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Executives

Jeff Warren

Omar S. Ishrak - Chairman and Chief Executive Officer

Gary L. Ellis - Chief Financial Officer, Principal Accounting Officer and Senior Vice President

Analysts

Matthew J. Dodds - Citigroup Inc, Research Division

Michael N. Weinstein - JP Morgan Chase & Co, Research Division

Bruce M. Nudell - Crédit Suisse AG, Research Division

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Kristen M. Stewart - Deutsche Bank AG, Research Division

David R. Lewis - Morgan Stanley, Research Division

Raj Denhoy - Jefferies & Company, Inc., Research Division

David H. Roman - Goldman Sachs Group Inc., Research Division

Michael Matson - Mizuho Securities USA Inc., Research Division

Frederick A. Wise - Leerink Swann LLC, Research Division

Medtronic (MDT) Q4 2012 Earnings Call May 22, 2012 8:00 AM ET

Operator

Good morning. My name is Christie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Medtronic Fourth Quarter Earnings Release Conference Call. [Operator Instructions] Thank you. It is now my pleasure to hand the program over to Mr. Jeff Warren. Please go ahead.

Jeff Warren

Thank you, Christie. Good morning, and welcome to Medtronic's Fourth Quarter Conference Call and Webcast. During the next hour, Omar Ishrak, Medtronic Chairman and Chief Executive Officer; and Gary Ellis, Medtronic Chief Financial Officer, will provide comments on the results of our fourth quarter and fiscal year 2012, which ended April 27, 2012. After our prepared remarks, we'll be happy to take your questions.

First, a few logistical comments. Earlier this morning, we issued a press release containing our financial statements and our revenue-by-business summary. You should also note that some 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. Therefore, we do not undertake to update any forward-looking statement. In addition, the reconciliations of any non-GAAP financial measures are available on the Investor portion of our website at medtronic.com.

Finally, unless we say otherwise, references to quarterly or annual results, increasing or decreasing, are in comparison to the fourth quarter and full year of fiscal year 2011, respectively, and all year-over-year revenue growth rates are given on a constant-currency basis. And with that, I am now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishrak.

Omar S. Ishrak

Good morning, and thank you, Jeff. And thank you to everyone joining us today. This morning, we reported fourth quarter revenue of $4.3 billion, which represents growth of 4%, with balanced contributions from both our CVG and RTG groups. Q4 non-GAAP earnings of $1,036,000,000 and diluted earnings per share of $0.99 increased 7% and 10%, respectively. Before commenting specifically on our Q4 performance, I would like to recap fiscal year 2012, my first as CEO of Medtronic. Overall, we made progress this year in positioning the company to succeed in the changing healthcare environment. Our constant currency growth improved modestly from 1% in FY '11 to 3% in FY '12. 3/4 of our business posted strong performances, growing a combined 8%. The remainder, consisting of our U.S. ICD and U.S. Spine businesses, declined 10%. While both of these businesses had unique factors affecting their performance, both were showing some signs of stabilization as we exited the year.

Looking down the P&L, we grew our operating margins faster than revenue by obtaining some SG&A and R&D leverage while holding our industry-leading gross margins relatively flat. At the same time, we made investments in markets where we see future growth. When I came to Medtronic, I decided that initially our 3 main areas of focus would be accelerating globalization, optimizing innovation and improving execution. We're making notable progress in these areas. First, let's discuss globalization. Our FY '12 international revenue grew 7%, with emerging markets growing 20%. Our team came together nicely, following the global reorganization we implemented in the fall. Over the past year, I've traveled extensively visiting our operations around the world, and I am seeing firsthand the improving alignment between our business units and geographies. Everywhere I go, I'm impressed by our local teams' skill and dedication as well as their deep knowledge of our customers and markets. I've also been positively surprised by the sizable opportunity that exists in emerging markets to expand the use of our existing products.

Longer term, we're also taking the necessary steps to enter the value segment more aggressively. We continue to reduce product costs through our continuous COGS reduction program, which gives us the flexibility to offer a variety of tiered products. We're also actively investigating opportunities to increase local R&D and manufacturing in emerging markets. Through this the structured approach, we intend to grow our emerging market revenue from 10% of the overall company revenue in FY '11 to 20% over the coming years.

We have also focused in optimizing innovation, including improving our R&D productivity. While it is still early and we have a lot of work ahead of us, we did see some progress in FY '12 toward our goal of getting more growth with the same or perhaps less levels of R&D and M&A investment. As we went through our FY '13 planning process, we made specific efforts to reallocate resources into driving growth in emerging markets and in evidence generation for our growth platforms. As part of this process, we eliminated a number of development programs in order to focus on projects that are more strictly aligned with our strategy and expected to deliver sustained short- and long-term business results.

We also assessed all programs and their ability to deliver economic value to the customer, which is increasingly becoming a critical factor in today's changing healthcare environment. We're engaging in active discussions with a number of major payors around the world to begin partnerships of specific economic value programs. One example is an agreement we recently reached with the government of Lombardy, the largest region in Italy, to partner on outcomes research and MedTech efficiency. This unique program will evaluate the quality and overall treatment cost of chronic disease for several Medtronic technologies.

Here in the U.S., we are also in initial discussions with Aetna regarding chronic disease management partnerships in diabetes and heart failure. Both of these partners have rich sources of patient outcome data, which is essential for the quick and effective evaluation of economic value. Partnerships like this will not only be beneficial to Medtronic but will also help support the sustainability of healthcare systems around the world.

We believe strongly that the ability to translate clinical value into economic value will be the key area of differentiation for success in healthcare over the longer term. We're excited about our strategy in this area and look forward to telling you more at our Investor Conference next week.

Let's now address my third initiative, driving crisp and consistent execution across the organization. We made improvements to our business alignment, ensuring focus and efficiency throughout our business units and regions. I've also focused our management team on improving operating rigor, which has resulted in addressing issues in a more proactive and decisive fashion. I'm seeing improvements in execution from our operating teams around the world, and the results of our efforts are beginning to show in our financial performance. We delivered total company revenue growth of 3% in FY '12, which improved through the year and finished at the upper end of the revenue range we provided at the beginning of the year. In the vast majority of businesses, we maintained or grew our share over the course of FY '12. We also delivered non-GAAP FY '12 EPS consistent with our guidance. Going forward, we will maintain our focus on execution, which we expect to result in improved and more predictable business performance.

Let's turn now to our Q4 results. Revenue growth of 4% was driven by solid performances across many of our businesses. Our U.S. ICD business showed sequential improvement as it was helped by the continued trend of market stabilization and expectation that we highlighted for you last quarter. In Q4, after excluding U.S. Spine, the remaining 87% of our business grew 7%, a marked improvement from the 4% growth we had in this portion of our business last quarter. Our international revenue grew 7% in Q4, including 20% growth in emerging markets, with strong finishes to the year, with growth well in excess of 20% in Central and Eastern Europe, Greater China and India. Looking ahead, I believe sustained emerging market growth greater than 20% continues to be a realistic goal.

In CVG, as I just mentioned, we continued to see signs of stabilization in the U.S. ICD market. Our U.S. ICD revenue declined 2% this quarter, which was a major improvement from the 14% decline last quarter, especially in light of decreasing hospital inventories. Our implant rates showed year-over-year growth for the first time in 6 quarters, and this trend is continuing. Growth in our overall high-power replacement share offset modest declines in our CRT-D initial implant share, resulting in flat total high-power market share. In fact, for the first 4 years -- in fact for the past 4 years, our U.S. ICD share has remained in a tight band. Apart from a couple of one-time events, our share today remains right in the middle of this band, and our expectation is to maintain or improve our share going forward.

Before moving on, I'd also like to note that in Pacing, we continued to gain significant share on the strength of our MRI devices, both in the U.S. and in international markets. Our global Pacing share is now at its highest point in 4 years.

Turning to Coronary. I want to acknowledge the impressive early results from the U.S. launch of Resolute Integrity, which sequentially doubled our U.S. DES revenue and our corresponding market share. This impressive share growth is attributable to the strong performance characteristics and long-term clinical evidence of Resolute Integrity, as well as solid execution by our Coronary commercial team. It is also a clear example of how leveraging the unmatched breadth of our entire CVG field organization can drive differential results. We use field personnel from across our CVG organization, including the extensive field sales and clinical support network of CRDM to meaningfully accelerate and expand the Resolute Integrity launch. Recognizing the power of our broad cardiac and vascular offerings, some of our competitors are now attempting to replicate our strategy, either on their own or through partnerships. However, only Medtronic has the ability to seamlessly provide a full breadth of leading technologies for our customers, both today and in the future. With the launch of Resolute Integrity, we are now able to offer a comprehensive set of leading technologies across the Cardiac and Vascular space. Next week, at our Investor Conference, Mike Coyle will tell you more about the increasing competitive advantage this represents in our ability to engage customers.

Let me now discuss our RTG business. I want to first acknowledge the success of our full U.S. and Japan launches of the RestoreSensor spinal cord stimulator. RestoreSensor grow over 6 points of sequential U.S. share gain and contributed to a doubling of our neuromodulation business growth rate in Q4 versus the prior quarter. We expect to sustain this improved growth rate over the coming quarters.

Our Surgical Technologies business had an outstanding Q4, growing 25%. Our new Advanced Energy business was a strong contributor to this growth, and I've been very pleased by the Advanced Energy's integration efforts as well as their continued growth trajectory. It's also impressive to note that even after excluding the impact of Advanced Energy, Surgical Technologies grew 14% organically. This was driven by strong capital equipment sales from ENT and navigation, which collectively grew 17%. Surgical Technologies is now nearly a $1.3 billion business and is an increasingly important contributor to our growth profile. It also plays a very important role in our broader neuroscience strategies, which Chris O'Connell will explain at our Investor Conference next week.

Now let me discuss our Spine business. While the total business declined 6%, our International Spine business actually delivered a strong performance in Q4, growing 8% and is now annualizing at over $1 billion. This business is particularly strong in China where our joint venture with Weigao is delivering solid results. I expect continued growth in International Spine while we focus in improving our U.S. Spine business.

Turning to U.S. Spine. Q4 revenue declined 12% with roughly 60% of this decline driven by INFUSE. In order to isolate the issues in U.S. Spine, it is important to look at the business across its 3 parts, namely BKP, INFUSE and core. Our U.S. BKP business was flat, which was encouraging after 10 consecutive quarters of decline, as our new products begin to gain traction. U.S. INFUSE declined 26% in Q4 but was relatively stable sequentially. Until we know the results of the Yale study, which we expect in Q2, there will continue to be uncertainty about our INFUSE financial results. As I've said before, we believe in the safety and efficacy of INFUSE for approved indications. However, we want to address any controversies by understanding the facts, which is why we requested Yale University to systematically analyze all the available data. In addition, we were pleased by the U.S. Department of Justice decision to close its investigation of INFUSE. We took the investigation very seriously and invested significant resources to identify the facts with complete transparency.

Now let's discuss our U.S. core business, including Other Biologics, which declined 7% and drove the remaining 40% of the decline in U.S. Spine. We're making changes to our strategy in order to restore the performance of this business, including innovating and differentiating Medtronic at both the product level and procedural level. We're investing in local product development and locations around the globe. We're also beginning to use breadth of our technologies more effectively in the neuroscience space. And finally, one of the biggest changes we're making is to incorporate economic value into the commercial messaging of our existing products, as well as into our new product selection process. Chris O'Connell will review these Spine strategies in detail at our Investor Conference next week.

Let me now address our operating results in Q4. In delivering non-GAAP EPS of $0.99, we made some conscious trade-offs during the quarter to take advantage of some compelling investment opportunities. As a result of this, SG&A spending came in higher than we had originally forecasted. As we move through the quarter, we could see that our new products were driving strong revenue and market share growth. And at the same time, we were able to execute the sales lease back financing strategy that directly benefited the bottom line through a reduction in tax expense. This presented a unique opportunity to make some focused sales and marketing investments, including pulling in some planned spending from FY '13. We believe this was the right decision, and we expect to see the payoff from these investments as we go through the next fiscal year.

Before turning the call over to Gary, I want to briefly address our capital allocation strategy, which remains an important commitment to our shareholders and a key driver of long-term value creation. We continue to generate significant free cash flow, including nearly $4 billion in FY '12. We returned $2.5 billion of this to our shareholders in the form of share buybacks and dividends. We remain committed to returning 50% of our free cash flow to shareholders, which still provides us with ample flexibility to make disciplined investments for sustainable growth.

Let me now ask Gary to take you through a more detailed look at our results. And at the end of the call, I will make some brief closing comments. Gary?

Gary L. Ellis

Thanks, Omar. Fourth quarter revenue of $4,297,000,000 increased 3% as reported and 4% on a constant currency basis after adjusting for a $42 million unfavorable impact of foreign currency. Q4 revenue results by region were as follows. Growth in Central and Eastern Europe was 27%. South Asia grew 25%. Growth in Greater China was 23%. Middle East and Africa grew 16%. Growth in Latin America was 11%. Asia-Pacific grew 6%, including a 7% growth in Japan. Growth in our Western Europe and Canada region was 4%, while the U.S. grew 2%, which is the highest quarterly growth we have achieved in the U.S. in 2 years. Emerging markets grew a combined 20% in Q4 and represented 11% of our total sales mix. Q4 GAAP earnings and diluted earnings per share were $991 million and $0.94, an increase of 28% and 31%, respectively. After adjusting for certain acquisition-related items, Physio-Control divestiture-related items and net restructuring charges and certain litigation charges and the noncash charge for convertible debt interest expense, fourth quarter earnings and diluted earnings per share on a non-GAAP basis were $1,036,000,000 and $0.99, an increase of 7% and 10%, respectively.

In our Cardiac and Vascular Group, revenue of $2,253,000,000 grew 4%. Results were driven by growth in Coronary, transcatheter valves, endovascular, AF Solutions, renal denervation and Peripheral, partially offset by small declines in Pacing and ICDs.

CRDM revenue of $1,295,000,000 was flat. Worldwide ICD revenue of $744 million declined 1%, and we estimate that the worldwide ICD market declined in the mid-single digits. Both the market and our results showed sequential improvement in Q4. In addition, our global ICD share improved on both a year-over-year basis and sequential basis. The combination of our Protecta ICD with its shock reduction and lead Integrity alert technologies, along with a proven long-term performance of our Sprint Quattro leads, continues to perform well, both in terms of share and pricing. In the U.S. ICD market, it is worth noting that the market did stabilize this quarter, as expected, even as we continued to see a reduction in customer inventory levels.

Pacing revenue of $492 million declined 2%, and the market declined in the low single digits. Our MRI SureScan pacemakers continue to drive our market outperformance as we continue to gain share in both the U.S. and international markets. Our AF Solutions business had solid growth in excess of 20%, despite anniversary-ing the U.S. launch of the Arctic Front cryoballoon. We continue to take share in this important growth market.

Cardiovascular had an outstanding quarter, with revenue of $958 million growing 10%, with 9% growth in the U.S. and 11% growth in international markets. Coronary revenue of $450 million grew 12% on the global strength of Resolute Integrity. Worldwide DES revenue in the quarter was $243 million, including $80 million of U.S. revenue. Resolute Integrity's deliverability, unique diabetes indication and long-term clinical performance received a strong customer acceptance during our recent U.S. launch, resulting in a doubling of our market share in less than a quarter. U.S. DES market pricing was relatively stable sequentially, with pricing down in the mid-single digits year-over-year.

In international markets, we gained 150 basis points of DES share sequentially on the continued strength of Resolute Integrity, with particularly strong performances in Europe and China. We look forward to extending our DES share with continued expansion in the U.S. and our expected launch of Resolute Integrity in the important Japanese market. We expect to become the global market share leader in coronary stents in FY '13, adding to our market-leading positions in ICDs, pacemakers and endovascular stent grafts.

Turning to renal denervation. We continue to lay the groundwork to realize the multibillion opportunity in hypertension, with major investments in our product pipeline, clinical evidence and market development, including building therapy awareness and care pathways. In Q4, we received approval for our SYMPLICITY system in Canada as we continued to expand this therapy into markets beyond Western Europe. We continue to enroll our U.S. pivotal study and remain on track for U.S. approval in FY '15. In FY '13, we expect our renal denervation revenue to nearly double to $60 million to $70 million. We intend to maintain our leadership based on our robust pipeline, growing breadth and depth of our long-term safety and efficacy data and strong intellectual property in both the U.S. and international markets.

Structural heart revenue of $289 million increased 7%, driven by strong growth in transcatheter valves. This quarter, data was announced at ACC and EuroPCR from our advanced study, one of the largest prospective, multicenter TAVI trials to date, which showed high procedural success combined with positive clinical outcomes and low complication rates with our CoreValve system. In the international markets, we continued to gain share, and we are the clear market leader in transfemoral, the largest TAVI segment. Our larger 31-millimeter CoreValve continues to perform well, bringing TAVI technology to a previously untreatable patient population. Cardiac surgeons are also increasingly attracted to our direct aortic approach, an alternative to transapical implantation. We will introduce our next-generation TAVI system later this year, which will leverage CoreValves' strong market and clinical performance while integrating new technologies to enhance deliverability and anatomical fit, as well as provide valve recapture ability. In the U.S., we are pleased with the progress of our pivotal trial. Enrollment in our extreme-risk arm is complete, and we are enrolling patients through a continued access. We expect our high-risk arm to be fully enrolled this summer.

Turning to endovascular and Peripheral. Revenue of $219 million grew 10%. Our Endurant Abdominal Stent Graft continues to drive performance in markets around the globe, including Japan, where it was launched in Q4. Endurant II, our next-generation AAA Stent Graft is performing well in Europe, and we are pleased to announce that we recently received FDA approval for U.S. launch.

In Peripheral, our drug-eluting balloons are delivering strong double-digit growth in international markets. At EuroPCR last week, 2 randomized controlled trials were presented that demonstrated the advantage of our IN.PACT drug-eluting balloon over uncoated balloons and drug-eluting stents. We intend to be in enrollment soon for our 1,500 patient global DEB study that will ultimately include more than 80 sites in over 30 countries. In the U.S., we began enrollment in our IN.PACT SFA II pivotal study in late April. On the commercial front, in the U.S., Assurant Cobalt Iliac Stent and Complete SE Vascular Stent are posting very solid results.

Now turning to our Restorative Therapies Group. Revenue of $2,044,000,000 grew 4%. Growth was driven by strong performances in Surgical Technologies, diabetes and neuromodulation, partially offset by declines in U.S. Spine. Global Spine revenue of $818 million declined 6% or down 2% after excluding the negative impact of U.S. INFUSE. International Spine grew 8%, including over 20% growth in the important Japanese market. In core spine, which includes core metal constructs, IPDs and BKP products, revenue of $629 million declined 3%. The U.S. core market continues to decline in the low single digits, with flat procedural growth and mid-single-digit pricing declines partially offset by positive mix. Our core metal construct products declined 3% but grew 5% sequentially. We continue to focus on a number of initiatives to improve performance, including the continued launches of Solera, POWEREASE, ATLANTIS VISION ELITE and our MAST MIDLF and navigated DLIF procedures. While we are still early in these efforts, we do expect their contribution to our growth to increase over the coming quarters.

BKP revenue grew 1%, an encouraging result, given this is the first time BKP has grown in nearly 3 years. Biologics revenue of $189 million declined 16% in the quarter. BMP sales declined 24% in the quarter, including a 26% decline in the U.S. However, it is important to note that INFUSE is one of our lower-margin products, muting its impact to our bottom line. Despite the increased pressure on INFUSE, our differentiated DBM offerings, including MagniFuse and Grafton, are driving double-digit growth in Other Biologics, including mid-teens growth in the U.S.

Turning to neuromodulation. Revenue of $463 million increased 8%, led by the strong acceptance in the U.S. and Japan of our RestoreSensor spinal cord stimulator. RestoreSensor with its proprietary AdaptiveStim technology allowed us to capture over 600 basis points of U.S. market share sequentially. Our DBS business had its strongest quarter in recent history, as our strategy to focus on neurologists' referrals is yielding results. Our Uro/Gastro business delivered strong double-digit growth in Q4, driven by acceleration of new InterStim implant growth. In fact, pain stim, DBS and InterStim all saw the strongest U.S. new implant rates in years.

Diabetes revenue of $392 million grew 8%, driven by double-digit growth in CGM and solid growth in insulin pumps. Our international diabetes business delivered another strong quarter, as we continue to see great acceptance of our Veo pump with Low Glucose Suspend, augmented by our Enlite Sensor and its improved comfort, accuracy and ease of use.

Surgical Technologies revenue of $371 million grew 25%, which included $34 million of revenue from Advanced Energy. Navigation had a strong 18% growth performance in the quarter, in Q4, led by capital equipment sales, including the StealthStation S7 and the O-arm. ENT also had a strong Q4 with growth of 16% driven by sales of image-guided surgery and power equipment.

Turning to rest of the income statement, the Q4 gross margin was 75.6%. After adjusting for the 30-basis point negative impact from foreign exchange, the Q4 gross margin was 75.9%. In FY '12, we completed our initial $1 billion COGS reduction program, which allowed us to mitigate pricing pressure, but we are not stopping there. In FY '13, we are starting a new product cost-reduction program with a goal of reducing COGS by more than $1 billion over the next 5 years. For FY '13, we expect gross margins in the range of 75.5% to 76% on an operational basis.

Fourth quarter R&D spending of $393 million was 9.1% of revenue. We remain committed to investing in new technologies and evidence-creation to drive future growth, and for FY '13, we expect R&D spending to be approximately 9%. Fourth quarter SG&A expenditures of $1,462,000,000 represented 34% of sales. This result was above the range we provided on our Q3 call. As Omar mentioned earlier, given the strong revenue that we saw from product launches in Q4, we decided mid-quarter to increase investment in these launches to maximize our share capture, as well as pull forward some planned FY '13 expenses in renal denervation in emerging markets. We expect to realize the return on these investments in FY '13.

In addition, our Coronary and Surgical Tech businesses had extremely strong quarters, with results well above our expectations, which led to higher incentive payouts and contribute to the higher SG&A expense this quarter. We continued to focus on several initiatives to leverage our expenses. In FY '13, we would expect to drive 30 to 50 basis points of improvement, which would result in SG&A in the range of 34.2% to 34.4%.

Amortization expense for the quarter was $80 million compared to $87 million last year. For FY '13, we would expect amortization expense to be approximately $80 million per quarter. Net other expense for the quarter was $48 million, driven by our hedging program expense. As you know, we hedge much of our operating results to reduce the volatility of our earnings. Based on current exchange rates, we expect FY '13 net other expense will be in the range of $185 million to $225 million, which includes the expected impact from the U.S. MedTech tax that will begin in January 2013, as well as higher royalty expense due to increased sales of Resolute Integrity. For Q1 FY '13, we expect net other expense to be in the range of $40 million to $50 million based on current exchange rates.

Net interest expense for the quarter was $46 million, excluding the $22 million non-cash charge for convertible debt interest expense. Non-GAAP net interest expense was $24 million. At the end of Q4, we had approximately $10.3 billion in cash and cash investments and $10.6 billion of debt. For FY '13, we expect non-GAAP net interest expense in the range of $70 million to $80 million, which excludes the noncash charge for convertible debt interest expense.

Let's now turn to our tax rate. Our effective tax rate from continuing operations in the fourth quarter was 13.9%. Excluding the impact of one-time items, our adjusted non-GAAP nominal tax rate in the quarter was 16.7%. Included in this rate was our favorable operational tax adjustments, which include the release of a valuation allowance associated with the usage of capital loss carryover and the impact of the finalization of multiple state and foreign tax returns. Excluding the impact of one-time items, our FY '12 tax rate was 18.5%. For FY '13, we expect an adjusted non-GAAP nominal tax rate in the range of 19.25% to 20.25%.

During FY '12, we generated almost $4 billion in free cash flow. We remain committed to returning 50% of our free cash flow to shareholders. In FY '12, we have paid over $1 billion in dividends and repurchased over $1.4 billion of our common stock, which includes the share repurchases we executed to offset dilution from our divestiture of Physio-Control. As of the end of Q4, we had remaining authorization to repurchase approximately 58 million shares. Fourth quarter average shares outstanding on a diluted basis were 1,049,000,000 shares. During FY '13, we expect diluted weighted shares outstanding to decline by 30 to 35 million shares.

Let me conclude by providing our initial fiscal year 2013 revenue outlook and earnings per share guidance. While we believe our markets have improved modestly, we estimate market growth remains in the low single digits. Based on this, as well as the expected growth from recent product launches, we believe that constant currency revenue growth of 2% to 4% is reasonable for FY '13 and would reflect improvement from our organic growth in FY '12. While we cannot predict the impact of currency movements, to give you a sense of the FX impact if exchange rates were to remain similar to yesterday for the remainder of the fiscal year, then our FY '13 revenue would be negatively affected by approximately $330 million to $337 million, including a negative $100 million to $120 million impact in Q1.

Turning to guidance on the bottom line. Based on expected constant currency revenue growth of 2% to 4%, we believe it is reasonable to model earnings per share in the range of $3.62 to $3.70, which implies FY '13 earnings per share growth of 5% to 7%. While we do not provide quarterly guidance, we would point out that the current consensus reflects Q1 earnings per share growth of 10%, which is outside our issued guidance, and therefore, we would not be surprised to see some modest shifts -- modest -- models shift a couple of pennies from Q1 to Q4. As in the past, my comments and guidance do not include any unusual charges or gains that might occur during the fiscal year, nor do they include the impact of the noncash charge for convertible debt interest expense.

With that, Omar and I would now like to open the phone lines for Q&A. [Operator Instructions] If you have additional questions, please contact our Investor Relations team after the call. Operator, first question, please?

Question-and-Answer Session

Operator

[Operator Instructions] Your first question comes from the line of Matthew Dodds with Citigroup.

Matthew J. Dodds - Citigroup Inc, Research Division

First off on the guidance, the 2% to 4% constant currency, Gary, when you look at the major regions, are you assuming this coming year the U.S. grows a little bit versus really not growing last year? And then what's your assumption for Europe?

Gary L. Ellis

Yes, well, overall, in the 2% to 4% assumption we have there, basically, it depends on where you're at in the range. If you're at the higher end of the range, obviously, you would assume a slight growth in the U.S. If you're at the lower end, you're probably assuming that the U.S. is more flat at that point. So low single digits at best for the U.S. Europe, we're assuming basically more kind of what they did during the current year, which is more in the mid-single digits. And obviously, within Europe, that will vary by country. A lot of the Northern European countries are still doing very well, Germany, et cetera. Obviously, some of the Southern European countries, we’re a little bit more cautious about, and that's why we're giving guidance more in the middle -- mid-single digits.

Matthew J. Dodds - Citigroup Inc, Research Division

And then just one more question on SYMPLICITY. It seemed like everyone and their mother was launching a renal denervation device at EuroPCR. You paid a lot of money for Ardian. At what point does IP become an advantage for you? Do we have to wait for the U.S? Or is it possible in Europe, we could see some movement on the litigation front?

Gary L. Ellis

Let me kind of respond, and Omar might have a comment too. But overall, the -- we have strong IP around Ardian and even some things that we have been doing ourselves. We have strong IP ourselves, plus what we've got with Ardian, both in the U.S. and international. So you should -- we do not -- we won't -- we'll address that as we go forward as far as what other people are launching, but we do have strong IP in both the U.S. and outside the U.S.

Omar S. Ishrak

I think the only thing that I'll add is just to reinforce that we're investing heavily and are committed to keep our leadership in both our technology, as well as in clinical trials and increasing the number of indications.

Operator

Your next question comes from the line of Mike Weinstein with JPMorgan.

Michael N. Weinstein - JP Morgan Chase & Co, Research Division

First, let me just clear up on the quarter. So the decision intra-quarter to increase the SG&A spend, did that reflect as well the knowledge that your tax rate would come in lower than it did? Because that was the principle delta versus street models was tax, not SG&A.

Gary L. Ellis

That's correct, Mike. I mean, we saw 2 things. Obviously, as we were going through the quarter, we saw the uplift occurring very strongly in some of the new product launches. But at the same time, we clarified the sale leaseback strategy and saw that we were going to have more of a benefit on the tax line, gave us an opportunity to invest a little bit sooner than what we had initially thought. And so that's -- that was the plan mid-quarter once we knew that the sale leaseback transaction was going to occur.

Michael N. Weinstein - JP Morgan Chase & Co, Research Division

Okay, that's helpful. Let me ask a couple of questions about the FY '13 guidance. So number one, how are you thinking about INFUSE and the potential outcomes of the Yale study, one? And two, Gary, I thought we'd see more of a benefit in FY '13 from the exclusion of Physio-Control on the gross margin line. Am I off-base there? But I thought that should be about a 50-basis-point impact.

Gary L. Ellis

Well, let me -- just first of all, on the gross margin line as far as the impact from Physio-Control, you're right. Physio-Control had a lower gross margin in general than the rest of the corporation, and so that has been pulled out. And you see even on the results now, where all the years have been restated to include Physio-Control out, so there is a slight positive having Physio come out of the numbers because it's a bit of a lower margin. So -- but overall, we still believe we'll maintain those gross margins even, for example, Q4 here, the 75.9 is still comparable with that FX adjustment versus what we had in Q3 with Physio-Control pulled out. So I mean, the reality is they are comparable. But you are correct, Mike, in that with Physio pulled out, it gives us a slight upward pressure on the margin. On the other hand, some of the things that we've been doing thus far is adding some of the newer products, for example, on Surgical Tech and some of those products grow as that business grows. Those are a little bit lower, below the overall corporation's gross margin. So there's a mix benefit that we're having to deal with as we go forward, but physio did have a benefit on the item -- on the gross margin, excuse me, as far as getting rid of that business. And the other question was INFUSE. On INFUSE, as far as what our assumptions are, what we have assumed is, obviously, that until the Yale results come out that we're going to probably -- until we anniversary really the INFUSE against when it started to fall, we are going to continue to see the financial results of that business being down. The good news is we did see -- as we indicated in our comments, we did see it sequentially kind of flat as far as the absolute number, Q4 versus Q3. But I think it's fair to say, INFUSE will continue to be a drag and a headwind for us, and until we see what the results of the Yale study are. And so right now, it is -- it will continue to be a drag for, at least, the next several months, couple of quarters, until we get the Yale results, and then we'll have to assess after that what the potential impact will be.

Omar S. Ishrak

I think the main thing that we're looking to here to the Yale studies is that the levels of uncertainty before that are somewhat greater. And we hope the Yale study will clarify things factually and will, at least, make things more certain and predictable.

Operator

Your next question comes from the line of Bruce Nudell with Crédit Suisse.

Bruce M. Nudell - Crédit Suisse AG, Research Division

Just several -- one very quick housekeeping item. Was there an extra day in the quarter? The next one is the renal denervation deluge at PCR almost suggested that SYMPLICITY is obsolete, and x U.S. with the IP is more of a problem probably. How do you expect to respond to that? And then the advanced study looked solid on the top line, but the pacer issue remained, even with the ACCU TRACK, and there was the French registry suggestion there's more paravalvular leak with CoreValve, at least, with the transfemoral approach. Just any responses to that stuff?

Gary L. Ellis

All right. I think there was 3 questions there, but I'll try to get through all of them quickly here. As far as extra day, easy answer there is no. We have same day -- number of days as the prior year. With respect to Ardian and our SYMPLICITY product line, yes, we-- there are a lot of people, obviously, trying to enter this market. We have been in the market. We feel good about where we're at with our product line. I think it's fair to say you should assume that, that's not our -- going to be our only generation. We are looking for enhancements to the product as we go forward, too, and especially with our catheter-based technology and our -- overall, we feel very, very strong about that. Mike will go in more detail next week at the Investor Conference and walk you through kind of exactly what's happening with that business, but the reality is we feel very good about our competitive position. But we've said all along, we knew there would be competition trying to come into this market place that highlights the strength of the potential benefit in this market and the industry in general. And the reality is, as we try to get reimbursement set up, having a few more competitors, helping us with that burden is not necessarily a bad thing. But we feel good about our competitive position and our IP position as we go forward, and we feel very good about our technology. With transcatheter valves, I'm not the one to get real specific about what's happening with the technology part. All I can -- on the pacing issue, we are continuing to focus on that. The focus on the pacing issue that's been out there, the reality is it hasn't impacted anything in the marketplace. We continue to take share in the marketplace, and we continue to work to improve that to have an effect -- minimize that effect if we can as we go forward, which we think we can do. On the other hand, it clearly has not impacted the product line in the marketplace at this point in time, and we feel good about the technology with our transcatheter valve technology.

Operator

Your next question comes from the line of Bob Hopkins with Bank of America.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

So first, just a follow-up on 2013 guidance. Given that going back in the last year or 2, obviously, ICDs and Spine have been the things hampering your growth the most. I was wondering, can you give us a sense in your 2013 guidance what are you assuming for the ICD and Spine kind of market growth rates? And then growth rates for Medtronic specifically?

Gary L. Ellis

Well, let me take a shot at that. This is Gary, and then Omar can maybe add some comments as he gets into it all -- overall also, as you indicated. By the way, I want to clarify one point that I did have in the commentary related to the guidance. I mentioned the foreign exchange impact were up by '13, and I said $330 million to $337 million. That should have been $330 million to $370 million. So I just wanted to clarify that, Bob. It wasn't one of your questions, but I'll throw it in here. With respect to your question about the guidance on the 2% to 4% and what our assumptions are, that -- as we indicated in our comments, that assumes overall that the market kind of grows in that low single digit, kind of 2% to 3% range in general for all of our product lines. That's a little bit faster, slightly faster than what we saw in the current year, and that primarily reflects the fact that we would expect to see some improvement, as we’ve indicated, in the U.S. ICD market as we've seen that stabilizing. Overall, again, obviously, our Q4 results were very strong. And if that trends would continue, we would probably at the higher end of that 2% to 4% even revenue guidance that we've provided. Our point is what we're trying to do on the guidance is just highlight the fact that, as you indicated, we did see some volatility in these markets in the last year. And until we see more stabilization and a continued stabilization really in the ICD and Spine markets, we don't want to get too far ahead of ourselves in the guidance, but basically, this assumes -- this guidance right now would assume that overall, the spine markets, for example, would continue to be down slightly, and we'd be down low- to mid-single digits. That's including INFUSE, obviously, in there, and that our ICDs, again, the market is flat to slightly down, and we'd be the same way, flat to slightly down in -- on the ICDs.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Okay, great. That's very helpful. And then just some quick follow-ups. Gary, can you just help us add up all the guidance you gave on the various line items? And what are you assuming overall for operating margin leverage in 2013? And then for Omar, can you just give us a quick comment on the Analyst Day and what we should expect, especially as it relates to any thoughts you might provide on aspirational growth goals going forward and anything you'd like to highlight about what we should be looking forward to on the Analyst Day?

Gary L. Ellis

Yes, let me address just quickly the -- our assumptions for next year. We are assuming some operating leverage, obviously, with a 2% to 4% revenue growth and then earnings per share growing 5% to 7%, even with the share buyback that we would continue to do. We are assuming that there is operating leverage, primarily in the SG&A line, as we indicated in the comments. We're assuming that gross margin basically stays relatively flat with our -- that we can offset the price erosion with the product take -- the cost takeout that we've been continuing to do. And that R&D is actually relatively flat also versus what we have in the current year. So our assumption for next year is SG&A does improve, as we indicated in the comments, 30 to 50 basis points of kind of an improvement overall. And that would be then the operating leverage we would also see. Now at the same time, we're also on the other income and expense line item, having to offset the medical device tax. So even just achieving some leverage of 30 to 50 basis points on the operating margins, we feel pretty strongly, that's pretty good results in this environment with pricing pressures and taking on some additional costs on the med device tax issue. Omar?

Omar S. Ishrak

Yes. Regarding the Investor Meeting, we're pulling together a pretty good meeting for you. Some things will be the same, as you've experienced before, in the sense that we’ll give you a pretty good walk-through of our product pipeline and technologies, and Mike and Chris will go through that in a fair amount of depth. But in addition, we will also be discussing with you how we are repositioning the company to participate in the changing environment and particularly around how do we translate our focus in economic value to real programs, to real decisions and eventually sustainable growth and why that's so important. The other thing we’ll give you details of is, obviously, our globalization strategy and we're really excited about that, and we want to share with you, again, details around that. So that will be the net mix of it and, overall, details around our strategic changes, as well as depth in our product pipeline.

Operator

Your next question comes from the line of Kristen Stewart with Deutsche Bank.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Just a follow-up on Bob's. So it sounds like you will not be giving any sort of longer-term growth goals at the Analyst Meeting?

Gary L. Ellis

Kristen, this Gary. I mean, no, I mean, we'll obviously talk about our -- we're giving guidance for FY '13, and we'll walk through that again. I mean, we'll get into some of the things as far as where we think some of the markets are going and what we believe that long-term we could see in some of these objectives and even aspirationally what we'd all like to see as far as when these markets return back. But we're not going to get into long-term guidance right now. I mean, these markets are just too volatile. It's hard to predict even kind of a year out, let alone to give more guidance past that.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And then just to go back to your comments on gross margin, can you just repeat the guidance for the year on the gross margin line? And I think you had said that was on an operational basis. So is that just, I guess, excluding FX? And what sort of impact would we expect to see if we look at gross margins on a more reported basis?

Gary L. Ellis

Yes. I mean, right now, we would say 75.5% to 76% on the gross margin, which is kind of consistent with where we're at in the current year, and we expect to be able to maintain that. And based on where we're currently at, I -- we're probably right in that range still. Obviously, based on the foreign exchange, where the foreign exchange rates would be at, we'd probably be towards the lower end of that range just as we saw this quarter, where we were at more 75.6% because of the negative FX impact aspect of it. If FX currency would happen to turn around and go a little bit more the other way, you could be at the higher end of the range. So it's really more within that range. It's consistent. It just depends on what -- whether you're at the higher or the lower end depends on what happens with the FX rates.

Kristen M. Stewart - Deutsche Bank AG, Research Division

And then just the MedTech tax, that's going to be in other operating expense. A lot of your competitors have said that they expect it to be more within SG&A. Can you maybe just help us understand, I know it's just for one quarter in FY '13, but just kind of what the quarterly run rate is going to be both from a pretax and post-tax basis?

Gary L. Ellis

Yes. As we’ve said over -- as we go forward, obviously, first of all, these rules are still getting developed, and so the regulations are not final yet. And even where you actually account for this is not final. There's been a lot of debate back-and-forth between SG&A and other expense. Right now, our assumption is other expense and -- but we'll have to firm that up as we obviously work with this with our -- with the accountants and everybody else. We're obviously the first ones who will be having it, and so that's where we'll have to make sure we get that resolved as we go forward. As we've indicated previously, the overall impact for a full year, we still estimate -- and there's still a big range on this because it is still not clear exactly what is in and out on the revenue side of the equation. But we're expecting a 12-month impact of about $120 million to $150 million, somewhere in that range. So for 4 months, which is what we’ll be covered with for the current -- for FY '13, we have about $40 million to $50 million assumed in our guidance related to FY '13. And as you indicated, it's in that other income and expense line item.

Operator

Your next question comes from the line of David Lewis with Morgan Stanley.

David R. Lewis - Morgan Stanley, Research Division

Just 2 quick questions, 1 for Gary and 1 for Omar. Gary, thanks for giving us the guidance for the next 5 years in the $1 billion cost restructuring program. I guess, can you just help us understand for this coming year fiscal '13 sort of what are you assuming for price in some of your major franchises, whether that’d be DES, CRM or Spine? If we can't get an absolute basis, just on a relative basis, does sort of fiscal '13 guidance assume price pressure stable with '12? Or does it assume some acceleration versus '12? And as you think about the next 5 years and the $1 billion program versus the last $1 billion program, do you kind of assume similar-type pricing declines? Or do you assume an acceleration in the pricing environment?

Gary L. Ellis

Well, overall, I'll just -- as far as the pricing assumptions overall, we're assuming that for FY '13 and as we go forward, the pricing pressure remains somewhat consistent with what we saw, obviously, in FY '12. That will vary by business as we go forward. For example, we have seen some stabilization even, for example, in drug-eluting stent pricing in the U.S. And so maybe that's not going to be quite as extreme as it was in FY '12. On the other hand, you could see continued pressure in other product lines. So our assumption, as we do this, is that you -- again across all of our business, you were probably kind of seeing that in the range of 2% to 3%. But as you know, it varies dramatically between businesses, whether it's drug-eluting stents to obviously some product lines continuing to see price uplifts. And new technology, obviously, gets price uplifts as we continue to see that. So we're assuming it's somewhat consistent with FY '12, not dramatically different than that in that it would continue. And then as a result of that, we do believe that our $1 billion -- over $1 billion cost-out program, going forward, will allow us to continue to maintain kind of the gross margins of where we've been at. Now you should -- I want to make it clear, that's kind of what we're committing to right now on the $1 billion. We're trying to drive that for even more to give us more flexibility, such that if there was even more pricing pressure, or as Omar has mentioned many times, as we go down into -- as we go focus on even going in the value segment, it gives us the opportunity to even tier our products such that we could have different pricing points as we move forward. So the cost-out program is -- the 25%, we feel very good about being able to achieve that. But we are trying to work this to try to be driving them more than that to give us even more flexibility and potentially offsetting any risks that there might even be more pricing pressure than what we've seen in the current year. But right now, our assumption is that it continues, that we will continue to have pricing pressure. But back to what we've seen historically, we've been able to offset that over the last 5 years, and we believe confidently we can continue to do that.

David R. Lewis - Morgan Stanley, Research Division

Very helpful. And then Omar, maybe just one more quick question for you. You talked about the value segment, I think. I found those comments pretty interesting. I think a lot of investors think about the value segment as an emerging market concept. Maybe you can talk about what does the value concept mean to you in developed markets? And can you start bringing some of these value device type products and commentary into the U.S. market or the developed European market?

Omar S. Ishrak

I think, absolutely, there's an opportunity for that. I mean, I think if we go aggressively after emerging markets in creating that value segment, that automatically positions us to create products at a lower tier. And we intend to -- as we look at the U.S. and the developed markets, as we see opportunities, especially where there's heavy pricing pressure and the feature sets are not being used and people aren't paying the price for those, we will go into our resources and product lines and the value segment and introduce them in the U.S. and developed markets. But at the same time, we will differentiate them adequately so that the price of our higher-tier products and the value that they generate remain, and -- but we think that as the pressures on cost savings in the developed world and the healthcare systems increase, there will be room for different tiered service lines. And if we can execute well in our global strategy for value segments, this will give us a significant advantage in developed markets.

Operator

Your next question comes from the line of Raj Denhoy with Jefferies.

Raj Denhoy - Jefferies & Company, Inc., Research Division

I wonder if I could ask a little bit more on the ICD business. I think it was in the fourth quarter of last year, you saw a pretty big falloff due to a lack of bulk sales. Did you see any reversal of that in the quarter? Or maybe could you describe what bulk sales look like in the quarter?

Gary L. Ellis

Yes. I mean, as we indicated in our comments, the reality is, actually, we saw even continued hospital inventory declines. And actually, the bulk purchases are at -- probably at the lowest level we've seen in 3 years overall. So they're actually even lower than what we saw last quarter -- excuse me, last year during this period of time. So that trend continues. I think that's what even our competitors have been indicating that we are seeing hospitals cutting back a little bit more on their inventory levels. And we've seen that over the last several quarters and as you indicated, even last year, we saw it. So that's our point as we highlight this. Even if you take that in consideration, the reality is we thought that we were happy to see the stabilization in the marketplace overall for ICDs, but to take into consideration the fact that, that was going on between ourselves and the competitors. And the fact is the implant rates are even stronger than what the actual results of ourselves -- the entire industry would show.

Raj Denhoy - Jefferies & Company, Inc., Research Division

Okay. And then you gave a little bit of commentary in terms of within the ICD segment where you're seeing strength and weakness, and I think you mentioned, obviously, that you're seeing a little bit on the core ICD business or perhaps a bit weaker on the CRT-D side of it. I think we sort of probably understand why that is, but maybe you could give us a little more clarity around why you're seeing that discrepancy in those 2 segments.

Gary L. Ellis

Well, as you imagine, in CRT-D, there's obviously some trialing of a competitor product going on, and so that's clearly had some impact, and we saw a little bit of share their lost. Now that being said, we feel pretty confident that, that -- after that trialing is over, we will get back to more of a normal CRT-D. In fact, in Europe, where we -- obviously, the product’s been in the marketplace for 2 years, we have the same unit share in CRT-D as we had prior to the competitive launch. So I mean, we feel confident. Yes, there's some trialing, and that has had some slight impact on -- in the CRT-D market or segment of the market. But then on the ICD side, we are obviously picking up share based on the strength of our product line and where we're at with some of its benefits. So net-net, overall, our market share has been basically relatively flat, and that's in spite of some of the trialing that's going on with the competitive product.

Raj Denhoy - Jefferies & Company, Inc., Research Division

And in the core business, there were this highly publicized lead issue that one of your competitors is having, have you seen much of a benefit in both your lead sales on the ICD side and then, taking that a step further, the can business as well because of that?

Gary L. Ellis

Well, again, we're not going to get into what's going on with competitive product issues. We have, as we indicated in our comments, because the ICDs, we're seeing an increase in replacement on our share. Our replacement units are up, and we are seeing slight increases in our lead ratios as we look at those. So net-net, there's some impact probably in our business. But it's still to be managed through. Obviously, as I had indicated, we're losing a little bit share on the trialing of one product, but we're gaining share in other areas. I'm not going to speculate on how much of that is related to any one item.

Operator

Your next question comes from the line of David Roman with Goldman Sachs.

David H. Roman - Goldman Sachs Group Inc., Research Division

Gary, I was hoping you'd go into a little bit more detail on the opportunistic SG&A spending that you picked up in the fourth quarter of fiscal 2012. As we think about those spending levels, to what extent is that necessary to generate the 2% to 4% revenue growth that you're guiding to in fiscal 2013? And I guess, the follow -- the sort of corollary to that would be how can you -- can you generate SG&A leverage and keep up the top line growth that you're talking about? Or is it sort of circular?

Gary L. Ellis

Well, overall, we -- again, the guidance we gave on the 2% to 4% assumes, obviously, we're going to continue to achieve leverage in the SG&A, because that was also in our guidance. So we're assuming we can do both, that we can continue to grow in that range and still achieve leverage on the SG&A. As far as what happened in the quarter here, again, a lot of what we saw was just on the strength of what was occurring already in the revenue. As you can assume, several of the businesses, Coronary, Structural -- excuse me, Surgical Technologies, as we mentioned in the comments, were having very, very strong quarters. Once you have -- you get above kind of your -- the quotas, et cetera, it becomes -- the incentives become very, very high, and they were resuming some very nice commissions and incentive payouts as a result of that performance overall. So that's higher than you would expect. At the same time, because of the benefit we saw on the tax line, as Omar mentioned in his comments and I said the same thing, is we did move some spending forward that we would -- we hired some sales reps that we were expecting to hire in FY '13 anyhow. We got started on some marketing programs with renal denervation. We accelerated some things in emerging markets that were going to occur in FY '13 and would've been in the expense structure that was in my guidance originally. So you shouldn't assume that -- and some of these items, obviously, in the quarter were also more one-time in nature just because of the strong revenue that was in some of the various businesses that won't be there once you have that in the quotas for next year. So net-net, we still feel very confident that even with the spending we saw here in the quarter that we can manage and can achieve the leverage we have for next year, and that should allow us to continue to grow the business, again, based on the 2% to 4% revenue growth.

David H. Roman - Goldman Sachs Group Inc., Research Division

That's helpful. And then I think during the quarter, you had issued some debt, and I think in the release, you talked about that as a source to fund working capital. Can we just talk about the cash generation from a U.S., o U.S. perspective and to what extent the issuance of debt might become more the norm as you remain committed to that 50% payout of free cash flow in the context of -- for a greater percentage of revenue coming outside the United States?

Gary L. Ellis

Yes, well, as we've indicated, and we've been very clear about this overall, our U.S.-OUS cash split, I mean, we generated again about $4 billion of free cash flow in FY '12. Again, 60% to 65% of that is being generated outside of the United States, with 35% to 40% in the U.S. And so when we are returning 50% back to shareholders, by its very nature, which has to come from the U.S. cash piece, that does require us then at this point in time to, obviously, continue to have the debt levels slightly going up in the U.S. while cash builds outside of the United States. So our net cash position improves, but the reality is we are taking on more debt in the U.S. Now it's relatively low levels. The difference I'm talking about here is about $500 million to $600 million per year, which is well within our financial capability to handle. But as we've talked about, we're taking major efforts across our organization to try to say, "How do we get that back more in line? How do we get back to a better split between the U.S. and OUS cash flow generation? And that includes a lot of initiatives underway to improve our working capital, especially inventory and capital expenditures. We have several initiatives underway across the company to drive that down, which should help drive the initiative. And as we talk through some of the comments and Omar's comments, we are focusing on shifting expenses to outside the United States where we can use that OUS cash. And so we are, in Spine, for example, we are doing R&D and manufacturing in other locations. We are shifting some of our marketing expenses even on the restructuring charges we talked about earlier. Some of what's going on here is we're shifting resources from the U.S. market to the markets that are growing. And so you are going to see a natural shift of some of those expenses outside the United States that will also help the issue. But currently, it is clearly -- creates a situation where we're having to borrow somewhat to continue our 50% commitment.

Operator

Your next question comes from Michael Matson with Mizuho Securities.

Michael Matson - Mizuho Securities USA Inc., Research Division

Yes, so I guess I just had a question on the Resolute Integrity launch. One of your competitors has talked about some trialing of that product going on, and obviously, you had a really strong quarter. But I'm just wondering to what degree do you think that, that type of sales trajectory is sustainable here. And then my second question would just be on the S-ICD product. What are your thoughts on that? What's the potential impact? And is that something that you're working on internally as well?

Gary L. Ellis

Okay. Well, with respect to Resolute Integrity and the strength there, obviously, we were very, very pleased with the launch and whenever you can double your share in effect in basically less than a couple of months, and right now, we are still probably only in probably 50% of the accounts that we'd like to be at this point in time. So it's still expanding quite dramatically as we go forward. So there is always -- with any product launch, there will be some who will trial it and might go back to other product lines. But the point you have to remember is this product line has performed well outside the United States. And we've seen people, obviously, try it and stay with it. And it's one of the leading products out -- has one of the leading shares outside the United States where it's been launched. And so as we've indicated before, we have every expectation that this product line, which is very, very competitive, it has on deliverability and, as we indicated, the diabetes indication, several things that are in its favor that it will also continue to be a well-accepted stent in the U.S. marketplace. And as we indicated, actually, the share came very quick, but we're not stopping there either. We believe that we still have opportunities with respect to this, and we think it's a very competitive product and will be one of the leading market share products in the U.S. as we go forward too.

Omar S. Ishrak

I think if I can just add a few words to that. I think we're only getting started in leveraging our CVG sales force, and we're getting traction from that already, and we expect that to accelerate as we go into accounts with our full value proposition of all our products. We think we've got significant growth ahead of us with that, and Mike will share that with you -- that strategy with you in greater detail at the Investors Conference next week.

Gary L. Ellis

And then your second part of the question related to, in effect, I'm assuming you're talking about Cameron Health product line that's out there, and Mike will also talk a little bit -- can talk about that more at the Analyst Meeting in more detail. But we really do see that it's kind of a niche kind of a product line that -- this is obviously the first-generation product that's coming forward. And there's a lot of other features that are in the current ICDs as far as PainFREE termination and pacing are kind of a standard part of it, and why you would want to give up on that, we have a question mark on that. But we're watching the market. We'll see how it plays out. But right now, we think it's more of a niche market.

Operator

Your next question comes from the line of Rick Wise with Leerink Swann.

Frederick A. Wise - Leerink Swann LLC, Research Division

Omar, just a bigger picture question. You highlighted how pleased you are at the impact of the team reorganization, and you indicated you're surprised about -- separately at the opportunity to leverage existing products. Could you expand on this a little more? And am I right in reading this that sort of a year into your role at Medtronic that you're feeling more confident about driving gradually accelerating growth and steadily sustained or improving margins? Just any larger perspective on that?

Omar S. Ishrak

No, I think you're right. I think our strategy is to execute and to gradually increase our growth levels, but we'll take that a step at a time. We intend to align our strategies with the market realities, and that takes a little time. And when we've completely aligned them, we feel we can get sustained growth because there's growth available in healthcare. And an example of that process is exactly what you mentioned in our globalization effort, where we find that there’s short-term growth available, simply by investing in market creation of existing products, which have high penetration rates in developed markets and have very low penetration rates amongst the affordable population of emerging markets. And by investing in addressing those barriers, we think we can get quick grow, and we're already beginning to see that in emerging markets. And longer-term, we use our cost reduction strategies in our products to create a value-tiered segments, which increases our penetration levels in emerging markets. And at the same time, as was pointed out earlier, we can leverage that capability to come back to developed markets and address the cost issues that are going to emerge in developed markets, and those pressures will increase. So what you'll see from us is a gradual realignment of our business in a step-by-step basis because a lot of things that we do today are of value. We have a product pipeline that's very exciting, and we think we can win in that space. And at the same time, we adjust our overall strategies to adjust to the new market realities that are happening, and we have to understand those, participate in those and lead those changes, and that's the way in which we'll grow and win in the future. Okay, well, thank you very much for your questions. And before I end today's call, I would like to remind you that we will host our Investor Conference next week on June 1 in New York. We look forward to discussing the progress we're making at the company to position ourselves to win like we just mentioned. And with that and on behalf of our entire management team, I'd like to thank you again for your continued support and interest in Medtronic.

Operator

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

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