Fresenius Medical Care AG & Co. KGaA (FMS) Q2 2016 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. I'm Patrick Wright, your Chorus Call operator. Welcome and thank you for joining the Fresenius Medical Care Earnings Call on the Second Quarter 2016. [Operator Instructions]. I would now like to turn the conference over to Oliver Maier, Head of Investor Relations. Please go ahead, sir.

Great, thank you very much, Patrick, much appreciated. We would like to welcome all of you on the call to the Fresenius Medical Care earnings call for the second quarter and half-year of 2016. As always, I would like to start our call by mentioning our cautionary language that is actually in our Safe Harbor statement as well as in our presentation and all the material that we distributed or provided today. For further details, please refer to these filings. With us today is Rice Powell, our CEO and Chairman and Rice will give you a general business update and go through some of the highlights of the quarter and he indicated to me he is going to be very quick today. And also we have with us Mike Brosnan, our Chief Financial Officer, who will cover with you the financials and the outlook in a bit more detail. So that's it from my end, Rice, the floor is yours.

Thank you, Oliver. Welcome, everyone. We're delighted to have you joining us today as we talk about our Q2 earnings. I think our headline is as it was written on our press release, we've accelerated our earnings growth, Q2 has been a very, very strong quarter for us. As I typically do, you see the numbers on the right side of page number 5, slide 5, I will take you through those, you had a chance to look at those over the course of number of hours since last night. But I would say that our solid revenue growth is driven by good results in the health care services business. North America is continuing to operate at an excellent level, they generated 72% of the revenue and 69% of the operating earnings. I know many of you will ask, so I will go ahead and tell you now, on the MACRA conversion, we closed Q2 with somewhere around 130,000 to 131,000 patients with multiple doses. I do my math right, I think that puts us somewhere in the low 80% range of conversion. And we've pretty much accomplished what we set out to do, there will be some movement in future quarters, a little bit here and there, but by and large, we've accomplished what we set out to do over a year or so ago. Our Care Coordination continues to show good top line growth, we'll talk some more about that later in the presentation, I'm sure. We have launched a new machine, our 6008. It was launched at EDTA, happy to take questions on that later on today if you like. And we've hit a milestone and that milestone is for the first time we're providing dialysis services to more than 300,000 patients worldwide. I think somewhere around 301,000 plus. And we're on track to achieve our full year guidance, Mike would be happy to give you some more color on that in a couple of more slides. If we turn to slide 2, let's focus our attention on the solid revenue development in all of the segments. I would say rather than going through each figure, I'm just going to give you in broad terms, North America a good 8% revenue growth, strong organic growth at 3%, approximately $3.2 billion in the quarter. You can see Asia just shy of $400 million in revenue, 6% in constant currency with 7% organic growth. Nice performance in Latin America, 9% in constant currency and the organic growth up in the mid-teens at 17%. Now EMEA, revenue growth is at 3% constant currency and organic growth came in at 0%. I think rather than try to comment our way through then I'm just going to wait and take your questions as you bring them to me later on in Q&A, but I'm happy to give you some more color on what we see in that particular situation. If we move to slide 7, looking at our quality outcomes, I would say we continue a stable performance there, not a lot of movement one way or the other. But if we look at the three or four key KPIs that I try to focus on, our dose of dialysis, you see good stable performance. Looking at hemoglobin, the U.S. convention of 10 grams to 12 grams per deciliter, you see good stability, a little improvement and 10 grams to 13 grams per deciliter as we focus on it internationally, you see the same little bit of improvement very stable. Our albumin performance is good and on our hospitalization days you can see we're very stable and I will caution you again when you look at the Latin America data as well as Asia Pacific a number of the countries that we operate in we don't have great, great data from them on hospitalization, so I'm just saying that as we get more stability there we'll probably see some change in those numbers but yet again we feel good about how we're progressing and managing hospitalization days. Moving to slide 8, health care services revenue. I think the key here just looking at North America again good constant currency growth at 8% organic growth at 7% and same market at 3%, I'm sure you'll have a few questions on that, I'm happy to explain to you how same store market growth at 3% in North America and EMEA came about, we can take you through it. Care Coordination continues a hot streak, 21% growth in constant currency, great organic growth at 17%. Our dialysis treatments are up 4% in the quarter, we continued to see growth in our commercial treatments and we're happy about that and I think we're off to a great start, I know the questions you might have we'll just take those as they come once Mike has finished his presentation. My last slide, slide 9, it is on the dialysis products business. It was a good performance for us 2% constant currency growth and we all know, I've seen it in your write-ups today as well, we had a very tough comparison due to a very hot quarter in performance last year, but be that as it may in North America you can see 2% constant currency growth, we had 3% down in EMEA and I'm happy to take you through that during Q&A. We're very pleased with Asia Pacific at 9% constant currency growth and Latin America at 8% as well. With that, I'll stop my overall business remarks, I'll turn it over to Mike and will continue on.

All right, thank you, Rice. Hello, everyone. Just continuing on chart 11 looking at the P&L, so I'll start with the second quarter down the left hand side of the page. Revenues, as just Rice commented, was 5% growth 7% in constant currency. Operating income increased by $94 million to $671 million or 17% improvement compared to last year. It was supported by lower cost for health care supplies and the savings from our GEP program. I'll come back and talk in more detail about margin performance in a few minutes on the next chart. Net interest expense was virtually unchanged for the quarter. Tax rate shows an increase from 30.4% to 31.3% and this was largely driven by a lower increase in tax free income and non-controlling interests compared to higher improvement in earnings on our taxable income. Our non-controlling interest as you know is a North American story, all the other regions combined only reflect about a $2 million influence on the number and the increase in non-controlling interest is consistent with the underlying developments of the dialysis and Care Coordination business in that region. Net income attributable to shareholders was up $53 million in the quarter or 22%. EPS increased essentially the same percentage amount. Moving to the right hand side of the page and looking at the first half, revenues increased 6%, 8% constant currency. Operating income increased by $130 million to just under a $1.2 billion, an increase of 12% compared to last year. And again this was supported by the lower cost for health care supplies and the GEP initiative. Interest expense moved up just a bit at $4 million and as I commented towards the back half of last year that actually relates more to the fact that we had an interest income decline because a note was repaid last year, then a fundamental change in the underlying interest expense. Tax rate shows a decrease from 32.2% to 31.5%, this was also driven by the same factors we had relatively speaking a higher increase in tax free income than in taxable income which resulted in a beneficial rate. Non-controlling interest is in line with the drivers in North America and net income went up $72 million or 16%, earnings per share up 15% just slightly due to dilution of the stock options. So moving to the next chart and taking a look at our margin development. The margins increased in a single quarter as you saw 150 basis points from 14.5%. Before I go through each region, I would say that the weighted contributions to this worldwide increase were 120 basis points of improvement coming out of North America, increases in each of the other regions by about 10 basis points, EMEA, Asia-Pacific and Latin America as well as mix effect on a global basis of about 10 basis points. Corporate costs were a little dilutive reducing our margins by about 10 basis points as well. So now if we look at the chart in North America, operating income was up $85 million to $513 million in total or 20%. Margins in total for North America increased 170 basis points from 14.5% to 16.2% and they were influenced by our dialysis business showing a strong margin improvement that we also saw in the first quarter and our Care Coordination business which is showing very strong top line growth at comparatively lower margins. More specifically in our dialysis business, operating margins were up 290 basis points, 15.8% to 18.7%, this is of course due to our lower cost for health care supplies, favorable impact by increasing commercial volumes, lower legal expenses as a consequence of settling the GranuFlo issue last year and increases from equity method investees, all contributed to that 290 basis point improvement. Care Coordination earnings were down $12 million. Year-over-year margins decreased in Care Coordination from 7.8% to 4.4% in the quarter due generally to revenue mix, growth of our health plan services, as well as costs that we're incurring to expand our programs. As expected sequential margins improved from 2% in the first quarter to over 4% in the second quarter, so our guidance for the year continues at 3% to 5% margins for the Care Coordination business in 2016. For EMEA, operating income was up $5 million or 4%. Margins increased 50 basis points from 20.1% to 20.6% largely due to favorable foreign exchange effects and a favorable impact from manufacturing due to higher volumes and production efficiencies. In Asia Pacific, earnings were up $8 million or 12%, operating margins increased 110 basis points, 17.8% to 18.9%. This was also largely due to favorable foreign currency business growth, partially offset by lower earnings from equity method investees. Latin America remained virtually unchanged at $16 million in operating income. We did see a margin increase of about 150 basis points mainly due to foreign currency effects and impacts from higher revenues in the region at constant exchange rates. And corporate cost increased by $4 million to $102 million with the 10 basis point impact mentioned that was largely driven by increased R&D spending in the quarter. Turning to the next chart, chart 13 and taking a look at our cash flow development. In Q2, operating cash flows were primarily driven by an adjustment during the first quarter to our invoicing in North America. We'd indicated that that would turn itself around pretty quickly and in fact you can see that impact in the second quarter. The development is reflected also in our DSOs which are showing 70 days for Q2 after 71 days at the end of the first quarter. In addition to this effect, cash flows benefited from the timing of other working capital items and increased earnings. These effects were partly offset by higher income tax payments in the U.S. this year as in 2015 in the second quarter, the tax payments benefited from a refund related to the OIG settlement that we had in the second quarter of last year. These effects result in cash from operations increasing to 15.3% of revenues compared to 9.2% in the second quarter of last year. CapEx in the quarter increased slightly, but still represents approximately 6% of revenues. And combined with some of our acquisition activities which is $67 million net of divestitures actually represents about $300 million of gross cash spending on acquisitions in the second quarter and the payment of our dividend, our debt increased from $8.9 billion at the end of March to $9.1 billion at the end of June. Leverage remains unchanged and is within our guidance. So turning to chart 14 and taking a look at our outlook and I'll make a few comments as I go through the outlook material. So we're confirming our outlook for 2016, so we're guiding to an increase in revenues of 7% to 10% at constant currency, an increase in income of 15% to 20%. The guidance we're providing considers what we know today and reflects our expectations for the operating results of the Company. This performance as a reminder also continues to exclude the impact of acquisitions closed in 2015 and anticipated for 2016 and it includes the savings from our GEP program. But obviously we're halfway through the year, so I would offer some additional comments. We're showing good performance year-to-date in line with our expectations and we expect further improvements in the back half of the year. In February, we indicated we were optimistic that we will bring the compliance investigation to a close this year, we now believe the investigation will likely slip over into the first half of 2017. In terms of legal and consulting spending for this matter, our guidance anticipated to reduce levels of spending this year as the year progresses. But with the prolongation of the discussions, this decline is occurring more slowly than we assumed. In addition, we anticipated that we could begin recognizing revenues under the government's BPCI program in the back half of 2016. We're confident we're tracking to savings under this multi-year program. But our ability to recognize revenues and the amount that we could potentially recognize in 2016 are dependent on the outcome of program discussions with CMS. All parties are working collaboratively to make this program successful, but progress on the specifics is slow. Last, we're reducing our expected effective tax rate from what I gave you in February of 32% to 33% to 31% to 32%. So finally if the legal costs and the BPCI developed negatively in the back half, it would be more likely that we would be in the lower half of the guidance range. So with that, I will turn the call back to Oliver.

Great. Thank you Mike, thank you, Rice for the update and the comments and I think Patrick, we can now open up the call for Q&A.

[Operator Instructions]. And our first question today comes from the line of Veronika Dubajova of Goldman Sachs. Please go ahead.

I would keep it for two, please. My first one is just Rice you mentioned, but if you can talk about why you saw the slower same-store gross rate both in the U.S. and in Europe that would be very helpful in particular in the U.S., you had made a lot of progress over the last couple quarters getting the growth rate up to 4%, so there is a little disappointed to see this slipped back to 3%. And my second question is just around BPCI and the recognition procedure, I don't know Mike, if you can talk to -- I guess what are the hurdles that you're facing with CMS and give us an update on how those conversations progressed and I appreciate the color you've given in terms of if you don't see those revenues materializing more likely to end up at the lower end, but maybe you can talk about more conceptually, what's the earnings potential that you see from the program?

Veronika, it's Rice, so let me take care of the same-store growth and then I'll pass it over to Mike for BPCI. So when you look at same store growth in North America, it's about a 100 basis point drop from what we've seen in prior quarters. It really kind of chunks out this way, about a third of that drop came from provider tenders in Mexico that we chose not to participate in, there were new tenders, the pricing was not rational to us, we chose to walk away from that. And then we had some timing of a few contracts in the U.S. that contributed about another third of that drop, but we think that will work itself out, then there were some ins and outs. So we don't see this as a developing trend, we think it's a blip, if you will, we would expect that we will have better performance more normal performance as we go forward in the latter quarters of the year. Looking at EMEA, what we saw there two of our very fast growing producing countries if you will have been Romania and Poland, they have really helped us when we were seeing higher same-store growth, they slowed a bit in the quarter, we don't think it's anything that is going to be a continuing problem, but those were two things that really drove us down a little bit from our past performance, so that would be my color on that for you. Hopefully, that gives you something to think about.

Veronika, I'll take the second question. With regard to BPCI it is all about the numbers. It's about being able to track the experience that our physicians are having managing the patients, post their hospital admission through their post-acute setting back into the home. And I think it's been pretty well publicized that everyone's heart is in the right place, but trying to get full alignment on those data sets coming out of CMS has proved to be more difficult than I think CMS initially imagined. So folks are working hard on it, but revenue recognition is first going to be dependent on getting some alignment on those data sets, so that the government is confident that there is a portion in the experience that all the participants are having under the program that it's getting to the right sponsor, if you will. Once that data has been cleaned up and folks have clear visibility through the extent to which they're seeing gains, then you will see a corresponding recognition of revenue which will kind of proceed a pace once we get to that run rate on a quarterly basis.

Mike and maybe can you comment on the number of patient encounters that you're having within the program just something to help us think about the ultimate revenue and earnings opportunity here?

Let me come back, we have the aggregate patient encounter number that includes a couple of things. So if you can come back and be more precise with regard to BPCI if we have that data and if you permit me Veronika, the only thing I'd say is when you asked your question, you said that my comments indicated we'll be on the lower-end, then I actually said the lower half.

And our next question comes from the line of Lisa Clive of Bernstein. Please go ahead.

I have three questions. First on your costs in North America and I know there is chunk in there for the legal expenses you had around the GranuFlo suite, have those started to trend downwards or is that still yet to come and if you could give us any update on the timing of that settlement getting finalized? Also in Care Coordination just the delta between the organic and the total constant currency growth, could you just remind us where are you getting that 4% contribution from external growth and specifically what segment of your Care Coordination business that's from? And then third question, good growth in the commercial treatments in the U.S., could you give us a little bit of detail on where exactly that's coming from, is it traditional EGHP, is it coming from exchanges, is it Medicare Advantage or is it some blend of those three?

On GranuFlo and cost per treatment legal expenses, they are ramping down, Lisa, so we've seen that go as we had imagined it would go once we announced the settlement. What I would say on the timing, we were due to have the 97% opt-in mid-July, there was a conference with the Judge Woodlock in Boston and everybody agreed to extend that to September 15 which is quite normal in this circumstance. So we're working toward that and they felt like they needed more time, there were a number of plaintiffs if you will that they were having trouble contracting to actually speak to like people in order to get them into the settlement. So that is progressing as we expected it would. So we still think that we'll have more to tell you come third quarter, because we will trip that September 15 window here in a couple months. Growth in the commercials I would say we're seeing nice progress kind of everywhere if you will, predominantly it's in the big folks, as well as Medicare Advantage, not so much in the exchanges but I would say it's a pretty equal performance if you will, Lisa. There is not an imbalance one place versus the other maybe I'll say it that way.

And your second question, Lisa, in terms of Care Coordination, the difference between the organic and the constant currency overall revenue growth rate is consistent with what happens in the core business, it's just the extent to which we had acquisitions over the period in which we don't count in the organic. And I'd say generally we've closed for the entire business in North America about 20 deals in the first half of the year and the hospitalist business, the vascular access business and the cardiology business all have their fair share of those deals.

And our next question comes from the line of Tom Jones of Berenberg. Please go ahead.

I've got a couple. First one for Rice, on your little trip round the disappointing numbers you missed out the EMEA products business which was I guess, the weakest of the three in your international space. Given that includes the Middle East and Africa I suspect it was the EMEA part of it rather than the E part that was weak, but certainly if you can give us some color there. The second question, maybe one for Mike, is on the BPCI accounting, not so much the issue is how you deal with the government, but how you deal within your own books. Are you accruing for any related cost as you go that might come with the revenues -- savings you might generate, basically I want to get to is if you do get some traction with the government what percentage margin are going to drop through the P&L, if and when you do book them? And then the final question, maybe one for Rice, I've seen a bit of noise lightly about coming from various quarters, I think Anthem made some comments on the conference call and one of your competitors had some issues on this front, but between the relationship between the dialysis industry and the commercial insurers you had a couple of years of exchanges, things are changing on that side. I'm just wondering if kind of the rules of engagement are shifting to between you and the insurers, is the relationship becoming more adversarial, more corporative, it is a big chunk of your profitability, so just comments on your relationships with broadly speaking with insurers will be helpful.

Yes, I skipped EMEA's product growth because I knew you were going to probably ask me this question so it's playing out perfectly. Couple of things, I think first people have to realize from a Europe standpoint, remember that we sold pharma assets to Vifor last year, so about 60 basis points of this in the quarter is the fact that those assets were sold and that revenue left our book of business. Secondly and the rest of this commentary is going to be about the Middle East as you intimated. In Algeria, we recently went from dialyses being reimbursed at three treatments per week, they've now dropped to two. As a result of the drop in oil prices and less funding coming from that for healthcare that created a product situation for us because we're doing a third less treatments in a week than we used to. So that's been an impact of about 30 basis points. And then lastly, when you look at the Kingdom of Saudi Arabia and Libya, we had very strong tender business with them in the second quarter of 2015. We have tender business in the second quarter of 2016, but it's not as strong, it slipped a little bit so that year-over-year comparison puts us down in the whole, if you will. But, so that's really the breakout of how we see this negative 3% constant currency growth. Mike, you want to hit number two?

I'll take number two. Tom, for BPCI I guess maybe the best way to say this is when in terms of the costs that we're incurring to actually operate under the pilot program, we're recognizing those costs as they're incurred, accrual basis accounting. So each quarter, we've talked about the fact that we're continuing to invest in some of the businesses in Care Coordination and that's an element of that investment because the folks that we have on board to meet the operating objectives we're recognizing those costs as we go. So when we do have the opportunity to start booking revenues, it's not dollar for dollar, but I'd say the lion's share of the revenues will drop through.

And then Tom, back on Anthem what I would say generally for us in the quarter and really for the whole year our relationships with our commercials has been cooperative, it continues to be good. So we have no issues, we're pleased there. In this specific example, it's just simply not us in this issue with Anthem and the exchanges I can assure you that we're not the problem there. Our exchange business does look in many cases and feel like a commercial negotiation, if you will we've talked about that in prior quarters, I don't really see any change there. But again specific to Anthem we're not in that mix if you will, relative to their comments from earlier in the week or maybe late last week.

So if there is enough annuity to pay too much attention to at this point.

No, I think we're fine.

So I'm going to come back to you and answer your question. Probably the best measure rather than encounters because we only report total encounters and that's obviously heavily influenced by the core hospitalist business, probably the best thing to talk about is the medical cost under management for the BPCI program and I think you've seen in the quarter we're reporting a little over $700 million medical costs under management per member a month which is the member months times the benchmark of our expected medical costs. So to give you an order of magnitude we're looking at a little bit over $500 million of that $722 million is related to BPCI.

And our next question comes from the line of Michael Jungling of Morgan Stanley. Please go ahead.

I also have three questions. The question number one is on the cost restructuring. And when you announced the program in 2014 you're guiding I think to $300 million and what is the run rates at the end of the second quarter and what are the net savings achieved in the second quarter of 2016 to the second quarter of 2015? And question number two is on Care Coordination. What is the time frame for the incurrence of costs to build the platform and what is the magnitude that you incurred in the second quarter? And then thirdly, a question really on Retacrit. Can you comment on why Retacrit did not hit Vifor FMC rather hit Vifor Pharma?

So Mike, [indiscernible] on the GEP, but we haven't guided separately to that in a while and we haven't teased out the numbers in a while, so we've confirmed that we're running to the $300 million for 2016 and obviously at the tail end of a three-year program. So I think we'll see a little bit more of a benefit as we move into the back half, but we've gotten I'd say most of the benefit leading up to our performance in the second quarter. In terms of Care Coordination and the time frame, I'd take two things. One, obviously since we started this program in April of last year there's been a bit of a ramp, we saw some of that ramp in 2015. As we move into 2016, I think we're in the part of a steady state but as we continue to grow the program, it will operate like any other business. So as the number of member months that we're managing grows, we'll make sure that we have the appropriate infrastructure in place to manage that incremental business. Not disclosing in terms of the pieces, how much XYZ is within Care Coordination, but I think when I gave the overall guidance of 3% to 5% margins for Care Coordination, that's probably the best way to model expectations for the back half of year.

And Michael on your question with Retacrit, it sits in Vifor not the JV and just a couple of things. That relationship was done by Vifor keeping in mind there is no product on the market, there's nothing approved yet, while we talk about this later on when a product gets approved, but there's really nothing for us to see or recognize or do anything with at this particular point in time as the product sits in the U.S. unapproved.

And Mike just mention that the run rate was I think $300 million for 2016, also the guidance was $200 million by 2016 and $300 million in 2017, did I get this wrong or have you been able to save more money?

It was $200 million in 2015 and $300 million in 2016, Michael.

$200 million, $300 million, 2015 and 2016.

And our next question comes from the line of Frank Morgan of RBC Capital. Please go ahead.

I was hoping you could comment about the one-time gains that you recognized in the quarter, if you discuss the segment results, kind of what that was related to and how big a number that was and how much that impact your overall business?

Sure. Frank, it's kind of high-single, low-double digit millions, so it's a small number.

And then one other question. In terms of just within the U.S. dialysis business, any change that you've seen in your Medicaid mix either year-over-year or sequentially?

No, Frank, I think it's pretty stable. I'm coming off of top of my memory, but I don't think we've seen any significant movement in that, though I think we're pretty steady in it if you will.

And our next question comes from the line of Alex Kleban of Barclays. Please go ahead.

I just want to ask one question on Care Coordination and then maybe a few technical questions just if I may. Just on the Care Coordination maybe it's a different way to ask a previous question, but can you give a sense of the overall infrastructure or start-up costs across all the different platforms, really what I am trying to get at is a sense of what is the drag that we're seeing on Care Coordination EBIT during the ramp-up phase and when do you really expect to hit a crossover point and start to get some leverage off of that infrastructure cost? And then just on some of the technical questions, one was just going to be on the run rate for income from equity method investees and then secondly, just to be sure I understood correctly, Mike, one of your earlier comments is that that income from equity method investees should be factored into our cost per treatment calculation, just to be sure that's correct.

Alex, I think those are both for me. So, in Care Coordination, what I would say and it harkens back to some of our earlier calls. In terms of sorting out the drag on Care Coordination for some of our growing pains if you will, I'd say when I guided 3% to 5% for 2016 in terms of margin, I've repeated that our expectations over the mid-term are going to be to get to mid to high single-digit margins. So I think you can use that as a way to benchmark kind of the level of investment we're making in that business in 2016. On the run rate for equity method investees, you've seen the nice ramp coming in the first half of this year, obviously Rice commented in terms of number of patients on the [indiscernible]. So, I would say in the back half there will be a slight increase in that, but I think most of it is probably in the Q2 itself, it will be slightly better in the back half.

Mike, just maybe I can just drill down on that one little bit, but it's also the health care supplies you talked about which is the material and then impacting this as well. Do we need to think about a cost inflator for that line or at least for the healthcare suppliers or is that unlike a multi-year fixed rate contract set for a set period in a specific period of time?

Alex, it's Rice here, you are kind of tripping down into some detailed territory I don't think I'm comfortable giving you, don't really want to kind of get into the details there. So I think we have to pass on that.

And our next question comes from the line of Gary Lieberman of Wells Fargo. Please go ahead.

I think you mentioned 20 acquisitions in the Care Coordination space. Could you just maybe give us a general sense of kind of the sub-categories of where you're most active and maybe where you expect to continue to be most active?

If we miss-spoke we didn't mean to. We've had about 20 acquisitions in the U.S., many of them in the core dialysis space, we've had a couple in the Care Coordination space. Mike, if you want to give a count exactly.

Yes. Maybe we've strung that sentence together too tightly, but 20 total vast majority dialysis, core business, a couple in the Care Coordination space.

I guess maybe I'd still ask the same question kind of where do you expect to be most active in Care Coordination.

In terms of acquisitions?

Yes.

I think my answer is the same.

I mean we're still strategically looking at things when they come about. But, I think we've been pretty consistent about looking at a lot of things when something comes we'll take a look at it and go from there. Globally, we still look at a couple of things, just give us some time here and I think we'll figure all this out.

Okay and then if I could maybe follow up on the questions you've got around Retacrit. What's your expectation for when the drug will be available in the U.S. and do you expect it to be distributed too broadly or only to Fresenius Medical Care?

So and this is dangerous because it's just my personal opinion. So keep that in mind, I think Retacrit doesn't hit the market till probably 2017. I think we're five months yet to go this year, so I just don't think that we're going to see it on the market and approved until may be H1 of 2017 and I would tell you without having a lot of discussion with my team I think we would hope this would be as broadly distributed it could be, but I would leave it at that and unfortunately I don't have the guys here with me to give you any more color on that, Gary, but we would hope it'd be broadly distributed.

And our next question comes from the line of David Adlington of JPMorgan. Please go ahead.

Most of it has been answered. So maybe just on the new machine 6008 system. Just wanted to, if the ASP margin differs materially versus the older machines, particularly on the consumables whether we might see any sort of impact on the product margins going forward and just was there any stocking impact of that in the quarter?

There was no stocking impact in the quarter. We've got somewhere around 200 to 230 machines that we've sold. So not a big number and we build these two orders, so we didn't really pre-build, we already had the orders in the hand. When you look at noticeable margin impact in the second half of the year, I don't think so, I don't think you're going to see it initially on, it usually takes a while to get to inflection point if you will or you're going to see a little bit of a pickup in margin. I would tell you that this is probably our most technologically advanced machine. We're really pushing for efficiency, we've got a, if you will, bloodline dialyzer combination and it all fits together they're not separate pieces. We think that's going to drive some set up time. This machine has multiple therapy options such as online, HDF, regular dialysis things of that nature. So we obviously are going to look to capitalize or monetize on the amount of technology we put into the machine, but I think it's pretty early on. Historically, for us a new machine coming out it takes eight months to a year before you really begin to see a movement of the dial.

And our next question comes from the line of Ines Silva with Bank of America Merrill Lynch. Please go ahead.

I have three very quick ones, please. First of all I was wondering if you could comment on the operational margins in EMEA, Asia and Latin America and how much or what would the underlying margin performance versus the tailwind I guess you saw from FX. Then my second question which would just be about the better pricing trend that we have seen this year in U.S. biologists and how you believe we should think about it in the second half of the year. And third question which is if you could make any comments at all about the revenue per treatment in Asia that negative evolution.

Ines, on the operating margins for the regions that we provide some granularity, but we typically don't break out every quarter the FX effect. So generally I would say obviously we had a bit of a hit in the first quarter and we had some improvement in the second quarter. So actually trending in a very similar way to what we saw last year. In terms of pricing and I think when you talk about that you're really talking I think about revenue per treatment in the U.S. and I'd say broadly we expect to see very slight improvement in the back half of the year on that measure. And revenue per treatment in Asia we actually stopped publishing our revenue per treatment data at the beginning of 2015. So if you're running a calculation yourself, I really can't comment on that.

We have so many puts and takes between reimbursement among the various countries, it's really hard for us to [Technical Difficulty] trying to measure that KPI and produce it. So we just really stopped doing it and focused on the one big country which was the U.S..

Can I just follow-up on the first question. So operational margins if FX stays where spot rates currently are how would you see tailwind or headwinds in operational margins in the second half of the year?

I think if rates stay where they are generally comparing the second half to the first half, it would be a tailwind.

And our next question comes from the line of Gunnar Romer of Deutsche Bank. Please go ahead.

One is left on Care Coordination. I think Rice in the Q4 call you indicated 25% to 35% revenue growth in Care Coordination or $2.5 billion absolute. I was wondering whether you have an update on this for us also what where your underlying assumptions back then, did you factor in any M&A? Just curious to hear your thoughts on this and also what we should expect in terms of potential contribution from BPCI and how that may affect the back half of the fourth quarter, to what extent that maybe significantly accelerating the growth rates on the top line as well?

Sure, Gunnar. Mike, you're probably closer to that on the details. So I'll let you take it and if I need to jump in, I will.

I would say consistent with confirming the guidance for the year that I did a bit ago, I'd indicated 25% to 35% is still we think achievable for revenue growth in Care Coordination this year. The influence of BPCI obviously we did have an element of BPCI in the revenues for the year that's why we indicated that we saw an opportunity that we'd have in the back half to recognize revenues and that's why I provided the color that I did earlier in the call. Beyond that, I would say it was a relatively modest revenue figure in the context of the business.

So we do get to the $2.5 billion number that you had referenced, we think that's doable and achievable in full year 2016.

Yes.

And that would not necessarily involve further M&A from here in the next few months?

That's correct. Yes, I think that's a fair statement.

And we have a follow-up question from the line of Lisa Clive. Please go ahead.

I just want to follow up on a previous question about the global efficiency savings for this year, you said $300 million, my understanding was from prior comments that it's an exit rate of $300 million, so we don't actually see the full impact of the $300 million until next year, if you can just clarify that. And then second on your comment on the new dialysis machine is that online HDF, as I understand the FDA approval process for that is much more complex than standard chemo. So are you not selling this machine into the U.S., have you actually gone through that approval process?

Lisa, it's Rice, you are correct, we said $300 million exit rate in 2016 and we would have that in 2017 as well, so your memory is absolutely gold plated. Relative to the new machine, we're focused in Europe, it will go Asia, Latin America first. We do anticipate we'd have this machine in the U.S. which you're absolutely right. There are discussions that are ongoing about online HDF and where FDA is going to shake out on what's required for approval there. So we'll do the work, but at this point in time it's not the beginning focus because they don't know what they want to do yet either in terms of FDA.

And we have another follow-up question from the line of Veronika Dubajova of Goldman Sachs. Please go ahead.

Just very quick two follow-ups from me. The first one is just, Rice, if you can update us on where you are with ESCO enrollment, I think last time we caught up, you were considering expanding the number of sites and what's the patient count on ESCO that would be great. And the second question related to that is, any thoughts you have on the bill pending really proposed in the House and the Senate on expanding the program?

Yes, Veronika, so we're still at about 8,000 patients today which as you recall, as we got into the first phase of ESCO, that's really where we needed to be. This was in a situation where we can keep adding patients. So we're maintaining what we'd anticipated we would around 8,000. As far as the opportunity for other locations, we had a few that we discussed and we did submit those back July 2015 and quite honestly we don't expect to hear anything back for a while before we know if that's going to play or not. So I think our bigger focus is just managing the 8,000 that we've got today and seeing what comes down the road if we get an extra site or too. And then your second question was, what? Can you repeat that?

The bill, we're going to have to see. I would say this, things are very interesting in DC right now with the election coming up, I mean we're happy that if they are -- but we're just going to have to see where it goes, it was committee path, it's got to go through both houses of Congress and so in a year like this year, it's already August and we know what's happening in November, we're optimistic we'll see where it goes.

And our last question comes from the line of also a follow-up question from the line of Michael Jungling of Morgan Stanley. Please go ahead.

I only had one more question and it's also related to the commercial insurers in the U.S. and I'm referring really to the UnitedHealthcare suing American Renal, you sort of partly touched upon it before, but I'm trying to work out how much of an issue this is in general that the allegations of convincing Medicare patients to switch to commercial insurance plans is in the U.S., do you expect this to escalate in the remainder of the year and how much of an issue has this been so far in the quarter in terms of investigations or concerns amongst various parties?

Let's do this in a reverse order. It is business as usual for us, there's not been an issue for us in the quarter. Let me say this American Kidney Fund been around since 1971, we think they do great work, we have an advisory opinion from Health and Human Services [indiscernible] Inspector General, we abide by that, we go by letter of the law to what they suggested the correct way to work within this program was. So we're very comfortable with that and quite honestly I couldn't comment on the specifics of ARA or United, I'm not going to go there, it'd be inappropriate. So we're just going to continue to do what we're doing, whether this escalates or not, it's only going to come over time, but we're going to continue to follow the advisory opinion, do what we've always done and try to make sure we're doing everything as appropriately as we can be and I think we're.

I think that was the last question, Patrick, as far as I know.

There's no further questions.

Great. Thank you so much. So, since there is no other question, I really appreciate everybody participated, so talk to you guys soon, thank you very much.

Take care. Thank you.

Thank you.

Bye, bye.

Ladies and gentlemen, the conference is now concluded and you may disconnect your telephone. Thank you for joining and have a pleasant day. Good bye.