美敦力 (MDT) 2013 Q2 法說會逐字稿

Good morning.

My name is Christy and I will be your conference operator today.

At this time, I would like to welcome everyone to the Medtronic second quarter earnings release conference call.

All lines have been placed on mute to prevent any background noise.

After the speakers remarks, there will be a question and answer session.

(Operator Instructions)

Thank you.

It is now my pleasure to hand the program over to Mr. Jeff Warren.

Please go ahead.

Thank you, Christy.

Good morning, and welcome to Medtronic's second quarter conference call and webcast.

During the next hour Omar Ishrak, Medtronic Chairman and Chief Executive Officer and Gary Ellis, Medtronic, 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 will be happy to take your questions.

First, a few logistical comments.

Earlier this morning, we issued a press release containing our financial statements and 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 in the investors 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 am now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishrak.

Good morning and thank you, Jeff.

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 med tech market by 200 basis points.

We had a number of businesses and geographies that deliver outstanding performances, while at the same time there were businesses and geographies that faced some pressures, and we're watching these very carefully.

Overall, we are focusing on effectively managing headwinds and tailwinds to deliver a balanced and consistent performance.

This quarter, two of our larger end markets, US ICD's and US 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 US 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 continued to reduce their bulk purchases on a year-over-year basis, they were relatively stable sequentially.

These positive implant trends suggest that the US market stabilization will continue.

Turning now to US core spine, we estimate that the overall market saw a modest year-over-year decline, without any fundamental shifts sequentially in the underlying dynamics.

Markets procedures declined in the low single digits, and positive mix offset pricing declines.

Looking at our own results, our US 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 NAS annual meeting, which occurred during the last week of the quarter.

Despite these headwinds, it is worth noting that our US 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 US 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 and more efficient procedures.

This is also resulting in significant pullthrough in navigation and powered-enabled spinal implants.

We are pleased with this progress, but we are 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 US 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 early 2013.

Looking at the remainder of our businesses, we had a number of standout performances where new products were making a difference.

In our cardiac and vascular group, our Resolute Integrity drug-eluting stent continues to perform well.

Our US 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 CVG 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 its 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 three businesses, ENT, neurosurgery, and advanced imaging.

Even after excluding the impact of our acquisitions 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 US approval for our MiniMed 530G insulin pump and sensor system in diabetes, and CE Mark NCIVM for our Viva and [evera] high-power family.

In FY '14, we're targeting the launch of our advisor MRI pacemaker in the US, and our next-generation multi-electrical venal derivation system in Europe.

We are 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 transapical valve and renal derivation products to the US markets, expecting to launch both CoreValve and SYMPLICITY in FY '15.

Turning to international, our revenue grew 8%, an improvement over the growth rate last quarter with relative stability in Western Europe, and improving growth both in Japan and the emerging markets.

Western Europe grew 3%, but the market conditions varied significantly country by country.

Growth was stronger in the UK, 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 two 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 had 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 about 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 acquire 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 execute on 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 of strong pipeline and future products, provides the foundation to deliver dependable top and bottom line growth over the mid-term.

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 Life Tech Scientific Corporation, a leading China-based developer of minimally invasive cardio and peripheral vascular devices.

Our agreement will allow us to distribute certain Life Tech products, as well as the option to acquire additional ownership of the company.

In addition to their current structural heart product lines, Life Tech 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 Life Tech.

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 we are just beginning to expand into 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 Life Tech are significant investments in China, fully aligned with our globalization strategy.

They immediately give us critical mass of knowledge and expertise in the specific needs 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 on our globalization strategy, we also continue 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 are making economic value more granular across all of our business units and geographies.

We're 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 costs by $1.2 billion over the next five years.

This is important not only to maintain our gross margins, but it also fuels the development of clear products, which are essential to create 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 US and international free cash flow.

The remaining 50% gives us ample flexibility to make investments for 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 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 on 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?

Thanks, Omar.

Second quarter revenue of $4.95 billion increased 2% as reported, and 5% on a constant currency basis, after adjusting for $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 US 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 million 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 non-cash 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 billion 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 billion was flat.

Worldwide ICD revenue of $689 million was flat.

Our protected 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 shares 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 US 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 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 US market at the beginning of next fiscal year.

Our AF solutions business grew 20% globally, with US growth in excess of 30%.

Growth was driven by the strong global performance of our next-generation Arctic Front advanced balloon with even cool cryotechnology, 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 US.

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 continued to lay the groundwork for this important opportunity.

On the clinical front, 18 month beta from HTN-2 was announced at the 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 in our renal denervation pipeline, completing the first phase 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 to 24 minutes today, to 2 minutes total, and all through a six per inch catheter.

We believe this product will further strengthen our leadership position in its important med tech 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 continued to leverage our innovative portfolio for global expansion, and our leading of introduction injection new valves, sizes, and indications that are driving growth and serving more patients.

We are continuing to roll out our CoreValve Evolute 23-millimeter valve, which promotes better sealing and provides future recaptureability.

With Evolute, we are now able to serve the broadest range of TAVI patients on a common 18-per-inch delivery system.

In Q2, positive data on direct aortic implantation was presented at London Valve, 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 US pivotal trial, as we continue to make progress in bringing CoreValve to the US 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 pulmonic transcatheter valve received a 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 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 2 in our other global markets.

Thoracic sales grew double-digit on the strength of Valiant Captiva in the US and China.

In peripheral, our global share also continues to climb, with double-digit growth in our peripheral stent business.

We completed enrollment in our impact deep [revoluting] balloon trial where I blow the [knee indication] in international markets.

Now turning to our Restorative Therapies group, revenue of $1.958 billion 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 US, primarily driven by declines in BMP.

Core spine revenue of $649 million declined 2% globally and 4% in the US.

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 Solaris system roll out is now at core capability, and we are now at 70% of set capacity.

Solaris, are 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 disc will allow us to capture significant share in the growing $100-plus million US market.

In interbody, we launched our AMP 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 thoracic lumbar 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 US.

It is important to note that BMP is one of our lower margin products, muting its impacts 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 US sales of our high-value OR-ARM imaging and StealthStation S-7 navigation capital equipment.

Our capital is driving solid results, and we believe we can continue to gain share.

Our strong performance also reflects increased surgeon demand for our differentiated navigation spine procedural solutions.

Turning to neuromodulation, revenue of $454 million increased 10%.

Our pain stim business continued its recent track record of double-digit growth, driven by sales of our Restore Sensor 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 investments in markets outside the United States, [spanning] Western Europe, are starting to show results, our Q2 growth over 25% in these geographies.

Diabetes revenue of $378 million grew 6%, driven by double-digit growth in CGM.

In the US, we are anticipating FDA approval of the MiniMed 530G insulin pump and Enlight Sensor to occur in late in FY '13, which we expect to re-accelerate growth in the US.

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, the Q2 gross margin was 75.1%.

Excluding the unfavorable impact of foreign currency, our gross margin was 75.6%.

The 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 five-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 -- expect the 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 billion 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 in 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 per quarter, an increased 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 through realized gains in our [Minonit] 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 US 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 for 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 gains 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 per quarter, which excludes the non-cash 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 expect an adjusted non-GAAP nominal tax rate in the range of 19.5% to 20.5%.

This does not include any benefit for the US 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 had remaining authorization to repurchase approximately 31 million shares.

Second quarter average shares outstanding on a diluted basis were 1.28 billion 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 cannot predict the impact of currency movements, it should give you a sense of the FX impact if the exchange rates were to remain similar to yesterday for the remainder of the fiscal year, then our FY '13 revenue would 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 US medical device tax, as well as the uncertain renewal of the US 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 non-cash charge for convertible debt interest expense.

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

Omar?

Thanks, Gary.

Before opening the lines for Q&A, let me conclude by reiterating that we were encouraged by our 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 our larger 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 strategies of economic value and globalization.

We're 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 Mike 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.

We are rarely able to get to everyone's questions, so we respectfully request that you limit yourself to only one question, and if necessary, one follow-up, so that we can get to as many people as possible.

If you have additional questions, please contact our Investor Relations team after the call.

Operator, first question, please?

David Lewis, Morgan Stanley.

Gary, I wanted to come back to one of your comments on gross margins.

You mentioned some of the one-time effects in this quarter, but if we go back, it was one of the strong as revenue quarters in two-plus years, but the margins were one of the weaker ones in the last two years.

Even though kind of in line with where you had margins in the third quarter of '11 when you also had some one-time impacts.

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?

I mean, not a lot, David.

I mean, overall obviously we're fighting headwinds as we do see growth in -- from the emerging markets, and we continue to see pricing pressure across a lot of our businesses, which again for the most part, we've been able to offset with price cost reductions.

So the way we look at it, our standard gross margins, which gets prior to some of the other product lines, which are more one-time in nature, the standard gross margins are relatively holding relatively firm, and 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 have some obsolescence, obviously related to the fact that Resolute Integrity is doing much, much better than we had expected, and obviously a more obsolescence with Endeavor's result of that.

We had some other integration costs, as we do some of these acquisitions that are more one-time in nature that are reflecting in the gross margin.

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 was more the one-time items that had an impact on us in a quarter plus FX, obviously.

And also, I think if I can add, Gary correct me, but the emerging markets themselves, the sorts of product we're selling, pricing environment is not that different.

That's correct.

From certainly Western Europe.

That's correct.

Okay.

Maybe just 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 two years.

You've got multiple product lines, where like neuromod, where growth is the strongest we've seen in three years.

Maybe you could 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?

Thank you.

I think there is some conservatism regarding the environment.

We obviously intend to drive growth as aggressively as we can, but look, there's all kinds of headwinds.

Western Europe, for example, has a lot of uncertainty built around it.

Southern Europe, and it's a fair amount of pricing pressures on 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 US we 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.

Great.

Thank you very much.

Matthew Dodds, Citigroup.

This might cut across a few of you, but following up on Dave'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, two to four quarters and more than offset some of the issues in Western Europe?

Well, it could.

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, 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.

Certainly, we have high expectations from the Japan market, and those I think were realized.

Yes, we, obviously, Matt, I can't say much more to what Omar has said.

I mean, obviously we don't expect Japan -- we expect Japan to continue to be very, very strong.

We saw increased growth in emerging markets, most of our markets, even Europe, obviously, had very strong growth compared to (inaudible) market 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're still being, well, maybe we are being viewed as somewhat cautious, but we feel that is 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 those things continue, we should expect (multiple speakers)

I mean, we don't get surprises (multiple speakers).

I think the tailwinds that we have, by and large, we think will continue, and we see increased momentum there.

But you just never know what headwinds come our way, and we just need to be cautious about that.

And just -- and I had one little quick thing.

That was a lot of answers.

Gary, on the FX on the other income.

Yes.

Versus expectations, was it right to think about that as a $0.02 to $0.03 hit, the difference between what should have been and what you ended up losing?

Yes, It was a couple cent impact of what we had there in the quarter.

And as I said in 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 and minority investment portfolio, but it was a couple cents, Matt.

Great.

Thanks, Gary.

Thanks, Omar.

Mike Weinstein, JPMorgan.

Omar, let me get you just to comment a little bit more about Europe.

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 talk about how you feel about the health of those markets going particularly into a lot of these countries fiscal year-ends, and whether you're seeing any slowdown in procedure volumes or purchasing in particular geographies?

Yes.

Well, first of all, look, the underlying demand is going to be there for the sorts of products that we sell.

So that's going to be there in the long-term.

Now, given that, there is clearly pressure from a volume perspective in Italy, which we've already seen, going towards the end of the fiscal year, certainly.

And then also, not only in volume but also we anticipate some level of pricing pressure in Italy.

Now, with the lower pricing, that might increase some volume at some point in the future, but we haven't seen that yet.

Now, Greece also, although there's the business is reasonably okay there, 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 on how fast we can go there.

Spain too, actually we have been collecting there, and although we had a 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 modest consideration.

Short-term move by the governments to just stop volume to save money, 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're also trying to structure our product lines so that even in that environment we can be sure to write economic value, but that's not the traditional way of doing business, and over a quarter or two, we'll just have to face that kind of volume pressure.

And as we said in the comments, Mike, I mean, France, Germany, the UK, and the Nordic, they're still seeing strong growth, both in -- I mean, especially in volume in those markets.

So we're not -- we could see a little bit of a slowdown as we get to the end of the calendar year that would normally see, but then we'll see a pick-up again for ourselves, and January the new budgets come into effect.

As Omar said, I mean, we are 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.

Okay.

You touched on it briefly, 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 the US, and B, how you think about this impacting your timing or plans for US launch?

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 US very shortly.

At this stage, we are planning US launch as driven by our clinical trials.

And I think it's in FY '14 that we are planning the US -- FY '15 we're planning the US launch, and that is what we're planning for.

And we don't expect this litigation to have any material impact on that.

Perfect.

Thank you, Omar.

Bob Hopkins, Bank of America Merrill Lynch.

Quick question on the pipeline, especially TAVI and Europe.

I think in the last couple quarters you guys had you 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.

Yes.

I think, look, procedures, I was just in Europe recently, and there is strong demand there.

And we're extending the patient days there.

But there are some pressures in Europe.

I'll let Mike comment on this.

We just introduced a new product there as well, which we expect to help.

Mike, why don't you fill us in?

Sure.

At the start of the fiscal year we were thinking it's a reasonable expectation to look for 15% kind of growth in the market.

That has contracted somewhat.

I think we're looking now at 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.

On the other hand, we are in a very robust product introduction cycle there with the Evolute 23-millimeter product that's been released.

We obviously released our Engager data and expect them to get 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 does still looks like high single-digit kind of growth.

Okay.

And then just as a follow-up, Mike, two other quick things.

One, can you comment on what you're seeing from a pricing perspective in TAVI Europe?

Is there any incremental pressure there from your perspective?

And then any update you could provide on the US trial for renal denervation?

Are we still on track there for completion in the timelines that you provided previously?

Thanks.

So on pricing for TAVI, that's holding 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 US, we continue to aggressively pursue enrollment in the SYMPLICITY HDM 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 it to get to the number we want randomized.

And that, at the moment, with enrollment rates is looking like it's going to be a challenge to get that completely enrolled by the end of the fiscal year.

This could spill into next year.

However, we have a number of plans that we are putting in place to try to accelerate that.

Some of those we can implement sort of unilaterally.

Other ones we'd have to work with FDA to get some modifications to the protocol.

We're 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 US from the standpoint that we had originally expected there would be a gap in time between FDA approval and then getting CMS reimbursement approval.

We're now trying to pursue a parallel path for those two, which we think would allow us to accelerate the ramp once we get approval in the US.

So those that are balancing sort of against each other.

Great.

Thanks for the detail.

Kristen Stewart, Deutsche Bank.

(Inaudible) question.

Just with the renal innovation in the US.

Trying to make sure your prior, I guess, assumption for the completion enrollment had been the calendar first quarter, I guess, of '13, and now you're saying that's going to be more calendar kind of midyear?

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

Okay.

And you're still comfortable with a FY '15 approval timeline?

That would still work with a FY '15 approval timeline.

Okay.

And then just ex-, I guess, US 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 mentioned reimbursement was constrained, but what are you also seeing from a competitive perspective, given that there's several other renal denervation systems approved for use as well?

We don't see the competitive pressure as being the big issue.

It is more the ability to -- when in fact we don't have separate reimbursement in many countries for this technology.

So our overall coronary renal denervation numbers are very much in line.

In fact, they're 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.

Okay.

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

What would be the path?

Yes.

We are still working with FDA on what the regulatory path for that would be, as we mentioned in our prepared remarks.

We've now completed the first phase of our first demand 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.

Okay.

Thanks very much.

Larry Biegelsen, Wells Fargo.

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 you're 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-digits in fiscal 2014?

And then I just had one follow-up for you.

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 mid-term is still valid.

And that's all I can add, that the tailwinds that we have will get further reinforced.

As we go through the next six months or so we'll get a better feeling for it.

I think lots of markets probably will, with some of the uncertainties, may well be removed as we go through the end of the year, and different policy areas may 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 look, we have every expectation to at least be in the high end of this range, and that will provide us good continuity and growth as we go into next year.

That's very helpful.

That's all I can say.

Yes.

I mean, obviously, this is Gary.

I mean, given the 2% to 4% guidance, obviously we're consistent with that 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 or 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 are just continuing to try to say, let's not get ahead of ourselves.

Let's keep the 2% to 4% growth expeditions out there, at least for the rest of this year, and as things firm up and we get a little bit better certainty on where some of these things are playing out, then obviously we will determine what our guidance for FY '14 is.

That's very helpful.

And then Omar, you talked about expanding into large joints earlier on the call.

Can you talk about your strategy in that area, and does Kanghui give you what you need?

Thank you.

Well, Kanghui's a starting point.

I mean, That's all I'll say.

We're excited about Kanghui, but largely reconstruction, the large joint reconstruction is actually at this stage a fairly small element of what we're going to get with Kanghui, and we're more focused on their spine and trauma business, and primarily their success in China.

I mean, into the orthopedics market in general, that capability will help us, but you've got to remember that we've got a series of other product that do address 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 -- and they reach the appropriate critical mass and breadth, as well as quality, we will have an opportunity.

It's really 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, perhaps?

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.

Thanks for taking the question.

Thanks.

Matt Taylor, Barclays.

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 could you really accelerate your growth year-over-year.

So you provide some comments on stability, but I was curious if you had some more feedback on your implants 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 pressure is 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?

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 in a little bit here, but on the spinal area, there too our core spine business 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 is 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 payer pushback, they are still there.

But they haven't worsened, and we're certainly, I think, beginning to demonstrate that some of our new products and procedures are of real value and are 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 first about to a bit about CRM, and then I'll ask Chris to comment on spines.

So Mike, say something?

Sure.

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 US pricing pressure that we've 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 support ratios increasing.

We are encouraged that we're heading into a product cycle in the CRM space, with obviously the (inaudible) CRT families in Europe with CE Mark in third quarter, the Evera product line in Q4.

We've 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 will help us immediately in Europe.

That's something that we feel like we will take to the US FDA to attempt to get labeling.

And then of course, as we head into next year, we will have the US Viva, Brava, and Evera product lines, as well as the Advisa MRI product line.

And then we are obviously encouraged with the AHA data also showed the benefits of CRT pacing in patients with AV block, which have been traditionally been standard pacer applications.

This will 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 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 in the market.

Chris, want to say a few --

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, two or three major strategies.

Number one is to continue to introduce new technology.

And we do get better pricing when we introduce new technology.

The Solaris 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 steps of the 5560, and we have also fully rolled out the minimally invasive package with Solaris.

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 mass mid-lift, for example, which is a mini-open procedure enabling more surgeons to do less invasive procedures, and now at NAS this year we just launched the O-lift 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.

Well, great.

Thanks for all the color.

I'll let some others jump in.

Thank you.

Glenn Novarro, RBC Capital Markets.

I had two 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 payers 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 payer pushback, if you're seeing any.

And then I had a follow-up on PODs.

Thanks.

Yes.

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 has been for the last 12, 24 months.

And so we certainly not seeing that.

So I don't know, Chris, you're close to this.

Any comments?

Yes, it's been a consistent theme.

It's really no worse now than it was a year ago or six 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 payers.

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.

Yes, and I think the healthcare delivery systems also finding ways --

Exactly.

Live within the constraints.

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

And just a follow-up on PODs.

While we were down at NAS, 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, or are you anticipating any surgeon losses?

Is PODs having any negative impact on your business?

Thanks.

Again, Chris?

Sure.

We started seeing the effect of PODs several years ago, and it tends to follow somewhat of a regional pattern when you see these things develop.

But right now we don't believe that the PODs are gaining share.

We believe they're 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.

In fact, 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 conflicts 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's not directionally worse right now than it was, say, a year ago.

Okay.

Thank you.

I know we're run a little bit over, but we'll take just a couple more questions.

Rick Weiss, Stifel Nicholas.

A couple 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?

Well, there's obviously short-term impact.

Hospitals are shut down and so on.

And we've had some ripple impact at the end of that.

I think over time we 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.

Rick, I mean, we obviously saw some 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 to see anything 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 -- so we saw small impact in the first week or two of this quarter, but the reality is, it's relatively minor.

Okay, and two other quick ones.

Omar, a bunch of med tech industry folks from Washington lobbying for rollback of the med tech tax.

Are you hopeful at all that we could see that changed, and maybe 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?

Thanks a lot.

With respect to the med tech tax, previously we've stated our position that it's something that we would like repealed if possible, and we worked with Advo Med through their leadership and supporting them.

However, we really like to focus on things that we can control.

Right now that's what the law is, that's what the projection's going to be, and we will assume that that's going to come into place, 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 are focused on building our business model to deal with it.

Again, we would like to focus on things we can control, and that's why we've given this approach.

Chris, you want to --

Sure.

On cervical, thanks for asking about cervical, Rick.

Yes, there have been a number of new entrants in the US 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 heretofore patients have had limited options for cervical discs in the US.

It's also important to note our overall cervical portfolio is really getting stronger.

Our cervical team's 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.

Appreciate that.

Thanks.

One last question.

Bruce Nudell, Credit Suisse.

Good morning.

Thanks for squeezing me in.

Mike, my first question is to you.

As you know, there is a pretty inflammatory paper published this week on the Optumcoding which suggested the potential for high mass loss six 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 urging you to publish it?

Which we've heard, and I guess the final question is, is what do you think the long-term implications of that for your share position in the market?

I think Mike is in the position to answer that.

Go ahead, Mike.

Bruce, we've been studying the 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 was our seven 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 (technical difficulties) identified this as a potential failure mode.

So both our internal advisors 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 and companies who are considering using this material, as well as global regulatory authorities so that they would understand how this plays out in the course of the use of a device.

So we chose the vehicle of the Macromolecules 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.

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 putting it out so that individuals can consider this in their evaluation of this material for use in future products.

Okay.

Omar, a follow-up to you.

In your prepared comments, if I heard it correctly, you said that US spine procedure growth was negative mid-single digits, but encouragingly, ASPs across price of 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?

Well, first let me clarify, the procedures were low-single-digits, not mid.

So that does make a little difference.

But beyond that, we continue to believe that, and as I kind of heard this from all my visits to customers and hospitals around the US and around the world, that their spinal procedures long-term will continue to grow because of demographic regions.

Low back pain is an issue, certainly, trauma and deformities and so on are clearly needs, but as the population ages, the back pain problems will only increase.

And so we are betting and are 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 payers, and we intend to work with both of them to firm up these guidelines so that we can work in a more 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 (inaudible) 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 we learn about the clinical procedure more effectively.

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?

On a global basis, yes.

We certainly see 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 emerging markets at some point will reach an inflection point and will provide growth.

But in the mid-term, you're right.

We expect this segment of our business to get close to our overall corporate profile.

Thanks so much.

Okay.

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 people in the US, 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.

This does conclude today's conference call.

You may now disconnect.