Abbott Laboratories (ABT) Q3 2017 Earnings Report, Transcript and Summary

Good morning and thank you for standing by. Welcome to Abbott's Third Quarter 2017 Earnings Conference Call. All participants will be able to listen-only until the question-and-answer portion of this call. [Operator Instructions] This call is being recorded by Abbott. With the exception of any participant's questions asked during the question-and-answer session, the entire call, including the question-and-answer session, is material copyrighted by Abbott. It cannot be recorded or rebroadcast without Abbott's expressed written permission. I would now like to introduce Mr. Scott Leinenweber, Vice President, Investor Relations.

Good morning and thank you for joining us. With me today are Miles White, Chairman of the Board and Chief Executive Officer; and Brian Yoor, Executive Vice President, Finance and Chief Financial Officer. Miles will provide opening remarks and Brian will discuss our performance and outlook in more detail. Following their comments, Miles, Brian, and I will take your questions. Before we get started, some statements made today may be forward-looking for purposes of the Private Securities Litigation Reform Act of 1995, including the expected financial results for 2017. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, “Risk Factors” to our Annual Report on Securities and Exchange Commission Form 10-K for the year ended December 31, 2016. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Please note that third quarter financial results and guidance provided on the call today for sales, EPS and line items of the P&L will be for continuing operations only. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand Abbott's ongoing business performance. These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings news release and regulatory filings from today, which are available on our website at abbott.com. Unless otherwise noted, our commentary on sales growth refers to comparable operational sales growth, which adjust the 2016 basis of comparison to include results for St. Jude Medical and to exclude the impact of exchange, as well as current year and historical results for Abbott's Medical Optics and St. Jude's vascular closure businesses, which were divested during the first quarter of 2017. Comparable growth also reflects a reduction to St. Jude's historical sales related to administrative fees paid to group purchasing organizations in order to conform with Abbott's presentation. Earlier this month, Abbott completed its acquisition of Alere, given there are only three months remaining in the year. I'd note that comparable sales growth guidance for the fourth quarter and full year 2017 do not include Alere, which is consistent with the guidance methodology we've utilized since the beginning of the year. With that, I will now turn the call over to Miles.

Okay. Thanks, Scott. Good morning. Today, we reported ongoing earnings per share of $0.66 at the high end of our guidance range and reflecting double-digit growth. We also raised midpoint of our 2017 adjusted earnings per share guidance and narrowed the range to $2.48 to $2.50 which is at the upper end of the range, we said at the beginning of the year. Sales increased more than [technical difficulty] in the quarter led by strong performance in established pharmaceuticals and medical devices. At the beginning of the year, I commented that we were entering a period where innovation and new product launches when enhance our competitiveness and fortify our leading market positions. We're seeing this play out through the first three quarters of the year with significant growth contributions from several recently launched products and important advancements across our innovative new product pipeline. I'll highlight several examples as I summarize our third quarter results in more detail before turning the call over to Brian. I'll start with diagnostics where we achieved sales growth of more than 5% in the quarter which was led by strong international performance during the quarter. We continued the initial European launch of our Alinity family of systems, which now includes five recently launched instruments in the areas of immunoassay, clinical chemistry, blood screening, hematology and Point of Care testing. As we've stated previously, our primary focus during this initial launch period has been to convert a number of long tenured Abbott customers to Alinity and we continue to make progress on that front across all of the major European countries. We continue to anticipate CE Mark for our Alinity molecular diagnostic systems in the coming months and expect to begin the launch of the Alinity instruments in the US in 2018. During the quarter, we also announced our acquisition of Alere establishing Abbott, is the global leader in Point of Care testing. This combination creates the broadest Point of Care testing portfolio in the world with leading positions across cardio, metabolic, infectious disease and toxicology testing. In nutrition, sales grew very modestly in the quarter. And pediatric nutrition continued above market performance and the US was led by recently launched infant formula products and strong growth of our PediaSure toddler brand. Internationally, we've seen some market stabilization in China and we prepare for the pending new food safety regulations that are set to go into effect on January 1 of next year. Outside of China as expected, we continue to see soft market conditions across few international markets and then adult nutrition international growth of 5.5% was led by our market leading Ensure and Glucerna brands. In established pharmaceuticals or EPD double-digit sales growth was led by strong performance across our key emerging markets including double-digit growth in Brazil, Russia, India and China. As expected and contemplated in our third quarter guidance, we saw a modest level of channel restocking in India after the implementation of a new tax system in that country on July 1, which contributed approximately 2.5 percentage points of growth in the quarter excluding this impact total EPD sales would have grown around 12% in the quarter. With our unique geographic footprint and business model as well as our scale and leading positions in several geographies, EPD is well positioned for sustained above market performance. And in medical devices sales growth was led by double-digit growth in heart failure, electrophysiology, structural heart, neuromodulation and diabetes care. In addition to strong growth we achieved several important new product approvals and clinical trial milestones across our portfolio during the third quarter. In heart failure, we received US FDA approval and launched our HeartMate 3 pump which provides crucial support for advanced heart failure patients as they wait for their treatment including heart transplants. HeartMate 3 offers a number of advantages compared to existing options and further strengthens our global leadership position in this area. During the quarter, we also received US FDA approval of our MRI compatible ICD or implantable defibrillator which follows FDA approval of our MRI compatible pacemaker earlier this year. These approvals significantly enhance our competitive position in the US Cardiac Rhythm Management market. In structural heart, double-digit growth was driven by continued global uptick MitraClip. During the quarter we achieved several important clinical milestones including completion of enrolment in our US trial for Portico, our TAVR product and we began enrolling patients in a new tricuspid valve disease trial which utilizes our market leading transcatheter valve repair system. In Neuromodulation, we achieved growth of approximately 50% for the third consecutive quarter driven by recently launched products that offer improved relief for chronic pain patients and help for those suffering from movement disorders. With our broad portfolio of innovative solutions, we continue to advance our leadership position in this fast growing market. I'll wrap up with diabetes care, where international sales growth of nearly 35% was driven by FreeStyle Libre, our innovative glucose monitoring system that eliminates the need for routine finger sticks. Libre now has more than 400,000 users internationally and during the quarter we obtained national reimbursement status in Japan and the United Kingdom which represent two of the largest diabetes markets in the world. In the US during the quarter, Libre received US FDA approval as a replacement for blood glucose monitoring. This revolutionary technology is the only system available that comes factory-calibrated thus eliminating the need for daily finger sticks that are required to calibrate other systems currently available. So in summary, we exceeded expectations for the quarter and raised the midpoint of our full year EPS guidance which is now at the upper end of the range, we said at the beginning of the year. Our sales growth increased sequentially and recently launched products are contributing significant growth across our portfolio and we're particularly pleased with the productivity we're seeing across our new product pipeline which is delivering a study cadence of approvals and launches of innovative technologies. I'll now turn the call over to Brian to discuss our results and outlook for the year in more details. Brian?

Thanks, Miles. As Scott mentioned earlier please note that all references to sales growth rates unless otherwise noted are on a comparable basis and do not include Alere, which is consistent with the guidance methodology we've utilized since the beginning of the year. Turning to our results, sales for the third quarter increased 5.6% on an operational basis. Exchange had positive impact on sales of 0.6% resulting in reported sales growth of 6.2% in the quarter. The favorable impact of exchange rates on our sales this quarter was driven primarily by strengthening of the Euro and other developed market currencies which considering our European cost base and hedging program have a relatively modest follow-through impact on our earnings. Regarding other aspects of the P&L, the adjusted gross margin ratio was 59.3% of sales. Adjusted R&D investment was 6.9% of sales and adjusted SG&A expense was 29.4% of sales. Turning to our outlook for the full year 2017, today we narrowed and raised at the midpoint our adjusted earnings per share guidance range to $2.48 to $2.50. Before reviewing our outlook in more detail, I'd note that Alere which we acquired earlier this month is expected to contribute around $475 million to our reported sales and we forecast a neutral impact on adjusted earnings per share this year. We continue to forecast full year 2017 comparable operational sales growth in the mid-single digits and based on current exchange rates, would expect exchange to have a positive impact of nearly 0.5% on our full year reported sales. We forecast an adjusted gross margin ratio of around 59.5% of sales, adjusted R&D investment of approximately 7.5% and SG&A expense of approximately 30% of sales. Turning to our outlook for the fourth quarter of 2017, we forecast an adjusted earnings per share of $0.72 to $0.74. We forecast comparable operational sales growth in the mid-to-high single digits and at current rates would expect exchange to have a positive impact of somewhat above 2% on our fourth quarter [technical difficulty] sales. Before I open the call for questions, I'll now provide a quick overview of our fourth quarter operational sales growth outlook by business. For established pharmaceuticals, we forecasted double-digit sales growth. In Nutrition, we forecast low single-digit sales growth. In Diagnostics, we forecast sales to increase mid-single digits and in medical devices, we forecast sales to increase mid-to-high single digits which reflects continued double-digit growth in diabetes care as well as several areas in our cardiovascular and neuromodulation business. With that, we will now open the call for questions.

[Operator Instructions] our first question comes from Mike Weinstein from JP Morgan. Your line is open.

Miles, if we could touch on two topics. First is Alere now that it's closed and second is Libre, now that you have an FDA approval. First Alere, can you talk now about how we should think about the outlook for Alere both topline growth and in accretion obviously or it is familiar what you initially were expecting from accretion with $0.12 to $0.13 year one, including [ph] $0.20 in year two, but a lot happened to your business over that time. You renegotiated terms, you've divested some assets. So I think everybody would appreciate an update on how we're viewing that business and then we'll circle back on Libre. Thanks.

Yes, I think it's premature Mike to give real specific about Alere. We closed the deal a couple of weeks ago, literally. And our new management team is taking over the business, but obviously very rapidly getting up to speed, meeting all their employees and going through all the things you do to start integration and so forth. And I'd say first of all, that's gone very well. The management team we put in place has moved very quickly and I'd say very deliberately to get their hands around everything, but that takes some time. As we've said the people given the timing of when we close it, we expect no accretion this year. So I wouldn't look for any particular impact on the bottom line in 2017 and with regard to 2018, since our initial estimates of accretion that were quite some time ago, as you know when we first announced this deal because it's taken a very long time close. There have been a number of changes including divestitures and so forth. So I don't want to give you a specific number. I'd say it's fair to think that the accretion will be much more modest and what we have initially indicated for the first year. We will get a full year, we'll get a quarter's head start. And obviously our intent is to be accretive to our company and our business and we believe that with the acquisition we've positioned ourselves as the leader in Point of Care testing worldwide and all of that has the intent of good solid growth and profit growth for our investors, but I'm going to be cautious about what I communicate for 2018 at this point until we've really had a chance to assess it more thoroughly.

And do you think the business as you own it and they call it the proforma that we're under Abbott, does that business grow in 2018 and is low single digits an appropriate expectation.

I think it's a good target. I don't know that we know yet, but that's certainly I think an expectation we Abbott ought to have and the question is, how rapidly we can do that. Look I think it's a fair expectation and if I was and I'm totally honest with you. I wouldn't have a lesser expectation.

Okay, all right. Let me switch to Libre, if I can. And maybe try and ask, get couple questions in. So one, obviously everybody is excited not only based on all your success outside the US with Libre that now that you had this opportunity in the US. What would you view as a successful launch for Libre in 2018? Is there something you could characterize or wrap in a number, is it a $50 million, is it $100 million, if you wanted to take a stab at that? And then second, what is your expectation commercial payers. Can you tell us about the conversations you've had and the willingness and the timing of you think commercial payers getting onboard? Thanks.

Well I'd say couple of things. Your estimate is - let's just say your estimate I'll take. And you gave me a nice range there, so thank you. And I think that you can assume that we'll be looking at this from a lot of perspectives because we've got a lot of data. Having had a run rate in Europe, we launched in Europe and it basically went country-by-country. We started as full patient pay and we had really terrific uptake in consumer interest and that was the first introduction of Libre to the market. The fact that there was no reimbursement early on, was an unknown to us and it was a new concept and a new way for diabetics to test. And we experienced tremendous demand. Our first year, we were capacity limited and yet, we had a fair bit of demand. Second year, obviously has gone exceptionally well and so as I indicated we've got over 400,000 customers. It was remarkably well embraced for reimbursement by government bodies in Europe and regions in Germany etc., that's extremely gratifying that the value proposition that we see with Libre is strong and it's intended to be. And consequently we believe that part of the appeal is not just, what Libre can do and the information that it provides to a diabetic was a very informed patient and a very self-managing patient. It provides them tremendous information, tremendous guidance in the management of diabetes and I know that first-hand, I wear one. And I got to say it's just a phenomenal device, it's a super product. I can see why consumers like it as much as they do and that's true for both Type I and Type II's and we're seeing that universally across the board, they use it in different ways or at least the information mean something to them in different ways. Whether they're managing insulin or whether they're managing diet and exercise and other things. So I'd say first of all, I expect demand to be pretty strong. Secondly, the US market knows about Libre, it knows a lot about Libre because of all the experience that we've had in the last year in Europe. So I do expect a more educated, ready, prepared, anticipating, demanding market in the US as it relates to payers, which I would call the second dimension of this. I think our value proposition is quite strong. The product is priced at a very economic and affordable level. The intention there is as much and broad access as possible and as rapidly as possible. And I think that value proposition is stunning compared to competitive offerings and I think that's going to be making it strong. We are in discussions with payers and we're in discussion with payers about that value proposition and I believe that will all go very well. I know that's not as much detail as you'd like to have, but it's as much I'm willing to share at this point because right now I would tell you we expect a good strong out of the block performance like you described and beyond that. I mean right now, Mike we're adding about 50,000 patients a quarter and that's across a continent that we had to go at one country at a time, one reimbursement system at a time. Of course the US is quite large, and Japan and UK as additions to this are also quite large. So I mean, we have a fair amount of optimism and trying not to get too far ahead of ourselves.

And obviously I've a lot more questions, but I'll let someone else jump in. Thank you Miles.

Thank you. Our next question comes from Matt Taylor from Barclays. Your line is open.

First thing I wanted to ask about was, certainly it was encouraging that you got MRI-conditional labelling for your ICD in the quarter, so just hoping we could get an update on how things are going in Sylmar and then when we might expect the approval for CRT-D and maybe the ICM as well.

Yes, I'd say a couple things Matt. First of all let me back up and give a bigger context to this. Over the course of the year, there was a lot of scepticism on the part of analyst end or investors about all the things that we had to get accomplished, that were back end loaded. A lot of third quarter, fourth quarter things and depending on how you're looking at it, it looks pretty daunting and we all know everything doesn't go right. And the Sylmar inspection put some of that in doubt. Now having said that, we stuck to our guns on what our estimates were and our projections were about when we would get product approvals and claim approvals, licensure approvals and so forth. And the third quarter alone here has been pretty gratifying in that. We basically got every approval we forecasted and let's call it, within 30 days or so of what we forecasted and I think that's been pretty gratifying, that what we said is what happened and that includes Libre, that includes the high voltage MRI claim, that includes HeartMate, it includes the closure of Alere, it includes Libre, it includes lot of things. I don't generally like being backend loaded because it feels like a lot of risk that everything has to go right, but everything did. And our progress with Sylmar is no exception as I've indicated on prior calls. Our team that has been working with the Sylmar team and so forth has done an exceptional job that we have provided all information, taken all actions, done all remediation, everything basically done on time, delivered to FDA, discussed with FDA etc. And at this point and we're just experiencing those new systems populating with new experience, new data, new decision making etc. and all of that is going exactly as planned, exactly as forecasted, exactly as communicated with the FDA and thus far without a hiccup and I think that's recognized by the FDA. I think it's recognized, they have discretion, they don't have to license new products out of that facility, but they have. And I think that is evidence of how we're progressing with Sylmar and the fact that the FDA is giving it all the scrutiny that they would and should and what we've submitted to them for approval has been given fair and objective consideration and we've gotten our approval so far. With that said, the remaining ones, I'm not going to change my estimates on. I'm not going to change what we forecasted. I have no reason to believe otherwise. They clearly have the discretion not to, but that's not been our experience and so consequently I remain optimistically that we're on track that we'll deliver what we said.

Thanks. And I wanted to turn to another thing that you mentioned in your prepared remarks. On China you said you were preparing for these regulations to change the Nutrition in the New Year and did improve a little bit sequentially. Could you talk about, what kind of opportunity you could have in China, if that comes to pass on time with regards to being able to maybe soak up some of the capacity that gets lost at local players have to shut down or change their operations.

Well I'll tell you what, I'm not sure. I would tell you this. First of all, we have product approvals we need. We're ready for the transition. Building inventory for such etc. So as far as responding to the new law and I think this is true for at least the large multinational competitors. I think most of us, if not all of us have our product approvals. We are ready for the transition etc. How we all manage that, who knows. But I think at least we are and I think others are, ready with new approved replacement products etc. as we've been required to do. So I think we're all ready for the transition on January 1. What you can't know very well, at least about everybody else is how much inventory everybody has in various channels? How long that transition will take for any given competitor and so forth. We are comfortable with our inventory levels were comfortable with our inventory levels both on current product and post January 1 product. So we're comfortable what we think we have to do with our own transition. What's hard to project is not just multinationals, but all the hundreds of other Chinese competitors that are faced with the same regulation. So I'd say we've seen a stabilizing of China, it hasn't been as choppy as it was in the last two years. I'd say our estimates around market growth are hard to pin down. We were more conservative on market growth than recent data we've seen. The market growth is better than we indicated or better than we believed or better than we thought and we're looking pretty closely at all the sources of our market data because there are many and they're not all perfectly comprehensive across all channels and then all sources of products or even all geography, so it's a hard win. China is a particularly difficult one to pin down because there are a number of channels, there are a lot of competitors, there are a lot of data sources, it's not like going to AC Nielsen in the US or something. So I'm cautious about it. I think we've seen the tough part and I think we're going back into a phase where it's the same kind of hand-to-hand competition, we've always had across multiple channels, I like that. I think that's better because at least then whether we do well or don't do well is a function of our execution, I haven't been particularly pleased with our execution and I don't exclude a number of other countries where we do see soft market conditions, but I also see less than great execution on our part. So this business is getting a lot of attention from us and from all of us top to bottom and it will get some attention. I think it's probably the one soft spot in our release. That make a lot of things you know are going awfully well as I just commented to you in the device area. But this one is going to get a lot more attention. I feel that China is at least reasonably stable or predictable. We haven't been right about the market growth rates. Those looked better than we expected, so that's a plus and I guess I would just leave it at there.

Great. Thanks Miles.

Thank you. Our next question comes from Bob Hopkins from Bank of America. Your line is open.

So first, I just wanted to clarify something now as you said on Alere. Obviously I heard you that the accretion for 2018 will be lower than you originally thought, that's not surprising. But I just wanted to confirm, do you still think it will be accretive in 2018 and is roughly half the original accretion reasonable placeholder?

Yes, I expect it to be accretive. We've got a lot of work to do, to identify our synergies and identify growth opportunities. We're going through reorganization of the business right now and I think that's actually going to be a plus. I don't want to describe how it was organized because I think that's kind of waste of time and it will take a long time, but we went through a restructuring of the old structure of St. Jude and we did it within six months and as you know organized in integrated business units that I'd say organization is still kind of setting, the glue is still kind of setting, but we move to within six months that might have been aggressive but the organization is very stable. The restructuring activities that we had to go through and a lot of synergizing as far as people go, we've gone through, changes and management we've gone through etc., that all got done. But about the six month level at St. Jude it all got done in Alere in six days. So that's a running start. And we've announced what we're moving to, I think it's an organization like all organizations all people want to do well. They want to achieve, they want to grow, they want to be proud of the businesses they're running, they want to do well and I'd say, our early days with the employees of Alere have been positive and we announced that we're going to go to that kind of structure, we've announced how we're going to do it, why we're going to do it etc. and I think that's well received at this point. So as far as we look into 2018, I think your question about was half of that, a good placeholder. I'd say, yes it's a good placeholder. I can't tell you with any precision that that's what it will be, but I think it's a good placeholder.

Okay, that's very helpful. Thank you. And then I'm sure there will be a lot of other questions on Libre but I want to focus on the rest of pipeline for a second because there are number of other things in addition to Libre that could help in 2018 and you touched on the MRI safe approvals, but I just wanted to kind of ask specifically on some of the other things that you've got in the pipeline and just to make sure that the timelines and your thoughts on those, haven't changed at all, relative to what you've been saying previously. And so, that would include things like the new stents that you've talked about Sierra that [ph] Confirm implantable cardiac monitor that's entering what is a very attractive market and so I'm just curious on those couple of things, the timeline is still the same as what you've been saying previously.

Well couple of things, first of all with regard to Sierra the same schedule, no change that will be first quarter of the year, we think. And with regard to Confirm, it's partly approved already. As you may understand it gets approved in pieces and so far, so good. There are some peripheral pieces we're waiting for approval on, but the first and very critical portion of that is approved. So yes I think that's - so far everything we've seen is very encouraging and no change.

Okay, so Confirm can be a full launch in 2018?

Well right now, that's what I bet on.

Okay, great. Thanks a lot. That's all I had.

Thank you. And our next question comes from Rick Wise from Stifel. Your line is open.

Miles, just after a solid quarter again coming out in the 2017 to the upper end of the range. I know it's early on to put all these pieces together in 2018, but as I reflect on it. And 2018 was multiple large new product opportunities launching St. Jude, Alere working shouldn't we expect at least similar topline growth and potentially better, if not accelerating topline growth against especially when you think about some of the headwinds you've faced in and worked through 2017, is the right way to think about it?

I'm trying to think about how to sound conservative to you. Look, we got our acquisitions closed. We're going to have a number of product approvals that happened in the third quarter and fourth quarter that obviously should hit their stride. I mean ideally you look at 2018 and you'd like to have your product approvals exactly where we got them, going into next year. We've had a really good 2017, we beat all expectations not just in the numbers, but in the approvals. You all have to admit you had a lot of scepticism about some of this and maybe rightly so after 2016, but look we hit every target, we had for this and with all those approvals, one ought to think that, should bode positively for 2018. That said, when we go through our budgeting every year it's kind of negotiating tussle with our managers around the world, about what's possible in their given market and so forth. But I think we ought to have pretty good momentum going into 2018 What can I say, all the organic R&D projects and system projects and launches and approvals and so forth, they're all happening. And the Alinity products probably most miraculously five of those began their launch process in Europe and they'll start in the US next year, that's been a huge, huge undertaking, we're extremely excited about Libre, we're excited about all the medical device products, everything that St. Jude represented to Abbott about its pipeline has come to fruition and is coming to fruition and so, we're very, very bullish about all that. And I think we're - and I think there is an awful lot of validation in this about that acquisition. We don't know as much about Alere yet, but we will. And whether it's a big impact for 2018 or if it's beyond 2018, either way I think we're pretty happy to have that business. So you know Rick, I think your assessment is right. It'd be kind of hard for me to say, no it's going to be a tough year.

Miles, that's a great answer and I'll take it. Another big picture reflection. One of the concern is obviously with two major acquisitions was balance sheet, cash flow, but my sense is in the first half at least you ran ahead of your cash flow generation commitments and goals. Maybe, can you give us any feeling how the third quarter went, remind us where your targets in terms of leverage and just again as we think about next six, 12 months or where do you think you can, where do you think you'll be from leverage and cash position? Thank you. Any color would be welcome.

Okay, well first I'd tell you that, this got great leadership and attention from our CFO and our EVP's and SVP's from day one and I'm going to let him answer that question because they've exceeded all of our targets not just by a little, but a lot. The cash flow is strong and I'll let him tell you that.

Thanks, Miles. Rick, we continue to make great progress in our programs. If you recall, I talked about operating cash flow being around $4.5 billion for the full year. I won't quote you an exact number for Q3, but I think you'll safely assume that when you see the quarter filed, that we're well on track to that and I will say ahead of it. So we're going to continue to make that progress. As you talk about some of the ratios, I think it's important to keep in mind both debt and net debt. So at the end of the year, we projected a debt to EBITDA ratio of around four, however when you look at the cash flow programs and look at our net debt position, we'll be closer to three when you look at the net debt as a ratio to EBITDA. So we're in great shape and we want to keep the momentum going because this is number one priority to build back strategic flexibility here.

I think [indiscernible] commercial out there. This all gets even better if there is tax reforms. I'm hopeful. I wouldn't put odds on any more than anybody else watching our government but we're extremely hopeful of the territorial system that and it gives us access to our cash flows and earnings around the world at a reasonable rate and at a competitive rate and that does make it difference to us, in addressing current debt and cash flow, but cash flow itself, super good.

Appreciated. Thank you.

Thank you. Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open.

I just had two. One it was noteworthy that you didn't mention the impact from the weather. You still had a strong quarter despite the weather. I imagined it had to have to some impact. So is there any color, you can provide and I have one follow-up.

Yes it did. I would comment a couple of things. First of all, it was a strange quarter for us in that, multiple hurricanes whether in the Texas Gulf Coast or across the Puerto Rico impacted, anybody who had operations there. The earthquake in Mexico impacted us. The brush fires and forced fires in California actually impacted us the day after we closed Alere had a key Alere facility there. And to be honest, it was more impact on our employees than on our plant operations. We had a little bit of roof damage and a little water leakage here and there, but it would appear the hurricane effected different companies, different ways going across Puerto Rico because I've noted that some competitors have indicated more damage or more impact than we've experienced. It took up a super human effort by a lot of our people to try to address some of that, which we did. The biggest issue was access to power generation in Puerto Rico and our folks address that really rapidly and we're very happy about that. Our plants, I guess back up and running, is the right way to say it. There is one that we're starting this week and we're back up, is what it amounts to. And so there is - I would call it a modest impact, it affected us, I'd say in a modest level, not a material level. Our first priority was to find all of our people and aid them, which we've done. And so in Puerto Rico, we have not experienced the kind of disruption that some others have. I noted that, another large healthcare company yesterday I think had similar comments that they've been able to address it. We're kind of large in Puerto Rico, so it could have been worse, but it wasn't and the St. Jude facilities that we inherited there with the acquisition. St. Jude were not particularly impacted, I mean they were but not to the degree we might have expected I mean everything is been more about power generation than damage. And unfortunately that's not true for our employees and it's not true for some other competitors and I wouldn't wish that on anybody. But we've been pretty fortunate to get everything back up and running. So we don't have an impact to report for the fourth quarter that we haven't somehow managed or absorbed already in our estimates. The facility that was threatened in California was not damaged. We were able to move things out of that facility and prepare for damage, but there wasn't damage and so we'll be back up and running soon, we did have employees who unfortunately lost homes and so forth and we're dealing with that as a company. But from the standpoint of the operation of the business, we are in good shape relatively speaking and to the extent that there is any impact, we've already included in our estimates for this quarter and absorbed it.

That's good to hear. For my follow-up, I wanted to ask about with management. That's the one business where if you improve that dramatically that really impact positively your growth. So I'm just curious what your expectations are for that business going forward, could it be potentially flat in 2018 and just a few to clarify at Confirm or X [ph] is going to be booked in that line or not? Thanks for taking the questions.

Okay, I'm going to have Scott answer that one for you.

As you know on the MRI safe [ph] side, we continue to see good progress on the pacemaker. We received approval for the ICD very late in the quarter, so that certainly didn't have an impact this quarter here and the third quarter. But we do expect to have an positive impact in the fourth quarter. So yes I do think you'll see a nice step up in growth starting quite frankly next quarter and then as we move into 2018.

It's gratifying that our experience with the pacemaker has matched our experience in Japan and Europe with the MRI approvals in terms of share recovery and so forth. So I think that bodes well for the ICD as well.

Thanks for taking the questions, guys.

Thank you. Our next question comes from Glenn Novarro from RBC Capital Markets. Your line is open.

Miles, you guys are doing a great job in terms of cash flow generation, you're going to get to your targets faster for 2018, but it sounds from Brian's commentary that 2018 is not going to be any type of deal here. It's going to be more about paying down debt, is that a fair assumption? Or do you actually have more flexibility there. If something does pop up, that's really interesting that you can do it next year. That and just some housekeeping questions after that.

Well let me answer it, this way. I don't really want the organization focused on M&A right now. I think I would give you that answer regardless of what Brian said about debt and cash flow and so forth. And secondly, I wouldn't forecast it even if I had it in my gun sights. Most of the - my experience with you guys over the past 19 years has been you liked to have some indication on what's coming, usually that surprised you more acquisitions or other things that we've done that hasn't always been particularly well received but they've always turned out pretty well, but I generally don't like the forecast where we're going or what we're doing until we announce it and so I probably wouldn't tell you anyway.

But is there some powder [ph] for next year or is next year really let's focus on St. Jude, let's focus on Alere, before we think about anything else.

Honestly I think there is focus on St. Jude and Alere and right now that is paying off. Look the focus on St. Jude it's clearly paying off, the focus on Alere will pay off. The focus on the internal product launches of Alinity and so forth, these things will pay off. These are fundamental drivers of sustained growth. I mean it's the hallmark and the identity of the company is sustained growth and we target double-digit earnings growth every single year, your organic performance both in terms of R&D, pipeline, commercial performance etc. has to be sustainable that is where the focus is, and we've acquired a couple of businesses that initially were criticized that's not growth and I beg to differ and I think that we're demonstrating so far with St. Jude that there is a terrific pipeline and growth and share gain, etc. and I think you can see that. You can see that in the initial couple of quarters here, so yes I think there is going to be a lot of focus on not just St. Jude and Alere, but the fundamental organic performance of all of our businesses. You know it took a while for analysts and investors to appreciate the uniqueness of our strategy in established pharma and I think it sort of called out that there is a segment of pharma that's not commodity generic, that's branded generic, that's higher margin, higher growth, etc. in pretty key markets around the world and right now that's our fastest growing business other than neuromod. And neuromod's hard to touch, but we're growing that business at double digits. The team is doing a terrific job. Those markets represent the kind of opportunity we said they did and those kinds of growths from an operating standpoint growth rates out of the business that's what you want. So to some point if we can add to our footprint and add to our strategies, we want to be in a flexible position to do that. We obviously want to get to a position where we have the strategic flexibility that we always felt we had, so I don't think it's a bad idea for us to focus on the operations. Keep pushing our cash flow, keep pushing that debt down. So that's where the focus will be next year and I think we get ourselves back to strategic flexibility quicker that way, which is a good thing.

Yes. Okay and then just I agree with everything you said, just some housekeeping. Maybe for Scott. You said Portico you finished in ruling next to US trial, would that put you on pace for 2019 US launch. And then I think you talked about Mitro [ph] which is the Tendyne program and I think you said you started enrolling, is that enrolling in the European trial and then is there an update on the start of the US trial? Thanks.

I'm going let Scott answer that.

Sure, Glen. On Portico, we would expect to file in the US in the first quarter of 2019 to your question, so then you have the regulatory process after that. With respect to the Tendyne in Europe, we expect to complete enrolment here in the first quarter. It's a one-year endpoint so you can kind of do the math after that, but we're in the 2020 range or so on approval on the Tendyne product. Really great opportunity though, really it's structural hard portfolio here in totality is really come together what Abbott brought - almost St. Jude brought [indiscernible] so we're excited about it, longer term.

It's a really good to know, that's one that came out of our own venture group from our own investments and so forth and we've been able to combine these things, with St. Jude in a way I think is pretty synergistic, pretty favorable so we're pretty excited about that one.

Any update on when you start the US trial for Tendyne?

Yes, we could initiate US trial here in 2018.

Okay, great. Thank you.

Okay, thanks. Operator, we'll take one more question.

Thank you. And our final question comes from David Lewis from Morgan Stanley. Your line is open.

Miles, I thought I'd end on couple of questions on growth, I guess I'm little surprised that neuromodulation has not come up in this call, given it's been biggest growth driver for St. Jude this year, 50% growth through the first three quarters. I think every single quarter we expect that growth rate to come in a little bit. It's been extremely durable across the three quarters. Can you just give us a sense of factors that are driving that growth and sort of how you think about the sustainability of that growth in due 2018? And I have a follow-up after that.

I mean I think anybody that claimed 50% growth rate was sustainable will be an idiot, but so I'm not going to be one. Look we're very pleased with the performance in Neuromod. I think it's obviously driven by the fact, we've got three great products there. They're being exceptionally well received by the market. They have an impact in real life on patients in their P&L levels. We're seeing great with real world results from Burst and DRG. I think it's a really great group of products and a strong organization. I think the products hit a segment that's in kind need of improvements for patients and particularly the time when pain drugs and so forth are a national issue. So I don't know, I think the new products are driving the growth and the execution is been strong, the uptick is been strong. We've got three quarters in a row, 50% better growth. How long will it be like that? [Indiscernible] lap it, with all big numbers we'll start to diminish the growth rate, but the actual raw growth will still be pretty strong, so I don't know, I like what we see but it's hard for me to hold it up with an example to all the other business, so you should do this.

Sure, very clear. And then I think Brian or Scott just to wrap up here. Into the fourth quarter because I think you can set the tone for investors as we think about next year's growth rate. You're certainly guiding to sequential acceleration sort of mid-to-high. Can you just kind of run through kind of sequentially what are those key components that get that acceleration because as I said, I think it sets the tone for 2018? Thanks so much.

I'll take this. I think it's just - Miles had talked about the continued growth of brand and generics business, it's been performing at a double-digit range. I think you should expect more of the same there. If we look in diagnostics just sustained what you're doing, we do expect improvement at that business overtime as we continue rollout out our Alinity platforms across the globe. Diabetes care you know that story, it's growing very strong and we're excited to bring that here to the US. And most notably, I mentioned this in my guidance on the medical device side, that's where the step up is, where I talked about the mid-to-high single-digit and Scott caught a broad color to that, by saying you should expect further sequential improvement on the CLI side of the business because we've always said the magic formula is just bring that back to flat and the double-digit growth of all these high growth areas will shine through and deliver 5% or 6% on our medical device business. Those are really the key catalysts here, so we look forward to have good fourth quarter here.

Okay, thanks so much.

Very good. Thank you operator and thank you for all of your questions. And that concludes Abbott's conference call. a replay of this will be available after 11 AM Central Time today on Abbott's Investor Relations website at abbottinvestor.com, and after 11 AM Central Time via telephone at 404-537-3406, pass code 88967373. The audio replay will be available until 9 AM Central Time on November 1. Thank you for joining us today.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a great day.