Monique N. Dolecki - Head-Investor Relations Vincent A. Forlenza - Chairman, President & Chief Executive Officer Christopher R. Reidy - Chief Financial Officer & EVP-Administration Thomas Polen - Executive Vice President and President - Medical Segment Linda Tharby - Executive Vice President and President - Life Sciences Segment.
Michael J. Weinstein - JPMorgan David H. Roman - Goldman Sachs & Co. David Ryan Lewis - Morgan Stanley & Co. LLC Lawrence S. Keusch - Raymond James & Associates, Inc. Frederick A. Wise - Stifel, Nicolaus & Co., Inc. Brian D. Weinstein - William Blair & Co. LLC Derik de Bruin - Bank of America Merrill Lynch William R.
Quirk - Piper Jaffray & Co (Broker) Jonathan Groberg - UBS Securities LLC Doug A. Schenkel - Cowen & Co. LLC Vijay M. Kumar - Evercore ISI Richard S. Newitter - Leerink Partners LLC.
Hello and welcome to BD's third fiscal quarter 2015 earnings call. At the request of BD, today's call is being recorded.
It will be available for replay through August 13, 2015 on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 78953246.
I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. 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 section of recent SEC filings.
We will also discuss some non-GAAP financial measures with respect to our performance, as we will speak to our revenue and earnings results on an adjusted basis, which exclude certain items we recorded during the quarter.
These items primarily reflect purchase accounting adjustments that include the amortization of acquisition-related intangibles as well as adjustments to reflect CareFusion's inventory, fixed assets, debt, and deferred revenue balances at fair value as of the acquisition date.
As a reminder, our third quarter results now reflect the New BD, which includes the results of CareFusion for the full quarter. To provide additional revenue visibility into the New BD, we will speak to our revenue results this morning on a comparable currency neutral basis, which include BD and CareFusion in the current and prior-year periods.
The comparable basis presents current period revenues on an adjusted basis that excludes a small impact related to a purchase accounting adjustment to record CareFusion's deferred revenues at fair value as of the acquisition date.
Details of the purchase accounting and other smaller adjustments and the comparable-basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides.
Lastly, we have provided slides that illustrate the new reportable segment and business unit structure of the combined company, which can also be found in the appendix of the Investor Relations slides. Copies of the release, including the financial schedules and Investor Relations slides, are 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; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Executive Vice President of BD Medical; and Linda Tharby, Executive Vice President of the BD Life Sciences segment. 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 performance this quarter, which was ahead of our expectations.
This quarter marks an important milestone in BD's history, as it is the first time reporting our results as the New BD, which combines the BD and CareFusion businesses, generating over $3 billion in revenues in the quarter. We continue to be on target with the integration of BD and CareFusion.
We've made excellent progress with our leadership assessment across the organization and are confident we have the team in place to execute on our strategy. We remain on track to achieve our fiscal 2015 and 2016 accretion commitments. Our solid results this quarter clearly demonstrate our early progress as the New BD.
This performance was driven by continued solid mid-single-digit top line performance from the BD business coupled with better than expected revenue performance across the CareFusion businesses. Once again, our solid results highlight the benefit of our diverse portfolio both on a product and geographic basis.
Additionally, the operating leverage in the quarter demonstrates we're making good progress towards delivering on our synergy commitments. Our strong performance to date and full-year outlook gives us the confidence to raise our adjusted diluted EPS guidance despite additional foreign currency headwinds.
Now I would like to turn things over to Chris for a more detailed discussion of our third quarter financial performance and our updated fiscal year 2015 guidance..
Thanks, Vince, and good morning, everyone. I'd like to begin by discussing our third quarter revenue and EPS results as well as the key financial highlights for the quarter. Total third quarter revenues of $3.1 billion grew 55.6%.
On a comparable basis, revenues grew 2.4%, which is above the 1% to 2% growth we had anticipated and communicated on last quarter's earnings call. This reflects solid growth in line with our expectation of 4.7% in the BD business.
The CareFusion business declined 2% in the quarter due to a tough comparison in infusion, which was better than the 5% to 7% decline we had anticipated and communicated last quarter. Fully diluted adjusted earnings per share came in ahead of our expectations at $2.05, growing at 34.3% over the prior year.
Growth was driven by continued solid underlying performance of the BD business coupled with the inclusion of CareFusion. As we just discussed, CareFusion's revenue performance exceeded our expectations, and we were able to realize some cost synergy benefits beginning in the third quarter, which is sooner than we had anticipated.
However, we continue to see an increasingly negative impact from FX, given the year-over-year strengthening of the U.S. dollar. As Vince mentioned earlier, we are very pleased with our first quarter as a combined entity.
Our results year to date combined with our full-year outlook give us the confidence to increase our EPS guidance despite the increased FX headwinds. These financial metrics remain consistent with our expectation for high teens currency neutral earnings accretion in fiscal 2016 from the CareFusion acquisition.
I'll provide more detailed guidance commentary later in my remarks. We are also pleased to announce that we have continued to deleverage, as we reduced the debt associated with the acquisition of CareFusion.
In addition to the $650 million paydown at the end of April, we paid down an additional $250 million of our $1 billion term loan facility in July. We remain on track to achieve our commitment of three times gross debt leverage within 24 months of close.
Moving on to slide seven, I'll review our third quarter revenue growth by segment on a comparable currency neutral basis. In the quarter, pricing was about flat on a legacy BD basis. Year-to-date pricing is better than our expectations. As such, we are revising our full-year guidance for pricing to be about flat year over year.
BD Medical third quarter revenues increased 1.6%. Underlying Medical revenue growth was approximately 4%, which includes normalizing for the tough comparison in infusion. Growth in this segment was primarily driven by Medication and Procedural Solutions, or MPS.
As a reminder, MPS includes BD's Medical Surgical Systems unit as well as CareFusion's Infection Prevention and Medical Specialties businesses. MPS growth was 5%, which reflects growth across all platforms, including strength in flush, ChloraPrep, and safety engineered products. Revenues in Medication Management Solutions, or MMS, declined 6.1%.
The infusion business had a difficult compare to last year's June quarter, which grew 40%. The dispensing business also had a difficult comparison to the prior year. However, we are experiencing continued strong demand for our Pyxis ES product, and it has continued to perform in line with our expectations.
Adjusting for the difficult comparisons, underlying MMS revenues grew about 5% in the quarter. Respiratory Solution revenues declined 2%, reflecting the lost revenues associated with the previously announced recall, as anticipated.
This was partially offset by favorable timing of other Respiratory Solution products which shifted from the fourth quarter to the third quarter. Growth in Diabetes Care was 3.4%, reflecting some softness in the U.S., due primarily to the slowing of conversion from syringes to pen needles and flattening of price trends.
Offsetting this were solid sales in international markets. Pharmaceutical Systems growth of 8% reflects favorable timing of ordering patterns, as expected, with year-to-date growth of 3.6%. BD Life Sciences third quarter revenues increased 4.2%, primarily driven by growth in biosciences and Preanalytical Systems.
Biosciences revenue growth was 5.1% in the third quarter, driven by strong performance in research, instruments, and reagents, and the timing of orders in our advanced bioprocessing business. As we expected and communicated to you on our last quarter earnings call, we saw a small favorable impact related to the timing of government funding in Japan.
Preanalytical Systems growth of 4.1% was driven by safety engineered products and growth in emerging markets. Diagnostic Systems growth of 3.7% reflects solid core microbiology growth and double-digit growth in our BD MAX molecular platform, partially offset by the impact of extended interval testing in the U.S.
and continued pressure in our ProbeTec Viper platforms. Moving on to slide eight, I'll walk you through our geographic revenues for the third quarter on a comparable basis. U.S. revenues declined 1.5%. I'd like to note that our third quarter results in the U.S.
are not indicative of our year-to-date results or our go-forward expectations, as we expect growth in the U.S. to normalize next quarter. U.S. Medical revenues declined 2.8% due to the aforementioned tough comparisons in Medication Management Solutions, or MMS. Normalizing for the tough comparison in MMS, U.S. revenues and U.S.
Medical segment revenues each grew about 2%. We saw solid growth in our Medication and Procedural Solutions unit, driven by flush and ChloraPrep, partially offset by a tough comparison in Pharmaceutical Systems and the AVEA ship hold impact on Respiratory Solutions. U.S. revenues in Diabetes Care were about flat. The U.S. Life Sciences segment grew 2.9%.
This reflects strong growth in our U.S. Biosciences business, driven by research instrument and reagent sales and timing in our advanced bioprocessing business. In our U.S.
Diagnostics business, we saw continued strength in our core microbiology business and growth in our BD MAX molecular platform, offset by the extended interval testing impact and continued pressure on our ProbeTec Viper platforms. Moving on to international, revenues grew 6.6%.
The Medical segment grew 7.4%, driven by strong performance in Pharmaceutical Systems and international safety sales. The Life Sciences segment grew 5.2%, reflecting strength in Preanalytical Systems and Diagnostics Systems.
Moving on to slide nine, before I get into the emerging market results, I'd like to start with some comments on developed markets. U.S. revenues grew about 2% on an underlying basis, as we just discussed. In the non-U.S.
developed markets, we saw strong performance, with Europe, Japan, and Canada all growing in the mid-single digits on a currency neutral basis. With the inclusion of CareFusion, developed markets have become a larger and more impactful portion of the total company revenue base.
Moving on to emerging market results, you'll see that emerging markets are presented on a legacy BD basis, as this provides a more meaningful comparison to the guidance we have been providing all year. Beginning in fiscal 2016, we will provide a bridge to a new emerging market baseline that combines BD and CareFusion.
With CareFusion revenues predominantly in developed marks, emerging markets will clearly be a lower percentage of total company revenues on a combined basis. It's important to note that emerging markets will continue to be a very important growth driver for the company.
In the third quarter, emerging market revenues grew 11% currency neutral over the prior year, bringing our total growth year to date to 10.4%. This growth was driven by Latin America and China. As we expected, our growth in Brazil improved slightly compared with last quarter's growth rate.
For the total year, we expect growth in the emerging markets in the BD legacy base of about 10%. China growth for the third quarter was 15.4%. We saw some softness in China, and as a result, have revised our growth outlook slightly lower, to 16% to 17% for the total year.
Moving to global Safety on slide 10, comparable currency neutral sales increased 6.2%. Safety revenues in the U.S. grew 0.9%, while international sales grew 13.5% currency neutral, with continued strength in Europe which grew double digits, as compliance with safety legislation continues. Safety revenues grew 13.5% in emerging markets.
Medical Safety sales grew 7.4%, driven by a range of safety engineered products, including infusion disposables, with strong international growth across Diabetes Care and Pharmaceutical Systems. Life Sciences Safety sales, which are driven by our Preanalytical Systems unit, grew 4.3% in the quarter.
Turning to slide 11 and our gross profit margin for the third quarter, foreign currency had an unfavorable impact of about 50 basis points on our gross profit margin in the quarter. On a performance basis, margin expansion was driven by continuous improvement initiatives and favorable raw materials.
These contributions were partially offset by higher pension expenses, product mix, and other items. Slide 12 recaps the third quarter income statement and highlights our foreign currency neutral results on an adjusted basis. As we discussed, revenues were ahead of our expectations, while gross profit was in line with our expectations.
SSG&A as a percentage of revenue was 24.3%. We are very pleased with the leverage we are getting that includes the accelerated cost synergy capture, as previously discussed. When you look at the results on a comparable basis to what the combined company would have been last year, we achieved 110 basis points of improvement year over year.
R&D as a percentage of revenue was 5.7%, which is slightly lower due to the timing of spending with the fourth quarter. We continue to invest in innovation and expect R&D spend to be about 6% for the full year. Operating income grew 62.9% in the quarter on revenue growth of 55.6%, reflecting strong P&L leverage as the New BD.
Our tax rate increased by 110 basis points, as expected, due to the inclusion of CareFusion's U.S.-based results. In the quarter, adjusted earnings per share were $2.05, which is a 34.3% increase versus the prior year.
This reflects operating profit growth, partially offset by the transaction impact on the tax rate, interest expense, and increased shares outstanding.
Earnings were ahead of our expectations due to the underlying strength in the CareFusion business, as well as our ability to achieve some cost synergies and eliminate some costs in the third quarter that we had anticipated would take place in the fourth quarter.
On slide 14, I'd like to update you on our organic revenue growth profile and phasing in fiscal 2015. Third quarter performance across the CareFusion business exceeded our expectations. While some of the Respiratory Solutions sales reflect favorable timing in the third quarter, we now expect organic CareFusion growth of about 3.5% for the fiscal year.
When combined with our continued expectation of about 5% organic BD growth, we continue to expect about 4.5% growth for the full fiscal year. Moving on to slide 15, there are a number of moving parts that impact earnings per share expectations. For modeling purposes, and to ensure consistency, I'd like to provide more color on EPS guidance.
Starting at the top of the slide with legacy BD, the guidance we provided last quarter of $6.43 to $6.50 assumed adjusted earnings per share growth of 9% to 10% on a currency neutral basis and an estimated unfavorable impact from foreign currency headwinds of about 10 percentage points.
Since our May update, the dollar has strengthened further against the euro and other major currencies to which we have exposure, such as the yen, the Canadian dollar, and the Brazilian real. The result is that we now expect an additional 50 basis points of FX pressure to legacy BD EPS at today's spot rates.
Incremental FX pressure resulted in a reduction of about $0.03 to our estimated BD legacy adjusted earnings per share guidance, to a range of $6.40 to $6.47. The chart at the bottom of the slide presents our total company guidance.
As you'll recall, we had expected about 10% currency neutral accretion from the CareFusion acquisition and a currency headwind to CareFusion's earnings of about 100 basis points, which when applied to our May legacy BD base of $6.43 to $6.50, resulted in a May total company earnings guidance of $7.00 to $7.10.
Given the stronger than expected performance in the third quarter from the CareFusion business and our ability to realize some cost synergies and eliminate some costs earlier than we had anticipated this year, we expect an additional 100 basis points of currency neutral accretion in fiscal 2015, partially offset by the incremental 50 basis points of headwinds from FX.
This gives us the confidence to raise our guidance to a range of $7.08 to $7.12. With the revised BD legacy base for fiscal 2015, we remain comfortable with what we have previously disclosed in terms of our currency neutral legacy BD and CareFusion accretion profile of high teens accretion in fiscal 2016.
We will update you for the FX impact in 2016 when we give guidance in November based on rates in effect at that time. Turning to slide 16, I'd like to walk you through the additional elements of our guidance for the full fiscal year 2015.
We expect total company currency neutral revenue growth of 28.5% to 29%, with BD Medical growing 48.5% to 49%, both of which are at the higher end of our previous ranges given better than expected CareFusion performance in the third quarter. We continue to expect Life Sciences growth of about 5%.
Also to note beyond revenues and EPS, all other P&L guidance for May remains unchanged. We continue to expect gross profit margin of 52% to 52.5% and SSG&A and R&D as a percentage of revenues of about 25% and 6% respectively. Our operating margin and tax rate guidance also remain unchanged.
With that, I'd like to turn the call back over to Vince, who will provide a brief update on our progress around our key initiatives..
Thank you, Chris. Moving on to slide 18, I would like to go over the Medical & Biosciences segment and the Life Sciences unit. We remain excited about the Intelliport opportunity. Excuse me one second. We remain excited about the Intelliport opportunity, our system for eliminating bolus IV injection errors at the bedside.
We're receiving early positive customer interest, and we remain on track for commercial release. We continue to expect to launch our insulin infusion sets in fiscal year 2016. Our collaboration with Medtronic, announced in June, will enable BD FlowSmart technology to be made widely available to as many people living with diabetes as possible.
We had presented three different evidence posters at the American Diabetes Association's annual meeting with data on BD FlowSmart technology. This included results showing a 75% reduction in pressure rise events or silent occlusions. We are confident that this product will have a meaningful impact for diabetes patients globally.
Within Biosciences, we continue to anticipate the launch of two additional BD Horizon dyes based on the Sirigen technology. As we have been sharing with you, these dyes combined with our high-end research instruments are enabling significant gains in multi-parameter flow cytometry analysis.
We also continue to anticipate the launch of two instruments, the X14 high-parameter multicolor research instrument and the BD FACSVia clinical instrument, aimed to enable increased market adoption in emerging markets, particularly in China. Turning to slide 19, you will see the various product launches in our Life Sciences Diagnostic unit.
Our BD MAX molecular instrument continues to gain traction with customers in Western Europe, where our expanded menu that includes the CE Marked GC/CT and GC/CT/Trich assays launched last quarter are enabling increased placements.
We remain focused on menu expansion on the BD MAX platform and expect the Enteric Parasite assay to launch later this quarter in the U.S., followed in fiscal 2016 by the Extended Enteric Bacterial and Enteric Viral assays in the EU and the U.S. in 2016 and 2017. In 2016, we also expect to launch GC/CT in the U.S.
and the Vaginitis/Vaginosis assays in the EU and the U.S. We also expect to launch the BD Totalys system in the U.S. in women's health and cancer for cervical cancer screening automation in the first half of fiscal year 2016.
As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you going forward. On slide 20, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we're very pleased with our results as the New BD.
Second, our performance was driven by continued solid mid-single-digit top line performance from the BD business coupled with better than expected revenue performance from the CareFusion businesses. Once again, our solid results highlight the benefits of our diverse portfolio, both on a product and geographic basis.
Third, we are making significant progress successfully integrating CareFusion into BD while achieving cost synergies. Fourth, our strong performance in the quarter and our full-year outlook gives us the confidence to raise our guidance for fiscal year 2015.
Finally, we look forward to the future with confidence, as we continue to deliver on BD's strategy of providing complete solutions for global health care needs. Thank you, we'll now open the call to questions..
The floor is now open for questions. Our first question is coming from the line of Mike Weinstein with JPMorgan..
Thank you, guys. Good morning.
Maybe I'll start with just the question of now that we are a quarter in, anything new or surprising that you found in CareFusion, either positive on the opportunity side or negative that you have to deal with?.
So, Mike, I can't think of any significant surprises. What I would tell you is that I think the implementation, it's not a surprise, we planned it out, is going very well. We're very much on track with what we expected.
As we think about both the cost synergies and the planning for the revenue synergies, I think all that detailed planning has come together quite nicely. I wouldn't say it's a surprise, but I did mention in my opening remarks that the talent assessment and integration, we feel very good about the team that we now have in place.
Now was it a little bit of a surprise in terms of the strong performance in the quarter of the CareFusion businesses? Yes, we had communicated a revenue expectation that was less. And so that was a bit of an upside for the short run, but in the longer-run issues, really nothing – really on-track performance..
Okay, good. Let's talk about China, because there were a number of reports over the course of the earnings season from companies with issues in China, most of them more consumer-facing companies than Becton-Dickinson. But you did comment that you thought China was a little bit softer and your expectations came in a little bit.
So number one, can you talk about that? And then second, I was hoping you could spend a few minutes on the infusion opportunity in China, which infusion pumps are still very very early in China. That isn't a market that has really developed to this point. And I was hoping you could talk a little bit about how you plan on developing that market.
I knew there was a product that you acquired from Israel that you thought might be a good fit, and I was hoping you could you spend a few minutes on that. Thanks..
Sure, Mike. That's great. So I'll take China in the quarter, and then I'll ask Tom Polen to talk about the exciting opportunity that we have in the infusion business in China going forward. So we did see a little bit of softness in China in the quarter. It was mostly on the diagnostics side, where we saw longer purchasing cycles for equipment.
And so that's what impacted the third quarter. We did change the guidance to 16% to 17%. It's down slightly from where we were last quarter.
We do expect that there will be some inventory adjustments on the medical side of the business in the fourth quarter, and that's just being proactive with our distribution partners, to make sure that they have the right level of inventory. That's how we get to 16% to 17%.
But when we look at it more broadly, it's still a very exciting opportunity for us. We're still outperforming our peers, but what is going on, it's becoming very big. And as it's becoming bigger, just the law of large numbers is starting to come into effect here.
And so, at these growth rates, it's still going to be contributing significantly going forward. And as you mentioned, and asked about, we see the opportunity in the core continuing, but on top of that, as we go forward, the opportunity, not just infusion, but in other product lines.
But let me turn it over to Tom to talk about the opportunity in infusion..
Okay. Hi, Mike. This is Tom. So as we think about the opportunity in infusion, maybe I'll break it into a time horizon approach. And so, across both consumables and capital, we've actually recently just launched CareFusion's IV needleless connectors through our sales channel in China.
And so that's a near-term opportunity associated with the infusion process. They're actually getting our first incremental sales from putting that through the BD sales force. So that's actually in the market underway. The next product that we're looking to launch there related to infusion are the infusion sets.
And those are actively being prepared for SFDA submission. But those will be the next products to be launched. And following that are the pumps. As you mentioned, the pumps per hospital bed in China are a fraction, less than 10%, of the ratios that you see in the U.S.
And we do see opportunities there, confirmed by research we've done directly and in the market space. We see both – and we've confirmed interest from customers for CME pumps broadly across hospital segments, but we also actually see opportunity for Alaris in the very top tier hospital segment.
And so we're preparing registration for both of those products now in China, with more to come. But those will take a couple years to get through the SFDA process..
Tom, I know you were coming up on a potentially new memorandum of understanding in China related to the medication delivery business.
Has that gone into place? Is there anything different about the new memorandum versus the prior one?.
So, Mike, I'm going next week to China to sign the new memorandum of understanding, and so I'm really looking forward to that. The last one was a couple years ago. This will include infection control products as well, and it will be focused on infusion therapy..
Perfect, thank you, guys..
Thanks, Mike..
Our next question comes from the line of David Roman with Goldman Sachs..
Thank you, good morning, everyone. I just had one question on the business and then one financial follow-up.
Maybe first on the business, could you talk a little bit more about the Special Order Research Processing [SORP] franchise, and just remind us how big that is? And one of the things we've seen across the biopharma industry is the resurgence of R&D spending, and to what extent that might influence that business on a go-forward basis? And I had one financial follow-up..
Sure. So our SORP business is over $100 million, and it's been a strong franchise for us for a long time. And I think, Linda, at the high end of the research market, you're now starting to see some real traction with that product line..
Hi, it's Linda here, a couple of additional comments to what Vince mentioned. So, with the addition of our Sirigen dyes and our multi-parameter flow analysis, we're really able to drive multi-parameters up above 50 parameters now, which is unheard of in the market, which is fantastic ,and driving double-digit growth across that research platform.
The other area that you mentioned is spending. Of course, we're seeing stability in spending, both in the U.S. and Western Europe, which is helping, and also the NIH budget, which just saw an increase recently with the passing of the 21st Century Cures Act.
So overall, as we look ahead to our research business, we continue to see strong performance, and with the funding, continue to see a positive outlook as we move forward..
Yes, so as Linda says that, it's more than just the SORP product line that I mentioned. Linda is also talking about the standard research products, which we're very excited about..
David, did you have a follow-up on the financials? Is David still there?.
FY 2016, I just want to confirm that you're still comfortable with that, which was taking the base BD earnings for FY 2015, growing that at 10% FX neutral, then adding in a high teens accretion number. And at that point in time, you had talked about being comfortable with a mid-$8 number.
Has anything changed with respect to those assumptions, and how should we think about changes in foreign currency in that context?.
You hit it on the head, David. As we said in and I said in my prepared remarks, we have the baseline of what BD would have been in 2015. You grow that 9% to 10%. It's high teens accretion off of that, but obviously currency neutral. And so you've seen the strengthening U.S. dollar impact that it had this year.
So that's why I said we'll address that on the next call based on where rates are at that time..
Got it, thank you very much..
Our next question comes from the line of David Lewis with Morgan Stanley..
Good morning..
Good morning, David..
Good morning, David..
Maybe just a couple quick questions. Chris, just coming back to margins for a second here, so they're obviously so far tracking higher than even our expectations, so two things. Where is the strength coming from the core BD? I think you talked about over 100 basis points.
So where is that strength coming from? And then as it relates to CareFusion, you talked about some strength there.
Is this faster implementation of the synergy plan or, frankly, is the magnitude of some of the opportunities proving to be larger?.
So far what we're seeing is that the savings are coming sooner, so I don't think it's a magnitude issue. But we were able to get some savings right out of the box in the third quarter that we originally thought would have been fourth quarter items.
So you actually pick up an extra quarter of that because we'll get those same kind of savings in the fourth quarter as well. So that's a nice little benefit. In terms of the margin improvements core business, as you know, the raw materials, when we laid that out on the gross profit side, is certainly benefiting us.
That is offset, as we always expected, by some pension expense and the like. And then on SSG&A, that 110 basis points improvement is fairly significant, and that's certainly driving good operating margins. So it's all of those things contributing to very nice margins..
Okay, and then maybe just two product segment questions. You talked about obviously CareFusion was stronger than expected. Respiratory was much stronger than we would have expected.
I know some of that reflects timing, but how much of that is timing? And then can you just update us on the progress on the recall, either revenue impact or earnings impact? And then on the core company, the only business line that looked a little weak to us was Diabetes.
Is there anything in particular we should focus on, or is that simply order timing or stocking? Thank you..
Sure..
So before we move to Tom, let me just say on the recall issue, I'll remind you that we gave an estimate last quarter of the impact that would have. That is already contemplated in our guidance, and so we're in good shape from 2015.
And in 2016, it's really not material, and I would just point out that this is a product line that's about $35 million in revenue, so not material going forward either. So I think we've got it contemplated both in 2015 and our expectations for 2016..
So, Tom, do you want to take those questions?.
Sure. Hi, David, this is Tom, so just maybe one or two other comments on respiratory. Some of the better performance we saw this quarter was driven primarily in our respiratory capital business with favorable timing of orders, as one could expect within those capital-type businesses. So that's the one point there.
Regarding the AVEA product, as Chris mentioned, it's about a $35 million product line. We have not assumed in our guidance that that returns to the market within this fiscal year. And so we don't see a risk for that from a timing perspective.
On diabetes and your question there, as Chris had mentioned earlier, we did see some softness in Diabetes Care growth of about 3.4%, driven essentially exclusively by the U.S., which was 0.3% growth. And we really see that due to flattening of the price trend coupled with a decrease in the conversion rate from syringes to pen needles.
As we sell pen needles at higher prices than syringes, slower conversion creates a drag on the revenue growth.
Now with that said, more broadly, we remain really excited about the future in Diabetes Care and we're focused on meeting needs of our customers and growth opportunities, both in the core business as well as in new adjacent spaces, such as the new upcoming infusion set launch in FY 2016 that Vince mentioned in detail with Medtronic..
Great, thank you very much..
Thanks..
Thanks, David..
Our next question comes from the line of Larry Keusch with Raymond James..
Hi, good morning, two questions actually dovetailing on your answers. Stepping back on CareFusion, I understand the comments around the respiratory business and the timing of orders.
But could you also speak to perhaps what else did a bit better there, CareFusion broadly? And then separately, on the insulin infusion set opportunity, which I think is a really good opportunity for you guys, could you help us think about either sizing that or putting some parameters around what this might mean to the company?.
Okay, Tom?.
Yes, this is Tom. So in the CareFusion business, across the board we saw good growth, as we mentioned. In MMS underlying, we were about 5% growth for the quarter. So Pyxis ES and infusion are both doing well there. As Chris had mentioned, we had a very large 40% growth in the prior-year quarter in infusion, which made a tough comp.
We also saw very good performance, though, in the Medication and Procedural Solutions business, the legacy CareFusion products, with a focus on both the ChloraPrep products but also the infusion consumables, the IV sets, valves, et cetera, so really positive momentum there.
As we think about the infusion set in Diabetes Care, we haven't sized that opportunity. But maybe some comments that I can mention is that we have received FDA, CE, and Health Canada approval. At this point, we're really focused on ramping up our manufacturing for that product and preparing for launch in partnership with Medtronic in FY 2016..
Okay, thank you..
Sure. Thanks, Larry..
Our next question comes from the line of Rick Wise with Stifel, Nicolaus..
Hi, Vince. Hi, Chris. Hi, everybody..
Good morning, Rick..
Maybe starting off, if you would, with two product questions. First, on the pump side of the business, Baxter reported that their pump business, their pump system rebounded nicely. And in talking to them after it, I had the sense that one of your other competitor's regulatory and other dislocations are maybe helping out.
Are you seeing any benefits on that side of business? I assumed you all gained share in pumps.
But is going to be an incremental better number going forward?.
We do continue to do very well in our pump business. That's probably what we would say there..
Yes..
Okay, that sounds good. Back to CareFusion, on the Pyxis side, just rereading last quarter's transcript, you were saying that you're seeing improved – you're throwing additional resources into the Pyxis install process.
Acknowledging the complexity of the installs, are you gaining those efficiencies, are you accelerating the penetration of your existing backlog? What's happening there?.
This is Tom, good question. We do have significant work underway. As we mentioned before, we've put in some Lean Six Sigma teams to help lean out the Pyxis ES installation process, and the team is making some early positive progress there. With that said, we do continue to experience very strong demand for the Pyxis ES system.
And so while we're installing off of the backlog, the backlog does remain essentially at those record high levels still because the pipeline is being filled in with new orders at quite a good rate. And so the process improvements are underway. We have made progress. More to do there, I would say, but we're heading in the right direction..
Yes, we're early on, but we think it's a real opportunity for us. And as Tom is saying, we're seeing the initial impacts, but we've got a long way to go..
Rick, and maybe just one other comment I could add is to the earlier question on infusion pumps that you're maybe looking for a little bit more color on, one other comment I could add is that we are seeing customers respond very favorable to the medication management end-to-end vision and the connectivity of our solutions across that process, valuing both the pumps and the Pyxis ES being interoperable with one another through the electronic medical record and our SmartWorks platform.
So that's resonating very positively with our customers..
Yes, both Tom and I have been out visiting accounts, and we've seen this first-hand. It's a really powerful value proposition that we have now..
I appreciate that, thank you..
Our next question comes from the line of Brian Weinstein with William Blair..
Hi, good morning. Thanks for taking the question..
Hi, Brian..
Hey. So you talked about product mix a little bit.
One of the things I'm trying to get my arms around is in the New BD, can you talk about within the different sub-segments? Which sub-segments have significantly stronger and significantly weaker growth in operating margins relative to the corporate average so that we can have some idea going forward about where strength is going to come from, one, and what that can potentially mean for margins?.
I'll take that, Brian. I actually don't see anything to point to across the business. I think it's partly, again, what we point to as the diversity of the business. And so there's nothing that I would call out as exceptionally weak or exceptionally strong.
I think each of these businesses have the ability to drive the mid-single-digits revenue growth and improving profitability from where they are now. So I don't think there's anything really to call out there..
They're pretty much clustered around the corporate average. Diagnostics may be a little bit below, but we see the margins there improving. So nothing in terms of modeling and going forward that I would really be pointing to, I think pretty much a cluster..
Okay. And then on BD MAX, you guys talked about, I think you said double-digit growth. Were you looking at new products driving that? Was it an easier comp? What's going on with BD MAX, and should we expect this level of growth going forward? Thanks..
It's Linda here. Thanks for the question, Brian. So on BD MAX, we continue to see expansion of the instruments in the U.S. and in EU being driven by the expanded assays. So we launched CT/GC and CT/GC/Trich in Europe and our enteric panels. We expect that to follow in the U.S.
And then Vince provided very good commentary on our expected assay launches in 2016 and 2017. So really now starting to see double-digit growth in the MAX platform and positive feedback from our customers..
Linda, maybe you want to comment on what you're seeing in Europe with the expanded menu..
So in Europe, what we're seeing there is, again, very high double-digit growth, and in terms of instrument placement, a double-digit growth percentage in terms of the uptake in overall instruments, so very positive in Europe. And as we get our expanded menu, expect great things in the U.S. market as well..
Great. Thanks, Linda. Thanks, Brian..
Our next question comes from the line of Derik de Bruin with Bank of America Merrill Lynch..
Hi, good morning..
Good morning, Derik..
Just a quick question.
The adjusted revenues for this quarter, is that a one-quarter phenomenon, or do we need to think about that $13 million or something similar to that going forward? How do we think about that?.
There's a little bit going forward that will continue to bleed in. It's not significant..
Great, and then just one quick follow-up.
On the intervals and on the Viper headwinds, when do those begin to subside? When do you start to annualize those?.
Hi, it's Linda here. Of course, the guidelines came into effect in late 2012. We put that number today at about 70% to 75% penetration, in terms of doctors who have adopted that new interval testing. So probably over the next year or so, we say – where does that finish out, 85% to 90% of doctors adopting.
So we probably have another year or so of the interval testing to get through..
Great, thank you very much..
Our next question comes from the line of Bill Quirk with Piper Jaffray..
Great, thanks and good morning, everybody..
Good morning, Bill..
Good morning..
I guess first question, Linda, just to follow up on that last response, we saw CMS recently talk about a five-year interval, from three years. And this actually follows up on, if I remember correctly, the additional guideline or recommendations made last year.
So I guess, on a long-range basis, should we think at all about intervals potentially going to five years on pap testing?.
So, I think those guidelines are probably way too early for us to comment on. I can tell you that what's out there publicly from the medical community would say that five years, depending on age bracket, is way too long for screening.
So it's something that we continue to monitor, but today, there's no healthcare system on a global basis that has moved to a five-year interval timing. So we'll monitor it. Too early to comment, but nothing that concerns us in the short term on that..
Okay, got it. And then I guess, staying on a similar diagnostic topic, microbiology in the U.S., can you flesh out for us a little bit how that's performing? I would certainly expect that we should see some pretty good things here, given the pretty updated suite of products that you have into that space..
Yes, thank you. Our core microbiology business is doing very, very well in the U.S. and ex-U.S. And it's driven by the strength of our BACTEC platform, driven by the strength of ID/AST and our new partnership with Bruker on the MALDI platform. And really tying all of this together is our new Kiestra lab automation system.
So we've now just begun our footprint on that in the U.S. We have less than 2% market penetration. So we see a lot of opportunity, as we move forward, to really reinvent that microbiology lab from the specimen through the ID/AST, really starting with automating the workflow.
We'll have papers now globally published that say efficiency with the Kiestra lab automation system installed are 60% to 70% improvements in their workflow efficiency. And the next thing we'll look to do is really introduce smart imaging into that platform. So I'm very excited about our U.S.
microbiology business and what we're doing across the entire platform..
And it really had good growth this quarter..
It did, very nice..
Very good, thanks..
Our next question comes from the line of Jon Groberg with UBS..
Hey, good morning, so just two quick questions. One, Vince, can you update us where you are on the strategic review process? Obviously, there were a number of press reports that there could be some businesses that might be divested. And then secondly, I think you maintained your emerging market growth outlook.
But China, which is a big part of that, was brought down. I'm just curious where you saw some offsets there to maintain it. And what do you think is a reasonable emerging market growth rate, say, for the next three to five years, just given a lot of the macro noise that you have seen this year? Thanks..
We haven't changed our perspective on emerging markets. We kept it at 10% for the year. I think that's a good way for us to be thinking about it. And you're right, there are moving pieces there. We saw Brazil bounce back, for example. India actually, we don't talk about, has been doing better and better for us. So, we expect Asia to continue to be strong.
So it's not just China. And as we said, China is going to – continue to be strong for us. It's not going to be at 20% going forward. So that's the way we think about that. In terms of the strategic review process, we're making good progress on that program, and we're to the point of doing some market checks on appropriate assets.
And we'll keep you updated as that moves forward..
Thanks..
Our next question comes from the line of Doug Schenkel with Cowen & Company..
Hi, good morning..
Good morning, Doug..
If cost synergies were to continue to track ahead of plan, how do you balance the opportunity to let that flow through, versus accelerating the pace of investment in growth and sales synergy initiatives?.
Clearly, we have some commitments and targets to meet. I would say right now, we're not seeing the acceleration increase in the total amount of synergies, so we're not saying that. And so we're going to meet our commitments of high teens, and that's very important to us.
Clearly, there's always a balance, but we feel like we are making the right investments. We're not holding back in investments. You saw us last quarter announce that we were going to do some registrations in China right out of the box because, even though it was a little bit of a drag, we knew that it was the right thing to do.
So I don't see anything we're holding back on because of that. So, that's the way I would leave it..
Okay, and I do have a second question, but just to be clear on that, you did pull forward some of the cost synergies into this quarter. I guess really the question is, as we think about the next few quarters that there are opportunities to do more of that.
Does that allow you to accelerate investment, or would you actually allow some of the upside to flow through for investment?.
It's a hypothetical question. We're going to do the right thing. If we think there's a benefit to accelerating something, we would accelerate it, keeping in mind, if we were in that position, keeping in mind our commitments that we're making.
We talked to you, I think it was last quarter, about the fact that we accelerated the work on registration for China. So those one-off decisions we'd be making; we'll just be rational about it..
Okay. And then I think for Tom, Earlier this year, we had talked about the ability to move some of the CareFusion products in Europe out of distributors and into the BD direct channel. I think that was something that maybe was at least one area of focus within the context of the annual strategic review, any update on that? Thank you..
Yes, we haven't been driving that yet. We've been focused in some markets where the products were not necessarily launched yet. It's been our focus, such as ChloraPrep has been a primary area. The other thing I would say perhaps is that we have integrated in our distributor for dispensing in Europe, and so we do now take that.
We are taking those products direct. So the entire dispensing business we are now taking direct through Europe..
Okay, thank you..
Our next question comes from the line of Vijay Kumar with Evercore ISI..
Hey, guys, thanks for squeezing me in here, and maybe one quick housekeeping question. On the guidance for the year, it looks like CareFusion came up a little bit, and you hinted that legacy BDX was around the mid-single-digit range. So I'm wondering.
Did the organic for the combined BD, did it just come up versus the prior guidance?.
As we laid out on that chart, Vijay, we're still at about 4.5%. And so a little bit up on CareFusion, but it's more rounding than anything else. So we've continued to show the 4.5%, and we laid that out on the chart as to where that's coming from, so pretty much in line with what we would have expected..
Great, and then one on pricing. It's heartening to see I guess pricing actually coming in flat. I think that's the first time we've had a flattish pricing year in quite a number of years. And I'm just wondering. Is this a market phenomenon? Are you seeing anything on the competitive front? Is that what's going on? I'm just curious.
How should we be thinking about pricing on a go-forward basis?.
We'll have to look at that again next year as we get into it. Last year we saw a little bit of negative pricing in the fourth quarter, and I know we're guiding pretty much flat pricing for this year. But it's still a very competitive marketplace. I'm very happy with the way we have managed pricing this year.
It's something we're really intensely focused on. But I think we have to stay tuned and do our plan before I say it's going to be – that the market has changed, I wouldn't be making that statement. I think we've done a good job this year, and so we'll revisit it next year..
I would just add that it feels to me pretty much the same as it did last year. We did have a little bit of a blip in the fourth quarter last year, but it was pretty flat up to that point. It feels the same here..
That's what I think..
And the last one, leverage levels, you reaffirmed that 3X within 24 months of deal closure. I'm just curious. Are there any adjacencies that you've reinvested? You're obviously getting into medication management, a lot of EHR, informatics opportunities.
And would that be appealing for you?.
So, Vijay, I wouldn't comment on a particular adjacency, but we do continue to think about plug-in acquisitions as we go forward, and we look forward to having more flexibility as we take those debt levels down..
Thanks, guys..
That was a good question..
Our final question comes from the line of Rich Newitter with Leerink Partners..
Hi, thanks for squeezing me in..
Sure..
Just on the CareFusion side of things, Pyxis or Pyxis ES, can you just update us on where you are with respect to the installed base, the opportunity, and the upgrade cycle, whether it's in innings or actual quantification? Can you give us a sense of where you are and where you see you can go?.
Sure, this is Tom. So we're less than 20% converted, our base business, and so we're in the early innings..
A long way to go..
Okay, that's very encouraging.
And then just maybe higher level, as you engage further with customers with the combined portfolio and the broad complementary nature of the BD and CareFusion full suite of offering across the hospital, are the conversations – or can you characterize where the conversations are going there, anything to suggest that maybe some revenue synergy potential could begin to formulate even faster than expected as we look to 2016 and beyond, anything to increase or decrease your confidence on that front? Thanks a lot..
No, I think we're pretty much where we said we were going to be. Tom mentioned that the concept in terms of Medication Management is resonating very well. We have some work to do with integrating Cato and CRISI into the system and getting the software aligned. So there's some technical work to be done that gates us a little bit in the short run.
But in terms of how we are thinking about it and the timing, I think we're right on track. Tom also mentioned we are making progress, getting products into the market outside of the U.S., as he mentioned, in China, so right where we expect it to be..
Thank you..
That was our final question, and now I'd like to turn the floor back over to Vince Forlenza for any additional or closing remarks..
Okay, thank you very much for your participation today and your thoughtful questions. It's a very exciting time at BD, and we look forward to updating you on the progress of this strategy as we wrap up the year. Thanks very much, thanks a lot..
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day..