Medtronic plc (MDT) Q2 2018 Earnings Call Transcript
Published at 2017-11-21 17:00:00
Ladies and gentlemen, thank you for standing by. And welcome to the Medtronic's Second Quarter Earnings Conference Call. [Operator Instructions] Thank you. I would now turn the conference over to Mr. Ryan Weispfenning.
Great. Thank you, Krystal. Good morning and welcome to Medtronic's second quarter conference call and webcast. During the next hour, Omar Ishrak, Medtronic Chairman and Chief Executive Officer and Karen Parkhill, Medtronic Chief Financial Officer, will provide comments on the results of our second quarter which ended on October 27, 2017. 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 this earnings call, many of the statements made maybe considered forward-looking statements and actual results might differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC and we do not undertake to update any forward-looking statement. In addition, the reconciliations of any non-GAAP financial measures are available on our website, investorrelations.medtronic.com. Unless we say otherwise, references to quarterly results increasing or decreasing are in comparison to the second quarter of fiscal year 2017 and rates and ranges are given on a comparable constant currency basis, which adjust for our recent patient care, DVT and nutritional insufficiency divestiture, as well as the impact of foreign currency. These adjustment details can be found in the reconciliation tables included with our earnings press release. Finally, other than as noted, our EPS growth and guidance does not include any charges or gains that would be recorded as non-GAAP adjustments to earnings during the fiscal year. With that, I am now pleased to turn the call over to Medtronic's Chairman and Chief Executive Officer, Omar Ishrak. Omar?
Good morning, and thank you, Ryan, and thank you to everyone for joining us. This morning we reported second quarter financial results including revenue of $7.1 billion, non-GAAP diluted earnings per share were a $1.07 growing 2% or 5% after adjusting for the approximate 3%, a $0.03 impact from Hurricane Maria. These financial results are very encouraging when considered in the context of a quarter in which we faced three hurricanes and the California wildfires. Hurricane Maria in particular significantly affected our manufacturing operations in Puerto Rico. The lives of thousands of our employees were affected by these natural disasters, yet the resiliency, dedication and persistence of our team to overcome these challenges was remarkable. Against this backdrop, which resulted in not only a quantifiable impact to our quarter but also an unquantifiable impact from the disruption to our teams. We delivered 3% comparable constant currency revenue growth or 4% excluding the direct impact from Hurricane Maria. Our performance continues to be driven by our growth strategies of therapy innovation, globalization and economic value. In therapy innovation as I noted last quarter, we have entered a period of clear acceleration in our innovation cycle. We see increased revenue momentum from several important new product launches which we expect will continue into the second half of the fiscal year. In Q2, organic growth in our Cardiac and Vascular Group was 6%, a sequential improvement of approximately 340 basis points and the main driver of our total company organic growth acceleration. Overall, CVG grew 7% year-over-year leveraging the breadth of its products and services, as well as its strong positions in important rapidly expanding markets to drive sustainable growth. In CRHF, which grew in the mid-single digits, we are maintaining market share in the core pacing ICD and CRT product lines while creating new markets that are meaningfully enhancing our weighted average market growth. This past quarter combined revenue from our high-growth CRHF product lines representing about a third of our CRHF business grew organically in the mid-20s. Specifically, these product lines included our infection control, diagnostics, transcatheter pacemakers, AF Solutions and Mechanical Circulatory Support systems. Similarly our CSH business is shifting its revenue mix towards higher growth transcatheter valve market which now represents about a third of total CSH revenues. In TAVR, we delivered low 40s growth in the U.S. and high 30s growth in international markets as we see both strong adoption around the world for our recently introduced Evolut PRO valve, as well as expansion in traditional U.S. TAVR centers and U.S. share capture resulting from our new intermediate risk indication. In Coronary, our DES product line returned to growth as we gain low to mid-single digits points of market share sequentially in both the U.S. and Japan driven by the recent launch of our Resolute Onyx in these markets. Next, our minimally Invasive Therapies Group grew 2% less than our initially expected given the impact of Hurricane Maria. In Surgical Innovations our 4% growth was driven by new products in advanced stapling and advanced energy. In advanced stapling, growth was driven by our endo stapling specialty reloads with Tri-Staple technology, as well as Signia, our new single-handed powered surgical stapling system that provide surgeons with real-time feedback during surgery. In Advanced Energy, we experienced strong growth as we continue to rollout new LigaSure instruments and our Valleylab FT10 energy platform. These innovations are providing momentum to the transition from open surgical procedures to minimally invasive surgery or MIS resulting in better patient outcomes and lower healthcare costs. As we look ahead, we see the opportunity to expand the availability of MIS procedures through the use of our surgical robot platform. The development team continues to drive toward first-in-human use by the end of this fiscal year. We look forward to offering a more comprehensive value proposition to our customers across all key surgical areas, open surgery, traditional MIS, robotic surgery and services. Next, our Restorative Therapies Group grew 2% this quarter less than initial expected given the impact of Hurricane Maria. Our Brain Therapies division had a very strong quarter with 13% growth. This was driven by high 20s growth in neurovascular with strength across the entire stroke portfolio and mid-teens growth in neurosurgery. Our Spine division declined 1%, a reflection of the hurricane impact, as well as a continued modest deceleration in the global spine market. Excluding the impact of Hurricane Maria, our core spine business performed better than the market. We attribute this is to the ongoing success of our speed to scale product launch initiative, as well as our surgical synergy strategy which combines our enabling technologies such as imaging, navigation, power systems, nerve monitoring and now Mazor Robotics with our spine implants to deliver integrated procedures. Inside the combination of our enabling technologies which are reported in our neurosurgery business with our spine revenue, resulted in 2% growth in Q2. We believe this is an indication of our overall growth in spine procedures and a more relevant comparison of our spine results against several of our competitors. Our Pain Therapies division recently received FDA approval at CE Mark for our Intellis spinal cords stimulator. While the initial rollout is affected by Hurricane Maria, the product has been received positively by our customer and we do expect Intellis to reverse the declines we have been experiencing with several quarters in the pain stem business. And finally the FDA lifted its distribution requirements in our implantable drug pump this last month and its warning letter earlier this month. The warning letter had affected not only our pain therapies division but also our brain modulation in public health businesses. Turning to Diabetes, revenue growth declined 2% better than what we had anticipated due to the strong demand from patients willing to purchase the MiniMed 670G pump ahead of the prepared CGM sensors. Although sensor supply constraints hampered overall growth, our ability to meet increasing patient demand has improved and our sensor capacity expansion plans are on track. Last month, JNJ announced that they were exiting the insulin pump market and we were pleased that they selected us as their partner of choice to facilitate the transition of the Animas patients. While the majority of the approximately 90,000 existing Animas patients are currently under warranty, we are actively working to ensure their smooth transition to Medtronic if they like to do so. Looking ahead we expect diabetes revenue growth to increase in the third fiscal quarter now that we've finished shipping pumps for our Priority Access Program and then continue to accelerate when we complete our sensor capacity expansion plans in the fourth fiscal quarter. In addition, our diabetes innovation pipeline remains robust across all three of its divisions. We're preparing for the international launch of the 670G and the U.S. launch of our standalone CGM system Guardian Connect with sugar IQ both later this fiscal year and our new professional CGM iPro®3 in FY 2019. Next let’s turn to our globalization growth strategy. Emerging markets again grew 12% this quarter in line with our long-term double-digit growth expectations as we continue to expand access to our products and services around the world. Latin America grew 18% but Brazil our highest market in the region growing in the mid-20s. We continue to drive our channel optimization strategy in Latin America expanding our direct operations. In the Middle East and Africa we grew 13% as recovery in the region continues with strong growth in Saudi Arabia and Turkey. Southeast Asia grew 12% with strength in spine, brain therapies and Coronary & Structural Heart divisions. Greater China also grew 12% with high-teens growth in RTG, mid-teens growth in MITG, and low double-digit growth in CVG. We've been outperforming the China market now for the past few years and believe we can continue this momentum over the coming quarters. Let’s turn now to our third growth strategy economic value. As mentioned previously, we are seeing strong growth in our TYRX value based program for infection control and implantable devices. Nearly tripling the accounts under contract in the quarter to over 900 hospitals. This past quarter over 20% of our U.S. CRHF's implantable revenue was covered under a TYRX related value-based healthcare arrangement that links total payment to patient infection outcomes. In the past two quarters, we have rolled out additional value-based programs in CVG linking payment to improve patient outcomes that result directly from our innovative therapies. Specifically, as part of these programs a portion of our payment is tied to reducing reinterventions when using our AF ablation, AAA and DCB therapies and reducing rehospitalizations when using our ICD, CRT and AF ablation technologies. We are aggressively developing other unique value based solutions across each of our groups and regions. We remain focused on leading the shift to healthcare payment systems that reward value and improve patient outcomes over volume. We're increasingly partnering with additional stakeholders on the healthcare value chain, as we believe medical technology has a key role to play in delivering better outcomes while improving efficiency for healthcare systems. As always, we expect to do this in a way that benefits patients and healthcare systems, as well as our shareholders. With that, let me ask Karen to now take you through a discussion of our second quarter financials and outlook for the remainder of the fiscal year. Karen?
Thank you. As Omar mentioned, our second quarter revenue of $7,050,000,000 represented a 4% decrease as reported and growth of approximately 3.4% on a comparable constant currency basis or 4.3% when further adjusting for Hurricane Maria. Foreign currency had a positive $35 million impact on second quarter revenue and tuck-in acquisitions contributed approximately 30 basis points to revenue growth. While all four of our groups had some level of manufacturing in Puerto Rico, the direct financial impact of Hurricane Maria was limited to MITG and RTG. As Omar mentioned, through the hard work and determination of many colleagues, we utilized alternate manufacturing sites, directed field inventory movement, and ultimately we're able to restore operations more quickly than anticipated. GAAP diluted earnings per share were $1.48, non-GAAP was $1.07. After adjusting for the divestiture, the $0.01 positive impact from foreign currency and $0.03 negative impact from Hurricane Maria, non-GAAP diluted EPS grew 5%. The operating margin for the quarter was 26.6% on a comparable constant currency basis representing a year-over-year decline of 100 basis points. As expected our operating margin declined in the quarter as we supported new product launches and experienced a temporary impact of lighter revenue in our diabetes group. In addition, the infusion set recall in diabetes and impact of Hurricane Maria further affected our second quarter operating margins. Despite the net decline, we continue to deliver on our Covidien synergies and expect to reach our goal of delivering $850 million of synergies this fiscal year. As we mentioned in the past, we expect to continue our focus on margin improvement even after delivery of the synergies and intent to provide detail on those ongoing activities in the near future. Non-GAAP net other expense which is included in our operating margin was $96 million compared to $65 million in the prior year, and negatively affected our operating margin by 20 basis points on a comparable constant currency basis. The change was impacted by increased expense related to our currency hedging program, as well as the prior year gain from our equity investment in hardware. Looking ahead we expect net other expense to be approximately $75 million per quarter including approximately $20 million to $30 million net per quarter related to our currency hedging program based on recent exchange rates. Our non-GAAP nominal tax rate was 15% better than initially expected given a year-to-date impact of our recent divestiture on our annual tax rate. We now expect our tax rate to be between 15% and 16% for the remainder of the year. Second quarter average daily shares outstanding on a diluted basis were 1,366,000,000 shares. We repurchased a net $568 million of our ordinary shares in the second quarter. As we enter the second half of the fiscal year, we continue to expect shares to stay roughly flat. Combining our share repurchase activity with the $622 million we paid in dividends in the second quarter, our total payout ratio was 82% on non-GAAP net income and 59% on GAAP net income. Before turning the call back to Omar, I would like to reiterate our annual revenue and EPS growth guidance. Unless specified, all of my guidance comments are comparable constant currency. For the full fiscal year, we continue to expect revenue growth to be in a range of 4% to 5%. This would imply second half growth of approximately 4.5% to 6.5%, a range we would expect for both the third and the fourth quarters. Looking at full year revenue growth by our business groups, given the strength of its new products, we continue to expect CVG to grow in a range of 5.5% to 7% with growth weighted to the third quarter due to more favorable prior year comparison. For MITG we now expect growth to be in a range of 3% to 3.5% given the lower growth in the first half due in part to Hurricane Maria. This implies accelerated second half growth of 3.5% to 4.5% which is consistent with our prior guidance range. We continue to expect RTG to grow approximately 3% balancing the impact of Hurricane Maria and in spine market that is flat to slightly down with continued strength in brain therapies. Finally in our diabetes group, we expect growth to significantly improve in the second half given the completion of the Priority Access Program, as well as an expected increase in sensor supply by the fourth quarter resulting in mid to high single-digit growth for the full-year. Regarding margins for the remainder of the year, we expect our gross margin to be roughly flat year-over-year and our operating margin to reflect significant improvement in the third and stronger improvement of over 100 basis points in the fourth quarter. With respect to earnings, we continue to expect non-GAAP diluted earnings per share to grow in the range of 9% to 10%. As I have previously noted, we expect EPS growth to accelerate in the back half of the fiscal year and would expect third quarter EPS growth to be at the midpoint to upper end of the annual 9% to 10% range. While the impact from currency is fluid and therefore not something we forecast, its recent exchange rates remains stable for the full fiscal year our full-year revenue would be positively affected by approximately $275 million to $375 million including an approximate $155 million to $175 million tailwind in the third quarter. Our third and fourth quarter operating margins would be negatively affected by approximately 50 to 100 basis points with the fourth quarter impact greater than the third. And our full-year EPS would be affected by approximately negative $0.02 including a positive impact of approximately $0.01 in the third quarter. Keep in mind the effect of FX on revenue, margin and EPS can differ due to the magnitude of the year-over-year change and expense related to our currency hedging program along with the timing difference of FX and cost of goods sold reflecting inventory turns on our balance sheet. Regarding free cash flow, we continue to expect it to grow in the high single-digits compounded annually from fiscal year '16 to '18 on a comparable basis given the divestiture which removes the tax and transaction costs, as well as the loss of free cash flow generated by the divested businesses. Lastly while we intend to give our fiscal year '19 guidance on our fourth quarter earnings call in May, I know that many of you are starting to think about your forward models. At this point, I would encourage you to keep in mind our longer-term mid-single digit revenue growth outlook, as well as our long-range plans to continue to drive operating margin expansion. While CVG is expected to ease back into mid single-digit growth next fiscal year given prior year comparisons, we are expecting MITG and RTG to grow in the mid-single-digits and diabetes to deliver double-digit growth. We intend to give our fiscal year 2019 growth guidance on a comparable basis that excludes the impact of the divestiture from the first quarter of fiscal year 2018 and has the effect of lowering the base revenue by approximately $550 million and EPS by approximately $0.07. It is also worth noting that if current exchange rates remain stable through next year, we would expect a positive impact to revenue up to a $100 million and a slightly positive impact on EPS. Now I will return the call back to Omar.
Thanks Karen, and I’d like to conclude by noting that I realized that our shareholders are expecting consistent execution and reliable results from Medtronic. Know that your management team and Board expect the same. Over the past few quarters our performance has been affected by some extraordinary events which have masked the improving overall fundamentals of our business. That said, we aspire to be a company that can manage through even extraordinary events similar to those that we've recently faced. So we're keenly focused on solid execution, as well as leveraging our diversification and scale around the world to deliver dependable results for our shareholders. Let's now open the phone lines for Q&A. In addition to Karen, I have Mike Coyle, President of CVG, Bryan Hanson President of MITG, Geoff Martha, President of RTG, and Hooman Hakami, President of our Diabetes Group to join us. We want to try to get to as many questions as possible. So please help us by limiting yourself to only 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. So with that operator first question please?
[Operator Instructions] And our first question comes from the line of Mike Weinstein with JPMorgan.
Omar first off, let me - forget the question, let me just say that I know how tough this quarter was in Puerto Rico and Santa Rosa and just congratulations, good work that we did on behalf of all your employees that were impacted by both the hurricanes and the fires so I know it was significant let me get two questions and I’ll do one question and then follow-up. The first question is on the growth outlook for the second half if I try and adjust for all the different activity, you effectively did 3% organic growth in the first half of the fiscal year adjusted for the hurricanes, you did 4% this quarter adjusted for the hurricanes. You're guiding to 4.5% to 6.5% in the second half of the year and that's organic, there is no acquisition contribution and that’s despite what is a tougher comp in the back half of the year to the overall Medtronic. So besides diabetes accelerating which I think that we can all see, can you just talk about the rest of the business and what gives you confidence in the overall Medtronic acceleration despite this comps?
I think let’s go through this group by group, I think they’re almost all product driven on a basis of emerging market growth that continues to grow in the double digits and we’re seeing that pretty consistently. And non-U.S. developed market growth in around 5% or so that we've been delivering. So if you take the U.S. which is really the recipient of most of our new products, CVG has the most exciting portfolio here with the CoreValve Evolut PRO currently launching in the U.S. and Europe to be a risk indication for TAVR. The HVAD destination therapy, as well as the Micra leadless pacemaker I think these are the key drivers for accelerated growth in CVG like we mentioned earlier and we are pretty confident given the momentum that we've seen in the just concluded quarter that this will continue. Now in the other groups too we’re seeing continued improvement and you’ll see a tick-up in growth in all of them and you mentioned diabetes yourself but in addition in MITG we have many product launches in FY 2018 including our Signia powered stapler and reinforced reloads instruments. And in RTG our enabling technologies are really taking hold, we had good traction with our capital equipment in Q2 and we expect that to continue. We think specifically the StealthStation S8 which brings an advanced solution to neurosurgeons we'll have this quite a bit in the upcoming quarters. So, as you can see Mike this confidence in our growth is really driven by an acceleration of our innovation pipeline and we feel pretty good about it.
And just my one follow-up, Karen can you spend a minute on free cash flow your free cash flow to the first half of the year was 1.1 billion, if I'm correct your commentary about high single upper single-digit free cash flow growth of FY 2016 to FY 2018 would imply somewhere around 4.9 to 5 billion correct me if I am wrong there, for FY 2018 so one, am I right on that and two can you just talk about cash flows and why they improve so meaningfully in the second half of the year?
For FY 2018 you're approximately right, we would expect high single digit growth compounded annually from FY 2016 on a comparable basis. So slightly high but you can do the math from FY 2016 with that growth rate. I would say on our free cash flow, know that we typically generate about a third of our free cash flow in the first half that's what we did last year what we're seeing right now. So we do remain confident about our ability to continue to grow in the high single digits from FY 2016 compounded annually. There have been some effects in the first half that we outlined on our fourth quarter earnings call. We expect a significant tax and legal settlement in FY 2018 most of that did occur in the first half of this fiscal year. We also had some payments fall into the first half that were in the second half of last year on a comparable basis specifically a couple hundred million related to the timing of the pension plan contributions, it happened in Q2 of this year versus Q3 of the prior year. And we also had some additional tax payment this first half. And then keep in mind that the divestiture of our businesses also had an impact of cash flow with both divestiture related expenses and foregone cash related to divestiture.
And Karen just so we have it, what is the FY 2016 free cash flow number that you are using obviously adjusted for the divestiture do you know that?
Yes, it is in the slide deck and it is 4.2 of free cash flow and if you look at it on a comparable free cash flow basis with the divestiture impact of about 100 million a quarter it nets to 3.9.
Our next question comes from the line of David Lewis with Morgan Stanley.
Just two questions from me, maybe I’ll start with Geoff on RTG. Geoff kind of it’s a two part question RTG related to market growth rates versus your performance, so spine obviously doing worse from a market growth perspective, SCS doing better from a market growth perspective. How do you think about the trends in those two businesses in the next two to four quarters and do you still think you can trend slightly above market in spine and with Intellis is the way to think about that getting back to market growth rates or just getting back to positive territory and I have a quick one for Karen?
So thanks, I’ll take the spine one first. We definitely see a pullback in the market here over the last couple quarters from I’ll call it 2% flat to slightly down. We still feel very confident about our ability to perform above that and it comes from two things, one continued product launches and launching them at scale which has worked for us over the last let's say five or six quarters. So betting on the product launches, making sure with the appropriate sets, making sure we’ve done the appropriate training of our reps and the physicians and launching with force and that's really helped us. And as we move forward, the surgical synergies is really taking hold, that's the combination of all of our enabling technology, power, navigation, robotics and that is having a halo effect and actually a tangible pull-through affect on our implants. We do a lot of equipment placements and that we've done over the last two or three quarters, now it will continue over the next year. And a year from now or so we'll have actually technological ties between our implants in the Mazor robots. So we feel really good about where we are in spine. I'd like to see the market go up because we given our market share globally at 30 so percent that would help but we feel good about our ability to continue to perform above the market. The other thing I’ll point out is that, I think Omar mentioned it if you combine our enabling technologies with our implants we're really growing and that's how a lot of our competitors look like Globus, NuVasive et cetera that put us to about 2% growth. So we feel good. And then we have a high exposure to the global markets. The global markets outside the U.S. are growing three times as fast as the U.S. markets and we have a pretty high exposure there and are doing well. So overall spine, we feel good. I wish the market were growing a little faster though. And in Pain stem, pain pumps, the end pain stem actually are experiencing a lot of acceleration here in the last quarter. Pain stem because of the launch of Intellis, we already have launched our evolved work flow. And that does get us from mid-single digit to high single-digit declines to I would say low to mid-single-digit growth not quite growing at the market yet. I think that’s going to take a little bit of time. But we feel very good about, for the next couple of quarters, well going forward here mid-single-digit growth in pain stem. And then pain pumps with the listing of the certificate of medical need that is really given that business a boost plus all of the products, the enhancements that we’ve launched over the last couple of quarters, we can, - re-launching that product as its kind of a new product if you will, and that’s picked up quite a bit of steam and now growing at like high single digits. So the pain business has really experienced a pretty rapid turnaround here in the last quarter.
Then quickly carrying on, I appreciate the early comments you gave us on next year’s guidance. Just in terms of thinking about that mid-single-digit corporate profile, how should we think about or what allotments did you make for various ex-U.S. pricing headwinds, whether they be China, India where the biannual Japan price cuts. Was there allotments made in that sort of mid-single digit range for those dynamics next year?
Yes we continue to have pricing pressure across all of our businesses and geographies and that is taken into consideration when we give our longer-term guidance.
Our next question comes from the line of Bob Hopkins with Bank of America.
So two questions, I will start with Karen if okay, and to echo David’s comments I appreciate some of the early commentary on fiscal 2019 on both revenue growth and currency. I am just curious on the earnings front though for 2019, is there any reason not to expect that sort of 10% earnings growth in fiscal ‘19 off of what I realize is a pro forma restated 2018, that $0.07 you were talking about. But just curious if there is any reason not to expect that sort of 10% growth in fiscal ‘19 off of that new base?
Bob, we are currently working on our long-range forecast and our annual plan for next year. So we'll give much better guidance in the normal timeframe. But in the meantime we clearly do continue to expect to drive that mid-single-digit revenue growth and significant operating margin expansion that should lead to very robust bottom line growth.
So I guess for my second question, Omar, I was wondering if you could make a comment on just sort of what you're seeing in terms of MedTech market growth rates generally both in the United States and in emerging markets and to some degree this follows on the last question little bit given the China pricing announcement on ICDs and stents. But Omar, could you just talk broadly of what the trends you're seeing currently in the U.S. and emerging markets as it relates to just broadly speaking MedTech market growth?
Let me start with emerging markets Bob. You know look, the growth in emerging markets continues and we are delivering in that diversified position across the major markets of China, Latin America, Middle East and Africa. You know these are big markets where we've got significant positions and are fairly well diversified. Given that backdrop we see ourselves going in the double-digit, say in a sustained fashion in emerging markets powered by markets that are pretty robust. Now there may be variations from year-to-year in the different markets as we have experienced but we have also shown that those variations are manageable, they are not that big. They’re still close to that range. And China market is perhaps going to be at sometime in the future the biggest market in MedTech. And it is one that to we expect to participate and work with stakeholders there and are confident that we can continue our performance thereof delivering double-digit revenue growth. So emerging markets we are pretty confident about and feel very good about our position for sustained delivery. The U.S. on one side the overall markets outside of spine are the surgical volumes are basically the same, around 1% to 2% with small variations which we really don’t want to try to forecast at that precision level. And the spine market you just heard Geoff say has got some pressure in the U.S. for a variety of reasons probably, in the elective procedures may be being one of them. But more importantly the U.S. market in the end is driven by new product introductions and we have seen that and we are experiencing that right now. With our new product cycles, that drives the U.S. market and that's the most significant impact that we see. So that’s the way I see markets, I mean not that different from what you have seen before, a lot that we can influence ourselves by our own actions and that's what we focus on doing.
Our next question comes from the line of Kristen Stewart with Deutsche Bank.
I was wondering if you could go over a little bit more specifically in the diabetes business. Just what, how you're feeling about the reacceleration? How confident you are and then maybe just touch on what gives that confidence for next year to grow in the double-digit range. Just kind of the path forward to bring some of the new supply onto the market for the sensors?
Kristen I'd say, you know first let’s start with the back half of this year and then we can talk about the FY 2019. I'd say the acceleration that we expect in the back half of the year is really driven by three things. The first one is that our sensor capacity plans are actually not only going according to plan but slightly ahead of schedule. And so we anticipate that we are going to be in a position by the end of this fiscal year where our sensor capacity will allow us to meet all of the demand, so that's one. So as we get that back up we expect to see acceleration not only of sensor revenue but also of pump revenue. The second one is the 670G and you know the real world performance of 670G as more of those systems get into the market. This is a system that now has 13,000 patients that are uploading their data into CareLink and what's really encouraging Kristen, is that what we’re seeing even at these volumes is outcomes and performance that are very similar to what we saw in the pivotal trial for the FDA. And so as those things really start to continue to take hold I think both from a physician perspective and a patient perspective, we will start to see traction. And then the third dynamic for the back half of the year which will also go into FY ’19 is Animas and the transition of those patients to Medtronic. And then as we look forward into FY 2019 as Omar mentioned, there's a series of new product launches in addition to all of these dynamics that I just mentioned. Guardian Connect and our entry into the standalone sensor market number one, iPro 3, which will be a new professional CGM for our Type 2 business. You combine all of these things and we feel good about the acceleration into the second half and also double-digits for FY 2019.
So you have full sensor supply for fiscal fourth quarter or ahead?
That's right. So we are going to ramp up and Q3 should be better than Q2. So we - our capacity expansion plans will allow us to produce more sensors this quarter than we did last quarter. And then by Q4 will be in a position where we can meet all of the demand.
And then Karen there is a question for you. Can you maybe just go through the dynamics year-over-year just kind of the gross margin the puts and takes of those?
We do expect our gross margin to be relatively flat year-over-year FY 2017 to FY 2018 and the real puts and takes are the fact that we see continued pricing pressure but remain focused on driving expense reduction in our COGS line item.
And when you mentioned for the full year I think you had said with respect to the guidance for, with respect to the hedges. Did you mean that that was going to be negative impacts from hedges with FX for the third quarter or was that positive?
Yes, from an FX perspective we talked about it on the operating margin perspective, and we said that our third and fourth quarter operating margin would be negatively affected by 50 to 100 basis points. But the fourth quarter impact a little bit greater than the third and that's assuming rates remain constant to where they are today.
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
One follow-up on China, and one of robotics. So Omar I just wanted to ask you directly about the proposed price cuts to drug-eluting stents hips and ICDs. You know we've heard the price cuts could be up to 40% but offset by the two invoice policy. How are you thinking about those pending changes in China and the potential for other device categories that have similar cuts? And then I have one follow-up on robotics.
Again on China look let's not forget the size of that market and access to healthcare for patients in China is a big priority for the government and a big priority for us. And we are working closely with the government to figure out the best way to optimize the distribution channels which has many factors as you noted, and now there may be certain price regulations but we're used to managing those and we feel the end that our ability to demonstrate value and our experience with value-based models will give us the right pricing in those markets, and the right trade-off between price and volume, as well as you know leading out the cost in the distribution channel working together with the government. So the many variables here in the end we feel pretty confident that we can maintain our performance in China through these dynamics which will change over time. It's a big market and a lot of work has to be done but through that we feel that we've got a team in place and products in place and a focus in place through which we can continuously deliver.
And then on robotics, I heard your comments about doing first-in-human, I think in fiscal 2018 if I heard correctly, but my question is are you still planning to launch in select international markets this year? And I think at the last analyst meeting, you said you expect to draw robotic program that contribute 50 to 150 basis points of growth in fiscal 2019 which I think at the time equated to about 50 to 150 million in revenues. I guess the question is, are you still comfortable with that? Thanks for taking the questions.
I’ll let Brian answer that robotic question. Go ahead Brian.
We obviously have a pretty complex project on our hands with a lot of moving pieces and parts on the robotics system quite literally actually, a lot of moving pieces and parts. And so there is always risk in slippage for launch but at this point in time we're sticking to the dates that we have committed to relative to launch timelines which would be consistent with what you said first-in-human at the end of this fiscal year and in full launch in FY 2019. So we are pretty excited and I would tell you just even going further beyond that, I probably feel more confident now about the robotic system then I have it any point in the past the fact that we're going have a viable and really competitive product and I will tell you why? We're already building our pilot systems off the production line. So we've already built and are continuing to build those pilot systems write off the production line. We are well passed any design development fees at this point where fully into verification and validation and although there's a lot of work ahead of us, the work really is more associated which is time to retire the work and the risk of a viable product is behind us. So we're not having a viable product is behind us. So I feel very confident about where we are. I feel very confident we're going to have not just a viable product but we continue to do so surgeon feedback and the feedback that we're getting from surgeons is that they're very excited about the technology that we have and I look forward to its launch.
Our next question comes from the line of Raj Denhoy with Jefferies.
Wonder if I could just ask around the U.S. growth in MITG. It was down 5% even after correcting for the hurricanes, it was still a negative results in the U.S. and so I am curious if that's a reflection of perhaps procedure volumes or something else happening now that we're seeing in that market?
So it's less around procedural volumes because where we see a lot of pressure in our business in Q2, one obviously was a result of some of the pressure that we saw because of the hurricanes, a lot of that concentrated on the surgical business but even through that pressure we saw pretty good strength in the surgical business overall. The real pressure came in the RGR business which specifically the biggest piece of that which is respiratory where we had some really challenging comps from last year as you probably remember we had relaunched the PB980 in Q2. We had real strength last year as a result of that and that carry through in Q3 and Q4 and as expected we saw some challenging growth rates in Q2 as a result of that. But I don’t see anything fundamentally in the procedures that we leverage to drive revenue that would be concerning for me.
Our next question comes from the line of Kaila Krum with William Blair.
So first I got starting off on emerging market any constraints that you guys saw in the quarter. Can you just speak a little bit more to the durability of that double-digit performance and I know that you don’t give too much color on fiscal 2019 but just high leveling and taking into account some of the anticipated headwinds you’ve mentioned. Is it fair to assume that sort of growth continues in the next year?
First let me take the emerging markets, like I said we've demonstrated double-digit performance in the emerging markets almost on a quarterly basis now for - I don’t know five years. So we have every expectation that that will continue because our position in these markets is only strengthening and there is no question about the need, you know you just need to look at the math based on population and the market requirement of our therapies and the need is clearly there. And we’re working closely with different stakeholders - we continue to work closely with different stakeholders in these markets to create methods through which access is provided going beyond our products, working with the government, as well as private providers to facilitate training of physicians, to creation of infrastructure, as well as creating awareness for our therapies. So we're pretty confident that this double-digit emerging market growth will continue given the size of that opportunity and given the diversification that we have across the different major emerging markets. I think the second question in terms of growth into next year the color that we provided really goes down to our three growth strategies built on a reliable and emerging market growth coupled with our new product launches that will become more. So uniform across our different groups, led by a strong recovery in diabetes, but also good improvement in both MITG and RTG like we mentioned. I think all of this put together gives us confidence that we can continue our mid single-digit growth trajectory that's in our short and long-term plans.
And then I guess it was in spine, I mean clearly you’re continuing to put up solid growth in the biologic segment of your business and you’re investing those incremental dollars in field research. But I guess there is some question is that the value of biologics as more companies introduce porous or titanium technologies that they require less biologic use, so I guess what's your view on that dynamic longer-term? Thank you.
Look I think there is a lot more research that needs to be done on the impact of the surface technologies in the porous surface edgings on some of the inner bodies, but we'll also participate in that market as well. We're just launching our first titanium porous cage and so we’re watching it. I think though that to dismiss the use of some of the biologics is premature based on the results we've seen over the last decade. And we’re so confident that we're investing $90 million over the next several years in clinical research. We feel very good about it but we are intrigued on the surface coatings and we’re going to invest in that as well, but I think dismissing the biologics, the existing biologics is a little premature and I think more of the questions are some of the new claims around stem cells and things like that, that is where the pressure is that's what we’re seeing. We’re not seeing it for example on Infuse, if that’s the question. We are hearing about it in some of the new stem cell related products that there is pushback from the payers, but in terms of existing biologics we feel that we have proven track record and we're confident thus investing in more clinical data. And the porous technology is intriguing but there's still lot to prove on that.
Our next question comes from the line of Josh Jennings with Cowen.
Just had a question for Mike Coyle, congrats on the CVG performance in the quarter. Having concerns, some concerns about competitors of ICD launches and for the CRM business specifically, it sounds like that competitor had almost limited in the quarter but just wanted to hear if you had any updated thoughts on your competitive positioning and ability to defend the share gains you capture for the last two years and did you see any impact from those launches in October?
Josh thanks for the question. As you mentioned those products were launched in mid-to-late September by both of our competitors and so we now have eight or nine weeks of experience with the launches and frankly we have not seen a lot of impact on our unit share in the high power segment. And I think there are a number of reasons why that is true, the first is that the competitive offerings that they have are really not matching up to what we already have in the market, it's not just the three test labeling that we have, but also they have very significant labeling restrictions on their product and workflow negatives when you try to implement to their labeling. And that obviously it works to our advantage but probably the bigger reason there hasn’t been a meaningful detectable shift is that this really was just labeling expansion, it’s really the same products that they have been selling and their field had done a good job I think of indicating to customers that when they got the approval for MRI say that they would be able to basically perform MRIs on implants even before the approval right. So that basically put them in a position where we never saw the kind of share shift that we saw in Brady, where they was a special lead and they had to wait until they had actual approval of the product before they could start selling it. So most of the share shift that we've seen from our product line is really come from features that are embedded in our devices that are highly differentiated like our busy AF or the smart shot technology that we have or the adaptive effective CRT features and these features have not been matched up with the products that have come in from competitor. So they represent 70% to 80% of our product mix, so we were not expecting to see a big - major share shift away from us as MRI labeling came in from competitors and at least eight or nine weeks into the launch we have seen that happen.
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Omar just wondering if you could comment on your views for the overall healthcare utilization environment in electric procedures in particular. Just kind of curious what’s baked into your outlook for the back half of the fiscal year? And the reason I ask is, the managed care and kind of provider community has struck - I would say a little more cautious tone on the quarter that they trend here as we went into the end of the year and it seems like the device companies have been a little bit more constructive around their expectations for underlying trend. So if you kind of maybe spend a minute reconciling that view a little bit as to what you're seeing that will be helpful?
Well like I mentioned before, some of our procedures are acute procedures that are needed. It's almost on an emergency basis and those procedures will continue and there's a demographic statistical need for that and we don't see that changing if anything with the demographics will even increase slightly. And then beyond that you have core surgical procedures like I said some of which were elective but most of it - is required and there we’re seeing a pretty steady performance in the marketplace. The spine area which I think is probably because of the elective nature of some of those procedures, we seen some pressure but not completely out of line with what we’ve seen historically in different phases and one that we expect to stabilize going forward. So from a procedural perspective we don't really see that much change, some shifts between the different areas that we're in primarily I think driven by the elective nature of some of these procedures. I think overall though like I mentioned before and I want to emphasize new product introductions in MedTech in general drive the market far more than these shifts and that’s what going to see us get the kind of accelerated growth that we are projecting into the second half and into next year.
And then Mike maybe a follow up for you on TAVR, just curious what’s baked into your outlook for the rest of the fiscal year in the U.S. and Europe for that business it’s obviously done well in the last couple of quarters here in competitive landscape does figure to shift again as we move into calendar 2018 so be interested in kind of how your game planning for TAVR in the contest of your guidance? Thank you.
We're obviously fairly early into the launch of Evolut PRO both in Europe and in the United States really which the last quarter was really the first full quarter for that product. It’s doing exceptionally well in terms of not only the improvements in lower paravalvular leak rates but the physicians are really being able to use that system to have lower pacemaker rates as well. So we really feel well positioned relative to our product line now obviously with both Evolut R and Evolut PRO available to our customers. And obviously the intermediate risk approval in the United States allowed us to really access where the growth in the market is and now we're expanding centers to basically take advantage of that. And then obviously the Evolut R approval in Japan is also driving significant growth. So the overall market remains robust in through the low to mid 20s and obviously we are in share capture mode, we think our product lines are well positioned to compete against any new entrants that come into the marketplace and obviously we continue to invest and expanded indications for use including low risk and looking at things like bicuspid indication. So we think there is plenty of room for continued expansion.
Our next question comes from the line of Glenn Navarro with RBC Capital.
A question for Karen on tax reform. Medtronic had an advantage versus competitors given its inverted status. So Karen, based on what you're seeing out of Washington D.C. in tax reform today, I wonder if you can give some of your initial thoughts on reform. Does it - what part of reform helps Medtronic? Is there any part of reform that puts you at a disadvantage? Thank you.
Thanks for the question Glenn. We pleased that Congress is working on potential tax reform right now. We do continue to support reform in general including the establishment of a territorial system and a lower U.S. corporate tax rate. As you know, the House has advanced its potential reform with the passage of a bill and the Senate has only just released last night its legislative draft. But we recognize that both Houses need to reconcile their versions into one bill so we are staying very close to this process. I would say it’s too early to speculate on the final version of the bill and its impact if any to us but the most positive impact of potential reform to us in the long-term would be the ongoing access to our OUS cash that is limited obviously today.
Our next question comes from the line of Matt Taylor with Barclays.
Karen I was wondering if you could talk a little bit about some of the things that impacted operating margin that you called out in the prepared remarks this quarter to help us quantify kind of the temporary impact of those product launch support programs and the hurricane. And then you eluded to you beyond the Covidien synergies some additional thing that you can do in operating margin. Can you give us any clarity on what those are and if there any different from what you laid out in the prior plan?
So we did talk about a margin decline that we had this quarter and that was really driven by four things, the impact of lower revenue - lighter revenue in our diabetes business along with the impact of the hurricane, as well as the infusion set recall in diabetes. And so going forward we do expect to improve our operating margins particularly this year in the back half substantially more in the fourth quarter. And that is really driven by the strength of revenue along with our continued focus on driving cost synergies and driving cost down where we can. Looking longer-term we do expect to continue to drive operating margin improvement as we’ve discussed in the past beyond the delivery of the Covidien synergies which we expect to close out this fiscal year. And the movement that we expect to do going forward is continued plant consolidation, increase used of shared service, continued focus on our enabling functions on a global basis driving center of excellence and improving our processes et cetera. So we do expect to continue to drive margin expansion going forward.
Our next question comes from the line of Joanne Wuensch with BMO Capital Markets.
Can you tell us sort of or share with us philosophically how you think about guidance I appreciate your verbiage in the prepared remarks regarding of you towards consistency but as we think about the second half of the year and then your remarks going into next year what you depreciated, how do you think about putting all of those pieces to the puzzle together?
Well like we mentioned we feel that we've got a set of businesses driven by growth strategies of therapy innovation of emerging market growth and of - drive towards value based healthcare which helps us with pricing and some new business models. You take all three of those things together across the spread of our businesses, we feel that we can deliver on the mid single-digit growth and I think we've demonstrated that, we've had issues in certain quarters for a variety of reasons and which we’re not happy about but in general on a yearly basis we certainly delivered that and we have every expectation that that will continue. And to do that that this fiscal year we need an acceleration in the second half which we have line of sight to given the new product launches and the dynamics that we see in our different businesses. So really is a straightforward as that, we think our new products fill this on a base of strong double-digit emerging markets growth.
And just as quick follow up, of the new products which are the two or three you really think are the drivers for the next 12 to 18 months. And then thank you.
It varies quite a bit - as we go through the next 12 to 18 months but CVG and cardiovascular we continue to have traction and our CoreValve Evolut PRO in TAVR in addition to the intermediate risk approval that we got is driving both market growth, as well as our own share position in the U.S. and across the world. We're really excited about our HVAD destination therapy approval that's a real game changer for us in that market and we're pleased with the success that we've seen with that product line. And then also repeating the Micra leadless pacemaker, which is the only leadless pacemaker that exist and we continue to benefit from full CMS reimbursement for that product in the U.S. and we're seeing a very strong growth in that segment as well. So all three of those areas in CVG continue to grow in addition to the other product lines. So we're pretty confident that will go on. There will be dynamics through the different quarters that we go through the year it will be higher earlier in the next 12 months rather than later in CVG. But then that’s supplemented by continued growth in MITG where we have regular cadence of launches that we're seeing deliver successful results specifically in surgical innovations but the other businesses also are contributing. And in RTG, in addition to the capital equipment that we’ve talked about like the StealthStation S8 and the O-arm and to some degree our partnership with Mazor Robotics, we also have Intellis platform that we should really look at which is a big turnaround and take us towards positive growth in spinal cord stimulation. In addition to the removal of the warning letter and the consent decree requirements that were in place for the pain pump in that product line. And then finally in diabetes, we've gone through a fairly difficult phase mostly to do with our supply shortage in sensors but very strong demand from patients for our highly differentiated technology. And we’re only in the beginning stages of the growth in diabetes with that kind of differentiated hybrid closed loop technology. And in addition to that, we’re supplementing that with our Guardian Connect with sugar IQ product which is a CGM product to be launched in the U.S. sometime later this fiscal year which is highly differentiated from anything that’s available in the market. So you put all that together, we see that while the relative dynamics of the different businesses may vary quarter-to-quarter, overall we've got enough diversification in the markets that we serve that we can maintain the mid-single-digit growth.
Our final question comes from the line of Chris Pasquale with Guggenheim.
One for Omar or maybe Mike, and then one quick one for Karen. Omar you highlighted the expansion of value-based contracts in CRM, based on your estimates it likely event rates into those contracts, what's the implied net impact on your pricing. Is this a situation where you're effectively getting a price increase by taking risk off the hands of the hospital and if so can you quantify that?
Yes, I think a better way to look at that is to - so we demonstrate the translation of the clinical value to economic value in the financials of the hospital that's what we’re doing. The clinical value is reduced reintervention rates for example for which we've got evidence, we’re not just guessing this we’ve got clinical trial evidence that shows that and that translated to the financials of the hospital is our value base healthcare program where the variables are highly technology driven or innovation driven. So then few other variables, our technology we know through evidence and clinical trials create this improved clinical benefit which we then translate to the hospitals financials as an economic benefit. And we think that through that, indeed pricing is not only protected but to some degree we would get enhanced overall pricing because in the end the hospital is better off financially with this new technology than without, that’s the essence of value based healthcare programs. And we’ve - as the overall payment model changes, we’re gaining a lot of experience as to how to create these contracts with providers in the existing fee-for-service model. As we translate more to a pay-for-value model, we think we’ll be very well positioned to even broaden the scope of these business arrangements.
And then Karen, you bought back a lot of stock in the first half of the year. I know a piece of that was sort of one time and tied to the PMR proceeds, but if I do the math on the free cash flow guidance and then add in a dividends in the back half of the year, it looks like you're on track to basically return a 100% of free cash flow to shareholders for the third straight year. How sustainable is that as we look ahead to 2019?
Our commitment on return to shareholders is greater than 50% of our actual free cash flow that we generate, and while we did use a portion of our divestiture proceeds to repurchase stock which does elevate our return to shareholders this year, going forward we would expect to stick with that greater than 50% of free cash flow commitment.
Okay, so with that let's close the call up. Thank you very much for all your questions. And on behalf of the entire management team, I would like to thank you again for your continued support and interest in Medtronic. And for those of you in the U.S., I want to wish you and your families a very Happy Thanksgiving. We look forward to updating you on our progress in our Q3 call which we currently anticipate holding on Tuesday, February 20. Thank you all very much.
This concludes today's conference call. You may now disconnect.