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 Isaac Ro - Goldman Sachs & Co. LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Vijay Kumar - Evercore ISI Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Richard Newitter - Leerink Partners LLC Derik de Bruin - Bank of America Merrill Lynch.
Hello and welcome to BD's Third Fiscal Quarter 2017 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 10th, 2017, on the Investor's page of the bd.com website or by phone at 800-585-8367 for domestic, and area code 404-537-3406 for international calls using confirmation number 50820826.
Beginning today's 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.
The third quarter comparable revenue growth rates and fiscal year 2017 comparable revenue guidance provided today excludes the revenues of divestitures, most notably, the Respiratory Solutions business that was divested in October of 2016, just after our 2016 fiscal year-end.
The details of 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. As a result of previously communicated changes related to the transformation of our U.S.
dispensing business model, we recorded a one-time non-cash charge of approximately $495 million net of tax during the third fiscal quarter of 2017. We continue to expect the impact of the change to be a headwind of approximately $50 million to $60 million to revenues, and 2% to 3% to EPS in fiscal year 2017.
The impact to revenues and EPS is ratable across the third and fourth fiscal quarters of 2017. As a reminder, this change results in a difficult comparison which is limited to the second half of this fiscal year and the first half of fiscal year 2018, but it creates a more predictable revenue stream going forward.
More complete details can be found in our 10Q, which will be filed later today. Please note that all fiscal year 2017 guidance provided is on a BD stand-alone basis. Regarding the Bard transaction, all strategic and financial parameters remain unchanged from the deal announcement.
After closing, we will provide more explicit guidance for the combined company. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer.
Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administration Officer; Tom Polen, President; 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. As you read in this morning's press release, we are pleased with our performance this quarter. Our core remains strong and we continued to deliver consistent solid results.
As we take you through the results, there are a number of puts and takes within the year, but the sum of it is that our performance is strong.
Year-to-date, adjusting for the Respiratory Solutions divestiture, we are growing 4.5% on the top line, with high-single digit operating income growth and strong mid-teens EPS growth as we are overcoming the impact of the U.S. dispensing change with strong underlying performance.
In the quarter, China and the broader emerging markets posted strong double-digit growth reflecting our momentum in these important markets. Total revenue growth was slightly lower than expected, which Chris will touch upon in just a few moments.
We continue to make excellent progress and are on track to achieve our CareFusion cost and revenue synergies. Our fiscal 2017 revenue synergies are being driven by international registrations of consumable products in MPS, along with dispensing in MMS.
We now have 225 approved or in-process product registrations in new markets, with an ultimate target of over 250 registrations. The strategic transformation of the U.S. dispensing business model that we communicated last quarter has been successfully implemented, and customer reception has been overwhelmingly positive.
As we look to the total year, we are very confident in our outlook. The strength of our year-to-date performance allows us to reaffirm our currency-neutral revenue and earnings guidance. Also, as a result of favorable foreign currency movement, we are raising our adjusted earnings guidance. Turning to slide 5, our pending acquisition of C.R.
Bard remains on track, with an expected closing date in the fourth calendar quarter of 2017, subject to regulatory and Bard shareholder approvals. Upon announcement, we communicated a fall 2017 closing timeframe. That remains unchanged, and our continued expectation is that we will close in the November to December 2017 timeframe.
Overall, things are progressing quite nicely. We are also pleased that Bard's business performance to date is strong and in-line with our expectations, as evidenced by their recently-recorded quarterly earnings. From an integration standpoint, we should receive regulatory approval sooner – if we receive regulatory approval sooner, we'll be ready.
We have been able to leverage our experience from the CareFusion acquisition to lay the plans for another successful integration, and we have made excellent progress to date. We've created a detailed execution plan that builds upon our CareFusion experience, and are very pleased that we are well ahead of where we were at this time with CareFusion.
In terms of talent, we have retained key Bard leadership, including John Groetelaars, who will serve as President of the new Interventional segment; John DeFord, who has been named SVP Research and Development for the Interventional segment; and Betty Larson, who has been named SVP, Human Resources for the new segment.
In addition, John Groetelaars' full leadership team has been established, with all regional and business presidents in place. We're thrilled with the number of exceptional Bard leaders dedicated to making the combined company a success as we move forward together.
We will share more information about the new company structure as we progress towards the closing. As you are aware, shortly after announcing the Bard acquisition, we went to market and successfully issued approximately $5 billion dollars in common and preferred shares. We also launched nearly $10 billion dollars in senior notes.
All offerings were over-subscribed by a multiple of over three times. As a combined company, we believe we will further accelerate and broaden our strategy, create new growth opportunities for both companies, and deliver meaningful long-term value for shareholders.
Together, we will be uniquely positioned to deliver innovative healthcare solutions that improve both the process of care and the treatment of disease. So now I'll turn things over to Chris for a more detailed discussion of our third quarter financial performance and our fiscal year 2017 guidance..
Thanks, Vince, and good morning everyone. Like Vince, I'm also pleased by the progress we are making with our integration planning for the Bard acquisition, and the value the combination will create for our customers, patients, and shareholders globally.
Moving on to slide 7, I'll review our third quarter revenue and EPS results, which I'll speak to on a currency-neutral basis. Total third quarter revenues of approximately $3 billion dollars grew 2.4% on a comparable basis, which was slightly below our expectations. We estimate that the U.S.
dispensing change lowered total company revenue growth by approximately 100 basis points, in line with our previously-communicated expectations. As Vince mentioned, our underlying performance is strong.
Accounting for the dispensing change and the timing of items within the year, our third quarter results would have been in the low end of our full-year guidance range of 4.5% to 5%. I'll provide more color on revenue growth in the quarter in a moment, when I take you through the results by segment and geography. Adjusted EPS of $2.46 grew 7.7%.
As expected, EPS was impacted by the divestiture of the Respiratory Solutions business, as well as the U.S. Dispensing business model change, which resulted in a combined headwind of approximately 600 basis points to EPS growth. We're very pleased with our performance year-to-date. Revenue growth is strong at 4.5%.
Accounting for the approximate 40-basis-point impact from the U.S. dispensing change, we estimate that the revenue growth year-to-date would have been near the high end of our 4.5%-to-5% guidance range. Year-to-date EPS growth of 13.1% reflects our ability to grow over the dilution from the Respiratory divestiture and the U.S. dispensing change.
Moving on to slide 8, I'll review our revenue growth by segment on a comparable currency-neutral basis. In the quarter, pricing declined about 20 basis points. BD Medical third quarter revenues increased 1.3%. Revenues in the Medical segment was slightly below our expectations in the quarter.
Year-to-date, Medical revenues grew a strong 4.5%, which includes an estimated 50-basis-point headwind from the U.S. Dispensing change. Medication and Procedural Solutions, or MPS, growth was 3.7%, which reflects strength in infusion-related disposables and infection prevention. Growth in MPS in the U.S.
was below our expectations, due to the normalization of inventory levels across several major distributors. Revenues in Medication Management Solutions, or MMS, declined 4.2%. We estimate that the U.S. dispensing change lowered MMS revenue growth by approximately 550 basis points.
MMS revenue growth was also impacted by strong capital insulations in dispensing in the first half of the fiscal year, as previously communicated. In addition, within our International Infusion business, certain customer orders planned for the third quarter are now expected to occur in the fourth fiscal quarter.
On an underlying basis that accounts for these items, we estimate that MMS would have grown in the mid-single digits. We continue to be pleased as we gain momentum in the market in our MMS business. Diabetes Care revenue growth of 2.7% was driven by 4.2% growth in the U.S. and double-digit growth in emerging markets.
International growth was impacted by some softness in Europe, primarily in the U.K., where we are seeing increasing pressure from government payers as part of austerity measures. Pharmaceutical Systems revenues grew 3.9%. Results were impacted by the timing of customer orders that benefited growth in the first quarter.
Year-to-date, Pharmaceutical Systems grew 6.1%. BD Life Sciences third quarter revenues grew – increased 4.8%. Growth was driven by strong performance in Biosciences and solid growth in Diagnostic Systems and Preanalytical Systems. Revenues in Diagnostics Systems grew 3.8%.
Strength in Core Microbiology was driven by blood culture and IDAST partially offset by the timing of BD Kiestra installations which we expect to occur in the fourth quarter. In addition, we saw strong accelerated growth in our BD MAX molecular platform driven by the recent introduction of new enteric's and women's health assays.
Preanalytical Systems growth of 3.9% was driven by strength in wing sets, including the recently-introduced BD UltraTouch. Biosciences revenues grew a strong 7.1%. This reflects continued strength in research reagents driven by our Sirigen dyes and growth from new recently-launched research instruments such as the FACSMelody.
Moving on to slide nine I'll walk you through our geographic revenues for the third quarter on a comparable currency-neutral basis. U.S. growth was about flat with BD Life Sciences growing at 5.2% and BD Medical declining 1.3%. We estimate the U.S. dispensing change lowered BD Medical U.S.
revenue growth by approximately 270 basis points and total company U.S. growth by approximately 200 basis points. Performance in BD Medical in the U.S. reflects growth in the MPS and Diabetes Care units. This growth was offset by the timing and geography of orders in Pharmaceutical Systems and the U.S. dispensing change.
Performance in the Medication Management Solution unit also reflects the timing of capital placements that occurred earlier in the fiscal year, revenues in MPS were driven by strength across a wide range of infusion disposables and infection prevention, partially offset by the normalization of inventory levels.
BD Life Sciences growth reflects strong performance in Biosciences and Preanalytical Systems. Growth in our U.S. Diagnostics business was driven by strong core Microbiology and BD MAX partially offset by the timing of revenues in some platforms.
Revenues in Preanalytical Systems were driven by growth in wing sets and also reflect strong performance across all product platforms. Revenues in our Biosciences business in the U.S. were driven by strength in research reagents and growth from research instruments such as the FACSMelody and the FACSymphony.
Moving on to International, revenues grew 4.7%. The Medical segment grew 4.9%. Growth was driven by customer ordering patterns in Pharmaceutical Systems and by performance from infusion-related disposables in the MPS business. Diabetes care revenues reflect strength in emerging markets partially offset by softness in Europe, as previously discussed.
Performance in MMS reflects the impact of strong capital insulations in the first half of the fiscal year as well as certain customer orders planned for the third quarter within our infusion business that are now expected to occur in the fourth fiscal quarter.
Growth in the Life Sciences segment of 4.4% was driven by performance in Diagnostic Systems and Biosciences. The Diagnostic Systems growth reflects strong sales in Core Microbiology including IDAST where we continue to see demand from the recently-launched Phoenix M50 and strength in BD MAX.
Biosciences revenues reflect strong research instrument sales that partially benefited from an easy comparison due to the prior-year funding delays in certain geographies. On slide 10, developed markets revenues grew 0.9% and emerging markets revenues grew 10.9%. We estimate the U.S.
dispensing change lowered developed markets revenue growth by approximately 130 basis points. The third quarter growth rate in emerging markets reflects double-digit growth across the Medical segment and also in Diagnostic Systems.
By geography, China, greater Asia and EMA grew double-digits and sales in Eastern Europe and Latin America were up high-single digits. China growth for the third quarter was strong at 12%.
Revenue growth was driven by continued strong demand for consumables in both segments as well as the Phoenix M50 and MALDI-IDAST instruments and diagnostic systems, and research instruments in Biosciences. For the total year, we continue to expect China to grow in the low double-digit range.
With year-to-date growth of 9.1%, we are confident in our high single-digit emerging market growth outlook for the full fiscal year. Now, moving on to Global Safety on slide 11. Currency-neutral sales were flat year-over-year.
Tough comparisons to the prior year in both segments and across all geographies were the primary driver of lower Safety growth across the portfolio. By geography, Safety revenues in the U.S. grew 1.5% and international sales declined 2% currency-neutral.
Emerging Market Safety revenues were about flat due to a tough comparison to the prior year in which EM Safety grew approximately 20%. By segment, Medical Safety sales declined 2.1% and Life Sciences grew 3.7%. In addition to the tough comparisons to the prior year, U.S.
and Medical Safety growth this quarter was impacted by distributor inventory levels in MPS as discussed earlier. International and Medical growth were also impacted by customer orders, planned for the third quarter within our infusion business that are now expected to occur in the fourth fiscal quarter as mentioned previously.
Slide 12 recaps the third quarter income statement and highlights our currency-neutral results. As discussed, revenues grew 2.4% in the quarter on a comparable currency-neutral basis, including approximately 100 basis points negative impact from the U.S. dispensing change.
As we move down the P&L, I'd like to point out that similar to prior quarters our results in the prior-year period include the Respiratory Solutions business, while the current period does not as the business was divested in October of 2016.
Starting with gross profit, the decline of 1.3% year-over-year reflects the loss of gross profit from the Respiratory Solutions business and the U.S. dispensing business model change. On a comparable basis that accounts for these items, gross profit would have grown over 100 basis points faster than revenue growth.
I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 23.7%, and we are very pleased with the leverage we are getting year-to-date. R&D as a percentage of revenues was 6.1% as we continue to invest in innovation to drive future growth.
The decline in R&D spending year-over-year is due to the divestiture of Respiratory Solutions business, as well as the comparison to prior year where we ramped R&D spend in the third quarter as a result of the medical device tax suspension. Our tax rate declined to 16.5% in the quarter, which is in line with our full-year guidance.
In the quarter, operating income was flat and adjusted earnings per share grew 7.7% compared to the prior year. Both operating income and EPS include 600 basis points of negative impact from the Respiratory Solutions divestiture and the U.S. dispensing change. Now, turning to slide 13 and our gross profit and operating margins for the third quarter.
On a performance basis, gross profit margin improved by 150 basis points as continuous improvement initiatives, cost synergies and favorable mix, which includes the positive impact of divestitures, were partially offset by a slight decline in pricing. On an operating margin basis, we delivered 100 basis points of margin expansion.
Year-to-date, we have achieved approximately 160 basis points of underlying margin expansion. We expect the fourth quarter margin performance to significantly improve, largely driven by the comparison to the high level of R&D spend in the prior year.
We remain confident in our ability to drive 200 to 225 basis points of margin expansion for fiscal year 2017. Moving on to slide 15 and our full fiscal year 2017 EPS guidance. We are particularly pleased that the strength of our performance year-to-date is driving our ability to offset headwinds from the Respiratory Solutions divestiture, the U.S.
dispensing change, and FX pressure. As a result, we are reaffirming our full-year fiscal 2017 currency-neutral adjusted EPS guidance of $9.70 to $9.80, which represents underlying growth of 15% to 17% and a 2% to 3% headwind from the U.S. dispensing change.
As you're aware, foreign exchange rates have moved since we last provided guidance in May, and the foreign currency headwind has moderated slightly with one quarter to go. As such, we are raising our adjusted EPS guidance to $9.42 to $9.47. Our guidance assumes a euro-to-dollar exchange rate of $1.15.
Turning to slide 16, I'd like to walk through the balance of our guidance expectations for the full fiscal year 2017. As we discussed, there are a number of puts and takes within the year, but our underlying performance is strong. Despite a headwind of approximately 50 basis points from the U.S.
dispensing change, we continue to expect total company revenue growth of 4.5% to 5% on a comparable currency-neutral basis. This was comprised of growth of 4.5% to 5% in BD Medical and 4% to 5% in Life Sciences. Based on our current view of the environment, we continue to expect a small amount of pricing pressure for the year.
All other P&L guidance from May remains unchanged. 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 you through our updates on new product innovation and strategic and business initiatives. Starting with the new production innovations within our Life Science business, we continued to expand the BD MAX system menu of unique, clinically-relevant panels.
We recently received 510(k) clearance from the U.S. FDA for our newly-developed molecular test for detecting harmful intestinal bacteria. The BD MAX Extended Enteric Bacterial Panel is the latest offering in the suite of BD MAX Enteric assays. We also recently received 510(k) clearance from the U.S. FDA for the BD FACSLyric flow cytometer system.
The BD FACSLyric system strengthens BD's portfolio of clinical flow cytometry solutions available in the U.S. with an easy-to-use in vitro diagnostic system for use with assays for immunological assessment of individuals and patients having or suspected of having immune deficiency.
Within strategic and business initiatives, we recently released our 2016 sustainability report. One full year after announcing our 2020 sustainability goals, we are already making notable progress across our four focus areas of innovation, access, efficiency and empowerment.
We believe that aligning our relevant environmental, social and governance factors with our capabilities will help BD continue to generate differentiated results for all of our stakeholders from shareholders to society. Moving on to our business update on slide 19.
We continued to make progress with our cost synergy capture through our G&A functional transformation. We continued to remain focused on our functional transformations as we leverage our shared service centers and continued to build out our Centers of Excellence.
In addition, our manufacturing-related synergies remain on track and we continue to expect the majority of these to be achieved in fiscal year 2018. We also 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.
As you can see, we continue to drive significant operating margin expansion over a multi-year period. The consistent performance of our businesses, combined with operating efficiencies, cost leverage, and cost synergy capture, is driving continued underlying operating margin expansion.
We continue to expect to deliver over 500 basis points of cumulative margin expansion over the three-year period through fiscal year 2017. Moving on to slide 20, I would like to reiterate the key messages from our presentation today.
First, while there were some timing items within the year that impacted the quarter, our core business remains strong across both segments. We're pleased with our continued solid performance year-to-date and our ability to drive performance to offset divestitures, the U.S. dispensing change, and foreign-currency headwinds year-to-date.
Second, our operating performance, cost leverage, and cost synergy capture continued to generate operating margin improvement and drive double-digit earnings growth. Third, as we look to the total year, we're confident in our increased outlook for the full fiscal year.
Finally, we're very excited about the powerful combination of BD and Bard, and our ability to deliver innovative solutions that position us to improve both the process of care and the treatment of disease. We're very pleased with the excellent progress we are making with the Bard integration, and look forward to the future with confidence. Thank you.
We will now open the call to questions..
The floor is now open for your questions. Our first question is coming from the line of Mike Weinstein with JPMorgan..
Thank you, and good morning..
Morning, Mike..
Chris, could you start by maybe providing us a bit of a bridge for this quarter? It's clear from your commentary that there were a number of timing items that impacted the organic performance this quarter, some of which you called as effectively timing of tenders, more contracts falling from the third quarter to fourth quarter.
Could you just call those out in the different businesses and what the impact was, and how much of that we will see recaptured in 4Q?.
Sure, Mike, be happy to do that. So, if you think about the 2.4%, the underlying growth is 4.5%, and the way to get there is about 100 basis points related to the U.S. dispensing business we had articulated on the last call. Then we had timing factors.
If you think about the first half of this year, we were running 5.6% year-to-date, and so we said that wasn't indicative. There was a lot of timing in there, and what was in there, particularly was, in MMS, they had a very strong first half, and so did Pharm Systems. Pharm systems grew over 7% in the first half, and we knew that is a lumpy business.
Then on top of that, we saw some timing this quarter. In MMS International, we saw some orders that we expected to see in the third quarter that we now expect to see in the fourth quarter. And there was some Kiestra installations that moved from the third quarter to the fourth quarter.
So when you normalize for all those items, you get to the 4.5% underlying growth. Now we did say we saw some softness in MPS related to normalization of inventory levels and a little bit of softness in Diabetes care in the U.K. But if you added those back, that would have brought us more to the 5% kind of level in the quarter.
So that's where we saw a little bit of softness, going from 5% down to 4.5%..
And do you think, do you have a read on whether inventory levels are now at an appropriate level, or whether you see any bounce back in the fourth quarter? And then, can you just clarify maybe, just so we're all on the same page, what you're implying for fourth quarter organic growth?.
Sure. So, since we're at 4.5% year-to-date through the third quarter, we're implying in the 4.5% kind of range for the fourth quarter, and we do think that the inventory levels was a one-time adjustment within the third quarter, so we don't expect to see any hangover from that in the fourth quarter. We do see emerging market strength across the board.
If you look at what we did in emerging markets this quarter, 9% year-to-date, 11% in the quarter, that's the best quarter in two years. China grew 12%, 11% year-to-date. So we're seeing – emerging market growth is very strong, so we see that continuing. Life Sciences, we see strength across (31:26 – 31:31) quarter bounce back.
Until (31:33) we see strength in the fourth quarter, we see Diabetes Care rebounding, primarily driven by the U.S., as we do think that the U.K. pressure will continue. MMS has the International Q3/Q4 timing, so we'll get a little benefit from that.
MPS will actually have a tough compare in the fourth quarter, but we already had that baked in to our guidance. So that's how we get to a good solid fourth quarter, and to the 4.5% to 5% for the year..
So then, Chris, if you take that and you add back in the dispensing, you get up really to 5%..
Yes. So that's why, as we said at the second quarter, we felt we were at the high end of our guidance range, and the pressure from the dispensing brought us down to the lower end of our – but still within our guidance range..
And that's what we continue to see..
Understood. Let me just follow up on one more financial question. So, we thought the FX swing from $1.07, which was where your last guidance was set on the euro, to $1.15, which is where you now set guidance, would be more of an impact on the second half or full-year guidance than what you announced today.
So could you shed some light on that? And then, if you have any early indication of what you think the FX impact will be on FY 2018, that would be appreciated..
Sure. Absolutely. So, as you said, when we gave guidance the last time, we were at $1.07. We use the 30-day running average, as you know, so that would be $1.15. Today, we are sitting at $1.18. So the $0.08 between the $1.07 and $1.15, if you think back to the rule of thumb that we've given in the past, 1 point of euro move is worth about $0.02.
So the $0.08 move is worth about $0.16 cents for a full year, but we just have one quarter to go. And, really, where you saw the move was in the month of July, so it's truly an impact of just one quarter. So that'd be about $0.04 for the quarter.
Then when you look at all other FX currencies, we actually are still seeing pressure from the pound, the yen, and the yuan, which really haven't moved at all in the past quarter, and so we still see pressures.
All other currencies, there's about $0.01 of benefit since May, and so that's the $0.01 there and $0.04, so we see about $0.05 running through, and that's how much we increased the guidance by.
In terms of your comment around next year, we use the 30-day average because the volatility in FX has been dramatic over the last year or so, and we like the direction it's going. So if it stays at $1.18, we certainly will see a benefit.
The average for this year, if it holds at $1.18 for the rest of the year, the average for this year will be about $1.10. So $1.18 for full next year would be about $0.08. If you use the rule of thumb, that's about $0.16 of benefit.
And then, you would expect to see a little bit of benefit from all other foreign currencies, where there was a little bit of pressure this year. So that's a way to think about next year, if things hold at $1.18, and we hope they do..
That's helpful. Thank you, guys. I appreciate it..
Okay. Yes. Thanks, Mike..
Your next question comes from the line of David Lewis with Morgan Stanley..
Good morning. Just a quick follow up on Mike's question. Just looking at the fourth quarter, I was under the impression back half of the year was going to be sort of 4%, 4.5%, so sort of implies the fourth quarter has to be closer to the 5% or a little higher.
It's also the hardest comp of the year, so I just want to make sure that just given the hardest comp of the year you're still sort of confident you can get back to that number in the fourth quarter..
Yes. So, David, as we said, the impact of the dispensing change would bring us from the high end of our guidance range of 4.5% to 5% for the year, down to the low end. So year-to-date, we're at 4.5%. So what that really implies for the fourth quarter is 4.5%. We do have some timing within the third and the fourth quarter, as I mentioned.
The MMS International orders have slipped. We got some Kiestra installations that slip into the fourth quarter. So the combination of those things give us the confidence, and we see good strength across the rest of the business. The core is strong. Emerging markets growth, as I said, is looking very good, and Life Sciences is looking solid as well.
So we feel good about the fourth quarter..
Okay. And then, Vince – maybe, Tom, a quick question for Tom and a quick question for Vince. On Pyxis, I just want to get a sense of is the transition sort of progressing as expected? Has there been any underlying business disruption based on Pyxis? One of your competitors actually had a decent quarter.
And then, Vince, for you, on Bard integration, dynamics that are kind of more encouraging as the pre-integration planning has been going on, and any additional thoughts on what business could move in or out of the Interventional segment? Thanks so much..
Good. Okay. Tom, you can take that..
Hey, David. This is Tom. Actually no, we see very positive feedback on the Pyxis ES business model conversion and actually positive momentum in terms of share gain in that space. So actually customers have been very satisfied with the new model.
Feedback has been very positive in terms of it aligning with their needs and flexibility interests going forward, as well as being able to capitalize on the new software solutions that we're coming out with today and ongoing in the future. I'll turn it over to Vince..
So, as we said, we are making some really good progress in terms of the integration planning, what the portfolio looks like. We haven't announced to the organization yet the answer to the question that you're asking, so I don't want to get ahead of that. We're doing work, of course, in the catheter area in terms of how that will come together.
We know that we have to maintain focus on both the Pyxs and, of course, the IV catheter franchise and the structure that we're contemplating will continue to do that. But we are also looking at how we create this overall benefit in terms of enabling the customer base to optimize. And we think we've got great ideas there.
And then we are looking at the surgical area and the various puts and takes there. So that's where we're at, but we'll be in great shape on those issues very, very quickly..
I should just add, too, that as we preliminarily look at the work on cost synergies, we feel real good about the $300 million of cost synergies that we articulated and we also feel equally as confident in having revenue synergies that are measurable in fiscal year 2019.
So we're really reaffirming everything we said at the time of the transaction that we feel good about the cost synergies, the revenue synergies and the potential for those. So we've made good headway in the last couple of months on those issues..
Great. Thanks so much..
Okay..
Your next question comes from the line of Isaac Ro with Goldman Sachs..
Good morning, guys. Thank you..
Good morning..
Just two questions end-market questions for you. One on Life Sciences. If I look across some of the peers this quarter there does seem to have been a little bit of a slowdown in the drug industry kind of spending rate and there are probably a wide range of reasons for that.
But I'm curious if you could comment on what you're seeing in terms of activity from drug companies? What's baked into your outlook for the rest of the year?.
Yes. Hi. This is Alberto. Good morning. We haven't seen any material change in the demand from the pharma companies. Now, a lot of these are driven by negotiations and discussions with us for a long period of time where the funding is secured. So we'll monitor that, but at the moment we are not seeing any big impact..
Advanced Bioprocessing is also a very small piece of our overall business. It tends to be lumpy, orders based, as Alberto was saying, and so we wouldn't see a big impact from that..
And certainly Pharm Systems year-to-date is 6.1% growth so we feel good about that, so..
Great. And then just a follow up on the hospital spending environment. Appreciate you guys don't necessarily have a lot of exposure to major CapEx-type debates or what not, but interested in just this purchasing behavior.
We've obviously seen a little bit of uncertainty around the policy side of hospital spending in the U.S., what that might mean for them. So I'm interested in how you're thinking about the evolution of hospital spending in the current environment..
Well, you know I've had multiple discussions on that point with the customer base in the U.S. And, basically, what I've heard back from the customer base is, listen, we all believe this is still going to population-based health and there are things that we have to do from a capital perspective, and those things are multiyear programs.
And so we are not changing the way we are going about things. Are we being careful? Yes, we are being careful. But those commitments, most of those larger capital commitments have been made in their multi year. So we're not really seeing anything from our standpoint.
Now when you step back and look at BD, we have small exposure to that, getting smaller with the move that we just made in terms of the change in the business model in MMS. And on the diagnostic side, most of what we do is reagent rental.
So not a huge issue for us, but I would say over the next couple of years, we're expecting stability unless there is some major discontinuity in terms of where Congress ultimately goes, and so far Congress hasn't gone anywhere..
Makes sense. Thank you, guys..
Your next question comes from the line of Rick Wise with Stifel..
Good morning, Vince. Hi, Chris..
Good morning, Rick..
Maybe just starting with your comments on the CareFusion cost synergies. You reaffirmed the $325 million, $350 million.
Just wondering, is there a lot more to go? Is the bulk of it in the fiscal – the next 12 months? Just how do we think about that? And just as part of that, recently you've seemed a lot more concretely optimistic about seeing some CareFusion sales synergies.
Not to be obsessed by it, but are you more optimistic about that as we look ahead as well?.
So let me take the cost synergies. As you remember, we talked about those being relatively ratable over the three-year period, and that's what's playing out. So through 2016, we had about $170 million. We run about $80 million more per year on top of that.
So that's what you would expect by the end of this year, and then the balance to the $325 million to $350 million would be in 2018. So that's pretty much on track, and you can see the benefit of that as we look at the margin growth.
As we talked about in our prepared remarks, we expect this year to drive 200 basis points to 225 basis points of operating margin improvement. That brings us to over 500 basis points of margin improvement in the last three years through 2017.
And then, as you think about it, we're talking about the Bard transaction driving an average of 200 basis points over the next three years. That's a lot of basis points of operating margin improvement over a five-to-six-year period. So we feel real good about that, and that's what we're seeing.
The first part of that is driven by the CareFusion synergies..
So coming to the revenue synergies, Rick, I think we're feeling very good about what we talked to you about when we signed the deal. And if you remember, the way this works is we can only do so much in that planning, where we are before close.
But where we are in that process is, we've had teams meeting together and we had a hypothesis in terms of where those were going to occur; which product lines, which geographies.
We feel very good about that hypothesis having worked with the Bard team in terms of these are the focus areas, this is where we're going, this is where we're going to go after and get these things. Of course, we can't do the account level detailed planning yet, that comes later. But net-net, we feel very good about what we told you. In addition ...
(44:38).
Yes. Hi, Rick. This is Tom. Maybe just to add and update some of the commentary, the details that we've shared in the past is, we do remain on track towards actually an ultimate target of now about 250 products registered ex-U.S. from CareFusion. We actually have about 150 of those approved already and are promoting and selling those.
There's another 75 products that has been submitted to regulatory agencies that are pending approval. And then, we're working on getting the final group of submissions made. So we're making really great progress there. We are seeing what I'll call kind of tens of bps of benefit in the overall Medical segment and company numbers.
And as we've always said, those revenue synergies have always been expected ex-U.S. and specifically focused on the International MPS and MMS businesses. And if you look at International MMS and MPS, you can see we're up about 7% growth year-to-date in both of those businesses internationally, and that's reflecting those revenue synergies..
Yes. And, Rick, I thought you were asking me about Bard, and I was answering that. And Tom, of course, answered about CareFusion, but we're a great team..
We got lots of revenue synergies on both sides. Yes..
Thank you. And just quickly, Vince, just you highlighted a couple of things in the pipeline. Thinking back to the Analyst Day, a part of the 5%-plus growth story pre-Bard was the exciting pipeline. Any updates on some of the exciting diabetes products, Kiestra, Barricor? You talked about BD MAX.
Any updates that we should be paying attention to or thinking about? Thanks so much..
Yes. Well, I'll ask Alberto to do that on the Life Science side, and then Tom can pick it up on Medical, because there's a lot of good things to talk about..
So just on the Life Sciences, I'll highlight three launches or approvals this quarter, and Chris mentioned them. The FACSLyric, which is our next-generation clinical flow cytometry. We are very excited by that. It'll be much easier to use. Clinical software standardization across the different sites really will enable our customers to do very nicely.
Second one is in Kiestra, our urine application, which uses imaging to essentially automatically discard no-growth plates, which really will lighten the workload and concentrate the limited amount of resources our customers have to a more valuable tests basically.
And the third one is Lyric, one more that I'm – the extended bacterial panel that was also that was also previously highlighted. That is the third element out of four of our Enteric series of panels overall. And the last one to be approved now is the viral panel..
And I'll just add a couple of longer-term comments on the Life Science side. So remain excited about the Resolve platform from the cellular research technology that we have. That's on track. And I think you've have been doing, Alberto, some customer testing with that..
Right..
And excited about that..
And just to complete the picture, MAX, we expect the 20-plus percent growth rate – normally we have this quarter, but for the year. Kiestra in the double digits, and our Core Microbiology franchise grew over 5% year-to-date as well. So we're very confident about our Core products..
And I also mentioned in the prepared remarks the UltraTouch showed some benefit this quarter..
It's being very well received in the market..
Yes. So on the Life Science side, we are feeling very good about it. If there's one thing, Rick, that's been a little slow, it's been the Barricor launch, and it's just taken longer. We've got a good pipeline, but it's taking longer to convert the customer base and we've got to improve that process. But everything else we were showing you is on track.
So, Tom, do you want to do the other side..
Sure. Hi, Rick. This is Tom. On the Medical side, maybe just to hit a couple highlights across the businesses. First, is we have launched in the last few quarters some new enterprise software for our Cato and Pharmogistics platforms in MMS. That's doing extremely well.
We've seen really positive customer uptake as those products are letting them manage compounding, as well as their inventory for pharmaceutical products across multiple hospitals within their network. Within MPS, we're continuing a launch of our Medication Management consumables there.
We've actually just launched a new infusion set for Asia as part of our revenue synergy strategy. That's off to a good start. And at Analyst Day, we had shared we have plans to launch two new infection prevention products per year going forward, and that's very much on track for 2018, those products, and you'll hear more about those as we move ahead.
And then on Swatch, as you mentioned, in diabetes care, no changes. We remain on track for end of fiscal year FY2018 for our launch in the U.S. of Swatch. Maybe one other area that we often get questions on is IV Solutions. As you know, there's a number of different formulations and bag sizes that customers need to run their institution.
And we have our partner, Fresenius, that we've been working with to bring that broad portfolio of products to the U.S. market. To date, our partner's gotten FDA approval for the 5% dextrose, and we've begun marketing and selling that to customers.
And additional formulations, including kind of the large volume saline product, we're still expecting approval in the coming months. Hopefully by the end of the calendar year..
Thanks so much..
Yes. Okay. Thanks a lot..
Your next question comes from the line of Vijay Kumar with Evercore ISI..
Hey, guys. Thanks for taking my questions. So maybe I'll start one on – the first one on the revenue guidance. Chris, obviously the stock is indicating off here in the pre-market. And I (50:28) think people are nervous, investors are nervous, on the set-up heading into back half and the implied fourth-quarter guidance.
I mean, if I take a step back to the picture laid out at the Analyst Day, right. So we were looking for north of 5% organic during the 17th and 19th year. So if you look at where we are today, (51:03) organic, we are looking at a stock with a story of – accelerating organic into 4Q and a step into 4.5% and then possibly 5%, or north of 5%, for 2018.
Can you talk us, one, what degree of confidence we have for the fourth quarter ramp up? And then, what's the delta between 2017 and 2018, right? Where is that incremental growth coming from?.
Sure, Vijay. So, as we mentioned before, if you really peel back the on the underlying performance for the year, year-to-date we're 4.5%, but that's in the face of significant headwinds from this U.S. dispensing change that we had of about 50 basis points. That puts you right at the 5% level, so we feel really good about that.
Clearly, the headline is depressed by the dispensing model. We knew that was the risk. We tried to communicate that, that that would be a pressure in the second half of this year. You're going to see that same kind of pressure year-over-year in the first half of next year. And that's to be expected. It's the right thing to do.
It positions us extremely well competitively in that business. And it actually helps us better focus on our customers and their needs. So, we're doing it for all the right reasons, but it clearly is going to depress the headline. We knew that.
We also knew that the timing was going to be a headwind in the second half of the year, because of the fact that we were running so hot in the first half of the year, 5.6%. So that had an impact as well. So, as I said earlier, the underlying for the quarter was 4.5%.
It would have been 5%, except for the little bit of pressure we saw in MPS in normalization of inventories in the diabetes piece. So that would have been a strong 5% in the quarter as well.
As we look out into the fourth quarter, we're very confident by a number of things that we see; the timing coming back to us a little bit on some of the things that moved from the third to the fourth quarter, but the strength of the core business is the most important.
And look at the emerging market growth; that's the strongest it's been in a couple of years. We really feel good about that. The rest of the business is solid.
So we really feel good about that as well, so it really hasn't changed from what we were talking about, in terms of the momentum of the business and the underlying business, when we talked at Analyst Day.
And then, going forward into next year, we feel that same strength continuing again, albeit with the pressure of the headwinds of the dispensing change in the first half of the year. But for the full-year, that will normalize, because it'll be six months versus six months this year.
So on the top line, we feel very good about the momentum that we have. And then, the ability to take that up to the 5%-to-6% level with the Bard transaction as that occurs. So, from a top-line basis, we're feeling like the momentum is there.
And then, we haven't really talked about the EPS line, but when you look at that chart 15, we're driving 15% to 17% underlying EPS, FX and growth, and that's overcoming the Respiratory dilution of about 1.5%. That's really strong growth. Then you got the headwinds from the dispensing change that we have, which is real.
That $60 million dollars of revenue that drops to the bottom line, there's some cost related to that as well. We're overcoming that. We're overcoming the headwinds that we saw in FX this year, which, although it's abated a little bit, that's still 3.5% of headwinds from year-over-year FX pressure. Hopefully, that turns around next year.
So from a bottom line, we're feeling really good going forward as well. So, hopefully that addressed your question..
That does, and that was very helpful. And then, maybe one for Vince. Looks like the confidence on the Bard deal closure, it just sounded – I'm trying to piece everything together, right? So you mentioned the November-to-December timeframe, the FTC's second request.
And then also, I think you mentioned about integration being ahead of where we were in a comparable timeframe on the CareFusion. Can you just put all of those together? What's the incremental confidence we have that this may not slip out to January? Or what's the key gating factors in terms of deal closing? I think that would be helpful..
Yes. Sure. And so, we never thought that the U.S. was going to be the gating factor in terms of getting the deal closed. We always thought that China was the long pole in the tent, and that remains exactly the way we saw it. So, we expected a second request in the U.S. It was no surprise to us.
We're dealing with the issues that they raised, and we expect to deal with them quickly. So our view in terms of the closing time really hasn't changed at all, because of those two factors..
Thanks, guys..
Sure..
Your next question comes from the line of Doug Schenkel with Cowen & Co..
Hi. Good morning. There's three topics I'd like to cover. First, on revenue guidance. Our math suggests that around 100 basis points of fourth quarter revenue growth is a function of revenue that moved out of Q3 into Q4. I just want to see if we're in the right neighborhood there. Secondly, on margins. Gross margin was solid this quarter.
It doesn't seem like there was anything abnormal there. How should we think about the sustainability? And moving lower in the P&L, third quarter operating margin was above the full-year guidance target.
I'm just wondering if we should be contemplating a pick-up in investment in our fourth-quarter model? And on the same topic, I just want to make sure that some of the Bioscience issues in the second quarter that impacted margins are now fully resolved. And the last topic is just on the pipeline.
What's the status of the diabetes infusion set rollout? Thank you..
Well, let me see if I can get some of those questions. I think your timing is about right in terms of Q3 to Q4; that feels about right. And we feel good about the ability to hit the 200 basis points to 225 basis points of margin improvement, you mentioned abnormal.
The only thing abnormal is that we are driving 200 basis points to 225 basis points of margin improvement this year, and 500 basis points over the last 3 years. So, we feel really good about that.
There is say a little bit of easier compare in the fourth-quarter as I think I mentioned, because R&D ramped so much in the fourth-quarter of last year as a result of the medical device tax repeal. And so that makes it a little bit easier.
The operating margins this quarter are a little misleading because of the fact that Respiratory really had an impact in there. When you peel back the Respiratory piece, you see really good margin growth. The gross profit margin in the quarter was 100 basis points faster than revenue growth.
And both OIBT and EPS were very strong in the quarter when you back out the overhang from respiratory. So feel real good about that..
Bioscience is back to normal, right, Alberto?.
Absolutely back to normal, minimal impact this quarter and 100% back to into stocked position..
Okay. You saw the growth of over 7% in the quarter. So we feel good about that..
And Bill (sic) [Doug] this is Tom. On the infusion set, so we are in the process of, as I think we had shared in the past, we've gotten some complaints during the initial launch.
We were in the process of running a clinical trial to confirm that some of the new training tools that we've included in the packaging optimized the patient's ability to start using this set. That clinical trial is going exactly as planned and our guidance assumes we resume the launch in FY 2018..
Okay. Thanks for your question..
Your next question comes from the line of Matt Taylor with Barclays..
Hi. Thank you for taking the question. I guess I was just wondering if you could update us on kind of the outlook for emerging markets for Becton as you think about it organically and with Bard. You had a little bit better performance this quarter.
So just curious if you could give us some insight into the moving parts there, and then how you think about the next year or two?.
Well, I'll kick it off and then if Chris wants to add some more detail. What you saw in the quarter was of course strong performance in emerging markets, strong performance in China. The Middle East bounced back, and the rest of Asia. So, and then good performance in Latin America.
So I would characterize it this way, Latin America has been stable through all of this, even with all the political stuff that has been going on. And they continue to prioritize health care down there in terms of spending and modernization and access. So with all of that, we see that continuing.
If I go back to Asia for you, what's changed China for us is the rebound on the capital equipment side. We had good performance through some difficult times in China on the device side of things, on the disposable side, but on the Life Sciences side has really come back.
We're seeing strong performance with multiple platforms in China, and we expect them to continue to ramp there. So, we feel very good about China looking forward. The rest of Asia continues to do well and had strong performance. India is a little bit more of a question mark from the standpoint of just things like tariffs and what not.
But we think we'll be okay from a revenue growth standpoint. And then lastly, just coming back to the Middle East, what we saw was the stabilization in Saudi Arabia. And where that was a big drag, that is no longer a big drag for us. And where we had in Africa a drag from CD4 testing, that's not a significant drag anymore.
And in fact, some new guidance came out just recently Alberto, I think, from the WHO on continuing using CD4. So all of that, we are feeling good about our guidance for the year in terms of high-single digits. And continued success moving on from there..
I have nothing to add. The year-to-date is 9.1%. That is a very high-single digits, and the momentum continues. And as I mentioned earlier, it was our best performance in two years in emerging markets. So we feel good about the momentum there..
Our next question comes from the line of Richard Newitter Leerink Swann – or Leerink Partners..
Hi. Thanks for taking the question. I just wanted to follow up on the comment, I think you said that pricing got a little bit worse or the headwinds intensified a touch. Can you elaborate on that specifically, and was there a specific division? Thanks..
Yes. So there was about 20 bps of pressure in the quarter. Year-to-date, it's about 20 bps in total after the first quarter being flat, and the second quarter, actually, was down about 30 bps, so it's actually moderated a little bit from that.
That's the kind of plus and minus we have seen for a while now, is 20 bps to 30 bps, up, flat, down, somewhere in that range. We did mention that we are seeing pricing pressure in the U.K. in diabetes care from the austerity measures and the government payers. So that's continued, but pretty much in that range..
Okay. Thanks. That's helpful. And then maybe on just your Safety business outside the U.S. Can you just talk about where you are on the conversion opportunity across the various geographies? I know that you were up against tough comps. The growth rate reflects that. But how should we think about the sustainability of kind of penetration from that ....
Yes. Tom can walk you through that and Alberto can pick up on the diagnostic side, so..
Hi, Richard. This is Tom. Yes.
As you mentioned, within the quarter, we did see – there's a very tough compare because last year in the quarter, Safety revenues grew 9% overall, and that was including 20% growth in emerging markets, driven – and that was particularly concentrated in the Medical segment, that difficult compare where there was timing of tenders in Asia and EMEA in that quarter that aided that high growth rate.
As you think about the outlook though for Safety, no fundamental changes to what we had shared in prior quarters. We still see about 50% of the way through the safety conversion in Europe, and so certainly, a runway remains there for the next several years.
And in emerging markets, we are still certainly sub 20% conversion as you think about markets like China, the rest of emerging markets even less than that, less than 15% or 10% conversion and so still a long runway to go there.
Obviously, the key to success in driving that is driving the legislative changes that really start mandating health-care institutions to convert to safety products. You saw that happen in Europe, and we continue to work with governments around the world, particularly, again, in emerging markets to help shape that policy and marketplace..
Anything you'd like to add, Alberto?.
Yes. For (65:22) for the quarter, we did have a very difficult compare last year, grew over 10%. So that was – and then it's mostly just timing of tenders outside the U.S. is mostly what affected it, but otherwise no big change..
And you continue to have a long runway in emerging markets?.
In emerging markets for sure. Yes..
Okay. Great. Okay. Thanks..
Our final question comes from the line of Derik De Bruin with Bank of America Merrill Lynch..
Hi. Good morning..
Good morning, Derik..
Hey. A lot of my questions have been asked, but just one follow up to something going on in this market. We've seen so many other suppliers of safety syringes and pre-fillables and injectable drug packaging sort of comment on generic de-stocking and sort of some issues with their customer and slowing (66:13).
Any of that sort of impacting you, are you noticing any change in buying patterns or buying behaviors from those customers?.
This is Tom. No. I mean, if you look at – now, keep in perspective, most of our drug delivery devices are probably not as much used for the generic space because a large portion are in the biologics. Obviously, that's still relatively early in biosimilars.
And if you look at our Pharm Systems business, I think we're up 6.7% year-to-date there, so very strong performance..
Okay. Thank you..
Okay. Thanks for the question..
There are no further questions at this time. I will turn the conference over to Vince Forlenza..
Okay. Well, thank you very much. Maybe to sum up here, we're really excited about Bard and the progress so far is exceeding our expectations. As we said, we're ahead of where we expected to be in the integration planning and getting more and more confident around the business model.
We're confident and feel good about our outlook for the remainder of the year. And lastly, we're really pleased we're able to jump over significant headwinds that we mentioned on the call. And I think we're doing this because of really excellent execution by the folks in the businesses around the world.
So thank you very much, and I look forward to briefing you next quarter. Thanks, everyone..
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day..