Becton, Dickinson and Company (BDX) Q3 2013 Earnings Report, Transcript and Summary

Monique Dolecki Vincent A. Forlenza - Chairman, Chief Executive Officer and President Christopher R. Reidy - Chief Financial Officer and Executive Vice President of Administration Suketu Upadhyay - Principal Accounting Officer, Senior Vice President of Finance and Controller William A. Kozy - Chief Operating Officer and Executive Vice President Tom Polen - President

David R. Lewis - Morgan Stanley, Research Division Kristen M. Stewart - Deutsche Bank AG, Research Division David H. Roman - Goldman Sachs Group Inc., Research Division Michael N. Weinstein - JP Morgan Chase & Co, Research Division Amit Bhalla - Citigroup Inc, Research Division Brian Weinstein - William Blair & Company L.L.C., Research Division William R. Quirk - Piper Jaffray Companies, Research Division Douglas Schenkel - Cowen and Company, LLC, Research Division Jonathan P. Groberg - Macquarie Research Derik De Bruin - BofA Merrill Lynch, Research Division Matthew Taylor - Barclays Capital, Research Division Vijay Kumar - ISI Group Inc., Research Division Robert M. Goldman - CL King & Associates, Inc., Research Division Eric Criscuolo - Mizuho Securities USA Inc., Research Division

Hello, and welcome to BD's Third Fiscal Quarter 2013 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 8, 2013, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and (404) 537-3406 for international calls, using confirmation number 15535210. [Operator Instructions] Beginning today's call is Ms. Monique Dolecki. Ms. Dolecki, you may begin.

Thank you, Jackie. 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. 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; Suky Upadhyay, Senior Vice President, Finance; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, President of Diagnostics Systems; and Gary Cohen, Executive Vice President. As we stated in our press release, we experienced a charge relating to a pending litigation settlement of $22 million or $0.07 per share related to the indirect purchaser antitrust class action cases. We also experienced a charge relating to the medical device tax of $13 million or $0.04 per share. For the purposes of our conference call today, we will refer to adjusted diluted earnings per share excluding the pending litigation settlement and the medical device tax. It is now my pleasure to turn the call over to Vince.

Thank you, Monique, and good morning, everyone. Our solid results against the backdrop of a challenging environment demonstrate that we are executing on our strategy and delivering on our commitments. Revenue and EPS growth in the third quarter were in line with our expectations. Revenue growth in the third quarter was driven by our Medical and Diagnostics segments. We experienced a decrease in our Biosciences segment, which we will provide more details on later. Strong international growth overcame slower U.S. sales growth in the quarter. Growth in the U.S. was impacted by ongoing softness in our Women's Health and Cancer business and the timing of orders in Advanced Bioprocessing. We also saw a continued strong growth in international Safety sales and emerging markets, and we continue to deliver on our strategy of improving patient and health care worker safety. Based on our third quarter and year-to-date results, we feel confident in our previously communicated 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 5.1%. Fully diluted adjusted EPS, excluding the device tax, came in at $1.58, which grew 7.2% in the quarter. Now I'd like to turn the call over to Chris Reidy to make a few opening comments. As you may already know, Chris was previously at ADP Corporation, where he served as Corporate Vice President and CFO for 6 years. He is well positioned to help drive BD's strategy of accelerating growth through innovation, geographic expansion and operating effectiveness. We're extremely pleased to have Chris onboard, and we will leverage his diverse experience as we lead the company to its next phase of growth.

Thanks, Vince, and good morning, everyone. It's a pleasure to be here. I'm equally pleased to have joined the team at BD. The company's long history, core values and ethical standards are attributes that really resonated with me. It's a particularly exciting time to join the company as we focus on product innovation, strategic acquisitions and geographic expansion, and I'm delighted to be a part of it. While I have been only here a few weeks, it's evident that BD leaders and associates are committed to delivering health care products that are more effective, efficient and safe. I'm also very much aligned with the financial model here at BD, which is similar to the model used at ADP. I'm looking forward to working with the board and the management team to continue to execute against the company's strategy. We're committed to accelerating top line growth, driving margin expansion and returning cash to shareholders through dividends and share repurchases. I'd also like to take the opportunity to thank Suky for his contributions and the work he has done serving as interim CFO. As you all know, Suky, along with the rest of the strong finance team, ensured a seamless transition over the past 9 months. Suky's productive working relationship with the management team and the board, as well as his commitment to shareholders, is invaluable to the company. Now I'd like to turn the call over to Suky to review our third quarter of fiscal results and our guidance for the total year.

Thank you, Chris, and good morning, everyone. It's been my pleasure to have had this opportunity. Today, I'd like to begin by discussing the key financial highlights for the third quarter. The diversity of our portfolio, in tandem with strong execution, helped deliver solid performance in a challenging environment. From a macro perspective, we continue to view developed markets as stable but constrained and emerging markets as a continued source of growth. Revenue growth in the third quarter was in line with our expectations, driven by new product sales, acquisitions, Safety products and geographic expansion. In addition, the quarter benefited as a result of the reversal of some negative timing matters from the second quarter. We also experienced a better-than-expected price and mix profile. Adjusted earnings per share, excluding the device tax, were better than expected due to the timing of certain legal expenses, which we now expect to incur in the fourth quarter. We also completed an additional $50 million of our share repurchase plan, bringing our year-to-date total repurchases to $406 million. Overall, we are pleased with our results, and we are on track to deliver our commitments of solid revenue growth and underlying margin expansion, which will ultimately translate into an improved quality of earnings profile. As Vince mentioned, our third quarter and year-to-date results give us the confidence to reaffirm our guidance for the total year. We expect revenue growth to approach about 5%, which is the upper end of our previously communicated guidance range. We also expect adjusted earnings per share growth, excluding the medical device tax, to be at the upper end of our previous range of 11% to 11.5%. On Slide 9, I will review our revenue growth by segment on a currency neutral basis. Third quarter revenue growth was 5.1% for the company with acquisitions contributing about 80 basis points. We also experienced the impact of positive pricing and mix of about 20 basis points in the quarter. This reflects the benefit of new product launches and more effective pricing management in a challenging environment. BD Medical third quarter revenues increased 7.9%. Growth in this segment was driven by strong international sales, Safety and the normalizing of unfavorable ordering patterns from the second quarter, as discussed earlier. Medical Surgical Systems growth was 6.6%, led by emerging markets and international Safety-related sales. Growth in Diabetes Care was 9.4%. This reflected continued strong sales of pen needles, which include our Nano and PentaPoint products, along with our AutoShield Duo Safety product. Growth in Diabetes Care also reflects a timing favorable -- timing benefit from the normalization of second quarter impacts. Pharmaceutical Systems growth was 9.2%, also driven by favorable timing of orders from the second quarter and our SSI acquisition. BD Diagnostics third quarter revenue increased 3.6%. The segment's growth was driven by solid sales in Preanalytical Systems. Growth in Diagnostic Systems was softer than expected due to the timing of lab automation systems installations on a global basis and due to continued softness in Women's Health Care and Cancer in the U.S. BD Biosciences revenue declined 2.5% versus the prior year. Slight growth in instrument placements in the U.S. were more than offset by a few geographic factors, which I will speak to on the next slide. Moving to Slide 10. I'll walk you through our geographic revenues for the third quarter. As we expected, softer growth in the U.S. was offset by continued strong international growth. BD's reported U.S. revenues increased 1.3% versus the prior year. Revenue in our U.S. Medical segment increased by 4.4%. As expected, this was partially driven by the reversal of unfavorable timing in both our Pharmaceutical Systems and Diabetes Care businesses, in addition to the positive contribution from our acquisition of SSI. U.S. growth in the Diagnostics segment declined by 1.5%. This reflects growth in Preanalytical Systems, which was more than offset by continued softness in Women's Health and Cancer due to extended cervical cancer screening intervals. U.S. Biosciences revenues declined by 3.3%. As I just mentioned, slight growth in the U.S. instrument placements were more than offset by an unfavorable timing of orders in Advanced Bioprocessing. While we have seen low single-digit growth in instrumentation this year, we remain cautious on the macroeconomic outlook related to research funding. This has been contemplated in our full year guidance. Moving on to international. We continue to see strong growth. Revenues grew 7.9% currency neutral, driven by Medical and Diagnostics segments. The Medical segment grew 10.3% and Diagnostics grew 8.6%. This reflects strong growth in emerging markets and international Safety sales. Biosciences declined 2.1%. This reflects continued softness in Western Europe due to austerity measures and continued delays of government research funding in Japan. On Slide 11, we continue to see strong growth in emerging markets, which accounted for approximately 25% of our total revenues. Emerging markets revenues grew 12.8% currency neutral over the prior year. This was driven by good performance across all segments and regions. China revenues and Safety sales in emerging markets both grew by about 18%. We continue to see solid growth across all key geographies driven by an attractive return on investment profile. Moving on to global Safety on Slide 12. Currency neutral sales increased 8.7% and grew to $538 million in the quarter. Revenues in the U.S. grew 5.6%, which benefited in part from our acquisition of SSI. International sales grew 12.7%. We are encouraged by the positive results in Europe as the market continues to convert to safety-engineered products. Medical Safety sales grew 12.8% driven by a range of safety-engineered products and Diagnostics growth was 4.8% in the quarter with particularly strong growth in emerging markets. Moving on. Since we have already discussed revenues in detail, I will not cover Slide 13. Turning to Slide 14. As we expected and outlined for you on the last call, sequentially, gross margins improved by about 100 basis points. However, on a year-over-year basis, reported gross margins declined by 60 basis points due to the unfavorable impact of foreign currency. On a performance basis, positive contributions from ReLoCo and pricing were offset by acquisition and startup-related costs. For the full year, we continue to expect underlying gross profit improvement of about 40 basis points. Slide 15 recaps the third quarter income statement and highlights our foreign currency neutral results. As we discussed, revenue and GP were in line with our expectations. SSG&A increased about 11% due to investments in new products, acquisition-related expenses, legal fees and the medical device tax. The medical device tax unfavorably impacted SSG&A by about $13 million or about 300 basis points. As mentioned, the third quarter included a year-over-year increase in legal fees. We expect a further increase in the fourth quarter as we prepare for the RTI trial in September. R&D increased 5.6%. This remains in line with our expectations at 5.9% of revenues as we continue to invest in new products. Operating income, excluding the aforementioned settlement, declined by 0.9% in the quarter. However, when you exclude the medical device tax, together with the increase in legal and acquisition costs, operating income growth was broadly in line with underlying sales growth. Our tax rate declined by 180 basis points, reflecting the benefit of the reinstated R&D tax credit in the U.S. and favorable geographic mix. In the quarter, adjusted earnings per share, excluding the medical device tax, were $1.58, which represents a 7.2% increase over the prior year. Slide 16 recaps the adjusted year-to-date income statement and highlights our foreign currency neutral results. I will not review this slide in detail but would like to highlight our year-to-date operating income growth of about 4%. Excluding the medical device tax, underlying operating income growth was a little over 6% and ahead of overall revenue growth. As we've communicated previously, we are still on track to deliver about 40 basis points of underlying operating margin expansion this year. Slide 17 illustrates our revenue guidance by segment. We expect revenue growth for the total company to approach 5% or the upper end of our previous guidance range. This assumes a euro-to-dollar exchange rate of about 1.31 and a dollar-to-yen exchange rate of about 99 for the balance of the year. Within the Medical segment, we expect growth to be between 5% to 6%. This is primarily driven by better-than-expected results across international, Safety-related sales and acquisitions. The Diagnostics and Biosciences segments remain unchanged. We expect growth of about 5% and 1% to 2%, respectively. Adjusted EPS guidance is expected to be at the upper end of 11% to 11.5%, excluding the impact of the medical device tax. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.

Thanks, Suky. Moving on to Slide 19. I would like to review the program and product launches in our Medical segment. In June, we closed the licensing agreement with CRISI, that's C-R-I-S-I, which is a privately held company in California. CRISI is currently developing a drug delivery device for verifying, monitoring and documenting manual IV injections. CRISI nicely aligns with our strategy in Medical Surgical Systems around the elimination of medication delivery errors. Additionally, this links with our latest acquisition of Cato Software Solutions to create a preparation and delivery solution for certain safety gaps. For BD Simplist, we are continuing to make progress. We recently received FDA approval of ondansetron, and we expect to launch this by the end of our fiscal year. Ondansetron is an antiemetic used to treat nausea and vomiting often following chemotherapy treatments. We have 3 additional drugs in various stages of the FDA regulatory approval process. As you can see by Cato, Simplist and now CRISI, we're continuing to focus on medication error management and enabling safer and more effective parenteral drug delivery in both hospital and pharmacy settings. In our Pharmaceutical Systems business, we launched the BD Neopak this quarter. This is a new glass prefillable syringe system specifically engineered for the administration of biopharmaceutical injectable drugs. This new product is designed to address industry challenges in developing, manufacturing and marketing biological drugs to patients. As you can see, we've continued to make good progress with our product portfolio in the Medical segment. Turning to Slide 20. You will see the various product launches in Diagnostics. We're extremely pleased with our BD Veritor System since its launch in early fiscal year 2012. More than 5,300 units of this system have been placed to date. We continue to broaden our customer base, as well as capture share gains with this innovative point-of-care platform. We have now expanded beyond doctors' offices and have gained the interest of large pharmacy retail chains across the U.S. Moving on to molecular. On the BD MAX platform, we're pleased with the progress we're making as shipments continue to accelerate in the third quarter. We expect shipments to continue to accelerate in the fourth quarter as well. Our StaphSR, enteric bacteria and GC/CT Trichomonas assays are also progressing well through clinical trials. Our BD Viper molecular platform remains well positioned for the high-volume screening market. And the launch of the BD Viper Trichomonas assay remains on track for launch in the fourth quarter of this fiscal year. The launch of the new Viper LT platform, which includes our Onclarity HPV genotyping assay and GC/CT assays has been delayed by 1 quarter. However, we've completed the European clinical trial and are very pleased with the data. On front-end automation system for Women's Health, the BD Totalys is now shipping in Europe after being delayed by 1 quarter. The launch remains on track for the U.S. next year. On Slide 21, I'd like to review the program and product launches in our Biosciences segment. In the third quarter, we announced the launch of our new BD LSRFortessa. This is the latest cell analyzer in this line of high-performance research flow cytometers. The LSRFortessa will enable researchers to conduct complex experiments with the additional parameters and increased sensitivity they need. It's been designed by BD's special order program that enables customers to configure BD flow cytometers and cell sorters to fit precise research and assay needs. This program is tailored to meet the needs of researchers at the leading edge of biomedical discovery. And we'll continue to invest in this business in order to continue our expansion in this market and drive future growth. On Slide 22, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we're pleased with our continued improved revenue and underlying operating income performance in the third quarter and year-to-date. Second, we continued to demonstrate that we're making progress delivering against our strategy of accelerating revenue growth, delivering underlying margin expansion and driving effective capital deployment. Third, we're seeing continued success with our key growth drivers of geographic expansion, new products and acquisitions, which are performing in line or better than our expectations. Finally, we're positive about our outlook for fiscal year 2013. Despite the challenging environment, we believe we are positioned to continue our track record of delivering value to our customers and shareholders. Thank you. And we'll now open the call to questions.

[Operator Instructions] And our first question is coming from David Lewis with Morgan Stanley.

Just want to focus in on earnings growth for this quarter and for the balance of the year. So you talked about the legal settlement for the third quarter. And Suky, I wonder if you could break out for us what was sort of the magnitude of the legal shift in the third versus the fourth quarter. And is the fourth quarter number -- you initially had talked about earnings growth building throughout the balance of the year. The fourth quarter implied guidance has a sequential downturn to a certain extent. Is that entirely due to the legal expense? Or does it reflect some type of conservatism? So just helping us net out that math would be helpful.

Sure, David. Yes, the back half, as we talked about the last quarter, remains intact. It really is around the calendarization and the phasing of those legal expenses. So what we're seeing is about a $0.06 beat versus overall consensus on EPS. That's primarily driven by those legal expenses, which will now occur in the fourth quarter. So the second half still remains intact. It's just a shift from third quarter into the fourth.

And just maybe just a quick one for Vince. In terms of the European Safety, obviously it continues to be a driver for the business. Post the regulatory action in May, have you begun to see any change in the relative growth rate here on this particular quarter? And would you expect to see that as early as the fourth quarter?

Well, we did see a bit of a step-up in the quarter in European Safety. In fact, it grew just under 10%. So it was strong in the quarter. And we expect it to continue to be strong. As we've said all along, more so in Northern Europe than Southern Europe.

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

I was wondering if we could just dive in a little bit more into the Medical business. Since you are raising guidance there, I just want to get a better understanding of the components that give you a higher expectation for the balance of the year and just generally whether you think it's sustainable going forward into 2014.

Yes. We're encouraged by what we're seeing in the Medical segment. And Bill will comment on that.

This is Bill. Just the real basis for our slight change there is driven by the success of the recent acquisitions and the new product. If you could literally break the performance of those 2 categories out of the segment, they're contributing in the quarter we just concluded, a little over $95 million on the top line or a growth that would have been a little north of 8%. So anyhow, as we had planned quite a while ago, the impact of new products and recent acquisitions would offset some of the known kind of nongrowth contributors that we have in the more mature pieces of the Medical segment, particularly in Med/Surg. So right now, that's the basis for us moving up. For the quarter, for the Medical segment, new products as a percent of sales were a little north of 15%, which is the highest number we've achieved there for quite some time. And so that's the basis for the uptick.

Okay. And then you had also commented just generally on improved pricing and mix. Can you also expand there? I don't know if it was specific to Medical or if it's...

Yes, that was company-wide. And Bill can comment on that as well.

Kristen, the comment I just made, we tend to think about our pricing always in the same kind of phrase with mix. So what's happening, there's a number of examples in the Medical business. For example, in our Diabetes Care business, every time we make a conversion to Nano, we gain some slight improvement, but some slight benefit in terms of price/mix. We like converting customers to the Nano or the PentaPoint because of the slight advantage we're creating. That's what's giving us a little bit of favorability. And you have to look back to that very assertive price management and contractual management systems that we talked to you about on the last call. Those 2 factors have just allowed us to get a little better performance in that price/mix category.

And Kristen, across the company -- and maybe Suky might want to make a comment or 2. But think about this, from what Bill said, we had good mix in Medical with the new products with Diabetes Care. PAS did well. The one business where we generally would have a positive mix effect from a corporate level that was lower was Biosciences. But net-net, it was a positive, right, Suky?

No, I think you're right on point, both Bill and Vince. I think the one comment I would make is that we still do continue to see the environment as challenging, both from a pricing and reimbursement perspective. And year-to-date, we are still seeing erosion overall in year-over-year pricing, but we're very optimistic with these results. But we're taking it 1 quarter at a time.

Yes. I'll sneak one last in. Suky, are you still expecting within the guidance range for this year about 60 to 70 basis points from acquisition contribution?

Actually, we're expecting a little bit closer to 70 to 80 basis points. So as Bill talked about, we're doing a little bit better on SSI, as well as KIESTRA, which we've been talking about. So we see that contribution going up slightly.

Your next question comes from the line of David Roman with Goldman Sachs.

I was hoping you could actually dive into a little bit more detail on the U.S. Diagnostic Systems business and particularly in the context of your comment that BD MAX placement [indiscernible] accelerated in the quarter.

Sure. Tom can handle that, no problem.

David, this is Tom. So let me just walk through some of the key elements. So overall in the U.S., we certainly do see overall lower testing volumes, I think, as you see reported by others in the industry and from labs. The most significant area of that, of course, for us is being LBC testing volumes due to interval extensions. So we see that impacting the U.S. We also see obviously the lack of -- just from a timing perspective from a lab automation install. Molecular, specifically, we saw flat overall in the quarter. And that was really a mix of lower GC/CT volumes that were partially offset by those increasing MAX sales. So we actually saw MAX sales double quarter-on-quarter going from Q2 to Q3, and we're expecting that type of continued trajectory going forward. As Vince mentioned, we reached another milestone on MAX placement at over 200 at the end of the third quarter, and we expect a ramp to continue going forward. So we are seeing that impact of MAX. Of course, Veritor has been another key growth driver of ours. You don't see that in Q3 because it's really a respiratory-focused product. You saw that in our 7.8% growth that was reflected in Q2. It came out of the Q3 numbers. So overall, we are seeing that ramp of MAX, but we are seeing some of those challenges, specifically on overall testing volumes in the U.S. with -- I'll point specifically to that LBC segment.

And keep one other thing in mind as you think about this. As we said on the previous call, a lot of what we're doing with MAX now is converting at our own base, not all but a lot of what we're doing. So you didn't see as big an impact as you might have thought in the quarter because of the cannibalization, which, of course, will change over time.

And are you willing to quantify in any way sort of, if you were to break out the Diagnostic Systems segment, the percentage of the business that's facing some other pressures that Tom just discussed versus the percentage of the business that's seeing growth?

Well, I think what Tom is really concerned about is the Women's Health and Cancer piece and specifically the LBC business, the pap smear business, where Tom -- testing volumes are down. I think office visits for OB/GYN were down about 6%, 7%, if I remember. That's the focus for him, right?

Correct. On a worldwide basis, our Women's Health business actually in the quarter we saw down about 10%. And that was driven by that being a higher number in North America, where the vast majority of our business is. And then you saw continued double-digit growth in emerging markets. And even in Europe, continued strong double-digit growth in that segment. So specifically within the U.S., Women's Health is in that 10% to 15% range of sales. So it's -- the bulk of the business is in our other -- microbiology is by far the largest followed by molecular followed by the smallest piece being our Women's Health.

Okay. And if I could just squeeze in one more quick one on Bioscience. I believe this is the second quarter in a row, where you talked about delays in Japanese funding, as well as European austerity measures. And any sense that either of those might be abating or anything that you're looking for to see those pressures start to lift?

Sure. Bill will address that.

David, this is Bill. We have been waiting for the release of some of the funding of the Japan stimulus program. This is part of Abe's economic policy. And we do have a signal that after these delays, we're expecting that some of this at least to show up in the fourth quarter. We have orders in-house for the first time already. And we have some formal release of funding from the government in Japan just in the last 3 weeks. So we're treating those as good signals and expecting to see some impact in the fourth quarter. Hard to predict exactly yet what it is, but it'll get back on the kind of the trajectory that we had described previously.

Your next question comes from the line of Mike Weinstein with JPMorgan. Michael N. Weinstein - JP Morgan Chase & Co, Research Division: Just maybe a clarification first. So for the fourth quarter, just so we're making sure we're apples and apples here, the implied guidance is $1.44 to $1.47 on continuing ops?

That's correct. Michael N. Weinstein - JP Morgan Chase & Co, Research Division: Okay, perfect. One thing, Suky, would be helpful. You guys don't talk about cash flows on these calls. And when we got the 2Q from -- sorry, the 10-Q from last quarter, it showed kind of a disconnect in the first half of the year between earnings growth, which I think net income growth was 4%, but operating cash flows were down like 5% to 6%. Can you talk about how cash flows did this quarter and whether inclusive of this quarter or next quarter, we'll see improvement in the back half of the year?

Yes, we do expect to see an improvement in overall free cash flow in the back half of this year. We're making several improvements around working capital, as well as we're going to see some abatement or sort of slowdown of overall EVEREST capital spending. So we do expect to see an improvement in the back half of the year on free cash flow. Michael N. Weinstein - JP Morgan Chase & Co, Research Division: Okay. And then Vince, you guys have historically used this call, I'll say it, opportunistically, to touch on the upcoming fiscal year. Is there anything that preliminarily you guys see where the street may be mismodeling or you want us to think about as we go into updating our models post this call for FY '14?

So Mike, there's nothing unique going on right now that we would want to talk about. I think we'll address '14 once we finish up our work for the year. So we'll be talking to you about that in the fall. But there's nothing exceptional to call out.

Your next question comes from the line of Amit Bhalla with Citi.

Two questions on Bioscience and Diagnostics. Both of those segments do need to rebound sequentially into the fourth quarter. So first on Biosciences, is it strictly your expectation that Japan's [indiscernible] is going to flow-through that leads you to bounce back Biosciences? And in Diagnostics, can you talk about what's happening on the competitive front in Diagnostics and how that will play out in the fourth quarter?

Sure. On Biosciences, Bill talked about improving situation on the Japan funding. Keep in mind, too, that we had some negative timing in this quarter with Advanced Bioprocessing. So that would be the other factor Bill would pick up on. So Tom, in terms of the competitive situation on Diagnostics?

And maybe just a comment overall on Q4. So we do expect and we do have in-house, as I mentioned earlier, lab automation timing impacted us in Q3 negatively, see that having more of a positive impact in Q4. You have to keep in mind for lab automation, these orders typically come in 6 to 8 months before we actually ship these pieces, so a very large capital. So we do have those orders, not only in-house but equipment built and they're being installed now, which we'll bill in the fourth quarter. So we'll see that as an impact in the fourth quarter. We'll obviously see the continued ramp of MAX we expect in the fourth quarter. Also in Women's Health, as Vince mentioned earlier, in the x U.S., we have Totalys launching and have instruments literally shipping now, which we'll bill in the fourth quarter as well. So those are where we see some rebound expected from that perspective. As we think about competitive dynamics, I would say that we certainly do see within molecular of all the categories, that which has been well-documented across the board, increasing competition there, certain pricing pressures in some categories and also well-documented by others, expect continued pricing pressures in the GC/CT space and some of the more, call it, mature segments of the HAI market, such as MRSA. And we've been managing through those accordingly. I would say that's the most specific focus from a competitive dynamic perspective.

Okay. And Vince, just a quick one on generic injectables. Any guidance you can give us on the contribution from that business in the quarter?

It's very small as we thought it would be. We're encouraged by the fact that we are gaining accounts. And of course, we have the launch, impending launch of this third drug. And for us, it's about continuing to get this breadth of product line out there. But the reaction from the customer base has been very positive.

Your next question comes from the line of Brian Weinstein with William Blair. Brian Weinstein - William Blair & Company L.L.C., Research Division: Tom, I appreciate the comments that you just made on the Women's Health space. But if you can just give us a little bit more on kind of what's the long-term outlook here. I mean, you're seeing changes on the competitive front and macro headwinds. How should we think about this business over kind of more than just a next quarter or next couple of quarter timeframe? And what is BD's strategy to kind of offset some of these headwinds?

Brian, this Tom. So as we look at -- maybe let me just talk -- break that into 2 parts, just an overall comment on the market and where we see that going, and then maybe break down into our strategy. So we still continue to see strong double-digit growth x U.S. And we expect that to continue because the vast majority of women still lack access to basic pap testing. And that's really what's driving the growth x U.S., increased access, as well as in some markets like in Europe, Germany, in particular, would be a conversion from conventional pap to LBC. In North America, we -- again well-documented from our contemporaries as well, this decline in pap volumes due to the extending intervals. The data that we see shows that about 60% of physicians have now implemented that expanding interval testing. That's up from about 25% 2 years ago. So as you think about just the longer-term trends there, the interval extension is not fully matured yet in the U.S. We think there's going to be some further occurrence of that through FY '14. And then of course, you also have to monitor the implementation potentially in the future, it's not certain, but the role of primary HPV screening, which could have a further impact on the LBC market. And we recognize that. Obviously, our strategy is providing a more integrated solution across cervical cancer. And that includes really the next 2 major product launches that we have coming in that category, which is our Totalys front-end automation, which is launching this quarter Q4 x U.S. and next year in the U.S., which fully automates that upfront process, fits with the consolidation of our customer base as well and making it much more labor-efficient and reducing errors. The other pieces, of course, us entering into that HPV market with a highly differentiated genotyping assay, which is also launching, of course, very shortly in Europe and we have not communicated the date yet for the U.S. So participating on both sides of that, we think will be important long term. And we recognize and are investing appropriately in the segments of the market that we think will be most attractive, specifically that molecular HPV segment and creating efficiencies in that large, consolidated customer segment of LBC. Brian Weinstein - William Blair & Company L.L.C., Research Division: Okay. The second, a follow-up on Veritor. With the Group A Strep product, is that actually being sold right now? I know it's out of season a little bit. But is there anything that has to happen as far as the units that you have to swap those out as you bring in the Group A Strep because of some differences there with the flu and the RSV product?

Yes. We have not launched the Strep A product yet, but we do have FDA approval for our clinical kit. The CLIA waiver is still ongoing. And so the CLIA waiver market is clearly the largest segment for Strep A, and so therefore, we've held up the launch for that. Regarding reader changes, et cetera, that's still under evaluation if that would ever be needed based on us and our CLIA waiver submission. So it's not something that we're actively doing at this point, no.

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

A couple of questions here. First, Tom, sorry to keep harping on this, but obviously, several moving parts in the Diagnostics franchise right now. Just to confirm, it does sound like KIESTRA is going faster than expected since the acquisition. And then secondly, staying on microbiology. Do you expect the MALDI-TOF approval by the end of the calendar year? And then just a quick housekeeping question here. Was there any effect of Quest on the Women's Health franchise in the quarter?

This is Tom. Yes, KIESTRA is doing actually, as Suky mentioned earlier, better than our expectations. Certainly, we see that ability to lower our lab's overall cost per test through labor efficiencies and accelerating time to results is really hitting home with our customers, particularly in Europe and the U.S. So very positive feedback there. Related specifically to Quest in the quarter, we do not see any impact of that within Q3. That's something that we would anticipate more as an impact going into FY '14.

And then just the MALDI approval?

MALDI, that's -- we understand that's submitted and under active review. That is Bruker's submission, though, so I'd rather not comment on someone else's submission time and approval time.

Understood. And then just a quick one, Vince, on the Biosciences franchise. As you think about the performance here over the past couple of years, a bit of a laggard here relative to the other 2 major segments. How are you feeling about the portfolio? Do we need to look at maybe some additional M&A in this space? Or are there some internal developments? How do you think about the franchise for the next couple of years?

Well, we think that there is opportunity for this business and to broaden the footprint of the business. Primarily right now, I would think it's more organic than acquisition. There's opportunities to use flow in different ways. And we have programs both internally and with partners to do that at the moment. So areas such as using flow as the front end for next-generation sequencing, we believe, is going to be an emerging market. We just published using flow not on the cell surface, but also inside the cell in measuring RNA. So just to name 2 things that we're looking at, but we're also looking at more. So we do think that in a reasonable funding environment, that this business can return to growth. But there's work to do here.

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

So first, just some guidance cleanup, and I guess, this is a multipart one. You noted delays in global automation installations were a driver to -- or one of the drivers to moderation in Diagnostics revenue in fiscal Q3. It sounds like you expect this to be recaptured in fiscal Q4 based on your answer to Amit's question. What was the magnitude of this dynamic? I guess, the second part is, was the delay in the RTI legal dispute, was that about a $20 million pretax charge? And then I guess, related to that, just to make sure we understand this correctly moving forward, is it your policy to exclude legal settlement charges but not litigation charges?

Why don't you do the first one, Tom?

Doug, this is Tom. KIESTRA in the quarter, we essentially had no KIESTRA shipments in the quarter, so wouldn't have the number right here in terms of the exact percentage on that. But it was essentially 0 within the quarter. And you'll see there's a significant pop in Q4. We also had shipments in Q3. So it was just a matter of timing of those shipments. Again it's not actually anything related to orders. Those orders typically come in 6 to 8 months prior. It's literally just when we do the installation, we get customer acceptance.

We have a very nice backlog of orders.

Absolutely.

It's just a matter of the customer being ready for installation and those sorts of factors. Suky?

Yes. Regarding legal expenses around RTI within the third quarter, the expectation, you're directionally right, was roughly around $20 million. We expect now about $15 million of that to now reside in the fourth quarter of the year. And it is our philosophy and our policy on legal settlements to actually put those into adjusted or pro forma basis from earnings per share perspective. But ongoing litigation-type trial expenses or costs, we expect to keep into core earnings.

Okay. And then Tom, if I heard correctly, I believe you indicated that you saw lower chlamydia and gonorrhea -- yes, I don't know if it was volumes or revenue in the quarter. So correct me if I'm wrong, but if you did say that, I guess, my question is keeping in mind that since the beginning of the calendar year, we've seen the approval of a couple -- I think what could be described as formidable competitive platforms for molecular chlamydia, gonorrhea testing. I'd be curious to get your take, at this point, on competitive dynamics in the U.S. market, specifically with regard to pricing, your ability to lock-in customers and how we should be thinking about how BD is going to position the new products as you get the new approvals over the next few quarters on MAX and Viper.

Okay. Let me give you one other bit of information actually on KIESTRA just to help maybe give a little bit more perception. The average price of a KIESTRA full automation line ranges from $2 million to $4 million. So just giving some perspective, as you get a couple of those in a quarter or not in a quarter, you can see that swing the Diagnostic Systems business within that 3-month window pretty significantly. Related to GC/CT and competitive dynamics happening in that space, certainly that is, as I mentioned, an area that's well-documented of increasing competition prices. Price pressure in that segment is happening. Prices are coming down there, and that's something that we are actively managing. We are seeing from ourselves, as we are actively solidifying and renewing our customer base, pricing pressure that we're managing through in that segment. We're working -- we're obviously doing some offsetting of that in other parts of the business. But that is an area that we don't expect to alleviate in the near term, right? As you mentioned, there are a number of new competitors in that segment. In terms of our portfolio and how we really view that, within the lower-tier segment, we'll be, of course, launching our MAX assay next year for GC/CT, which is really meant for those that are more mid-sized hospitals or those who may be sending it out, so that segment will be covered there. We've got our, obviously, high-throughput Viper platform, Viper XTR, which is on the ultrahigh-throughput segment of the marketplace. And then our Viper LT, which is also launching next year, as our bench-top version, which will also have HPV in the future, is in that, let's call it, upper mid to low high volume segment of the marketplace. That will ultimately replace our ProbeTec manual product as well. So where we do see kind of our oldest platform within that segment, which is ProbeTec, which is a highly manual system, is where we also tend to see the pricing pressures. The Viper LT, as that launches early in 2014, we'll be actively upgrading that business to what we see as a much more competitive and automated system.

Okay. And I'm sorry, just one follow-up, Suky, on your comments on the legal charge. The fact that you said it was basically about $20 million that slipped out of this quarter and you expect it to be $15 million in fiscal Q4, does that suggest that your expectation now is that the timing of that -- of incurring that charge will be late in fiscal Q4? In which case, is there a chance that this actually slips into fiscal '14?

Yes. So just one clarification, we said about $15 million slips into Q4, not that full $20 million that I mentioned, which was the absolute amount that we had originally expected in Q3. And we do have a trial date set for early September. And as where we stand today, we still believe that, that trial will occur in September and in the fourth quarter.

Okay. So $5 million of the $20 million was in this quarter. You expect the balance in Q4.

That's right.

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

Just a couple of cleanups, I guess, and I'm sorry if I missed this earlier. But on Quest, I know you said you didn't see anything in this quarter. But have you kind of sized what you expect that impact to be on an annual basis in, say, like 2014?

Well, we're not going to disclose that. But it will be to your point at 2014. There will be some impact in 2014 and we don't know what that is yet. So we can't even comment on it.

Okay. And I mean, have you disclosed before for Diagnostic Systems like what percent of revenues it is for you guys?

No, we don't disclose it down to a customer level.

Okay. I just thought it was a fairly -- it was a fairly public piece of information around what had happened there. And then on the microbiology platform, I'm just curious. I think that's still roughly, all-in, close to 2/3 or so of your revenues in that Diagnostics Systems. And many of us who go out and speak with folks in those labs hear about new technologies obviously on the MALDI Biotyper [indiscernible] the 2. But others think that ultimately that moves to more of a sequencing application as costs comes down. I'm just curious how you're thinking technologically about your position in microbiology over the next, say, 5 years or so.

Sure, Tom will talk to that.

And maybe -- and just to give some context of the Quest. We haven't given a specific percentage, but I would just say less than 5%. That is maybe a number I could share because that's how much represents of DS worldwide sales. In terms of then specifically in microbiology, I think we're very actively -- first off, we see the most near-term areas, as you mentioned, will be mass spec, which we have a partnership and now have our own BD branded mass spec that's pending FDA approval. So that is one that we're actively behind and engaged in. Of course, that's being completely automated as part of our KIESTRA system. So those who attend shows would see, for example, at AECC this week, us demonstrating our fully automated colony picking system that completely integrates our KIESTRA with the Bruker mass spec system, taking advantage of that trend going forward. After that, you see molecular starting to really, in the near term, I think, begin to have an impact on optimizing turnaround time and efficiency within the microbiology lab. And you can see we're investing in a series of assays on our MAX platform to do exactly that. The Enteric Bacterial Panel is probably one of the examples that Vince talked about earlier. It's really meant to eliminate enteric cultures within a microbiology lab and upgrade that through molecular testing. We have other assays in our pipeline that are meant to do the same thing, including our OMP assay or our respiratory assay that's in the pipeline that we've talked about. When you look at sequencing, we are making, I would just say, some low-level investments at this point in time in sequencing. We're monitoring that very closely. We would see sequencing within the infectious disease space as being a bit longer term, beyond that 5-year horizon, really driven by, as you mentioned, still iterations of the platform needed but also collapsing of the turnaround time and the level of automation that's required in that space. And that's very consistent with the feedback that we hear from partners within the marketplace, as well as our customers. With that said, we are investing to some level, exploring opportunities for infectious disease and microbiology testing and NGS. But we do see that as kind of the third wave, as I've just described beyond Bruker, beyond molecular. And the next window after that will be NGS.

Okay. That's helpful. And then if I could have just one more quick one. On diabetes, can you just remind me, Vince or whoever wants to answer there, given these significant reimbursement cuts that have happened there and others kind of commenting around that particular business, can you -- I know it's more around strips and so, can you just remind us whether or not you think that will have much of an impact on your business over the next 12 months?

No, it won't. That's in a very different segment. You're thinking about BGM and durable medical equipment, so different segment.

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

I'll be quick. Hey, the R&D as a percentage of sales in the third quarter came down a bit, 5.8%, I think, versus some good trading north of 6%. Can you talk about how you see sort of R&D and spending for the rest of the year and, I guess, where you sort of see that number on a go-forward basis?

Yes, I think Suky guided R&D for the year, if I'm remembering right, is like right around 5.9%. Did I get that right, Suky?

It was low 6s, so somewhere around 6.1%.

Yes. So there's just a little bit of lumpiness here, what's happening from a clinical trial standpoint, those sorts of things.

And Suky, can you just give me the breakout of M&A between Medical and Diagnostics?

From what perspective?

Just basically what it was as a contribution to the growth. [indiscernible].

Yes. We haven't directly quoted that. What we are saying is that our acquisitions from 2012 are beginning to turn accretive in 2013. And those acquisitions that we've done towards the end of '12 and within '13 are starting to approach becoming neutral or slightly accretive into 2014.

So Suky, the acquisitions we're talking about this year are which ones?

So they'll be Cato and SSI.

Great. And then just one quick one...

Which are Medical acquisitions, okay?

Got you. Okay, great. So just one quick one, I heard there's been a couple of other companies that have noted some issues with order timing and bio process. Could you should shed some light on that, what you're sort of seeing what's going on there?

Anything we can add to that at all?

Yes, this is Bill. Not much I can really add. We do expect a normalized fourth quarter, meaning that we'll recover in that timing mode in the fourth quarter with BD AB. And this business because of the kind of the big pharma relationships, it just tends to be lumpy. So we had a softer-than-expected third quarter. We're expecting that to recover in the fourth quarter and be very much in line with our FY '13 expectations.

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

Just wanted to ask one on the margins. You had some underlying improvement in gross margins this quarter and negative impact from FX. Could you help us think about those 2 factors over the next few periods? I was just curious in terms of your ability to continue to drive organic improvement in gross margins.

Go ahead, Suky. But we feel good about our continued ability to drive gross margin improvements. And there were some acquisition costs and some other one-off things this quarter. But Suky, maybe you want to mention...

Yes. So for the year, we talked about ReLoCo -- excuse me, for the quarter, ReLoCo, as well as some improved pricing being offset by some acquisitions and start-up costs, as Vince talked about. Really I think for the full year, it's probably the better way to look at it because there's always going to be lumpiness from quarter-to-quarter when you think about $4 billion cost base of cost of goods. And overall, the way we see it for the year, if you get about 100 basis points of improvement or tailwind from ReLoCo, some of the 2012 acquisitions now becoming accretive, as well as continuous improvement, that's broadly being offset by about 60 basis points, driven by acquisition, startup, several other types of things, like year-over-year resins, et cetera. So that's kind of the makeup. Again, it's primarily driving our operating margin improvement is through gross margin. And we see that profile from a top-level sort of continuing forward as we continue to invest SSG&A against new products and acquisitions.

Great. And I wanted to ask one about SG&A, I guess, and as it's related to investments, specifically in emerging markets. Your emerging market sales growth has been remarkably consistent over a multiyear timeframe. And I'm wondering, is that a growth goal that you're driving towards and gaining your investments to grow at about that level? Could you grow faster? And how has some of the declines in overall GDP in some of those areas impacted or not impacted your business?

Sure. So we were concerned going into this year that we would see a decrease in health care -- the growth of health care spending in those regions. We haven't seen that. We've seen the governments prioritize health care, specifically in China but also in Latin America, of course, where there's been a lot of discussion about potential government cutbacks. And as you saw in the quarter, we're doing quite well in Latin America. We're doing well in the Middle East and in Asia. So across all of those because it's so important to our social stability, we see continued spending. It's not that we have targeted a particular growth rate for emerging markets. And as I said, we're going to fund to that growth rate. We're funding to the opportunities that we have, our capability to build really strong organizations, do the right training and the right partnering in those marketplaces. And that's working quite well for us. So the result has been very consistent growth. And we're very encouraged by what we're seeing, not just on the top line but the capability that we're building.

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

I just had a couple of follow-up questions. One, on LBC, I know that you mentioned the extension of interval is impacting volumes. And when you look at it sequentially, do you think -- can you parse out what the impact of lower overall health care utilization was versus the actual extension of intervals? Do you think the complete 6% to 7% decline was adjusted because of extension of intervals?

So Tom could comment on that, but...

Vijay, this is Tom. By far and away, intervals is the most significant piece. I mean, again putting in perspective, you're looking at women going from once a year to once every 3 years, in most cases. So that is obviously a significant impact.

And as Tom said, we're up to about 60% of the market or so converting to that longer interval from 25%, Tom, you were saying.

About 2 years ago, 25%.

2 years ago. So it's been a major shift. That's the biggest portion.

Got you. My next one was on BD MAX. I know you mentioned sort of 50-plus placements in the Q and most of it was replacing your existing installed base. I guess, my question is when you think you'll run through replacing your existing installed base and how should we think of placements beyond that?

Yes. So Vijay, this is Tom again. So not all of our placements, about 70% of the placements were upgrades, which was part of our base strategy. If you can see the menus, the menu that we began with was an HAI menu, which was specifically the exact same assays that were on our GenOhm platform to secure that, what was a manual system, up to a more automated system in MAX. So we've been working our way through that very aggressively. We are -- there are, of course, a portion of those, about 1/3, are brand-new accounts that we've been converting to date and within the quarter. And we expect that to continue to ramp as we not only work through our upgrades and our focus now shifts into other areas, but also as our menu expansion goes into areas where GenOhm was not present in. So enteric bacteria is a very good example of that, as well as the GC/CT Trich assay in that segment of the market is another good example of that, of ones that are in the clinical trial. And of course, pretty much every other assay -- we have over 15 assays in the MAX pipeline. Every other assay that we'll be launching on that platform are new markets for us that are not going after GenOhm upgrades.

Your next question comes from the line of Robert Goldman with CL King. Robert M. Goldman - CL King & Associates, Inc., Research Division: Wanted to follow up as well on the step-up you said you're seeing in the European Safety sales growth. I think it was only within the last few weeks that half the member states of the EU enacted the regulation or legislation that was required. So I'm wondering in your quarter if the step-up in growth related near as you could tell to a step-up in the market or a share shift in your favor. And then the second part of the question is, previously, you had thought that the EU Council directive wouldn't result in a step-up. It would just continue the growth that you've already had. But since, in fact, you're now seeing a step-up, just wanted to see if you're internally prepared for greater growth than you've been projecting relative to capacity and your infrastructure for order fulfillment.

Well, we're prepared for the marketplace. So let me just start there. And just remember, too, a lot of these countries started implementing before the directive went into force. The U.K. started, Germany was moving ahead. But Bill, anything else, any other color that we can add on Safety growth this quarter in Europe?

Well, I think to the longer-term piece, the policy work has continued to progress. Remember that not all of the countries had their legislation in place back in May, at the time of the expectation. But there's a lot of good policy work that is being done there, in part, by the way, led by a number of companies from the industry, including BD. And we're seeing really good progress in seeing countries now get their legislation drafted and at least start the front-end process of figuring out how they might move. I don't think that impacted the quarter. And to your question about market growth or share, I think it's more market evolution taking place and particularly, as Vince already mentioned, in the Northern part of Europe, where the conversion rates and the growth tend to be higher than what we've historically seen. Robert M. Goldman - CL King & Associates, Inc., Research Division: And if I could just follow up with that, since as you say, you don't think the regulation and the legislation has yet impacted the market and since I believe every member state of the EU, except for Croatia, has now passed legislation or regulation, is it rational to assume the 10% growth that you saw in the quarter as sort of the new base and you would expect growth beyond that going forward?

It's 1 quarter, it's hard for us to say. Keep in mind that countries, you mentioned Croatia, but Spain and Portugal and Italy, they're going to move slow on this. So it's going to take us another quarter or so to just see what happens here and do they get more aggressive in terms of ramping up Safety. They've moved slow. So we've got 1 quarter at higher rates, so we're not going to project from 1 quarter. But we'll come back and take another look at this at the end of the year. So we should talk about it then and see if we've got 2 in a row.

Our final question comes from the line of Eric Criscuolo with Mizuho Securities.

Just filling in for Peter. The share count looks like it ticked up a little bit in the quarter. What was the cause of that? And wondering maybe if you could talk about how you think that's going to look going forward or at least for the next quarter.

Yes. So as I mentioned as part of my opening remarks, we completed another $50 million of repurchases in the third quarter, bringing our total to about $410 million. And we've been talking through that this year of repurchases, up to $500 million. So we're about 80% there. And we're still on track to continue to work somewhere between the $400 million to $500 million range.

Okay. And then the Veritor systems, are they -- are you placing them with customers that haven't had any real point-of-care testing? Or are they displacing competitive products out there?

Eric, this is Tom. Nearly all of those are competitive displacements.

[indiscernible] off this marketplace primarily, and now it's starting to go into retail chains.

Right. It's not a segment that we've been in historically, so we're not upgrading really any BD base.

Yes. So everything we're doing is...

All brand-new.

Taking from competition.

That was our final question. I'd like to turn the floor back over to Vince Forlenza for any closing remarks.

Well, thank you very much for your participation on the call. As I said in my remarks as I was finishing up, we're pleased with the progress in the third quarter and year-to-date. We're very happy to reaffirm the guidance and take you up to the higher end of the guidance range. And we're encouraged by both our growth strategies and our operating effectiveness strategies. And we look forward to updating you on our next call. Thanks very much.

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