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Becton, Dickinson and (NYSE:BDX)

Q3 2014 Earnings Call

July 31, 2014 8:00 am ET

Executives

Monique Dolecki -

Vincent A. Forlenza - Chairman, Chief Executive Officer and President

Christopher R. Reidy - Chief Financial Officer and Executive Vice President of Administration

Alberto Mas -

William A. Kozy - Chief Operating Officer and Executive Vice President

Tom Polen - President

Linda Tharby -

Analysts

Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division

David R. Lewis - Morgan Stanley, Research Division

Kristen M. Stewart - Deutsche Bank AG, Research Division

David H. Roman - Goldman Sachs Group Inc., Research Division

Vijay Kumar - ISI Group Inc., Research Division

Robert Justin Marcus - JP Morgan Chase & Co, Research Division

Brian Weinstein - William Blair & Company L.L.C., Research Division

Derik De Bruin - BofA Merrill Lynch, Research Division

Jonathan P. Groberg - Macquarie Research

William R. Quirk - Piper Jaffray Companies, Research Division

Douglas Schenkel - Cowen and Company, LLC, Research Division

Richard Newitter - Leerink Swann LLC, Research Division

Glenn J. Novarro - RBC Capital Markets, LLC, Research Division

Daniel Sollof - Barclays Capital, Research Division

Operator

Hello, and welcome to BD's Third Fiscal Quarter 2014 Earnings Call.

At the request of BD, today's call is being recorded. It will be available for replay through August 7, 2014, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls, using confirmation number 69111053. [Operator Instructions]

Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.

Monique Dolecki

Thank you, Christie. 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.

Current quarter results include a pretax charge within R&D of $9 million, or $0.03 diluted earnings per share from continuing operations, relating to program asset write-offs and obligations. For the purposes of our conference call today, we will refer to adjusted diluted earnings per share, excluding this charge, and other items detailed in the reconciliation of non-GAAP financial measures.

Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Group President; Linda Tharby, Group President; and Alberto Mas, Vice President of Diagnostic Systems.

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

Vincent A. Forlenza

Thank you, Monique, and good morning, everyone. As we stated in our press release, we were pleased with our solid performance this quarter. As you already know, there have been a number of changes in the marketplace in which we compete, but we are operating in a very dynamic health care environment. Our consistent performance demonstrates that our strategy remains sound.

Moving on to our quarterly results. We achieved record revenues this quarter, and EPS growth was solid, as we expected. We saw strong core product growth, coupled with our recent acquisitions, which are overall performing in line with our expectations.

Revenue growth in the third quarter was once again driven by our Medical and Biosciences segments. Diagnostics international growth was partially offset by continued challenges in the U.S. We saw continued strong international Safety and emerging market sales, and they remain key growth drivers for the company. Based on our third quarter and year-to-date results, we feel confident in our previously communicated revenue and EPS guidance ranges. We will review our guidance for the full year in more detail shortly.

On Slide 5, we've outlined our third quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues were solid, increasing by 4.6%. Fully diluted adjusted EPS came in at $1.68, which grew 7.8% in the quarter.

Now I'd like to turn things over to Chris for a more detailed discussion of our third quarter financial performance.

Christopher R. Reidy

Thanks, Vince. Thanks, Vince, and good morning, everyone. I'd like to begin by discussing the key financial highlights for the third quarter.

As Vince just mentioned, revenue growth was driven by both core products and acquisitions performing in line with our expectations, with all segments contributing to growth. The quarter was impacted by the reversal of some favorable timing matters from the first half of the year, as we anticipated and shared with you earlier in the year. Pricing was about flat for the quarter.

We also completed an additional $187 million of our share repurchase plan, bringing our year-to-date total repurchases to $400 million. As we continue to focus on new products and innovation, we remain disciplined as we evaluate our portfolio.

In our reported results this quarter, you will see a pretax charge of $9 million, or $0.03 diluted earnings per share, resulting from our decision to end the continuous glucose monitoring program, or CGM. We have reallocated those resources to other areas of our Diabetes Care portfolio, in addition to our broader R&D efforts.

Overall, we are pleased with our results, and we are on track to deliver on our commitment of 4.5% to 5% revenue growth and 11% to an 11.5% EPS growth for the full fiscal year.

On Slide 8, I'll review our revenue growth by segment on a currency-neutral basis. Third quarter revenue growth was 4.6% for the total company. BD Medical third quarter revenues increased 4.7%. Growth in this segment was primarily driven by strong sales in our Medical Surgical Systems unit, which grew 6%. We saw a continued strength in emerging markets and international Safety sales.

Revenue growth in Diabetes Care was 3.6%. This reflects continued strength of pen needles, partially offset by an unfavorable comparison to the prior year period and the timing of the tender order. We expect growth in this unit to normalize in the fourth quarter.

Pharmaceutical Systems growth was 3.4%, which reflects the reversal of a favorable timing of orders that occurred in the first half of the year. This is in line with our expectations and consistent with our communications on prior earnings calls.

BD Diagnostics third quarter revenues increased 3.7%. The segment's growth was driven by strong sales in our Preanalytical Systems unit. Growth in Diagnostic Systems was impacted by continued softness in U.S. Women's Health and Cancer.

BD Biosciences revenues increased 6.6%, driven by solid instrument placements, new platforms and continued stability in the research spending environment in the U.S. Growth was also aided by a favorable comparison to the prior year.

Now moving on to Slide 9. I'll walk you through our geographic revenues for the third quarter. BD's reported U.S. revenues increased 2.8% versus the prior year. We view the environment in the U.S. as stable.

Revenue on our U.S. Medical segment increased by 4.4%, driven by strong growth in Pharmaceutical Systems and solid growth in Medical Surgical Systems. The Diabetes Care unit was impacted by the previously aforementioned difficult comparisons with the prior year period.

Revenues in U.S. Diagnostics declined by 0.2%. This reflects continued softness in Women's Health and Cancer due to extended cervical cancer screening intervals and U.S. share losses, partially offset by solid growth in Preanalytical Systems.

U.S. Biosciences revenue increased 5.1% due to solid instrument placements, reagent growth and a favorable comparison to the prior year.

Moving on to international revenues grew 6% currency neutral, driven by growth in all 3 segments. Medical segment grew 5% and Diagnostics grew 7.3%. Growth in both segments was driven by emerging markets and international Safety sales. The Biosciences segment grew 7.4%, reflecting strong growth in Western Europe and a favorable comparison to the prior year.

On Slide 10, we continued to see strong growth in emerging markets, which accounts -- accounted for approximately 25% of our total revenue. Emerging market revenues grew 8.9% currency neutral over the prior year, bringing our year-to-date growth to 12%. Slightly slower emerging growth this quarter reflects an unfavorable comparison to the prior year in Latin America. Growth is expected to normalize in the fourth quarter.

As expected and discussed on our last call, revenues in China have returned to a more normalized growth rate, coming in this quarter at 20.9%. Sales of safety-engineered products in emerging markets grew 18%.

Moving to global Safety on Slide 11. Currency-neutral sales increased 6.1% and grew to $569 million in the quarter. Revenues in the U.S. grew 1.2%. International sales grew 12.4%, driven by good performance in Western Europe, Asia and Latin America. Medical Safety sales grew 6.6%, driven by a range of safety-engineered products. Diagnostics growth was 5.7% in the quarter. Both segments experienced strong international growth, particularly in emerging markets.

Turning to Slide 12. Gross margin performance in the quarter reflects benefits from ReLoCo, continuous improvement and favorable pension expenses. These items were more than offset by a mix, raw material and start-up costs. Currency had a favorable impact on gross profit by about 10 basis points.

For the total year, we are reducing our gross profit guidance to between 51.2% to 51.4%. This is largely due to the cost to remediate quality issues, including an incremental investment in our manufacturing processes within the Pharmaceutical Systems business that impacts the second half of the year. Additionally, we are seeing continued margin pressures associated with the challenges in our Diagnostic Systems business.

Slide 13 recaps the third quarter income statement and highlights our foreign currency-neutral results. As we discussed, revenues were in line and gross profit came in slightly below our expectations.

SSG&A increased 3.4%. R&D increased 5.4% as we continued to invest in new products. Operating income grew 4.7%, impacted by a lower gross profit in the quarter.

Our tax rate declined by 50 basis points, reflecting the benefits of favorable geographic mix. In the quarter, adjusted earnings per share were $1.68, which represents a 7.8% increase over the prior year. All of these items were in line with our expectations.

Slide 14 recaps the adjusted year-to-date income statement and highlights our foreign currency-neutral results. I'll not review this slide in detail, but I would like to note our year-to-date operating income growth of 7%. Excluding the incremental impact of the medical device tax in the first quarter, underlying operating income growth was 8.2%. Also, despite our lower gross profit expectations for the year, we are still on track to deliver about 70 to 80 basis points of underlying operating margin expansion for the year. As a reminder, about half of the margin expense is the result of favorable pension expenses. All other P&L guidance remains in line with our previously communicated ranges.

Slide 15 illustrates our revenue guidance by segment. We expect revenue growth for the total company to be between 4.5% to 5%. For the BD Medical and BD Biosciences segments, we expect growth to be at the upper end and Diagnostics to be at the lower end of our previously communicated ranges. This assumes a euro-to-dollar exchange rate of about $1.37.

Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.

Vincent A. Forlenza

Thank you, Chris. Moving on to Slide 17, I would like to review the program and product launches. As we remain focused on new products and innovation, we're very pleased with the progress we've made. This year, we expect new products to account for approximately 16% of total revenue.

In the Medical segment, we are continuing to make progress on our BD Simplist line of prefilled generic injectables. We currently have 4 drugs approved by the FDA, and we have applied for 4 additional drug approvals. We are continuing to focus on the commercial launch of Morphine, which was approved a few months ago. As we have been sharing with you, we continue to expect that this new initiative will take time to gain traction in the marketplace.

In our Bioscience segment, we continue the launch of our BD FACSPresto. FACSPresto is a portable instrument which is used to stage and monitor HIV/AIDS patients by analyzing their CD4 and hemoglobin levels. This innovative instrument was created with resource-limited settings in mind, and it can be easily transported to meet customer needs in rural areas.

We are also excited about our Sirigen dye portfolio, which has been making news in the flow cytometry community for its capabilities. We have launched 3 dyes throughout this year, and we plan to launch 3 more before the end of the year.

Turning to Slide 18, you will see the various product launches in Diagnostics. On the BD MAX, our worldwide Enteric Bacteria launch is now underway, with the U.S. launch this quarter. Our Enteric Parasite assay has also launched this quarter in Europe. These unique assays combined our core microbiology and molecular competencies for a novel and rapid approach to enteric testing.

Finally, we are pleased with our new GC/CT test has been approved on the BD Viper LT platform, in both the USA and Europe. This assay and platform combination will provide midsized testing facilities with the ability to use this smaller, efficient instrument with improved assay functionality. This is the second test approved on the Viper LT, joining BD's CE marked Onclarity HPV Assay with genotyping capabilities. As always, we will continue to update you on the progress as we are -- that we're making with our various pipeline opportunities.

On Slide 19, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we are pleased with our solid performance in the third quarter and year-to-date. Second, our consistent performance demonstrates that our strategy remains sound in this dynamic health care environment. Third, we're seeking the continued success with our key growth drivers of geographic expansion, new products and acquisitions, which are overall performing in line with our expectations. Finally, we are pleased to reaffirm our guidance for fiscal year 2014. We believe we are positioned to continue our track record of delivering value to our customers and shareholders. Thank you.

We will now open the call to questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question is coming from Rick Wise of Stifel.

Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division

Let me start off with just a bigger-picture question. I hate to quibble about yet another excellent quarter. This was a slightly smaller beat in recent quarters. Chris highlighted a couple of the moving parts there. But just broadly, anything we should appreciate about the quarter and the environment in a bigger-picture sense? And Chris, given the healthy divisional performance with Medical, Diagnostic, Biosciences all at or above your fiscal '14 guidance year-to-date, why wouldn't they do better if they've outperformed 3 quarters in a row through the fiscal year?

Vincent A. Forlenza

So Rick, I'll take the environmental piece then Chris will get into the guidance a little bit. But we had a long discussion here about do we see anything really changing significantly globally, and the answer to that is no. We see the environment primarily as stable and not a whole heck of a lot of change. We know other people have talked about maybe some increased volume coming from the ACA. We don't think we've seen that yet. So -- and the same is true in emerging markets. We see consistency in emerging markets. Obviously, there's always some moving pieces with some of these tenders, but nothing significant in the environment. Chris, you want to add...

Christopher R. Reidy

Right. And Rick, yes, you're absolutely right, we are doing better in...

Vincent A. Forlenza

[indiscernible] mic.

Christopher R. Reidy

It is on.

Vincent A. Forlenza

Well, okay, fine.

Christopher R. Reidy

We are doing better in the Medical and Biosciences business. We're coming down slightly on Diagnostics. If you do the math, that kind of takes you to the high end of the 4.5% to 5% range, and we thought that the range was tight enough at this point in the year. But you're absolutely right. If you do the math, you're a little bit better on BDX in the midpoint of the range.

Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division

Yes. And just a follow-up question. If the -- you talked about the "difficult U.S. diagnostic environment." Maybe a little more color on that. And does the expanding BD MAX and Viper menu help stem the difficult environment or ward off that you've been talking about? Or are these secular changes as opposed to company specific? Just help us understand that a little more.

Vincent A. Forlenza

So to that point, first just one more comment on the guidance. Keep in mind, as we go into the fourth quarter, that we had that large performance with Biosciences, and that was really driven by Japan and the stimulus. So you have a very tough compare there. So that all also figures. In terms of Diagnostics, would you like to comment, Alberto, on what's happening in the U.S. marketplace.

Alberto Mas

Yes, I think the launches that happened this quarter in Enteric, as Vince mentioned, in Bacterial and Parasite in Europe, will give us momentum to continue growth, as expected, in the MAX platform. So I think that would -- definitely will be -- but most of the -- again, the international growth is solid. Our core growth is very solid. And what we're seeing, as we've been saying for a while now, the headwinds are more in the U.S. in Women's Health in terms of the interval testing, some account losses because some of our overall platforms are aging. But fundamentally, we're not seeing any, as Vince reiterated, any huge changes. We just have to execute on our strategy.

Vincent A. Forlenza

And we think we're up to about 70% conversion on the intervals now. But thanks for your questions, Rick.

Operator

Your next question comes from David Lewis of Morgan Stanley.

David R. Lewis - Morgan Stanley, Research Division

Vince, it's nice to have you back. It wasn't the same without you last quarter.

Vincent A. Forlenza

Thank you for the [indiscernible].

David R. Lewis - Morgan Stanley, Research Division

So 2 questions, one strategic and one very specific for Chris. So Vince, if we go back to last -- I think if we go back 10 years and think about your diabetes initiatives, specifically the ones to expand your diabetic reach, we talk about the strip and meter business with Nova Biomed and, obviously, the CG mass initiative you announced this morning. So you clearly want to get bigger in diabetes, but some of these partnership models, to be frank, haven't really worked well for the company. So do you think in light of some of these partnership models these last 5 to 10 years, your view on how to get bigger in diabetes changes at all? You've got a lot of reach but not enough products, and these partnerships aren't working. So a very directed question there, and I had one quick follow-up.

Vincent A. Forlenza

Sure. So I don't think it's an issue of it being a partnership model. I think that specifically, right now, this was an issue of technology that we had brought into the company a long time ago. The fact that we partnered on the development of it was really not the issue. The issue was did the technology work or not. And when we got into some human testing, we saw some issues. And so there was a technological failure. It had nothing to do with the partnerships. But we think that the partnerships we've put in place with the JDRF are very important, and we've very enthused with the partnerships that we have on the infusion area. So I certainly wouldn't draw that conclusion. Where I would agree with you is that we're working hard to expand the product portfolio, and this gave us the opportunity to reinforce some of the other programs in Diabetes Care. So I think we're optimistic about the other programs, and we'll be moving ahead.

David R. Lewis - Morgan Stanley, Research Division

Okay. You think you're any more likely, Vince, to pursue M&A in diabetes? Is this more likely externally? Or are you still comfortable internally you can grow the portfolio?

Vincent A. Forlenza

Well, we're still comfortable internally we can grow the portfolio, and we're making good progress on our other programs. But like -- each one of our businesses are challenged with developing solutions for the customer, okay? Whether it's Diabetes Care or Diagnostics or MedSurg, yes, you've seen what we've done across the portfolio. Diabetes Care would also fall under that blueprint. Chris?

David R. Lewis - Morgan Stanley, Research Division

Okay. Just last quick one for me. Chris, just the gross margin guidance change for the year, obviously not very dramatic. But the outset for that wasn't clear to me. Is it likely that you offset that pressure through SG&A or more through R&D?

Christopher R. Reidy

It's actually a little bit of both. We're running -- if you look at where we are year-to-date and with the slight improvement on revenue that we were talking about, holding the SG&A line about where we expect it is giving us a little bit more leverage in the fourth quarter. R&D is a favorable compare in the fourth quarter. And I'll remind you that on SG&A, last year we had legal expenses related to RTI in the fourth quarter. So there's a little bit of an easy compare in the fourth quarter as well. The combination of all those factors gets you down to the 7% of operating margin improvement.

Vincent A. Forlenza

Okay. Thanks, David.

Operator

Your next question is coming from Kristen Stewart of Deutsche Bank.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Just a follow-up on the Diabetes business. Can you maybe just talk through, I guess, where exactly you are with some of these other opportunities? I know you talked about the Infusion. That's just -- what would be the expected timeline by which you may have some new announcements to make within Diabetes?

Vincent A. Forlenza

So Bill Kozy will take that question. Bill?

William A. Kozy

Yes, we're focused on the portfolio on Diabetes on 2 programs. First is the insulin infusion. And we're not ready yet to talk about the exact time, but it's certainly within the business planning window here over the next 24 to 36 months that we expect to make significant progress on insulin infusion. And then as we've mentioned before, we are looking at, right now organically, internally, at type 2 opportunities within the -- for insulin delivery. And it's really just too early for us to start talking about that, but those are -- in terms of portfolio management, those are the 2 priorities in that R&D development cycle with Diabetes Care.

Operator

Your next question comes from David Roman of Goldman Sachs.

David H. Roman - Goldman Sachs Group Inc., Research Division

I wanted just to come back to the pipeline a little bit. I know, Vince, in your prepared remarks you did you walk through some of the milestones with respect to product launches, both in the U.S. and elsewhere. But very specifically, as you look at maybe BD Diagnostic Systems and then also the BD Rx business, when do you think we can see some of the initiatives in each of those segment lines start to overwhelm some of the macro pressures that you're facing in each of those categories? And how long, really -- how long do you think it takes to build scale there?

Vincent A. Forlenza

Well, let's start with Diagnostics. We expect that this interval issue is -- we're up to about 70% conversion. It's hard to say exactly how much more we have left in that, but we've been thinking it's more than a year before the rest gets converted. I don't know if it tops out at 80%, where we might fall. In terms of ramping up the growth rate, we expect as we move forward into next year and whatnot, it -- this business will be improving. We're excited about what we have going on with KIESTRA. And with these new launches that we talked about with the enteric assays, it's going to give us more traction. The last other key piece, of course, is going to be the BD Viper and getting traction outside the U.S., both on chlamydia and HPV. Alberto, do you want to add anything more to that?

Alberto Mas

I think the only thing that I'll add is that the account loss that we've been talking in last quarters will be played out mostly this fiscal year, a little bit still in the future but mostly in this fiscal year. So that will make it easier from a growth perspective.

Vincent A. Forlenza

Yes, and that's why I was thinking that when you look at those product launches and you think about annualizing that, you'll start improving forward in that. Now BD Rx. Tom?

Tom Polen

Right. This Tom. I think, as Vince mentioned before, we have 4 drugs approved by the FDA and have applied for 4 additional drug approvals. Well, at this point, we're really focused on the commercial launch of the Morphine as that's our most important drug approval so far. So once we make some progress with the Morphine launch, we'll have more information to share with you on our outlook going forward. Again, as we've previously said on prior calls, this is still a relatively new initiative for us, and it's going to take some time for us to see traction on these products in the marketplace. It's not a fast version product, yes.

Vincent A. Forlenza

It's going to take a few more months for us to understand where we're really at with Morphine. We see that as a [indiscernible].

Tom Polen

And we'll circle back, yes.

Vincent A. Forlenza

Okay?

Operator

Your next question comes from Vijay Kumar of ISI Group.

Vijay Kumar - ISI Group Inc., Research Division

So maybe one -- first, a big-picture question for you. And, I mean, Diagnostics, right, you can see the environment changing, a lot of consolidation going. And clearly, you guys have seen the effect, just given the compare of landscape. Do you feel like you guys are at scale within this unit? Or do you feel like you need to add particular platforms just given what some of your competitors like Roche, Danaher, some of the large guys, what they're planning, right? So I'm just trying to think in this changing health care landscape how do you feel about your Diagnostic positioning.

Vincent A. Forlenza

So we actually feel pretty good about our Diagnostic positioning. We don't think there's a lot of crossover, for example, in terms of applying hematology, applying microbiology. We think it's a much more potent strategy to have a complete solution like we had put together in the infectious disease, microbiology area, where we now have total lab automation. What we think we have to do is execute on the programs that we have in place and continue to drive in those segments. We have a lot of pieces like the previous questioner asked. David asked about when is it going take you -- how long is it going to take to get to scale? We have to implement on the assays and the menus that we have talked about and get approval through the FDA. And we're working to get Totalys approved, for example, right now. So it's building out those complete solutions before even getting broader in Diagnostics. It's more the strategic priority.

Operator

Your next question comes from Mike Weinstein of JPMorgan.

Robert Justin Marcus - JP Morgan Chase & Co, Research Division

This is actually Robbie Marcus in for Mike. Maybe just ask the first question. You put up another good quarter in Safety products, really good outside the U.S., just 1% growth in the U.S. Can you talk about what kind of runway you see there, both in the U.S. and o U.S.? and how much longer can this good growth last for?

Vincent A. Forlenza

Sure. Tom Polen will answer that question.

Tom Polen

This is Tom. So Safety continues to really remain largely in line with what we've discussed in the past. We see the U.S., acute care market in particular, is -- it already is highly converted, and so we're not expecting any significant trajectory change there going forward and it is mature. The U.S. is -- or the EU is continuing to actively convert, and we see emerging markets at still quite an early stage. Just maybe a little bit more perspective on that. The EU is just under about 50% converted for catheters and about 15% converted for injection devices. And we continue to see really positive market response to the new legislation, with strong growth in both Safety catheters and injection across the majority of the Western European market. I guess it's still early, and we're seeing some really promising signs of broadening Safety implementation and potential in Southern Europe. And certainly, the rate of conversions varies by country there. Maybe just a comment on emerging markets, Safety there continues to go well, as you just mentioned, and we're growing double digits really led by Asia and Latin America in emerging markets. Again, it's still early. We're seeing good progress. We're seeing continued interest in partnering in a number of emerging countries who are really committed to the safety of their health care workers. So I think x U.S., we see a good runway ahead still.

Operator

Your next question comes from Brian Weinstein of William Blair.

Brian Weinstein - William Blair & Company L.L.C., Research Division

I just want to follow up on kind of a question that was just asked a little while ago. And that is, given the struggle that you've had in Diagnostics, it would seem to me that it would make sense to continue to invest heavily in some R&D there in specifically places where you have an advantage like in micro where there's new ID products coming out and direct-from-patient products that are beginning to emerge in micro. Can you comment specifically about that -- those types of projects within micro? And then are there areas within Diagnostics that you think might be interesting for additional investments?

Vincent A. Forlenza

Yes, sure. Alberto Mas will talk to that. Alberto?

Alberto Mas

So it's -- definitely, our core credibility market is in our microbiology franchise that we've built over many, many years. We're very credible there, and we base our strategies on that. And we are definitely watching the radar screen in terms of any technologies and capabilities that we need to add to that portfolio, including all the Directed detection that you mentioned is definitely on the radar screen, and we'll be monitoring that space in -- over time and within our -- on microbiology.

Vincent A. Forlenza

This is Vince. We'll continue to invest in our molecular platforms as well as, obviously, as -- rapid detection methods. We have the partnership with Bruker [ph]. So we are really focused in this area. And as Alberto said, it will be a matter of internal and external kind of plug-in thing.

Operator

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

Derik De Bruin - BofA Merrill Lynch, Research Division

So could you talk a little bit about the HPV program? I mean, that's another market where HPV pricing has obviously been coming under pressure. I guess -- and specifically, pressure driven by your major competitor in the CT and G market. Can you talk about how you're pricing that product and sort of your expectations for when that is approved in the U.S., where you'll price it? And I guess how do you see the HPV/AIDS business, the molecular business, synergizing with what you currently have with your opportunities for bundling and gaining some share back?

Vincent A. Forlenza

So we wouldn't get into the specifics of how we price the product. We would certainly price it competitively. We think we have a good cost position on this product. So we will have flexibility, and we think we can be very competitive with the HPV product. And we don't think about so much as bundling as we do about complete solutions for the customer, total automation, a complete menu and providing more value for the customers.

Operator

Your next question comes from Jon Groberg of Macquarie.

Jonathan P. Groberg - Macquarie Research

So maybe just a couple of clarifications. First, on gross margin. Chris, would you mind -- I think pricing seemed like it's actually coming in better than you anticipated at the beginning of the year. So can you maybe just give me -- just help us understand exactly again why gross margin is going to be a little lighter than you expected? And then on the launch of the new CT/GC product, I'm just curious, you had that day. You mentioned, Alberto, the loss in the U.S. Is there any way for you with this new launch -- are you going to -- aggressively trying to gain back that market share? Or -- I'm just -- I'm trying to think how you're going to go about in the U.S. with the launch in CT/GC, if it's just about stabilizing your share or if you're able to think about more aggressively going after regaining markets that you've had in the past.

Christopher R. Reidy

Sure. Let me start with the pricing and gross profit comment. As we've been saying all year on our pricing focus, the fourth quarter is where we expect to see some negative pressures. Having said that, Q3 was slightly favorable to our expectations, and year-to-date pricing is slightly favorable. So as we now look at, we would anticipate that we'll finish the year flat to slightly negative on pricing, which is a little bit of a lift. And to your point, that drives a little bit of a lift in gross profit. But going back to gross profit, the way to probably think about is for the full year, we're anticipating, consistent with our original guidance, that the drag from FX would be about 60 basis points. Now originally, we said that we thought we could offset that operationally with a positive 60 basis points, and that was driven by the ReLoCo effort, pensions and continuous improvement. Now we expect that to be flat to up 20 basis points operationally. And the impact was the continued pressure from Diagnostic Systems. We brought that revenue guidance down. And that certainly has a mix issue, so that's dragging us down a bit. And as we talked about in our remarks, the remediation of the quality issue on -- in Pharm Systems and the related spend on improving the manufacturing processes puts pressure on it. But the bottom line is we still expect on an operational basis to be flat or slightly up 20 basis points, and the margins are in that 51.2% to 51.4% kind of range. So still very solid margins with a potential for a little bit of lift year-over-year.

Operator

Your next question comes from Bill Quirk of Piper Jaffray.

William R. Quirk - Piper Jaffray Companies, Research Division

Yes. Two questions for me. First off, just on emerging markets, guys. It did slow down here in the quarter. I would love some additional color there, particularly considering that we are heading into what looks like probably the most difficult comp here in the fourth quarter.

Vincent A. Forlenza

So in emerging markets, we had strong performance, but there was a timing issue in Latin America on a tender. And that was really the issue. Otherwise, as we mentioned in the prepared remarks, China bounced back to where we expected it to be. And overall, we were pleased with the performance with that.

Christopher R. Reidy

Yes, the big thing was Latin America. The year-over-year compare in Latin America was difficult because last year's third quarter was up over 18% in Latin America, and that's the timing of tenders that hit last year that didn't repeat. So that was the big driver. And Vince said China's back up over 20%. We're seeing good, double-digit growth in EMEA. India is very solid. And we are seeing some other timing of tenders in other parts, but we expect that to bounce back to more normalized growth rates going forward.

Operator

Your next question comes from Doug Schenkel of Cowen and Company.

Douglas Schenkel - Cowen and Company, LLC, Research Division

I wanted to start with a question on Sirigen and then just as a quick one on Women's Health. So on Sirigen, you noted the launch of 3 new dyes, plans to launch 3 more by year end. I believe there's also a couple of new lasers available. In combination, this allows for flow cytometry customers to perform higher parameter analysis on existing traditional flow cytometers, which also, importantly, allows customers to subsequently store up the cells if they so choose. So it does seem like you're moving towards a completely competitively unique value proposition with the addition of these dyes and lasers. With all that in mind, how many more dyes are expected in 2015? And how would you describe the demand for higher parameter analysis given some of the bioinformatics hurdles that exist in flow cytometry? And then quickly on Women's Health, would you be willing to quantify the year-over-year impact of intervals versus the loss of the account? And you did indicate the vast majority of the burden associated with the account loss is expected to be incurred by the end of the fiscal year. When does that negative base effect get annualized? Is that really in the second half of next fiscal year where the account loss becomes less of a headwind?

Vincent A. Forlenza

Sure. So I'm going to move you into the flow cytometry marketing group. You really stated the value proposition very well, but I'll turn that to Linda.

Linda Tharby

Thanks so much for the question. So as you noted, doing multiparameter analysis in flow cytometry is becoming more and more important. So very excited about the opportunity to bring together, as you mentioned, both the improved colored parameter on our flow cytometers with the Sirigen platform. So we did discuss that we intend to repeat the performance that you saw in Q4 that we saw in terms of new launches of dyes that we saw in Q3, which is 3. I can't speak on a go-forward basis, but you would expect us to continue to roll out many new dyes and many new SKUs related to our Sirigen platform. It's really helping to power both the traditional immunology and also some expansion into single-cell parameter analysis in the broader area of genomics. So very excited about that.

Vincent A. Forlenza

Alberto, are you going to pick up the other piece?

Alberto Mas

Yes. In terms of the -- our SurePath business, we estimate that about 2/3 of the impact is driven by interval extension and 1/3, more or less, off from an account loss perspective. Just to put it into perspective as well, the performance of the quarter, if you normalize for the big account loss that we've been referencing, would have been 3.9%. So I want to put that into context as well. And this will normalize in the first half of next year.

Vincent A. Forlenza

3.9% positive.

Alberto Mas

3.9% positive, yes.

Operator

Your next question comes from Richard Newitter of Leerink.

Richard Newitter - Leerink Swann LLC, Research Division

Vincent, if I could just ask a quick big picture and then just a follow-on, if you have time. The sort of the bigger picture, just we're seeing more consolidation, particularly across the medical device landscape. But elsewhere in health care, scale is increasingly becoming a topic of focus. I'd love to just hear your thoughts on where within your businesses you think scale actually has a significant advantage, if at all. And if you can comment on your view just of the consolidating landscape that we're seeing and where Becton stands today.

Vincent A. Forlenza

So we're not a believer in scale for scale's sake. Our strategy is really focused on creating complete solutions for the customer and driving value that way. We think that, that aligns much more with the basic customer needs and how buying processes are evolving. So we really think strategically around each one of these business units and how they can build out solutions. And if you look at how we might work across business units to create more complete solutions, it's a second element of our strategy that we are developing. All of that lines up with -- more with our plug-in M&A strategy. And so that's really the core of what we're trying to do. And certainly, there are people who are playing this out differently in terms of just more and more breadth, but that's not what we're attempting.

Operator

Your next question comes from Glenn Novarro of RBC Capital.

Glenn J. Novarro - RBC Capital Markets, LLC, Research Division

Two questions. First, just a follow-up on the gross margin. I understand the issue that you're facing here in the near term and the offset being lower SG&A. But as you look at the gross margin going forward, what specifically can you do to address some of the pressures that you're facing? For example, as you look at ReLoCo, is there a little bit more from ReLoCo that you can extract? And then second, on the ACA and volumes, Vince, I understand that you said you didn't see much of a benefit here in the quarter. But I would imagine hospital volumes and physicians are just going to pick up and momentum's going to grow from the ACA. So does this benefit your U.S. business over the next 6 to 12 months?

Christopher R. Reidy

I'll start on the gross profit margins. I think if you look at the performance that we would have had excluding these 2 pressures, which are focused on in-year pressures, we would have had 60 basis points of improvement. ReLoCo has been very successful for us. It's -- we're still seeing benefits from that this year of around $30 million. And initially, it was a bit larger, but we're still seeing some benefits from that. So without giving guidance on gross profit margin for future years, which we will do on the next call, I don't think you should view this kind of pressure as having a significant impact on our ability to drive margin growth, either at the gross profit or at the operating margin going forward.

Operator

Your next question comes from Matthew Taylor of Barclays.

Daniel Sollof - Barclays Capital, Research Division

It's actually Dan in for Matt. I just had a follow-up on SG&A. It came in better than we're expecting it. It's actually lower than it's been for a while. So I just wanted to ask, is there -- was there anything like deferral of spend, at least on a percentage of sales basis that, like, helped this quarter? Is this like a base where we can kind of, like, further leverage off of? I'm just kind of curious for some more color there.

Vincent A. Forlenza

Yes, the best way to look at SG&A, I think, is for the year-to-date, and I think that's a pretty good indicator of where we'll be going forward. You're right, we're seeing some positives. We'll actually see a little bit more of a positive in the fourth quarter, as I mentioned, with the easy compare. But we are seeing leverage in the SG&A line. So that's positive.

Operator

Your next question comes from Kristen Stewart of Deutsche Bank.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Yes, on the operating margin outlook, I know that you had mentioned half of the expansion this year is coming from favorable pension. Just how should we think about -- that the opportunities for margin expansion? You commented on gross margins seemingly having a runway for expansion, but you did also mention quality spending. How long does that last? And are you still kind of more in the investment spend area for emerging markets as well?

Christopher R. Reidy

Well, we are investing in emerging markets. We're continuing to do that, as we have said. So we have that investment. We are making the investment this year. And we're just in the middle of our budgeting process, so how much of that extends into future years is still a question. Right now, it's a focus in-year more than anything else, but we'll give more color on that going forward. And so overall, we are making the right investments. We're investing in R&D but at the same time being very focused on reducing SG&A and improving the gross profit line, as we said, through ReLoCo. So there's a lot of levers that we're pulling while still making sure we're making the right investment that makes sense to drive future revenue growth and drive both. And we think we have evidence that we've been able to do that consistently to drive additional margin growth. Last year, it was 25%. And this year, 70% to 80%, with about half coming from pension. But again, continuous improvement in driving additional margin. So we'll talk more about that as we give guidance for next year on that as well.

Operator

Our last question is coming from Bill Quirk of Piper Jaffray.

William R. Quirk - Piper Jaffray Companies, Research Division

A follow-up. I'm just thinking about microbiology, guys. You've been in a nice position here relative to your principal competitor having some manufacturing challenges over the better part of the last year. Supposedly, this is going to be rectified here roughly by the end of this year. So how are you thinking about that competitive dynamic and just the franchise in general?

Vincent A. Forlenza

I think in terms of microbiology, we feel very good about the product line that we've put together. Alberto, would you like to comment further?

Alberto Mas

Yes, we definitely have had a strong quarter, especially in our BACTEC blood culture business that also was -- began to pick up in the last quarter. But we're seeing very, very healthy growth rates in that part of the business for sure.

Vincent A. Forlenza

All right. Well, thank you very much. Are there any more questions, operator?

Operator

There are no further questions. I would like to turn the floor back over to Vince Forlenza for closing remarks.

Vincent A. Forlenza

I want to thank all of you for joining us today. It was a pleasure updating you on the quarter. We look forward to getting back with you next quarter and providing you with our guidance going forward. But we're very pleased with the strong results, and thank you for your attention. Thank you very much.

Operator

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

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Source: Becton, Dickinson and's (BDX) CEO Vincent Forlenza on Q3 2014 Results - Earnings Call Transcript
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