Medtronic Plc (MDT) — Q3 2016 Earnings Call Transcript

Thank you, Jackie. Good morning and welcome to Medtronic’s third quarter conference call and webcast. During the next hour, Omar Ishrak, Medtronic Chairman and Chief Executive Officer; and Gary Ellis, Medtronic’s Chief Financial Officer will provide comments on the results of our fiscal year 2016 third quarter, which ended January 29, 2016. 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 for the first time a presentation that provides additional details on our revenue performance and as a result had reduced our prepared revenue by division commentary in Gary’s section. Next, you should note that many of the statements made during this call may be considered forward-looking statements and that actual results might differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed 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 the Investors portion of our website at medtronic.com. Unless we say otherwise, references to quarterly results increasing or decreasing are in comparison to the third quarter of fiscal year 2015, and our year-over-year growth rates are given on a comparable constant currency basis, which adjusts for the negative effect of foreign currency translation and includes Covidien plc in the prior year comparison, aligning Covidien’s prior-year monthly results to Medtronic’s fiscal quarters. These adjustment details can be found in the reconciliation tables included with our earnings press release. With that, I am now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishrak.

Good morning. And thank you, Ryan, and thank you to everyone for joining us. This morning, we reported third quarter revenue of $6.9 billion, representing growth of 6% in the upper half of our mid-single-digit baseline expectation. Q3 non-GAAP diluted earnings per share were $1.06, growing at 17% on a comparable constant currency basis and reflecting 1,150 basis points of leverage, significantly above our baseline expectation of 200 to 400 basis points. Our performance in Q3 was solid, with sustained execution, resulting in another quarter of market outperformance. We continue to deliver on our three growth strategies: therapy innovation, globalization, and economic value; which are driving increased diversity of our growth, an important and differentiated attribute of our company. Our revenue growth may modestly ebb and flow from quarter to quarter indicative of the challenges we’re absorbing in certain businesses or regions as we capitalize on success in others. However, our confidence around the sustainability and consistency of our revenue growth within the mid-single-digit range continues to build with each passing quarter. In addition, the Covidien integration is delivering robust operating leverage, as we realized our committed cost synergies, which combined with our financial leverage, drove high-teen EPS growth and double-digit EPS leverage in Q3. Through FY 2018, as we continue to realize cost synergy benefits, we expect to be at the high end of or exceed our EPS leverage goal of 200 to 400 basis points. While our operational performance remains strong, we recognize foreign currency translation is still a significant pressure to our bottom line on a reported basis, as it is for most multinational companies of our size and diversity. We’re attempting to offset this as much as possible by stretching our operations and through our conventional hedging programs. We also continue to generate significant accessible free cash flow, which we are deploying with discipline, investing for our future, while at the same time allocating capital to reduce debt and provide strong returns for our shareholders through dividends and share repurchases. In summary, our formula for long-term success is to deliver consistent mid-single-digit revenue growth, with 200 to 400 basis points of EPS leverage and return a minimum of 50% of our adjusted free cash flow to shareholders through dividend growth and share repurchases. The expected net result is creating enormous value with sustainable double-digit total shareholder returns. Now, let's turn to the drivers of our revenue growth. As we have noted before, we have three growth priorities stemming from our overall strategies: new therapies, emerging markets, and services and solutions. With specific growth expectations for each, we continue to quantify and communicate our performance against these goals. In therapy innovation, we continue to see strong adoption of our new product and our pipeline remains robust. Our new therapies' growth vector accounted for nearly two-thirds of our total company growth, contributing approximately 350 basis points, at the high end of our goal of 150 to 350 basis points. Based on our pipeline and product breadth, we believe performance in the upper half of this range is sustainable over the long term. In our Cardiac and Vascular Group, which grew 7%, we continue to see strong growth from recently launched products that are helping to create important rapidly growing medtech markets such as transcatheter aortic valve replacements, MRI-safe implantable technology, AF ablation, predictive diagnostics, and drug-coated balloons. CVG has also seen a highly differentiated new products drive growth from its base businesses. In drug-eluting stents, our Resolute Onyx and Resolute Integrity stents are holding share despite major competitive launches. Our position in Europe has been strengthened further by the recent addition of new sizes and indications for Resolute Onyx. In High Power, the Evera MRI ICD that we launched last fall resulted in improved pricing in the U.S. ICD market and a multiyear high share position. Looking ahead, we have a number of new products that will continue to differentiate us in the CVG market and help protect and grow our leadership position. These include our MR-Conditional CRTD devices, which recently received FDA approval and are currently launching in the U.S. and Europe. We also continue to make progress in bringing our Micra Transcatheter Pacing System to the U.S. and Japan. And we had a successful FDA advisory panel in this technology two weeks ago. Our longer-term CVG pipeline is also robust with potentially disruptive therapies like our Drug-Filled Stent, Intrepid Transcatheter Mitral Valve, and Symplicity Spyral renal denervation system. Our Minimally Invasive Therapies Group grew 5%, with Surgical Solutions growing above market and PMR growing at market. Innovative technologies that advance and enhance minimally invasive surgery are driving strong above-market growth. Looking ahead, the majority of MITG’s growth will come from five key growth drivers. Within Surgical Solutions open to Minimally Invasive Surgery or MIS, Gastrointestinal cancer, and Lung cancer, and within PMR End-Stage Renal Disease and respiratory compromise. Of these, the largest contributor to growth is expected to come from our open to MIS strategy, which is focused on sustainable long-term surgical market leadership by improving open surgery, transitioning open surgeries to MIS, and advancing MIS technologies. Our recently created new business, Renal Care Solutions, supplemented its breadth with the acquisition of Bellco last month. Bellco is a full line of therapies and systems for the treatment of renal failure. This combination of Bellco with our legacy renal access business and our internally developed portable dialysis system offers a complete product solution for End-Stage Renal Disease. With the few global growth drivers that I just mentioned, MITG has a strong product portfolio and expects to launch more than 20 products through the end of fiscal year 2017, with approximately 75% in Surgical Solutions and approximately 25% in PMR. These new offerings are expected to generate approximately $500 million in cumulative revenue over the next three years. Across MITG, we are developing solutions to expand the entire care continuum, aspiring to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive solutions. In our Restorative Therapies Group, which grew 4%, we also have a number of new products driving growth. In Neurovascular, our Pipeline Flex and Solitaire FR devices are leading the rapidly growing stroke market. Following the four clinical trials published last year in the New England Journal of Medicine, the market continues to adopt our Solitaire mechanical thrombectomy device. A segment of the global ischemic stroke market that we think can triple in size by 2020. In Surgical Technologies, we are seeing strong growth from our recently launched O-arm O2 Surgical Imaging System. In Spine, despite posting mid-single-digit growth in international Core Spine and double-digit growth in U.S. BMP, Q3 results came in below our expectations, primarily because of weakness in U.S. Core Spine. We are focused on executing our turnaround plan in Spine. Our primary focus is growing our market share to what we are calling speed-to-scale product launches. Speed-to-Scale involves coming to market with a steady cadence of new products as a result of faster innovation cycles and launching these products at scale with sets available for the entire market. These new products will also be combined with enabling technologies, biologics, and targeted physician training at the time of launch. The goal is to constantly innovate procedures such as OLIF and TLIF and improve upon their outcomes. We have several near-term launches, including accelerated ramps of Solera Voyager, and our ELEVATE expandable interbody device, both of which are expected to improve our share in TLIF procedures, an area where we’ve been struggling. This quarter we will launch the Atlantis Essentials another Cervical Plate System, the first product in our Spine Essentials platform. Spine Essentials will bring efficiency to the most common spine fusion procedures through more streamlined pre-sterilized sets. Additionally, we are further integrating the development roadmaps of our enabling technologies with our spine instrumentation, offering a differentiated surgical synergy experience for our customers. And finally, we intend to focus our efforts and gaining share in biografts, utilizing our broad biologics portfolio, including infuse. We had challenges this quarter in our Neuromodulation division as well. While we continue to make progress against our FDA consent decree commitments and are focused on resolving this matter, our drug pump revenue has been affected. We are also facing increased competition in Pain Stim, our recently approved MRI Surgical Lead is expected to help our competitive position in Pain Stim, as we are the first company to have a complete Spinal Cord Stimulation System approved for full-body MRI scans. In addition, we continue to market the benefits of our differentiated AdaptiveStim and SureScan MRI technology. And more surgeons are adopting our AdaptiveStim HD High Density programming options. While we are focused on solving the issues in Spine and Neuromodulation, and our efforts in Spine are expected to result in steady improvement. Neuromodulation could be under some pressure for the next several quarters, resulting in overall RTG growth around the low end of the mid-single-digit range. In our Diabetes group, which grew 11%, we continue to see strong adoption of our MiniMed 640G System in the markets where it is available as well as strong demand for our MiniMed Connect, which is the only system providing remote access to pump and sensor data on the users’ smartphone. We also continue to make excellent progress in bringing the world’s first hybrid closed-loop system, the MiniMed 670G, to market. We expect to complete enrollment in our pivotal trial in the next few weeks with PMA submission to the FDA targeted before the end of June. Outside the U.S., we had strong Q3 performance. We were pleased by the positive guidance recently issued by NICE in the United Kingdom, which recommended the MiniMed Paradigm Veo as the only system for reducing the risk of potentially life-threatening hypoglycemic episodes. In our Non-Intensive Diabetes Therapies business for Type 2, our partnership with Henry Schein is underway and we are already starting to see interest from primary care physicians for our iPro 2 Professional CGM system with Pattern Snapshot. In our Diabetes Services & Solutions business, we are preparing to bring our standalone CGM system, Guardian Connect, to market with the PMA submission in the U.S. next week, as well as expected launch in Europe in early FY 2017. This product will allow us to provide both Type 1 and Type 2 patients on multiple daily injections with a real-time glucose monitoring solution. When you combine our standalone CGM product with the applications and cognitive computing capabilities that we will bring through our partnership with IBM, we are well-positioned to provide patients with not just a sensor, but with a comprehensive diabetes management solution. Overall, we are excited by the progress of our diabetes business and feel we are well-positioned for sustained growth. Next, let’s discuss our globalization strategy. In Q3, emerging markets grew 14% and contributed approximately 190 basis points for our Q3 total company growth, at the upper end of our baseline goal of 150 to 200 basis points. We have consistently delivered double-digit growth in emerging markets, despite the fact that several of these markets have faced macroeconomic pressures. This is a result of continued execution of our differentiated strategies in channel optimization, and in developing public and private partnerships. We have also benefited from increased geographic diversification of our emerging market revenue, which stabilizes the growth rate and reduces the dependency on any single market. In Q3, Middle East and Africa, Southeast Asia, India, and Greater China all grew in the mid to upper teens. In China, we grew 14%, where our strong sales execution and expansion of our multiline selling presence into tier 2 and tier 3 markets is resulting in above-market growth. We continue to implement our channel optimization strategy, which aims to transition our distribution partnerships to include consolidated logistics platform distributors. We are also developing comprehensive partnerships with provincial governments, like that to the Chengdu Government in Sichuan Province, where we previously announced a partnership to manufacture our portable hemodialysis equipment. In Q3, we broadened our partnership with Chengdu, agreeing to manufacture our next-generation diabetes pump technology in Chinese language for the local market in Sichuan, while working together with local authorities to expand access for this product. China continues to represent a tremendous growth opportunity. Despite the complexities of this market we have shown that we can grow double-digits in China on a sustained basis. We believe China will become our largest healthcare market over the long term, serving more patients than doctors in any other country. And we can never lose sight of this potential. In the Middle East and Africa, we grew 19%, driven by the joint venture we formed earlier this year with our largest Saudi distributor as part of our channel optimization strategy in the region. In Latin America, we grew 10%, including 7% growth in Brazil. While we continue to outperform the market in Brazil, we do see continued market volume weakness, resulting from public spending constraints, as well as some difficulty in getting inventory into the country because of customs holds. Across the emerging markets, we’re applying our standard market development activities, as well as our differentiated approach of local channel optimization, like in China, India, Saudi Arabia, and Turkey, establishing government partnerships in Chengdu and developing private partnerships like the one we established with the Abraaj Group last quarter. All of these initiatives have the ability to accelerate growth in these regions and lead to sustained market outperformance. We believe strongly that the penetration of existing therapies into emerging markets represents the single largest opportunity in medtech over the long term. Turning now to our economic value growth strategy, our Services and Solutions' growth vector contributed to approximately 20 basis points to Medtronic growth. While this overall result was below our goal of 40 to 60 basis points revenue growth, our revenue growth was in the mid-30s and contributed 50 basis points to CVG growth, where our efforts are most developed. We expect to further improve our growth of Services and Solutions model and expand it across all our business groups. In Care Management Services, formerly known as Cardiocom, our growth rate was in the mid-20s in Q3, driven by strong performance within the U.S. Veterans Administration Healthcare System, where we are managing a cohort of over 85,000 patients with multiple co-morbidities. Care Management Services represents an important platform for us, especially as post-acute care services become even more critical in bundled payment models for different interventions. In our Hospital Solutions business through which we provide expertise and operational efficiency as well as daily administrative management of hospital cath labs and operating rooms, we had service revenue growth rates in the mid-30s. Since the time we started this business a little over two years ago, we have now completed a total of 72 long-term managed service agreements with hospital systems, representing more than $1.7 billion in contracted service and product revenue over an average span of six years. While the majority of these hospitals are in Europe, we also have seven hospitals in Latin America and seven in the Middle East and Africa. We continue to attract strong customer interest in Hospital Solutions in regions around the world. And we have a full pipeline of potential contracts. We are pleased with the progress we are making in expanding hospital solutions into operating rooms, utilizing the breadth of our MITG products and associated expertise. We have signed five operating room managed services deals, representing approximately $140 million in cumulative revenue with an average life of seven years. We are also expanding our solutions offerings into chronic disease management through Diabeter, a Netherlands-based diabetes clinic and research center we acquired almost a year ago. We continue to grow the number of contracted patients and expect to expand Diabeter beyond The Netherlands over time. Through initiatives like Diabeter as well as others that I mentioned earlier, we are transforming our diabetes group from a market-leading pump and sensor business into a holistic diabetes management business. While all of these Services and Solutions, Care Management Services, Cath Lab and Operating Room Managed Services, and Diabeter are still relatively early-stage businesses, they represent important future building blocks that we will use to create comprehensive value-based healthcare offerings, where payments will be based on measurable patient outcomes over a specific time horizon. We are rapidly developing expertise in these areas with a particular focus in supporting bundled solutions across the care continuum targeting specific patient cohorts requiring a particular intervention. This is consistent with the direction of CMS’s bundle payment initiative and their first implementation, Comprehensive Care for Joint Replacement or CJR, which we fully support. While this initiative is still evolving, it is one that is mandatory, consistent and measurable, which allows it to be scalable. We encourage CMS to expand bundled payments to other clinical areas where we participate more broadly. Healthcare is going through a necessary transformation, where stakeholders are seeking not only to improve clinical outcomes and expand access to care but are also looking for solutions to optimize cost and efficiency. Our confidence continues to grow in Medtronic’s ability to lead and compete in these new value-based healthcare models around the world. Our organization is exploring new and novel ways to not only deliver better clinical and economic value but to tie our success to these outcomes through innovative new business models with providers and payors. We remain convinced that our technologies and services can play a central role in making the shift to value-based healthcare successful. Turning now to the P&L, as I mentioned earlier, we delivered EPS leverage in Q3 of 1,150 basis points on a comparable constant currency basis, which significantly exceeded our baseline expectation of 200 basis points to 400 basis points. All areas of our global operations are executing to the plan we laid out at the beginning of the fiscal year, as we deliver on our productivity improvements and cost synergy programs. Operating leverage in the quarter was 510 basis points, driven predominantly by the improvement in SG&A, which is the line item with the majority of the Covidien integration cost synergy that we are realizing today. The remainder of our EPS leverage was driven by improvements in our interest expense and tax rate, as well as share repurchase activity. Our strong revenue growth and operating leverage is generating significant adjusted free cash flow. In Q3, we generated $1.8 billion and expect to generate nearly $40 billion in adjusted free cash flow over the next five years. We also continue to look for ways to untrap cash in our balance sheet. Last September, we announced that we had untrapped $9.3 billion of cash. And last month, we announced how we intend to use these proceeds. We’re executing an incremental $5 billion share repurchase that we intend to complete by the end of FY 2018. We intend to use the majority of the remaining proceeds to either prepay existing debt or pay debt that comes due by the end of fiscal year 2018 in order to meet our commitments to our debt investors. We’re deploying our capital with a balanced focus on M&A investments, meeting our debt reduction commitments, and returns to shareholders. We are committed to returning a minimum of 50% of our adjusted free cash flow to our shareholders through dividends and share repurchases. As an S&P dividend aristocrat, we expect to deliver dependable long-term dividend growth. Earlier this fiscal year, we increased our dividend by 25%, and we expect to grow our dividend faster than earnings, with intent to reaching a 40% payout ratio on a non-GAAP basis even earlier than we had previously announced. Regarding share repurchases, with an incremental $5 billion share repurchase, we expect to return approximately $15 billion to shareholders over three years, more than double the amount we returned over the past three years. With our M&A investments, we remain disciplined when evaluating potential opportunities. Any investment we make must meet our portfolio criteria, which are: the targets must provide a line of sight to improving outcomes, allow for Medtronic to add value, and we must have a team that is positioned to win. In addition, our investments must be aligned with and strengthen one or more of our three growth strategies, meet our high financial return hurdles, and minimize any near-term shareholder dilution. Before turning the call over to Gary, I’d like to conclude by commenting briefly on our Covidien integration activities, which continue to go extremely well. We’re executing on our priorities to preserve, optimize, accelerate, and transform. We have preserved and in many cases accelerated the growth of both companies. Talent retention and employee satisfaction remain high as our two cultures continue to come together. Our value capture programs are resulting in strong operating leverage. And we have meaningfully improved the sustainability of both our growth through the diversification of our revenue base and our capital allocation goals through the increased access to our cash. In summary, Q3 was another quarter of solid execution by our organization. Our operating leverage is coming through as we expected, and I’m pleased with how we are positioning the company to deliver growth consistently and reliably. Gary will now take you through a more detailed look at our third quarter results.

Thanks, Omar. Third quarter revenue of $6.934 billion increased 61% as reported or 6% on a comparable constant currency basis, which excludes $344 million of unfavorable impact of foreign currency. Acquisitions and divestitures contributed a net 20 basis points to the Q3 revenue growth. Q3 non-GAAP earnings per share was $1.06, a decrease of 1% versus the $1.07 delivered by legacy Medtronic last year, or an increase of 17% on a comparable constant currency basis after adjusting for the $0.11 impact to earnings per share from foreign currency translation. Q3 GAAP diluted earnings per share were $0.77, a decrease of 21%. In addition to the $374 million after-tax adjustment for amortization expense, this quarter’s non-GAAP adjustments to earnings on an after-tax basis were a $43 million charge for acquisition-related items, a $16 million net restructuring charge, and a $25 million benefit resulting from the establishment of a deferred tax asset related to the realization of a one-time capital loss. Our Cardiac and Vascular Group, which accounted for 35% of our total company sales, grew revenue by 7%, with all three divisions growing at or above overall company growth. CRHF grew 6%, as we took significant share in a flat global implantables market. In High Power, our strong Evera MRI launch resulted in our highest U.S. High Power shares since early in the decade, despite the fact that we had declines in CRTD. While CRTD business experienced sequential growth in U.S. implants share, we also had an intentional reduction in customer inventories ahead of our Q4 CRTD MRI launch. In Coronary, we are holding global diluted earnings drug-eluting stent share in the face of major competitor data releases and product launches, which we attribute to increasing preference for the Resolute Onyx in Europe and our CVG multiline contracts in the U.S. In transcatheter valves, we grew in the low-30s consistent with the market. Market share growth in Europe and the initial launch of CoreValve in Japan in the back half of Q3 balanced modest U.S. share loss, where our competitor product launch and a lack of having Evolut R in the largest valve segment limited total U.S. growth to the mid-20s. We were pleased to receive IDE approval for our U.S. low-risk trial and it is worth noting that we now expect the global TAVR market will grow to approximately $4 billion by the end of 2020. In Peripheral, we maintain drug-coated balloon market leadership globally and in the U.S. on the strength of our clinically differentiated impact IN.PACT Admiral balloon. Our Minimally Invasive Therapies Group, which accounted for 33% of our total company sales, grew revenue 5%, with strong at or above market performance in both divisions. In Surgical Solutions, both Advanced Stapling and Advanced Energy grew in the upper-single-digits, although we estimate that U.S. surgical volumes have normalized now at 1% to 2%. The PMR division grew 1%, as the business was affected by a product hold of the Puritan Bennett 980 ventilator, which resulted in an approximately negative $10 million to $15 million impact to the quarter. This is expected to affect quarterly PMR revenue by approximately $20 million to $25 million, until the product returns to the market, which is expected in the first half of next fiscal year. Our Restorative Therapies Group, which accounted for 25% of total company sales, grew revenue by 4% with strong growth in neurovascular and surgical technologies offsetting declines in Spine and in Neuromodulation. In Spine, while U.S. Core Spine was challenged, we gained international Core Spine share. In BMP, the U.S. had strong low double-digit growth. However, the InductOs ship hold in Europe is expected to continue through mid-FY 2017. In Neuromodulation, we recently received FDA approval for Parkinson’s patients with early-onset motor complications, expanding the number of potential patients that can be treated with DBS therapy. Our Diabetes Group, which accounted for 7% of total company sales, grew revenue at 11%, with strong broad-based performance across all three divisions. In IIM, our Type 1 business, we are seeing very good growth driven by the MiniMed 640G. In NDT, our Type 2 business, while the revenue base is still small, we are seeing growth over 250% as we continue to drive our iPro 2 professional CGM solution and the new easy-to-interpret pattern snapshot report into primary care channel. In DSS, our Diabetes Service & Solutions business, we saw high-single-digit growth driven by U.S. consumable sales, our Diabeter acquisition, and continued strong adoption of our MiniMed Connect remote connectivity platform. Now turning to the P&L, as I discuss the operating items, it is worth clarifying that my comments will be made on a non-GAAP comparable constant currency basis unless I say otherwise. The Q3 operating margin was 29.2%, this represents a 140 basis point improvement over the prior year, but this improvement was completely offset on a reported basis by a negative 140 basis point impact from foreign currency. The 140 basis point operating margin improvement included a 140 basis point improvement in SG&A, offset by a 20 basis point decline in gross margin, a 10 basis point increase in R&D, and a 20 basis point improvement in net other expense. This resulted in operating profit growth of over 10% or operating leverage of approximately 510 basis points over revenue growth. Our operating margin included gross margins of 70.5%, SG&A of 33.3%, and R&D of 7.6%. Also included in our Q3 operating margin was net other expense of $9 million, which included net currency gains of $78 million, primarily from our earnings hedging program. It is worth noting that including these net gains was an unexpected $21 million expense resulting from a revaluation of the Argentine peso denominated assets, which devalued by approximately 30%. Regarding our earnings hedging program, while we hedge the majority of our operating results in developed market currencies to reduce volatility in our earnings from foreign exchange, a growing portion of our profits are un-hedged, especially emerging market currencies, which can create modest volatility in our earnings. Assuming recent exchange rates for the remainder of the fiscal year, which include a €1.09 and ¥113, we expect Q4 net other expense to be in the range of $5 million expense to $15 million of income, which includes approximately $110 million in currency gain and no longer includes the U.S. medical device tax, which has been suspended. We expect our Q4 operating margin to be in the range of 31% to 31.3% on an as-reported basis, based on current exchange rates. This forecast implies an approximate 300 basis point improvement in our operating margin on a constant currency basis. Our value capture programs as a result of the Covidien integration remain on track. And we now expect to exceed our original FY 2016 savings goal of $300 million to $350 million and continue to target a minimum of $850 million by the end of FY 2018. Below the operating profit line, Q3 net interest expense was $176 million, in line with our forecast. Based on current rates we would expect Q4 net interest expense to be in the range of $205 million to $210 million. This is an increase over prior quarters as the execution of our incremental share repurchases results in reduced interest income. At the end of Q3, we had approximately $35.8 billion in debt and approximately $17.3 billion in cash and investments, of which approximately $6 billion was trapped. Our non-GAAP nominal tax rate on a cash basis in Q3 was 14.3%, which was an improvement from our forecast due to the permanent extension of the U.S. R&D tax credit as well as operational tax adjustments. For Q4, we expect our non-GAAP normal tax rate on a cash basis to be in the range of 16% to 16.5%. In Q3, adjusted free cash flow was $1.8 billion, we remain committed to returning a minimum of 50% of our adjusted free cash flow to shareholders and also continue to target an A credit profile. In Q3, we paid $534 million in dividends and repurchased $710 million of our ordinary shares. As of the end of Q3, we had remaining authorization to repurchase approximately 81 million shares. Third quarter average daily shares outstanding on a diluted basis were 1.422 billion shares. For FY 2016, we now expect diluted weighted average shares outstanding to be approximately 1.427 billion shares, including approximately 1.419 billion shares in Q4. Next, I would like to comment on our revenue outlook. We expect revenue growth for the fourth quarter of FY 2016 to be in the range of 5% to 5.5% on a constant currency basis, which is consistent with our prior outlook of second-half revenue to be in the upper half of our mid-single-digit baseline goal. This is solid revenue growth, especially when you consider the strong upper-single-digit growth we delivered in Q4 last year. While we cannot predict the impact of currency movements, to give you a sense of the FX impact of exchange rates were to remain similar to yesterday for the remainder of the fiscal year, then our Q4 revenue would be negatively affected by approximately $180 million to $220 million. Turning to guidance on the bottom line, we continue to expect non-GAAP cash earnings per share in the range of $4.36 to $4.40, which includes an expected $0.45 to $0.50 negative foreign currency impact based on current exchange rates. As in the past, my comments on earnings per share guidance do not include any charges or gains that are recorded or would be recorded as non-GAAP adjustments to earnings during the fiscal year. Next, I would like to provide some high-level framing comments on fiscal year 2017. While we intend to give our revenue outlook in earnings per share guidance per our normal practice on our Q4 call, here are some items to keep in mind as you think about our next fiscal year. First on revenue growth, while we are not formally providing our FY 2017 revenue outlook, we believe it is reasonable to think about our revenue growth in the mid-single-digit range on a constant currency basis consistent with our baseline expectations. However, keep in mind that we had an extra selling week in the first quarter of FY 2016. This will negatively affect our Q1 FY 2017 revenue growth rate by approximately 600 basis points and our full fiscal year revenue growth rate by approximately 150 basis points, and as a commensurate impact to earnings per share. Regarding foreign exchange, given current rates, we expect a $200 million negative impact in FY 2017 revenue and expected to negatively affect FY 2017 earnings per share by approximately $0.20 to $0.25, primarily from the loss of significant hedging gains we had in FY 2016, as well as continued pressure from unhedged emerging market currencies. Based on the operating leverage from our Covidien integration activities as well the financial leverage from share repurchases, we expect constant currency earnings-per-share growth to be in double digits to lower teens, after adjusting for the extra week in FY 2016, which would exceed our baseline goal of generating 200 to 400 basis points of earnings per share leverage. Before turning the call back to Omar, I would like to remind you that we plan to hold our Q4 earnings call on May 31. We also plan to host our Investor Day on June 6, which will be held in New York City.

Thanks, Gary. And we will now open the phone lines for Q&A. In addition to Gary, I have asked Mike Coyle, President of our Cardiac and Vascular Group; Bryan Hanson, President of our Minimally Invasive Therapies Group; Geoff Martha, President of Restorative Therapies Group; and Hooman Hakami, President of our Diabetes Group to join us. We want to try to get as many people 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 our Investor Relations team after the call. And operator, first question, please?

Thank you, guys, and good morning. Let me start with a couple of items. So, Gary, probably the first question people will have is just the operating margin expansion this quarter wasn’t what people were hoping and maybe which you were thinking in the last quarter. Can you just talk about how much of that was FX, which you touched on and any other comments just relative to the progression of the synergies from Covidien?

Yes, I mean, as we indicated, Mike, I mean, obviously we are getting a lot of leverage in the quarter, 1,150 basis points on the bottom line on a constant currency basis. And as I mentioned in my comments, 510 points on the operating margin line just of leverage there and 140 basis point improvement on an operating basis. Unfortunately, with foreign exchange, it has been a headwind all year, it’s having a similar negative impact on the margin and so we didn’t get as much of an improvement than you might see on an as-reported basis just because of that. So as we’ve been doing all year, we are continuing to execute against our operating leverage plans and our cost takeout synergies that we have from the Covidien transaction, but as with many companies we are experiencing the foreign exchange that is mitigating or eliminating a lot of that benefit that we are rolling through that. We are trying to manage that the best we can, but clearly that’s having a big impact. The Covidien synergies, the integration costs were coming in right on plan. In fact, as I mentioned in my comments we’re ahead of schedule and we’re probably going to - we clearly will exceed the $300 million and $350 million that we assumed in the current year. We are seeing a lot of leverage here in Q3 and as we indicated - even in Q4 we’ll continue to see improvement in that operating margin as a result of the synergy. So we are right in line with things, but I agree with you, I think FX is kind of camouflaging some of the real benefits you are seeing from an operations perspective.

And for FY 2017, the $0.20 to $0.25 that’s let's say, $0.05 to $0.10 more than maybe you were taking a month, month and a half ago?

Yes. I mean, I think overall the gains are - we even said for the current quarter was like $100 million, and it is $100 million in Q4. So, I mean, we are generating almost $400 million in gains in the current year. Obviously, we are not hedged at these favorable rates next year and as a result that’s going to have a negative impact. I think it’s a little bit higher than what we would have been expecting a month or two ago in emerging markets. Some of the currencies in the emerging markets have continued to weaken and that’s become a little bit greater part of the total. But the biggest portion of the $0.20 to $0.25, the majority of that is just the hedging gains that we will not have in FY 2017 that we had in FY 2016.

Right. And then last one, the CRTD inventory drawdown that you highlighted in the quarter, any estimate for how much that was, because obviously the ICD performance was a little bit weaker than this year was expecting?

Yes. It was in the range of about $15 million to $20 million.

Good morning. Just a couple of quick questions here, I guess, Omar, I think the hallmark the last several quarters of the business has been a significant strength in the U.S. This is sort of the first quarter in a couple where we’re seeing U.S. performance is a little slower here in the third quarter versus the prior two or three quarters. It was pretty broad based. There were certain specific things you called out. Is there anything broadly you’d sort of comment on as it relates to the U.S. market performance in the quarter?

Like I had mentioned in the last call, the three things that we look at in the U.S, one is one which we knew was going to slow things out a little bit was the anniversarying of the Affordable Care Act and that probably had a little bit of an impact. The overall procedure volumes based on the economy I think were more or less steady. I think in the Surgical Solutions maybe a slight drop in procedure volumes, but essentially it was steady. There was no economy-related issues. The third aspect was simply our new products. And like I said, these new products going to come and go on a quarter-by-quarter basis and in general we still had pretty strong performance from new therapies. But in prior quarters, it was even stronger, given a larger kind of sort of synergy of different products coming in at the same time. I think that’s going to go float up and down and that I think is the main factor here in the change in the U.S. market. But I have to point out that our whole model is based on the diversification, because we can’t depend on just one market. And as you saw this quarter, emerging markets picked up a little bit and essentially sort of offset the drop in our U.S. revenue. But I think overall from a market perspective, it’s pretty steady.

Okay. And then, Omar for you and the broader team, I mean, obviously durable growth is what you’re trying to drive people towards. I think as of outside sphere over the next couple of quarters that your CRM performance is not sustainable, and obviously that’s going to weigh on kind of relative growth the next couple of quarters. Maybe, either from like why is CRM growth sustainable. And I guess Omar or for the broader team, if you think about certain franchises whether it’s Spine or PMR, what are the key franchises that start getting better as CRM performance begins to decelerate? Thanks so much.

Thanks. Mike you go first and then I’ll kind of talk about it.

Yes, actually, we see the CRHF business is being one of the prime drivers of sort of the near-term catalyst for the business over the next couple of quarters. Obviously CRTD, MRI being launched now in the United States, but with the 3T kind of CRTD MRI in Europe we think that’s going to be a big contributor. We’re going to continue to add expanded MRI capability in the standard ICD segment with Evera MRI 3T for Europe and that will follow on into the U.S. early next year. Visia AF is the single chamber offering in that space where we will be actually adding to sort of the free capability of the link diagnostics where a single chambered device were really the first device which can actually detect atrial fibrillation. We have the Micra that we would expect to come in, in the first half of next year in the pacing segment. And after the upcoming ACC meeting we’re going to be releasing the data on the FIRE AND ICE trial, which is the first very large head-to-head comparison of CryoAblation technology to point-by-point ablation technology. Not mention in fact that we also have things like Core Valve coming into Japan and LINQ coming into Japan next year. So we think there are plenty of catalysts to keep the business growing here over the next several quarters.

Yeah. I think we’re confident in our steady growth in CVG overall and certainly in CRM. But like you point out, our business model is based on diversification of a variety of other products. And I think the two examples that you gave are pertinent. I think in PMR we started seeing acceleration, especially as the ventilator starts to resolve the issues that we’ve had and we expect that early next year, early next fiscal year. And in Spine, I think, we try to lay out as much detail as possible our change in approach. And we like, Geoff had mentioned earlier, we expect to see results in Spine in steady improvement every quarter. So an overall balance is what we look for. And then we also have pretty good cadence in diabetes as well. But we’re - Mike is pretty confident that we can keep our growth rate in CRM going at least to a large degree.

Great. Thanks, David. Next question, please?

Thank you and good morning, everybody. Omar, can you maybe come back to Spine for a second? It’s obviously a business where there’ve been several iterations of sort of a turnaround plan over the past, call it years. So I think at the analyst meeting right before announcing the Covidien acquisition you were talking about the opportunity for cross-selling within RTG, now you’re talking a little bit about ramping up the product cadence. What signposts are you watching to identify whether you have the right strategy in Spine? How long are you willing to continue to let this business underperform?

Well obviously, underperformance is not acceptable. The thing is that market is still a very attractive market for us and we’ve got core expertise. So we’re going to get this thing fixed. And then, I completely take your point. We laid out these strategies earlier. We haven’t talked about the new product in as much as depth, we talked about in general terms. But as we start to dig into it under Geoff’s leadership, we found that the way in which we were launching these products was just completely suboptimal, which was really kind of almost compromising the value of these products. And the overall cross-RTG synergies, what was missing before as we just end on specific targets on this. That’s why we made the changes. We’ve made changes in the field level. We’ve made changes in the overall leadership level. And we are looking at this thing closely on a quarter-by-quarter basis and we expect to see improvement. The real guideline here is U.S. Core Spine, and the correlation of the product launches to an uptick in performance. I think it’s as straightforward as that. That’s the benchmark that we are looking at. That’s the benchmark that you should look at. And we’re going to get this thing fixed and because - again, like I said, we are in a position of high share. We are in a position where we’ve got the biggest breadth with our customers. We’ve got to do this thing right. So that’s the portion we are taking and those are the guideposts I suggest that we look at - we’ll point out and you should look at.

Okay. And then, maybe for Gary, I know a lot of moving parts here around currency, synergy capture etc. Can you maybe just help us again - I’m sorry, frame the impact that of the medical device tax suspension with currency hedging losses and how that all kind of ties into your comments around FY 2017, because I would have thought that the positive impact from the device tax suspension would at least give you some relief on currency and hedging losses? So can you maybe just walk us through the different moving parts there again?

Yes. Well, I mean, again, we are not obviously giving the FY 2017 guidance. And so, I don’t want to get too much into what’s going on there. We try to give some highlights of some things just to consider as you go through the model. But the point is, as we try to highlight here, I mean, for the current year as we go forward, we are continuing to expect the revenue growth to be in that mid-single-digit range as we go forward. We are expecting we are going to continue to get the operating synergies and be at the high-end of the - or in fact exceed probably the earnings growth that we’ve been expecting from the value capture of the Covidien transaction. And that’s going just as we expected. It’s coming in, in fact a little bit ahead of the schedule at this point. And so we feel confident that will be positive as we go into the next fiscal year, obviously. Foreign exchange continues to be a major headwind for us as it is with the many multinational companies and ours because of the hedging programs we did. If anything - if you think about it from foreign exchange, we had a $0.45 to $0.50 impact from the current year, but that was with significant gains that we had from our hedging programs. So our impact was somewhat muted from maybe where other companies who don’t hedge were at. That is going to come to ahead for us in FY 2017. And as we indicate, that’s potentially another $0.20 to $0.25 of impact as we go into next year. You’re right; we are going to have some benefit from the medical device tax. We are getting some already in the current year that’s helping give us even more operating leverage than what we were expecting previously. But again, the foreign exchange is kind of offsetting that as we kind of drive through this. And so there are positives from the medical device tax. There are going to be positives from our share repurchase. All those are factors we have taken into consideration. But I think if you weight all those together, I think you’re going to find that they play out like we’ve indicated in our comments, because - but the issue is foreign exchange is clearly still a significant headwind for us. And then, we obviously have a tough comparison next year in FY 2017 because of the extra week we had in the current year. Those are all the factors that we try to lay out for you as you put together your models and we’ll probably obviously provide more details and more guidance as we get to our Q4 call.

Hi, good morning. Gary, I hate to come back to this. But I wanted to get to the operating margin question again. And really the reported number was just slightly below the guidance you gave of 28% to 28.5% last quarter. And I understand currency had an impact, but you did also give us currency guidance, which was - and you did come in line with that. So I guess, I’m curious, what the disconnect was between what you actually did in currency and what you thought the impact would be on the quarter.

Yes, well, I think overall, we gave currency guidance from the standpoint of revenue, which did come in line with what we had expected. But I think where currency was a little bit greater was on the bottom line and it’s primarily because of the Argentine peso that I mentioned earlier, that that cost us an unexpected a little over $20 million, $21 million impact that we had not expected in the guidance that we provided back in the Q2 call. So that was the primary thing now. So FX was a bigger negative on the bottom line in the quarter than what we had originally expected at the beginning of the quarter. As you indicated, the revenue was right in line, but the bottom line was a larger impact. So from an operating margin perspective, we came in with basically where we expected originally, but it was a little bit more offset on the bottom line from FX than what we had originally expected.

And so, when we think about - you gave us guidance also for the fourth quarter here of 31% to 31.3% on operating margins. How do we get comfortable - and I hate splitting hairs, because I realize there’s only 20 basis points or so. But given that it’s sort of the marker that investors are using for the integration of Covidien, how do we get comfortable that we won’t again see perhaps an outsize impact on currency or is it just simply the nature of the beast here?

Again, I wish I could predict currency and be able to tell you that there is not going to be surprises to positive or negative on the currency side. Currency is what it is, I mean, though that the impact will be as we go forward. Again, we were trying to give guidance on - as you said, I mean, 20 basis points, trying to call that in our operating margin line with all the moving parts there going on is not easy. So we understand there are lots of moving parts here. Currency was negative in the quarter. I’m not expecting another devaluation here in Q4. But if it happens in one of the currencies that could be a little bit of a negative. On the other hand, what we’ve tried to provide as far as guidance on what we expect based on what we know right now and based on the current rates and where things are at, that gives the guidance on the operating margins. So we feel confident about that, assuming, again, that there are no surprises positive or negative. So that’s all the best we can do at this point in time, just to give you some indication on which direction these things are going.

Okay. Listen, first of all, I just want to also reemphasize what Gary just said. As I’ve said, ever since I started here, we can work on things that we can control. What we accept other variables and we try to understand completely, the valuation of the company is based on the actual performance. We can only kind of drive what we can control as best we can, meet our commitments and drive it aggressively as we can. And that we are completely committed to doing. And on that basis, as Gary just pointed out, the cost synergies that we expect from Covidien, we’ve got pretty granular look at that. We’re delivering. We’re delivering, this operating team is delivering, and they’re stretching hard and then trying to cover for other things. But there is only so far we can go about things that are not in our control. So I just do want to make that point that we haven’t lost our operational focus on delivering these synergies one bit and in many ways are a little bit ahead of our original commitments. But there are lots of moving parts there. And then, we are optimistic about the future and our plans are pretty solid going into fourth quarter and into next year.

Thanks, Omar. We will now close the call.