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Medtronic (NYSE:MDT)

Q2 2013 Earnings Call

November 20, 2012 8:00 am ET

Executives

Jeff Warren

Omar S. Ishrak - Chairman and Chief Executive Officer

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

Michael J. Coyle - Executive Vice President and Group President of Cardiac & Vascular Group

Christopher J. O'Connell - Executive Vice President and Group President of Restorative Therapies Group

Analysts

David R. Lewis - Morgan Stanley, Research Division

Matthew J. Dodds - Citigroup Inc, Research Division

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

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Kristen M. Stewart - Deutsche Bank AG, Research Division

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

Matthew Taylor - Barclays Capital, Research Division

Glenn J. Novarro - RBC Capital Markets, LLC, Research Division

Frederick A. Wise - Stifel, Nicolaus & Co., Inc., Research Division

Bruce M. Nudell - Crédit Suisse AG, Research Division

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's Second 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 second quarter conference call and webcast. During the next hour, Omar Ishrak, Medtronic's Chairman and Chief Executive Officer; and Gary Ellis, Medtronic's Chief Financial Officer, will provide comments on the results of our fiscal year 2013 second quarter which ended October 26, 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 a 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 statements.

In addition, the reconciliations of any non-GAAP financial measures are available in the Investor's portion of our website at medtronic.com. And finally, unless we say otherwise, references to quarterly results, increasing or decreasing, are in comparison to the second quarter of fiscal year 2012, and all year-over-year revenue growth rates are given on a constant currency basis.

With that, I'm 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 for joining us today. This morning we reported second quarter revenue of $4.1 billion, which represents growth of 5%. Q2 non-GAAP earnings of $902 million were flat, and diluted earnings per share of $0.88 increased 5%. Our GAAP earnings include a non-cash charge related to our ongoing litigation in our TAVI business, and Gary will discuss this item in a little more detail later.

Building on the last couple of quarters, Q2 represented another positive step toward our goal of delivering consistent and dependable growth on both the top and bottom line. In fact, we believe our organic revenue growth outperformed the MedTech market by 200 basis points with a number of businesses and geographies that delivered outstanding performances but at the same time, there were businesses and geographies that face some pressures, and we're watching these very carefully. Overall, we're focusing on effectively managing headwinds and tailwinds to deliver a balanced and consistent performance. This quarter, 2 of our larger end markets, U.S. ICD and U.S. Spine, continued to show signs of stabilization. Growth in both these markets were relatively stable sequentially, and we also executed well and took share in both of these important markets.

Let's first discuss U.S. ICDs in more detail. Similar to last quarter, we estimate the market declined in the mid-single digits. Our business was down 3%, enabling us to gain approximately 1 point of share year-over-year and 2.5 points sequentially. Pricing declined 3%, a slight improvement to last quarter's rate. Concurrently, our implant volumes improved sequentially and were up over 5%. While hospitals continue to reduce their bulk purchases on a year-over-year basis, they were relatively stable sequentially. These positive implant trends suggest that the U.S. market stabilization will continue.

Turning now to U.S. Core Spine. We estimate that the overall markets are modest year-over-year decline without any fundamental shift sequentially in the underlying dynamics. Market procedures declined in the low single digits, and positive mix offset pricing declines. Looking at our own results, our U.S. Core Spine business was down 4%, with Q2 being the most difficult comparison from last year. Our year-over-year and sequential growth was also affected by the timing of the NASS Annual Meeting, which occurred during the last week of the quarter. Despite these headwinds, it is worth noting that our U.S. Core Spine business was sequentially flat and delivered modest share gains. Our business continues to stabilize, driven by the increasing broad surgeon acceptance of our new products and procedures. We're also differentiating our Spine business to enabling technologies, such as O-Arm imaging, StealthStation navigation and POWEREASE powered surgical instruments. This is also evidenced by the strong growth in our U.S. navigation business, which grew over 35%.

Hospitals continue to invest in our capital equipment for spine surgery, as they see clear value from better outcomes in more efficient procedures. This is also resulting in significant pull through from navigation in power-enabled spinal implants. We believe that there's progress, but there is still only on the leading edge of this large opportunity, and we need to continue to drive navigation to become the standard of care in spine procedures.

The other part of our U.S. Spine business, BMP, declined 20% in Q2. Pressure will continue to exist in this portion of the business until the questions around INFUSE are better clarified. Yale continues to work on finalizing its report and while the timing is controlled by them, we are now expecting the systematic reviews to be published in the early 2013. Looking at the remainder of our businesses, we had a number of standout performances with new products where we're making a difference. In our Cardiac and Vascular Group, our Resolute Integrity Drug Eluting Stent continues to perform well. Our U.S. DES share is still improving and in Japan, our share has more than doubled since we launched the Resolute Integrity stent early in the quarter. Across the balance of our CBG portfolio, we are seeing double-digit growth in AF, TAVI, aortic stent grafts and our peripheral vascular product lines. In our Restorative Therapies Group, our neuromodulation business continued a strong performance with double-digit growth in pain stim, DBS and InterStim.

In pain stim, our RestoreSensor spinal cord stimulator gained share again this quarter. Our DBS business also had a strong quarter, with our referral development efforts enabling more patients to receive our pioneering Activa therapy. Our Uro/Gastro business is performing well with its expanded indications for InterStim Therapy. Surgical Technologies had a stellar quarter, growing 17% with double-digit growth across all 3 businesses: ENT, neuro surgery and Advanced Energy. Even after excluding the impact of our acquisition of last year, which we have now anniversaried, Surgical Technologies grew 13%.

In Diabetes, our CGM business also grew double digits. While we are executing on our product launches, we're also making progress in advancing our industry-leading product pipeline. Before the end of the fiscal year, we expect to receive U.S. approval for our MiniMed 530G insulin pump and sensor system in diabetes and CE Mark and CIVM [ph] for our Viva and Evera high power family. In FY '14, we are targeting the launch of our Advisa MRI pacemaker in the U.S. and our next-generation Multi Electrode Renal Denervation System in Europe. We're also planning the European launch of our next-generation insulin pump, the MiniMed 640G system early next fiscal year and finally, we continue to execute on bringing our transcatheter valves and renal denervation products to the U.S. market, expecting to launch both CoreValve and Symplicity in FY '15.

Turning to international. Our revenue grew 8%, and improvement over the growth rate last quarter was relative stability in Western Europe and improving growth both in Japan and in emerging markets. Western Europe grew 3%, but the market conditions varied significantly country by country. Growth was stronger in the U.K., Germany, France and the Nordics, all delivering mid-single-digit growth or better, partially offset by softness in Southern Europe. In fact Italy, Spain and Portugal combined negatively affected our Western Europe growth rate by 2 percentage points. Italy was particularly soft this quarter, declining 3% as we started to see significant pricing and volume pressure in October. These pressures in Southern Europe are affecting the overall market, and we continue to monitor the situation very closely as we manage this headwind going forward.

Japan had a strong quarter with growth of 12%, more than absorbing the unfavorable impact of R-Zone pricing that went into effect in April. In addition to Resolute Integrity's strong performance that I have mentioned earlier, several new products are making a difference in Japan. We're seeing great acceptance for Endurant, which has quickly become the leading AAA stent graft in Japan. In CRDM, the launch of our Advisa MRI Pacemaker late in the quarter helped drive mid-single-digit pacing growth. Our pain stim business is also experiencing strong growth in Japan with RestoreSensor gaining 10 points of share year-over-year.

Turning to emerging markets. Our Q2 growth rate was 18%, a 400 basis point improvement from our growth rate last quarter. Central and Eastern Europe, Latin America, the Middle East and Africa and India all grew above 20%. And although China's growth of 11% was below our long-term target, it is worth noting that results were significantly affected by the decreased revenue from our Weigao joint venture, following our announcement to part China Kanghui Holdings. We are in active discussions with Weigao about the future, and we are working to minimize disruptions to our business as we position ourselves for long-term success in the broader China orthopedics market. We're putting plans in place in all our China businesses to achieve our long-term growth goals, and we expect steady improvement going forward.

While emerging markets in total have not quite met our 20% growth goal the last couple of quarters, I strongly believe that as we're executing our strategies, we will achieve this level of performance consistently over the long-term. We feel that continued emerging market growth, combined with market stabilization, as well as our broad portfolio and strong pipeline of future products, provides the foundation to deliver dependable top and bottom line growth over the midterm. In addition, we are executing on our long-term strategies of creating economic value and further accelerating globalization in order to achieve the upside to our baseline expectations. In support of our globalization strategy, we took steps this quarter in both of our groups to become a long-term leader in the emerging market value segment.

In CVG, we announced our intent to purchase an equity interest in LifeTech Scientific Corporation, a leading China-based developer of minimally invasive cardio and peripheral vascular devices. Our agreement will allow us to distribute certain LifeTech products, as well as the option to acquire additional ownership of the company. In addition to their current Structural Heart product lines, LifeTech also has a robust development pipeline, including surgical heart valves, LAA closure devices and peripheral vascular products. With this alliance, we intend to bring together the resources of Medtronic with the local market expertise, brand recognition and growth potential of LifeTech.

In September, we also announced our acquisition of Kanghui, a leading Chinese orthopedics company. Kanghui has a broad portfolio of trauma and spine products focused on the growing value segment, and they are just beginning to expand into a large joint reconstruction. The company has a strong local R&D, manufacturing, distribution and emerging market export capabilities. We recently closed the transaction, and we welcome the Kanghui employees to the Medtronic family. Both Kanghui and LifeTech are significant investments in China, fully aligned with our globalization strategy. They immediately give us critical mass of knowledge and expertise in the specific need of the Chinese market and patients. It is also important to note that both deals exceeded our high financial return hurdles, which is my expectation with any investment or acquisition that we make.

In addition to executing in our globalization strategy, we're also continuing to make progress in our economic value initiative. As I meet with payers and healthcare system administrators, I remain convinced that our breadth and scale, combined with economic value, will differentiate our company in the changing healthcare environment. We're making economic value more granular across all of our businesses and geographies. We are implementing the science that will help us translate economic value principles into a real advantage not only for us, but also for our customers. Improving our operating rigor remains key to fully capitalizing on our long-term strategies. We are making progress in reducing our product cost by $1.2 billion over the next 5 years. This is important not only to maintain our gross margins, but it also fuels the development of clear products, which are essential to creating new value segment opportunities. In addition, our strategies to improve working capital by increasing our inventory turns are beginning to gain traction. Not only does this instill good fiscal discipline, but it will strengthen our already robust levels of free cash flow generation. We remain committed to returning 50% of our free cash flow to shareholders through dividends and share repurchases. As an S&P Dividend Aristocrat, Medtronic has a long track record of consistently increasing our dividend. We believe the level of our shareholder return commitment is appropriate, given our current mix of U.S. and international free cash flow. The remaining 50% gives us ample flexibility to make investments with sustainable growth, and we are and will continue to be very disciplined in how we deploy this capital with a particular focus on returns. We expect any M&A transaction to pass -- to surpass our mid-teens risk-adjusted hurdle rate, and we do not intend to pass along EPS dilution to our shareholders. Our belief is that our strong capital allocation policy combined with consistent and dependable growth, which we will deliver by executing in our near, mid- and long-term growth drivers, will create sustainable shareholder value.

Let me now ask Gary to take you through a more detailed look at our results before we take any questions. Gary?

Gary L. Ellis

Thanks, Omar. Second quarter revenue of $4,095,000,000 increased 2% as reported and 5% on a constant currency basis after adjusting for a $118 million unfavorable impact of foreign currency. Q2 revenue results by region were as follows: growth in Central and Eastern Europe was 26%; Latin America grew 23%; growth in Middle East and Africa was 22%; south Asia grew 21%; growth in Greater China was 11%; Asia-Pacific grew 10%, including 12% growth in Japan; growth in Western Europe and Canada was 3%, while the U.S. grew 2%; emerging markets grew a combined 18% in Q2, and represented 11% of our total sales mix.

Q2 GAAP earnings and diluted earnings per share were $646,000,000 and $0.63, a decrease of 26% and 23%, respectively. These declines were due to a litigation charge resulting from the recent Federal Circuit Court of Appeals affirmation of the April 2010 jury verdict in the Federal District Court of Delaware related to our Structural Heart business. Based on this ruling, we believe the one-time non-cash $245 million pretax charge represents our best estimate of the exposure at this time. After adjusting for this certain litigation charge as well as certain acquisition-related items and the noncash charge for convertible debt interest expense, second quarter earnings and diluted earnings per share on a non-GAAP basis were $902 million and $0.88, flat and an increase of 5% respectively. Adjusting for the net gains related to the Advanced Energy acquisition of PEAK and Salient in Q2 last year, non-GAAP earnings and diluted earnings per share increased 4% and 9%, respectively.

In our Cardiac and Vascular Group, revenue of $2,137,000,000 grew 6%. Results were driven by solid growth in Coronary, Endovascular, Structural Heart and AF Solutions, partially offset by declines in Pacing. CRDM revenue of $1,227,000,000 was flat. Worldwide ICD revenue of $689 million was flat. Our Protecta ICD, with its shock reduction and lead integrity alert technologies, combined with the proven long-term performance of our Sprint Quattro leads, continues to receive strong market acceptance. We gained over 200 basis points of global ICD share sequentially, and our share is now at the highest level in 10 quarters. We were also pleased to see our lead-to-port ratios continue to increase, and our replacement market share is up nearly 400 basis points.

Pacing revenue of $480 million declined 2%, slightly better than our estimate of the global market. Our U.S. Pacing revenue declined 8% in line with the market. These declines were driven primarily by pricing, which was down in the mid-single digits and to a lesser extent, hospital inventory reductions and fewer industry replacement procedures. We captured share in our international markets on both a sequential and year-over-year basis, driven in part by the launch of our Advisa MRI pacemaker in Japan, a device that we expect to launch in the U.S. market at the beginning of next fiscal year. Our AF Solutions business grew 20% globally, with U.S. growth in excess of 30%. Growth was driven by the strong global performance of our next-generation Arctic Front Advance balloon with EvenCool Cryo Technology as we continue to gain market share.

Coronary revenue of $429 million grew 19%, as our Resolute Integrity drug-eluting stent continued to capture global share. Worldwide DES revenue in the quarter was $258 million, including $99 million in the U.S. Resolute Integrity's deliverability, unique FDA labeling for diabetes and long-term clinical performance is receiving strong customer acceptance globally. As Omar mentioned, we more than doubled our DES share in Japan to 16%, with the late August launch of Resolute Integrity and exited the quarter with good momentum.

In renal denervation, we continue to lay the groundwork for this important opportunity. On the clinical front, 18 months data from HTN-2 was announced at ESC. And while still on a limited number of patients, the data showed SYMPLICITY continues to provide superior and sustained blood pressure reduction in patients with treatment-resistant hypertension while maintaining safety. We are also advancing our renal denervation pipeline, completing the first stage of our First-In-Man Study for our next-generation multi-electrode system.

As we discussed at our Analyst Meeting in June, this system is expected to reduce average total ablation time from 16 minutes to 24 minutes today to 2 minutes total, and all through a 6 per inch catheter. We believe this product will further strengthen our leadership position in this important MedTech growth market. Commercially, while SYMPLICITY is available in many international markets, we lack broad reimbursement for the therapy which is affecting the update, and will likely remain that way until we get additional clinical data. While SYMPLICITY revenue is ramping somewhat slower than expected, we still believe our technology, strong clinical data and robust intellectual property represents a large multibillion-dollar opportunity.

Turning to Structural Heart. Revenue of $271 million increased 6%, driven by double-digit growth in TAVI. While market growth slowed in Europe, we continue to leverage our innovative portfolio for global expansion, and are leading in introduction of new valves, sizes and the imitations that are driving growth and serving more patients. We are continuing to rollout our CoreValve Evolut 23-millimeter valve, which promotes better sealing and provides future re-capturability. With Evolut, we are now able to serve the broadest range of TAVI patients on a common 18 French delivery system.

In Q2, positive data on direct aortic implantation was presented at London Valves, and we continue to see increased adoption of this innovative implant technique by cardiac surgeons. We also completed enrollment in the high-risk arm of our U.S. pivotal trial as we continue to make progress in bringing CoreValve to the U.S. market. In transapical, the first results from the Engager European Pivotal Trial were presented in October, which showed positive clinical outcomes, including exceptional hemodynamic performance. Finally, we were honored that our Melody Pulmonary Transcatheter Valve received the prestigious Prix Galien USA 2012 Award for the best medical technology, which is our industry's highest accolade.

Turning to endovascular. Revenue of $210 million grew 17%, with strong balanced growth across our intra-aortic and peripheral businesses. In aortic, we gained global AAA share on both a sequential and year-over-year basis, driven in part by the launch of Endurant in Japan, as well as the continued acceptance of Endurant II on our other global markets. Thoracic sales grew double digits on the strength of Valiant Captivia in the U.S. and China. In peripheral, our global share also continues to decline, with double-digit growth in our clinical stent business. We completed enrollment in our IN.PACT Drug-Eluting Balloon trial for our below-the-knee indication in international markets.

Now turning to our Restorative Therapies Group. Revenue of $1,958,000,000 grew 4%. Results were driven by growth in Surgical Technologies, neuromodulation and Diabetes, partially offset by declines in spine. Spine revenue of $782 million declined 5% globally and 8% in the U.S., primarily driven by declines in BMP. Core Spine revenue of $649 million declined 2% globally and 4% in the U.S. While the spine market declined, we are not seeing any significant changes sequentially in the underlying market conditions including procedure trends, pricing pressure or competitive dynamics. It is worth noting that our Core Spine business grew on a sequential basis. We are seeing signs of improvement in our business as new products and procedures continue to perform well.

In thoracolumbar, our Solera system rolled out its core capability, and we are now at 70% of set capacity. Solera, with its advanced biomechanics and new capabilities, including its attractive combination of navigation and powered instruments, is generating strong surgeon interest. In cervical, we launched our BRYAN ACD and based on its acceptance in other countries, we believe this disk will allow us to capture significant share in a growing $100 million-plus U.S. market. In interbody we launched our AMT implants, as well as the CAPSTONE CONTROL, and we believe that in addition to improving our interbody growth, these innovative implants will generate pull-through revenue for the rest of our thoracolumbar portfolio.

Our Other Biologics products had double-digit growth, with continued adoption of our Grafton and MagniFuse DVMs. In BMP, revenue of $133 million declined 19%, including a 20% decline in the U.S. It is important to note that BMP is one of our lower margin products, muting its impact on the bottom line. We expect the Yale Systematic Reviews on INFUSE to be published in the first calendar quarter of 2013.

Surgical Technologies revenue of $344 million grew 17%, which included $35 million of revenue from Advanced Energy. Organic revenue growth was 13%, driven by double-digit growth in ENT and neurosurgery. Neurosurgery in particular had a very solid quarter, led by strong U.S. sales of our high-value O-arm imaging and StealthStation S7 navigation capital equipment. Our capital equipment is driving solid results, and we believe we continue to gain share. Our strong performance also reflects increased surgeon demand for our differentiated navigated spine procedural solutions.

Turning to neuro modulation. Revenue of $454 million increased 10%. Our pain stim business continued its recent track record of double-digit growth, driven by sales of our RestoreSensor spinal cord stimulator with AdaptiveStim technology. In DBS, we had another strong quarter of double-digit growth, as our referral channel development efforts have led to strong new implant growth. Also growing double digits this quarter was our Uro/Gastro business, driven by the adoption of our InterStim Therapy. Across neuromodulation, our investment in markets outside the United States and in Western Europe are starting to show results, our Q2 growth of over 25% in each geographies.

Diabetes revenue of $378 million grew 6%, driven by double-digit growth in CGM. In the U.S., we are anticipating FDA approval of the MiniMed 530G insulin pump and Enlite Sensor to occur in late FY '13, which we expect to reaccelerate growth in the U.S. We also continue to make progress in our next-generation MiniMed 640G pump, which we expect to launch in Western Europe early next fiscal year.

Turning to the rest of the income statement. Q2 gross margin was 75.1%. Excluding the unfavorable impact of foreign currency, our gross margin was 75.6%, but gross margin was also unfavorably affected this quarter by approximately 30 basis points related to one-time items, including obsolescence charges from new product launches and one-time integration-related activities. We continue to offset pricing pressure through our 5-year $1.2 billion cost of goods reduction program. For the remainder of FY '13, we expect gross margins to be approximately 75.5%, excluding the negative -- expected negative impact of foreign currency.

Second quarter R&D spending of $387 million was 9.5% of revenue, which was driven by higher clinical spending in transcatheter valves and renal denervation. We remain committed to investing in new technologies and evidence creation to drive future growth. And for the remainder of FY '13, we expect R&D spending to be in the range of 9% to 9.5%.

Second quarter SG&A expenditures of $1,417,000,000 represented 34.6% of sales versus 35% in the second quarter last year. We continue to focus on several initiatives to leverage our expenses, while at the same time investing in new product launches and adding to our sales force and faster growing businesses and geographies. In FY '13, we continue to expect to drive 30 to 50 basis points of improvement. Amortization expense for the quarter was $79 million. For the remainder of FY '13, we would expect amortization expense in the range of approximately $90 million for the quarter, an increase due to the Kanghui acquisition. However, as we have previously stated, we intend to offset this dilution.

Net other expense for the quarter was $63 million. Net losses from our hedging programs were $27 million during the quarter. As you know, we hedge much of our operating results to reduce the volatility in our earnings from foreign exchange. In Q2, our hedging losses were greater than expected due to a one time hedging issue related to a balance sheet exposure during a period of significant change in euro exchange rates. We have taken steps to prevent this from occurring in the future, and we were able to cover the impact to earnings to realized gains in our minority investment and debt security portfolios. Based on current exchange rates, we expect FY '13 net other expense will be in the range of $215 million to $235 million. This includes the expected impact from the U.S. medical device tax that will begin in January and higher royalty expense due to increased sales of Resolute Integrity. For Q3, we expect net other expense to be in the range of $40 million to $50 million.

Net interest expense for the quarter was $24 million. Excluding the $23 million non-cash charge with convertible debt interest expense, non-GAAP net interest expense was $1 million. Interest expense was lighter than expected in Q2 due to the one time gain that helped to offset the previously mentioned increased hedging expense. At the end of Q2, we had approximately $11.5 billion in cash and cash investments and $11.5 billion of debt. For the remainder of FY '13, we expect non-GAAP net interest expense to be in the range of $25 million to $30 million for the quarter, which excludes the noncash charge for convertible debt interest expense.

Let's now turn to our tax rate. Our effective tax rate in the second quarter was 24.4%. Excluding the impact of one time items, our adjusted non-GAAP nominal tax rate in Q2 was 20%. For FY '13, we expected adjusted non-GAAP nominal tax rate in the range of 19.5% to 20.5%. This does not include any benefit for the U.S. R&D tax credit, which has not yet been extended by Congress. Historically, the R&D tax credit has an annual benefit in the range of $30 million to $35 million or approximately $0.01 per quarter. In the first half of FY '13, we generated nearly $2 billion in free cash flow. We remain committed to returning 50% of our free cash flow to shareholders.

During Q2, we repurchased $614 million of our common stock or approximately 1% of our outstanding shares. As of the end of Q2, we have remaining authorization to repurchase approximately 31 million shares. Second quarter average shares outstanding on a diluted basis were 1,028,000,000 shares.

Let me conclude by commenting on our fiscal year 2013 revenue outlook and earnings per share guidance. We are tightening our constant currency revenue growth outlook to 3% to 4% for FY '13. This implies a continued outlook of 2% to 4% constant currency revenue growth for the second half of FY '13, which we believe remains reasonable and conservative. Although we can not 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 will be unfavorably affected by approximately $305 million to $345 million, including an unfavorable $40 million to $60 million impact in Q3.

Turning to guidance on the bottom line. Given the uncertainty surrounding final IRS implementation guidelines of the U.S. medical device tax, and as well as the uncertain renewal of the U.S. R&D tax credit, we continue to remain conservative and expect FY '13 non-GAAP diluted earnings per share in the range of $3.62 to $3.70, which implies annual earnings per share growth of 5% to 7%. As in the past, my comments on 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.

I will now turn it back over to Omar, who will conclude our prepared remarks. Omar?

Omar S. Ishrak

Thanks, Gary. Before opening the lines for Q&A, let me conclude by reiterating that we were encouraged by Q2 results, but we recognize that it was only another step toward achieving our goal of delivering consistent and dependable growth. While we continue to manage a number of headwinds, we believe that our leading portfolio and pipeline, combined with stabilization in emerging markets and continued strong growth in emerging markets, position us well to deliver on our baseline expectations over the mid-term, and these baseline expectations are: consistent mid-single-digit revenue growth; consistent EPS growth, 200 to 400 basis points faster than revenue and returning 50% of our free cash flow to shareholders. At the same time, we are also preparing to be a leader in the transformation of global healthcare by implementing our long-term strategy of economic value and globalization. We are only at the beginning of our journey, but we believe that crisp execution of both our baseline and long-term growth strategies, combined with strong and disciplined capital allocation, will enable us to create long-term value in healthcare.

With that, we would now like to open the phone lines for Q&A. In addition to Gary, I've asked Michael Coyle, President of our Cardiac and Vascular Group; and Chris O'Connell, President of our Restorative Therapies Group, to join us again for the Q&A session. [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

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

David R. Lewis - Morgan Stanley, Research Division

Gary, I want to come back to one of your comments on gross margins. You mentioned sort of the one-time effects in this quarter. But if we go back, it was one of the strongest revenue quarters in 2-plus-years, but the margins were one of the weaker ones in the last 2 years even though it's kind of in line with where you had margins in the third quarter of '11 when you also had some one-time impact. So I guess adjusted for the one-time impacts, are we seeing the beginning of your very strong performance in emerging markets beginning to weigh somewhat on gross margins?

Gary L. Ellis

I mean not a lot, David. I mean overall, obviously we're fighting headwinds as we do see growth in the -- some of the emerging markets, and we've continued to see pricing pressure across a lot of our businesses, which again for the most part, we've been able to offset with product cost reductions. So the way we look at it, our standard gross margins, which gets prior to some of the -- our other product lines, which are more onetime in nature, the standard gross margins are relatively holding relatively firm. We haven't seen a big change in that over the last several quarters, and we didn't see that in this quarter either. So that's why it was primarily one-time issues. We had some obsolescence obviously related to the fact that Resolute Integrity is doing much, much better than we've expected, and obviously a more obsolescence with endeavor as a result of that. We had some other integration costs as we do some of these acquisitions that are more onetime in nature that are affecting the gross margins. So overall, I don't want to make light of it because I think there are pressures on the gross margin that we've seen for the last several years, but we've managed that relatively well. It's more of the one-time items that had an impact on us in the quarter, plus FX, obviously.

Omar S. Ishrak

And also, I think if I can add very quickly, the emerging markets themselves, the sort of products we're selling, the pricing environment is not that different from certainly Western Europe.

Gary L. Ellis

That's correct.

David R. Lewis - Morgan Stanley, Research Division

Okay. Maybe just a kind of a follow-up question related to growth. So we think about the growth in the first half of the year, 5% constant currency, the strongest growth we've seen in the last 2 years. You've got multiple product lines, like neuromod, where growth is the strongest we've seen in 3 years, maybe you can just talk to us about your view that the second half of the year will slow incrementally off the first half of the year, what are some of the driving factors of that? Or does that simply reflect conservatism given the environment?

Omar S. Ishrak

I think there is some conservatism regarding the environment. We obviously intend to drive growth as aggressively as we can and -- but look, there's all kinds of headwinds. Western Europe, for example, has a lot of uncertainty built around Southern Europe, and there's a fair amount of pricing pressure in some of these markets. So overall, there's enough -- still enough uncertainty out there in the marketplace that it's best for us to give the guidance that we just did. There's -- in the U.S., we're going to get through the end of the year, and the policy implications that will be put in to place and again, there's uncertainty there. So I think we have to take into account that headwinds will come our way, and we'll do our very best to manage them, and we certainly will drive growth as aggressively as we can, but I think the guidance that we put out is probably maybe somewhat conservative, but we want to be realistic about this.

Omar S. Ishrak

I think there is some conservatism regarding the environment. We obviously intend to drive growth as aggressively as we can. And -- but, look, there's all kinds of headwinds. Western Europe, for example, has a lot of uncertainty built around it. Southern Europe, and there's a severe amount of pricing pressure in some of these markets. So overall, there's enough -- still enough uncertainty out there in the marketplace that it's best for us to give the guidance that we just did. There is, in the U.S., we are going to get through the end of the year and the policy implications that will be put into place and again, there's uncertainty there. So I think we have to take into account that headwinds will come our way, and we'll do our very best to manage them, and we certainly will drive growth as aggressively as we can. But I think the guidance that we put out is probably maybe somewhat conservative, but we want to be realistic about this.

Operator

Your next question comes from the line of Matthew Dodds with Citigroup.

Matthew J. Dodds - Citigroup Inc, Research Division

Just might cut across a few of you, but following up on David's question on the growth second half of the year. If you look at this quarter, the one market that really jumped is Japan, and that's your biggest international market. And it was driven by a bunch of different products. You had the Resolute Integrity, Endurant. You highlighted Advisa MRI, RestoreSensor. Why couldn't that market continue to be strong the next, say, 2 to 4 quarters, and more than offset some of the issues in Western Europe?

Omar S. Ishrak

Well, it's good. I mean we expect Japan to be strong. We were very excited about what we're seeing in Japan. In fact, the Resolute Integrity will have its first full quarter of launch this coming quarter. So I think there is -- it's certainly in the next 12 months or so, Japan is going to be -- definitely going to be one of our premier growth engines. We're just balancing everything here, Matt. There's no concrete headwinds and tailwinds that we can lay our hands on, we just know that there's still enough uncertainty out there that you just cannot tell. And certainly, if you just look at the overall economic environment, there are pressures across the world. And you just need one of them to fall into a crisis level and it could take a lot of tailwinds from a market like Japan, away, and we just have to be careful with that. And that's really all I can say around that. But certainly, we have high expectations from the Japan market, and those, I think, we'll realize.

Gary L. Ellis

We, obviously, Matt, can't say much more to what Omar said. I mean obviously, we don't expect Japan -- we expect Japan to be very, very strong. We saw increased growth in the emerging markets, most of our markets, even Europe, obviously, had a very strong growth compared to some markets this quarter. So our teams continue to do very, very well, and we feel good about that. But as Omar said, there's just -- there's so much uncertainty in the marketplace right now. We are still being -- maybe we're being viewed as somewhat cautious, but we feel that's the appropriate thing right now. And we'll continue to execute, but you're absolutely right. There was a lot of strong points in this quarter that if the -- if those things continue, we should expect...

Omar S. Ishrak

I mean, we don't get surprises. Negative surprises. I think because the tailwinds that we have, by and large, we think will continue, and we're seeing pretty good momentum there. But you just never know what headwinds come our way, and we just need to be cautious about that.

Matthew J. Dodds - Citigroup Inc, Research Division

And then just one little quick, and that was a lot of answers. Gary, on the FX, on the other income, versus expectations, was it right to think about that as a $0.02 to $0.03 hit, the difference in what should have been and what you ended up losing?

Gary L. Ellis

Yes. It was about -- it was a couple of cent impact for our -- what we had there in the quarter. And as we said in some of my comments, we saw that early in the quarter. It happened in August. We saw it and we took steps to offset it in taking some gains out of the debt minority investment portfolio. But it was a couple of cents, Matt.

Operator

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

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

So let me -- Omar, let me get you just to comment a little bit more about Europe. And we saw with a lot of other companies reporting through their September quarters commentary about Europe. I know you guys commented about Italy. Could you just talk about how you feel about the health of those markets going, particularly into the largest countries' fiscal year ends and whether you're seeing any slowdown in procedure volumes or purchasing in particular geographies?

Omar S. Ishrak

Yes. Well first of all, look, the underlying demand is going to be there for sorts of products that we sell. So that's going to be there in the long-term. Now given that there's clearly pressure from a volume perspective in Italy, which we've already seen going towards the end of the fiscal year certainly. And also not only in volume, but also we anticipate some level of pricing pressure in Italy. Now with the lower pricing that might increase on volume at some point in the future, we haven't seen that yet. Now Greece also, although there's a -- the business is reasonably okay there, let's say, yes, we still have to watch collections which are out there and see how the market performs in terms of our receivables. And that might put constraint in how fast we can grow there. Spain, too. Actually we have been collecting there and all the way, the tougher quarter, the outlook is improving a little bit. But in all of these Southern European markets, at any time, policies could come into place which would simply ration the volume, primarily because of budgetary reasons with Nordic consideration, short-term move by the governments to just stop volume to save money and just as simple as that, that can easily happen and that's essentially what we're seeing in Europe. Now we're working the best we can to manage that in that environment, and we are also trying to structure our product lines so that even in that environment, we can show that we provide economic value. But that's on the traditional way of doing business and over a quarter or 2, we'll just have to face that kind of volume pressure.

Gary L. Ellis

And as we said on the comments, Mike, I mean, France, Germany, the U.K. and the Nordic, there's still, I think, strong growth in both -- I mean, especially in volume in those markets. So we're not -- we could see some -- a little bit of a slowdown as we get to the end of the calendar year that we normally see, but then we'll see a pick up again for ourselves in January as the new budgets come in effect. So as Omar said, I mean we're very cautious, especially about some of the Southern European countries and we're watching Europe in general, just overall. But some of the countries are continuing to see very strong growth.

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

Okay. You touched on it briefly, just -- could you just comment a little bit more on the Edwards litigation? And, a, what you're doing to shift your manufacturing relative to your existing business outside of the U.S. and b, how you think about this impacting your timing or plans for U.S. launch?

Omar S. Ishrak

Okay. First of all, we are making good progress in shifting our manufacturing, and most of it is already complete and we intend to complete that very, very shortly. So by and large, we think we'll get our volume outside the U.S. very shortly. At this stage, we're planning U.S. launch as driven by our clinical trials. And I think it's in the FY '14 that we are planning the U.S. -- FY '15 we're planning the U.S. launch, and that is what we're planning for. And we don't expect this litigation to have any material impact on that.

Operator

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

Robert A. Hopkins - BofA Merrill Lynch, Research Division

So quick question on the pipeline, especially TAVI in Europe. I think in the last couple of quarters, you guys have said that you're comfortable, that you think the TAVI market in Europe could be growing 15% to 18%. I assume that outlook has changed now. But I would just love to get some comments from you on what you think of the outlook for TAVI in Europe going forward given current market conditions.

Omar S. Ishrak

Yes. I think -- look, the procedures -- I was just in Europe recently, and there is a strong demand there, and we're extending the patient base there. But there are some pressures in Europe. I'll let Mike comment on this. I mean, we just introduced a new product there as well which we expect to help. But Mike's going to [indiscernible].

Michael J. Coyle

Sure. At the start of the fiscal year, we were thinking it was a reasonable expectation to look for 15% kind of growth in the market. That has contracted somewhat, and I think we're looking now at that sort of high single-digit growth based on the numbers that have been reported so far this year. This is one of the procedures that I think is getting a lot of scrutiny from just the reimbursement perspective, and there are drags being put on the procedure volumes as a result of that. Now on the other hand, we are very robust in product introduction cycle there with the Evolut 23-millimeter product that's been released. We obviously released our Engager data and expect -- we did CE Mark for that in the near-term, and that's going to give us an opportunity to continue to drive share. We actually think we took market share in the addressable market in Europe here during the last quarter. So we think we are looking at a slowdown versus what we had expected at the start of the fiscal year. But it's -- it does still look like high single-digit kind of growth.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Okay. And then just as a follow-up, Mike, 2 other quick things. One, can you comment on what you're seeing from a pricing perspective in TAVI in Europe? Is there any incremental pressure there from your perspective? And then any update you could provide on the U.S. trial for renal denervation? Are we still on track there for completion in the time lines that you provided previously?

Michael J. Coyle

So on pricing for TAVI, they're totally up very well. We've not seen any real pricing pressure there, it's been more of the procedure volume pressure that we've seen there that has resulted in this bit of a slowdown from what we had thought at the start of the fiscal year. On the TAVI, or on the renal denervation activities in thee U.S., we continue to aggressively pursue enrollment in the SYMPLICITY HTN-3 trial. As we've said in the past, this is a challenging trial to enroll. It's turning out that we have to enroll more patients than we had expected to get to the number we want randomized. And that at the moment with the enrollment rates, is looking like it's going to be a challenge to get that completely enrolled by the end of the fiscal year, so this could spill into next year. However, we have a number of plans that we are putting in place to try to accelerate that similarly as we can implement sort of, unilaterally. Other ones, we'd have to work with FDA to get some modifications to the protocol. We are pushing on those fronts, and we're going to do everything we can to get that enrolled as quickly as possible. On the other hand, we think we can actually accelerate some of the commercialization aspects in the U.S. from the standpoint that we had originally expected there be a gap in time between FDA approval and then getting CMS reimbursement approval. We are now trying to pursue a parallel path for those 2 which, we think, would allow us to accelerate the ramp once we get approved in the U.S. So those things are balancing sort of against each other.

Operator

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

Kristen M. Stewart - Deutsche Bank AG, Research Division

A follow-up on Bob's question. Just with the renal denervation in the U.S., just want to make sure, your prior, I guess, assumption for the completion of enrollment had been calendar first quarter, I guess, of '13 and now, you're saying that's going to be more calendar kind of midyear?

Omar S. Ishrak

Mike...

Michael J. Coyle

Based on the current run rate, that's where would be expect to be coming in.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And you're still comfortable with the FY '15 approval time line?

Michael J. Coyle

That would still work with an FY '15 approval time line.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And then on just x, I guess U.S. sales, you guys had originally expected I think it was $60 million to $70 million in FY '13. Can you maybe just comment on where you are now? I know that you had reimbursement was constrained. But what are you also seeing from other competitive perspective given that there's several other renal denervation systems approved for use as well?

Michael J. Coyle

We don't see the competitive pressures being the big issue. It is more the ability to -- with the fact that we don't have separate reimbursement in many countries for this technology. So our overall coronary renal denervation revenue numbers are very much in line. In fact, they are tracking ahead of what we had provided as guidance at the Analyst Meeting. There is more in the Coronary and slightly less in the renal denervation side than we had been talking about. But on balance, we are in good shape in terms of the revenue growth for that business. I would point out that because there is no separate reimbursement for renal denervation in a lot of these countries, what we're seeing is a very high desire to do the cases but no budgets to do it. We are using the breadth of our cardiovascular product line to basically provide opportunities for incremental growth of other parts of our business in exchange for credits that can be applied to these non-reimbursed market segments. And that is giving us an opportunity to grow revenues broadly across the group based on our ability to offer renal denervation as a therapy option.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And then what would be the path for the multi electrode system in the United States?

Michael J. Coyle

What would be the path? We are still working with FDA on what the regulatory path for that would be. As we've mentioned in our prepared remarks, we've now completed the first phase of our first-in-man activities at very good results. We are now focused on CE Mark studies for that and then we are working with FDA on what regulatory treatment would be for that product.

Operator

Your next question comes from the line of Larry Biegelsen with Wells Fargo.

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

Two questions for you, Omar. First, 5% constant currency growth in the first half and 2% to 4% is the guidance in the second half, and the conservatism is certainly appreciated. But on the call, you also mentioned your mid-single-digit target near-term growth expectation. At the Analyst Meeting, you were very clear that you would expect to be there in fiscal 2014, I believe. Could you help us reconcile the conservatism in the second half and how you get back to mid-single-digit in fiscal 2014? And then I just have one follow-up for you.

Omar S. Ishrak

Well first of all, we expect to be in the high end of the range given our momentum. And then we'll see as the quarter plays out what kind of ranges are applicable for next year. But we're close enough at this point that we think that, that outlook for the midterm is still valid. I mean that's all I can add. That the tailwinds that we have will get further reinforced as we go through the -- go through next 6 months or so, we'll get a better feeling for it. I think lots of markets probably will -- with some of the uncertainties that will removed as we go through the end of the year and different policy areas will be more concrete. And we think some of our tailwinds will get firmer. That's what we're expecting. And that will take us into next year along the same lines. So Europe, [ph] we have every expectation to at least be in the high end of this range, and that'll provide us good continuity in growth as we go into next year.

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

That's very helpful.

Omar S. Ishrak

Yes, that's all I can say.

Gary L. Ellis

Yes, I mean obviously, this is Gary. I mean we've given a 2% to 4% guidance. Obviously, we're consistent with because there are some uncertainties as we've talked about and we've highlighted. We don't want to play those up too much because the reality is we have been performing better than that, and we've been performing better than our guidance. And again, we have every expectation and our hope that we can do better than our guidance even in the back half of the year. But it's just with the uncertainties in the marketplace, we're just continuing to try to say let's not get ahead of ourselves, let's keep the 2% to 4% growth expectations out there, at least for the rest of this year. And as things firm up and we get a little bit better certainty in where some of these things are playing out, then obviously we'll determine what our guidance for FY 14 is.

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

That's very helpful. And then Omar, you talked about extending into large joints earlier on the call. Can you talk about your strategy in that area and does Kanghui give you what you need?

Omar S. Ishrak

Well, Kanghui's a starting point. I mean that's all I say. We're excited about Kanghui, but largely construction -- the large joint reconstruction is actually, at this stage, a pretty small element of what we're going to get with Kanghui. And we're more focused on the spine and trauma businesses, primarily their success in China. I mean into the orthopedics market in general, that capability will help us. But you got to remember that we've got a series of other products that do impress the orthopedics market, and we have a good sales channel into that market. So when these types of products do come along and they have -- they reach the appropriate critical mass and breadth as well as quality, we'll have an opportunity. But it's very, very early for us to either depend on it or even comment on it in too much detail. Chris, do you want to add anything to that?

Christopher J. O'Connell

I think you said it well. It's relatively early. We're new to this business as you know. Our primary focus is on China. We do have multiple product lines in large joint reconstruction for China, more of a premium line as well as more of a value line. We're just getting some of those products or Kanghui is just getting some of those products into the marketplace right now and it's going to be a learning opportunity for us starting in China.

Operator

Your next question comes from the line of Matt Taylor with Barclays.

Matthew Taylor - Barclays Capital, Research Division

Just wanted to ask one on CRM and spine. Those markets continue to struggle. You've actually performed a little bit better there the last couple of quarters. But maybe that's the area that -- because you really accelerate your growth year-over-year. So you provided some comments on stability, but I was just curious if you had some more feedback on your implant volume growing versus the bulk ordering in CRM and how that could lead to better growth going forward? And then in spine, it seems like the pricing pressures kind of overarching some of the new product launches. But can you maybe talk about how we might see growth improve sequentially in the spine market for you?

Omar S. Ishrak

Well, let's take those one at a time. First of all, you're right. In CRM, the implant rates do give us line of sight to what the future will look like. And also, the reduction in these bulk end of quarter purchases will anniversary to some degree as we move forward. So the implant rate growth gives us some confidence in the future. And I'll let Mike comment on that a little bit here. But -- and on the spinal area, they too, our Core Spine business actually is showing some pretty good traction, primarily based on our new products and procedures. Remember, in these numbers we've got our Kyphon product line as well which s actually a negative drag to the overall numbers. So if you really look at the Core Spine, which is the bulk of the market, our performance is quite encouraging. And the market dynamics certainly have not changed. I mean some of the pressures related to pricing as well as peer pushback, they're still there, but haven't worsened. And we're certainly, I think, beginning to demonstrate that some of our new products and procedures are real value and now they're getting customer acceptance. I think both of these markets are important and deserve a little more color. So I'm going to ask Mike first to talk a bit about share, and then I'll ask Chris to comment on spine. So Mike [indiscernible].

Michael J. Coyle

It is encouraging to see the ICD implant rates stabilizing. We still have the pricing pressures that we've referenced, obviously looking at that 3%-ish U.S. pricing pressure that we referenced in the call, continues to be an issue for us. On the other hand, we were very encouraged to be in a position of taking market share there that's primarily been in the replacement arena. And we also obviously have seen our lead-to-port ratio increasing. We are encouraged that we're heading into a product cycle in the CRM space with obviously the [indiscernible] the CRT families in Europe, with the CE Mark in the third quarter, the EVERA product line in Q4. We showed data at the recent AHA meeting that pointed to the value of Lead Integrity Alert on identifying issues with competitive leads. That's something that will help us immediately in Europe. That's something that we'll take to U.S. FDA to attempt to get labeling. And then of course as we head into next year, we'll have the U.S. Viva/Brava and EVERA product lines, as well the Advisa MRI product line. And then, we obviously -- and we're encouraged with the AHA data on BLOCK HF which showed the benefits of CRT pacing and patients with AV block which have potentially been standard pacer applications. This would give us a pricing opportunity in that space. So there are a number of positive trends there, and we are hoping to drive market share further. And we that we think we have the catalyst to do that, but we also want to be cautious given the pricing pressures that we've seen the market.

Omar S. Ishrak

Chris, you want to see if...

Christopher J. O'Connell

Sure. Just on spine. The pricing pressure in spine has been pretty consistent over the last number of quarters, and we're managing that through really 2 or 3 major strategies. Number one is to continue to introduce new technology. And we do get better pricing when we introduce new technology. The Solera system, for example, is really hitting on all cylinders now with critical mass, not just in the smaller rod diameters, but the larger rod diameters. We have now more than 400 sets of the 5 5 6 0 [ph]. And we have also rolled out the minimally invasive package with Solera. And when that technology comes into the market, we're able to offset some of the bigger declines in the legacy-type systems. But also, trying to bring new procedures to the market. We've talked in the past about MAST MIDLF for example, which is a mini open procedure enabling more surgeons to do less invasive procedures. And now at MAST this year, we just launched the OLIF procedure which is another example of procedural innovation that's setting us apart and also firming up our pricing. So we don't expect pricing pressure to go away, to answer your question, but we expect that we'll have more and more tools to combat that and to position Medtronic well. And as Omar said, we feel really good about the direction of our Core Spine business.

Operator

Your next question comes from the line of Glenn Novarro with RBC Capital Markets.

Glenn J. Novarro - RBC Capital Markets, LLC, Research Division

I had 2 follow-ups on spine. One, some of the smaller players have reported in the last month and have commented that they're anticipating or currently seeing greater pushback from payors on the commercial side. I'm wondering if you can give us your color on what's happening on the commercial side with respect to pay or pushback, if you're seeing any. And then I had a follow-up on PODs.

Omar S. Ishrak

Yes. Look, let me first comment on it and then, I'll let Chris talk to this as well. From everything we can see, the underlying dynamics have not changed. It's basically what it has been for the last 12, 24 months. And so we certainly are not seeing that. So I don't know. Chris, you're closer to this, any comments?

Christopher J. O'Connell

Yes, it's been consistent beam. It's really no worse now than it was a year ago or 6 months ago. And I think what's happening is that the overall medical system is anticipating this, is experiencing this and is finding ways to work through it. Additionally, I'm encouraged by a more concerted effort on the part of some of the medical societies in pushing for more guidelines for a range of different types of spinal procedures which are helping with the commercial payor. So I don't think we expect this trend to change one way or another. But I think we are finding ways to manage it better.

Omar S. Ishrak

And I think the healthcare systems are also finding ways to live within the constraints.

Christopher J. O'Connell

To live within the constraints to answer the questions in an efficient way and to generate the evidence from the guidelines over time that will help mitigate the issue.

Glenn J. Novarro - RBC Capital Markets, LLC, Research Division

And just a follow-up on PODs. While we were down at NASS, it seemed like the emergence or the growth of PODs at least was increasing a bit and that surgeons were moving towards PODs. What are your thoughts there? Are you anticipating any surgeon losses? Is PODs having any negative impact on your business?

Omar S. Ishrak

Chris?

Christopher J. O'Connell

Sure. We started seeing the effect of PODs several years ago, and it tends to follow somewhat of the regional pattern when you see these things develop. But right now, we don't believe that the PODs are gaining share. We believe they are somewhere around 10% in the market, it has been a headwind for a period of time, but it seems relatively stable. We are encouraged by some of the pushback that the PODs are getting by states as well as the federal government, the fact that the OIG is now surveying hospitals on PODs is a very encouraging step in our direction. We are very concerned about the PODs and the complex of interest that they represent. And so we have an active position against PODs. We do not participate in that business model. And it is a little bit of a way of life right now, but it is not directionally worse right now than it was say a year ago.

Operator

Your next question comes from the line of Rick Wise with Stifel, Nicolaus.

Frederick A. Wise - Stifel, Nicolaus & Co., Inc., Research Division

A couple of things. I was thinking fourth quarter that we might see some color on -- initial color on the impact of Hurricane Sandy on the East Coast, but then I realized your quarter ends on the 26th. Was there much impact? And will we see some impact at all on procedures or volumes in the next quarter?

Omar S. Ishrak

Well there is obviously short-term impact because hospitals are shut down and so on. And we've had some ripple impact at the end of that. I think over time, this will recover. To the extent that they will impact Q3, we'll have to see. But it's one of the headwinds we're going to manage.

Gary L. Ellis

Rick, I mean we obviously saw something in the first couple of weeks after with some of the hospitals. But it seems to be getting back to kind of normal as we go forward. And so we don't expect it to be meaningfully too impactful here in the quarter overall. Hurricane Sandy really had no impact on our distribution capability. We were able to, with all of our offices and things, be able to manage that aspect of it. Obviously as Omar said, hospitals were shut down there for a period of time, but we saw a small impact in the first week or 2 of this quarter, but the reality is it's relatively minor.

Frederick A. Wise - Stifel, Nicolaus & Co., Inc., Research Division

Okay. And 2 other quick ones. Omar, a bunch of MedTech industry folks in Washington lobbying for a rollback of the med-tech tax. Are you hopeful at all that we could see that changed? And maybe a last -- a quick one for Chris. Chris, there's some new approvals in the cervical space, new products getting approved. Maybe any updated perspective on how that market's likely to evolve with some new and changing evolving technology?

Omar S. Ishrak

With respect to the med-tech tax, previously we've maintained our position that it's something that we would like repealed if possible. And we've worked with AdvaMed to their leadership in supporting them. However, we’d really like to focus on things that we can control. Right now that's what the law is, that's what the projection is going to be. And you can assume that that's going to come into play. And therefore, we've got to build our business to deal with it. And hence, we've built our plan assuming that the medical device tax will come into play in January. We've potentially got $50 million or so that we're going to manage through the balance of the year, of the fiscal year for us. And it's like we've stated before, it's something between $125 million to $175 million a year that we've got to manage. And we're focused on building our business models to deal with it. Again, we like to focus on things that we can control, and that's why we've taken this approach. Chris, you want to...

Christopher J. O'Connell

Sure. On cervical. Thanks for asking about cervical, Rick. And yes, there have a number of new entrants in the U.S. cervical disc market. We're very, very excited about the BRYAN ACD which we've launched now. We've done more than 100 procedures, all of them competitive. We've trained more than 300 surgeons and, obviously, there are more options on the market right now. I think that's going to be good for patients because here for patients that have limited options for cervical discs in the U.S. But it's also important to note our overall cervical portfolio is really getting stronger. Cervical teams doing a great job with the ATLANTIS VISION ELITE as well as the VERTEX SELECT. So now, BRYAN ACD kind of completes the circuit for us in that important segment, and it's going to be good for the market.

Operator

Your last question comes from the line of Bruce Nudell with Credit Suisse.

Bruce M. Nudell - Crédit Suisse AG, Research Division

Mike, my first question is to you. As you know, there is a pretty inflammatory paper published this week on the Optim coating, which suggested the potential for high mass loss 6 years out even at body temperature. I guess the question is, is what were the origins of that? Was the FDA involved in it? The decision to -- urging you to publish it, which we've heard? And I guess the final question is this, what do you think the long-term implications of that for your share position in the market?

Omar S. Ishrak

So go -- I think Mike is [indiscernible]. Go ahead, Mike.

Michael J. Coyle

Bruce, we've been studying this silicone polyurethane copolymer materials for about 10 years here at Medtronic for numerous applications in multiple businesses, both chronic-lead applications as well as more acute device uses. And the lead project for that was the SEVENTO project which is our 7 French ICD lead where we were considering using this material as the primary lead insulation material. Now, given the experiences that we had with Fidelis, we were intent on characterizing the performance of this material over the entire expected life of its use in a patient 10-plus years. And so we engaged in a very thorough analysis of the materials, looking at all of the potential mechanisms for failure that we thought could come into play. During the course of that work we determined, quite to our surprise, that there was a failure mode called hydrolysis, which basically is a chemical reaction that is occurring within the material that is causing over the useful life of the material, the molecular weight of that polymer to degrade. So we shared that information with the suppliers and found that not only had it not been reported but in fact it was, from our perspective, unknown and that this was the first time that had identified this as a potential failure mode. So both our internal advisers and we ourselves determined that it was important that this information get into the scientific literature through the peer review process so that this performance characteristic of the material could be considered by scientists and engineers of companies who are considering using this material, as well as global regulatory authorities so they would understand how this plays out in the course of the use of a device. So we chose the vehicle of the Macromolecules which is a journal which is the journal of the American Chemical Society, and that was published last week. I'm kind of surprised to hear you use the term inflammatory. Does -- anyone who's read the paper would say that this is a very thorough technical paper. I, myself, am a chemical engineer, and I found it difficult reading just in terms of the complexity of the information that was being relayed. But this was purely a technical journal that we are -- that we're putting it out, so that individuals can consider this and the evaluation of this material for use in future products.

Bruce M. Nudell - Crédit Suisse AG, Research Division

Okay. And one more follow-up to you. In your prepared comments, if I heard it correctly, you said that U.S. Spine procedure growth was negative mid-single digits. But encouragingly, ASPs across price and mix were flat. I guess the question is, is on a strategic basis, where do you see case growth over time? And do you feel -- how long will this readjustment period last?

Omar S. Ishrak

Well first, let me just clarify. The procedures were low single digits, not mid. So that does make a little difference. But beyond that, we continue to believe that the -- and I've kind of heard this from all my visits to customers and hospitals around the U.S. and around the world that the spinal procedures, long-term, will continue to grow because of demographic reasons. Low back pain is an issue. Certainly, trauma and deformities and so on are clearly leads. But as the population ages, the back pain problems will only increase. And so we are betting, and I'm quite sure that long-term these procedures will come back. Now having said that, there is a level of certainty that as we put in the market through guidelines, better guidelines, good coordination with healthcare delivery systems as well as pairs, and we intend to work with both of them to form up these guidelines that can work in the most certain environment. And that's what's driving some of the volatility in this marketplace. And that's going to take a little time to resolve, but we are in the middle of that effort working because of our leadership position, working very closely with societies and with our customers to put these guidelines in place so that things are more stable as we go forward, and really learn about the clinical procedure in a more effective way.

Bruce M. Nudell - Crédit Suisse AG, Research Division

So on a worldwide basis, I guess you expect this to kind of match the overall corporate profile in the midterm, is that fair to say?

Omar S. Ishrak

Yes. On a global basis, yes. We're certainly seeing a significant opportunity for growth in emerging markets in this area because they're very underpenetrated. And again with the right awareness levels, the right training of physicians and again, putting in place the right guidelines, we think that the emerging markets, at some point, will reach a inflection point and will provide growth. But in the midterm, you're right. We expect this segment of our business to get close to our overall corporate profile.

Okay. All right. So with that, let's close the call here. Thank you very much for your questions. And on behalf of the entire management team, I'd like to thank you again for your continued support and interest in Medtronic. For those of you in the U.S. I want to wish you and your families all a very happy Thanksgiving. And we look forward to updating you on our progress in our Q3 call in February. Thank you.

Operator

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

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