Ladies and gentlemen, thank you for standing by, and welcome to the Medtronic third quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you. I would now like to turn the conference over to Mr. Ryan Weispfenning, Vice President, Investor Relations. Please go ahead, sir.

Great. Thank you, Paula. Good morning and welcome to Medtronic's third quarter conference call and webcast. During the next hour, Omar Ishrak, Medtronic's Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic's Chief Financial Officer, will provide comments on the results of our fiscal year 2017 third quarter, which ended on January 27, 2017. After our prepared remarks, we'll be happy to take your questions. First, a few additional comments, earlier this morning we issued a press release containing our financial statements and a revenue-by-division summary. We also issued an earnings presentation that provides additional details on our performance and outlook. You should note that many of the statements made during this call may be considered forward-looking statements and that actual results might differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC and we do not undertake to update any forward-looking statement. In addition, the reconciliations of any non-GAAP financial measures are available on our website investorrelations.medtronic.com. Unless we say otherwise, references to quarterly results increasing or decreasing are in comparison to the third quarter of fiscal year 2016 and all year-over-year growth rates and ranges are given on a constant currency basis. Other than as noted, our EPS growth and guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year. These adjustment details can be found in the reconciliation tables included with the earnings press release. With that, I'm now pleased to turn the call over to Medtronic's Chairman and Chief Executive Officer, Omar Ishrak. Omar?

Good morning and thank you, Ryan, and thank you to everyone for joining us. This morning we reported third quarter revenue of $7.3 billion, representing growth of 6%. Q3 non-GAAP operating profit grew 10% and non-GAAP diluted earnings per share or $1.12 growing at 10% and representing EPS leverage of 480 basis points. In Q3, we achieved solid results across all of our groups with mid single-digit growth in CVG, MITG and RTG and high single-digit growth in diabetes. Geographically, we also demonstrated solid performance with mid single-digit growth in the U.S., high single-digit growth in the non-U.S. developed markets including Western Europe and Japan and double-digit growth in emerging markets. At the same time, we delivered meaningful operating profit growth, executing on our synergy programs from the Covidien integration and our operating excellence initiatives. Our revenue and operating profit growth resulted in continued strong free cash flow. As stated before, we expect to deploy this capital by balancing returns to shareholders with disciplined reinvestment in our business. We remain confident in our ability to deliver mid single-digit constant currency revenue growth and double-digit constant currency EPS growth, not only in our current fiscal year but also into the future. Our solid revenue performance resulted from crisp execution on our three growth strategies. Therapy innovation, globalization and economic value. These strategies are designed to create competitive advantages for Medtronic by capitalizing on the long-term trends playing out in health care, namely the continued desire to improve clinical outcomes, the growing demand for expanded access to care and the optimization of cost and efficiency within the healthcare systems. When combined with the demographics of an aging population, they produce secular growth tailwinds that we believe will create sustained long-term opportunities for Medtronic. Now let's discuss each of our growth strategies. In…

Thank you, Omar. Our third quarter revenue of $7.283 billion increased 5% as reported or 6% on a constant currency basis. Foreign currency exchange had a negative $40 million impact on third quarter revenue, and acquisitions and divestitures contributed approximately 150 basis points net to revenue growth. GAAP diluted earnings per share were $0.59. Non-GAAP was $1.12. After adjusting for the $0.05 impact from foreign currency, non-GAAP diluted EPS grew 10%. Our operating margin for the quarter was 29.1% on a constant currency basis, representing a strong 130 basis point year-over-year improvement. With the impact of currency included, our third quarter operating margin also improved, increasing by 40 basis points year over year. And we continue to cover the earnings dilution from our recent acquisitions, which means we maintain operating profit expectations while realizing the incremental acquisition revenue. Taking into account acquisitions that we have done in the past year, our operating margin improvement on an organic basis would have been approximately 170 basis points in the quarter. This meaningful margin improvement was driven in part by efficiencies in SG&A, as we continue to deliver on our Covidien synergies. It is worth noting that our extensive effort to move Covidien onto Medtronic's global ERP system is underway and meeting our expectations. As we have outlined, this activity is an enabler, driving a portion of the cost savings we expect to realize in the latter half of the synergy period. We remain on track to deliver $225 million to $250 million of synergy savings this fiscal year and expect to deliver on our commitment of $850 million of savings by the end of fiscal year 2018. Beyond our integration efforts, we will remain focused on driving additional operating excellence initiatives to deliver continued margin improvement. Net other expense was $46 million…

Thanks, Karen. To conclude, Q3 was a solid quarter, and I was pleased by the revenue growth and sequential improvement in our groups and regions. Along with revenue growth, our organization delivered meaningful operating margin improvement and double-digit constant currency EPS growth as well as growth in free cash flow. Looking ahead, we remain confident in our ability to deliver mid single-digit constant currency revenue growth and double-digit constant currency EPS growth, not only in our current fiscal year but also into the future. With our differentiated growth platforms, leadership in strong end markets and disciplined capital allocation, we believe we are well positioned to create long-term dependable value for our shareholders. We will now open the phone lines for Q&A. In addition to Karen, I've asked Mike Coyle, President of CVG; Bryan Hanson, President of MITG; Geoff Martha, President of the RTG; Hooman Hakami, President of our Diabetes Group, to join us. We want to try to get to as many people as possible, so please help us by limiting yourself to only one question, and if necessary, any related follow-up. If you have additional questions, please contact Ryan and our Investor Relations team after the call. Operator, first question please?

Your first question comes from Kristen Stewart of Deutsche Bank.

Hi, good morning. Thanks for taking my question. I guess just a quick one for Karen, just on the topic of the IRS transfer pricing dispute. With the change – I guess with the increase in cash and the movement of trapped debt, what does that also do to the tax rate longer term?

Yes, it doesn't really impact the tax rate longer term. We continue to expect a 17% cash tax rate, both for the rest of this fiscal year and likely going forward.

Okay, perfect. And then just a bigger picture question for you, Omar. If there had been some conjecture during the quarter just in terms of the medical supplies business, maybe if you could just – from a bigger picture perspective, just talk about now that we're two years past the anniversary of Covidien, maybe just talk more broadly about how the acquisition has gone, and just generally, if there are some assets that may be better monetized outside of the portfolio, whether it's with Covidien or just looking at the whole portfolio and just your thoughts on how that's added value to Medtronic. Thanks.

Well, firstly, we are, as I've noted several times before, quite pleased with the way the Covidien acquisition has gone through. It's been a very complex transaction as you know. It's one of the biggest in medical devices, perhaps the biggest. And we've now into year three of our integration process. And we've done it exactly the way we planned it. We're preserving our revenue, optimizing our costs and beginning to transfer healthcare through this process. And employee satisfaction ratings are high. We've had good retention ratings. So we've really hit all the strategic and tactical objectives of the Covidien acquisition, and we continue to do so. We've still got a year more to go, and as Karen outlined, we're optimistic about the rest of the integration. I'm not going to speculate on the future of specific products and businesses. What I will say is that, as part of good portfolio management, we ask a series of questions. What value does Medtronic add to that product or business? What value does that product or business add to Medtronic overall? And is the business appropriately resourced, given Medtronic's overall priorities? We look at these questions across all our portfolio and we will take action both in terms of divestitures and acquisitions on that basis. I think that's the best way to comment on this subject, Kristen.

Okay. Thanks very much.

Thank you.

Thank you, Kristen. Paula, can we take the next question please?

Yes, your next question comes from Mike Weinstein of JPMorgan.

Thanks, and good morning, everybody. Let me start, Omar, with your comments where effectively you reiterated the outlook that you gave back last June at the Analyst Meeting. You said we remain confident in our ability to deliver mid single-digit constant currency revenue growth and double-digit constant currency EPS growth, not only in the current fiscal year but also into the future. And I think I want to draw attention to that because obviously that's an important statement. I think on the back of last quarter and the lowering of FY 2017 guidance, I think the confidence in the LRP had waned on the Street. So could you just spend a few minutes, and Karen chime in here, on why you're still confident in, not only the mid single-digit top line, I think where the Street has always struggled, has been on the margin expansion piece, the ability to go after the significant margin opportunity that you've talked about and deliver double-digit EPS growth over the next several years? Thanks.

First of all, from the mid single-digit growth, we've stated in our Q2 call that a lot of that was a result of some unrelated market factors, some of which still persist, but also related to the timing of some of our new product launches, which are now playing through as expected. So the mid single-digit revenue growth is more or less in line with what we'd always projected on a yearly basis, and we have every expectation to maintain that into the future. In terms of the operating margin rate, we're delivering according to what we talked about, including acquisitions for that matter in terms of the operating margin rate. We still have a year's more of Covidien synergies to deliver on. And like I stated at the Analyst Meeting and subsequently, we're using that opportunity to build a structure through which we can look at other opportunities throughout the company as we leverage our scale, starting with the consolidation of several manufacturing operation plants, reducing that from over 100 to something between 50 and 60. If you do the math on all of that plus centralizing some of our support functions and comparing it against industry benchmarks for the size of business that we are, we get to a number that we talked about at the Analyst Meeting. So nothing fundamentally has changed from that. Karen? No? Okay.

And maybe I'll bring Karen in. So, Karen, as you've had a year now or coming up a year to get further into the business and to get your own arms around the numbers, your confidence in the ability to go after what was 500 basis points to 650 basis points of margin expansion over a five-year period, that number at this point appears achievable or reasonable to you?

Mike, we remain focused on delivering on our commitment of double-digit EPS growth, and there's no way that we can get there without meaningful margin improvement. So we are focused on it, and we have plans in place in the near-term around Covidien synergies and then beyond Covidien synergies in the longer-term to continue on that effort.

Okay. Perfect. I'll let some others jump in. Thank you, guys.

Thanks, Mike.

Thanks, Mike.

Paula, next question?

Your next question comes from David Lewis of Morgan Stanley.

Good morning. Let me start, Omar, with you and then move on to Karen. Omar, we've seen some recovery in the U.S. businesses of many of your peers this quarter. Your U.S. business this quarter was really stable on a comp adjusted basis, no material improvement, but your ex-U.S. business was much stronger than we thought. Could you just walk us through sort of U.S., ex-U.S. dynamics this quarter and how you see the future unfolding?

We felt pretty good about our U.S. business. We've had some significant product launches which sequentially for us has made a big difference, and those are progressing on plan. We also see new products coming out into the fourth quarter, into early next year in several areas across the board from CVG, diabetes, MITG and RTG which we think will sustain that growth, and the U.S. is most sensitive to growth as new products are launched because that's usually where they're accepted first. Outside the U.S., we've done well. I think Europe continues to grow in a consistent fashion. I think some of our Hospital Solutions effort, although the Hospital Solutions represents a relatively small portion of our overall business, it does drive meaningful share and performance on those accounts. And outside of Western Europe, I think, let me just reemphasize that our strategy of consistent strategy of focus in emerging markets, of building both private and public partnerships and optimizing our channels is resulting in sustained growth. And we've been through several macroeconomic related market fluctuations in many geographics and still delivered double-digit emerging markets revenue growth. And I think we have plans in place to sustain that. So I think that's really all I can say, a repeat of perhaps what I said in the commentary.

And, David, I would just add, you had mentioned U.S. growth being stable. In the third quarter with U.S. growth at 3.5%, that represented a meaningful improvement over the last couple of quarters.

Sure. Yeah, Karen, I just meant stable on a comp adjusted basis. Sorry if I was being confusing. So looked stable to us around 30 basis points improvement comp adjusted versus the optical acceleration, but thank you. And then quick question for you, Karen. You've been very clear on Puerto Rico. That cash is going to be used to pay down debt. I know we're not going to get you to talk about what's being divested or could be divested. But to the extent that we see a material divestment in fiscal 2018, are you committed to using the proceeds of that divestiture to repurchase shares to offset dilution? Or is there a chance that you still would use that cash to further pay down debt? Thanks so much.

Yeah, I can't speculate on anything potential in the future because any potential cash inflow will depend on the circumstances and the timing unique to that situation. But just to reiterate our capital allocation philosophy in general, we do remain focused on both reinvestment and return to our shareholders. I did note around the Puerto Rico proceeds that debt paydown does remain a near-term priority, but we will also continue to focus on acquisition strategy and to allocate additional resources to share repurchase when appropriate.

Thank you.

Thanks, David. Paula, next question?

Your next question comes from Bob Hopkins of Bank of America.

Hi. Thanks, and good morning. Can you hear me okay?

Yes.

Great, great. Good morning. So congrats on a solid revenue growth quarter in Q3 here. I just wanted to kind of get a little bit better sense for the drivers of that growth. So maybe broadly speaking, can you just talk about – was the strength sort of balanced across the months of the quarter? Can you talk about the environment for surgical procedure volumes? I'm trying to get a sense for the degree to which this was kind of Medtronic execution versus a positive environment and just sort of what happened over the course of the quarter. Thanks.

I think the new product launches that we had planned for this time in the quarter had a meaningful impact, especially sequentially and we stated that before. I think the market conditions weren't that different. We still had macroeconomic issues in the Middle East. And at the same time, the U.S. overall procedural volume remained more or less stable. However, as I noted earlier as you introduce new products, the U.S. gets the biggest benefit and then we realize that. In terms of new products, just to be specific, at CVG we launched Evolut R 34-millimeter CoreValve, and that really contributed to its growth. We really expect some continuance of this as we introduce the Evolut Pro and the Resolute Onyx in the U.S. towards the fiscal year end. We also achieved Micra reimbursement, which was significant. That's the small pacemaker. In MITG, we've launched over 50 new products in the second half of FY 2017 to drive growth. And as I mentioned, in RTG with our consistent level of launches and the speed to scale methodology that Geoff has introduced, we are really beginning to see some benefits of that. So these things put together – and obviously the traction on the diabetes 6 Series pump, right now with the 630G which if you recall, in Q2, we barely launched and really hadn't started selling. So that has gained some traction, and our Priority Access Program is also getting a good degree of interest for the 670G. So you put all that together, those are meaningful set of product launches. And what we're really excited about is that we expect that momentum to continue in terms of product launches in Q4 and have a good pipeline into next year. So I think that's the best way to think about the differences.

Great, thank you. I appreciate that. And then just quickly for Karen, can you give us some quick thoughts on the accounting changes you'll be implementing at the beginning of fiscal 2018? How much does that add to earnings? And do you have any preliminary thoughts on the impact of tax reform and what that means for Medtronic? Thank you.

Yes, if you're talking about the accounting change around stock compensation...

Right.

...we will be implementing that next year. The impact would be very dependent on stock price and option exercise, so very difficult to tell. But it will be part of our overall tax planning for next year. So I wouldn't expect any positive or negative from that to fall to the bottom line. In terms of tax reform, we outlined at the JPMorgan Health Care Conference the fact that if we look at the overall Republican blueprint, which has the most detail but still not enough detail to really assess the impact out there, we do think that we would benefit slightly from that blueprint and benefit in the near term on just tax rate. In the longer term, it could be a slight detriment as interest deduction on debt going forward may no longer apply. But the biggest benefit to us, as we talked about at the conference, would be the potential repatriation of our cash. Today, we have about 55% accessibility to our ongoing cash that we generate. And if we were able to have 100% accessibility, that would be meaningful to us. Just for this fiscal year alone, that could be another approximately $2.5 billion of cash accessible. And obviously, we anticipate growing our cash every year, so that could be very meaningful.

Thanks very much.

Thanks, Bob. Paula, next question?

Your next question comes from Danielle Antalffy of Leerink Partners.

Hi, good morning, guys. Thanks so much for taking the question and congrats on a great rebound this quarter. I just wanted to follow up on some of the revenue commentary. As we look into fiscal 2018 and you do have some incremental headwinds coming online. You guys have been very transparent about the replacement headwind for your high-power devices. You've got some competitors coming on the MRI/CT side as well, persistent competitive headwinds in spinal cord stimulation. You've got another transcatheter heart valve coming in the U.S. Can you talk about how you're thinking about what the drivers will be to manage through those headwinds and keep you guys at that mid-single-digit top line growth trajectory?

You've got to understand that, while there is competitive new product activity, we also have new product activity. We've used our lead, for example, in the cardiac MRI space by launching differentiated products in cardiac rhythm implantables. We've got approval now for 3T MRI, which our competitors don't. We've got a series of new algorithms in our cardiac rhythm implantable products that again are unique and differentiated. We've got the Micra, the smallest pacemaker, which no one else has and recently got reimbursement and only beginning its growth trajectory. So just in the cardiac rhythm space, we've got ammunition too against our competitors. Now it will have to play out in the marketplace, and we certainly don't take our competition lightly, but we're not exactly sitting still. In the transcatheter valve area, again, there is new competition, but we just came out with our second or third generation of these valves, building on the live clinical experience that we've built over the past two years in that space. So again, product launches coming out towards the end of this fiscal year and well into next year. In diabetes, we have the 670G hybrid closed loop system, which we think in FY 2018 will gain full traction and will be a meaningful growth driver for Medtronic into next year. Recall that this is a unique hybrid closed-loop pump product, which in many ways promises to be revolutionary in the treatment of Type 1 diabetes patients. And again, we've barely – we haven't really benefited from that successful approval in the middle of last year. And then in the neuro space, there is significant competition and we've got our work cut out for us there, but we are also launching products. We just talked about the Evolve Workflow that we just launched which has got good physician enthusiasm, which we are just beginning to get traction on. We've got INTELLIS implantable neurostimulators, which are the smallest stimulators there are in the market, which again, will have an impact. In MITG, a series of new launches, led by the LigaSure instruments, our stapling products, all of this put together with a cadence of launches, like I said earlier, about 15 new launches in MITG in the second half of this year alone. That's a pretty big list which is broad and diverse.

Yes, I know.

And we expect this will make a difference.

That's very helpful, Omar. And I guess just following up on that, you've broken out what you expect in new products, growth factors you contribute. Should we still be thinking about that as contributing what it has in the past, or do you think that's going to be a bigger contributor going forward because of all that you just listed?

No, I think our growth efforts are to some degree diversified, although the new product segment or the new therapy segment is the biggest portion of our growth. We've talked before about new therapies contributing something like between 200 to 250 basis points of growth for Medtronic every year, and that remains on track. In addition to that, we've had steady performance from our emerging markets, and we expect 150 to 200 basis points of contribution from that, and delivering in the low double digits will give us that. And Services and Solutions driven by annuity revenue from Hospital Solutions as well as some of our value-based healthcare business models also contribute meaningfully to our growth. So we've got a balanced growth effort across these different areas. But of course, new therapies form the heart and the core of our growth. And they also, in fact, lead to future emerging market and economic value growth.

Thank you so much. I appreciate the response.

Thanks.

Thank you, Danielle. Paula, can we have the next question please?

Your next question comes from Brooks West of Piper Jaffray.

Hi, thanks for taking the questions. I want to start with Hooman if I could. A lot of moving pieces in the diabetes market right now and, Hooman, I'd love to get your thoughts on the market overall, especially given J&J's recent announcement. And then we're trying to connect the dots in terms of how we should think of the ramp of your business. So you've talked about spring launch for 670G, but you've talked about that being a controlled launch. You've got the Priority Access Program. I'm just wondering how that all works as we think about the launch cycle of that device? And then last, just how should we think about the contribution from the UNH relationship? Thanks.

Sure. Okay. So a few pieces there, Brooks. I'll try to take them one at a time. As far as the market overall, as you pointed out it's a dynamic market, and certainly over the last, call it, 90 days a significant number of competitive sort of announcements. But what I would say is that, if you take a look at that market and you look at our positioning in that market, we feel great about where we are. We've got the 630 in the US. We've got 670 that we're going to launch in the spring, number one. Number two, we have a stand-alone sensor that we anticipate getting approval on towards the end of this fiscal year, beginning of next fiscal year which will signal our entry into that market. And then on top of that, our international growth continues to be good. So you put all of those pieces together on top of the work that we're doing in value based healthcare and Type 2, we really like how we're positioned in the marketplace overall. Now in terms of the 670G specifically, you pointed it out. The launch is spring as planned. Absolutely no deviation from that. It is going to be a staggered launch as we've talked about before. And the reason we're doing the staggered launch is to make sure that we're rolling this out in a methodical way, so that we do the right thing for patients and physicians, make sure they get the proper training. And then also it's staggered because we do have a Priority Access Program. We want to make sure that the participants in the Priority Access Program are first in line for this new technology, our employees as well, and then as we conclude with payers and manufacturing capacity, we'll open it up and really get the full capacity. And then I think your – the last part of your question, Brooks, on UnitedHealthcare, that relationship continues to go well. We're very pleased with how that has gone. It really was our first step into value based healthcare with a payer, and we were thrilled to be able to do it with United. And we've been able to have ongoing discussions about how we can continue to broaden that partnership. And so that landscape looks well. You touched on other payers. I'm not going to comment on specifics related to other payers, but I would say, as other payers look forward, they're also looking to ensure that they are driving, not only costs but also outcomes. And that's going to continue to be very important.

Thanks. Let me just follow up if I could on the 670G launch. So I'm curious, how as a patient do you get into the Priority Access Program? How does that work? And given the kind of four-year cycle around pumps, how many patients in your installed base, broad numbers, do you expect will be in that Priority Access Program? And then if I think about when are you going to hit full launch on 670G? Is that by year end? Is it further out than that? Just a little bit more clarity would be helpful. Thanks.

Sure. So, on the 670G, the Priority Access Program essentially – so let me provide some additional background. Back in August, we received approval from the FDA for the 630G product. Literally less than a month later, we received approval for the 670G product which was far faster than what we had anticipated. And if you remember, we had submitted the 670G to the FDA in June of last year, so far accelerated timeline by the FDA for the 670 approval. So literally in less than a month, we had two products approved right on top of each other. We created the Priority Access Program so that patients who purchase the 630G would be first in line for the 670G once it was released in the spring. And so that's really how you get on the Priority Access Program. As far the uptake question that you have, Brooks, we don't disclose the actual number of participants that have chosen to enter into the Priority Access Program. But I think, as Omar talked about in the commentary, we're very pleased with our U.S. results as we really start to get into the swing of things here, first full quarter with the priority access program and the uptake continues to be great. And there's a number of things that need to happen in order for us to really get the full launch, not the least of which is payer coverage which we're actively working, and it's hard to estimate how that's going to go. But those are the kinds of things that we're working on in order to ramp up as fast as we can.

Thank you so much.

Sure.

Great. Thanks, Brooks. Paula, next question please.

Your next question comes from Joanne Wuensch at BMO Capital Markets.

Good morning. Thank you for taking my question. Can you give us a little bit of an update of how you're approaching, entering the United States with your Hospital Solutions business? Obviously, you've got your first contract here in public on the print, but how do you think about pushing that business further in the U.S.?

Well, again, in a measured fashion, we're going after significant accounts where there is an interest in our overall capability. We think in the U.S., given the strong sort of innovation platform that we have here that these accounts can serve as launching pads for future value based healthcare programs where we really work on the value for our new therapies on these platforms. And again, we do these in a measured way. I think a lot of the efficiency initiatives that we have in other regions around the world, the U.S. hospitals do by themselves. So, again, we're being selective about where we go. But there is a considerable degree of interest, and we are going to be adding a few more accounts in the coming months.

And then as my second question, there's a lot of moving parts, some coming out this weekend at ACC, and the TAVR space and structural heart. Can you give us an update on what your view is on that market, and particularly, where you are in mitral? Thank you.

Yeah, I think Mike Coyle is the position to comment on this. So, Mike, go ahead.

Sure. We continue to expect the market growth that we outlined at the analyst meeting back in June. So the growth profile is really going to be driven by the expansion of indications of use into the intermediate risk group at ACC at late breaking clinical trials. We will be presenting the SURTAVI data which will be the basis of our clinical module for support of that indication for use in the U.S. And so everything we see is pretty much on track for what we described as a $4.5 billion to $5 billion market opportunity around 2021. So, in terms of mitral, we continue to do the feasibility enrollments for the Intrepid product. We're now up to about 40 implants and those continue to go well. We're going to be sitting – we are sitting down with the FDA to talk about pivotal study design and we expect to kick that off in fiscal 2018.

Thank you. See you at ACC.

Great. Thanks, Joanne. Paula, question please.

Your next question comes from Matt Taylor of Barclays.

Hi, thanks. I wanted to ask about two product factors specifically. I guess one is the last couple quarters you called out the replacement headwind. I was wondering how that impacted results in this quarter? And how you see that playing out in the results over the next couple quarters? That's kind of the first one.

Is this a replacement headwind in cardiac rhythm?

That's right.

Mike, do you want to comment on that?

Yes, we actually saw an improvement in the replacement growth this quarter from the standpoint that I pointed out last quarter. We were seeing high single-digit declines. We expected that to get marginally better just by the modeling of kind of where we were in the replacement cycle. But we also benefited in the quarter from two additional things. One is there was a fairly significant competitive recall that took place, and that actually drove some competitive replacements for us that we typically don't get. But we also had unrestricted release of TYRX in the quarter which is our anti-infective envelope. And it actually is particularly valuable in replacement procedures and especially high power replacement procedures. So, actually, the replacement growth was a low single-digit decline this quarter versus what we saw in Q2.

Great. And then one product that we haven't heard much about in a while could be a bigger one over the next year or so is the surgical robotics system. I was hoping we can get an update there on timing or if you want to give us any kind of preview in terms of the features and benefits and how you think that will compete.

I'll let Bryan comment on that. Go ahead, Bryan.

All right. Great. Yeah, no real change from the time that we talked to everybody in June. I still am very bullish on the project. We will be launching on a limited basis in specific countries towards the end of FY 2018. And then as I've said before, I would expect material revenue coming in FY 2019. The real difference between what we're going to launch and what you're going to see out there is the endo factors. I mean the robotics system itself I think is – will be interesting and will be unique in a certain way. But the endo factor is where we bring a lot of value to our end users today. There's a lot of confidence in those endo factors and to be able to combine that with a full suite of endo factors at launch of robotics system will be a big benefit to us. The other thing, outside of robotics by itself, I think this is important, as much as I'm excited about robotics as a microcosm, I got to look at the macro. And when we do launch robotics, we'll be the only organization that will have a full suite of instruments in open surgery, traditional MIS and robotics. And the combination of those things will be unique to us and the value then as a result of that that we can bring to the customer will be beyond what anybody else can. And that's probably the thing that I'm most excited about. Again, robotics by itself, very interesting. That broader portfolio is the thing that really gets me excited.

Thanks, Bryan. Thanks, Mike.

Thanks, Matt. Paula, next question, please.

Your next question comes from Vijay Kumar of Evercore ISI.

Hey, guys. Congratulations on a nice quarter here. So maybe my first one for maybe Mike Coyle is probably better suited for this one. Mike, back when you guys launched CoreValve in the high-risk group, right, we had this massive market expansion rate, patients on the sidelines. So there's been – do you think there's a large pool of patients sitting on the sidelines and when you guys launch intermediate risk, will it have a similar effect on the market?

When we do our modeling, we basically see the approval, general approval of intermediate risk expanding the sort of prevailing high and extreme risk patient population by another 50%. So you don't want to think about it as a third, a third, a third in terms of the distribution of these patients. So, obviously, getting the data out and then having that adopted to drive penetration is going to be the key item but that's the way we would outline it. And then of course, we've begun the low risk clinical trials as well as have some others in the space. And so we would expect that to be sort of the next wave of expansion as those data become available.

Great. And then maybe one for maybe Omar and both Karen can pitch in on this one. I think, Omar, when you look back on that question on operating margins, right, I think the thought process was you guys managed to an operating dollar rate on the profit equation. Has anything changed on that metric? The way you're thinking about the business given Karen's comments and, look, we're focused on margins. Because, obviously, from our side, this week, we look at margins, right, and versus how you guys are modeling or running the business internally. So I'm just wondering if there's been any change in the thought process. Thank you.

No real change in our thought process. I mean we said consistently that for sustained EPS growth, you need to do that through operating margin. Now that doesn't mean that there aren't other vehicles which we could use intelligently and which we will use and that's financial leverage. But at the end of the day, the majority of our improvement will have to come through operating improvement in the business. And we outlined and I said earlier in the call what kind of things we're looking at. I do think that the manufacturing consolidation is one of our biggest and most significant strategic moves in that area. And as that comes to play, we'll give you more details but that's one that we're working on very, very actively. And we think we'll be the platform which will give us sustained operating margin improvement in the future. I mean that's essential. And then like I said before, the scale and size of our company is such that many of the support functions have never been integrated and with the introduction of the IP systems around the world which are now sort of not complete but well on the way to being complete. Leveraging those will give us further capability to drive the efficiencies in that regard. So operating margin remains our focus. That's where we provide the most detail. But again, let's not forget that we sit on a lot of other assets and some degree of financial leverage we can get to shore up our EPS growth, I think is something that's the right thing to do.

Great. Thanks, guys.

Thank you, Vijay. Paula, next question, please.

Your next question comes from Bruce Nudell of SunTrust.

Good morning, thanks for taking the question. I had a question for Mike and then a follow-up for Omar. So, Mike, could you just talk about the growth rate in the LVAD market? I know it's a small acquisition but a space we're historically interested in, and U.S./ex-U.S. growth. And also the competitiveness of HVAD, I know the data is coming up at ISHLT, but just given the very low thrombosis rates seen with HeartMate 3, how do you think HVAD will compete even if the stroke rate is tamed in the ISHLT presentation?

Overall, the growth of the market is low double digits, so very much in line with what we had expected when we did the acquisition. In terms of the overall performance of HVAD, we are very bullish on its performance, and I think the data sets that we will be using to get the destination therapy results or the leading indications in the U.S. I think will show a high degree of comparability between the two products. And we think the size advantages of the product as well as its long-term ability to be done in atherectomy procedure we think offer some significant advantages and we're looking forward to competing in the segment.

Thanks for that. And, Omar and Karen, the company has successfully initiated an impressive globalization effort. But with that, you institutionalized currency risk. Can you foresee – firstly, do you foresee any secular changes, or do you think that negative stuff today will become positive stuff tomorrow? And secondly, what's the philosophy going to be in terms of just delivering cash EPS quarter-on-quarter irrespective of currency? Thanks so much.

Currency is clearly an issue and we do have exposure, that is true. We've got some hedging programs which softens the peaks and valleys in the currency rate. But in the end, that's all it does. We are, however, beginning to put to together, in accordance with our manufacturing operations optimization, a natural hedging program which will allow us to have cost and revenue in the same geography or at least in the same currency. That is the only ultimate protection against currency swings. But having said that, I will say that we're very early in that journey and it will take a while before that strategy really plays out but that's the course we have taken. Karen, do you want to add to that a little bit?

I would just add on natural hedging that it's not just where we place our centers, but it's also how we negotiate contracts with both our vendors and our customers. So we are focused on driving as much natural hedging as we can into the business. That said, we will always have currency risk just being a big global company. We recognize that currency risk is not something that we can control but something which we do indeed need to manage, and that's what we're focused on.

Thanks so much.

Thank you, Bruce. Paula, next question, please.

Your next question comes from Josh Jennings of Cowen & Company.

Hi, good morning. Thanks for taking the questions. I just had a follow-up for Mike Coyle on ACC and the SURTAVI data. I was wondering if you could help us just think about how the data is going to be presented. There have been numerous revisions to the inclusion criteria. It is an interim look and a Bayesian statistical analysis, but I was hoping if you could just answer the specifics. With the interim analysis pre-specified, is there any statistical penalty for the look? And then secondarily, what types of subgroup analysis should we think about being presented at ACC in terms of lower STS score, patient subgroups, as the inclusion criteria was expanded. And then also the two different valves being in the study, is there going to be Evolut R specific subgroup analysis as well?

Josh, obviously these are all embargoed data and just a late-breaking clinical trial presentation, so I'm not going to go into any real detail on it until the data have been presented, and we'll be doing an analyst discussion at ACC following the presentation of the data. I would just say that this Bayesian analysis and design criteria and intermediate look were all designed into the original study in 2012, so there's nothing new here. So we're looking forward to presenting the data and then being able to discuss it afterward.

Great, thanks. And, Karen, just to follow up on the operating margin expansion trajectory and the FX impact, is there any way you can provide us with any directional guidance for fiscal 2018 just in terms of where currency rates are now and how you're hedged and whether or not your positions will be a headwind or tailwind to reported operating margins in fiscal 2018?

Yes, so we will give full fiscal 2018 guidance on our next earnings call. But just from an FX impact perspective, if currency rates remain stable to where they are today, we would expect a negative impact on revenue of between $100 million and $300 million and on EPS of $0.05 to $0.15. Is that helpful?

Great. And anything specific to the other income line?

We are not going to give line item guidance at this stage on FY 2018, but expect more guidance on our next earnings call.

Okay, thanks a lot.

Thanks, Josh, next question please, Paula.

Your next question comes from Raj Denhoy of Jefferies.

Hi, good morning. I wonder if I could ask a bit about emerging markets. I guess it's about 14% of sales now, still growing low double digits. But I guess you're still seeing some headwinds in Saudi Arabia and some countries in that area. So maybe you could just give us an update on when you'll see that potentially rebound and where you think that 14% of revenue from emerging markets could eventually get to over time.

In terms of the Middle East first, year over year the decline is significant. Like I said, in Saudi Arabia alone, it's like 30% down year over year. But on a sequential basis, it's stabilized. So a lot of this has to do with built-up inventory of implantable devices in the Saudi system itself, which they're cleaning out right now, and we're helping them optimize the deployment of these devices into the market. We see that action happening today. So therefore, this stabilization, the sequential stabilization will lead to anniversarying of this decline by fiscal year end. At that point, we expect to return to growth, although I think it will be measured because there's still some inventory in the system. And I think that the healthcare systems there are responsibly deploying that inventory over time. So that's what I'd expect out of the Middle East that I don't think we'll see major declines and start to begin to see growth come back early into next fiscal year. At least, that's our expectation today. In terms of where this could be, our target is in the low double digits and aiming to get to the mid-teens. I think that's an entitlement given the size of that market. It isn't as easy as it sounds given the size of this market because the infrastructure just isn't there. But we're working in a very focused fashion with both the public authorities in many of these countries as well as private – both providers as well as other interested stakeholders in developing, in trying to develop inflection points in growth in singular countries. So those are the approaches we're taking, and each country is different. The macroeconomic conditions vary. There could be surprises in any one country at any time. But I think we're getting increasing confidence with the level of diversification that we have and the size of our emerging markets business across Latin America, Middle East, China, Asia Pacific, Eastern Europe including Russia, all of that put together, that diversification gives us some level of confidence that double-digit growth in the emerging markets can continue. And if you put that math together, that 14% ratio probably goes up a point or so every year.

So just to put a finer point on it, as the Middle East improves over this fiscal year and you move into 2018, is that mid double-digit growth from emerging markets, is that something we should expect even as soon as next year?

Look, again, I cannot comment on that because, like I said earlier, we look at this diversified sort of portfolio of emerging market countries and you don't know what's going to happen where. So it's – the whole object of diversification is that you balance upsides and downsides. And so I think sticking to the double-digits is what we're seeing, and you'll have occasional quarters where we do better. But I think we've shown that we've held the double-digit line even through bad circumstances, and that's just our historical performance based on factors that, in many instances, are outside our control. So that's the best I could comment. I think it's not prudent to speculate on what's going to happen only from an upside perspective in these markets.

No, that's helpful. Thank you.

Thanks, Raj. Paula, let's take one more question please.

Okay. Your final question comes from Matt Miksic of UBS.

Good morning. Thanks so much for squeezing me in, and congrats on a really nice job, sequential improvement. So I have one follow-up here on TAVR and one if I could on spine. So, on TAVR, increased market awareness and market development is emerging as an important driver for this new intermediate risk segment you talked about earlier. Mike, I would love to hear you may be talk about the cadence of data, new products and importantly your efforts and initiatives, or if you see that as important, when we can start to see that kind of activity in the market. And then I mentioned I have one follow-up.

Sure. I think just in terms of the cadence of things that are going to drive growth for us, the 34-millimeter valve that we talked about, Omar talked about in his commentary, continues to roll out in the U.S. And that segment is 25% to 30% of our historical segment, so it's been important in terms of its contribution to our overall growth. And it requires training, and basically, we are only in 200 of our 400 plus centers with fully trained access to the products in Q3, so there's still growth opportunity in the U.S. for that. And then of course, we just released that product in Europe, so we will get full quarter benefit of that here in Q4. In addition, our next-generation product, the Evolut Pro, is basically expected to come into the market in the first half of fiscal year next year. So that will provide us growth opportunity in advance of other competitors coming into the market. And then the SURTAVI indication or the intermediate risk indication is something that we expect in FY 2018. And of course, we can talk more about that and its impact on the market after the data are released. So I think those are the main catalysts I think that I would point to for that business over the course of Q4 and into next year.

And I guess, Mike, just to make – one of the things we're hearing in the marketplace is this need for getting back out into the community. Is that something that you've started, that you expect to start? Is that something that comes after SURTAVI or with the new launches?

I think market development activities will follow when we have indications for use to pursue them. So we can talk about that. In fact, Rob [ten Hoedt] will be discussing our general program here at ACC, so that might be a good place to have that discussion.

Great. And then if I could just on spine, the robotic initiative, the partnership you've struck up with Mazor, from their commentary, appears to be working quite well. Your spine business appears to be tracking a bit better. I'd love to get your view just on spine robotic surgery and then robotic surgery in general given that you're coming at this a little bit differently than sort of a stand-alone robotic surgery player in that you're a leader, trusted provider in both spine and general surgery. And maybe if you could talk about some of the key elements, considerations, as a market leader that you're running into or see as advantages or see as considerations as you look to roll those systems out or drive further into that part of the market?

Yeah, I don't know if you heard Bryan Hanson's response on his view on robotics and a broad portfolio, but I take a similar viewpoint on this. And for the spine market, we're looking at it holistically in terms of implants and enabling technology. And an enabling technology has several different layers. Intraoperative imaging, navigation, surgical tools and robotics. And so we believe – you mentioned our spine business is doing better, and that's just a result of us introducing – that has no impact from Mazor. This is a result of introducing a lot of the new technology over the last several quarters, launching that technology at scale, right. So, when we launch it, we have enough of the inventory and instruments to support the cases. So that's really what's in it. And finally, I guess rep engagement. Our U.S. team in particular, where we have 65% of our spine business, is humming on all cylinders. So that's what's driving our growth. As we move forward, our goal in spine, first, was to get back to market growth and now start to take some share. But as we move forward, what we need is to grow the spine market and we believe that the combination of this enabling technology which robotics is just one piece of, combined with our market – that combined with our implants, we believe we can improve outcomes, both from a clinical perspective and an economic perspective. And robotics fits right in there. What we're most excited about Mazor is their pre-surgical planning software that helps physicians plan pre-operatively versus intraoperatively which happens a lot today. And then the surgical – the robotic arm capabilities also will help do things a little bit more consistently and we believe this will help democratize a good spine surgery, not just in the U.S. but outside of the U.S. So it's a holistic viewpoint. Mazor is one part of our enabling technology strategy which we call – and then as you integrate that into our implants, we call that surgical synergy. So we are excited about the Mazor relationship. It is going better than we had anticipated in terms of faster uptake from our – our physicians are very interested in this enabling technology strategy and how robotics fits in, and I think that's upside to our future results.

Thanks so much.

Thank you, Matt.

This concludes the question-and-answer session of today's program. I will now turn the floor back over to management for any additional or closing remarks.

Okay. Well, thank you all for your questions. And on behalf of the entire management team, I would now like to thank you again for your continued support and interest in Medtronic. We look forward to updating you on our progress in our Q4 call which we currently anticipate holding on Thursday, May 25. Thank you all very much.

Thank you. This concludes your conference. You may now disconnect.