needle side and then what we're doing in the microbiology labs..

And from your question in terms of margin on – the product will have attractive margins. There's no big impact in terms of start-up costs next year; it's kind of in the regular course of things..

Your next question comes from the line of Doug Schenkel with Cowen..

Hey. Good morning, guys..

Good morning..

I guess, my first question is for Vince. My second is for, I think, Linda or Chris. Vince, we appreciate all the detail on operating investment in Q4.

Could you share any detail on areas of prioritization associated with the increased R&D investment? And should we think about this as a pull-forward or more of the new normal or maybe a bit of both? And then, again, for Linda or Chris, regarding the cut in Life Science revenue growth guidance for the year, I think you only called out Africa and Middle East weakness as specific reasons for the cut.

I think the reduction translates into about $200 million. Assuming my math is right, on the surface, it seems like this is a lot to attribute all to geographic weakness, especially at this point in the year. I'm just wondering if there's other dynamics worth calling out. Thank you..

Let me address that one first before we get into the other piece. Your math is off by a decimal. It's about a $20 million impact on a $4 billion business. It's about 50 basis points..

Okay. That makes more sense. Thank you..

There you go. In terms of the R&D spend, you should assume that we will continue to spend the medical device tax as it is suspended and think about that going into next year. And you don't start a program and finish it in one quarter. These things will continue.

As I was mentioning, this is an acceleration of the strategy that we have, and we've seen some really attractive opportunities to accelerate that strategy, both on the Life Sciences and on the Medical side. You were mentioning microbiology in your question.

We said that is one of the areas in terms of the automation that we felt, with the opportunity that we're seeing for that platform globally, that we could extend that platform. We had finished the technology feasibility, so we felt really good about it. And so, Linda took the opportunity to do that.

Now, on the other side, Tom had a series of opportunities in the Medication Management area, where he could accelerate his programs around Medication Management, including the informatics piece of that strategy and there was some opportunity to get some technology from the outside, which we took advantage of.

And so, we were very happy that these things came together in that way. We think it positions us well going forward..

And I just want to be clear, Doug. I referenced the fourth quarter margin or the investment as about 7.5%. That's not the new normal. I think, going forward, you would still think about R&D as a percentage of revenue in the 6% to 6.5% percent. But fourth quarter is a bit of an anomaly that it's a bit of a catch-up.

It's a bit of a catch-up and there's a little bit of onetime, and that's what I was indicating with my opportunistic comment..

Right..

Your next question comes from the line of Matt Taylor with Barclays..

Hi. Thanks for taking the question. I just wanted to ask an emerging market follow-up question. You talked about expecting high-single digit growth going forward. When you looked through some of the, kind of, near-term temporary headwinds....

Yeah?.

You've had better growth than that in the past.

I guess, can you just talk a little bit about how you developed that forecast, the factors that go into it and what could be sources of upside or downside to that number?.

Sure. When we think about emerging markets, obviously, we start with Asia. And within Asia, we start with China, and we're looking at healthcare spending in China and how that is unfolding. And what we're seeing is consistent spending in China.

We break that down then to look at business by business, what's happening on kind of the capital side of things as they're purchasing. That's more of an impact obviously on the Life Science side than on the Medical side. And then, we go back and look at the Medical piece in two ways.

Of course, what's the opportunity for core growth and then, as Tom was talking about earlier, all the product registrations that we have for China and other marketplaces from the CareFusion acquisition. So, that's China, number one.

Number two, we're looking at India as a growth driver and that has – in the last two years, that has picked up and have been a good growth driver for us. Now, there's pluses and minuses in India. We're seeing good fundamental demand there with the burgeoning middle class. We're expanding our distribution in India, so we will take that into account.

There are some headwinds in India in terms of tariffs that have been put in place. So, we make sure that that's not any significant impact, but – so, I would say we still find it as a very attractive marketplace for us. In Middle East and Africa, of course, we're much more careful about what's going on in Saudi Arabia.

We follow what the government funding is. In this case, of course, the funding was not just in healthcare, but it was a significant change, linked to the price of oil that we saw.

And so, the way we're thinking about that is, kind of, the price of oil staying where it is, which means on the low side, which says that they're going to fund their healthcare, but it's not a big expansion of healthcare. That was going on in the first half of the year. That's not happening now. But they have to continue to provide care.

That's what we're thinking about there. In Africa, we talked about the CD4 business and some of the shift in the guidelines. We've seen – we believe we've seen the majority of that impact that's really driven by PEPFAR, not the entire marketplace. So, it's a segment of that market. So, we'll watch how that evolves, as Linda said.

Then, Latin America is a mixture for us. Mexico is doing well. Brazil is doing okay is what we would say and we watch the economy there and what's happening from an inflationary standpoint. And of course, funding – but the other countries in Latin America are contributing quite nicely. That's how we build it up..

Your next question comes from the line of Richard Newitter with Leerink Partners..

Hi. This is Ravi in for Rich. Thank you for taking the questions. Just wanted to build on some of the other questions that have been asked.

Just in terms of the CareFusion, the growth registrations that you're going through right now, could you maybe just give us a look into what's the denominator behind that? I mean, is this sort of the bolus of all the registrations that you're doing or is there a lot more products that remains to go to that pathway? And then, I have a few follow-ups.

Thanks..

Sure. Tom will take that..

Yeah. Hi, Ravi. This is Tom. So, I wouldn't say this is the bolus of them. The numbers that we've cited are certainly less than half of the products that we intend to have registered outside.

We obviously started with those products that we have the data available for that didn't need to have additional data generated, and we're in existing formats that those markets would accept, take, for example, as we would think about pumps. In some cases, we need to do translation and get the language done first.

That's an R&D program to get that ready. Some of the markets require infusion sets to be adapted a bit for local practices. And so, what you saw come through first are obviously those products that meet the needs of specific geographies, we the data ready and we'll move forward and submit right away.

And so, most of those also tend to be on the consumables side I shared earlier, which is why, as we think about FY 2017, we would expect those synergies to really be focused within our MPS business because that's where those more simple medical devices that are more universal in nature in terms of how they fit in with the healthcare system that's (01:03:42) to be focused..

Great. Thanks, Tom..

Your next question comes from the line of Kristen Stewart with Deutsche Bank..

Hi, everybody..

Hi, there..

Good morning, Kristen..

Just as a follow-up to that, I was wondering, Tom, if you could just give us a sense for just how much of an acceleration we should expect to see from some of these filings and how fast can some of this ramp up or how meaningful are these registrations?.

Yeah. As Chris mentioned, we think about it in tens of bps, not dramatically higher than that. And again, just to put things in perspective, we're really pleased with the performance and outlook even that we've gotten as early as in FY 2016. Of course, as we have said, CareFusion was 3%, 3.5% at best, growth business as a standalone.

We're holding at our 4.5% to 5% growth for the segment overall. And as you know, when you take a 3% grow and a nearly 5% grow, you don't get within the range that we're sharing. And so, we're already. We see some good performance this year already as a result of the two companies coming together.

We think some incremental improvements on that, in FY 2017, specifically within the MPS business in that 10s of bps as Chris described. The other thing also to keep in mind is that some geographies take a lot longer. So, China, although it's a market that we are filing registrations in, once you file a registration in China, it's a three-year process.

So, you can't get into certain markets that fast. Typically, more of the European, Latin America, Southeast Asia markets are those geographies that you can actually get into within an 18-month window. And so, that's where you'll see us enter in first.

Those aren't necessarily as large as some of the markets like China, which will be later on in our three-year and outlook horizon. Okay. All right. Thank you..

At this time, there are no further questions. I will now turn the conference back over to Mr. Vince Forlenza..

Okay. This is Vince. Listen, thank you for your questions and comments on the call. We look forward to briefing you at the end of next quarter. Thanks very much..

Thanks, everyone..

Thank you..

And this concludes today's conference call. You may now disconnect..