Medtronic plc

Good morning. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Medtronic third quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. I would now like to turn the conference over to Ryan Weisfenning. Sir, you may begin.

Thank you. Good morning and welcome to Medtronic's third quarter conference call and webcast. During the next hour, Omar Ishraq, Medtronic Chairman and Chief Executive Officer, and Karen Parkhill, Medtronic Chief Financial Officer, will provide comments on the results of our third quarter, which ended on January 25, 2019. After our prepared remarks, we will be happy to take your questions. First, a few logistical 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. During today's earnings call, many of the statements made may be considered forward-looking statements, and actual results may 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 revenue growth rates and ranges are given on an organic basis. which exclude the impact of any material acquisitions, divestitures, and foreign currency, and are in comparison to the third quarter of fiscal year 2018. All of these adjustment details can be found in the reconciliation tables included in our earnings press release. Finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year. With that, I am now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishraq.

Thank you, Ryan, and thank you to everyone for joining us. This morning, we reported another quarter of solid top and bottom line performance. Revenue grew 4.4% organic, reflecting the benefits of our diversified model. We leveraged our top line to grow adjusted operating profits 7.7% and adjusted diluted EPS 10.3%, or 8.5% at constant currency. Execution is our top priority, and in Q3 we executed on multiple fronts to deliver a strong quarter, despite difficult comparisons we were facing in the back half of our fiscal year. Revenue outperformance in MITG and RTG, driven by a number of recent product launches, offset the challenges in CVG that we talked about in January. The other big driver was emerging markets, which grew 14%, reflecting a strong quarter across all businesses and geographies. Down the P&L, we saw the benefits this quarter from our focus throughout the organization on margin improvement, resulting in 140 basis points of operating margin expansion, including a benefit from currency. We continue to execute on free cash flow, working to improve our cash conversion and ultimately drive greater shareholder value. Through the first three quarters of the year, we generated over $4.1 billion of free cash flow, compared to $2.9 billion in the prior year. We've made significant progress on this front, and I really appreciate the engagement of the entire Medtronic team. Overall, it was another good quarter for Medtronic. But what continues to be even more exciting than our results is the progress we're making in our pipeline. As I commented last quarter, We believe we have more opportunities for growth than at any time in our company's history. I'll come back to the pipeline shortly, but first let's review our performance this quarter in a little more detail. I'll start with our minimally invasive therapies group. MITG had an outstanding quarter, growing 6.6% with outperformance in both SI and RGR divisions. Our surgical innovations division grew 6.4%. with strong growth in both advanced energy and advanced stapling. Advanced energy products grew in the low double digits, driven by the adoption of enhanced ligature vessel sealing instruments and the Valley Lab FT10 energy platform. In advanced stapling, we grew in the high single digits as our tri-staple 2.0 endo-stapling reloads and Signia surgical stapling system continue to perform well in the minimally invasive surgery market. Our respiratory, GI, and renal division grew 7%, with strong results across all businesses. GI grew mid-single digits, led by strength in beacon endoscopic ultrasound products and Bravo reflux testing systems. Respiratory had high single-digit growth, driven by Puritan Bennett 980 ventilators and Nelcor pulse oximetry products. Renal care grew in the mid-teens, with solid sales of Belco and Renal Access products. Next, our restorative therapies group had another strong quarter, growing 5.5%, driven by sustained momentum in the brain therapies division. Brain grew 13.2%, with high teens growth in both neurovascular and neurosurgery. In neurovascular, we're seeing broad strength across our stroke franchise, with double-digit growth in stent retrievers, flow diverters, neuroaccess, and embolic products. In neurosurgery, we delivered high 30s growth in capital equipment driven by our stealth station navigation, ORM imaging, Mesora Robotics, and Midas Rex powered surgical systems. We launched our Mesora X Stealth Edition robotic guidance platform last month, and we've received early enthusiastic feedback for this combination of best-in-class robotics and navigation capabilities. We believe our strong capital equipment sales supporting our brain therapies growth are a leading indicator for future growth in our spine business as customers choose to link future spine implant purchases with the capital equipment that they're acquiring. As we execute more of these contracts, we would expect our core spine implant sales to grow over the coming quarters. In our spine division, while results were flat this quarter, when combined with sales of our capital equipment used in spine surgery, which is the way many of our competitors report their results. Our spine division grew 4.6%, including 5.4% growth in U.S. core spine. In pain therapies, our performance was driven by high single-digit growth in spinal cord stim. As the market continues to appreciate the differentiation of INTELLIS with its evolved workflow algorithm and snapshot reporting. Our diabetes group grew 6.5% this quarter. As expected, this group is facing difficult year-over-year comparisons in U.S. pump sales in the back half of this fiscal year. Despite this, we grew 5% sequentially from Q2, including high single-digit sequential growth in insulin pumps specifically. Our performance outside the U.S. was especially in Europe, Latin America, and China, growing 25%, 17%, and 16% respectively. CGM as a category grew over 30% this quarter, with over 60% growth in Western Europe. Our recently launched standalone CGM system, the Guardian Connect, posted its third consecutive quarter of triple-digit growth. Our cardiac and vascular group grew 1.6% this quarter, in line with the revised forecast we provided in early January, with mid-single-digit growth in both CSH and APV divisions. Coronary and structural heart had another strong quarter in transcatheter valves, with 16% TAVR growth in the U.S. and 15% in international markets. We're seeing solid momentum in share gains in the U.S. and in other global markets because of the clinical performance characteristics of our Evolute Pro valve, and we're the market leader in many regions around the world, including Western Europe. In aortic, peripheral, and venous, growth was driven by the continued launch of the valiant Navion thoracic stem graft system, as well as mid-teens growth in both venous seal vein closure systems and impact admiral drug-coated balloons. In cardiac rhythm and heart failure, we had mid-single digit growth in pacemakers and the strength of our microtranscatheter pacing system and Azure wireless pacemaker. This was offset by mid-teens declines in heart failure, primarily due to a mid-40s decline in LVADs as a result of market share loss and heart transplant guideline changes. AF Solutions grew in the mid-teens, driven by continued growth in cryo balloons. We also announced the acquisition of Epix Therapeutics. Epix is developing what we believe is a highly differentiated technology for the over $3 billion focal catheter segment of the ablation market. When combined with our leading cryo balloon technology, Epix provides us with a complete portfolio of best-in-class AS ablation catheter technology. It's worth noting that CVG services and solutions faced a number of comparison headwinds, including a revenue recognition change that started in the second quarter, a large order from the U.S. Department of Veterans Affairs in the Q3 of last year, and the exit of a product line in Q1 this fiscal year. Excluding services and solutions, CVG's growth would have been 110 basis points higher, and CRHS growth would have been 180 basis points higher. Now, turning to emerging markets. Our performance continues to be strong, growing 14% this quarter, and now representing 16% of Medtronic revenue. Our strength has diversified across multiple geographies, with China growing 13%, South Asia by 23%, and the Middle East and Africa by 20%. In addition, Eastern Europe grew 12%, Southeast Asia 11%, and Latin America 9%. Our differentiated strategies of public and private partnerships and optimizing the distribution channel are paying off and making a real difference in emerging markets around the world. In addition to our solid performance in the quarter, I remain excited about the unprecedented opportunities for growth that our pipeline presents. We're building upon leadership positions in several of the fastest growing markets in medtech by intentionally allocating our capital to high growth markets and new opportunities. As we invest in these opportunities, we're doing much more than simply improving today's products and therapies. We're disrupting existing markets and inventing new ones. And when we do this, When we successfully disrupt and invent markets, we distance ourselves from the competition and raise our weighted average market growth rate. All of this creates significant value for patients, for physicians, for healthcare systems, and for our shareholders. It's worth highlighting some of the most exciting elements of our pipeline that we expect to bring to market in the near future. In RTG, as I mentioned earlier, we're just launching the Mazor X Stealth, our integrated robotics and navigation platform, which we expect to drive growth in our neurosurgery business, along with creating demand for our core spine implants. In neurovascular, we're now in limited market release of our 071 React catheter and continuing the launch of our Riptide Aspiration System. We expect to launch our next-generation solitaire stent for ischemic stroke by the end of FY19. In FY20, We intend to launch our DBS primary cell device with unique sensing capabilities, the first of a series of disruptive product launches planned in our DBS business. In CVG, we're awaiting the presentation of two landmark clinical trials at the American College of Cardiology meeting on March 17th. The first is the interim results of our low-risk TAVR study, which has the potential to expand indications for our transcatheter valve therapy to the largest segment of the market. The second is the results of the rapid trial of our Tyrex antibacterial envelope, which could enable guideline changes in cardiac rhythm implantables. In FY20, we're expecting to launch our next generation TAVR valve, the Evolut Pro Plus, which features a lower profile and improved predictability of placement for enhanced ease of use. We also expect to launch our next generation insertable cardiac monitor, the RevealLink 2.0. which will include Bluetooth connectivity, five-year battery longevity, and the ability to monitor additional physiological parameters. In the second half of FY20, we're planning to launch new conventional ICD and CRTD product families based on our Polaris high-power technology platform, and we expect to receive a new drug-coated balloon indication in the U.S. for the AV fistula market. Finally, around year-end FY20, We're expecting FDA approval for our micro-AV transcatheter cardiac pacemaker, which would enable us to access and disrupt over 55% of the eligible pacemaker market, up from 16% today. The pipeline at MITG is equally impressive. We're currently expanding into key specialty areas of our tri-staple technology, and we're launching our new micro-stream advanced capnography solutions for the CapnoStream 35 portable respiratory monitor. We're also currently launching a next-generation sonicision ultrasound dissection system. Regarding our robotic-assisted surgery platform, we're hitting key milestones that are on track for an expected launch in FY20. We've had several pre-submission meetings with regulatory bodies around the world, including the US FDA. More than 100 surgeons have used the system and provided us with very positive feedback. We're also partnering with physician societies to develop guidelines for use of the platform. We believe this robotic-assisted surgery platform, combined with our industry-leading surgical instruments and surgeon training centers around the world, will expand the market for minimally invasive surgery. In diabetes, we're continuing the introduction of the 670G into new geographies around the world. In FY20, we expect to launch our advanced hybrid closed-loop system with Bluetooth, which we're calling the MiniMed 780G. The 780G will feature next-generation algorithms designed to improve time and range to over 80% by automating insulin delivery following a snack or a meal. In addition, the system will reduce the burden of carb counting and enable remote monitoring and remote software downloads. We also expect to submit our application for non-adjunctive designation for our Guardian sensor tree in the next few months. So we expect the next five quarters or so to be very exciting as we bring these innovative pipeline products to market. However, I'm equally excited about our longer-term pipeline. In CVG, we're developing several technologies that will create large and important new markets, including the intrepid transcatheter microvalve replacement system and the simplicity spiral renal denervation system for hypertension. We also expect to disrupt existing markets, with our pulse field ablation technology for AF and the extravascular ICD. When launched, all of these new products are expected to create multiple new multibillion-dollar growth opportunities. In RTG, we're developing InterStim Micro, a 3cc sacral nerve microstimulator for bladder control with full-body MRI compatibility. In DBS, we expect to build on our sensing technology to develop a closed-loop deep brain stimulation system. In addition, we're planning to introduce a cranial-mounted DBS system, leveraging our differentiated miniaturization and battery technology. I'm really excited about our plans to disrupt the deep brain stimulation market with a series of new products and make a real impact to patients. In MITG, we continue to develop disruptive products for these markets, too. with our portable hemodialysis system, as well as a next-generation capsule endoscopy product called PulCam Genius. Overall, we expect to launch more than 90 products over the next five years in MITG. In diabetes, I hope you saw our announcement this morning that the FDA has granted breakthrough device designation to our personalized closed-loop system. This system will feature real-time personalized algorithms that are designed to automate insulin delivery in a personalized basis that continuously adapts to the user. The system will also provide insights and predictive diagnostics unique to the individual, all of which will dramatically simplify diabetes management for the patient. In addition to this product, we're also advancing our CGM sensor pipeline by reducing the need for calibration and making the sensors smaller and longer lasting, all while using cognitive computing to enhance personalized insights. Of course, our pipeline is deeper than the few highlights that I've mentioned today. But the key takeaway is that we're executing well on the strongest and most exciting pipeline in Medtronic's near 70-year history. Let me now ask Karen to take you through a discussion of our third quarter financials. Karen.

Thank you, Omar. Our third quarter revenue of $7,546,000,000 represented organic growth of 4.4%. Foreign currency had a negative $149,000,000 impact. And adjusted diluted earnings per share was $1.29 and grew 10.3%. Adjusted operating margin was 29.2%, increasing 140 basis points in the quarter and 120 basis points through the first nine months of the year. including a tailwind from currency. We continue to drive underlying operating margin improvement as we execute on our company-wide enterprise excellence program, driving improved efficiency, cost savings, and generating leverage on solid sales growth. As a result, our SG&A this quarter improved by 70 basis points. Our adjusted nominal tax rate was 13.4%. which is better than expected due to the increased benefits associated with the finalization of taxes owed on certain returns. For fiscal 19, we expect our tax rate to be in the range of 13.5% to 14%, including the non-recurring tax benefits that we have received year-to-date. Excluding those benefits, our four-year adjusted nominal tax rate would be approximately 15%. And with the addition of changes associated with U.S. tax reform, We continue to expect a tax rate of 16% to 17% in fiscal year 20. Third quarter free cash flow was $1.8 billion. Improving cash generation is a priority for all of us at Medtronic, from the top of the company on down, and you have seen the results of our increased focus on cash flow in our performance over the last several quarters. We remain committed to disciplined capital deployment. balancing reinvestment with returning a minimum of 50% of our annual free cash flow to our shareholders. Year to date, we have returned $3.9 billion to shareholders, including $1.8 billion of net share repurchases, resulting in a total shareholder payout of 77% on adjusted net income. We also remain focused on increasing our return on invested capital through strong execution with our disciplined investment process around R&D and tuck-in acquisitions, including three we recently announced, Mazor, Neutrino, and Epix. We believe that this focus, combined with our strong and growing dividends, can create long-term value for our shareholders. Before turning the call back to Omar, I would like to update our guidance. For fiscal year 19, we are raising our organic revenue growth guidance to 5.25% to 5.5%. which is the top half of our prior range. This reflects continued strength in MITG and RTG, offsetting the second half headwinds in CVG and difficult comparisons in diabetes. For the year, we now expect RTG to grow 5.5% to 6%, up from 5% to 5.5%, and MITG to grow 5.5% plus or minus, up from 5% plus or minus. We continue to expect CVG to grow 3% to 3.5%, and diabetes to grow in the low to mid-teens. For the fourth quarter, we would expect growth for MITG and RTG to be between 3.5% and 4%, for CBG to look similar to the third quarter, and for diabetes to look roughly flat year over year. I would highlight that our expected fourth quarter growth for diabetes is a bit of an anomaly. given the prior year comparison when we were able to finally clear our large backlog for 670G and sensor orders. And on a two-year stacked basis, the fourth quarter growth from diabetes should look more normal. Most importantly, as we move into next year, we believe fourth quarter growth represents a likely bottom, and as such, would expect growth to improve for both diabetes and the company. Turning to margins, we continue to forecast 50 basis points of four-year underlying operating margin expansion as we deliver to more than absorb the impact from product mixed headwinds, China tariffs, and the dilution from the Missouri acquisition. With respect to earnings, given our operational performance through three quarters, including our ability to offset the headwinds I just mentioned, we are increasing our fiscal year 19 adjusted EPS guidance to 514 to 516, up from 510 to 515. While the impact from currency is fluid, if recent exchange rates hold, our four-year revenue would be negatively affected by approximately $425 to $475 million. And despite the headwind on the top line, given the benefits of our hedging program, FX is expected to be a modest positive to fiscal 19 operating margin, earnings, and free cash flow. Finally, on the heels of strong free cash flow performance over the last nine months, we are increasing our expected fiscal 19 range to $5 to $5.2 billion, up from $4.7 to $5.1 billion. And in fiscal year 20, we expect to make additional progress on improving our conversion of non-GAAP earnings into free cash flow as we continue to drive increased focus across the organization. Now I'll return the call back to Omar.

Thanks, Karen. Before we go to Q&A, I want to take a moment to thank all of our employees around the world for executing to deliver another strong quarter and fulfilling the Medtronic mission. As I mentioned at the start, this was another solid quarter where we delivered the top line along with strong adjusted operating profit and EPS growth. You're also seeing our ability to generate strong free cash flow. This is important. as it enables us to both reinvest and return to our shareholders. As a reminder, we continue to allocate our capital to our biggest growth opportunities as we focus on driving our WAMGR, our Weighted Average Market Growth Rate, upwards and to the right. Our investments are resulting in a pipeline of numerous growth opportunities that has never been stronger. We expect to develop and bring to market innovations that will improve the lives of millions of people around the world, help health care systems become more efficient and ultimately grow the intrinsic value of Medtronic. And when we do this, we expect our shareholders will benefit as well. We know there is much work to be done, but I'm excited about where Medtronic is headed. With that, let's now move to Q&A. In addition to Karen, our four group presidents, Mike Coyle, Bob White, Jeff Martha, and Huma Anhakami are also here to answer your questions. We want to try to get to as many questions as possible So please help us by limiting yourself to one question and, if necessary, a related follow-up. If you have additional questions, please contact Ryan and our investor relations team after the call. Operator, first question, please.

Our first question will come from the line of David Lewis with Morgan Stanley. Please go ahead.

Good morning. Thanks so much for taking the question. Just two quick ones. for me here. Karen and then Hooman as a related follow-up. So Karen, you've been very helpful on tax guidance for 2020 as well as currency. Can you just help us think about margin guidance next year, Karen, when I think about gross margin, mixed headwinds, slower growth relative to SG&A savings? So it's 50 basis points still. a decent way of thinking about 2020. And then, Hooman, for you, I appreciate the fourth-quarter commentary. How should we think about diabetes heading into next year? Is this still going to be a high single-digit growth business for Medtronic, or should we start thinking more about mid-single digits as you anniversary the first wave of 670G? Thanks so much.

Good morning, David. Thanks for the questions. So on margin for next year, we are confident in our long-range plan. and that continuing into next year of our ability to deliver between 40 and 50 basis points of underlying operating margin expansion.

David, I'll take the next one. And maybe before talking about FY20, it's probably instructive to talk about the comps that we're dealing with in Q3, because this impacts Q3, it impacts Q4. And, you know, you've seen a deceleration in the year-over-year growth versus what we've posted for the past four quarters. But we have indicated all year that we're coming up against these more difficult comps. And I'll just maybe call out a few of the critical ones. If you recall, David, in the back half of last year, we started to increase CGM capacity that allowed us to fulfill shipments and up demand for both pumps and CGM that carried over from the first half of last year. In addition, in Q3 of this year, we anniversary-ed Animas. And so all of the consumable revenue and all of the out-of-warranty conversions no longer provide a year-over-year benefit. And then the third thing, in Q3 of last year, we also had one of the last large commercial payers approve the reimbursement of 670G. All of these three things distort the year-over-year performance. In Q3, they'll do so as well in Q4, and it's primarily a U.S. dynamic. And maybe just to kind of point out some perspective to give you a flavor for the impact of the comps, last quarter diabetes delivered $583 million of revenue, and we grew 27%. This quarter, we're delivering $610 million of revenue, which is 5% higher than it was a quarter ago, and our growth rate is 6.5%. And so hopefully that should give you a sense of the difficult comps. That's going to carry into Q4, and you heard sort of the outlook in the commentary from Karen for Q4. But from a growth rate standpoint, we absolutely expect Q4 to be the low point. For diabetes growth, we expect the comp dynamics to normalize. We expect a return to growth in Q1 of next year. And then for FY20, you know, certainly the full year comp impact will normalize. And we are very confident that diabetes is going to grow above the corporate average, as we've indicated all along.

Great. Thanks, David. Next question, please, operator.

Your next question comes from the line of Joanne Walsh with BMO Capital Markets. Please go ahead.

Good morning and thank you for taking the questions. As we go back to our models and take a look at fiscal year 20, could you please remind us of some of the puts and takes as we think about all of that? I know you've previously commented on foreign exchange and tax, but I just want to make sure that the street numbers get set up correctly as we head into next year. Thank you.

Thanks, Joanne. Appreciate the question. Yeah, we are continuing to work our annual plan right now, so it's early for us to issue our full-year outlook. We'll do that on our fourth quarter call. But from what we can see today, we are confident in our ability to deliver a 4% plus top-line revenue growth on an organic basis, despite the fact that our pipeline is weighted to the back half of the year. And that's obviously in line with our long-range plan. As I mentioned to David too, we're also confident in our ability to continue to drive annual underlying operating margin expansion to the tune of 40 to 50 basis points, also consistent with our long range plan. I mentioned that you should continue to model our tax rate next year to be between 16 and 17%. We're continuing to work that tax rate as well as any other additional financial levers But at this point, we are comfortable with current street consensus. And on an FX basis, FX has been a headwind for us in the fourth quarter. We expect that to – in the third and fourth quarter, we expect that to continue into next year. From an FX perspective, we would expect FX to be about, you know, several hundred million dollars on top line on the headwind and a modest impact on the bottom line.

Your next question will come from the line of Bob Hopkins with Bank of America. Please go ahead.

Hi. Thank you, and good morning. So just one clarification, either Omar or Karen. I think you said a couple times on the call that the fourth quarter organic revenue growth rate would kind of be the low point for Medtronic. So I just – to be specific, what is – can you just remind us what is your specific – Q4 organic revenue growth rate, and I just wanted to confirm that I heard that correctly, that you think going forward that's the low point.

Yeah, so when you look at our full-year forecast or our full-year guidance for revenue growth, that would imply about 3% plus or minus for the fourth quarter, Bob. And that's what we're referring to as our low point.

Okay. And then the other things I wanted to kind of follow up on is just in terms of – the upcoming ACC meeting. I was wondering if you could just help us sort of set expectations heading into that meeting, sort of any comments around setting expectations would be helpful. And then, you know, specifically on Tirex, maybe help us. If that study is positive, can you kind of frame the market opportunity and how you might be able to bundle with ICDs? Just, you know, if that trial is positive, how should we be thinking about the incremental opportunity there? Thank you.

Okay, Mike. So, Bob, obviously, the two late-breaking clinical trial presentations that we have coming up at ACC are the low-risk average study and Tirex. Both of those have been accepted and will also have simultaneous publication. On the Tyrex in particular, we would estimate right now about one-third of what we would consider high-risk device implants actually use a Tyrex product. So that would imply that if we have, obviously, a 7,000 patient study, that it's power to answer the question of who's going to benefit from this. that it would give us, if positive, ammunition to basically highlight this as a standard of care in what we would consider high risk. And what we consider high risk is any large device implant, so an ICD or CRT device, CRTP device, or any de novo implant of those or any replacement procedure, including pacemakers. Again, right now we have a utilization of about one-third of our cases are actually using a Tirex by being able to add about $1,000 per procedure. And given the unique nature of this technology that it's only available from us, we think we can use it to drive market share as well in terms of both initials and potentially even on a replacement basis. So we consider it to be a very important technology and a very important study.

Thanks. Next question, please.

Your next question comes from the line of Matthew Taylor with UBS. Please go ahead.

Hi. Thanks for taking the question. So I appreciate you talked about a lot of big pipeline drivers that are coming up here in fiscal 20. And I was curious if we could get any kind of update on your surgical robotics program. That's one where investors have a lot of focus and we're still waiting for some more details on what that looks like and when it might come into the fold. So can you give us the latest and greatest there and just how you're feeling about that program?

Thanks, Matt, and I appreciate the question. So as Omar mentioned during his commentary, we've had actually over 100 surgeons use our robotic systems, and in fact, Just a couple of weeks ago, I had the chance to sit in with one of them during our preclinical labs as we did a partial nephrectomy. And as I chatted with the lead surgeons, you could tell it was a really impressive experience, both from the aspect of the way the system performed, the procedure, the workflow associated with the system. And so as we previously communicated, we're absolutely on track for an FY20 launch. But importantly, and I think interesting to you is, once procedures have begun and we're collecting additional clinical data, then we'll arrange opportunities for you to experience one of these cases live. So we're excited with our progress. We're excited with the feedback we get, and we're excited to bring the system.

Great. Thank you very much. Thank you very much.

Thanks, Matt. Next question, please, operator.

Your next question comes from the line of Matt Mixick with Credit Suisse. Please go ahead.

Hi. Thanks for taking the question. I'll keep it to one. So for Karen, you mentioned, just maybe for background, the changes you talked about in January to the tax rate and the impact on the bottom line growth, clearly non-op impact. And you reiterated here just a couple of questions ago, I think the top line growth of four plus percent and the 40 to 50 basis points of margin improvement. So operationally, if we look at 2020, I guess I'm asking a question but kind of confirming, you know, that it's fair to think about operationally, you know, the sort of long-range plan in effect and hitting on those metrics. I guess the question is below the line. You mentioned some financial opportunities, and I guess I'm thinking below the line. you know, either in the deadline or other non-op lines to sort of help offset the non-op impact of tax. If you could maybe flesh out what some of those might be and perhaps what some of those were as you were heading into the end of the year as to how you can potentially offset that would be very helpful. Thanks.

Yeah, thanks, Matt. Appreciate your question and definitely appreciate the fact that you got that our long-range plan holds for next year on an operational performance basis. Below the line, there are additional financial levers, looking at our tax rate and what we can do to work to improve that, also looking at our interest expense and income line item, and then obviously share or purchase. We will focus on all of those levers, and when we have updates on that, we'll be sure to give them to you.

You know, let me just throw in a little word here. You know, I understand operationally all the things that Karen just said, and you understood and confirmed that, but let's not forget our pipeline. Our pipeline is extremely exciting. We have some really exciting new product introduction next year. The micro-AV is one that I'm really excited about, robotics and so on. So let's not forget that. Operationally we'll be there, but the pipeline sets us up not only for next year but for the future as well.

Terrific. Thanks.

question please operator your next question comes from the line of pedo chickering with georgia bank please go ahead uh good morning uh they give a very impressive short-term and long-term pipeline new products i want to sit back and look at the rd spend as a total you know i'll look at the percent total revenues it's been pretty consistent despite the strong pipeline so two questions the first one with a strong pipeline ahead uh does it make sense to increase the rd spend to take advantage of your momentum you have a new products and second From a process perspective, how is the IRR tracking versus your own internal expectations, and how has it changed over the last few years?

Let me just take a cut at that, and then, Karen, maybe you can add to it. You know, first of all, you know, our pipeline is funded. So we're spending R&D money to fund our pipeline, and we will ensure that that happens. As we see overall operational success, the first place we'll put our – our money into is organic R&D spending because that's the highest return that we can get out of any kind of investment that we make. Having said that, we also always look at continued R&D productivity. We look at sharing between different groups, transferring of technology between one group and another that makes our R&D more efficient and it actually accelerates a pipeline. Miniaturization technology and battery technology are the two biggest examples where our fixed capability can move across different groups and make that R&D quite efficient. So that's the way we look at that, and I think from a return perspective, they're certainly within our projections, the organic ones, and I think most of the acquisitions, too, have had – returns that are better than our, you know, cost of capital. So can anyone add to that?

Well said. The only thing I would add is that we're focused on improving our overall return on invested capital for the whole company, and obviously our R&D pipeline is a big part of that. And as we look at tuck-in acquisitions, we're focused on, you know, making sure that those ROICs are strong and accretive for the company, too.

Thanks, Tito. Next question, please.

Your next question comes from the line of Vijay Kumar with Evercore ISI. Please go ahead.

Hey, guys. Thanks for taking my question, and congrats on a nice print here. So just maybe I'll limit myself to one question now. Maybe I'll have two bits in that question. But, Omar, you know, for you, if you look at the organic for the company, you know, it's coming really, really strong. We're looking at, you know, close to five and a half for fiscal 19. You're talking about pipelines. You know, when we think about first half versus second half for next year, are we looking at first half maybe, you know, at the low end of your, you know, four to five and maybe back half coming in at the high end? And when these pipeline, you know, when it actually comes to fruition, is that organic going to accelerate in fiscal 21? And then, Karen, for you, just quickly on margins, you know, 40 to 50 bps constant currency, but I think I heard you say, FX headwind a few hundred million dollars on the top, but more modest. Does that imply that FX is going to be a benefit next year on margins? Thank you.

Okay. First of all, I think you're right about the pipeline, that it is back-end loaded towards the second half of the year. And as the quarters progress, you'll see the benefit of that in our growth rates. And I think you read that correctly. But I think more importantly, the other point that you made is that, you know, product introductions are the starting point. These things carry through into FY21, and some of these products will get approval in other countries, and other new products will also come up towards FY21. So, again, from a product introduction perspective, you'll see a gradual increase, back-end loaded, like you mentioned. And the growth rate will correspondingly follow that, lower in the first half, higher in the second half. I think that's the right way to look at it.

And then the other thing I would add, Vijay, is that, you know, we mentioned that we think that our fourth quarter growth rate is a low point for us. And so you can think about that as you look ahead next year, too. And then from a benefit, your question about benefit on FX on the operating margin line, you know, we see FX as being a headwind for us. and you can expect a little bit of a headwind on the operating margin line right now, at least as where rates are today and where our hedging is right now.

All right. Thank you, guys. Thanks, Vijay. Next question, please, operator.

Your next question comes from the line of Robbie Marcus with J.P. Morgan. Please go ahead.

Oh, great. Thanks for the question. Hooman, I wanted to circle back to diabetes, and you talked about the outlook for 2020, but I want to touch on the breakthrough designation you got this morning for the personalized closed-loop pump. Maybe talk about what the recently acquired neutrino health adds to this, when we might see data and approval of this in the U.S. and outside the U.S. Is there new hardware involved on the CGM and pump side? And maybe touch on how this compares to where you think the competition is in next-generation systems. Thanks. Okay.

Thanks, Robbie. What I'll say is there's probably not enough time on this call to do personalized closed-loop justice, but I'll give you kind of a flavor for it. We really think that personalized closed-loop is going to be a system that truly paves the way for a true closed-loop system. And because of that, we don't feel that closing the loop is aspirational any longer. It's actually achievable. And if you really think about today's algorithms, Robbie, they essentially behave the exact same way for every single patient, even though every single patient is different. Personalized closed-loop changes all that. It's a real-time system. It automates all facets of insulin delivery in a way that is personalized and adaptive to the user. In addition, the system is going to provide unique insights to help the patient help them with predictive diagnostics, which we think is going to dramatically simplify diabetes management for the patient. And so we really think this is going to be a transformative system, and we're thrilled to have received a breakthrough designation for it from the FDA. Now, as far as launch date goes and all of that, we just received the breakthrough designation. For competitive reasons, I think it would be premature to talk about launch dates. But what I will say, and you touched on this, is that we're investing heavily in personalized closed loop. Our acquisition of Neutrino was made with personalized closed loop in mind. We are fully resourced from an R&D standpoint to drive this program as aggressively as possible. And, you know, we're excited to share more details with you, you know, as we progress with the program.

Is that something we might see data at ADA 2020?

Yeah, so ADA 2020, I think we will outline for you more details around personalized closed loop, for sure. And, you know, I think what you will see as we start to, you know, more articulate what the system is and what the capabilities are, you'll see that it will be completely differentiated with respect to not only what's out there today, but what's also coming.

Thanks. Thanks, Rob. Operator, next question, please.

Your next question comes from the line of Bruce Newdell with SunTrust. Please go ahead.

Good morning, and thanks for the question, and congratulations on a very balanced quarter, given the challenges you had. I have a question for Mike. Mike, I know the upcoming trials at ACC are embargoed, but could you just help investors think about on the basis of death and stroke in particular, is superiority needed to change the paradigm of surgery versus TAVR in that low-risk population? And I think it's important because there are probably around 30,000 surgeries that suddenly come on the table. Just your thoughts about, you know, surgery might be great, but, you know, does the tie go to the runner or do you actually need superiority to kind of change the discussion between patients and practitioners. Thanks so much.

Well, certainly we've seen patients be highly enthusiastic about less invasive approaches to therapy. And so there is a large patient pull that is associated with these technologies in TAVR and ultimately in the mitral space. So I think non-inferiority is certainly a good starting point at this stage if that's where it ends up. But over time, from my perspective, as we get more experience with these technologies and we see durability in the technology, we're going to see significant patient pull to expand the market.

Thanks so much.

Thanks, Bruce. Next question, please.

Your next question comes from the line of Isaac Rowe with Goldman Sachs. Please go ahead.

Good morning, guys. Thank you. Omar, I had a question, I guess for you and both, Karen, on expense growth, you know, in the context of your margin goals. You have a number of pretty compelling technologies on the table between robotics, you know, the TAVR market expansion, diabetes, heading into next year. So I'm interested in how you, if you could help frame the way in which you're going to fund those growth initiatives while also delivering the margin expansion? Are there a couple of areas of obvious savings on the SG&A line that would help allow for that? Thank you.

You're right. Look, there's two big areas that we look at. In the SG&A line, we're looking at better productivity in our go-to-market methodologies, primarily around the back office, commercial back offices, which we're concentrating and putting into one place. That actually saves a lot of money. We're also using new types of technologies to be able to do these processing tasks much more efficiently. So the commercial back office and the commercial go-to-market, not from a salesperson perspective, but more from a support perspective, is a good area of opportunity for us, and that will yield a lot of dividends. The other one which we've mentioned all along in our program is in full flight and We've got a program to reduce the number of manufacturing sites we have from, I don't know, 80 or 90 a few years ago to more like 50 to 60. And, I mean, that clearly gives us some level of productivity. In addition to that, we have a continuing effort in each factory to improve the efficiency of our lines through different quality processes that are continuously improving. And they're improving in sites which already have those processes, and they put them into new sites as they get ready for production. So I think those are the main drivers through which we get cost reduction, the back office, commercial back office, and the cost-down programs that are concentrating on manufacturing sites. Our supply chain, our overall indirect and direct supply also because of our size is a leverage point. And finally, our services from our functions are ones that we monitor a lot like HR, finance, legal, et cetera. We monitor those services and we compare them to benchmarks against companies of our size. And we expect to be best in class in one or two of those areas or higher. because of the integration we've had to do. But over the next few years, we'll get them to best of class, and that will also give us free some extra funds to do the R&D, which we're focused on. I think I covered it. Karen, anything to add?

You totally covered it. I would just say that our Enterprise Excellence Program is specifically designed to drive that operating margin expansion and enable us to continue to invest heavily in R&D.

Got it. Thanks very much, guys. Thank you, Isaac. Operator, next question, please.

Your next question comes from the line of Larry Beagleson with Wells Fargo. Please go ahead.

Good morning. Thanks for taking the question. One for Karen, one for Mike. So, Karen, on the guidance in fiscal Q4 is about 3% organic, you said, and you expect that to be the bottom. I guess my question is, when we look at the first half of fiscal 2020, why would it be higher than that 3%? You know, what drives the improvement in Anything besides, you know, the diabetes comps getting easier. And then, Mike, I think drug-coated balloons at mid-teens growth this quarter came in better than people expected. Just any color commentary on the outlook for that business? Thanks for taking the questions.

Sure. Thanks, Larry. You already noted the comps, which is a big deal. We had very tough comps in the back half, and that changes as we move into next quarter. You know, when we think about CVG, too, you know, We expect that to improve as we launch new products, but also keep in mind that we will anniversary the revenue recognition change that we made to the services and solutions part of CVG in the first quarter. And then we'll also anniversary the MCS decline in the third quarter. So hopefully those things help you.

And then as it relates to the drug coated balloons, we actually were quite pleased with the growth profile of the business. Obviously in January we were a little concerned when the meta-analysis came out where we saw certain accounts basically kind of pushing the pause button on utilization while they waited for additional data. I think the communication across the board from the manufacturers looking at their own data in detail and especially our randomized control data from both the U.S. Pivotal Trial, the Japan Trial, and our Global Registry data were helpful in terms of providing a patient-level analysis. And then we've seen independent publications like the one we saw in JAMA here last week that basically was showing on claims databases no correlation with death for paclitaxel. So as more and more data come out, it's obviously getting the market more comfortable with the conclusions around the performance of the technology. We know it offers significant efficacy benefits relative to standard balloon technology. And for us, we're looking at continued expansions of indications for use into new areas. We should have U.S. approval for an AV fistula indication in FY20, and we continue to do work on below the knee. So we see that technology as an important, strong, long-term growth driver for our APB business.

Thanks for taking the questions.

Thank you, Larry.

Next question, please.

Your next question comes from the line of Danielle Antolfi with SVB Learing. Please go ahead. Hey, good morning, guys.

Thank you so much for taking the question. Mike, a quick question for you on the heart failure business. And, you know, as expected, we saw some weakness in LVADs. Curious how you're seeing that continue to play out there. How much of that would you characterize was impact from competition versus the change in the transplant guidelines, just trying to get a sense of the go-forward outlook just for that market and for that business overall? overall and then I had one quick follow-up. Thanks.

through a little bit to uh... uh... issues that i identified at the jp morgan meeting were almost simultaneous right the with the approval of the competitive uh... uh... heart rate free product and the changes to uh... heart failure guidelines as we went through the quarter uh... the the front end of the quarter really took the brunt of uh... uh... that uh... martin sort of market correction uh... we think the the u s market was down to twenty to twenty five percent uh... as uh... basically l that uh... patients without that we're going to put to the bottom of the list for heart transplants, and obviously a lot of those patients are now being bridged to transplant with technologies like ECMO. So the question will be, how do they do in their transplant surgeries when they're on a less robust support system over time? And obviously that's going to take quarters to play out in terms of being able to look at what it does to the overall market. But clearly the bigger issue for us was the competitive share shift that we saw. Our competitor brought out a meaningful improvement over their older technology. There was a lot of interest in the market to try it and see how it was performing. We have seen some of those accounts coming back, but there is a big correction that now has taken place. And I think whereas we were looking at sort of a 35% market share prior to that new product coming in. During this quarter, it was closer to 20. On a global basis, it has settled out at sort of a 25% share for us, and I think that is probably a good way of thinking about the go-forward for the overall market. We obviously have a lot that we're working on in terms of our thoracotomy indication for a less invasive surgical placement for the HVAD technology, and we have a number of important technology developments that are taking place to the system that we think can help improve complication rates to both grow the market and grow our share. But at least in the short term, this will be a headwind for us for the next several quarters.

Okay, and you answered my follow-up on what's next, so thank you so much.

Thanks, Danielle. Next question, please.

Your next question comes from the line of Kristen Stewart with Barclays. Please go ahead.

Hey, good morning, everybody. Thanks for taking my question. Karen, I just wanted to quickly make sure I understood your comments correctly on the consensus EPS for next year. I think you had said you were comfortable in that. That implies about I guess 5.6%-ish growth. I thought in January you guys were saying that it might be 150 basis points off the CAGR. How should we just think about that overall kind of growth for next year and then just longer term? I think in the breakout commentary Mike had mentioned something about growth perhaps coming in a little bit higher in 2021. because of some of the new products and just want to kind of flush out how we should really think about that 8% mark.

Thanks for the question, Kristen. So, you know, FY20, we've talked about, you know, we've got the big headwind of our tax rate. You know, we also have some FX headwinds that I mentioned. And so at this point, yes, we are comfortable with current street consensuses. We will give our annual outlook on our fourth quarter earnings call. We're continuing to work our long-range plan. But at this point, I would say we're comfortable. As we think about the strength of our pipeline, though, you know, it is weighted toward the back half of next year and beyond. And so we're really excited about that and beyond piece of it.

Yeah, just to sort of confirm that, Kristen, clearly the pipeline comes through. the growth rate is going to accelerate. And we're very confident in the plan that we've laid out of a 4-plus percent growth rate over time. And, you know, it's too early to talk about FY21 at this point, but clearly the expectation is that as the quarters go by here, the rate will grow, will rise. And, you know, just the pipeline itself would imply that. So we're confident in increasing growth profile over time as we look into the future.

Okay, and then I think the two things that you mentioned on pipeline intrepid and simplicity longer term, just real quickly on intrepid, are you now able to do that transeptally and any sort of data that we could be expecting on either that program or simplicity in the near term?

I think my – go ahead. So on Intrepid, we continue to enroll in the Apollo study. We've been very pleased. We have not seen any drop-off in enrollment rates in the wake of the COAPT data. And we continue to work. These are all trans-ethically delivered technology or products right now. We continue to work on the pipeline for transfemoral, and obviously we're still making a sort of strategic decision around how small do we need to make the profile of the device. You know, we can make it transfemoral right now in a transeptal design, but it's a large technology, so the decision of whether to actually make that an engineering device smaller solution and then go into market with it or into clinical trials with it, or to go with a larger version that we're currently developing is still a work in process. And then on the simplicity trial, we continue to enroll in both the off-med and on-med pivotal trial results, which will be the basis for the PMA approval. We would expect data availability for that early at FY21.

Thanks, Kristen. Operator, we'll take one more question, please.

Your final question will come from the line of Raj Dhanoi with Jefferies. Please go ahead.

Hi, thank you. Good morning. Maybe, Omar, I could ask about emerging markets. You know, another very strong quarter. I think you contributed about a little above two points to your growth in the quarter. So maybe you could help us understand if there are particular products that are driving that and how we can get comfortable with the sustainability of that contribution going forward.

Well, yeah, I'm glad you brought that up. I was going to make a comment on it anyway, because for sure our pipeline is exciting, but the emerging market's performance and its consistency and its gradual increase over time is something that we feel pretty good about. And I think the way to look at that is that, look, there's no question about the demand rising and the fact that there's a huge opportunity to increase penetration of existing products, which have been approved for years. And we've, over time, built core expertise in how you do that, in aligning patient awareness, helping build infrastructure and training physicians, and then deploying our technology. So that process, and then going direct or optimizing our go-to-market processes. strategies in those emerging markets. You put all of that together, that's our strategy. Now, that isn't something that you just flip a switch and you do it. You build that expertise over time. And we've done that over the last, I'd say, at least five to seven years. And we have got a pretty clear understanding of how to continue to grow on that platform. And so we're pretty confident about the consistency of this double-digit profile in emerging markets. And sure, there will be macroeconomic changes here and there, but by and large, the health care need is somewhat independent of that, and also the geographic diversification we have within emerging markets has proven to be an asset in enabling us to demonstrate consistency. So, yes, we're very confident in our emerging markets of maintaining the double-digit profile and one that we've built a track record on, built experience on, and one that you can depend on.

Great. That's very helpful. Thank you. Thanks, Raj. Omar, do you want to finish?

Yeah, sure. Thanks, everyone. Thanks for your questions. And, you know, on behalf of the entire management team, you know, thanks for your continued support and interest in Medtronic. We look forward to updating you on our progress and the results for our full year on our Q4 earnings call, which we currently anticipate holding on Thursday, May the 23rd. So thanks again to everyone for participating and for your support.

Ladies and gentlemen, this does conclude today's call. Thank you all for joining, and you may now disconnect.