Monique N. Dolecki - Head-Investor Relations Vincent A. Forlenza - Chairman, President & Chief Executive Officer Christopher R. Reidy - Chief Financial Officer & EVP-Administration Thomas Polen - President, BD Preanalytical Systems Linda Tharby - Executive Vice President and President - Life Sciences Segment.
David Harrison Roman - Goldman Sachs & Co. David R. Lewis - Morgan Stanley & Co. LLC Robbie J. Marcus - JPMorgan Securities LLC Kristen M. Stewart - Deutsche Bank Securities, Inc. Brian D. Weinstein - William Blair & Co. LLC William R. Quirk - Piper Jaffray & Co (Broker) Doug Schenkel - Cowen & Co. LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Matt C.
Taylor - Barclays Capital, Inc. Vijay Kumar - Evercore Group LLC Harris Iqbal - UBS Securities LLC.
Hello, and welcome to BD's fourth fiscal quarter and full fiscal year 2015 earnings call. At the request of BD, today's call is being recorded.
It will be available for replay through November 11, 2015, on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls, and 404-537-3406 for international calls, using confirmation number 51724857.
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, Christy. Good morning, everyone, and thank you for joining us to review our fourth 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 fourth 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.
As a reminder, our fourth fiscal quarter results reflect the new BD, which includes the results of CareFusion for the full quarter. To provide additional visibility into the new BD, we will speak to our revenue results this morning on a comparable currency neutral base, which includes 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.
In addition, we would like to note a change in a distribution agreement effective in the fourth quarter of fiscal year 2015.
Fisher & Paykel terminated its agreement with CareFusion for the sale of F&P's hospital respiratory care products, which has an unfavorable impact to revenues of approximately $12 million in the fourth quarter of fiscal year 2015 and approximately $90 million in fiscal year 2016.
The fiscal year 2016 revenue guidance provided today will exclude the year-over-year impact of this contract. The impact to the bottom line is not material and is included in our EPS guidance. 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 and President of the Medical Segment; and Linda Tharby, Executive Vice President and President of the Life Sciences Segment.
It is now my pleasure to turn the call over to Vince..
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are very pleased with our results this quarter and our great finish to the year. Many of you already know that this was a unique year for BD in which we successfully completed the largest acquisition in the company's 118-year history.
The powerful combination of BD and CareFusion has already delivered measurable results, which we will speak to throughout this presentation.
As we continue to make progress with the integration of these two great companies, I've become increasingly confident in our ability to deliver end-to-end solutions that increase efficiencies, reduce medication errors, and improve patient safety in all healthcare settings.
Turning to slide 4, I'd like to highlight some key achievements in fiscal year 2015. First, our results reflect our consistent performance and the benefit of our diverse geographic and product portfolio, with revenues growing at 5.3% this year. Our core remains strong, and our product pipeline continues to drive growth across the portfolio.
Second, we moved into two highly strategic areas. Through the acquisition of CareFusion, we significantly expanded our presence and are now the global leader in a $20 billion medication management industry. We also entered into the high-growth area of genomics through our strategic acquisitions of Cellular Research and GenCell.
We believe that BD is well-positioned to add long-term value in these spaces by providing researchers and clinicians with leading technologies that are scalable, high-quality, efficient, and cost-effective. Third, we have continued to invest in higher-growth emerging markets.
Emerging markets grew over 9% this year and continued to be a key driver of growth for the company. We're also working to create new growth opportunities for CareFusion products in these markets and expanding their global reach by leveraging BD's international infrastructure.
We currently have numerous products in the registration process across multiple geographies. Fourth, we have continued to refine our operating effectiveness and efficiency initiatives, which have generated accelerated margin expansion.
Together with CareFusion, we drove approximately 100 basis points of underlying margin expansion year over year, which includes approximately $50 million in cost synergies, demonstrating our ability to deliver on our synergy capture commitments.
Our synergy cost savings have largely been driven by G&A, and we have already made good progress with our optimization of our manufacturing footprint, with six plant closures this fiscal year. Over the deal horizon, we have detailed plans to continue our plant network optimization and drive increased automation across the network.
Lastly, we completed our 43rd consecutive year of dividend increases, in addition to paying off the $1 billion term loan used to partially fund the acquisition, which highlights our effective deployment of capital. As we look back, we closed our first combined year with broad business strength.
We exceeded our financial and operating goals, and we are successfully executing on our acquisition of CareFusion. As we look forward, we will continue to build on our strong foundation, and our acquisition of CareFusion helps us significantly accelerate our ability to deliver effective healthcare solutions for customers around the world.
Moving to slide 5, you'll see the guidance for fiscal year 2016 on a currency-neutral basis. For fiscal year 2016, we expect currency-neutral revenue growth of 4.5% to 5%, based on our current view of the environment and various macroeconomic factors.
Of course, we have contemplated a number of items that could bring us above or below that range, including pricing, a stronger or weaker flu season than expected, the performance of new product launches, and emerging market growth. On the bottom line, we will continue to drive accretive, high-quality earnings growth.
For fiscal year 2016, we expect adjusted EPS of $8.73 to $8.80, currency-neutral. On a reported basis, we expect adjusted EPS of $8.37 to $8.44, while overcoming significant FX headwinds. This reflects operational accretion from the CareFusion acquisition of about 22%, an increase from our previously stated deal accretion target of high teens.
In addition, we are pleased to announce that we've increased our cost synergy target from $250 million to $325 million to $350 million as we exit fiscal year 2018.
Now I'd like to turn the call over to Chris, who will walk you through our financial performance in the fourth quarter and full year, along with additional details about our fiscal year 2016 guidance..
Thanks, Vince, and good morning, everyone. I'd like to begin by discussing our fourth quarter revenue and EPS results, as well as the key financial highlights for the quarter and total year. Total fourth quarter revenues of approximately $3.1 billion grew 49.1%, or 5.1% on a comparable basis.
Fully diluted adjusted earnings per share came in ahead of our expectations at $1.94, growing at 21.8% over the prior year. Top and bottom line growth was driven by broad-based overperformance versus our prior expectations from both the BD and CareFusion legacy businesses.
As Vince mentioned earlier, we are very pleased with our strong finish to the year as a combined entity. For the total year, revenues grew 5.3%. We significantly expanded our margins and captured approximately $50 million in synergy cost savings. EPS of $7.16 exceeded our expectations, driven by stronger revenues and margin expansion.
We were also pleased to announce that we have continued to deleverage as we reduce the debt associated with the acquisition of CareFusion. We have successfully paid off the $1 billion term loan facility and remain on track to achieve our commitment of 3 times gross debt leverage within 24 months of close.
On slide 8 I'll review our revenue growth by segment on a currency-neutral basis. Fourth quarter revenue growth was 5.1% for the total company. In the quarter, pricing was about flat on a legacy BD basis. BD Medical fourth quarter revenues increased 5.2%.
Medication and Procedural Solutions growth was 5%, which reflects strength in Flush, ChloraPrep, and safety-engineered products. Revenues in Medication Management Solutions, or MMS, grew 11.1%. This was driven by strong infusion capital installations, which can vary quarter to quarter, and disposables.
On the dispensing side, we continue to gain traction with the Pyxis ES platform, as we place focus on the continuous improvement of the installation process. Respiratory Solutions revenues declined 12.4%, as expected.
This reflects timing of orders that occurred in the third quarter, which negatively impacted the fourth quarter, the loss of the F&P distribution agreement, and the AVEA ship hold. After adjusting for these items, revenues would have been about flat. The AVEA ship hold has been released and we began shipping again last month.
Growth in Diabetes Care was 5.8%, driven by solid growth in pen needles. Pharmaceutical Systems growth of 9% reflects favorable timing of ordering patterns as expected, in conjunction with strong safety sales. For the total year, BD Medical grew 5.5%.
BD Life Sciences fourth quarter revenues increased 4.8%, primarily driven by growth in Diagnostic Systems and Preanalytical Systems. Diagnostic Systems growth of 5.9% reflects solid core microbiology growth driven by increased installations of our Kiestra Lab Automation system and continued core blood culture strength.
We saw continued strength on the BD MAX platform, which grew double digits in the quarter. Preanalytical Systems growth of 5.8% was driven by safety-engineered products and growth in emerging markets and Western Europe.
BD Biosciences growth of 2.2% reflects strong research instrument placements and reagent sales in the U.S., partially offset by delays in government funding in Japan and some operational management changes in Japan. For the total year, Life Sciences grew 5%.
Moving to slide 9, I'll walk you through our geographic revenues for the fourth quarter on a currency-neutral basis. U.S. growth was strong at 4.6%. This was comprised of BD Medical growing at 5.1% and BD Life Sciences growing at 3.3%. BD Medical's performance reflects broad portfolio strength, including Flush, ChloraPrep, and Infusion Systems.
BD Life Sciences growth reflects strong performance in the U.S. Biosciences business driven by research instrument and reagent sales. In our U.S. Diagnostics business, we saw continued growth in our BD MAX molecular platform, as well as seasonal distributor stocking related to the flu offset by continued declines in our ProbeTec/Viper platforms.
Moving on to International, revenues grew 5.5%. This is below our normal growth rate, which primarily reflects the aforementioned challenges in our Respiratory business and a moderation of growth in China in the fourth quarter. I'll provide more color on China in just a moment.
The Medical segment grew 5.4%, driven by strong performance in Pharmaceutical Systems and safety-engineered products. The Life Sciences segment grew 5.8%, which reflects strong growth in Diagnostic Systems, driven by solid performance in microbiology, including Kiestra installations.
Preanalytical Systems was driven by double-digit growth in emerging markets and strength in safety-engineered devices in Europe. On slide 10, emerging market revenues grew 5.9% currency-neutral, bringing our year-to-date growth to 9.2%.
The fourth quarter growth rate in emerging markets reflects a tough comparison to the prior year coupled with some moderation in China and Brazil. China growth for the fourth quarter was 8.5%, bringing the total year growth to 15.4%.
This was primarily due to longer purchasing cycles and softness in instrumentation sales, consistent with what we shared on our last earnings call. In addition, we took proactive steps to align inventories in our distribution channel. On an underlying basis, China grew about 12% in the quarter.
In Brazil, the challenges are largely macroeconomic, which we expect to continue into fiscal year 2016. Despite softness in Brazil, the rest of Latin America was strong, growing double-digits.
Looking into fiscal year 2016, we expect emerging markets to grow at about 10% driven by a diversified base, with China growing in the low to mid-teens, continued strength in Latin America outside of Brazil, fewer headwinds in EMA and strength in India.
With CareFusion revenues predominantly in developed markets, emerging markets will be a lower percentage of total company revenues on a combined basis at about 16%, with China accounting for about 5% of total revenues. Moving to global safety on slide 11, currency-neutral sales increased 8.2% and grew to $744 million in the quarter.
Safety revenues in the U.S. grew 4.4%, while international sales grew 13.4% currency neutral, with continued strength in Europe, which grew double-digits, as compliance with safety legislation continues. Safety revenues grew 10% in emerging markets.
Medical safety sales grew 9%, driven by a range of safety-engineered products, including infusion disposables, catheters and a range of products in Pharmaceutical Systems. Life Sciences safety sales, which are driven by our Preanalytical Systems unit, grew 6.8% in the quarter. Turning to slide 12 and our gross profit margin for the fourth quarter.
On a performance basis, margin expansion was driven by continuous improvement initiatives and favorable raw material prices. These contributions were slightly offset by higher pension expenses and other items. Currency had a positive impact on gross profit in the quarter.
This was driven by a translation adjustments recognized in the quarter due to the timing of inventory movements, otherwise known as profit and inventory.
In addition, our gross profit margin reflects the impact of a reclass from SSG&A to cost of goods sold associated with the alignment of accounting policies in connection with the acquisition integration. Slide 13 recaps the fourth quarter income statement and highlights our currency-neutral results.
Since we have already discussed revenue and gross profit, I'll move down the income statement to SSG&A. SSG&A as a percentage of revenue was 24.4%. We're very pleased with the leverage we're getting, which includes the benefit of cost synergy capture, as previously discussed.
R&D as a percentage of revenue was 6.4%, which is slightly higher than normal due to the timing of spend, as anticipated, while full-year R&D as a percentage of revenue was 6.1%. Operating income grew 52.3% in the quarter on revenue growth of 49.1%, reflecting strong P&L leverage as the new BD.
Our tax rate increased by 160 basis points, as expected, due to the inclusion of CareFusion's U.S.-based results. In the quarter, adjusted earnings per share were $1.94, which is a 21.8% increase versus the prior year. This reflects operating profit growth driven primarily by strong revenues and continued margin expansion.
Now turning to slide 15, I'd like to walk through our expected revenue guidance for the full fiscal year 2016. In summary, we expect revenue growth of 4.5% to 5% on a currency-neutral basis. This is comprised of legacy CareFusion growing at about 4% and legacy BD growing at about 5% on the top line.
This is very consistent with our long-term growth profile of BD growing midsingle digits and our objective of accelerating CareFusion's top line growth profile to reach BD's average over time. From a phasing perspective, we expect currency-neutral revenue growth in the first quarter to be well below this range.
This is primarily due to a tough comparison to the prior year period, in which legacy CareFusion grew 9.9% and legacy BD grew 5.3%. This will result in currency-neutral revenue growth of about 1% to 2% in the first fiscal quarter.
After adjusting for the tough comparison, as well as the loss of F&P, growth would be roughly in line with revenue guidance for the total year. On a reported basis, revenue growth for the total year is expected to be between 23% and 23.5%, reflecting a currency headwind of about 150 basis points. This assumes a euro-to-dollar exchange rate of $1.13.
The depreciation of Brazilian real year over year, as well as other currencies, such as the euro and the Canadian dollar, results in a significant impact to our performance. We expect this unfavorable impact to be the most acute in the first quarter, with a headwind of approximately 450 basis points.
We expect the currency impact to moderate through the rest of the year. We expect growth in both BD Medical and BD Life Sciences of 4.5% to 5%, driven by continued growth in the core in conjunction with new products in both segments. BD Medical growth will be driven by dispensing, pen needles, and infusion infection prevention relatable disposables.
Life Sciences anticipates continued growth in biosciences instruments and reagents, microbiology, including expansion of the KIESTRA platform, as well as growth in molecular driven by BD MAX. Both segments expect continued growth of safety-engineered devices and solid growth in both developed and emerging markets.
Based on our current view of the environment, we expect pricing to be flat to slightly negative for the year. Moving on to slide 16, there are a number of moving parts that impact earnings per share in fiscal year 2016. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance.
First, we are very pleased with the strong performance from legacy BD, growing 9% to 10% on an underlying basis. In addition, we now expect to deliver a significantly lower tax rate, which results in 3 percentage points of improvement to the bottom line.
We're particularly pleased with our execution on operational synergies and expect to outperform our high teens target by driving accretion of 22%. As Vince mentioned earlier, we have also increased our cost synergy target to a range of $325 million to $350 million over the deal horizon.
As a result, we expect to achieve very strong earnings of $8.73 to $8.80. This enables to us overcome an unfavorable impact from pension expense and a significant headwind from foreign exchange. We expect to deliver adjusted earnings per share of $8.37 to $8.44 for fiscal year 2016.
Turning to slide 17, I'd like to walk through additional elements of our guidance for the full fiscal year 2016. But first I'd like to make some comments on the phasing of earnings. Similar to revenue, the impact of unfavorable currency will be most acute in the first quarter, and we expect EPS to be between $1.80 and $1.85.
This reflects a currency headwind of approximately 1,500 basis points and a euro-to-dollar exchange rate of $1.13 versus $1.26 when compared with the prior-year period. In addition, the Brazilian real has declined 55%, and the Canadian dollar has declined 15%.
Moving on to the total year guidance, we have provided comparable fiscal year 2015 results, which include BD and CareFusion for the full year. We expect gross profit margin to be between 52% and 52.5%. Performance improvements are partially offset by negative currency translation and pension.
SSG&A as a percentage of sales is expected to be between 24.5% and 25%. Our guidance also reflects continued investments in emerging markets, as well as costs related to new product launches and registration cost.
We expect our R&D investment to be in line with fiscal year 2015, at about 6% of revenues, as we continue to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 21% and 22% of revenues.
Excluding the unfavorable impact of foreign currency, we expect our underlying operating margin to improve by 130 to 150 basis points. This also excludes slight pension headwinds. We expect our tax rate to be between 21.5% and 22.5%. For fiscal year 2016, we anticipate our average fully diluted share count to be approximately 217 million.
Cash flow is expected to remain strong, with operating cash flow of about $2.6 billion in fiscal year 2016. Capital expenditures are expected to be about $650 million to $700 million. In summary, we have strong momentum exiting fiscal year 2015. And looking forward into 2016, we are building off of a very solid foundation.
Our core remains strong, and we've moved into new adjacencies. We're outperforming on our synergy and accretion targets, as well as delivering earlier tax efficiencies.
As we continue to execute and deliver on the factors that are under our control, I'm confident that fiscal year 2016 will be another year of strong performance, positioning us well for continued success. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio..
Thank you, Chris. Moving on to slide 19, we have been discussing our pipeline for some time now, and in fiscal year 2015, there were a number of product launches. I'll not review them in detail, but they are highlighted on slide 19.
We're committed to the successful ramp up of these products while we also look to the future and continue to expand our portfolio. Moving on to slide 20, we have some new product launches that we would like to share with you.
In BD Medical, we continue to make progress with our insulin infusion sets, with an expected product launch in the middle of the fiscal year 2016.
This product will improve the consistency of insulin delivery by significantly reducing silent occlusions, simplify the user's experience, and increase a patient's overall satisfaction with insulin pumping. Also launching in 2016 is the new Pyxis Mini tabletop medication management platform.
This is a unique system that supports customer needs in non-acute care settings, such as ambulatory care centers, long-term care, and surgery centers. Leveraging the Pyxis ES platform, the Pyxis Mini extends the value of the ES server and the hospital's IT infrastructure by providing safe and secure medication management.
We look forward to sharing further details on the newly combined Medical Segment with new product portfolio launches later in fiscal year 2016. While there has been a strong focus on the Medical Segment due to the CareFusion acquisition, I'd like to note that our Life Sciences Segment remains an important growth driver for BD.
It was an exciting year for BD Biosciences, which includes our new genomics business. In fourth quarter we acquired Cellular Research and launched the BD FACSseq, a high-throughput cell sorter which targets solving significant unmet needs in single cell analysis.
The combination of Cellular Research's molecular indexing technology paired with cell sorting allows researchers to choose which cells to study and enables the correlation of cell surface markers with genetic data. The combination is intended to enable a more simplified workflow, time reduction to isolate cells, and all of this with higher accuracy.
Also in the fourth quarter we launched the new X-50 research flow cytometer. The X-50 represents a significant advancement in technology, enabling simultaneous measurement of up to 50 unique characteristics at the single cell level.
The X-50 single cell analyzer enables superior resolution of rare cell populations, providing richer scientific insights to advance the understanding of human disease and intervention strategies. In fiscal year 2016, we expect to launch our GenCell library preparation system.
This platform will consolidate and automate NGS library preparation workflow at a reduced total cost position. In our Diagnostic Systems business, we anticipate launching four new assays in the next year, including CT/GC and vaginitis, as we continue to drive menu expansion on the BD MAX platform.
We're also on track with our launch of the next-generation Veritor point-of-care instrument, which incorporates smart features to enable connectivity. In our Preanalytical Systems business, we anticipate launching two new products during 2016.
The UltraTouch push-button blood collection sets will deliver significant improvements in patient outcomes for patients with challenging venous access. The BD Barricor tubes are an innovative technology which will enhance sample quality as well as lab turnaround time.
As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you as we make progress throughout the year. On slide 21, before we conclude and open the call to questions, I would like to take a moment to discuss a leadership change within the organization.
BD announced this morning that, after 41 years of outstanding service to BD, Bill Kozy, EVP and Chief Operating Officer, has decided to retire effective April 1, 2016. Bill has had an exemplary career at BD, and his accomplishments are too numerous to mention them all.
As we all know, he has spent the past year leading the successful integration of CareFusion and BD. While we believe this process is well under way, and Bill will stay on until March to ensure a successful transition of these duties to Chris Reidy, who will lead the current integration team.
I would like to make a special mention of Bill's relentless commitment to operational excellence to our customers and to our associates. They are highly valued and have made a tremendous difference for all of us and for the company. We would like to express our sincere gratitude and also congratulate him on reaching this milestone.
Now, I'd like to reiterate the key messages from our presentation today. First, this was a pivotal year for BD in history, and we are pleased with our strong results.
We've exceeded our financial and operational goals for this year, and our increased synergy and accretion targets are evidence that we are successfully executing on our acquisition of CareFusion. Second, our core remains strong. Our investments drive robust revenue growth of 5.3%, and we continue to deliver high-quality double digit earnings growth.
We expect to deliver a similar growth profile in fiscal year 2016, with top line growth of 4.5% to 5% and earnings accretion of about 22%. We are pleased with our financial performance, and we continue to deliver and believe we have built a strong foundation for future growth.
Third, we expanded into new areas of medication management and entered the genomic market. We're excited about the value that CareFusion brings to BD and our customers as we execute our medication management strategy.
We're also very pleased with the progress we've made in Life Sciences with our acquisition of GenCell and Cellular Research, which underscore BD's commitment to drive value through our genomic strategy. Finally, I would like to say thank you to all of our associates around the world.
It's a testament to the hard work of the BD and CareFusion employees that we are here today, with what I believe is a tremendous opportunity to create a true industry leader. As we embark on this next phase of growth, I look to the future with enthusiasm and confidence. Thank you. We will now open the call to questions..
Thank you. The floor is now open for questions. Thank you. Our first question is coming from David Roman of Goldman Sachs..
Thank you. And good morning, everybody. Hopefully I can just sneak two in here along the same lines. Vince, maybe you could just start with the pipeline. The list of products that you're laying out for FY 2016 is probably one of the deeper pipeline benches that you've presented in some time.
Can you maybe help you think about the contribution from that pipeline and how that squares with the growth rates that you're presenting here in your guidance? Because it would seem like, given that breadth of product launches, we would see an acceleration in the base business.
So can you maybe help us think about some of the gives and takes with respect to product launches versus the performance of the base business?.
Yeah, David, we feel really good about the guidance that we have given on revenue, the 4.5% to 5%. And you are right. There is a strong breadth of products across the entire portfolio.
I think the one business you might have noticed in the guidance that we hadn't talked about before was PAS, with the new launches of the Barricor tube in there and the new push-button product.
But I think what you haven't taken into account is it's just going to take a while to ramp up those new products as we get the automated manufacturing in place. So not as much of an impact that would take us above the range. Now, if they go faster, as I said in my remarks, okay, there's some potential upside.
And I'm not just talking about the PAS products, but the Pyxis Mini and others, the infusion sets, which is in a similar situation. So I think across the board we're feeling good. We're feeling good about the base business as well.
There's little puts and takes, as I mentioned, from a geographic standpoint, but we're still going to get about 10% in terms of emerging markets. So when we put all of that together, we're saying, look, developed world up a little bit, emerging markets still a strong growth driver. And when you put it all back together, it gets you to the 4.5% to 5%.
So anyway, that was your first question?.
Yeah, then the second was just on emerging markets. In your prepared remarks, you talked about product registrations on the CareFusion side.
Can you maybe just walk us through the steps and timeline associated with product registration to commercialization and then financial impact, just to maybe frame up how we should think about the progression of that opportunity on a go-forward basis?.
Yeah, sure. Tom Polen will do that for you..
Hey, David. This is Tom. So, as we've discussed in the past, we are pursuing a number of opportunities for revenue synergies in the combined portfolio. We have begun investment work on those registrations and actually submitted several dozen registrations in FY 2015. Of course, that process does take some time.
And as I've said in the past, we expect it to take about two years to start seeing the benefits of those pull through in sales. So more of an FY 2017 effect than a 2016, and that's right in line with what we've said since the deal announcement..
Yeah, and we really haven't changed our view on the revenue synergies from the start of all of this. The geographies may have moved around a little bit, but in total, it's looking like the same opportunity..
Thank you. Your next question is coming from David Lewis with Morgan Stanley..
Good morning..
Good morning, David..
Chris, just one quick question on first quarter guidance and then I had another question for you on tax rate and synergy, if I could. So just on first quarter guidance, just reviewing, the 1% to 2% constant currency.
I'm assuming that just reflects CareFusion numbers year on year, which were, I don't know, 11% in dispensing and 8% in Procedural Solutions, so an unexpected CareFusion quarter.
Is there anything else going on in the first quarter we should be aware of besides that harder comp?.
Yep, you got that piece right in terms of infusion. So, as we pointed to, the overall CareFusion was 9.9%. If you remember, that was a quarter that was their closing quarter, so that comes into play. You also got the F&P contract loss that we talked about.
And then on the legacy BD side, we have the normal pharmaceutical sales, timing of orders, and so that tends to be weaker in the first quarter. And then last year you had Diagnostic Systems with a strong flu season. We're just calling a normal flu season this year.
So that could vary, but you put all of those things together and it makes for a tough comp in the first quarter..
Okay. And then maybe two questions about the long-term outlook. One on tax. You signaled the tax rate continuing to move down maybe to the upper teens over time, but the 2016 guidance is coming in stronger than we expected.
So do you have greater tax opportunities before 2018 than you thought and can we get down to upper teens maybe quicker than we thought? And then on synergies, just help me understand with the 30% raise, what are the principal drivers, and what's the pacing of synergies across these three years, and any update on revenue synergies? Thank you..
Okay. That's about four questions, David, but they're all good ones. So on the tax, I think we've said from the beginning that we do expect to get tax synergies, but we thought that when you put two big companies like ours together, it'll take a while to get those structures in place and see through that.
We've done a lot of that work and we do see those synergies coming sooner than expected and so you're seeing that in 2016. We do say that ultimately we want to be at the high teens, which is where we've been driving for a number of years. But I wouldn't say past 2016, 2016's in that 21.5% to 22.5% range.
After that, I wouldn't ramp it much more than 50 basis points a year after that. We'll provide more insight into that going forward, obviously. But that wouldn't get you down to the high teens by 2018.
So I wouldn't say it's an acceleration of the ramp to the high teens, but we are getting it earlier than we had originally anticipated and it's showing up in 2016. In terms of the synergies, what's driving the increase from $250 million to $325 million and $350 million is, as we've been saying all along, we needed to see some traction.
Initially, you get out-of-the-box synergies early on, so a reduction of public company costs. And we had good visibility to that.
What we needed to see is visibility to the next wave, which is things like IT synergies, putting the combination of the two companies together and getting system synergies and system synergies throughout all of the functions. And so we've now seen some of that traction. We've also even seen some traction in the manufacturing area.
As we mentioned in the remarks, we've had six plant closures. So we've started to see some visibility and traction along those lines and that's what gives us the confidence to raise it to the $325 million to $350 million. Now, in terms of the timing that you talked about, we mentioned that we had about $50 million in the first six months.
We see that turning into about $100 million for next year on a full-year basis. Then you get about an extra $40 million incremental and that turns into a full-year impact the following year of $80 million.
We see the about $40 million incremental kind of ratably over the next couple years, and if you roll it out that way, you get to the $325 million to $350 million..
Thanks a lot, David..
Your next question comes from Mike Weinstein of JPMorgan..
Hi, this is actually Robbie Marcus in for Mike. I was wondering if you could talk a little more about your 10% growth target for emerging markets and how you see that rebounding off fourth quarter, particularly in China and Latin America.
And then also, if you don't mind touching on hospital budgets for 2016, given how poorly some of the facility reports have been lately, and what you're considering in your guidance for budgets next year. Thanks..
Well, I think you're talking about the U.S. from a hospital budgeting standpoint, and we're assuming pretty much status quo in terms of the U.S. marketplace. Not a lot of improvement, but continued, consistent demand. And we feel good about where we are from a capital standpoint and the backlog that we have. So I think we're in good shape there.
In terms of emerging markets, as we mentioned in the quarter, in China we did some proactive work with the distributor community. Remember, we don't give credit to the distributors. So we want to make sure we had the right amount of inventory, and so we've completed that work. So underlying growth I think was closer to 11% in the quarter for China..
Actually 12%..
12% Excuse me, 12%. And so we see China continuing to grow in the low teens. And of course it's become quite large at this point in time. It's about 5% of BD's sales. We expect India to do well, and we saw good performance this year in India.
If you look at Latin America, Latin America did well, with the exception of Brazil, and we continue to expect weakness in Brazil this year, but the rest of Latin America has grown quite nicely, and so we're getting good growth out of that. We think EMA is going to be okay as we move forward. And we're projecting Russia to be soft.
And when you add all of that up, you get to our guidance..
Thank you. Your next question comes from Kristen Stewart of Deutsche Bank..
Hi, thanks for taking the question. I was just wondering if you could I guess talk to the longer-term outlook. I know when you originally did the CareFusion deal, you had talked about CareFusion being about a 3%, maybe 4% growth company.
Sounds like it's coming in a little bit better with the cost synergies, talking about like bottom line growth being more around that 10%. It sounds like things are going better on the cost synergies. Certainly the legacy BD business is doing much better.
How should we just think about sustaining the growth? Would you let the higher cost synergies kind of flow through? Would you think about reinvesting those? Or just looking to do more acquisitions to kind of further fuel the top line growth?.
Well, let me start on the top line. And if I go back to the beginning, what we said was that CareFusion was about a 3.5% grower. BD was growing at about 5%, and our long-term goal was to get CareFusion up to about the 5%.
And that would come through both the geographic expansion and new product opportunity as we synergized with CareFusion across the medication management process. And that is still the strategy. And you're right, the base business in both CareFusion and BD is performing well. And we had a strong quarter.
It was about 4% underlying, I think Tom was trying to tell me..
Correct. And we expect CareFusion, like you said, historically, about 3.5%. We expect them to be about 4% in 2016..
Right, this year. Yes. 4% this year. Long term, we'd like to get them to 5% is what we said..
Right..
That is still our goal, and we still have work to do to get there. But we are pleased at where we are at. Now, in terms of letting this all – how we think about this, Chris has laid out what the financial characteristics are going to be for the next couple years. What Chris has said in the long term was 5% and 10%. And we haven't come off that.
Chris may want to add some color to that, but that implies that we will be investing for the future and also returning value to the shareholders. So, Chris, I don't know if you want to add anything to that..
Right, so the only other thing I would add is, as you think about 2017 and 2018, you have that base model of 5% on the top and 10% on the bottom, but then you do get some incremental pickup from the synergies. And as I answered earlier, we see that incremental amount per year to be about $40 million, then annualizing it for the following year.
And so if you run that math, you pick up a couple of percentage points on the bottom, on top of that 10%. So that's the way to think about it..
Yeah..
Okay.
So you'd be inclined to let that fall through to the bottom line for shareholders and then kind of think about it growing more traditionally 5% to 10%, 5% and 10% thereafter?.
Yeah, I think once you get out and you're past the synergies, you kind of go back to that base model..
Past 2018..
Yeah, past 2018..
Okay, perfect.
And then just on BD Simplist, are we getting to the point where that's sort of breakeven, or is that still dilutive overall to the P&L?.
BD Simplist is still dilutive at this point in time. It did grow. It's still not all that big. We still haven't gotten the approvals on the two drugs that we have been talking about for some time.
Tom, is there any update on those two drugs in the pipeline?.
Hi, Kristen, this is Tom..
Hey, Tom..
I think as we've shared in the past, we've been realigning our portfolio. We are on track for the next two launches in the high-alert drugs; hydromorphone and heparin we do expect to launch in FY 2016.
And so as we add those to morphine, which is our current high-risk drug that's doing very well in the marketplace, we expect those sales to continue to accelerate, so..
Okay, Kristen, thanks for the questions..
Thank you. Your next question comes from Brian Weinstein with William Blair..
Hi, guys, thanks for taking the question. Maybe a question for you on genomics in general.
Can you kind of just talk about what the longer-term plan is here? Are you looking to add additional assets? Or are you looking to add things in things like bioinformatics or kind go deeper in next-gen sequencing? Just talk about what the overall strategy looks like in genomics at this point. Thanks..
Hi, Brian, this is Linda. So, over the long term, we're focused on building a leading genomics position in next-generation sequencing, from sample preparation to sample collection to sequencer ready. So it'll be platforms that are ubiquitous and can be used with any next-generation sequencer.
So today those platforms involve our PAXgene sample collection and stabilization products. They involve our library preparation platforms from GenCell, and of course now the combination of our BD flow cytometry with Cellular Research's molecular indexing technology.
So all of these in combination, again, we think we will have technologies that allow researchers and clinicians as we move to the clinic, more scalable, high-quality, efficient, and cost-effective. So you'll see us continue to build franchises in that whole upfront sample collection process..
So, Brian, certainly we will continue to look for assets in the space. We're very excited about the Cellular Research deal that we just concluded, because we think it is such a great fit with the flow cytometry business, and really does give researchers a new process and a better way of understanding cells.
I mentioned in my remarks, you can look at the cell surface markers and you can look at the DNA. And this is where we're really enabling that for the first time. So it's pretty exciting. So Linda will continue to build that business. Thanks for your question, Brian..
Thank you. Your next question comes from Bill Quirk with Piper Jaffray..
Great, thanks. Good morning, everyone..
Good morning..
A couple questions. First off, Chris, the reclass from SSG&A to cost of goods. Should we think about that as a recurring charge, or is this more one-time in nature? And then, secondly, I guess, kind of question on the pricing assumption, the flat to slightly negative for the coming year.
I guess could you give us a little more color into some of the underlying assumptions there, given that it generally kind of outperformed on an incremental basis this year? Thanks..
Sure. So, the accounting adjustment. There's nothing unusual; when you put two companies together, you do see sometimes a difference in the way certain expenses are accounted for. So the adjustment kind of brought costs from SSG&A, mostly related to things like quality and up into cost of goods sold.
So it doesn't affect the bottom line, it's just within the P&L itself. When you look at our chart 17 and we talk about the guidance, we've kind of done the comparable basis for you. So there's two things going on when we adjust for comparable basis. One is these accounting adjustments. The other is the fact that CareFusion had a half a year before us.
So their percentages were different. So we wanted to put it on an apples-to-apples basis, and chart 17 does that. So if you look at, for example, SSG&A or gross profit on chart 17, what we're showing in 2015 actual on a comparable basis is equivalent on an apples-to-apples basis with our 2016 guidance. I forgot what your second question was..
Second question was -.
Oh, pricing. Pricing, I'm sorry..
That's all right..
So pricing, the way to think about that is over the last couple of years, essentially pricing has been relatively flat. Last year it was down slightly in 2014. This year, it's relatively flat. And so that's really indicative of the guidance that we're going forward with. Flat to slightly down.
So it's very consistent with what we've seen over the last two years..
Thank you. Your next question is coming from Doug Schenkel of Cowen & Company..
Hi, good morning. Just a couple of quick questions. First on R&D, R&D spend increased notably sequentially, and on an absolute and percentage of sales basis.
Would you be willing to share if there are areas where you are proportionally directing more money that we should be thinking about as we look forward and how we think about this in the context of you driving synergies over the next few years? And then my second question is really a – I guess, really just clarification on guidance.
Why did you assume $1.13 versus the current spot rate of $1.09 for the euro, and would you be willing to quantify what the assumption is for new product contributions that are factored into revenue growth? Thank you.
Yeah, Doug, first, this is Vince. Listen, in terms of R&D, there's nothing unusual going on in R&D at all. We're not shifting funding or anything, and we haven't changed our outlook in terms of 6% of sales. So there's just some timing going on in projects. So nothing to really report there.
And, Chris, on the $1.13?.
Yeah, the $1.13 is the last-30-day average; it's actually the last-90-day average, too. The euro was at $1.13 about 10 days ago. So there's been a lot of volatility. We've set our budget up at the $1.13.
What I would point to, the fact that as we look forward, the euro really had a big impact in the current year, going from the $1.26, for example, in the first quarter, down to $1.13. And that was the biggest impact on FX in the current year.
As we look forward to next year, that $1.16 down to the low $1.10 to $1.13 is much less of an impact going forward than some of the other currencies that we pointed to. So if you looked at our prepared remarks, we point to things like the Brazilian real, as well as the Canadian dollar. Those are huge drivers going forward into the 2016 guidance.
We did decide we didn't want to mark-to-market, for example, on a euro basis, and we're comfortable with the guidance we gave, given the full basket of FX currencies..
Thanks, guys..
Thanks. Your next question is coming from Rick Weiss of Stifel..
Good morning, Vince. A couple questions. First, just a general question. Vince, you said early on in your comments that you're increasingly confident about delivering end-to-end solutions.
Just curious, what's that mean exactly? What's giving you more confidence? Are you seeing larger contract system wins? Is that what's driving that statement, or just how do we think about that?.
Okay, so if I start on the Medication Management side of things, as we have proceeded with the integration, including the product lines, the work that Tom and his team have done with Cato and CRISI is actually expanding the solution set there, and that seems to be well-received by the customer base.
I mentioned also in my prepared remarks that the Pyxis Mini, we're in the process of launching that. And we see that as very important as integrated delivery networks start to think about how they coordinate care across the entire network. So we see ourselves doing quite well from a product standpoint to support that solution going forward.
And the more conversations Tom and I have with the customer base, that seems to be the right strategy. So that was the reason behind my remark on the Medication side. On the Diagnostics and Life Science side of the business, Linda can speak to this a little bit more, I'll ask her to in a second.
But the ramp-up that we are seeing in Kiestra is quite strong. And so a full automation solution on the microbiology side is really coming along, and we've also added to that with Bruker. So, Linda, you might want to mention how we did with Kiestra, especially in the U.S. this year, and how that's ramping..
Sure. Thanks. So as Vince mentioned a total solution. And if you look at the microbiology lab today, many of the labs look like they looked 50 years ago. So the opportunity with Kiestra and the opportunity to automate that lab from sample in to full now with our connectivity to MALDI's ID system, and our AST solution, you really see a full solution.
So we saw great traction. One of our key growth drivers in the fourth quarter was BD Kiestra. Great traction in Western Europe, but also and very exciting for us is traction we're seeing in now China, Saudi Arabia, Japan, South Africa. And we ended the year with a significant number of new orders for the U.S. market.
So this really is a tremendous opportunity for us.
And then just maybe one other solution I'll speak about on the Life Sciences side, a great growth driver for us with some research and the research market is the high-parameter research solution that we're offering now in combination with our high-parameter flow cytometers, with our X-30 and X-50, but also our Sirigen platform, so really enabling activity at the cell level an understanding that that has never existed before..
So, Rick, just to add to that and take it up to a different level here, at the 50,000-foot level, the informatics capability as we understand it now and the way we can leverage that capability across the company, not just on the Medication Management side, but we believe also into the Life Science side, we think is going to be a real enabler of solutions going forward.
Now, we're not going to get into detail about that today, but as we evolve that strategy, that's something we'll be talking to you about as we go forward..
Thank you. Your next question comes from Matt Taylor of Barclays bank..
Hi. Thanks for taking the question. I wanted just to delve into a couple things a little bit deeper that you hadn't talked about earlier on the call. One, I think people definitely focus on emerging markets. And I know you talked a little bit about macro in Brazil.
I guess I want to understand what are the macro factors that you're talking about? Is it currency? Are you seeing flagging demand? Could you characterize that a little bit more in more detail? And then I guess in terms of your EM sales, can you talk a little bit about just visibility in terms of working with distributor partners and how you're able to really see the end market demand versus what you're selling into?.
Sure. So in terms of Brazil, what we were referring to really is the timing of tenders in Brazil. So that's related to government funding and how aggressively they ramp that up. And so we generally have a good sense of what the timing of those tenders would be as we put together our budget.
And so my remarks reflected that knowledge base from the team down in Brazil and also what they're seeing in the other countries in Latin America, where they see government funding continuing to ramp up and a continued build of those systems. And so that's the macroeconomic factors that I'm talking about. It's mostly government funding.
Now, if you go over to China, it's a situation where the government is continuing to build out the healthcare system. It is growing somewhat slower, a couple percentage points slower, than it was in the past. And we've reflected that our guidance.
It also reflects what we mentioned last quarter and this quarter, which was a slowdown of action on diagnostic instrumentation tenders. And that is driven by a desire of the hospitals not to get audited as part of the anticorruption process that's going on there. Doesn't mean the hospital did anything wrong.
It's an added burden on the hospital, and if they can avoid that in the short run, they would like to do that. We've taken all that into account as we guide. Now, in terms of working with our distributors, we work with them very closely on what their inventory levels are. We have our own sales force calling on the accounts.
So we have a view to the pipeline. We do not leave that to the distribution community. So those are the factors that we look at as we take this all into account..
I would just add that we feel real good about the China growth. If you look at this year over 15% and next year low to mid-teens, that's really strong growth, continues to be strong growth and outpaces our peers from a growth standpoint..
Yeah, we continue to out-index our peers in emerging markets by a substantial amount, too. And of course it's become so big, even though, if you take something like China, where the growth rate has come down, the actual absolute number is still about where it was. So it's still a big impact and a big growth driver.
And if I look out over the long term, we still see a very long ramp there..
Thank you. Your next question comes from Derik De Bruin of Bank of America..
Hi. Hello. Good morning..
Good morning..
This is (1:02:18) filling in for Derik. I had a couple of questions quick. I was wondering if you could provide a little bit more color on the Diagnostic volumes outside of the United States and competition in Dx in general and also if you could quantify your revenue exposure to Brazil..
Well, we haven't broken out Brazil any time in the past, so I don't think we will do that. All I would say is, as I was mentioning, that we've taken that softness into account and that the rest of Latin America has become a much bigger piece of Latin America.
Chris, anything you can add to that?.
Just to put it in perspective, though, if you look at China, one thing we have said is a 2% decline in China, for example, in their growth rate is only worth a 0.1 point of growth on the BD level. And Brazil is much smaller than China. So just to put things in perspective..
That's good.
Linda, why don't you talk about Diagnostics?.
Yeah, just in terms of overall Diagnostic volumes in emerging markets, we continue to see strong growth in those areas, driven primarily by our BACTEC business, SurePath. We also see strong double digit growth in TB. So continuing to see increases in rollout of our platforms in all of our emerging markets..
Thank you. Your next question is coming from Vijay Kumar with Evercore ISI..
Hey, guys. Congrats on a nice quarter. So maybe a first question on the guidance. So if I look at the operating margin improvements, at the midpoint it looks like about 50 bps. So that's about a $65 million uplift to your EBITDA. You had legacy, as a standalone BDX, you had margin improvements.
And I think CFN, they had their annual margin improvement targets. So I'm just trying to think – and plus, you add in about the synergies, it feels like at the midpoint, it should be slightly better, the absolute dollar increase in EBITDA. So I'm wondering if you could sort of help us walk through? Especially given that pricing is kind of flattish..
Yeah, so just – there's a lot of ins and outs because of the fact that CareFusion had lower operating margins for the first half of last year. And so if you look at that, we're giving guidance of 21% to 22% versus the 20.7% last year. That's about 130 to 150 basis points of underlying growth, and we mentioned that in the script.
And you have about 40 basis points of FX headwinds in there. So we feel good about the fact that we're driving that operating margin improvement, both next year and gross profit. So you can see that we're up year over year on the GP line. Again, overcoming about 40 basis points of FX.
So about 50 basis points of improvement operationally, and we're continuing the SSG&A performance with another 30 to 40 basis points of operating margin improvement. Now, if you look at SSG&A, if you went back to a combined basis in 2014, you're looking at like 25.7% of revenue. And we're now looking at that down over 100 basis points.
So we obviously got a lot of synergies in year on the SSG&A line, and we're doing better on top of that going into next year. So the combination of all of those things point to the increase that we had. And if you look back at the chart that we had, chart 16, you can see that the accretion we talked about being 22% versus the high teens.
But the thing that I would point to is that, excluding FX, we're driving $8.73 to $8.80 in terms of EPS on an FXN, neutral, basis. So really doing extremely well on the operation accretion. We've got the tax rate efficiencies kicking in and overcoming that FX headwinds, which are significant with about 5% headwinds from FX..
Thanks, Chris. So just one quick follow-up on the synergies. Raised their total targets to $3.25 to $3.50. Does that include I guess – legacy CF, then, had about 100 bips of annual expansion. Does that include or exclude – which was about $75 million by my math over a three-year period. And, I guess, Bill Kozy, congratulations to you.
A long, successful career. And he was leading the charge on the integrations, and now with him sort of in there transitioning, I'm curious who's going to lead the integration now..
So as Vince said, that would be me. And I've been working hand in hand with Bill over the last year. And now we're down to the execution phases, as we said.
We've seen those synergies, the traction on those, our ability to use shared service centers, some of the end-to-end process improvements that we have, some of the plans that we have in place on manufacturing. So those are well under way, and hopefully in good hands as Bill retires. So we feel real good about our look forward.
In terms of your math, Chris, he was asking about the 100 basis points that CareFusion had in their plan..
Oh, sure. So, as we've said from the beginning, Vijay, that our synergies are truly incremental. So you can see what we did on slide 16, that those synergies are on top of the 9% to 10% that we would've normally driven on the BD side.
And as we said from the beginning, CareFusion had indicated operating margin improvements that we haircutted from 100 to down to about 70 basis points. And what we're driving in these $3.25 to $3.50 are on top of those underlying improvements that they would have done on their own anyway. And so it really, truly is incremental..
So, Vijay, just one other point on the integration. So think about as Bill transitions, Bill is transitioning the manufacturing operations side. He's been working with Steve Sichak, of course, who runs all the reloco and all that. Success is getting it into that process, getting it into the business, and executing on it.
And what we were indicating is we're already doing that with the six plants that we started. So we put it into our normal process. The other big bucket is the G&A side, and of course who's been driving that but Chris. So we're well aligned on this. Bill has done just an absolutely fantastic job.
And I can tell you, he won't go out the door until he gets this thing buttoned up, because that's just his nature. But, anyway, thanks for the question..
Thank you. Today's final question is coming from the line of Jon Groberg of UBS..
Hi, good morning. This is actually Harris on behalf of Jon. Appreciate the question.
So first one, can you talk about the impact of recent initiatives to accelerate the Pyxis installation process? I think – I know you mentioned recently putting into place the Lean Six Sigma team, so maybe any update on the impact of these moves and how backlog is now trending?.
Yeah, sure, Tom Polen can take that as soon as he turns on his mic..
Hi, Harris, this is Tom. So, as we have discussed, as you said, we've been working on the process improvements. We're quite pleased at the progress that we've been making there. We are seeing that process improve over the last six months in particular.
And so we still have more work to do, but we have been applying some of our operational systems and Lean approaches to make that better. And we will be continuing that over the balance of FY 2016. What I would say, as well, is that while we're improving the installation process, we are continuing to see very strong demand for customers for ES.
So we do not expect any change in that going forward..
Thank you. I would now like to turn to floor back over to Vince Forlenza for any closing remarks..
Yeah. So I would like to thank all of you for your participation today on the call. I look forward to reporting on FY 2016. And, once again, I would like to thank all of the BD associates around the globe for their tremendous work in 2015. Thanks very much..
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day..