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

Michael Weinstein - JPMorgan Securities LLC David Ryan Lewis - Morgan Stanley & Co. LLC Kristen Stewart - Deutsche Bank Securities, Inc. Rick Wise - Stifel, Nicolaus & Co., Inc. Lawrence Keusch - Raymond James & Associates, Inc. Vijay Kumar - Evercore ISI Brian D. Weinstein - William Blair & Co. LLC Jonathan Groberg - UBS Securities LLC William R.

Quirk - Piper Jaffray & Co. Derik de Bruin - Bank of America Merrill Lynch Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Richard Newitter - Leerink Partners LLC.

Hello and welcome to BD's fourth fiscal quarter and full fiscal year 2016 earnings call. At the request of BD today's call is being recorded.

It will be available for replay through November 10, 2016, on the Investors page of the BD.com web site or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 94169710. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin..

Thank you, Christy. Good morning, everyone, and thank you for joining us to review our fourth 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 fourth 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 fourth quarter results reflect the new BD in both the current and prior year periods. In addition, comparable prior year revenues are adjusted to exclude the sales related to the terminated agreement with CareFusion for the sale of SMP's respiratory care products.

The impact to the bottom line was not material. Comparable organic revenues are adjusted to further exclude the impact of non-annualized acquisitions and closed divestitures.

The fiscal 2017 comparable revenue guidance provided today will exclude revenues of closed divestitures, most notably the Respiratory Solutions business that was divested in October of 2016, just after our fiscal year end. In the fourth quarter the company recorded a non-cash impairment charge for capitalized internal use IT software assets.

This charge, along with the details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides.

Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Chief Administrative Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Alberto Mas, 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. First, congratulations to the Cub fans out there, especially the BD associates in Chicago. In the words of Brian Weinstein, go Cubs! Moving on to my presentation. As we stated in our press release, we are extremely proud of our accomplishments in our first full fiscal year as the new BD.

As you already know, the acquisition of CareFusion 18 months ago significantly accelerated our strategy. And the powerful combination of BD and CareFusion continues to deliver positive results. We've seen significant benefits as a result of this transaction from a customer, employee, and shareholder standpoint. And we think there's more to come.

Turning to Slide 4, I'd like to highlight some key achievements in fiscal year 2016. First, our results reflect our consistent performance and the benefit of our diverse geographic and product portfolio. Legacy BD remains solid. And the CareFusion portfolio has performed in line with our expectations.

Second, emerging markets continue to be a key growth driver for the company. We experienced some headwinds this year, particularly in the Middle East and Africa, but remain confident that emerging markets are well positioned for continued growth.

We also continue to create new growth opportunities for CareFusion products in these markets and expand their global reach by leveraging BD's international infrastructure. We're on track with our new product approval and submission plans and look forward to providing more color at our analyst meeting later this month.

Developed markets continued to show stabilization. And growth has accelerated over the past year. Third, we made key strategic decisions to optimize our portfolio. This included the divestitures of BD Rx and the Spine business in conjunction with the joint venture for the Respiratory business, which we just completed in October.

These actions further enable the organization to prioritize and invest in the most important opportunities for future growth. We were deliberate in increasing our R&D investment in targeted high growth areas and fully utilized the benefit of the medical device tax suspension.

Fourth, we remain focused on our operating effectiveness and efficiency initiatives, which have generated significant margin expansion. This year, we drove approximately 200 basis points of underlying margin expansion, which includes approximately $120 million in cost synergies.

We also delivered robust earnings growth of almost 30%, which is greater than our initial expectations. Lastly, we closed our first full year as the new BD, having achieved all important milestones. And also demonstrated that we are successfully executing on our acquisition of CareFusion.

As we look forward, we continue to build on our solid foundation and look to fiscal year 2017 and beyond with confidence. Moving to Slide 5, you will see the guidance for fiscal year 2017 on a currency neutral basis.

For the fiscal year 2017, we expect currency neutral revenue growth of 4.5% to 5%, based on our current view of the environment and various macroeconomic factors.

There are a number of items that could bring us to the top or bottom end of that range, including a stronger or weaker flu season than expected, the performance of new product launches, emerging market growth, and pricing. On the bottom line we will continue to deliver high quality earnings growth.

For fiscal year 2017 we expect EPS of $9.45 to $9.55, or $9.62 to $9.72 currency neutral, which reflects growth of 12% to 13%. Now I'd like to turn the call over to Chris who will walk you through our financial performance in the fourth quarter and full year, along with the additional details about our fiscal year 2017 guidance..

Thanks, Vince, and good morning, everyone. Moving on to Slide 7, I'd like to begin by discussing our fourth quarter revenue and EPS results, as well as the key financial highlights for the quarter and the total year. Total fourth quarter revenues of approximately $3.2 billion grew 6.4% on a comparable basis.

Fully diluted adjusted EPS came in ahead of our expectations at $2.12, growing at 16.5% over the prior year. As Vince mentioned earlier, we are very pleased with our solid finish to the year, as the first full year as a combined entity with CareFusion. For the total year revenues grew 4.3%.

We significantly expanded our margins and captured approximately $120 million in synergy cost savings. Adjusted EPS of $8.59 exceeded our expectations, driven by solid revenues, margin expansion, and an improved tax rate.

In addition to the cost synergies, tax synergies have materialized sooner and have exceeded the benefits we anticipated in the early days of the transaction. We are also pleased to announce that we have continued to delever, as we reduce the debt associated with the acquisition of CareFusion.

We are currently at 3.3 times gross leverage and remain on track to achieve our commitment of 3 times gross leverage by March of 2017. On Slide 8 I'll review our revenue growth by segment on a currency neutral basis. Fourth quarter revenue growth was 6.4% for the total company. In the quarter pricing was about flat.

BD Medical fourth quarter revenues increased 7.9%. Medication and Procedural Solutions growth was 6.6%, which reflects strength in Flush [PosiFlush], ChloraPrep, and safety engineered products. Revenues in Medication Management Solutions, or MMS, grew 12.8%. This was driven by double digit growth in both dispensing and infusion sales.

Respiratory Solution revenues increased 12.7%, as expected. This reflects strong capital installations and a favorable comparison to the prior year period. Growth in Diabetes Care was 3.6%. This reflects solid growth in pen needles which was partially offset by an unfavorable comparison to the prior year period.

Pharmaceutical Systems growth of 5.1% reflects strength in our self-injection platform. For the total year, BD Medical grew 4.7%. BD Life Sciences fourth quarter revenues increased 2.7%, primarily driven by growth in Preanalytical Systems and Biosciences. Diagnostic System revenues were about flat compared to the prior year.

This reflects continued strength in core microbiology in BD MAX, which grew double-digits in the quarter. This growth was offset by the timing of Kiestra installations outside the U.S., which I will speak to in just a moment. For the total year we are extremely pleased with our Microbiology business with Kiestra growing at about 19%.

Preanalytical Systems growth of 4% was driven by safety engineered products and growth in the U.S. and emerging markets. BD Biosciences growth of 4% was driven by continued strong research instrument placements in the U.S., and reagent sales. For the total year Life Sciences grew 3.4%.

The headwinds we experienced in Africa negatively impacted segment results by 60 basis points, bringing underlying growth to 4% for the total year. Moving to slide 9, I'll walk you through our geographic revenues for the fourth quarter on a currency neutral basis. U.S. growth was very strong at 7.2%.

This was comprised of BD Medical growing at 7.7% and BD Life Sciences growing at 5.8%. BD Medical's performance reflects strong growth in capital placements and a wide range of infusion disposable products in our Medication and Procedural Solutions business. Growth was also driven by our Pharmaceutical Systems business.

BD Life Sciences growth reflects strong performance across the segment in the U.S. The growth in our Biosciences business was driven by high parameter research instruments, including FACSymphony, our FACSCelesta midlevel analyzer and the launch of the FACSMelody. Our U.S.

Diagnostics business saw continued growth in Microbiology, including Kiestra and the BD MAX molecular platform. The Preanalytical Systems business grew 5%, driven by safety engineered products. Moving on to international, revenues grew 5.2%. This is below our normal growth rate, which is primarily related to the Life Sciences segment.

The Medical segment grew 8.2%. This was driven by strong performance from infusion disposable products in the MPS business and strong performance in China. Growth was also driven by medication management, reflecting double-digit growth in both dispensing and infusion. Growth in the Life Science segment was about flat compared to the prior year.

We experienced a decline in Diagnostic Systems due to the timing of Kiestra installations. Increased installations in the third fiscal quarter negatively impacted the fourth fiscal quarter in conjunction with a tough comparison to the prior year fourth quarter.

Biosciences growth was slower in the quarter due to continued declines in Africa, as we anticipated. The Preanalytical Systems business grew 2.9%, driven by strength in China, which was partially offset by a tough comparison to the prior year period. On slide 10, Developed Markets grew a healthy 5.8%, bringing the total year growth to 4.1%.

Emerging Market revenues grew 8.5%, currency neutral, bringing our year-to-date growth rate to 5.3%. China growth for the fourth quarter was 17.7%, bringing the total year growth rate to 10.1%. Growth in Emerging Markets this fiscal year was slower than initially expected in the Middle East and Africa.

And we believe those challenges are largely behind us after we exit the first quarter of fiscal year 2017. Emerging Markets remain an important growth driver. And given our robust international footprint, we are well positioned to drive growth well into the future.

Looking into fiscal year 2017, we expect Emerging Markets to grow high single digits, driven by a diversified base, with China growing low double digits, continued strength in Latin America, and fewer headwinds in EMA and Africa.

In terms of Developed Markets we believe the stability we have seen in the market over the past 12 to 18 months will continue, yielding a growth rate of about 4%. Moving to Global Safety on slide 11. Currency neutral sales increased 5.9% and grew to $783 million in the quarter. Safety revenues in the U.S. grew 5.7%.

This reflects continued strength of safety catheters, as well as a benefit from the timing of orders across our hypodermic products. International sales grew 6.2% currency neutral. International performance in the Medical segment was driven by continued strength in China. And safety revenues grew 13.8% in emerging markets.

Medical Safety sales grew 7%, driven by infusion disposables, catheters, and a range of safety engineered products. Life Sciences Safety sales, which were driven by our Preanalytical Systems unit, grew 4% in the quarter. Slide 12 recaps the fourth quarter income statement and highlights our currency neutral results.

Revenues grew a strong 6.4% in the quarter. Gross profit was strong, growing faster than revenues at 7.9%. And I'll provide more details on gross profit in just a moment. SSG&A as a percentage of revenue was 24.4%.

We are very pleased with the leverage we are getting, which is masked in this quarter by key strategic investments in product launches in both segments. R&D as a percentage of revenues was 7.8%, which is higher than normal due to the timing of spend, as anticipated.

As a result of the medical device tax suspension, we were able to make additional investments in a number of high growth areas. After normalizing for the significant additional investment in R&D, underlying operating income would have grown about 10% in the quarter.

Our tax rate declined to 16.2% in the quarter, due to the reinstatement of the R&D tax credit, tax synergies materializing earlier than expected, and continued favorable geographic mix. In the quarter adjusted earnings per share were $2.12, which is a 16.5% increase versus the prior year.

Turning to slide 13 and our gross profit and operating margins for the fourth quarter. On a performance basis gross profit margin improved by 90 basis points, driven by continuous improvement initiatives. This was more than offset by significant currency headwinds of 110 basis points.

On an operating margin basis we're extremely pleased to have delivered about 100 basis points of underlying margin expansion. As I mentioned on the previous slide, the leverage we are getting in SSG&A as we continue to drive cost synergies is being masked in the quarter by investments in key product launches.

In addition, margin expansion was partially offset by significant R&D investments, as expected, and unfavorable currency. I'd like to take a moment on slide 14 to highlight some of our key operational achievements for fiscal year 2016.

The acquisition of CareFusion provided BD a unique opportunity to leverage the transaction to optimize the combined organization through functional transformations. And we have made significant progress in this area. All of our efforts have yielded results, and we are on track to deliver continued synergies.

In aggregate we have achieved over $170 million in total cost synergies to date. We have also driven significant margin expansion on a multi-year trajectory. Starting with fiscal year 2015, we delivered 100 basis points of operating margin expansion. This year we achieved another 200 basis points.

And we believe we are well positioned to deliver another 175 to 225 basis points in fiscal year 2017. Over those 3 years we will have driven over 500 basis points of cumulative margin expansion. And I believe that we continue to drive robust performance with additional synergies in conjunction with continuous improvement going forward.

We are extremely proud of the organization's ability to continue improving on our skills and expertise by executing against our synergy commitment initiatives through these transformations. Moving on to slide 15. I'd like to highlight our robust EPS growth, which exceeded our expectations this year.

Starting with 2015 EPS of $7.16, we had communicated last November that we would grow EPS 22% to 23% on a currency neutral basis. Beyond our initial expectations, we delivered an incremental 400 basis points from margin improvement.

We also realized incremental benefits from our tax rate improvement, which yielded 300 basis points, bringing EPS to $9.24. Unfavorable currency headwinds impacted earnings per share by 900 basis points. Despite that significant headwind, we were still able to deliver $8.59 of earnings.

On a currency neutral basis earnings grew 29.1%, which we believe demonstrates our ability to deliver on our commitments. Moving on to slide 17. There are a number of factors to consider when discussing our earnings per share in fiscal year 2017. For modeling purposes and to ensure consistency, I'd like to provide more color on our EPS guidance.

First, as I mentioned, we are extremely pleased with strong EPS growth this year. Looking forward, we expect currency neutral EPS to grow between 12% and 13%. This is partially muted by the impact of the Respiratory JV, as we have previously communicated. Pension also presents a headwind next year of approximately 100 basis points.

Contributing to EPS growth is approximately 200 basis points from the adoption of a new accounting standard related to the tax accounting on our stock compensation programs. In addition, we estimate that currency will once again present a headwind. Our guidance assumes a euro to dollar exchange rate of $1.10.

On an adjusted basis we expect to achieve very strong earnings of $9.45 to $9.55. Turning to slide 18, I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2017.

As Vince mentioned earlier in the presentation, we expect revenue growth of 4.5% to 5%, with BD Medical growing 4.5% to 5% and Life Sciences growing between 4% to 5%. Growth in both segments contemplates a small amount of pricing pressure. From a phasing perspective we expect currency neutral revenue growth in the first quarter to be below this range.

This is primarily due to some lingering softness in the EMA region and the timing of tenders in our Biosciences business. This will result in a currency neutral revenue growth of about 4% in the first fiscal quarter.

We expect revenue growth to return back to our guidance range in the second fiscal quarter with continued acceleration over the back half of the year. We expect gross profit margin to be between 53% and 54%, which is a significant milestone for BD. SSG&A as a percentage of sales is expected to be between 23.5% and 24%.

Our guidance also reflects continued investments in emerging markets as well as costs related to new product launches and registration cost. We expect our R&D investments to be in line with fiscal year 2016, at about 6% to 6.5% of revenues, as we continue to invest in new products and platforms.

As a result of the items I just detailed, operating margin is expected to be between 23% and 24% of revenues, up from 20.8% (sic) [21.8%] this year. Excluding the unfavorable impact of foreign currency, we expect our underlying operating margin to improve by 175 to 225 basis points. This also excludes slight pension headwinds.

We expect our tax rate to be between 17% and 19%, driven by tax synergies, favorable geographic mix, and a benefit from accounting change in our stock compensation program. For fiscal year 2017 we anticipate our average fully diluted share count to be approximately 219 million.

Cash flow is expected to remain strong with operating cash flow of about $2.7 billion in fiscal year 2017. Capital expenditures are expected to be about $700 million. In summary, we have good momentum exiting this fiscal year. And looking forward into 2017 we are building off a solid foundation.

I'm confident that fiscal year 2017 will be another strong year of performance, positioning us well for continued success. Now I'd like to turn the call back over to Vince, who will provide you with our concluding remarks..

Thank you, Chris. Moving on to slide 20. We are pleased with the progress we continue to make on our pipeline and believe we have the most robust pipeline in the company's history. We have recently obtained a number of approvals. I'll touch on just a few.

On the Medical side of the business we are pleased that our partner, Fresenius, received their first FDA approval for IV solution products. Additional approvals are expected. And we are on track to start shipping these products late in the first half of the year.

Last quarter we received our first orders for FlowSmart, our new insulin infusion set, where Medtronic serves as our distribution partner. Early patient feedback has been extremely positive. On the Life Science side of the business, we are pleased that the FDA has approved the BD MAX vaginal panel and also the GC/CT/TV [CT/GC/TV] assay.

We launched our new Phoenix ID/AST instrument. We launched the FACSMelody and received approval for Barricor in the U.S. We plan to share more about our pipeline on November 17 at our upcoming analyst day.

Also on analyst day we will discuss the company's strategy and vision for the future and how we are helping to address healthcare's most pressing challenges. The segment leaders will do a deep dive into our business units, which will include some key product launches that we will be unveiling for the first time.

We will conclude the day with a financial framework that will outline our plans for sustainable revenue growth, continued margin expansion, strong cash flow generation, and capital deployment.

And ultimately demonstrate how all of those things will drive long-term value not only for our customers and patients they serve, but also for our employees and our shareholders. Moving on to slide 21, I would like to reiterate the key messages from our presentation today. First, we're extremely pleased with our first fiscal year as the new BD.

We believe that we have demonstrated that we can successfully execute on the integration of our – of the largest transaction in the company's history. Second, the diversity of our portfolio from a product and geographic perspective provides consistent and reliable earnings growth.

Third, we continue to invest in key strategic areas and at the same time deliver significant margin expansion and double digit earnings growth. We're looking forward to sharing more details about our pipeline at our analyst day in 2 weeks. We believe we have the most robust pipeline in the company's history.

And we look to fiscal year 2017 and beyond with confidence. Finally, I would like to say thank you to all of our associates around the world for our successful first full fiscal year as a combined company with CareFusion. It's a testament to the hard work of all of our employees that we delivered on our commitments.

I believe we have a tremendous opportunity to create a true industry leader, as we continue to advance the world of health. So with that, thank you. We will now open the call to questions..

Operator. Thank you. Our first question is coming from Mike Weinstein with JPMorgan..

Good morning, guys, and thanks for taking the question. So as a starting point, Vince, I'd love to hear your thoughts, just as you looked at FY 2017 about some of your end markets. And some of the businesses, as I look over the quarter and the full year 2016, did a little bit better. Some businesses were a bit more challenged.

And so maybe just focusing a bit on the more challenged businesses first, can you just talk a little bit about some of the headwinds that you saw? Particularly internationally in the Life Sciences business this quarter, this year? And how you think about some of those end markets in FY 2017? And then if you think about that in aggregate, that 4.5% to 5% revenue growth target for FY 2017, what gets you to the higher end of that range? Thanks..

Yeah. Yeah, Mike, sure. Happy to do that. I feel good about the 4.5% to 5%. And let me walk through the markets, and I'll hit the Bioscience issue which you brought up, which was really the real drag, along with, quite frankly, the flu early on in the year. So from a market perspective, let me just start with the developed markets.

The developed markets certainly have stabilized. And you've seen that our growth rate going up in the developed markets, in the U.S. The U.S. was very strong by the way, including Biosciences. Europe was good. Japan was good. So we feel good about our position in developed markets and the product pipeline we have for those marketplaces.

If I come to emerging markets, the issue really this year was, number one, Saudi Arabia, where we saw the government do a 35% cut of all types of expenses, not just healthcare. And that will annualize during the year. We already saw stabilization in Saudi Arabia. In terms of Africa, Africa was basically CD4 testing.

And CD4 testing was driven by, one, some conversion to viral load, and two, actually confusion over a change in the purchasing organization for CD4 and viral load. And we think we have one more quarter of that. We did start to see some CD4 orders come in in the fourth quarter and a little bit of a rebound.

But we know we have that in the first quarter, and then that annualizes and improves. Coming back to opportunities on China. You saw the strong growth in China in the fourth quarter. If you actually go back and look at China, after the first quarter, where we had some inventory takedown, China was strong for the other three quarters.

We expect that to continue. It was especially strong this year on the Medical side of the business. And we think we're well positioned with the work that Tom and the regulatory team have been doing with the CareFusion product lines there.

And as I've mentioned on previous calls, we've started with some of those product lines, kind of the simpler disposables. And I'm sure Tom will talk more about that later on in the call. If there was any softness in China this year from a true demand standpoint, it was on the Life Science side. And it was related to those anticorruption campaign.

And what we saw was stabilization starting in the third quarter and continuing into the fourth quarter. And Alberto can mention to you, he's starting to get ramped up. The Bruker deal in China as well, which was a whole new thing for us. We had to learn how to do that and work our way through some issues. So we feel good about China.

The rest of Asia has been good. Latin America has performed well this year, in spite of all those issues in Brazil. It's been the rest of the geography that has done fine. Come back to the 4.5% to 5%. Then the other element that you have to think about is two other things. One is we will not have Respiratory anymore.

And that has been a bit of a headwind for the company. And then we think in the back half of the year you'll start to see more traction with our product launches. Things like Barricor, they have to do the validation first. So that takes a little while to get going. Customer feedback has been excellent.

Alberto can talk about the product launches that you heard for BD MAX. Those are really critical assays to that program. We're excited about them. And so there's a whole list of these things. And we'll show you more about that as we do the analyst day. So that's the way we're thinking about it..

One way to sum that up – this is Chris – is that if you back out the light flu season and the headwinds from Africa and Saudi, the rest of the business was at the high end of the 4.5% to 5% this year alone. We see those headwinds abating after the first quarter. Because it really came up in the second quarter – second, third, and fourth of this year.

So we still have a little bit of a tough compare in the first quarter that we talked about, particularly in Saudi and Africa. But once we get through that with the new product launches that we're seeing, the strength of the rest of the business, we feel real good about our prospects for 2017..

So what takes you to the top end of the range? Obviously, if those product launches, we get faster traction on them, number one. Two, with flu, flu was very mild last year. It's hard to believe that it would be milder. So if we got a strong flu season, that would take us up, too. Those are probably the two factors that I see.

So thanks, Mike, for the question..

Thank you. Your next question comes from David Lewis of Morgan Stanley..

Good morning..

Morning, David..

Two quick questions. I'll just – I'll throw them both at you here and jump back in queue. So I guess first off, hats off to Antoinette and the tax team in reaching your target here at least 2 years early from our model.

So, Chris, is this a structural kind of new low? Can you do better? And obviously, you're reinvesting these savings both in the fourth quarter and next year.

Can you give us a sense of where the 2017 reinvestment is going? And can you do better than these levels long term? And then for Vince or Tom, o-U.S., Pyxis, and Alaris, very strong this particular quarter. Can you talk about the drivers? And sort of update us on how those numbers relate to progress on the CareFusion cross sell? Thanks so much..

Sure, David, thanks for the question, and thanks for the call-out to Antoinette and team. We've been talking about taking the tax rate down to the high teens for some time now. And we've been making great progress against that. As we mentioned on the last call, the tax synergies coming from CareFusion happened faster and greater than we ever expected.

And so we're seeing the benefit of that. So as we look out into next year, we see that bringing us to the high teens. Then we've got the benefit of the stock comp accounting adjustment. That brings us down to the 17% to 19% range.

So this move down is part of the march down in the tax rate that we have been seeing, coupled with the benefits that we're getting from the synergies from CareFusion. And so we really feel good about that. We've also closed out a lot of tax exams in multiple jurisdictions.

We're part of the IRS's CAP program, so they're auditing us on a real-time basis. So the sustainability of this tax rate is extremely strong. And we feel real good about it..

Okay, thanks, Chris.

Tom, you want to pick up on the second part?.

Hi, David. So as you mentioned, MMS had a very strong quarter, a little under 13% growth in the quarter, about 7% growth for the full year. And maybe just to touch base on the two areas that you mentioned, Pyxis and Alaris. Certainly, Pyxis ES continues to go very well.

We had talked earlier in the year about some of the process improvements we had made to accelerate the installation process. I think you're seeing the results of that work come to fruition now with faster installations, getting those systems in.

We now have over 1,100 sites live on ES or about a third of our install base is now upgraded to the ES platform. And the receptivity is very solid. And we expect strong demand on that going forward. Alaris, we continued to gain about 2 to 3 points of category share this past year in FY 2016.

And we're looking at kind of a similar progress outlook for FY 2017 as well. And so we certainly do have organizations that are cross selling those as an integrated offering.

You'll see at analyst day us talk about some new informatic capabilities and other new products coming out that will further strengthen the integration and the value that we can deliver to customers who are using that complete end-to-end offering. And so we'll look forward to talking to you about that very shortly..

Thanks, Tom..

Thank you. Your next question comes from Kristen Stewart of Deutsche Bank..

Morning, Kris..

Hi, good morning, thanks for taking the question.

I was just wondering, as you're approaching your I guess targeted debt levels, how you guys are thinking about M&A kind of beyond that? Are you guys looking at doing some strategic tuck-ins? Or just given the success that you've had with CareFusion, whether or not you'd be willing to do another larger deal? Or would it be back to doing more share repurchase activity?.

So, Kristen, thanks for the question. When we think about M&A, we are strategy driven and shareholder value driven. And so the size of the transaction actually follows from the strategy. As Chris mentioned, we're about 3.3 [times] right now.

By the time we get to March, we're pretty sure that we're going to be meeting our requirements to the rating agencies. What I would say is that gives us more flexibility around those strategic imperatives. And so we believe we now have the capability to do large. And of course continue to have that capability to do tuck-ins.

And a little bit more flexibility to do the tuck-ins in the short run than we've had over last 2 years. And so I'm not sitting here saying we're going back to do a large one. We'll be strategy driven around this, with increased flexibility and capability that we have built over the last couple years.

Chris, you want to talk about share buybacks?.

Yeah, sure. So what I would say though is in addition to that, the continued strong cash flow is terrific. So we have a lot of flexibility. And as Vince mentioned, the balance sheet will be very strong. It is strong now at the 3 times 3 (sic) [3.3 times], but when we get to 3 times leverage, we get a lot of increased flexibility.

So as we think about the use of that cash flow, we'll probably do something on the dividend rate. You know that the payout ratio has come down a little bit. We increased 10% a year for the last couple years. The good news is our EPS has gone up over 20%. So the payout ratio has come down a little bit. And we will have to address that going forward.

I think CapEx, as you think about it, will be in the $700 million range. That's pretty consistent with where it has been. So that leaves a lot of cash left over. We'll allocate some of that for tuck-in acquisitions. And that will still leave a lot of cash left over. And we're not going to let that cash build up on the balance sheet.

So we'll return to doing some share buybacks. You'll hear more about that at analyst day. And certainly as we approach the March period of getting to the 3 times leverage, we'll be giving a little bit more specificity on where we're going. But the good news is, really strong cash flow and a really solid balance sheet with a lot of flexibility..

Okay. Great. And then just one other question. You had mentioned building in a little bit more pricing pressure into the forecast.

Can you maybe comment on where you're seeing a little bit more pricing pressure, or expecting that to occur?.

So we haven't really seen the environment change all that much. We know that there's going to be pricing pressure. We've talked a lot about it being in Europe. And of course over the last few years we continue to see consolidation in the U.S. marketplace. So I think we're being prudent in terms of how we're thinking about this.

And we'll continue to work as we have in the past to offset it..

And it's already built into the range of guidance that we're giving..

Right..

So it's kind of the part of the range is the pricing..

Thanks, Kristen..

Thanks very much, guys. Thank you..

Thank you. Your next question comes from Rick Wise of Stifel..

Good morning, Vince. Hi, Chris..

Morning..

Maybe I'll start off with the gross margin. Chris, you emphasized, underscored the excellent gross margins and hitting significant milestones. I'd just be curious to hear your thoughts on your aspirational goals from here over the next 2 to 4 [years], 3 to 5 years. And maybe talk about the drivers, volume cost, mix.

I mean what gets us to those higher levels I have no doubt you aspire to?.

Sure. Thank you, Rick. We are really pleased with what we've seen this year. The FXN growth rate was 140 basis points. That's a little bit of synergy from CareFusion. But more it's just the continuous improvement that we've demonstrated that we can execute on within our operations group over the last few years.

And as we look forward, the guidance that we gave of 53% to 54%, and that would be inclusive of FX headwinds and pricing headwinds, et cetera, is extremely strong. It's a significant milestone for us to hit that 53% to 54%.

We do see a little bit of more synergies coming, because as we execute on the synergies that affect gross profit and the cost of goods sold, which we said would come towards the latter end of our synergies, and that is the way that it's playing out. But again continued continuous improvement in that area.

So feel really good about the gross profit margin. Also that flows down to the operating margin. So as we mentioned, this year 200 basis points, last year 100 basis points, next year in that 200 basis points kind of range. 500 basis points in total, again driven both from execution of the synergies as well as continuous improvement initiatives.

So feel real good about that. And as we look forward even past next year, 2018 will have continued cost synergies. And you'll see some benefits from that. So all in all, really strong margin improvement. And we feel real good about it.

Thanks, Rick..

Thank you. Your next question come is from Larry Keusch of Raymond James..

Thanks, good morning, everyone. I was just wondering if we could go back and expand a little bit on – I know Tom talked a little bit about Alaris.

But I was wondering if you could weave in some thoughts around the Fresenius IV solution that was approved, a little bit about what you do anticipate launching with towards the end of the first half, and what drives that share gain for the year that you're sort of suggesting of 200 to 300 basis points..

Sure..

Hey, Larry, this is Tom. So that share gain that we saw this year is actually relatively consistent with the share trajectory that we've seen over the last, let's call it 4 to 5 years within the Alaris platform.

I think what customers certainly value in the platform around the power of one, the ability to do not just large volume but also syringe based and narcotic infusions off the same platform, as well as its leading interoperability position with electronic medical records are some of the key reasons why people have been choosing it at a higher rate and continue to do so going forward.

Again we do have some new technologies being added to the platform, which we'll share also at the upcoming analyst meeting. So we're very positive on the outlook there. I think we think about IV solutions, and we've mentioned before, that you're going to see a – I would expect a rolling series of approvals on that platform. This is the first.

Of course, there is a number of different formulations of IV solutions as well as bag sizes when you think about building out a portfolio that customers really need to run their institution. And so what you just saw get approved was the first in a series of products. And we would expect additional products to be coming out over the months ahead.

And that leads us up to where we'll have an early critical, kind of mass of a portfolio for a launch at the end of the first half of the year. Thank you..

Thank you. Your next question comes from Vijay Kumar of Evercore ISI..

Morning, Vijay..

Hey, guys. Hey, morning, guys. It looks like the numbers were actually a lot better than what it seemed like at first blush there. Just maybe a couple of questions from the guidance, Chris or Vince.

What does the guidance assume from a pricing assumption for next year? And can you just talk about the quarterly cadence, Chris? Because obviously this year was a back half loaded on the revenue front. And given the flat share count and your comments on free cash generation, it looks like maybe there's some upside from cap deployment potentially.

Thanks..

Yeah, pricing is just slightly negative in the plan. And as Chris said, it's already in the guidance..

Yeah, which is no different than the beginning of just about any year. You got to look at that. The pricing environment, as Vince said, hasn't really changed. And so then I think the next part of your question came to the phasing of revenue going forward.

And as we said, we do see some headwinds continuing as we annualize the headwinds from Saudi and Africa. That'll bring us down in the area of about 4% in the first quarter, plus or minus 20 basis points, particularly as that's a high quarter for the flu. So it could go one way or the other on us.

But then the ramp in the second quarter brings us back well within the range, the high end of range. And the ramping of new products we see in the second half of the year brings us back to a strong 4.5% to 5% range. So that feels real good.

In terms of capital deployment, the share buybacks, we were committed to not buy back any shares, other than what we've already done for Respiratory, which we've talked about. But we're not looking to do anything until we get to the 3 times leverage. We want to hit that commitment that we had.

And that brings us through March, so halfway through the year. And then from that point on, you're right. There could be some. But you don't get the full year impact of that at that point. So more to come on that.

But there is some potential as we buy back shares to have a little bit of impact on 2017, but probably more likely the impact would be on 2018..

Thank you. Your next question comes from Brian Weinstein of William Blair..

Hey, guys. Thanks for taking the question. You'll obviously excuse the crackly voice this morning. It was a late night for us in Chicago, and a good one, a very good one..

Congrats on that..

Congratulations..

Thank you. Wanted to ask about kind of U.S. headwinds that we've heard about from others, specifically flu year over year was a tough comp for a lot of people. Utilization seems to be a little weaker. We're hearing about things taking longer to get through committees on capital projects and worked out of inventory distributors.

So how do you guys think about those? And how do you think about kind of the U.S. market going forward? What are the positive offsets that you're seeing to those? And are you guys seeing any of those same headwinds that I described? Thanks..

Well we're generally not procedural driven. An Alaris conversion to make the hospital safer and more effective, they're not being driven by this on the margin procedures. And in fact Tom was talking about interoperability before. And just to give an example, Brian, we were at one account, and we were saving 5 million keystrokes a year.

It's a kind of thing that you want to do in this environment. And it was a very intentional part of our strategy. So what I would say is generally across the board, we're seeing pretty good stability and some increase.

We're just getting started with Kiestra , for example, in the U.S., which is a major cost saving, whether it's in the hospital market or in the clinical lab market. And so we don't have a lot of exposure to the kind of headwinds that you were mentioning..

I think what demonstrates that, Brian, is the 7.2% growth we saw in the U.S. across the company, which was strong in both segments, 7.7% in Medical and 5.8% in Life Science. And I'd also point to Biosciences growing in the U.S. around 8% for the quarter and for the year.

A lot of that was new product introductions, the Symphony [FACSymphony], Celesta [FACSCelesta], the new Melody [FACSMelody] introduction, whatever. So U.S. is feeling particularly strong for our business..

Thanks, Brian..

Thank you. Your next question comes from Jon Groberg of UBS..

Hey, thanks a million. So Vince, it's the first analyst day coming up since – in November here since 2011. And I know you don't want to give away all the details.

But just kind of big picture, maybe you can help us understand what you hope people take away from the meeting?.

Yeah. I hope that they take away a true understanding of when we are talking about this move to complete solutions for the customer based on anchor products and then value-added services, all the way to complete solutions, what that means from a portfolio standpoint.

And when I'm saying that we have the most robust pipeline in the history of the company, I want you to understand what that all means. And we will lay that out for you in a lot of detail. So that's number one on the list, that you understand why we have that confidence going forward. And I think it's going to be fun, quite frankly.

It was fun doing this 5 years ago. So I'm looking forward to it. And then we're going to take that, and Chris is going to kind of give you a financial model of how this all holds together. And lastly, we're going to talk about the capabilities that it's going to require to do all this.

And we're going to show you how we built the capabilities foundationally over the last 5 years. And then how we build upon them. Tom mentioned informatics, for example. But we'll also get into how we approach emerging markets, what's different about our strategy, and why we see that continuing to work.

And some of the other capabilities that we will be bringing to bear, which all is an extension of the work we've done over the 5 years. So that's the kind of day and look forward to seeing you there, Jon..

Great. Look forward to it. Thanks..

Yeah..

Thank you. Your next question comes from Bill Quirk of Piper Jaffray..

Great. Thanks. Good morning, everybody..

Morning..

Couple of questions here. First off, international safety, Vince, you mentioned China in particular as the standout. Just remind us where we are on the ongoing European conversion. And then secondly, the Life Sciences business, at least relative to Medical, has been a little less predictable.

And we certainly appreciate all the new product launches, both in launch as well as the near term development. But do you think this can improve the predictability of the business? Or do you think we may have to look at some tuck-in deals to improve the consistency? Thanks..

Well let me just take Life Sciences first. And the lumpiness that we've seen on Life Sciences, there's two elements. One is just Kiestra, which is a positive thing. These are big installations. They're $2 million. And so you're seeing some quarterly jump arounds as customers are ready for us to install.

And because there's some major changes that they have to make to the laboratory, number one. Number two, and we've had this issue with Africa, and that's been a bit of a problem. We think that's going to annualize. Are we interested in tuck-in acquisitions there? Absolutely, as we are on the Medical side.

I'm just going to ask Alberto to comment on Kiestra. And kind of what you're seeing from a pipeline standpoint. And how you see the U.S. market evolving, because we just got started there..

Yes, good morning. Where we're seeing the most growth and positive growth is in the U.S. market. Traditionally this has been an acquisition that was based in Europe and that market was most developed there. But we're beginning to see some significant traction here in the U.S.

In fact the sales this last year doubled versus the previous one, admittedly on a small base. But we're seeing a lot of positive momentum, especially as we build the platform. And you'll hear the capabilities of the platform that you'll hear about in the analyst day. So we would continue to build on those capabilities.

And that gets the customers very excited about the future of the platform, not only the present of the platform..

Great. And so the second part of the question was on where are we in Europe from a Safety conversion standpoint. And if I remember right, Tom Polen gave you a baseball analogy last quarter.

So what inning are we in, Tom?.

Yeah. Hey, Bill. Tom. So we're in the middle innings when it comes to E.U. Safety. And maybe it'll be an overtime as well, like there was last night. But overall, we see Safety continuing to perform well in Europe. Compliance with the regulation certainly is fueling that.

We see implementation strongest in the conventional hospital settings, a little weaker in the alternate settings. That's true in most markets where individual doctor compliance may be less than a large, governed hospital setting. Strongest conversion rates we see in infusion therapy and blood collection, a little bit lagging in injection.

That's also the exact same trend that we saw in the U.S. So still good growth prospects there. And we're in the middle innings. You also mentioned China. Overall, in Emerging Markets we see Safety in the very early innings at less than 15% conversion, so still quite a ways to go..

Okay, thanks very much..

Thank you. Your next question comes from Derik de Bruin of Bank of America..

Hi, good morning..

Morning, Derik..

A lot of the questions been answered. But just wanted a little bit more color on sort of your emerging market expectations. I mean there was a number of reductions in terms of the outlook and the growth over the year – or during 2016. And I realize a lot of that was sort of due to the Africa and the Middle East situation.

But what sort of gives you confidence that that's going to reaccelerate this year, other than tougher comps, or easier comps? What are you sort of seeing right now that gives you confidence that that's going – you're not going to have to face another slower year?.

Well I think you have to start with Saudi Arabia, which was a major impact to our emerging market growth this year. And as I said, government policy was, cut all expenses by 35%. Now if you're going to run your healthcare system, you can't just stop buying product, number one.

So our expectation was they were running down their inventories, and then – and they would start to buy. What we've seen in this quarter was stabilization there. And so it didn't come all the way back to positive growth, but there was significant improvement. So that gives us a sense that our hypothesis in this case is right, number one.

Number two, it's really Africa and the annualization of Africa. It was still negative. But we started to see, and Alberto could give you more detail, some CD4 orders starting to come in, which we did not see. So, and then we saw good performance across Asia, as I was mentioning before. I expect that to keep happening.

I expect Latin America, that Brazil is going to remain status quo. And we're going to continue to see strong growth in the other marketplaces.

But, Alberto, any other comments on CD4?.

Yeah. I just want to go back to a comment that you said before, in terms of the change in the supply chain..

Yeah, yeah..

That created a little bit of instability in the ordering process and the delivering. And that created a little bit more variance than we had anticipated too..

Yeah, where people didn't know how to order..

Yeah..

And that's behind them.

Then, Chris?.

I think the other point is that China, we saw a little bit of inventory adjustments in the first quarter of last year. But since then, as Vince mentioned earlier, it's been growing very nicely. And you see the fourth quarter grew extremely nicely. A little bit of an easier compare there, but still very strong.

Vince and I and Tom just got back from China. I can tell you that there's a lot of enthusiasm for the – some of the newer products that we're bringing in. So we see a lot of good stability. And as we mentioned, we're looking at low double digits on China in the next year..

And then the last piece is that we do expect to start getting some traction with the CareFusion products. And that's tens of basis points for the corporation, but it's more than that obviously for the Emerging Markets..

Thank you. Your next question comes from Doug Schenkel of Cowen & Company..

Hi, good morning. Just a couple topics. First, could you provide a bridge for 2017 operating margin guidance? I guess I'm just trying to get at how much of this is synergies, removal of respiratory, mix, et cetera.

And then second, on the topic of new products, what was new product contribution to 2016 revenue growth? And looking ahead to 2017, it seems like new product contribution to organic growth should account for a bigger part of overall growth, as you accelerate revenue synergies and some important launches, such as the infusion sets.

Could you comment on that? Thank you..

So this is Chris on the first part of that question.

As we look at the margin next year, the roughly 200 basis points of operating margin, about 50 basis points of that from the normal continuous improvement kind of stuff, another 50 basis points coming from cost synergies, and about 100 basis points coming from the Respiratory JV coming off our income statement. So we get a benefit there.

And on the gross profit, it's roughly the same kind of area. There's a benefit from Respiratory. About half of it coming from Respiratory, about half of it coming from CI and synergy..

In terms of new products, the growth that you're seeing in Biosciences is really driven by the new product instrumentation. So I can point you directly to that. But in terms of the other major new product launches that we are talking about, they really haven't gotten traction yet. Barricor, people are just starting to validate Barricor.

The approvals on BD MAX we just got in the last month or so. So they really haven't hit. And then you're talking about tens of basis points in terms of the CareFusion products in the emerging markets at this point in time.

We haven't done the – we haven't completed the work, let me say it that way – in terms of trying to get a really good analysis around breaking out new product from the entire company. As we're going through the CareFusion integration, we haven't counted the geographic extension of those products as new products. But we're working our way through that.

And you'll have a better sense after the analyst day of how this is coming together..

Thank you. Your next question comes from Matt Taylor of Barclays..

Hi. Thanks for taking the question. I was wondering if you could comment, given that you do have some bigger product cycles here coming up in the fiscal year, and one of the more robust pipelines at the company.

Could you comment on some of the bigger opportunities, like fluids, diabetes, and some of the diagnostic launches, in terms of how we should expect the revenue contributions from those to flow? Help us size them? And just give us some thoughts on timing?.

So I'll ask Tom to start with talking about diabetes and FlowSmart.

Okay?.

Okay. Hi, Matt, this is Tom. So certainly we're excited about the upcoming launch or the recent launch of the infusion set. In September we did make our first shipments to Medtronic on the MiniMed Pro-set with our FlowSmart technology. Medtronic has begun shipping that to patients. And the feedback that we're hearing is very positive.

And there's been a number of bloggers actually write their experience. You can look that up online. But it's very, very good feedback as that's moved into the marketplace just over the last couple months. We do expect that that pilot will expand to a broader full launch in early Q2. And that's well on track.

So I think back to one of the earlier questions, as we think about within the Diabetes Care business, we do expect – and obviously we don't give guidance by business unit. But we expect an uptick in 2017 in Diabetes Care, driven by that FlowSmart launch. And that's on track, proceeding as planned..

Okay.

So Alberto, why don't you comment on BD MAX and Barricor as well, in terms of kind of phasing on those things?.

Yes. So for the BD MAX, the two approvals that we got in the U.S., FDA approvals, we're very excited about, because they're very unique assays. They're very differentiated assays that will bring a lot of value to the market. The CT/GC/TV assay is the first one that is integrated, which is a guideline from the CDC to do the three tests all in one.

And we're the only ones that will have it in the same assay. The vaginal panel will be a significant improvement versus the only approved assay, the Affirm assay that we have out there will be better accuracy, more targets, and much improved performance from that side.

That will take a little bit of time to be built into the sales, as people evaluate and accounts evaluate and convert to these. But we are very, very optimistic. And all the interest has been very high in both accounts. And on Barricor, similar thing. The evaluations are beginning to happen.

There's more than 50 accounts currently evaluating the Barricor products. And that momentum we anticipate to continue in the rest of the year..

So if you think about it, Alberto, from a cycle standpoint, an evaluation of a new assay takes about how long generally? 90 days? Customer....

Yeah, between – yeah. I would say between – the quickest 45 [days] to it can be up to 100 days. So somewhere in there..

To 100 days..

Yeah..

Yeah. And then you have to – they got to work off their old inventory and whatnot..

Correct..

Now the last piece we haven't mentioned at all, and we will talk to you about it at the analyst day, of course is Genomics. And Genomics, where we stand there is for BD CLIC, we are putting our first instruments as early access into customer accounts. So they will just start to do their validations as well.

And so I don't expect that to be a big contributor this year. I expect since it's such new technology, it's going to take a little longer. But we're also starting to get good feedback there.

Anything else you want to add?.

And we will be issuing and launching new protocols as well, new assay protocols....

Yeah..

...as we go along the year..

Yeah..

And that will build up momentum at the same time..

Yeah. It's really coming into I think 2018 with those protocols..

Yeah..

Okay. Thanks very much for the question..

Christy, do we have any other questions?.

Yes, your final question is coming from Richard Newitter with Leerink Partners..

Hi, guys. Thanks for squeezing me in..

Morning, no problem..

Just you've now had some time to kind of digest all the opportunities that maybe you had in front of you, that CareFusion had in front of it, but didn't have the means to exploit. And I'm thinking a little bit more about the dispensing business in Europe.

And I know the business model in that part of the world is just different, and it hasn't historically lent itself well. But I do believe you had begun to talk a little bit about Rowa and leveraging that technology..

Yeah..

I'm just wondering if that's going to factor in in 2017 in the cross sell or the synergy phase of the acquisition integration? And any kind of thoughts there? And is that something that we could hear more about at the analyst day? Thanks..

Yes, you will hear more about it at the analyst day. It's not so much a cross selling opportunity, but an additional opportunity is the way that I would think about that. And we will share that, because we haven't kind of detailed what that product line looks like for you. And there's multiple aspects to that.

So, yeah, we'll be happy to talk about that. Thanks for the question..

Thank you. I will now turn the floor back over to Vince Forlenza for closing remarks..

Well thank you all for your participation on the call today. It was a pleasure going through, which was a strong year for BD, to talk about 2017. And we're looking forward to getting together with you at the analyst day in 2 weeks. So thanks very much, and we'll see you there..

Thanks, everyone..

Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day..