Becton, Dickinson and Company (BDX) Q2 2012 Earnings Report, Transcript and Summary

Hello, and welcome to BD's Second Fiscal Quarter 2012 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through Tuesday, May 8, 2012, 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 conference ID 68128968. [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 second 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 cause such differences appear in our second 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, Chief Executive Officer and President. Also joining us are David Elkins, Executive Vice President and Chief Financial Officer; BD Executive Vice Presidents, Gary Cohen and Bill Kozy; and Tom Polen, President of Diagnostic Systems. It is now my pleasure to turn the call over to Vince.

Thank you, Monique, and good morning, everyone. As we stated in our press release, we are very pleased with our second quarter results. We believe we continue to demonstrate BD's commitment to drive revenue growth and our focus on high-growth areas with our recent acquisition of KIESTRA Lab Automation. This acquisition offers total lab automation solutions to hospitals and laboratories worldwide and nicely complements our microbiology portfolio. We expect this acquisition to add about 1 percentage point of growth through the Diagnostic Systems unit in the near future. The integration is going as planned, and the KIESTRA platform was very well received at the European Conference of Clinical Microbiology and Infectious Diseases back in March. Recently, we announced our plans to sell the majority of our Discovery Labware unit, excluding Advanced Bioprocessing. This sale will enable BD Biosciences to focus resources and management attention on both our recent Biosciences acquisition and our recently launched new instrumentation products, which are important to our accelerated growth efforts. David will provide more details around this later in the call. In the second quarter, we continued to face challenges in our Biosciences business in the U.S. due to an uncertain research spending environment and lack of overall demand for instrument and in research reagents. David will provide more details around this later in his financial discussion. Despite these headwinds, we posted solid overall revenue growth, driven by our Medical and Diagnostics segments. We believe our results this quarter highlight the diversity of our portfolio with softness in 1 segment being offset by strength in our other 2 segments. We saw organic growth from new product launches in addition to growth coming from recent acquisitions. On a positive note, we continue to see strong growth in the international safety sales and emerging markets. Also our initiatives around new products are in line with our expectations as we continue to invest for future growth. We recently went live with our new ERP system in North America with BD Biosciences as the first implementation under EVEREST. This is our global ERP project that we have been discussing for the past few years. Our largest go live will be next year with the balance of North America, which includes our manufacturing plants. Our results year-to-date give us confidence to increase the bottom end of our currency neutral revenue growth guidance to 3% to 4%. We expect currency neutral EPS growth to be 4% to 5% as we continue to invest in new products and absorb costs from our recent acquisitions. On Slide 5, we've outlined our second quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Revenues were solid, increasing by 4.6%. Fully diluted EPS came in at $1.38, growing at 2.9% over the prior year as expected. For the 6-month year-to-date results, revenue growth was 3.5%. EPS of $2.59 declined by 3.3% due to a difficult comparison over the prior year period as we outlined on our first quarter conference call. Now I'd like to turn things over to David for a more detailed discussion of our second quarter financial performance.

Thank you, Vince, and good morning, everyone. I'd like to begin by discussing the key financial highlights for the second quarter. As Vince just stated, we're very pleased with the results, which were in line with our financial projections. We saw solid growth in our Medical and Diagnostics segments. As expected, we experienced higher SSG&A expenses in the quarter due to increased investments in emerging markets, new product launches and acquisition-related expenses and EVEREST costs, as Vince just mentioned. We are raising the bottom end of our total year revenue growth guidance to 3% to 4%. We expect EPS growth of 4% to 5% as we increase investments in new products and absorb costs from our recent acquisitions. I'll provide additional guidance details later on the call. On a reported basis, we are raising our full year revenue and EPS guidance to reflect the anticipated effects of favorable currency translation. Our revised guidance assumes a full year average year exchange rate of $1.32. Additionally, during the second quarter, we completed about $600 million in share repurchases. Year-to-date, we've completed approximately $1 billion of our estimated $1.5 billion share repurchase program. Now let's move on to Slide 8, where we'll review our revenue by -- revenue growth by segment, which I'll speak to on a currency-neutral basis. As I just mentioned, revenue growth was 4.6% for the total company. Pricing erosion was about 110 basis points, which was also in line with our expectations. BD Medical's second quarter revenues increased 5.3%. The growth in this segment was driven by positive results across all 3 business units, which benefited from the recent product launches, including our newly acquired PhaSeal product. Diabetes Care growth was driven by continued strong sales of pen needles and fueled by BD Nano. We had a solid second quarter in our Medical Surgical Systems unit with strong performance coming from our BD PhaSeal and safety engineered products. Pharmaceutical Systems growth was 7% aided by some favorable timing of orders. For the first half of the fiscal year, the Medical segment grew 4%. BD Diagnostics' second quarter revenues increased 5% despite a very mild flu season. Growth in this segment was driven by Preanalytical Systems, which benefited from a favorable prior year comparison in the quarter and continued strength in our Women's Health and Cancer platforms. For the first half, BD Diagnostics grew 4.1%. BD Biosciences revenue came in about 1.7%, with strong international growth being offset by declines in the U.S. I will provide more details around this on the next slide. For the first half of the fiscal year, our Biosciences segment grew 1%. Moving to Slide 9. I'll walk you through our geographic revenues for the second quarter. Overall BD's U.S. revenues were up 2.2% versus prior year. Growth in our Medical segment was 5%. This is driven by strong growth in our Pharmaceutical Systems and Diabetes Care and partially offset by difficult pricing comparisons in our Medical Surgical Systems unit, which we discussed last quarter. Growth in our Diagnostics segment was 2.6%, driven by solid sales in our Preanalytical Systems unit. Diagnostic Systems growth of 1% was attributed to the lack of a flu season and softness in our HAI platform due to tough competitive environment. In response to this situation, our expectation of an FDA approval of BD MAX MRSA assay in the fourth quarter remains on track. Biosciences sales for the second fiscal quarter declined by 8% or $9.5 million. Segment growth continues to be negatively affected by weakness in the U.S. research market, as well as a tougher competitive environment in our research reagents sales. There continues to be lower demand for high-end instruments in Cell Analysis due to continued funding concerns in the academic markets. International revenues grew 6.3% currency neutral, with growth coming from all 3 segments. Medical segment grew 5.4%, driven by strong sales of Safety products and continued growth in emerging markets. The Diagnostics segment grew 7.6% mainly due to strong emerging market growth. Biosciences grew at 7%, driven by strong performance in Japan due to favorable comparisons to prior year, which is impacted by the earthquake and tsunami. We also saw good performance in the emerging markets. For the first half, reported U.S. revenues grew 1% with Medical increasing 3.6%, Diagnostics growing at 1.7% and Biosciences declining about 9%. Total international revenue growth was solid at 5% currency neutral in the first half with Medical growing 4.2%, and Diagnostics and Biosciences both growing at 6.7%. Moving to global Safety on Slide 10. Currency-neutral sales increased 11.5% and grew $488 million -- to $488 million in the quarter. Excluding the PhaSeal product, growth in the quarter would have been about 8%. Revenues in the U.S. increased 7.3%. International sales were up 17.7% on a currency-neutral basis with Western Europe and emerging markets both growing double digits in the quarter. Medical Safety sales grew 15.6%, driven by Infusion Therapy products and our PhaSeal device. Diagnostic Safety sales increased 7.9%, driven by a range of safety-engineered products. For the first half, Safety growth was 9.6% on a currency-neutral basis. This was due to a combination of international growth of 17.2% and a growth rate of 4.8% in the U.S. On Slide 11, we'll review our revenue growth in the second quarter. Our reported growth rate was 3.6%. Performance contributed 4.6% to growth, offset by about 1% of unfavorable currency. Moving to Slide 12, looking at our gross margin. We experienced 90 basis points of decline, which again was in line with our expectations. This primarily reflects the negative effects of higher raw material costs, our acquisition-related expenses and software amortization in our Biosciences business unit. Unfavorable currency translation contributed about 30 basis points of the decline. The negative effects of pricing erosion were offset by efficiency gains, including our ReLoCo program. Now Slide 13 recaps the second quarter income statement and highlights our foreign currency neutral results. As discussed earlier, second quarter revenue increased 4.6%. The gross margin declined 90 basis points due to the aforementioned items. This is in line with our expectations and the guidance we provided on our first quarter earnings call. Moving down the income statement. SSG&A increased almost 13%. This was primarily due to increased investments in emerging markets, acquisition-related expenses. EVEREST and SAP implementation costs were higher than expected as we prepared for our recent go live on the system. We also experienced higher legal expenses and higher medical benefit claims in the quarter. R&D was about flat, which was in line with our expectations as the prior year had accelerated R&D costs. Our operating income decreased by 5% due to lower gross margin and the higher SSG&A costs. This resulted in earnings per share of $1.38, which is a 2.9% increase over the prior year period. Now turning to Slide 14. As indicated earlier, we expect our total year revenue growth to be between 3% to 4% on a currency-neutral basis. Based on our results year-to-date, we are raising our guidance for the Medical and Diagnostics segments to reflect revenue growth to between 4% and 5%. For our Biosciences segment, we are lowering our revenue guidance to about flat from our previously communicated guidance of 2% to 4%. This is due to continued weakness in the U.S. research market and the tougher competitive market. Turning to next slide. I would like to outline our expectations as we move down the P&L. I'll start with gross profit. We expect gross profit margin to be between 51.3% and 51.5%. This is in line with our previously disclosed guidance. SSG&A will be higher for the year as we estimate it to be between 24.4% and 24.6%. This is primarily due to accelerated investments in new product launches, acquisition-related expenses, legal fees and higher medical benefit claims. We also have an increase in our deferred compensation plan expense, which was offset in our interest income line. R&D remains in line with our previously communicated range of 6% to 6.1% of revenues. For the total year, we expect our operating income margin to be between 20.9% and 21.1%. This reflects the aforementioned expenses I just reviewed in the SSG&A and product mix. We also expect an improvement in our tax rate due to positive geographic mix. Our expected range is now 25.5% to 25.7%. We expect revenues to be in the upper end of our previous guidance range. We now expect EPS to be in line in the range of $5.68 and $5.73 for the total year or about 4% to 5% growth currency neutral. Total year EPS guidance reflects the aforementioned items that resulted in lower operating margin guidance. I would like to take a moment to discuss the impact of our pending sale of the majority of our Discovery Labware, excluding our Advanced Bioprocessing platform. The transaction is expected to be completed by the end of the calendar year 2012 subject to the satisfaction of customary closing conditions, including regulatory approvals. Therefore, the financial results associated with this unit should be treated as continuing operations. We will update you on this on our next call. At that time, BD will determine if the asset group will be reported as discontinued operations for all comparable period. The transaction will be a cash sale for approximately $730 million. For fiscal year 2013, we expect this transaction to have a dilutive impact of about $0.23 to $0.27 to earnings per share on a full year basis. Also as a reminder, in fiscal year 2013, we have to account for the new Medical device excise tax, which is estimated to be about $55 million to the SSG&A line, which is tax-deductible. This tax excludes research sales in our Biosciences segment, our Pharmaceuticals prefillable devices sold business to business and our Diabetes Care products sold at retail. Now I'd like to turn the call back over to Vince, who will provide more detailed update on our performance in emerging markets and our progress against key initiatives.

Thank you, David. Moving on to Slide 17, I would like to highlight our emerging market results. We continued to see strong growth in emerging markets, which accounted for approximately 21.4% of our total revenues in the second quarter. Emerging market revenues grew about 10% in total over the prior year, bringing the first half to 10.8%. We continue to see double-digit growth in a number of key markets with China growing at about 17% in the quarter and 21.6% year-to-date. We are very pleased with Safety revenue growth in emerging markets, which was up about 26% over the prior year. Progress continues on policy-related activities with regulations already in place in Brazil and Taiwan and similar provisions and progress in Russia and Korea. We're encouraged by the positive actions that these governments in making protection of health workers a priority as has been accomplished in the U.S., European Union and Canada. We have many exciting opportunities in our pipeline this year. I'd like to review our key products that have launched year-to-date. In our Medical segment, we launched the BD Nexiva Diffusics Closed IV Catheter System with the diffusion tip. Also at the end of the second quarter, we launched the BD insulin syringe with the Ultra-Fine 6-millimeter needle. This is the shortest insulin syringe needle made by BD and is preferred by a majority of patients. In our Diagnostics segment, in the first quarter, we launched our BD Veritor platform and CLIA-waived Flu A+B test in the United States. Despite the weak flu season in the U.S., we've made about 400 new Veritor placements to date. In the first quarter, we launched the BD MAX MRSA assay in the EU. We've made several conversions with this new assay, and we continue to receive positive feedback from customers. In the second quarter, we launched the BD MAX Group B Strep assay, which received FDA clearance. Also in the second quarter, we launched the BD MAX C. difficile assay in Europe, which was one quarter ahead of schedule. And in our Biosciences segment, we launched our new cell culture medium, Mosaic, in the first quarter of fiscal year 2012. Now on Slide 19, I'd like to provide an update of our key products and our expectations for the balance of the year. In our Medical segment, we are planning to launch our BD PentaPoint pen needle, the first and only pen needle with patented 5-bevel needle tip. This is expected to launch in the second quarter of the year. In the Diagnostics segment, the U.S. launch of MRSA on BD MAX remains on track for later in 2012. The U.S. launch of C. difficile remains on track for the first quarter of fiscal year 2013. These are important milestones in our efforts to develop a range of clinical tests on the BD MAX System, and we believe it is well positioned to be a vital resource for lab testing needs. Our BD Viper molecular platform remains positioned as delivering best-in-class lab efficiency and performance for high-volume screening assays. In the fourth quarter of fiscal year 2012, we plan to launch the Trichomonas assay on this platform. The Trichomonas launch in the U.S. has been delayed until the back half of fiscal year 2013. Our launch of the bench top BD Viper LT and the Chlamydia gonorrhea assay remains on track for fiscal year 2013 globally, followed by the launch of our HPV genotyping assay on Viper LT x U.S. Along with this launch, our Women's Health Front-End Automation System remains on track for launch in the beginning of fiscal year 2013 in the EU and later in the year in the U.S. Our BD SurePath Molecular Pap test completed the initial phase of our clinical trial with very promising results. Our launch remains on track. Also as we have mentioned in previous earnings calls, we have 2 new CD4 analyzers launching in the near term. Both analyzers have been delayed from our original launch expectations. In fiscal year 2013, we plan to launch a CD4 analyzer that is designed for mid- and smaller-volume laboratories in both emerging markets and the developing world. The other CD4 analyzer is more portable point-of-care instrument, targeted towards rural clinics in the developing world. This is now expected to launch in fiscal year 2014. Of course, we will continue to provide you with updates on our products and programs as we continue to make progress throughout the year. Before we summarize our key messages and open the call for questions, I would like to announce a new strategic and organizational change effective June 1. In a new role reporting to me, Gary Cohen, Executive Vice President, will advance BD's leadership in creating shared value, achieving strong business performance aligned with positive social impact through a primary focus on external engagement and cross-sector collaboration. One of the most effective ways to address health care challenges is through collaborative efforts among governments, corporations and nongovernmental organizations to create shared value. We have a notable track record in this area, and Gary is ideally positioned to help BD extend our legacy of contributing to society through such collaborations. Global geographic leadership will be shared by 2 senior leaders in new roles, also reporting to me. Alex Conroy, President, will be responsible for Europe, EMA and the Americas; and James Lim, President, will be responsible for Greater Asia, including Asia Pacific, China and Japan. We're extremely pleased to have these leaders in their new roles and believe these changes will advance our evolution to becoming a truly global company. Moving on to Slide 20. Before we open the call to questions, I would like to reiterate the key messages from our discussion today. We're very pleased with our second quarter and year-to-date results. Despite the headwinds we faced in our Biosciences business in the U.S., we posted solid top line growth. This was driven by new product launches in addition to growth coming from recent acquisitions, which are on track versus our expectations. We look forward to moving past the tough comparisons that occurred in fiscal year 2011, which are impacting our year-to-date results. We are encouraged by our results in emerging markets and international Safety sales. We continue to build capabilities in these areas, and we believe they are well positioned for future growth. Also, we have many exciting opportunities in our pipeline across our 3 segments, and we continue to invest in these opportunities to drive our top line. Our results year-to-date give us confidence to raise the bottom end of our revenue growth guidance on a currency-neutral basis. While we are not immune to challenges in the macroeconomic environment, we believe we have the tools to overcome these challenges through our product and geographic diversity as demonstrated this quarter by the performance in our 3 segments. Lastly, we remain committed to executing against our strategy of investing and innovating for growth, and we believe our ongoing investments in growth opportunities will ensure our future success. Thank you, and we'll now open the call to questions.

[Operator Instructions] Your first question is coming from Kristen Stewart with Deutsche Bank.

I was just wondering if you could just maybe provide a couple of broad comments just on health care utilization trends. It's certainly been something that investors have been focused on this entire reporting season. You guys clearly touch a lot of the end markets within hospital and labs. So any update on how you're feeling just in trends in the U.S., and then maybe just a couple of comments on Europe as well?

Sure, and thanks for the question. I think we saw a stabilization of health care trends in the U.S. I know if we look back to last year, we saw some falling doctor's office visits, but this quarter, things seem to have flattened out. And I think you saw that in both -- you saw it clearly in our Medical segment and in our Diagnostics segment even if it was a little camouflaged by a weak flu season. So on the clinical side, U.S. flattening out. Obviously, still some issues in the high end of the bioscience marketplace especially around high-ticket research instrumentation, where we have a large presence. Europe, once again, was quite good, continuing a trend that we saw last quarter. And then moving on to emerging markets, as we go through the emerging markets, we continue to see strong growth across the emerging markets, especially in Asia Pacific and in Latin America. The only issue from an environmental standpoint that is giving us more concern internationally right now, of course, is we're tracking what the European governments are doing, especially Spain, from a payment standpoint. And you might be aware that they've announced a deal. Receivables for the industry have been going up. We think we're appropriately reserved in this situation, but they've also announced a deal to refinance and then pay the industry, which we're expecting will happen in the back half of the calendar year. So that's the one kind of warning sign we're watching.

And then would you be able to also just provide what the constant currency organic growth was, just the impact of acquisitions on the quarter from a top and bottom line basis?

So on -- Kristen, it's David. On the quarter, it's $24 million is the revenue impact, so it's about 1%. And on an EPS perspective, it's about $0.02 dilutive.

Your next question comes from Amit Bhalla with Citi.

You called out the strength within Diagnostics and specifically Women's Health. Can you talk in more detail about the components there and the growth rates within Women's Health?

Sure, Amit, and thanks for the question. Tom will do that.

Amit, this is Tom Polen. So TriPath, our Women's Health business, grew 5% in the quarter, and that was a mix as we've talked about it in the past few quarters in the U.S. relatively flat and positioned to continue to increasingly recommend a 3-year interval for testing. X U.S., we continue to see strong double-digit growth in essentially every region outside of the U.S., and that's happening really by 2 things. One is as customers are upgrading from conventional pap liquid-based cytology and as developing countries continue to expand access to cervical cancer screening. So we continue to be pleased with solid performance in our Women's Health business.

Tom, can you go into some of the other components within Diagnostic Systems, GeneOhm, your STD testing, and your growth rates there? And can you also comment on your views of the announcement yesterday within the women's health space Hologic Gen-Probe and your impact on strategy?

Sure. So just in terms of growth characteristics across the business. So as we think about the quarter, we had 3.2% growth, which was driven on a couple plusses and a couple minuses there. So on the negative impact side, we saw obviously an extremely light flu season. Our flu business was down 25% for the quarter as a result of that. Also we see that as a onetime event that we don't expect to repeat for the balance of the year. The second topic, which Vince mentioned at the beginning of the call, was that our GeneOhm business was down 7% for the quarter, driven exclusively by increased MRSA competitiveness and MRSA pricing pressures in the U.S. I emphasize that's strictly in the U.S. And that's ahead of our BD MAX assay in the U.S., which is planned for launch later this year. And I've mentioned that trend on MRSA pricing and the competitive tendency over the last few calls. Cdiff continues to grow at very strong double digit, both in the U.S. and x U.S. Of course, that's off of a smaller base than the MRSA market. On the other side, we're continuing very solid performance this quarter in our microbiology business. I don't think we've typically disclosed the growth rate of that. Our molecular STD business was up 6% for the quarter. So we're very pleased with the ongoing performance there. And of course, as Vince mentioned, we're very pleased with the acquisition of KIESTRA, which we finished this quarter, and the integration is moving forward as planned. On your other question just regarding the Hologic's acquisition of Gen-Probe and how we view that. Of course, Gen-Probe has been very publicly in play over the last year, and so the acquisition doesn't come as a surprise to us. We've made our integrated molecular cytology strategy in Women's Health clear for some time now. And I think actually through this move, Hologic is making it clear that they see value in a similar type of approach. We're moving full speed ahead with no specific change in our strategy. And our new solutions remain on track to begin launching next year, as Vince described. And just to summarize, those being our Viper LT molecular platform with the new HPV genotyping assay, our Trichomonas assay on Viber, our new SurePath Plus Molecular Pap and our new Women's Health automation that manages that front-end sample processing across, both our molecular and cytology platforms.

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

This is actually James in for David. I wanted to see if there's any way to put the higher spending in context a little bit here. You've talked in the past about needing some near-term investment in new products, emerging markets and EVEREST to build the business and set the stage for driving positive operating leverage in the future. Obviously, your new guidance, looking for operating margins, down over 150 bps year-over-year. Can you just talk a little bit about the path forward for margins and your timing of when we can see operating income start to grow faster than sales again?

So we're not going to get into guiding next year but there's a number of trends, I think, that we can talk about to help you out here. One is in terms of the gross margin this year, we've talked about the higher material costs that we were seeing plus the major impact on pricing with the biggest impact being on the first half of this year, and that starts to get better in the second half. And pricing is pretty much where we expected it to be this quarter, around 100 basis points and still including that the big issue from last year. On the gross margin, some of the things to be thinking about going forward is we'll be seeing an increased benefit from ReLoCo I and ReLoCo II going forward, with ReLoCo II being about a year behind ReLoCo I. And we'll continue to look at driving that. On the SSG&A line, we do expect that we'll continue to invest in emerging markets going forward. We would start to -- we expect one more year of increasing spending on EVEREST. We're happy that we've got the first go live now behind us here. We're in the what I'd call the stabilization and optimization phase on this first phase, but we have the biggest go live coming up next year. So we would expect that to peak -- that spending to peak next year and then to flatten out from there as the amortization of the system comes in. Then lastly, on the SSG&A line, we would expect going forward to start to see some benefits from our shared service center in the U.S. as we get towards the tail end of '13 or so. So and R&D, we'll continue to invest in a pretty much the same rate that we already are. So those are the major components that we think that are going to start to drive operating leverage, and I'll come back to the point, I know this is a timing issue that you're asking, but we do remain committed to getting 50 basis points of leverage. I realize we didn't get this year, we have some significant investments. We're actually pleased that we have to accelerate some of these investments against new products in the back half of the year because things are on track, or accelerated for most of our programs with the exception of those 2 analyzers in the main at Biosciences.

Perfect, that's helpful. And then just second a question on the Discovery Labware divestiture. First, can you tell us what the after-tax proceeds from the sale would be? And then just the dilution, obviously, about 4% to 5%, should we just expect that to run through the P&L off this year's earnings base or is there anything you can do in terms of offsetting cost reductions or redeploy some of the proceeds into buybacks you would use to cushion the earnings impact?

Yes, this is David. And just a couple of things. One is that the proceeds from the sale, $730 million as we talked about, a good estimate is probably net of tax will be around $500 million for planning purposes. That's our view on it. As far as dilution, as we said, dilution going into next year, the full year impact of the divestment will be about $0.23 to $0.27. And that will be -- right now it's in continuing operations. There's a couple of things as far as determining when we move that to disc ops around manufacturing agreements and transition services agreement before we can make that accounting change. But as far as going forward, I would use that guidance range of $0.23 to $0.27. There are some stranded costs in there that over time, we'll be looking to take out associated with the business. But for planning purposes now, it's -- we're guiding in that $0.23 to $0.27.

Your next question comes from David Roman with Goldman Sachs.

I was hoping we could talk a little bit more about the mix of business between emerging markets and developed markets. Obviously, EM has been a key part of your growth story, although that business looks to have slowed a little bit versus the performance in last quarter. But I was hoping you could provide some perspective on is taking out the acquisitions, it looks like your organic growth rate in developed markets is running between 1% and 2% and then emerging markets just below 10%. Why isn't that sort of the new normal on a go-forward basis for the company?

Well, the reason is not the new normal will be the impact of both the acquisitions as they normalize into our base; and number two, launches of new products. In terms of -- and I was talking about the developed world as I said that. On the emerging market, we do expect to see continued strong growth there. And I think Gary can comment on a little bit more in terms of what we saw in the quarter and what we expect going forward. Gary?

And so in general, the emerging markets were strong. One of the reasons that the second quarter was a little bit lighter than the first really pertains to our eastern Europe, Middle East, Africa region, which had extremely strong, unusually strong first quarter, so that came a little bit at the expense of the second quarter. Otherwise, the trends were very consistent. Asia Pacific and Latin America both in double digits. And so over the course of the remainder of the year, we're expecting the second half in total to be very similar to what the first half was. And otherwise generally, similar in China, we're expecting the second half for China to be similar to the first half, which would imply some stronger growth in the back half of the year relative to what you saw in the second quarter. And all the signs, otherwise, are positive in the emerging markets. The situation in EMA was based principally in Africa, which is a little bit lumpy based on timing of orders from international funding -- national and international funding agencies.

So, Dave, to go back to the beginning of your question, I would go back to what we were saying in November in terms of the new product launches and the impact that we expect to have by 2014, and so that was 250 basis points. So we're expecting a gradual increase. And then, of course, Safety now is really starting to do well around the globe as one of those drivers.

Okay. And then I know it hasn't been really that much time since the November meeting, but is there any early signs or indicators you can provide us with that track some of those new product launches, that those products that you have launched since that time period, to what extent are they tracking toward the incremental growth benefit that you had put out there in November, and are there any that have deviated from that?

Yes, so I'm going to ask Bill Kozy to talk about that because I think he's got some good news on the acquisition front and some of the product launches. So, Bill, you want to talk?

David, this is Bill Kozy. We're going to give you an example here from BD Medical related to your question. But if you looked at Medical's growth for the quarter of about $52 million year-on-year foreign exchange neutral, about $30 million of that growth is coming from either acquisition or new product launches. And you saw some of those products and heard them mentioned during Vince's remarks. But if you took pharmacy solutions, Autoguard with Blood Control, Diffusics, ReKindle, Nano and the Auto Shield Duo pen needle, I mean, that's kind of the category of products in the mix of both acquisition and organic new product launches that are starting to have some impact. And these are all, as you know, with the exception of the acquisition are all very early stage. So we're encouraged by those launches and, at least, some of the early penetration activities that are underway. We are tracking this as you would expect quarterly, and we'll look forward to discussing this more.

Okay, and maybe just as a clarification to the earlier question on HAI. Are you saying that the competitive environment is intensifying because the market is challenging, or there are new players coming in, posing a competitive threat when it comes to pricing?

Yes, Tom will talk to that.

Tom Polen. So specifically again, to the U.S. it was referring to more of a competitive player, and this goes back actually this last quarterly call. It goes back to last year as Roche entered the MRSA market in the U.S. with a very different pricing approach is where we started seeing the significant change competitive intensity and price around MRSA in the U.S. So it's really that specific event and that specific entry that we saw being to change the U.S. dynamics of it.

Your next question comes from the line of Jon Wood with Jefferies. Jon Davis Wood - Jefferies & Company, Inc., Research Division: So just want to better understand the comments around the Labware divestiture. Should we assume from David's comments that you guys are not focused on directly replacing that operating income, or is it just a function of not being able to kind of call out your options at this point? I mean, I want to make sure that you're actually looking at those proceeds in a reallocation event around those proceeds next year in a discrete fashion.

Yes, Jon, this is David. I think really we'll update you on what we do with those proceeds, we'll update you in November. Clearly, it'll go to general corporate purposes, which as we talked about from an acquisition perspective looking what's out there, if there's opportunities to fund those. But obviously, we're not looking to let cash stay idle on our balance sheet either. So we could do share repurchases. But at this point, it's too soon, and we'll update you when we provide guidance on '13 in November. Jon Davis Wood - Jefferies & Company, Inc., Research Division: All right. Understood. My follow-up question is on the Biosciences business. So it seems like the comments around the funding environment pretty consistent, but the comment about the intensifying competitive landscape and reagents, that seems new to me. Can you kind of flesh out those comments where you're seeing the competition, how much is that impacting kind of your view from the prior guidance of 2% to 4% there?

Sure. So Bill Kozy will give you some more detail on that. Just I would say before he does, majority of what we are talking about was related to the large instrument sales. But there was a competitive situation that has been going on for a while but maybe a bigger impact right now with some pricing on reagents, particularly in the research market. Bill, you can talk to that.

Yes, this is Bill. I think Vince has hit the key topic here. This is on the not the clinical reagents but the life science research reagents, and the competitive activity, particularly in the U.S. and Europe, we've seen escalate in the last year or 2 driven by both numbers of competitors and price. So it's classic competitive situations in a market where it's a little bit soft. So we're seeing a little bit more intensity there than we've seen in the past. It's combined with the slower instrument activities. It really put some pressure on the Bioscience business in this last quarter.

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

I'll try and just to keep it to one, but a bunch of questions, but maybe just to clarify a couple of items, that'll be my question. One, David, just to be clear, obviously, you gave when you talked about '13, you talked about the device tax, as well as this divestiture is clearly a moving target. But I mean, wouldn't it make more sense to assume that you do a buyback to, at least -- for the numbers for 2013? Just want to be clear there if there's some other message that you're trying to get across as you think about estimates for '13. And then kind of second kind of clarification if you wouldn't mind. On your revised revenue guidance, would you mind talking about in the Medical and the Diagnostics segment, how much that is better organic outlook or is that the KIESTRA deal, principally, and maybe just talk about the components of what on a currency-neutral basis is allowing you to upgrade the growth there?

Okay, yes, I mean, it's really all we're saying, Jon, as far as the proceeds from the Discovery Labware is just wait till November. And when we do total guidance on what we're doing with our capital allocation, we'll provide it at that time. We're not paying anything more other than that at this point.

And then in terms of the organic growth, in Diagnostics, there's some KIESTRA in there, but also good performance as we start to get some of these new products out. So it's a nice balance there, and the same thing is basically true in Medical, where we do expect PhaSeal, the products to continue to do well. It's off to a good start. But also, as Bill can say that we're seeing good growth in Diabetes Care, and we went through a series of product launches that we have going on in that business in the, both syringe and pen needle category. And then Pharm Systems is also doing better as well. So there's a nice piece of organic growth driven by the new products that we're seeing as well, not just the acquisition. So kind of both things going for us.

Okay. But fair to say relative to your initial outlook in Medical and Diagnostics that organically the business is doing a little bit better than you had anticipated.

That's a very fair comment. We're on track with the acquisition and a little bit better with the new products.

Your next question comes from the line of Rick Wise with Leerink Swann.

Let me come back to, David, your comment, I think, it was your comment on Pharm Systems. I think you mentioned it was helped by favorable order timing. Can you just give us some sense of the fiscal second quarter impact, then do you see it go the other way in some sense in the fiscal second half?

Yes, I think as we talked about on the last quarter call, Pharm Systems came in at around 7%, and that market is growing in that 3% range. So as we always talk about, there's timing of orders given the customers that we have. We do expect to see an improvement in the second half for the year as we normally do with the cycle of our business. And I'll just ask -- I'll pass it over to Bill to see if there's any more color he wants to provide around Pharm Systems' second half growth.

This is Bill. Just a little bit more color to build on David's comments related just to the quarter and to the 7% growth. We had some strong demand from vaccine customers in the quarter, and we also got some increased demand related to this expanding use of generic low-molecular-weight heparin as another competitor has entered that market but, of course, also utilizing our product portfolio. We also had some favorable impact in Europe due to some onetime demands from one of our major pharmaceutical customers who was up against a favorable comp versus the prior year. So just to build on David's comments, we got a good 3%, 3.5% growth in the quarter. That's a little stronger than what we see for the year. So we had a little tailwind in the quarter.

And it'll be bumpy on the second half of the year too. It's not going to be flat growth rate. It's just the way the orders come in. And Bill, when you said that there was a new competitor in low-molecular-weight Heparin, you meant pharmaceutical.

A pharmaceutical competitor in that space also using prefilled.

Yes, our devices. They're using our devices.

I got you. On a separate topic, sorry to drag you back to fiscal '13 again, Vince, it was very helpful color. The 2 follow-up questions on that. How do we think about Discovery Labware when we're thinking how are you likely as to give us guidance off of fiscal '12 base that doesn't include it? That pro forma, will it be in there? And therefore, your highlighting the dilution the following year? And I'm not sure that you said, and I apologize if you did, on the share repurchase side. My impression is that you're likely -- you're likelier to repurchase fewer shares in fiscal '13. That's your thought as of now, if I'm correct. Just want to make sure I understood.

So a couple of things. One is that what we said is that $1.5 billion was certainly at the high end of our buyback range, in that we haven't guided to exactly where we're going to be on share repurchases, and we're not going to do that now. In terms of -- we will guide you -- we've given you the $0.23 and it will be in November, as David just said a little while ago is that we'll finalize our share repurchase with the board and then we'll give you some guidance. So you can put the whole thing together.

And on the pro forma follow-up, David, is it likely to be in the base when you give guidance or out of the base when you give guidance?

As I said there's a couple of things as far as the transition, the deal stuff, to close and get regulatory approval. When you look at doing the accounting from disc ops perspective, you have to finalize all the transition services agreement, you have to finalize any kind of tool manufacturing agreements and that determines when. Eventually it will go to discontinued ops. You just have to finalize all those parts of the agreement before determining when it actually go to discontinued ops. But our expectation is once all these things are finalized, it will go into discontinued ops and for your planning purposes, as you look at fiscal year 2013, I would take out the $0.23 to $0.27 that we talked about once it goes into discontinued operations.

Your next question comes on the line of Brian Weinstein with William Blair. Brian Weinstein - William Blair & Company L.L.C., Research Division: Maybe you can talk a little bit about in the early uptake that you've seen or any comment on BD MAX outside the U.S. And if you're seeing any competitive wins there or just comment on how that launch is going in general.

Sure. We have seen some competitive wins, and Tom can talk about it.

Brian, it's Tom Polen. We have seen typically in Europe, obviously, which is where we launched our MRSA and more recently, our C.diff assay, we have seen some competitive conversions. We're off to about 60 placements year-to-date there. So solid initial traction. About that many customers also using the system as an open platform. Obviously, the most significant launch for MAX will be the MRSA launch in the U.S. just driven by that market size. As Vince had mentioned earlier, I think we remain on track for that launch scheduled for later this year. Brian Weinstein - William Blair & Company L.L.C., Research Division: Okay, and then we haven't seen anything out of you guys as far as assay development deal for a little while. Are there more coming or have you guys just stopped announcing those?

No, there are more coming. We've got them in the pipeline -- just more to come later this year, we would expect.

Yes, there was just some sequencing in terms of the R&D work and getting the, let me call, the sample prep kits and whatnot lined up so we could handle more partners. And so you couldn't throw a ball at it one time, but we have a lot of companies that are interested in working with us.

And just a note. So at this point, for MAX we've got about -- we have 18 assays in the pipeline in combination of internal and external partnerships. And again by the end of this year, we will expect that number to be well north of 20 as we communicated in the past.

[Operator Instructions] Your next question comes from the line of Mike Weinstein with JPMorgan. Kimberly Weeks Gailun - JP Morgan Chase & Co, Research Division: It's Kim in here for Mike. My question -- first question for David, you made some helpful comments earlier on the moving pieces for gross margin. And for the year here, your gross margin guidance is unchanged. With the FX easing in your guidance, I would think that all else equal, the gross margin outlook would also rise. So curious what's the offset in there versus your prior guidance that keeps the gross margin steady for the year.

Yes, as we talked about before, if you look at it for the full year, from a guidance perspective, price is about 50, raw materials is sitting about 20 and the acquisitions as we talked about building that into all the line components, particularly the recently announced KIESTRA, is really having the offsetting effect. And then the software amortization, as we talked about before, is unchanged at about 20 basis points. So to your point, Kim, you have the -- incorporating the acquisitions into the gross profit line. It's offsetting any minor improvements that you have from a currency perspective. Kimberly Weeks Gailun - JP Morgan Chase & Co, Research Division: Okay. That helps. So it's really the acquisition piece, which makes sense. And the follow-up question from us is just on pricing wanting to kind of tie up the pricing discussion we've had here this morning. We talked through the impact in Diagnostics with Roche's pricing strategy and hoping to improve upon that with both the anniversary of the Roche impact and also your own launch where your hope is to bring pricing back up to more rational level with the BD MAX MRSA. But what's going on in Medical from a pricing standpoint? How would you characterize the overall -- that's your largest segment. We're just trying to look at pricing on an ongoing basis. So how would you characterize the pricing?

Sure, Bill can talk to that.

This is Bill. For the quarter, just looking at the second quarter we saw a little bit more of a normalized price impact in that range of 1% to 2%, which we've talked about historically. If you think about that, the largest pressure's on the Med/Surg business, positive impact from Diabetes Care and pretty much close to flat in Pharm Systems. So think about Diabetes Care and Pharm Systems serving as a little bit of an offset to some ongoing price pressure that we have in the Medical Surgical business but pretty much in the range that we planned on.

So for the year, we think pricing is about where we guided right from the start across the company pretty much.

Your next question comes from the line of Jonathan Palmer with CLSA. Jonathan J. Palmer - Credit Agricole Securities (USA) Inc., Research Division: I just want to come back to the topic of industry M&A. We've seen some consolidation of both the Diagnostics and Bioscience businesses the last few years. And Vince, I was wondering if you could just talk about how you're thinking about the scale of your businesses in light of those deals, and then has your appetite changed at all to do a larger scale acquisition?

Sure. We haven't changed our outlook in terms of -- and our strategy in terms of acquisitions. Certainly aware that there has been consolidation. Let me start on the Biosciences side, and that's been going on for quite a long time not just last couple of years. But we feel good about where we are in terms of the Bioscience businesses and the opportunities that we have there. On the Diagnostics front, and as Tom was talking about, not just in the Women's Health and Cancer space but with what we're doing with BD MAX, we think that still you'll have to compete vertically more than horizontally, and we think we have the right programs in place. So we think we could be very competitive. So we will continue to look for plug-in acquisitions to round out the portfolio. We've always looked at larger acquisitions, and we've done that for years. They just have to make sense both strategically and financially in creating shareholder value. So we're not sitting here saying we wouldn't do a larger one, but we have -- we continue to be more focused on plug-in acquisitions and adjacent spaces. That's our strategy.

Your next question comes from the line of Peter Lawson with Mizuho Securities.

Vince, just a forward question. Where do you think you're taking share in the product lines, and which products passed expectations in the quarter?

So okay, across the entire company in the -- I think we're continuing to do very well in the Medical business. I think in Diabetes Care, we're doing well. Obviously, we're creating a category with PhaSeal. Bill, you have a couple of other remarks here?

I think what probably worth mentioning our success the quarter with safety and particularly with the IV catheters, particularly outside the U.S.

Sure. Yes, going extremely well. And as we create the momentum behind that, we're usually developing the market we're gaining share at the same time. So Safety probably would be the #1 area where we've gained some share. Tom, any other comments we have some conversions with BD MAX going on. We lost obviously some business going back a year ago. We expect to reverse that as MAX comes out.

I think our Women's Health and core pap business is growing, ahead of the above market rates. And our microbiology business is solid, again, on a global basis as well.

Right, and I think basically in Biosciences in the instrumentation side, we continue to maintain share. It's more of a market issue. And we did have this pricing and a little bit of share loss in the research reagents. So those are kind of the big factors across the company.

And just quickly, do you have an extra selling day in the quarter?

Did we have an extra selling day?

Yes, yes, we did.

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

Two-part question. First off, for Bill. I just wanted to come back, just given the weaker flu season, can you talk to us a little bit about how we should the thinking of the Pharm Systems business really over I guess, I would say the next 6 months to the extent and look out about a year from now, that'd be great. And then secondly, Tom, any update on HPV? I saw it obviously noted in your pipeline, but any color on both O U.S. and U.S.?

Sure. This is Bill. In terms of the vaccine campaigns that ran of course in first half of the fiscal year, those were pretty much on expectation. Nothing extraordinary. Nothing way behind. No disappointments. So we would anticipate our second half of the year to reflect kind of traditional ordering, and that's the way we're thinking about it in the guidance that we provided. And as you might recall, it's that third quarter where we tend to see our flu vaccine order processing take place. So we'll have much more for you in the next quarter to affirm that position.

Tom?

Bill, this is Tom Polen. So on our HPV assays, it is progressing well in development. We're pleased with the performance we're seeing internally, as well as roughly 2 or 3 Polish studies now against pure assays and pure assays are performing very, very well. And as Vince mentioned earlier as we communicated in the past, we remain on track to launch in EU in FY '13, and we will have not shared yet but we will be sharing this year our timing on the U.S. launch. We're beginning trials for both those launches over the next few months.

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

First, Roche recently indicated there were some reimbursement challenges in diabetes across several key European markets for them. Did you see any impact from this quarter?

No, we didn't.

Okay, and then just a few loose ends. Peter asked, I think, about the extra day in the quarter. Could you quantify the impact? I think last quarter you talked about a $0.04 per share benefit from tax. You said that was going to come back over the balance of the year. Did you take that hit in Q2? And then could you define what the M&A contribution is that you factor into full year guidance?

Okay, the M&A we mentioned earlier -- this is David, it's about 1 percentage point of growth in total, and dilution for the full year is about $0.10. As far as the extra day, it's really not material for our business within the quarter. And I believe your last question -- could you repeat your last question?

The tax.

It is the tax.

The $0.04 tax.

As we said for the full year, we're going to be coming in that 25.5% to 25.7% for the year, and that's mainly driven by the geographic mix of our business.

Your next question comes from the line of Bill Bonello with RBC Capital Markets.

Just one additional follow-up question on the guidance. How much of the EPS boost is coming just from the favorable currency outlook?

For the full year, the currency is about -- we're sitting at about $0.24, that's about $0.18 is the currency impact. So about $0.06 is, and that's what we raised the guidance by so about 1% impact on our EPS growth rate.

Okay, sorry. I just want to make sure I understand that. The impact was about $0.06 on the raise?

That's right, on the guidance. That's why we raised our guidance was...

Okay. But if we think about it the acquisitions are diluting EPS by about $0.10, the currency is boosting at about $0.06. So should we be thinking about it as it did sort of net-net kind of a raise, or am I missing something there?

No, I think net-net what we're saying is we're still within our range.

Within the range. Okay, that makes sense. And then all of the revenue boost is really from the acquisition of the currency-neutral boost, is that right?

Well, we had 2 offsets going on. So we had very solid performance as we talked about in the Medical business, which was benefited by the acquisition. But as you saw on the quarter and as you saw last quarter, we had continued very strong growth from a Safety perspective. On the Diagnostics side, we had good solid performance in our Preanalytical Systems within the quarter, and offsetting that was the challenges that we saw in the research instrumentation within Biosciences and the tougher competitive environment in the research reagents, as Vince and Bill both talked about earlier. So and again, this just shows that geographic, as well as business diversity despite some headwinds, to be able to deliver some solid numbers in the top line.

Your next question comes from the line of Sara Michelmore with Brean Murray. Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: Vince, just to go back to this fiscal '13 commentary on and just thinking about the margins, I mean, I look at some of the headwinds that we know exist for you guys and as I think about the SG&A line in particular, which has often been a source of leverage in your model. I mean, you've got EVEREST again as a headwind. It sounds like the intent is to continue invest in emerging markets. Some of the other things like pension and medical claims, I assume, would still be going in the wrong direction. I mean, know we have med tech tax as well. I mean where does the cost savings come from? It's really easy for me to pick out the headwinds, and I'm just not sure where the leverage points are in the model at this point. So if you could talk about that, that would be very helpful.

We don't think the pension is going to be a big issue going forward. So yes, on the negative side, we're going to be seeing an increase in EVEREST. We haven't finalized that number. It's likely to be smaller than what we've seen in the last couple of years. And in emerging markets, yes, we will continue to build. But we'll be getting good productivity from the investments we're already making there. In terms of other elements of leverage, it's really going to be around the functional effectiveness, and the -- we'll start to see some leverage from the acquisition piece that we've done as well, too, because we had that infrastructure come in. So you have Accuri that now starts to improve, PhaSeal starts to improve so, and even KIESTRA will get better. So I think that's where the leverage is going to come from. Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: Okay, and then specifically, I mean, you guys did call out that med tech tax and I know it's sort of a tricky question, but how do you deal with that? I mean, are you passing through some of the costs? Are you making specific cuts to offset it? What's sort of the framework that we should think about you absorbing that incremental cost next year?

Sort of on the device tax? Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: Yes.

Well, this where in seeing this coming and seeing the pricing pressure that's out there, we started focusing on ReLoCo I and ReLoCo II. And so really attacking the gross margin line and then supporting that with some of the shared service centered work that we've been discussing with you. Now in terms of -- so we'll attack every element of the P&L basically to try to offset the $55 million. On the more difficult side, a lot of our U.S. business that will be impacted by this will be under contract, and so we can't just go out and start changing prices. So there'll be a whole dynamic there that we're going to have to work our way through. And it's really -- a lot of is going to have to come from the efficiency side.

Your next question comes from the line of Jeff Frelick with Canaccord.

Just a molecular diagnostic question for Tom. Tom, could you share with us the total molecular diagnostic growth rate in the quarter? And then just specifically, how would you characterize the MRSA test volume?

So we don't report about -- we usually reported GeneOhm separate from our STD business. As I just described earlier, the STD business, our Viper and ProbeTec, up 6% in the quarter and GeneOhm down 7%, as I described. In terms of MRSA volume overall in the U.S. certainly we've seen a stabilization -- not stabilization at 0, but a stabilization of growth in MRSA. The conversion to the screening in the U.S. specifically around MRSA is certainly not the same growth rate that it was several years ago, but it is still growing north of probably that 10% range in the U.S.

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

Just a clarification, I guess, on the impacts of acquisitions for the full year. David, I think you had said $0.10. That does include not only KIESTRA, which was new since you last gave guidance, but also prior acquisitions that you closed.

That's right. That includes 3 acquisitions that Vince mentioned earlier. Carmel, Acurri and our KIESTRA acquisitions.

Okay. So the impact of acquisitions this quarter, the $24 million, I think, you had referenced earlier, those were primarily the past acquisitions, not KIESTRA?

That includes a tiny bit of KIESTRA. About $1 million.

Okay. And then just to kind of go back to the med tech tax. Are you guys comfortable that you'll be able to offset most of it or do you think that, that will be kind of net-net, an additional headwind impacting kind of the year-to-year comps?

Well, it's something we're working on. So as I was mentioning just before, excuse me, I got a bit of a cold here -- we'll be looking at all elements of our P&L to see where we can go for efficiencies, not just in the U.S. but globally to see what we can do to offset. So it will be a challenge. It's a headwind but one that we're going to take on.

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

So thank you very much for your participation today. We look forward to next quarter and further updates. We're very pleased with the results in the quarter and the progress on our programs, and have a great day. Thanks very much.

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