Medtronic plc

Good morning, my name is Carol and I will be your operator today. At this time I would like to welcome everyone to the Medtronic Fourth Quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speakers remarks we will have a question and answer session. If you would like to ask a question at that time simply press star then the number 1 on your telephone keypad. If you would like to withdraw your question please press the pay on key. At this time I would like to turn the call over to Ryan Weissfending, Vice President, Investor Relations.

Thank you. Good morning and welcome to Medtronic's Fourth Quarter conference call and webcast. During the next hour Omar Ishrac, Medtronic Chairman and Chief Executive Officer, and Karen Parkhill, Medtronic Chief Financial Officer, will provide comments on the results of our fourth quarter in fiscal year 2019, which ended on April 26, 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 statements. In addition, the reconciliations of any non-GAAP financial measures are available on our website, .Medtronic.com. References to organic revenue growth exclude the impact of material acquisitions to vestitures and currency. References to pro forma exclude the impact of material divestitures. Unless we say otherwise, quarterly rates and ranges are given on a constant currency basis which compares to the fourth quarter of fiscal year 2018 after adjusting for currency. Unless we say otherwise, annual rates and ranges are given on a comparable constant currency basis which compares to fiscal year 2018 after adjusting for currency and the fiscal year 2018 divestiture of the patient care, DVT, and nutritional insufficiency business. All of these adjustment details can be found in the reconciliation tables included with 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 Ishrac. Omar?

Thank you Ryan and thank you to everyone for joining us. This morning, we reported a solid finish to a strong fiscal year for Medtronic. We delivered revenue growth, operating margin, and EPS all ahead of street expectations. Q4 revenue grew .6% organic, with outperformance in RTG and MITG offsetting challenges in CVG and difficult comparisons in diabetes. In addition, emerging markets continued to be a big driver, growing 12%. Our adjusted operating margin expanded 140 basis points, including currency, reflecting our entire organization's focus on enterprise excellence. On the bottom line, we grew adjusted denuded EPS .5% or .2% at constant currency. For the full fiscal year 2019, revenue, EPS, and free cash flow all came in above the guidance ranges we set at the beginning of the year, as we executed against our commitments. Revenue of $30.6 billion grew .5% organically. Adjusted diluted EPS grew 10% on a comparable constant currency basis and .5% pro forma. Free cash flow of $5.9 billion grew 62%, much faster than earnings, reflecting the focus of our entire organization on improving this important metric. Last June at our investor day, we set a target to improve our free cash flow conversion to 80% over the next two to three years, and we achieved it in just one year. FY19 free cash flow conversion was 83%, notably above our payor average. In FY19, we invested our capital into future growth platforms with a focus on returns, while at the same time increasing our returns to shareholders through share repurchases and a rising dividend. In Q4, we overcame significant challenges and relied upon the diversification of our business to deliver another quarter of solid top and bottom line results. Let's discuss some of the more important drivers of our performance, starting with our restorative therapies group, which had another very strong quarter growing 6.5%. The launch of the Mazor X stealth navigated robotic system is off to a strong start and building momentum. We sold 26 systems this quarter, increasing our spine robotic market share to more than 70%, with an installed base that is now more than three and a half times that of our closest competitor. While Mazor sales are driving brain therapy's growth, we believe they're also a good leading indicator of future growth of our spine division, as customers that are purchasing our Mazor system are also choosing to increase their share of metronic spine implants. In fact, in Q4, over 80% of our Mazor systems were sold to customers who chose to enter into combined capital and implant contracts, and the percentage of Mazor robotic cases that use our metronic spine implants continued to climb, exceeding 60% in Q4, a double digit increase from Q3. When you combine our spine division sales with the sales of our capital equipment from our brain therapy division used in spine surgery, our spine division grew 5.6%, with the U.S. core spine business growing 11%. This is how our competitors report, and a strong indication that our enabling technologies, robotics, navigation, imaging, and powered surgical instruments will help increase sales of spine implants. In RTG, I'd also highlight neurovascular and pain therapies. In neurovascular, our market leading stroke portfolio continues to perform extremely well, with double digit growth and stent retrievers, flow diverters, coils, and neuro access products. In pain therapies, we continue to gain market share despite the market's recent slowdown. Our pain stim business achieved a number one share position in Q4 for the first time in two and a half years, driven by our differentiated IntelliS system with its evolved workflow algorithm and snapshot reporting. In MITG, we grew 5.1%, driven by strength in advanced stapling and advanced energy. This is an impressive performance, as the surgical innovations business overcame challenges resulting from the shutdown of a major sterilization supplier's facility. I just cannot say enough about how our team stepped up and successfully managed this issue, quickly identifying alternative suppliers and re-routing our supply chain to get inventory to the right place at the right time. We expect to be back to full sterilization capacity late in Q1. In CVG, we grew 1.1%, as we faced challenges in drug-coated balloons and LVADs, as well as CRM replacement devices, given where we are in our replacement cycle. At the same time, multiple product lines showed exceptional strength in the quarter, with high teens growth from our Reveal Link insertable loop recorder and mid-teens growth from both our micro-trans catheter pacing system and our Arctic Front AF ablation catheters. We also continued strong double-digit growth in our TAVR franchise. Our Tyrex anti-infection product grew in the high 20s, and we saw a notable pickup in its utilization following the rapid data presentation at the American College of Cardiology meeting in March. In diabetes, we grew 0.6%, an anomaly, given difficult prior comparisons that we described on our last earnings call. Despite the challenging comparisons, diabetes delivered mid-teens growth in international markets and our fourth consecutive quarter of triple-digit growth in standalone CGM. Looking ahead, we expect diabetes growth to re-accelerate in the first quarter and to be accretive to total company growth in FY20. At the ADA conference in June, we plan on hosting an investor meeting, where we will update you on the progress of our pipeline and an exciting series of product launches we have planned over the next 24 months. Now turning to merging markets, our performance continues to be strong, growing 12% this quarter and representing 16% of metronic revenue. Our strength was diversified across all four groups and across multiple geographies, with China growing 13%, South Asia by 22%, and Southeast Asia by 20%. In addition, Middle Eastern Africa grew 13% and both Eastern Europe and Latin America grew 8%. Our strategies of public and private partnerships, optimizing the distribution channel, and in the markets, localization of R&D and manufacturing are driving growth and differentiating metronic. Overall, it was another solid quarter, despite the noted headwinds, and a really strong year for metronic. But as we look forward, we're even more excited about what lies ahead, as the investments we've been making in our pipeline begin to pay off with accelerating revenue growth and ultimately value creation for our shareholders. We expect our top line to accelerate over the course of FY20 and into FY21, driven by the anniversary of recent headwinds, combined with major products that are launching now or will launch over the next 12 months. It's worth highlighting some of these new term launches. I'll start with CVG. In our TAVR business, we're expecting low-risk indication expansion in the U.S., as well the launches of our next generation TAVR valve, the Evolute Pro Plus. We intend to launch this valve across all sizes, including a large 34-millimeter valve. In CRHF, two of the biggest launches we have in FY20 are, number one, our Reveal Link 2.0 insertable cardiac monitor, and number two, our Micro AV Transcatheter Basing System. Link 2.0 will feature Bluetooth connectivity, 5-year battery longevity, enhanced sensing specificity, and the ability to monitor new physiological parameters. Micro AV, which is one of the most disruptive products in our pipeline, is expected to launch around fiscal year end. It will enable us to access and disrupt over 55% of the eligible pacemaker market, up from 16% today. At MITG, we continue to make great progress with our soft tissue robotics program, and we are now preparing for the initial launch in FY20, consistent with our commentary over the last several quarters. Our initial launch activities will occur outside the U.S. and support our clinical and regulatory strategies in geographies around the globe. I know everyone is anxious to see the robot, and for competitive reasons, we've obviously kept this program close to the vest. The good news is that we plan to host an analyst event this fall to show the robot. We're in the process of working on dates, and as soon as we get everything confirmed, we'll be sure to send the analyst an invitation. In RTG, as I mentioned earlier, the launch of the Mazor X stealth is off to a great start, and we expect this will continue to drive growth in our neurosurgery business, along with creating demand for our core spine implants. In neurosurgery, we're preparing for the launch of the MinusREX MR8 drill platform in the first half of FY20, and we expect its differentiated features to drive share growth. In neurovascular, we just launched our next generation Stent Procrever Solitaire X and our React 071 aspiration catheter, advancing our leadership in the treatment of ischemic stroke. In pain therapies, we expect the full launch in FY20 of our Akurian nerve ablation platform. In diabetes, we expect to file for a non-injective indication for our CGM sensor in early FY20, thereby allowing us access to the U.S. Medicare market for the 670G. In addition, in FY20, we expect to launch the Minimed 780G, our advanced hybrid closed loop system with Bluetooth connectivity. The 780G will feature next generation algorithms designed to improve time and range to over 80%. The system will reduce the burden of carb counting, enable remote monitoring as well as remote software downloads, and include several key enhancements to our CareLink system. What all this means for the company as a whole is that we expect our growth rate to accelerate over the course of FY20, with the second half growing faster than the first, as we, one, anniversary recent headwinds, and two, bring these innovative products to market over the next several quarters. Moreover, we expect our top line momentum to build heading into FY21, as we get the increasing benefit of FY20 product launches that I just mentioned, as well as the benefit of several products that we expect to launch early next fiscal year, such as our Percept Deep Brain Stimulation System, the very first deep brain stimulator with sensing capabilities, our Diamond Temp Focal Ablation Catheter System, which will initially launch in Europe, and our InterStim Micro 3CC MRI Compatible Sacral Nerve Simulation System, which is fully rechargeable and 80% smaller than our current market leading device. While there isn't enough time today to go through the longer term pipeline, with all of these products launching, the takeaway that I want you to have is that each of our four groups has the potential to see accelerating growth in FY21. Let me now ask Karen to take you through a discussion of our fourth quarter financials. Karen?

Thank you. As Omar mentioned, we delivered fourth quarter organic revenue growth of .6% and EPS growth of 8.5%. For the full year, our adjusted operating margin expanded 120 basis points, including 50 basis points on a constant currency basis, and in line with the guidance we gave at the beginning of the year. We remain focused on our Enterprise Excellence Program, better leveraging our size and scale and driving improved effectiveness and efficiency across the company. This past year in particular, the benefits of the program were most evident in SG&A, where we drove 40 basis points of improvement. Our fourth quarter adjusted operating margin was 31.5%, an improvement of 140 basis points or 50 basis points on a constant currency basis. In addition to driving expansion by executing on our Enterprise Excellence Program, we also absorbed the unplanned expense of China tariffs as well as a negative 20 basis point impact on our operating margin from the sterilization issue, with purposeful cost control throughout the company. In the fourth quarter, we successfully executed a 7 billion euro debt offering and used the proceeds to reduce U.S. dollar denominated debt. The new euro issuance carries a weighted average coupon rate of 7.8%, lowering the effective interest rate on our long-term debt portfolio and providing savings for the company for years to come. Our adjusted nominal tax rate was .1% for the quarter and .6% for the year, in line with the expectations we set on the third quarter call. Excluding the nonrecurring tax benefits we received in fiscal year 19, our adjusted nominal tax rate would have been approximately 14.75%. Perhaps most exciting is our annual free cash flow at $5.9 billion, a significant improvement the $3.6 billion we generated last year and well above our guidance and expectations. All of our colleagues have made improving free cash flow a priority, and this focus is yielding strong results, enabling us to achieve our conversion goals well ahead of the schedule I gave you at our investor day in June. Going forward, you can expect our free cash flow to grow largely in line with earnings as we continue to target an 80% conversion rate above our peer average over our long-range plan. Before I move to guidance, I want to reiterate our commitment to balanced capital deployment. We continue to invest in future growth through disciplined investment in R&D, along with tuck-in acquisitions like Mazor and Epix, among others. And we remain committed to returning a minimum of 50% of our annual free cash flow to our shareholders. In fact, in fiscal 19, we returned $4.6 billion, 78% of the free cash we generated, to our shareholders through both dividends and net share repurchase. Our total shareholder payout for the year was 65% on adjusted net earnings. Now, turning to our guidance for fiscal year 20. As a starting point, we expect organic revenue growth to be 4% plus or minus. While the impact of currency is fluid, if recent exchange rates hold, foreign currency would have a negative impact on full year revenue of approximately 1 to 1.5%. By business group, we expect MITG to grow .5% to 5%, RTG to grow 4% to 4.5%, diabetes to grow 6% to 8%, and CVG to grow 2% plus or minus, all on an organic basis. We expect our first quarter growth rate to be lower than normal. On the heels of a better than expected fourth quarter, transitory headwinds from the sterilization shutdown in MITG and a slowdown in our peripheral business from pachytaxel-coated balloons. Given these, we expect organic revenue growth in the first quarter to be in the range of 2 to 2.5%, with currency having a negative impact of 2.1 to .6% at recent rates. By business group, MITG and RTG are expected to grow 3 to 3.5%. CVG looks flat and the diabetes is expected to grow 5% plus or minus, all on an organic basis. From there, we expect our revenue growth to accelerate over the course of the year, with constant currency growth closer to 4% in the second quarter and north of 4% in the second half. We expect to continue to drive margin expansion of approximately 40 basis points on a constant currency basis, driven by our Enterprise Excellence Initiative. For modeling purposes, we would assume a modest improvement in the first half of the year, given lower revenue growth and a slight FX headwind, with increasing improvement in the second half. We expect our tax rate to increase from .6% last year to 16 to .5% in fiscal year 20, given the changes associated with the U.S. tax reform that we discussed previously. Of course, we remain focused on optimizing our underlying operating tax rate over time under these new regulations. With respect to earnings, we expect non-GAAP diluted EPS in the range of $5.44 to $5.50, which includes a negative 10 cent impact of currency at recent rates. For the first quarter, we expect $1.17 to $1.19, including a 4 cent currency headwind at recent rates. After delivering on each of our commitments in fiscal year 19, I couldn't be more excited about fiscal year 20 and beyond. As Omar outlined, we expect our revenue growth to accelerate over the course of the year as we anniversary recent headwinds and launch a series of major products. And we expect this momentum to build into fiscal year 21, with each of our four groups having the potential to see accelerating growth next fiscal year. Now I will return the call back to Omar.

Omar Thanks, Karen. Before we go to Q&A, I'd like to acknowledge our 90,000 Metronic employees who work tirelessly and are dedicating to fulfilling the Metronic mission, alleviating pain, restoring health, and extending life for so many around the world. In fiscal 19, our employees, together with our physician partners, served over 75 million patients, or more than two patients every second. Let's now move to Q&A. In addition to Karen, our four group presidents, Mike Coyle, Bob White, Jeff Martha, and Humaan Hakimi, 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. Thank you. Good morning

and welcome to MedTram.

Operator And as a reminder, if you would like to ask a question, please press star followed by the number one on your telephone keypad. Our first question this morning comes from Bob Hopkins from Bank of America. Please go ahead.

Bob Hopkins Hi, thank you and good morning. Congrats on a strong finish to the year. I just wanted to kind of ask a little bit about some of the revenue forecasts that you're making. So two very quick things. One, given your first quarter guidance of that two to two and a half, can you just walk us through in as much detail as you're willing to provide, some of the incremental headwinds that you're seeing in Q1 or that you're forecasting in Q1 versus the .6% growth that you put up in Q4? And then I'll just go ahead and ask a quick follow-up right here. This is a question for Mike. I'm just wondering if you could comment on TAVR and what you're seeing since the presentation of the data at ACC because the TAVR number looked maybe a smidge lighter than we were thinking. So those are the two questions. Thanks for taking them.

Mike Hopkins Karen, you want to take the

two ones? Karen Smith Sure. Thanks, Bob. Appreciate the question. So in the first quarter, we have guided the two to two and a half percent. And as you know, the fourth quarter came in a little better than we expected. Recall that we had guided around 3% for the quarter and we came in at 3.6%. So given the strong finish to the fiscal year, it's likely that we'll see a little bit of softness in the first quarter. We also have the lingering effect of the sterilization issue in MITG. We did use our inventory on hand to help mitigate that in the fourth quarter. And now we have less on hand as we move into Q1. We expect the sterilization issue to be behind us, as we said, at the end of the quarter. But we'll face some slowdown in revenue given that. Probably to the tune of about 20 to 30 million, which is about 100 bits of MITG growth there. And then as you know, Q1 will be the first quarter, the full impact of the DCB issue following the uncertainty of the FDA announcement in June. That could be another 20 to 30 million dollar headwind in CBG and about 100 basis points of CBG growth. But as we noted on the call, we do expect our growth to accelerate over the course of the year as we anniversary various headwinds and we introduce, you know, our strong pipeline. So I'll let Mike answer the TAVR question.

Yeah, Bob, thanks for the question. You know, we were quite pleased with the TAVR number. I think the overall growth rate for both the global growth rate was around 11 percent, U.S. growth rate around 12 percent. And we were very much in line with that. The announcements at ACC obviously were for low risk and there have been no low risk approvals yet. And of course, there's no reimbursement for products that are unapproved. So we didn't see a marked increase in penetration of that group. That will follow after the FDA does the actual approvals of the expanded indications for use. But I would point out, you know, a year ago we were much more active in terms of opening up new accounts which carries with it stocking. That would have, you know, put more revenue in the prior year number. So implant growth rates for us were, you know, more in the mid teens rate in the U.S. So we're very pleased with obviously the momentum in the business and especially with the potential to further grow into the low risk patient population.

Great. Thank you.

Thanks, Bob. Next question, please, Carol.

Our next question comes from David Lewis from Morgan Stanley. Please go ahead.

Hi. Good morning. Just one for Karen and one for Hooman here. So Karen, I wondered if you could help us with the earnings bridge here for 2020. Other income was a significant driver of EBIT in 19. We also had a very significant debt restructuring. So as you think about 2020, can you just sort of help us understand our assumptions, what they should be as it comes to other income and more specifically actually interest expense because to us the earnings guidance looks a little conservative. So any help there would be very helpful.

Sure. Thanks for the question, David. So on other income, it was a little strong this quarter and we had, you know, a significant strength in it from just the currency and our hedging program. But we also did have other royalty expense come in better and, you know, we had you know, as we focused on driving improved royalty income where we can, you're seeing that play out and that should continue. In terms of the debt restructuring, we were obviously pleased with the Euro debt offering in our U.S. debt tender. And going forward, you should expect around 200 to 210 million a quarter in interest expense from us.

Okay. That's very helpful. And then just two men, quick question on diabetes. I think in the recent month there's been sort of this emerging concern that the industry is changing very rapidly just given reimbursement regulatory and various technology changes. I just wonder if you can help us understand how has Metronic positioned over the next, you know, one to two years from a share perspective in both your pump and CGM business. And do you think, you know, an independent diabetes business would allow you to adapt or grow more quickly? Thanks so much.

Sure. Thanks, David. Let me actually take the second one first. We get a lot of benefit from being part of Metronic. You know, the scale and breadth of the company we leverage every single day with respect to things like wafer scale technology that we're doing with CVG. As we think about global expansion, we leverage our regulatory resources and relationships around the world. So there's tremendous benefit. And I think that helps us drive the growth that we need. Now with respect to, you know, the competitive positioning and all of that, you know, for all that's been, you know, said and written about the competition and its impact on us, let me just maybe give you a few data points with respect to how we finished. First, our install base in FY19 group by MidSingleDigits. This is true globally as well as in the United States. In addition, our patient retention rates were in line with historical rates globally. And you know, as we think about FY20, we see a lot of things to be excited about. International, that you heard from the commentary, is going to be and continue to be a big portion of our growth. This is about 45 percent of our global revenue and it's growing, you know, in the mid-teens and we expect it to grow in the mid-teens. And the other dynamic that we outlined at the analyst day is the CGM penetration and the CGM growth of our install base as well as standalone CGM growth, which had four consecutive quarters of triple digit growth. You put all of those things together, David. You know, we feel really good about our ability to be accretive to overall Medtronic and FY20. And that's even before we talk about the pipeline that we'll share with you at ADA, which is incredibly exciting and will bring a whole host of new innovation over the next 24 months.

Thanks, David. Can we take the next question, please, Carol?

Our next question comes from Vijay Kumar from Evercore ISI. Please go ahead.

Hey, guys. Congrats on a nice quarter here. You know, two quick ones for me, one product and one maybe on the guidance here. On the product side, Omar, you know, the, the, the robot, the analyst day, you know, this is new information to the street. There had been some concerns maybe this could get pushed out. I'm just curious on is this now the preview of the robot? Does that mean, you know, we could see a launch of the robot end of the year, you know, some really nice meso-rex numbers? Is that, is that sort of a preclude to what we could see on the surgical robotics side in terms of RAM? And then on the guidance front, Karen, you mentioned tax headwinds. Are the tax regulations finalized? And if they're finalized, you know, when we think about fiscal 21, are there any tax planning new structures you could put in place to, you know, offset some of this as we look forward for 21? Thank you.

Okay. Let me start on the robot and let Bob also comment on it. You know, first of all, you will see the actual robot when we invite you. That is the product that we intend to commercialize and I think, you know, our commitment for an FY20 launch is still there as I mentioned in the commentary. But, but let me just say a little bit about the comparison of the meso-rex. You know, meso-rex is a different robot, but this methodology of combining our high value human bones, which in the Mazor case are actually our tools as well as the spinal implants. In commercial packaging with the capital equipment is a big differentiator from a tronic. And I can tell you that Bob's team is all over this looking at the experiences that we are getting with the Mazor X launch and we'll translate them. And this is not just the commercial, you know, framework. It's how we structure the sales force, the training and a whole variety of other areas. So, I don't know, Bob, do you want to add anything? No, perfect,

Omar. VJ, again, thanks for the question. We're excited about where we're at with the program. We look forward to you learning a lot more this fall when we hold the analyst's day for you. For obvious reasons, we're not going to go into the details about our global launch and which countries and when, but it consists of what Omar said and consists of what we said in the past when we were preparing for an FY20 launch.

And VJ, in terms of the guidance on the tax headwind, the final regulations are not yet out, so it is not final. We will obviously be focused on optimizing our tax rate over time and we've been working on that already. And so you've seen our guide in taxes move from a range of 16.7 to the lower end of that range, 16 to 16 and a half. And of course, once the regulations are final, we'll be focused on, you know, continuing to optimize where we can. In terms of FY21, you know, our hope is that we can improve from there, but we'll see. And if you just think about the guidance that we've given with the tax rate headwind, tax is about a 20-cent headwind on our year. We've offset some of that with the debt offering that we did, call it about 8 cents. And we've got the 10-cent headwind on FX. So when you look at all of that together, if you look at our adjusted EPS growth, it would be about 8 to 9 percent.

Thank you, guys. Thanks, VJ. Next question, please, Carol.

Our next question comes from Robbie Marcus from JPMorgan. Please go ahead.

Great. And again, congrats. Either, maybe for Karen or Omar, if you could just talk about some of the product launches in fiscal 20 and then fiscal 21 that give you confidence in accelerating growth throughout the course of this year, but also, you know, I think it's great to hear accelerating growth in fiscal 21 as we sit here over a year out from that. What are the products that give you confidence?

Well, there's a whole series of them, and I'll go through them because they're all contributing and they're all exciting. You know, first, the LORISC indication on the TAVR, plus the EVOLUV Pro Launch, which gives you a larger valve, and the confider sheet. You know, that's an FY20. Together with that, the LINC2, which we're really excited about with more accuracy, with more physiological parameters, as well as Bluetooth connectivity, that's in CBG, like straight up with that in FY20. And then in RTG, you have the Akuren RF ablation system and the Midas Rex MRA. I mean, these are continuous innovation products that we think will make a difference. And then back to CBG, actually, the Micro AV, which will have an October submission, and we expect sometime late in the year, you know, the FW21 will also have a carryover into FY21 on a strong basis. And then last but not least, diabetes, we expect the 780 to launch towards the end of the year, as well as the non-adjunctive labeling, which will allow us greater market access, and that will happen much sooner in the year. So those are things that we can talk about, like right now, in FY20. And all these will in many ways carry on into FY21, but there are other specific ones. And I'll repeat the Micro AV because that will have a full year benefit, and that's a big disruptive program for FY21. But also the Diamond Temp RF ablation catheter that comes out of CBG. And then RTG has a whole series of products. You know, the DBS Percept product from Neuromodulation, which is the first product for sensing, that will be launched in FY21. In addition to that, Pelvic Health has the InterStim Micro, which will launch again, you know, early in FY21, maybe towards the end of FY20. And, you know, the diabetes will have the, you know, continued rollout of the 780G, which will have significant benefits, as I mentioned in the commentary. And again, RTG, the soft tissue robotics, which I've just talked about, will launch in FY20, but the full benefit of that will start to see in FY21. So, you know, that's a lot of products, and I'm telling you, I didn't even mention all of them. You know, there's some in staplers and other areas in neurovascular, and so there's a whole series of products that continue our momentum in CRHF. So, you know, we're pretty excited. And the pipeline here is solid. These are solid products, many of them very close to launching, and others close to approval. So, we're really excited about this.

And, Robbie, our pipeline is the most exciting, but I would just remind you, too, that particularly in CVG, we have some anniversary of some headwinds that will help us with the growth acceleration as well. We had the accounting change in our services and solutions business in Q2, which is one anniversary. We'll anniversary the loss of our MCS share loss in Q3, and then we'll have a partial anniversary of the drug-coded balloon issue in Q4.

That's really helpful. And maybe, Karen, just to follow up for you, appreciate all the commentary on the operating margin progression through the year. Is there any help you can give us on maybe gross margin versus operating margin and how currency might flow through that line of item? Thanks.

Sir, thanks for the question. On gross margin, the gross margin, as you know, can be impacted by our product mix. And so, you haven't seen, at least in FY19, expansion in gross margin. We've driven the expansion in operating margin in SG&A. You know, while our Enterprise Excellence Program is designed to offset the pressure that we have in pricing and mix, there could be some years where we see expansion in gross margin, but I wouldn't count on a lot there. In terms of FX, we do have an FX headwind next year, and that should show up some in the gross margin line.

Great. Thank you, Robbie. Go to the next question, please, Carol.

Our next question comes from Joanne Bunch from BMO Capital Markets. Please go ahead.

Thank you for taking the question. Can you hear me okay?

Yes, yes we can. Go ahead, Joanne.

Wonderful. I have two questions. The spinal cord stimulation market, could you please give us an update on your view of that? I think you mentioned that you believe that Metronic grew faster than the market in the quarter. And then my second question has to do with the PacoTaxel panel that's upcoming. What do you think we should expect out of that? Thank you.

Okay, thanks, Joanne. I'll let Jeff take the spinal cord question and then go on to Mike.

Yeah, yeah. So, Joanne, how you doing? On the spinal cord stimulation market, it is a little bit down, you know, flashed even down last quarter. But we did, and Intellis is performing strong relative to the competitors. We're getting great feedback on the battery, you know, the recharge speed and how long the charge lasts and the outcomes we're getting from the Evolve workflow, which we published in the Vectors trial and the Vectors study. So we're getting great feedback and we've picked up by our estimates about two points a share year over year and we're back to the number one share position, which is the first time in two and a half years. So, you know, we're feeling good. Now the overall market, like I said, I wish it were growing faster. It has slowed and we have, you know, a couple thoughts on that. I mean, one is that we see a lot of technology that's been, we're on the back end, I'd say, of a nice wave of technology innovation and clinical indication expansion. So we're on the back end of that. And then, you know, there are, I wouldn't say there's new payer policies out there, but there is increased payer scrutiny that we're seeing really primarily driven by the performance of our competitors' devices that has slowed the market a bit.

And then on the question of PAKLA-Taxel, obviously we're looking forward to that opportunity to broaden the discussion of the data that's available on PAKLA-Taxel products. Obviously we have full visibility to our own data and are very confident in the performance of our ADNL product because we have over 1,800 patients' worth of data that has been carefully followed. From my perspective, the discussion to date has really focused on the three TMA submissions from Medtronic, Bard, and Cook. And I think there's a much broader set of data to be looked at that in all cases is more favorable from our perspective. First, there's additional follow-up, you know, the capture of patients who are lost to follow-up in the data that we have been doing and has certainly been helpful to the overall numbers for the submissions on the TMA data, which will be presented at this session. In addition, we have other data sets, the Japan randomized controlled study of 100 patients that basically not only showed no statistical difference in death rates between the PCP and blue, but also showed a numerical higher rate in the PTA arm. And then we'll also be submitting data from the IMPACT-Deep study, which is in the critical and mischemia group, which is a study that was sized very similar to the SFA study that FDA referenced 358 patients followed after five years. And in fact, there we saw higher death rates associated with the PTA arm than the DCV arm in five years. So these additional data sets we think will be helpful. There are also data sets that we would expect to see from patient meta analysis that DIVA is doing, as well as we think there will be interesting data from claims analysis that should be helpful. Of course, we don't have visibility to all of the other companies' data, so we'll only see those when we get to the actual panel itself. But everything we have seen has us even more comfortable than we were in the beginning in terms of the safety of these products, and they are profoundly efficacious for limiting re-interventions in the patient group. So we go into the meeting really believing the data is very strong, but it's important to understand that no studies have been sized to answer the question of mortality in this patient group. And so it's going to be important that we look at the risk-benefit of these data sets. And as I said, everything we've seen from our own data sets, which are the largest in the industry, make us very confident.

Thank you very much. Have a good quarter.

Thank you, Joanne. Next question, please, Carol.

Our next question comes from Matt Taylor from UBS. Please go ahead.

Hi. Thank you for taking the question. I just had one follow-up on the Paclitaxel question. I wanted to understand if you had a view on the PCR statement that came out this week. It seemed relatively favorable. And if you could talk about how much of a headwind is baked into your guidance, or maybe if things go well in June, how much of that you think could come back?

So we were pleased to see the PCR statement. It certainly was a more encouraging or, let's say, softer statement than FDA had made basically pointing out the limitations of the meta-analysis data that had been shown and reinforcing the verification nature of these products in terms of improving patient outcomes. So they were clearly more balanced in their view than we had seen in the FDA discussion. Now, obviously, we'll see more data coming in, and we'll have to weigh that. In terms of how we have provided guidance, we are basically assuming that what FDA has stated is going to remain for the entire balance of the year. And obviously, we've seen how the market has reacted to that. And so we've just extrapolated that out through the rest of the year. So if FDA were to become more favorable in their commentary, obviously, that could improve outcomes. But right now, our guidance would assume there will be no change coming out of

it. Thank you. I just wanted to ask one question on neuro. So neurovascular growth is very strong. Could you talk about some of the components of that and whether you're seeing a stronger market there? Are there any product launches that helped you this quarter?

Yeah, sure. So first of all, neurovascular, we have Metronik, we have a broad portfolio playing in every segment. And that is our strategy. And we're number one positions in both ischemic and overall hemorrhagic. And we've recently refreshed that entire portfolio. Nobody else can say this. So it's a very strong market. We're very well positioned across every segment. Now, what's driving our growth in the near term is the first of all entering the aspiration market. We've already launched the 068 and now the 071, Riptide systems or catheters. And we've got, we're getting really, really positive feedback on both. The 068 started out a little slow because we had to make some adjustments to it. We had a soft launch, made some adjustments to the product. And now it's picking up. The 071 hit the ground running and we're getting great feedback. And we estimate that we're somewhere about 15% of this market already, well ahead of our plans, the aspiration segment, well ahead of our plans. We see ourselves getting to 25% by the end of the fiscal year and we think we'll eventually get to 50% of this aspiration market. And on top of that, we just launched our next gen StenTreever to maintain and extend our lead in that segment. So those are some of the things that are driving it. And I'd say the other big drivers, just the global nature, we're just growing very fast in China. And so the fact that we're global is also helping, especially in China. So it's a global and broad and refreshed product portfolio.

Thank you. Great color.

Thanks. Thanks,

Matt. Next

question, please. Our next question comes from Kristen Stewart from Barclays. Please go ahead.

Hi. Good morning and thanks for taking the question. I just wanted to just talk a little bit just about the free cash flow. You guys did a great job of really improving the metrics there. How should we just think about the deployment of capital? I know in the prepared remarks you talked about the commitment to at least 50% to shareholders, but how should we just think about more on the M&A side? I think you mentioned tuck-ins, but should we expect an increase in the rate of maybe acquisitions going forward and more focus on products and really leveraging the portfolio or just how should we think about that going forward?

I think, Kristen, you're sort of on the right track there. Yes, we have a lot of firepower here and we're building it. And we intend to use it in M&A. And the focus on M&A indeed is in tuck-ins that accelerates our growth. And examples of things that we've already done expect more of the same. We just did the Titan spine acquisition. We did Epix therapeutics earlier in the year. We did neutrino health, which is a great plug-in to our diabetes pipeline with a nutritional database. And you'll see that that works through into our next generation pumps. And then the Mazor robotics, obviously, which I congratulate Jeff on that one because that's a great acquisition and what it's really pulling through in spine. So those are examples and they're not exactly that small either. And you expect more of that. Now, we'll always be disciplined about this. We'll look at the returns that we get and it has to be above our cost of capital. We look at the strategic fit and we look at the earnings impact. And we look at those three things in a balanced manner as well as our team's ability to execute and put all that together. And that's the strategy that we have for M&A. And we've got tremendous firepower. And you'll see us accelerate that process as much as is available.

Okay. So it sounds like kind of taking the M&A focus and driving more depth across the businesses versus going broader. You feel like you're in all the spots that you are or need to be today?

Yeah, that's correct. There's enough out there that will help the growth of our current business.

Okay. Thanks very much.

Thanks, Kristin. Next question,

please.

Our next question comes from Larry Biggleson from Wells Fargo. Please go ahead.

Good morning. Thanks for taking the question. One high-level question for Omar, one product related question for Jeff. So Omar, it feels like there's been a little bit of a shift in the regulatory environment towards more post-market action from FDA. Do you agree with that? Has anything changed on the pre-market approval side? And what are the implications for Medtronic? And second, for Jeff, there's a new competitor coming out in the sacral neuromodulation space, potentially the second half of this calendar year. So what's your plan for protecting your position in that market? And just remind us of the timeline for your next generation smaller rechargeable device. I think I heard earlier, fiscal 2021. Thanks for taking the questions,

guys. Okay. First of all, the FDA question. Look, the FDA's fundamental mission is to protect the safety of the American public, and they do an excellent job in fulfilling that mission. And I think as more data becomes available, they're using it wisely to make sure that their post-market studies and that the approval process has in it enough of a safety profile, and we're completely supportive of that. They're working closely with industry in making sure that approval processes are accelerated the right way, but not compromising safety at any time. So we're pretty supportive of the moves that they're making. And we don't really see any major changes to the device approval framework that they have in place. I think that's about it. You know, Jeff, do you want to talk about sacral nerve? Sure.

Hey, Larry. So good question. You know, I'd say first and foremost regarding our new product that's coming to market, we expect it to launch in the beginning of FY21, and it is going to be this is a rechargeable device with really strong MR labeling, and, you know, it's a 5.5 cc device. So with our overdrive battery technology on this, which we've proven with Intellis and Payne STEM, it's just superior. And so between the size and the overdrive technology, we think this is a winner. The product that a competitor is launching here in the near term will also be a rechargeable device, but I think it's 5.5 cc. And I think we compare it very well. And the gap between when they launch, we expect them to launch. You know, we don't know, we don't really know, we don't know how the FDA is going to treat things like cyber security and things like that. So we really don't know when they're going to launch, but conservatively for us, we expect a three to four quarter gap there. And you know, look Larry, I could say this, this isn't the first time that we've faced at RTG a new competitor coming into our markets that we've pioneered and we maintain a high share. And I'd like to think, matter of fact, I'm confident we've learned from these experiences which have been painful, especially like Payne, when you go back to think about Payne STEM, we've learned, we've built these lessons learned into our commercial playbook, we've changed our commercial leadership across RTG, and all I can say is we're ready. And you know, I don't know what else to say, we're ready for this.

Thank you guys, thanks for taking the questions.

Thanks Larry.

Next question please, Carol.

Our next question comes from Matt from Credit Suisse. Please go ahead.

Hi, thanks for taking the questions. So I thought maybe just a couple of quick pipeline type questions if you could expand on your thoughts around a few things. Just one on Intrepid, any update on the transeptal delivery system pathway forward on that and thoughts on left atrial appendage closure, which is something that you know, ought to be and I'm sure you plan to be exposed to. And then the second, just kind of general topic, we see often in these meetings a lot of activity clinical evidence interest around renal denervation, kind of rebounding for both hypertension and arrhythmias. And just if you could update us on your intermediate or long term strategy for returning simplicity to commercial product. Appreciate your thoughts.

Go ahead Matt. So I'll take the questions. On Intrepid, we do expect in the fiscal year to do our first demand on a transeptal version of Intrepid. So that work is progressing and we're confident we're going to find a path forward to, just as we did in the TAVR world, to start with a valve that was transapical but then moved to a transeptal delivery system. On left atrial appendage closure, we do not currently have a product in development that we very, follow developments in this space very carefully. We do have a lot of poor competency in our structural heart business that's applicable to this space. But we also would want to have a superior product before entering into that type of market. So we have a list of designs that we're interested in but we have no announcement to make today on that topic. And renal denervation is actually progressing as we discuss. We expect to have the typical trial result presentation next spring which will be sort of key to the FDA approval cycle. But as you pointed out, there's a lot of clinical evidence being generated around this topic that has been presented both at the PCR meeting here this week as well as at the HRS meeting two weeks ago. And in support, both at late-breaking clinical trials, both very supportive of the technology. And the ones on atrial fibrillation were particularly interesting. We sponsored the one that was presented for the late-breaking clinical trials here this week at PCR. It basically showed a 60% reduction in patients who developed atrial fibrillation in a highly selected group of patients who had hypertension and were randomized to renal denervation. So the data continues to be very encouraging but obviously given the events of the HCN3 study results, it's going to be very important that we have highly controlled data to show the efficacy of this product. And we're very confident based on the pilot studies that we've already published on and the trial we are executing with FDA that when we get to next spring we're going to have some very good efficacy and safety data to discuss. So we're excited about that market.

Thanks.

Our next question comes from Josh Jennings from Cowen. Please go ahead.

Hi. Good morning. Thanks for taking the questions. I was hoping to ask Mike just about cardiac rhythm and heart failure and the road to recovery there. It's about half of the revenue pie for CVG. Maybe you could just focus on the anchors, you know, high voltage and LVADs, whether we just have to wait for anniversaries or if there are anything incremental you can share in terms of returning those businesses either to flat or back to follow up. At HRS you had some really interesting data on some pipeline products, pulse field ablation and the extravascular ICD. And just any incremental thoughts there in terms of the signal that those data sets provided and your outlook for those two platforms. Thanks a lot.

Starting with the heart failure product lines, actually on the CRT side we have, I think, some very exciting product development activities in addition to some easing headwinds. And obviously the biggest challenge we've had in CRT has been as we've significantly extended the battery life of these products, we've run into that replacement headwind. And as you know, in the CRT space for high power, half the market is replacements. We still have a few quarters to go in terms of those headwinds being significant. But as we head into next year into FY21, we actually see that go neutral and that will really help us in terms of just the overall growth profile of the business. But beyond that, at HRS we launched the first active fixation quadrupolar lead for use in CRT for both CRTD and CRTP, which physicians seem very excited about. And we have our new Galaxy platform, our next generation of ICDs, which will be leasing in the third quarter, which basically will both add Bluetooth connectivity to the product, but also some very important pacing features that both will enhance the performance of our product from an HWF relation perspective as well as from heart failure rehospitalization rates. So those will be, I think, really helpful in terms of just getting our CRTD and CRTP product lines accelerating from where they have been. And then obviously we'll get the headwind going away as we head into FY21. On the LVAD side, obviously we saw a fairly significant reduction in market share that took place at the middle of the year as a result of competitive product launches. We are going back on the offensive with our lateral data to basically take advantage of the smaller size of the HVAD system to basically show lower complication rate in surgical implants of the thoracotomy approach to the placement of the device. And we also think the data sets around the stroke are going to be in our favor as we get further evidence of the performance of these products. And so obviously the anniversary in the second half of next year is going to be very helpful to our overall growth rate, but then obviously we're hoping to take sequential market share as we take advantage of the performances of the product. And then in terms of your question around PFA and the EVICD, we're very excited about both of those programs. We will expect to basically go into pivotal studies with the EVICD this year, which obviously has the benefits over existing sub-Q products of actually allowing anti-tacky pacing and post-shock pacing to be done with the product. So that we think will provide a big advantage. It's also got a footprint that looks like a standard ICD as opposed to a much larger device you see in the sub-Q application. And so we believe that will carry with it benefits and implant, including potentially lower infection rates. And then PFA is probably the most exciting thing that we see in the whole atrial fibrillation ablation space. This allows us to actually do ablation without thermal energy, neither heating nor cooling, by essentially disrupting the myocytes directly, which has the potential to really address all of the major complications associated with ablation of atrial fibrillation. So that, coupled with our entry into the focal ablation segment with the EPICS device, the Diamond 10 device, really now significantly broadens our portfolio from where we have traditionally been a cryo company focused on PAF ablation. So really nice work by the team to basically expand our product offerings. Both EVICD and PFA, of course, are beyond the FY20 window, but we will speak to those, I'm sure, at the analyst meeting next year to give you more guidance as to when we expect them to be major revenue drivers for us.

Thanks, Josh. We'll take one more question, please,

Carol. Our next question comes from Peter Tickering from Deutsche Bank. Please go ahead.

Good morning, guys. Thanks for squeezing me in here. A few questions on China. China is obviously a very important market for you guys. It looks like revenues in China slowed in the quarter to 13% from 16% last quarter. How are the tariffs impacting that business? What growth have you embedded within your 2020 guidance? And how should we think about the doubling of tariffs and how that impacts your growth in that market?

Well, first, look, we're really excited about China. And that is an important market, like you point out. In the end, it will be the biggest healthcare market just by the size of the population and opportunity. So it's a market we intend to be present in. And look, we're quite pleased with our performance. The business certainly grew sequentially quarter over quarter and continues to grow. And we expect pretty reliable double-digit growth from China on a very consistent basis. And we're getting that. And so it is a market that we are committed to, one that we see is a big growth driver for us. You know, the tariffs do pose somewhat of a headwind in terms of our margins. But it's one that we will cover and we will offset. We faced some of that in FY19, which we successfully managed to offset. And we don't expect a major increase in FY20, but there may be some towards the back half of the year, which we will manage. But more importantly, the need for our products in the Chinese population is very clear. There's a demand from both the doctors and the patients, and we will follow through with that. We have an outstanding team there with scale, with critical mass, presence in the big cities as well as the outlier regions, in private hospitals as well as the government hospitals. And all of those are growth drivers for us across the board and all our businesses. So make no mistake, China is a big priority for us that we're all focused on and we're very confident that it will be a continued, consistent growth driver in the double digits for Metronik.

Okay. And then one follow-up. This is a very big quarter on Azure. How does the pipeline look for new robot sales in 2020? And how has the spline consumable market share in hospitals we've had the robot installed for over a year changed?

Can you speak to the second part of that question?

Yeah, you bet. For hospitals where the robot has been for over one year, how has the spline consumable market share changed within that year?

Well, starting with that question, we're definitely seeing where we have robots installed and to your point up and running and we've trained the physicians, the surgical teams and our reps, we're clearly seeing faster growth and greater market share versus accounts that we don't have a robot. And that same can be said to maybe a slightly lesser degree where we have navigation and the OARM without the robot. So basically where we have enabling technology, our value proposition is better and we're seeing faster growth and better market share. You know, we're seeing quite a bit different and especially in competitive accounts. And the difference I'd say from a competitive standpoint between just having Nav and the OARM versus having Nav and the OARM and the robot is the amount of competitive accounts that we're getting into. Customers that are big spine centers where we were zero and our competitors had these accounts very well covered, they're calling us and we're getting in there and not only getting robotic share but we're getting non-robotic cases. So it's quite dramatic and we're very happy with it. And it's the overall value proposition of all of this technology working together and the path to better outcomes for patients and better financial outcomes for the hospital. And we're building evidence around both of those. So in terms of the outlook going forward, you know, we feel bullish. So far it's much better than our deal model, the Mazor sales, for a variety of reasons. And we feel that we've continued strong double-digit growth in this area based on the existing, we just launched the Mazor X-Delf Edition with Navigation, we just launched that. And so that still has a lot of runway, but we have a series of, I'll call it, continuous innovation on top of that. Things like, so we can navigate with the robot more of our enabling technology, like more of our Midas platform, our drills and such. And then we'll be, which I don't want to talk about for competitive reasons, we'll be adding other features that I think are even more differentiated that will improve basically the spine procedures, take time out of these spine procedures, and also drive more consistent, reliable outcomes. So we feel very strong, and that's what's generating the excitement around the robot, is the improvement in outcomes.

Great, thanks so much. Thanks, Peter. Omar, do you want to pitch?

Yeah, let me just close out here. Thanks to all of you for your questions. And on behalf of our entire management team, thank you for your continued support and interest in Metronic. We look forward to updating you on our progress on our Q1 earnings call, which we currently anticipate holding on Tuesday, August 20th. And with that, thank you again very much.

This does conclude today's conference call. You may now disconnect.