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Boston Scientific (NYSE:BSX)

Q4 2011 Earnings Call

February 02, 2012 8:00 am ET

Executives

Sean Wirtjes -

William H. Kucheman - Chief Executive Officer and Director

Jeffrey D. Capello - Chief Financial Officer and Executive Vice President

Ken Stein - Senior Vice President and Associate Chief Medical Officer of Cardiac Rhythm Management

Analysts

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

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

Kristen M. Stewart - Deutsche Bank AG, Research Division

Miroslava Minkova - Leerink Swann LLC, Research Division

David R. Lewis - Morgan Stanley, Research Division

Bruce M. Nudell - Crédit Suisse AG, Research Division

Tao Levy - Collins Stewart LLC, Research Division

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

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division

Matthew J. Dodds - Citigroup Inc, Research Division

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Boston Scientific Q4 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Mr. Sean Wirtjes. Please go ahead.

Sean Wirtjes

Thanks, Rochelle. Good morning, everyone. Thanks for joining us. With me on today's call are Hank Kucheman, Chief Executive Officer; and Jeff Capello, Executive Vice President and Chief Financial Officer.

We issued a press release earlier this morning announcing our Q4 and full-year 2011 results, which included key financials and reconciliations of the non-GAAP financial measures used in the release. We posted a copy of that press release, as well as reconciliations of the non-GAAP financial measures used in today's conference call to the comparable GAAP measures and other supporting schedules to the Investor Relations section of our website under the heading Financial Information.

Hank will begin this morning's prepared remarks with an update on our business progress and his perspectives on the quarter. Jeff will then review our Q4 and full-year 2011 financial results and business performance, as well as Q1 and full-year 2012 guidance. We'll then open the call up to questions.

During today's Q&A session, Hank and Jeff will be joined by our President, Mike Mahoney, as well as our Chief Medical Officers, Dr. Dawkins and Dr. Stein.

Before we begin, I'd like to remind everyone that this call contains forward-looking statements within the meaning of federal security laws which may be identified by words like anticipate, expect, project, believe, plan, estimate, intend and similar words. These forward-looking statements include, among other things, statements regarding our market share; markets for our products; new product approvals; launches and performance; clinical trials; our cost reduction and growth initiatives; our investments in emerging markets; the timing and volume of share repurchases; our free cash flow and uses thereof; our future financial performance, including sales, margins and earnings guidance for the first quarter and full-year 2012; and our future tax rates, R&D spending and other expenses.

Actual results may differ materially from those discussed or implied in these forward-looking statements. Factors that may cause such differences include those described in the Risk Factors section of our most recent 10-K filed with the SEC as updated in the 10-Qs we've subsequently filed. These statements speak only as of the date hereof, and we disclaim any intention or obligation to update them.

At this point, I'll turn it over to Hank for his comments. Hank?

William H. Kucheman

Thanks, Sean. Good morning, everyone, and thank you for joining us. Before I get started, I want to let you know that starting today, we are implementing a revised approach to our earnings calls, which is intended to reduce call duration, as well as streamline and focus the information we provide. And we look forward to your feedback on this revised format.

Now let me move on and show my perspectives on the fourth quarter and the progress we are making on our key initiatives to drive revenue growth and increase EPS, including a glimpse forward into 2012.

I'll start with a couple of key points regarding fourth quarter results and then move on to some of the more important product introductions we expect to benefit from in 2012 and beyond.

Fourth quarter revenue of $1.848 billion was down 8% on a reported basis and down 5% in constant currency and excluding the Neurovascular divestiture. This decrease was primarily the result of continued weakness in some of our end markets, particularly CRM in Europe, as well as some other factors Jeff will address in his comments. We delivered adjusted EPS of $0.13 in the quarter, which was in line with consensus and within our guidance range of $0.13 to $0.16, despite the fact that the negative EPS impact of inventory charges relating to the earlier-than-expected U.S. launch of PROMUS Element Plus were not included in that guidance. Jeff will detail our financial results in guidance, as well as several positive developments which should help set the stage for BSE in 2012.

As you know, we're a global leader in a diverse $30 billion marketplace. Some of those markets are growing, others are not, but we continue to believe that the markets we're in are some good ones, with long-term growth prospects supported by demographic and disease trends, underutilization, underpenetration and the growing middle class in emerging markets. Our potential for future success starts with new products, so let me share with you why I'm excited about our pipeline.

In CRV alone, we expect to launch 24 new products in 2012. Our U.S. PROMUS Element Plus Stent launch is now fully underway and meeting our high expectations, and we anticipate approval of PROMUS Element in Japan ahead of our previously announced time line of mid-'12. Once we have this approval, our platinum chromium element drug-eluting stent series will be approved in all major markets worldwide, and we should be well on our way to realize in the approximate $200 million profit opportunity that we expect to come with the conversion from PROMUS to PROMUS Element in the U.S. and Japan.

In addition, we just received approval for PROMUS Element Plus in Canada much earlier than expected and have also begun a rollout of this new delivery system in Europe. Although the worldwide DES market was relatively flat, it is still a large and profitable market, any market where we expect to continue our share momentum on the strength of the Element platform.

In CRM, we've historically focused on the higher end of the market, with single product offerings which often limited our ability to compete effectively in all segments. We expect to change that with our new tiered defib and pacer platforms. In defib, we began the U.S. launch of our INCEPTA, ENERGEN and PUNCTUA ICDs and CRT-Ds in earnest this quarter. These new devices maintain our advantage in size and shape, which is often a critical factor for patients. They also offer improved programming options. Our LHFM capability, 4-SITE, DF4 universal connector system built off our highly dependable RELIANCE lead platform and our market-leading battery longevity warranties of up to 10 years, are key platform differentiators. To date, we're very pleased with the rollout based on the positive feedback received from customers.

Turning to the pacing side, we expect to launch our INGENIO family of pacemakers in CRTPs in Europe and the U.S. in the first half of the year. Similar to our new tachy devices, INGENIO incorporates clinically relevant features that offer tangible benefits to patients. For example, INGENIO includes a feature called right rate, which builds on our unique capabilities around the treatment of chronotropic incompetence. The INGENIO platform will also be RF-enabled, support remote patient monitoring, have advanced heart failure diagnostics and be compatible with MRI systems, the last of which is planned for Europe in the middle of this year. We believe that our new tachy and Brady platforms will be a one-two punch for our sales teams, who are very excited at the prospect of beginning to offer these new devices and targeting market share gains in 2012.

In PI, we've increased our investment in new products over the past several years. We believe this strategy is starting to pay off, and we expect the combination of new products and market dynamics to continue to drive good growth. We now offer best-in-class balloons across all size platforms with our Coyote, Mustang and Charger devices, which has enabled us to regain our #1 PTA balloon position in the U.S. We also began a limited market release of our recently acquired TruePath crossing device in the U.S. and Europe and offer reentry catheter to treat chronic total occlusions in international markets. We expect to move to a full launch for TruePath and offer them in approved markets this year.

In addition, following very positive results from the ORION trial in January, we expect to receive FDA approval of the Epic Self-Expanding Stent this year. Epic will allow us to offer a complete line of advanced iliac solutions in the U.S. We also anticipate launching our INNOVA Self-Expanding Stent internationally in 2012.

In our EP business, we continue to leverage our expertise in catheter and ablation technology as we execute our global AFib strategy and our 6 internally approved AFib-focused products. Within EP this quarter, we expect FDA approval for the ZºFLEX-270 steerable sheath, which is designed to facilitate the introduction and placement of catheters within the heart. This device can provide more than 270 degrees of tip deflection, allowing access to difficult-to-reach areas of the heart.

In Endo, we have an established track record of bringing innovative new technologies to market which drive above market sales growth. Consistent with that history, we are pleased to receive clearance from the FDA in Q4 to market the WallFlex Biliary Stent System for malignant strictures. We expect to begin full launch of this product, as well as our Expect 19 Flex Ultrasound Aspiration Needle, which is used for tissue acquisition to diagnose GI malignancies this quarter.

In Urology and Women's Health, we're looking forward to the expected 2012 global launch of our BackStop Gel designed to prevent stone migration during stone management procedures. Despite what we expect to be a temporary headwind in Women's Health, we are focused on creating new and differentiated technologies such as our Genesys HTA System to drive continued growth in this business.

In Neuromod, we believe we are the technology leader with Smoothwave. In our constant cadence of innovation, additions to our product set has helped to drive above market growth over the past several years. We recently launched the Infinion Lead, the industry's first and only 16-contact percutaneous lead, and physician reaction has been enthusiastic. This new lead is right in line with our strategy to introduce meaningful innovations that optimize the treatment of chronic pain.

So as you can see, our pipeline is real. Bottom line, our goal with these launches is to continue to further strengthen our current worldwide market positions which, in my view, is growing in accordance in an era where economic buyers have increasing influence and purchasers are considering fewer vendors, not more.

Let's now shift to emerging markets, which is one of our critical elements of our business strategy. This initiative provides us with significant potential to expand and accelerate profitable growth, while at the same time improving the scope and quality of global patient care. We continue to make excellent progress in building our infrastructure and driving growth in these key markets. Allow me to provide a few examples. In the fourth quarter, combined sales in China and India increased by more than 70% over the prior year. We also continued investments in our sales force, clinical and marketing teams, distributor networks and infrastructure, including progress under our announced $150 million investment to build a manufacturing training facility in China. In China, we recently initiated several important product launches, including PROMUS Element in our ALTRUA pacemakers.

In India, we launched the WallFlex Stent Dreamwire Guidewire. We also continued patient enrollment in the TUXEDO trial to assess the TAXUS Element or ION Stent in diabetic patients. We now have a total approaching 500 patients at almost 40 sites initiated. Earlier this week, we announced the creation of an Asia-Pac regional organization to help drive growth by leveraging best practices in the region, assessing a strong pool of local talent and collaborating with local healthcare professionals and regulatory agencies. We appointed Supratim Bose, an industry veteran with extensive experience in the region to lead this organization.

We're also doing well in other emerging markets where we have more of a established presence. One example is Brazil, where we began introducing PROMUS Element in late 2010. Since then, we rapidly converted our PROMUS share to PROMUS Element and increased our overall DES share by an estimated 800 basis points. By the end of 2012 -- I'm sorry, 2011, we had grown our share to over 60%, and we're optimistic we can push it even higher. This spells growth.

Our strategy in emerging markets is to offer innovative, leading technologies, backed by a global respected brand. One example is in DES where we currently have single-digit shares in China and India, which together represent a nearly $700 million market growing at around 20%. We believe that we can increase these shares share significantly and that this will be an important contributor to our growth going forward.

In summary, we are making real progress in generating significant year-over-year growth and are targeting emerging markets. We feel we have the right structure, the right people and a clear path supported by products and investment that will allow emerging markets to be an important growth driver for us in 2012 and beyond.

Now let's shift briefly to the cost side. Another key element of our plan is to optimize the company and execute on significant cost reduction opportunities related to our organization, systems and infrastructure. We have previously outlined $650 million to $750 million in operating profit improvement opportunities we expect to realize over the next several years. Jeff will cover some of these later, but I want to reinforce here that efforts to realize these opportunities are well underway. We are making excellent progress in all areas, and we expect to begin to see tangible benefits from several of these initiatives, including gross margin benefits tied to our PROMUS Element launch in the U.S. and expect to launch in Japan our plant network optimization program, as well as SG&A savings from our restructuring program as we move into 2012 and into 2013. The bottom line here is that we're delivering on our commitment to improve efficiency and effectiveness across the organization.

Lastly, I'd like to update you on several of the acquisitions that we have made under our priority growth initiatives where we continue to make good progress towards achieving meaningful revenue contribution to overall top line, starting in 2013. We are pleased with the progress we're achieving during our first full year commercializing the Alair Bronchial Thermoplasty System, our proprietary device for the management of severe asthma. Alair is now available in 92 sites across 7 countries, including the U.K., where nice recently issued positive guidance supporting BT as a safe and effective treatment option for severe asthma sufferers. We expect to be more than double the number of countries and sites offering this technology in 2012 and believe that potential market for this unique device could exceed $1 billion.

During Q4, we're also pleased to learn that CMS acknowledged that substantial improvement associated with the use of the Alair System for the management of severe asthma. As a result, effective January 1, '12, the Alair catheter is eligible for Medicare reimbursement through a separate pass-through payment when the procedure is performed in an outpatient hospital setting. This is in addition to unique category 3 CPT codes that are now available for the procedure. The combined Medicare payments for the catheter and procedures should provide a strong benchmark for private insurers to support establishing reimbursement for BT.

In structural heart, our WATCHMAN Left Atrial Appendage Closure Device is now launched in more than 20 countries in Europe, Asia Pac and Latin America. Again, we plan to double this number by the end of 2012. In the U.S., we plan to complete the enrollment of PREVAIL trial and submit our PMA by the end of the year. This would set us up for expected FDA approval and launch in 2013. Similar to Alair, this is a product that plays in the market with a very large potential, and we expect both of these innovative products to begin to positively impact revenue growth in a noticeable way in 2013.

Our other foray into structural heart is the Lotus Valve. Now while this product is a little further out, we believe it provides us with an opportunity to become a major player in what most expect to be a multibillion-dollar market for percutaneous aortic valves. Development of the Lotus Valve is based on extensive clinical feedback, and we expect it to bring true differentiation to the market that resonates with physicians and patients. We plan to begin the reprise to our CE Mark trial for Lotus in the second half of this year with European approval and launch expected in the second half of 2013.

Finally, I'll touch on 3 internal development products -- projects that we're extremely excited about. We believe that these areas represent a next wave of revenue contribution commencing in 2014. The first is our fourth generation Synergy DES stent which is built on our platinum chromium element stent platform and incorporates a thin bioabsorbable polymer coating on the outside edge of the stent. At the TCT conference in November, we announced impressive clinical and angiographic results supporting the safety and effectiveness of Synergy. CE Mark approval is expected as early as late 2012, with full EU launch anticipated in 2013. We expect that the U.S. IDE trial called EVOLVE 2 will commence as early as mid-2012.

As a part of the randomized trial, we will also formally investigate short and dual antiplatelet therapy or DAP. And as you know, the cost of DAP is significant and we believe the Synergy stent may be ideally suited to a shorter DAP treatment protocol, potentially offering both patient benefit and healthcare system cost savings. A second internal program is exploring multiple approaches to device-based treatment of hypertension. These approaches leverage our core competencies in catheters, RF ablation and stimulation technology in an effort to address a market expected to reach $3 billion within the decade. The first human use of one of our renal denervation devices is planned for this year. We anticipate CE Mark approval and commercialization in Europe next year, with the U.S. trial expected to begin in 2014.

Another market with $1 billion plus potential that we are pursuing is deep brain stimulation or DBS, which is also characterized by a refractory patient population with a highly unmet need. The initial indication we're targeting with our unique neurostimulation technology is Parkinson's disease. We're currently enrolling patients in the VANTAGE trial in Europe to study this indication and expect to complete the trial in 2013. Once approved, we expect to have the only available DBS system that incorporates multiple, independent, current control designed to enable greater customization of the therapy.

I've just laid out 6 high potential opportunities involving technologies that we have either acquired or developing internally that we believe will provide us with competitive entrees in the major growth markets. They are all minimally evasive device-based procedures intended to address unmet clinical needs and help reduce overall healthcare system cost. Characteristics, we believe, that are critical in our marketplace today, as well as in the future.

Finally, we continue to generate strong cash flow in the fourth quarter and for the full year. During the second half of 2011, we repurchased close to 500 million of our stock or roughly 5% of the company under an estimated $1.25 billion in stock repurchase programs announced in July. We expect to continue to generate good cash flow, which should allow us to continue to both repurchase shares and acquire new technologies to increase our growth opportunities. We like the bets we've placed so far, and we continue to expect to be able to add new technologies through our business development initiatives.

In closing, we continue to show measurable progress in the execution of our business strategy to achieve our goal of double-digit EPS growth. We have built our pipeline, and we are building commercial capabilities in emerging markets. We are achieving key milestones relating to our cost reduction opportunities and our Priority Growth Initiatives, and we have improved our financial situation so that we now have added flexibility to balance investments in new markets and growth technologies, along with returned capital to shareholders.

That's it for my comments. Let me now turn the call over to Jeff for a review of our results in 2012 guidance. Jeff?

Jeffrey D. Capello

Thanks, Hank. Let me begin by providing some overall perspective on the quarter. Despite global economic and end market conditions that continue to be very challenging, we generated adjusted earnings per share of $0.13, within our guidance range of $0.13 to $0.16 and in line with Street consensus, driven by continued strong attention to cost control. Once again, we also generated strong operating cash flow which allowed us to repurchase another 52 million shares in the quarter.

Let me now move to the detailed review of the quarter to discuss the operating results and highlight the progress being made. Consolidated revenue for the fourth quarter was $1,848,000,000 and represents a decrease of 8% on a reported basis and a decrease of 5% in constant currency compared to the fourth quarter last year, excluding the negative impact of the Neurovascular divestiture, which negatively impacted revenue by 300 basis points. The actual tailwind from foreign exchange was $9 million, less than the $18 million assumed in our fourth quarter guidance range. At this point, I'll move on to address our sales results and drivers for our businesses.

Worldwide DES revenue came in at $356 million, which included an $8 million negative impact from the sales returns reserve relating to the early U.S. approval of PROMUS Element Plus. Excluding the impact of the sales returns reserve, this represents a constant currency decrease of 4% compared to the fourth quarter of 2010. Our worldwide DES revenue included $101 million for TAXUS and TAXUS Element, $136 million for PROMUS and $119 million for PROMUS Element.

We once again held clear worldwide DES market share leadership during the fourth quarter, with an estimated global share of 34%, which we estimate to be a full 400 basis points higher than our nearest competitor. These figures exclude the negative impact of the PROMUS Element Plus reserve in the U.S. With the continued strong customer adoption of our element platform, now including PROMUS Element Plus in the U.S., the expected launch of PROMUS Element in Japan and building momentum in India and China, we are focused on growing our worldwide market share leadership going forward.

U.S. DES revenue was $168 million, including the $8 million negative impact of the PROMUS sales returns reserve. Excluding the impact of this reserve, U.S. DES sales declined 7% compared to the fourth quarter of last year. The revenue shortfall compared to our Q4 guidance was primarily driven by some continued softness in PCI volumes.

The launch of PROMUS Element Plus has been extremely well received in the U.S. marketplace. In particular, physicians have remarked on the product's outstanding deliverability, conformability and the improved visibility of the platinum chromium alloy. Our PROMUS Element sales began exceeding our PROMUS sales in the U.S. a few weeks ago, and we expect full conversion and a return to 100% self-manufactured DES margins in the U.S. this year.

U.S. DES revenue in the quarter included $69 million TAXUS and TAXUS Element, $89 million of PROMUS and $10 million of PROMUS Element Plus. Excluding the impact of the PROMUS sales returns reserve, we estimated that our U.S. DES share was 47%, which was an increase of 100 basis points compared to Q4 last year, off of the strong ION and early PROMUS Element Plus launches. We continued to maintain drug-eluting stent market share leadership in a competitive U.S. market with an estimated 800 basis points more market share than our nearest competitor.

During Q4, we experienced an improvement in year-over-year ASP erosion to down mid single digits compared to the high single digits we've seen in recent quarters. Although we believe it's a little too early to tell whether this will continue, we are encouraged by this improvement and expect to leverage the unique value proposition that the differentiating features of the PROMUS Element now allows us to bring to the market.

International DES sales of $188 million represented a decrease of 1% in constant currency compared to Q4 last year, due largely to continued pricing pressures. Q4 revenue included $32 million in TAXUS and TAXUS Element, $47 million in PROMUS and $109 million in PROMUS Element sales. The rollout of our element platform continues to do very well internationally, and we are starting to see some contribution from the launch of our element DES platform in emerging markets, primarily India and Brazil. We expect this to accelerate in 2012 as we anticipate gaining additional important pricing approvals in India and expanding the recent launch of PROMUS Element in China.

Worldwide CRM revenue was $482 million in the fourth quarter, representing a constant currency decrease of 15% compared to the fourth quarter of 2010. We estimate that our worldwide CRM share was down slightly on a sequential basis at just over 18%. In the U.S., CRM revenue of $278 million represented a 20% decrease from the prior year quarter. Worldwide defib sales were $348 million in Q4, which was down 18% in constant currency from Q4 2010. In the U.S., defib sales were $214 million. This was down 21% compared to Q4 last year due primarily to the continued year-over-year market declines, as well as replacement headwinds in our business.

Given the earlier-than-expected approval of our new line of ICDs and CRT-Ds, we purposely managed to lower book sales in the fourth quarter to minimize customer inventory of COGNIS and TELIGEN as we prepare to aggressively roll out the new products in Q1. The U.S. defib market appears to be showing some signs of stabilization. However, despite these encouraging signs, a number of factors are still at play and visibility remains very limited. As a result, we expect it will take another quarter or 2 to confirm whether the market has truly bottomed out. We believe that our de novo share in the U.S. has remained stable over the last several quarters and are optimistic that our share outlook will improve further as we continue the launch of PUNCTUA, ENERGEN and INCEPTA in the U.S.

International CRM sales of $204 million were down 7% in constant currency compared to the prior year quarter despite a 3% constant currency increase in international pacer revenue off of continued strong double-digit growth in Japan and intercontinental. International defib sales of $134 million represented a 12% decrease in constant currency from Q4 last year. While international defib was below our expectation from the quarter, we are launching new products in many countries outside the U.S. and expect improved performance as we move through the year.

Our worldwide Peripheral Interventions business continued on its recent growth trajectory and was up 6% in constant currency in Q4, with 1% growth in the U.S. and 10% constant currency growth internationally. We continue to make excellent progress driven by a rejuvenated pipeline as all 3 PI franchises grew sales in the quarter on the strength of multiple products, including the Epic self-expanding stent, the Carotid WALLSTENT in Japan and our Mustang and Coyote PTA balloon and dilatation catheters. In addition to these new products, we have a half-dozen more in 2012 we expect to support continued growth in this business.

Worldwide non-stent Interventional Cardiology was down 8% in constant currency. Consistent with recent periods, this decline was largely attributable to some procedural softness, share declines in IVUS and continued price erosion in PTCA balloons. As we progressed through 2012, we expect to see some improvement in vascular access, balloons and IVUS results due to planned new product launches.

Worldwide Electrophysiology was flat in constant currency. During the quarter, we experienced continued softness in the small tip market and a flat market in the large tip business. However, we did see growth in Inter Cardiac Echo or ICE capital and diagnostic product categories in the quarter. Sales of the recently released Blazer Open-Irrigated Catheter continued to ramp in Europe. As we've previously stated, this launch is a significant step in the execution of our global AFib strategy.

On a worldwide basis, our Endoscopy business continued to have solid growth, with sales up 6% in constant currency in the fourth quarter. Growth in the U.S. was 4%, while our international sales grew 8% in constant currency with strength across all geographic regions, driven by continued strong new product introductions, expanded indications and increased adoption of our single-use products.

This performance was led by strength in our biliary device franchise, supported by continued growth in the Advanix Biliary Plastic Stent for the treatment of biliary structures, our Metal Stent franchise led by our WallFlex Biliary RX Fully Covered Stent and our Hemostasis franchise on a continued adoption and utilization of a Resolution Clip for GI bleeding.

In constant currency, our Urology/Women's Health business declined 1% on a worldwide basis, but was up 8% internationally. The Urology business maintained its leadership position and delivered 4% worldwide constant currency growth, driven by an 8% increase in our international core stone management business. The Women's Health business declined 8% on a worldwide constant currency basis as continued procedure -- pressures on electro procedures due to the weak macroeconomic environment and the recent FDA public health notice update on the use of uro/gynecologic surgical mesh for pelvic organ prolapse more than offset strong double-digit growth of our next-generation Genesys HTA System for the treatment of abnormal uterine bleeding.

Outside of the U.S., our international Women's Health business continued to experience good growth and was up 13% in constant currency, driven by new product introductions, increased sales investments and the penetration of new therapies.

In Neuromodulation, we grew our worldwide business 6% in constant currency during the fourth quarter despite continued weakness in macroeconomic conditions. The growth was driven by our differentiated product portfolio and strong commercial execution strategies.

Let me now briefly address full-year 2011 revenue. On a reported basis, consolidated 2011 revenue was $7,622,000,000, which represents a 2% decrease from the prior year on a reported basis. In constant currency and excluding the impact of the Neurovascular divestiture and the ship hold, sales decreased 4% compared to 2010, driven largely by the decline in U.S. and euro market. For the full year, foreign currency positively impacted reported full-year sales growth by approximately 260 basis points or about $204 million.

Moving on from sales. Adjusted gross profit margin for the quarter was 64.8% or 280 basis points lower than Q4 2010. In the quarter, margins were negatively impacted by the Neurovascular divestiture, pricing pressure and inventory charge related to the U.S. launch of PROMUS Element and unfavorable foreign exchange, somewhat offset by the positive impact of manufacturing efficiencies and a continued mix shift towards self-manufactured product in DES. For the full-year 2011, adjusted gross profit margin was 65.7%. Adjusted SG&A expenses were $620 million or 33.5% of sales. This compares to $677 million in the fourth quarter of 2010. The decrease was primarily due to the divestiture of the Neurovascular business and the benefit of expense discipline and the recent restructuring activities, partially offset by higher spending on strategic growth initiatives, primarily in emerging markets and costs relating to recently acquired businesses. For the full-year 2011, adjusted SG&A expenses were $2,478,000,000 or 32.5% of sales.

Adjusted research and development expenses were $230 million for the fourth quarter or 12.4% of sales. This compares to $225 million in the fourth quarter of 2010. R&D spending was relatively flat as lower expenses due to the Neurovascular divestiture were offset by costs relating to recently acquired businesses. For the full-year 2011, adjusted R&D expenses was $895 million or 11.7% of sales. Royalty expense was $33 million or 1.8% of sales for the quarter compared to $37 million in Q4 of last year. For the full-year 2011, royalty expense was $172 million or 2.3% of sales.

On an adjusted basis, pretax operating income was $315 million or 17% of sales, down 370 basis points from Q4 2010. As a percentage of sales, the decrease in adjusted operating income was due to lower gross margins and the impact of lower sales on operating expenses. GAAP operating income, which includes GAAP to adjusted items that had a negative effect of $145 million on a pretax basis, was $170 million in Q4.

Now I'll move on to Other Income expense. Interest expense was $72 million in the fourth quarter, which was $35 million lower than in Q4 2010, primarily due to substantial debt repayment since December 2010, and a $15 million accelerated interest charge which occurred in Q4 2010 related to the prepayment of our June 2011 bonds. Our average interest expense rate in Q4 2011 was 5.9% or about 50 basis points lower than Q4 2010, primarily due to the prepayment of our bank term loan during the first half of 2011, which had a lower average interest rate than our public bonds.

2011 interest expense was $281 million, which was $112 million lower than in 2010, primarily due to the debt repayment and accelerated interest charge I just mentioned, as well as a benefit from interest rate swaps executed on some of our public debt in 2011. Our adjusted tax rate for the fourth quarter was consistent with our previously forecasted Q4 rate of around 20%. During the quarter, we recognized a $24 million benefit from discrete tax items relating to our operating businesses. This benefit was offset by a slightly higher than anticipated full-year operational tax rate of 19.3% due to the timing and geographic mix of sales generated under new product launches.

For the full year, our tax rate was 12.2% on an adjusted basis and 31.3% on a reported GAAP basis. Fourth quarter EPS was $0.13 on adjusted basis and $0.07 on a GAAP basis, both of which were within our respective guidance ranges despite the fact that the negative EPS impact of inventory charges of approximately $42 million or $0.02 related to the earlier-than-expected U.S. launch of PROMUS Element Plus were not included in that guidance. GAAP EPS for the fourth quarter included $0.01 of acquisition-related net credits, $0.01 of divestiture-related net credits, $0.01 of restructuring-related costs and $0.02 of litigation-related charges, as well as the normal $0.05 of amortization expense.

Stock compensation was $32 million in the fourth quarter, and all per share calculations were computed using approximately 1.5 billion shares outstanding. And the end of 2011, we had approximately $1.45 billion shares outstanding.

For the full year, we reported adjusted earnings per share of $0.67 per share. This included a total of $0.12 of net onetime benefits. On a reported GAAP basis, 2011 EPS was $0.29.

GAAP earnings per share for 2011 included $0.47 per share of goodwill and intangible asset impairment charges, $0.02 per share of acquisition-related net credits, $0.35 per share of divestiture-related net credits, $0.06 per share of restructuring-related costs, $0.02 per share of litigation-related charges, $0.02 of discrete tax benefits and amortization expense of $0.22 per share.

Moving on to the balance sheet, DSO of 62 days was up 1 day compared to the fourth quarter 2010 due to weakness in EMEA, partially offset by strong U.S. collections. Days inventory on hand was 130 days in Q4, which was 1 day the higher than the prior year quarter. Higher inventory to support new product leases was partially offset by the benefit of inventory reductions attributable to the Neurovascular divestiture and finished goods reduction programs.

Adjusted operating cash flow was $374 million, including the receipt of $76 million from Abbott in the quarter in settlement of our outstanding PROMUS cost adjustments in the U.S. This compares to $377 million in Q4 last year. On a reported GAAP basis, operating cash flow was $349 million compared to $449 million in Q4 2010.

For 2011, adjusted operating cash flow was $1.45 billion, which is $377 million lower than 2010, primarily due to lower tax refunds and lower operating profit, partially offset by lower interest rate payments as a result of our recent deleveraging, the benefit from the termination of our fixed to floating rate interest rate swaps on our public bonds and the receipt of the settlement payment from Abbott in 2011. On a reported GAAP basis, operating cash flow was approximately $1 billion or $682 million higher than 2010.

Capital expenditures were $81 million in the fourth quarter. For the full year, capital expenditures were $304 million or $32 million higher than 2010, primarily due to the ongoing automation of our largest distribution center and increasing manufacturing capacity for the launch of PROMUS Element in the U.S. and Japan.

Based on the above, adjusted free cash flow was $293 million in Q4 and $1.27 billion for the full-year 2011. On a reported GAAP basis, free cash flow was $269 million in Q4 and $704 million for the full year.

As I mentioned earlier, we repurchased 52 million shares or over 3% of the outstanding common stock of the company for approximately $300 million in the fourth quarter. At a current stock price, we estimate we have over $700 million of capacity remaining in our current stock repurchase program. We continue to believe that our stock price is undervalued and currently expect to use approximately 1/4 of our free cash flow to repurchase shares in 2012 subject to applicable law, market conditions, our stock price, business development opportunities and other factors.

We remain confident that we can balance our priorities from investing in growth and returning capital to shareholders, all while improving our investment-grade metrics on the strength of solid cash flows.

Let me now briefly provide some perspective on our outlook and walk you through our guidance for first quarter and full-year 2012. As we enter 2012, we continue to face headwinds and limited visibility in several of our markets, most notably CRM [indiscernible] and we plan to continue to invest in emerging markets and other targeted areas. However, we also expect to start seeing an increasing level of benefits from several key components of our $650 million to $750 million in cost saving and profit enhancing opportunities as we progress throughout the year. Having considered those factors, we estimate that consolidated 2012 sales will be between $7.3 billion and $7.7 billion. Assuming that current foreign exchange rates hold constant, we expect full-year headwind from FX to be approximately $86 million. On a constant currency basis, consolidated 2012 sales should be in the range of up 2% to down 3%. The upper end of this range assumes that the U.S. defib market does not deteriorate further and therefore year-over-year comparisons improve progressively through the year.

We expect our adjusted gross margin for the year to be between 66.5% and 67.5%. Although we expect to continue to see downward pricing pressure, we expect this headwind to be more than offset by lower costs due to our anticipated conversion from PROMUS to PROMUS Element in the U.S. and Japan, as well as our Plant Network Optimization and manufacturing value improvement programs. The impact of these benefits should ramp as we progress through the year. As a result, we expect Q1 margins to be below the full-year range and margin in the second half of the year to be above it.

With respect to SG&A expenses, we expect to continue to make investments in emerging markets and additional selling investments in other international markets. In 2012, the cost of these investments should be partially offset by restructuring savings, although we expect most of the benefit of these savings to be realized in the second half of the year.

For the full year, we expect adjusted SG&A as a percent of sales to be between 33% and 34%, with much of the increase compared to 2011 due to onetime benefits realized in the prior period. We expect to be near or above the high end of our SG&A guidance range in the first half of 2012 and closer to lower end in the second half for SG&A.

We continue to transform our R&D organization and refocus our spending to drive innovation and growth. In 2012, we expect R&D spending to increase slightly and to be between 12% and 12.5% of sales as we ramp spending in several of our priority growth initiative areas. We currently expect Other Income expense to be relatively flat last year.

Royalty expense is expected to be slightly lower in 2012 compared to 2011 due to product mix changes involving products that incur royalties at different rates. We expect our adjusted tax rate for the full-year 2012 to be approximately 17%. Excluding any discrete tax items that may arise during the year and assuming that the U.S. R&D tax credit will be retroactively extended for the full-year 2012, we are subject to tax authority examinations in many jurisdictions that are scheduled to include in 2012.

The final resolution of these exams may result in additional favorable or unfavorable discrete tax items during the year that are difficult to forecast, but may impact our full-year adjusted tax rate. As a result, we expect adjusted EPS for the full-year 2012 to be in the range of $0.60 to $0.70, and we encourage you to model the midpoint of that range. Excluding any onetime items that may arise, we expect adjusted earnings per share to increase sequentially as we progress through the year, driven by the timing of the cost benefits we expect to realize. On a reported GAAP basis, we expect EPS to be in the range of $0.25 to $0.38.

Lastly for 2012, we expect adjusted free cash flow to exceed $1 billion, which we believe to be conservative but appropriate given the uncertain economic environment and prospects of additional austerity, particularly in Europe, CapEx of approximately $300 million, pretax amortization expense of roughly $100 million per quarter and stock comp expense of around $130 million.

Now turning to Q1 2012, we expect consolidated revenues to be in the range of $1,825,000,000 to $1.9 billion. If current foreign exchange rates hold constant, the headwind from FX should be approximately $10 million or 50 basis points relative to Q1 2011.

On a constant currency basis, we expect consolidated Q1 sales to be in the range of flat to down 5%. On a worldwide basis, we expect DES revenue to be in the range of $365 million to $385 million and CRM revenue to be in the range of $480 million to $510 million in the first quarter. For the first quarter, adjusted earnings per share is expected to be in the range of $0.11 to $0.14 per share on an adjusted basis, and reported GAAP EPS is expected to be in the range of $0.02 to $0.05 per share.

That's it for guidance. So with that, I'll turn it back over to Sean who will moderate the Q&A. Sean?

Sean Wirtjes

Thanks, Jeff. Rochelle, let's open up the call to questions. [Operator Instructions] Rochelle, please go ahead.

Question-and-Answer Session

Operator

[Operator Instructions] And your first question comes from the line of Mike Weinstein of JPMorgan.

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

First I’d like to make sure, Jeff, that I caught a couple of your comments correct. You're assuming that your free cash flow would be about $1 billion in 2012 and then on the repurchase, you would use about 1/4 of your free cash flow to buy back stocks. Is that right?

Jeffrey D. Capello

That's correct, Mike.

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

Okay. And what's defining the percentage that you're assuming on the buyback? Why 1/4 versus 1/2 versus or some other number?

Jeffrey D. Capello

Well I think as we said, the strategy revolves around primarily driving the top line of the company. I think Hank did a good job of outlining our internal programs, particularly the ones that we expect to kind of start to get some traction in 2013. Having said that, our aspiration is to drive the growth rate of the company up to kind of the mid single digits, if not higher. And so from a shareholder perspective, I think you're going to see us get a little bit more aggressive from a business development perspective to try to drive some new technologies into the business to drive the revenue growth. However, I think we can do both. And that the 25% is just an estimate at this point in time and we'll wait and see what happens as we work our way through the year in terms of what assets are available at an appropriate price.

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

With the pressure you have on the pricing side in DES and CRM and submitted parts of your mentioned cardiology bag, [ph] could you just give us your thoughts on how gross margins play out beyond 2012? You're getting at the net of in '12 obviously the conversion from PROMUS to PROMUS Element across the U.S. and Japan. But if we look beyond '12 and then step up, do you think you can hold gross margins in the face of these pressures assuming they don't moderate at some point?

Jeffrey D. Capello

Yes. And that's a good question. If you go back and look at the Investor Day material we laid out in 2010 and kind of look at the different factors and look at what's different one way or the other, clearly price is a little bit more of a headwind than we anticipated. And we were starting with 68% margins. We assumed that price would be about 400 basis points of headwind. That's become a little stronger, although we saw some benefit in the fourth quarter. What's important to recognize, however, is that despite the pricing pressures, unit volumes are actually increasing in Europe and in other locations relative to the DES market and other markets. So we're getting fixed cost leverage. So if you go back and look at the Investor Day model, we get a volume benefit even though revenues are not where we want them to be. In some sectors, they are growing and the bonds are growing quicker. So we get fixed cost leverage, which helps offset some price. We continue to do very well in the productivity side. We have an objective to take out 5% of the standard costs every year. We continue to do very well in that front. So that's another positive headwind -- tailwind, rather. The PROMUS Element, if you look at kind of the distribution of the $200 million, we'll get the majority of that, call it 2/3-ish, here in 2012. There's another 1/3 to come, though, in '13. And then we've got the plant network optimization program, which a lot of it will happen in '12. We'll get a little bit of a tailwind in '13. But also, that doesn't count. So those are all positive factors that help offset price. The other dynamic that happens is, some of these new technologies come in, Mike, they're all designed to have much higher gross margins than our average. So there should be a mixed benefit as Alair kind of starts to be a bigger piece, Atritech comes in and Sadra. These are all designed to be -- have gross margins in north of our average. There will be a mixed benefit that will start in '13 and accelerate in '14.

Operator

And the next question is from the line of Glenn Navarro, RBC Capital Markets.

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

2 questions, 1 on ICDs. It seems like in the quarter, you may have taken some reserves or pulled inventory here in the U.S. in front of the Progeny launch. Can you quantify that? And then provide any commentary on pricing. You gave pricing on stents, but I don't recall getting pricing on ICDs. And I just had one follow-up.

Jeffrey D. Capello

Okay, Glenn, this is Jeff. So I don't think we're going to be as specific, perhaps, as you like. But as you look at our performance for ICDs, we still think that the market -- U.S. ICD market was down kind of mid-teens, if you will. I think that's consistent with the competition we're saying. We were down kind of in the 20% -- 21%, 22%, 20%, if you will. That delta is split between kind of our -- some replacement headwind that we have that will start to dissipate as we work our way through '12. And the other piece of it is kind of what we call kind of less bulking or less -- placing less inventory on the shelves, which is driven by dynamic that we have a new exciting technology coming in. We didn't want to put more COGNIS and TELIGEN on the shelves and have it come back in returns.

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

And pricing?

Jeffrey D. Capello

Pricing, as you look at pricing domestically and internationally, within the CRM market, kind of mid single digits, not much change kind of domestically. Outside the U.S., a little bit -- we identified in the third quarter that pricing was a little bit more of a challenge in Europe. That's still the case. And then DES, I think we called kind of lower kind of mid single-digit price erosion in the U.S., which was very encouraging. Still kind of upper single-digit erosion outside the U.S., though.

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

Okay. And then just maybe for Hank. I'm just curious how he sees your business playing out in the ICD market in 2012. In the single and dual chamber segment of the market, you have St. Jude having to deal with, say, Riata issues that could be an opportunity for taking share. But conversely, they've also launched their quadpole, which suggests you may be -- you could lose share there. So maybe talk to us about how you see yourself positioned in the ICD market, particularly in the U.S. in 2012.

William H. Kucheman

Glenn, great question. I believe it's somewhat of a mixed bag. We believe that with the platform that we're launching that we're actually going to take share. And one of the things that I'm not sure that's well appreciated yet in terms of differentiation factors is the growing importance of our LATITUDE Heart Failure Management System, one; and then two, battery longevity. Now within the healthcare system environment today, you can argue that battery longevity has been a headwind for us due to the impact that it has on replacements. But I think there's a growing recognition on the part of various healthcare systems that as time marches on, and actually some systems are beginning to anticipate this fact this year, is that, that actually can work to their advantage and our advantage in a world of value-based pricing. So we're seeing the key differentiators of ICDs beginning to change a bit perhaps in our favor in ways that historically have not acted on our behalf. That would be quite candidly the essence of what I would respond to your question. And I think it's a play out. We're very excited by the platform, the 3 tiers, the features that we have, the DF4 connector tool that we have, we call it a green machine. That is a very key ease-of-use feature that the EPs are really attracted to, and we're getting some great feedback on it. So I think we'll have to see how the execution plays out here with the coming quarters. But basically from what I see so far, I'm very, very encouraged.

Operator

And next question from the line of Kristen Stewart, Deutsche Bank.

Kristen M. Stewart - Deutsche Bank AG, Research Division

I was just curious on the -- within the context, I guess, of cash flows, you had mentioned that you did receive money from Abbott on the adjustment. Was there any impact on the gross margin this quarter or any P&L impact with the true up with PROMUS?

Jeffrey D. Capello

No, Kristen. We made that true up back in the first half of the year.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. So that was not fourth quarter specific for cash flows?

Jeffrey D. Capello

No.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay, great. And then can you also just comment generally on Europe? You mentioned a couple different times that the market is more challenging. It sounds like it got worse within the quarter. So what are you seeing? It sounds like it's tougher in CRM. It doesn't sound like it's getting any better in stents, either. So any comments on Europe would be helpful.

Jeffrey D. Capello

Yes, Kristen, it's Jeff. So I think what we saw in the quarter, particularly in Southern Europe, is we saw instances of certain facilities either restricting procedures or not doing any procedures as we worked our way through the fourth quarter because of budgetary issues. And that had an impact on our sales for certain. As we've opened up now for the new year, we're seeing a little bit less pressure with some of the budgets being kind of freed up again for the new year. So that's not unusual for Europe to do. The issue here is that we've got a lot more of a difficult situation ahead of some of those Southern European countries. So the answer is we're just going to have to wait and see what happens and how things play out.

Operator

And the next question comes from the line of Rick Wise, Leerink Swann.

Miroslava Minkova - Leerink Swann LLC, Research Division

It's Miroslava for Rick today. Let me start by asking about the gross margin. Can you help us ease out the impact of divestitures, the inventory changes that you had with the PROMUS -- with the Progeny line price, et cetera? And how should we think about your key assumptions for gross margin expansion heading into 2012? How much of that is PROMUS Element versus these other factors reversing perhaps?

Jeffrey D. Capello

Well, let me start with the fourth quarter. So as you look at the gross margins for the fourth quarter on a percentage basis, if you look at kind of the impact to gross margins, you can almost think of kind of the value improvement programs and the cost initiatives pretty much offset price. And really, the big delta is year-over-year. So price was negative. We take out cost every year. That's positive. Those 2 more or less offset one another from a margin percentage perspective. And so what we were then left with was a $42 million reserve, which is a sales returns reserve of $10 million and an inventory reserve of $32 million. That had a 200-basis-point impact to gross margins, negative kind of onetime impact to gross margins. We also had the divestiture of Neurovascular, which we've consistently said has weighed on gross margins by about 170 basis points. So it's really those 2 factors that compress gross margins. The good news is heading into 2012, those 2 things go away and we get the benefit of about 100 -- call it $150 million-ish operating improvement and gross margin improvement for the introduction of PROMUS Element. So if you do that as a percentage of revenue, that's a couple of hundred basis points. So that's why our guidance for gross margins, we've kind of guided 65 to 66 for this year. And absent kind of the benefits in the first quarter and the negative things in the fourth quarter, we pretty much hung in that range. Now we're putting out a slightly higher range for 2012, and we will end -- we expect we'll end 2012 above the high-end of that range and build off that gross margin trajectory.

Operator

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

David R. Lewis - Morgan Stanley, Research Division

Hank, I wanted to come back to some of your earlier introductory comments. You talked a lot more about the pipeline in much more specifics, and I guess it's been about a little over a year since the introduction of the POWER strategy. I guess as you think about this plethora of products in the pipeline and you think about the strategy and your stated goals of driving leverage, do you think you have allocated the appropriate amount of spend either in sales, marketing and R&D to drive the execution across those time lines and still deliver the same type of margins that you laid out a little over a year ago?

William H. Kucheman

Yes, I believe we have, David. I think the pipeline that you are beginning to sense and see is a result of -- we've gotten passed -- if you go back in time a little bit where the organization was internally focused a lot on in terms of some of the quality challenges that we've had, a lot of the organizational resources that we had at our disposal were focused on remediating that. They have now transitioned of getting back to what we love to do, and that's our focus on innovation. So saying that, we're spending roughly about 12% of -- on R&D. I think that's an appropriate percentage. The infrastructure that we have in terms of commercial channel is strong, particularly in the U.S. We're making incremental investments in the commercial infrastructure, especially in emerging markets as we've talked about previously. So one of the things I love about our situation is the fact that we have, especially in emerging markets, Asia Pac, we have the products. And I think you know, both those markets, if you talk specifically about India and China, are very much Interventional Cardiology markets. What we've lacked historically is the commercial infrastructure to deliver those products to the customer base. That infrastructure is building. It's being trained. And I think in the days and months and years to come, we'll see good execution that will drive growth.

David R. Lewis - Morgan Stanley, Research Division

And then just maybe one quick follow-up for Jeff. I mean, Jeff, last year emerging markets was incrementally a surprise headwind. I wonder, could you update us in terms of the investment in '11 versus the investment in '12? And is emerging market investment still a relative EBIT headwind? Or do we start getting leverage in the emerging markets or contribution leverage at the back half of '12?

Jeffrey D. Capello

Yes, it's a good question, David. So we will continue to invest. That's one of the reasons you'll see kind of slightly higher SG&A percentage in the first half of this year. We still have plans to add incremental reps, particularly in countries like India and China where we've gotten approvals or we expect to get approvals for certain regions. So you'll see a little bit more heaviness with respect to OpEx, after which the back half of the year, you should start to see both acceleration of revenue growth, which we really haven't seen yet despite the fact we had pretty good results in India and China. We're not seeing the results that we expect and in terms of getting more of an acceleration. And we're seeing signs that will occur in the back half of the year and start to take off. The other dynamic is that I think people are aware that we announced plans to build a manufacturing facility in China. So we have a little bit of headwind relative to cost to get that factory up and running in 2012. But that's more in the gross margin side.

Operator

Next question from the line of Bruce Nudell of Crédit Suisse.

Bruce M. Nudell - Crédit Suisse AG, Research Division

Jeff, one of the things -- or Hank, one of the things that was never totally clear to us and maybe you could kind of like frame for us is back at the Investor Day, there was about 800 bps of operating margin improvement. What sort of top line assumption kind of went with that over that period? And if, let's say, over that initial 3- or 4-year period revenues are more like 2%, what has that 800 bps become?

Jeffrey D. Capello

Yes, Bruce, that's a good question. So we were clear with people that our short-term objectives relative to revenue growth were kind of in the 2% to 4% range back in 2012, and then kind of the medium term were kind of 6% to 8%. So the period of time we're talking about in terms of the expansion of margin more in 2% to 4%, that was before the CRM market. CRM market was growing in the low single digits. Now we think it's kind of contracting globally in the mid single digits. So I think we've come up recently, said kind of 0% to 3% is kind of our objective in terms of the short term and in terms of growth, which is consistent with the range of guidance we've given out for 2012. So as long as we can drive revenue growth in kind of that low single digit perspective, we ought to be able to get a lot of the margin expansion because some of it -- for example, PROMUS Element is driven by just converting our PROMUS to PROMUS Element. The Plant Network Optimization is driven by taking care of existing volumes and converting them over. And the value improvement programs are 5% of gross costs. So where we'll get hit a little bit would be on the volume side. We won't get quite as much fixed cost leverage through gross margins. Conversely, through the SG&A line, a lot of the benefit is coming out of our restructuring initiatives, which really are not volume dependent at all. So we announced the $225 million and $275 million of restructuring plant in the second quarter of 2011, that really is agnostic to revenue. So we expect to be able to get a lot of that. Some of that we'll get in '12. Really, the majority starts to come through in '13. So we still think that there's ample opportunity even in a difficult environment to expand in margins. And as Hank has outlined in his presentation, we have been riveted on doing that.

Bruce M. Nudell - Crédit Suisse AG, Research Division

Terrific. And one other question I had is could you give us the kind of PCI growth rates for the U.S., Japan and the other international markets?

Jeffrey D. Capello

Sure. So if you look at kind of from a year-over-year perspective, units in the U.S. were kind of down in the low single digits. Europe, they were actually up in kind of the high single digits. Japan down low single digits. Emerging markets up in kind of the mid-teens.

Bruce M. Nudell - Crédit Suisse AG, Research Division

So worldwide, there was a lot of price pressure?

Jeffrey D. Capello

Worldwide, the price pressure was consistent, although we saw a better fourth quarter from a price erosion perspective in the U.S. than we've seen in the last 3 years that I've been here. So that's encouraging.

Operator

Next question from the line of Tao Levy, Collins Stewart.

Tao Levy - Collins Stewart LLC, Research Division

Just wanted to be clear, in the U.S. this year, are there any more PROMUS sales or are you completely done with PROMUS sales?

Jeffrey D. Capello

You mean in 2012?

Tao Levy - Collins Stewart LLC, Research Division

Yes, in 2012.

Jeffrey D. Capello

Well in 2012, we began the rollout. The rollout will take some time, and we would anticipate probably by kind of end of the first quarter, early second quarter we'll have full rollout. So we'll still have some sales in the first quarter with PROMUS and probably a short tail into the second quarter.

Tao Levy - Collins Stewart LLC, Research Division

Got you. Okay. And then when you look at the international ICD market, you did indicate it is a little bit weaker. Do you feel like you lost share there? I mean, obviously we need to wait for [indiscernible] to report but based on St. Jude's results, it looks like things fared a little bit worse for you there, and I just -- if you had any reasons behind that.

Jeffrey D. Capello

Yes, I think that's fair. I think part of that is we're in the midst of rolling out a whole new refresh of our ICD CRT-D platform. And I think in the rollout of that, we probably didn't hit the ground as hard and as fast as we thought we would have. And so I think that's one factor from an execution perspective which we're addressing right now. The other factor is other competitors have come out with some technology. So part of that is we expected some headwind relative to some other technology competitors had brought out. And now with the full rollout of our INCEPTA, ENERGEN and PUNCTUA lines, we expect to kind of take some share now back, now that we have it fully ruled out.

Operator

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

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

I wonder if I could ask sort of on the drug-eluting stent side. We've [indiscernible] in the market and obviously that was an opportunity, but you at several times talked about the ability perhaps go after this additional part of their Interventional Cardiology business. Are you starting to see any of that come through for you yet?

William H. Kucheman

I think -- a great question. In the U.S., the answer to that is yes. We have -- we had a goal set for ourselves in terms of what we wanted to garner from their departure from the market. And we hit that goal and, in fact, exceeded it. In the international markets, it's a ball in play. What I mean by that is the tender process and many of the regions outside the U.S. kind of gate when you can take advantage of those opportunities. Those tenders will come off over the course of time. And we think the full potential of what we can garner from the quarter's opportunity outside the United States will be realized starting this year and quite frankly, in some regions moving into 2013.

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

Okay. And maybe just ask a bit of a product question, a part of the strategy you guys laid out back in 2010, the CRV idea with the combining of the Interventional Cardiology and the CRM sales management and ultimately sales forces. As you see that play out, have you seen much of an impact in a sense in your ability to perhaps sell in the U.S. market? Is there perhaps a risk that maybe you've been a little too aggressive in pursuing that as to what's actually happening on the ground with actually individual clinician behavior?

William H. Kucheman

Well, I think a great question again. I think my answer is going to be multidimensional. First, in terms of I think what you're alluding to is the alignment of physicians within healthcare institutions. Actually, from the standpoint of why we did what we did in terms of CRV, that was one of the trends that we saw in the horizon that we wanted to address. And what we are seeing, and I think this is evident by the success that we've had with our CrossCare Program, where we've increased the number of cardiovascular service line deals, so specifically kind of a bundled deal between CRM and CV, that's increased fairly dramatically over the past year. So I would say I consider that a success. Secondly, if you look at how we've organized ourselves, we have a good percentage of the CRV sales organization in the United States that are now engaged in cross selling. And one example I'll give you is one of our reps on the IC side in the fourth quarter had 11 implants. Historically, that has not been in play. But it's more of a team orientation that I think is growing in its importance within the commercial channel and has been well received by our customers.

Operator

And the next question from the line of Bob Hopkins, Bank of America.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Jeff, just to start out, I'd love to continue with your 2012 guidance. If you could give us a sense as to how much of the $650 million to $750 million is -- you anticipate being realized in 2012, and if you're willing to break that out kind of between COGS and SG&A.

Jeffrey D. Capello

Sure. Give me a minute here. I've got that right in front of me.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

On a gross basis.

Jeffrey D. Capello

Yes, sure. I'll do it in total and then try to give you some detail relative to gross margin and SG&A. So as you look at 2012, just going through the pieces, the 5% reduction in cost of goods sold is a program we have every year. It's an ongoing program and frankly, I think we've got one of the best manufacturing organizations around. So you can consistently count on them taking out 5% of cost of goods sold. That stays in all year. So that was in '11, that will be in '12. The PROMUS profit share, we said it was a $200 million opportunity. The vast majority, I said $150 million, that won't be far off for 2012. That will sit in '12, and then we'll get a benefit for that relative to '13, kind of the tail of that. Those are the 2 big pieces relative to gross margin benefit for '12 and '13. And then as we look at the restructuring, which is more of an SG&A, it really started a little bit in '10. We'll get a piece of the $225 million to $275 million in '12, a small piece. And then we'll get the lion's share kind of in '13 and '14. So as you look at kind of what I think some people have said, well, all the benefit of $650 million to $750 million really happens in '12, that's really not accurate. The benefit -- the large benefit of PROMUS Element will occur in '12, but the vast majority of the restructuring benefit will happen in '13 and then into '14. And you've got to remember that the VIP programs continue every year as well. And then you've got project transformation, which is reducing R&D costs, that's spread almost equally over the year. So we do have -- we always said that the $650 million to $750 million would start in earnest at the end of '11 and be kind of '12 and '13 and part of '14 benefits. And that's still a plan. And as Hank has highlighted and I'll reiterate, that is still a plan.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

The Plant Optimization?

Jeffrey D. Capello

Yes. And the Plant Network Optimization program, the majority of that really will hit in '12, and there will be a small tail of that in '13.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

And then just as my follow-up. I was wondering if I could get a couple of little -- just little data points. Could you give us the EMEA PROMUS Element share in the quarter? And then I just want to make sure I heard you right. On that bulk order for ICDs, is that in the $10 million to $15 million range? And was it a negative impact this quarter?

Jeffrey D. Capello

So we're not going to get in on the specifics on both. We're not going to comment on. I don't think anybody is doing that. So we'll pass on that comment. Relative to the share, in our share, it was relatively slightly unchanged relative to DES sequentially from the third to the fourth quarter. And the vast majority of that was PROMUS Element.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

And then buybacks, could you just comment on why those seem to tail off so much in 2012? Do you anticipate acquisitions? Is that just a function of what you have authorized? Or just -- you bought back more in this quarter than you're anticipating for next year. So I just wanted to put some perspective around that.

Jeffrey D. Capello

Yes, I think as we continue to roll out the strategy and get more specific with some of the targets we're looking at and given the environment that we're in, we're anticipating that it may become a slightly better environment from a business development perspective in terms of targets that are available that may not have been available historically. So -- but I think why I threw that out there is we're getting a lot of questions saying, will you buy back? I think we will buy back and I think we're comfortable saying we will use at least 1/4 of our cash flow to do buybacks. And then thereafter, it will all be governed by what's available and what we can get done at an appropriate price from a business development perspective.

Operator

And the next question from the line of Derrick Sung of Sanford Bernstein.

Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division

I wanted to go back to your outlook for the ICD market in 2012. I thought I heard you say that the upper end of your guidance assumes the ICD market doesn't deteriorate further. So are you implying that kind of midpoint of your guidance, your baseline case is that the ICD market does deteriorate further? And maybe if you can just kind of give us your baseline kind of outlook for pricing and volume for the ICD market.

Jeffrey D. Capello

Yes, so Derrick, it's Jeff. So relative to our guidance, the upper end of the guidance assumes that from an ICD perspective that, that market flattens out in the back half of '12. So it started kind of eroding in the second quarter. We thought it was down mid-teens in Q3 and Q4. We're assuming that we have headwinds in Q1 and then partially Q2. And then almost like on a same-store sales basis against a comparable low benchmark, it kind of flattens out in the back half. So that's what we've assumed relative to that.

Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division

Okay. And how about price -- sort of your pricing assumptions for the market as well? And then maybe you could do the same -- if you could do the same for the drug-eluting stent market as well is my follow-up.

Jeffrey D. Capello

Yes. So pricing, we're assuming pricing is down mid single digits here in the U.S., a little higher than that outside the U.S. and CRM. And then relative to DS, we've assumed kind of up per single-digit price erosion both in the U.S. and outside the U.S.

Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division

And one other question, in 2013, as you look forward towards the med tech tax, can you talk a little bit about how you expect to offset that? And do you still expect to be able to see sort of the same kind of growth trajectory and absorb that tax? Or what are your thoughts relative to that?

Jeffrey D. Capello

Well, I think we've been very clear from the beginning that this tax is going to put a lot of pressure on all corporations. And assuming that we're going to pass it through to a hospital group that's under pressure that's going to get their tax, I think it's optimistic. So we're assuming we're going to have to be kind of tighter from an OpEx perspective. And that was always in our plans back when we did the Investor Day, and that's one of the reasons why we're being pretty aggressive on the cost side. It's because we're assuming we're going to have to manage our way through that.

Operator

And our final question comes from the line of Matthew Dodds, Citigroup.

Matthew J. Dodds - Citigroup Inc, Research Division

Just one quick question, Jeff, for you. On amortization interest, is the current run rate for the fourth quarter the $96 million amortization, is that a good carry through for 2012?

Jeffrey D. Capello

Yes. When you say amortization, your amortization of intangibles, not interest, right? That's what you're looking for?

Matthew J. Dodds - Citigroup Inc, Research Division

Yes.

Jeffrey D. Capello

Okay. Amortization is about $100 million per quarter.

Matthew J. Dodds - Citigroup Inc, Research Division

Okay. And then for interest, it seems like when you said other would be roughly flat year-over-year, you're assuming the interest is also run rate around $70 million for next year per quarter?

Jeffrey D. Capello

Exactly flat with the current run rate.

Matthew J. Dodds - Citigroup Inc, Research Division

Okay. Then just 2 quick product questions for U.S. In 2012, do you expect to start clinical trials for an MRI compatible pacemaker and quadripolar leads early 2013?

William H. Kucheman

Right now, we do not have a plan to start a clinical trial MRI Conditional in '12.

Matthew J. Dodds - Citigroup Inc, Research Division

And how about on quadripolar leads for ICDs?

William H. Kucheman

I don't believe so. Dr. Stein, are you on the phone? Can you confirm that?

Ken Stein

Yes, I'm on. Not a chronic study. We already have started some acute testing on quadripolar leads.

Sean Wirtjes

Okay with that, we'll conclude the call. Thanks for joining us today. We appreciate your interest in Boston Scientific. Before you disconnect, Rochelle will give you all the pertinent details for the replay.

Operator

Okay, thank you. And ladies and gentlemen, this conference will be made available for replay after 11:00 a.m. today until February 16 at midnight. You may access AT&T Executive playback service at any time by dialing 1 (800) 475-6701, entering the access code 231996. International participants, dial 1 (320) 365-3844. And again, that access is 231996. And that does conclude our conference for today. Thank you for your participation and for using AT&T Executive teleconference service. You may now disconnect.

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