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Johnson & Johnson (NYSE:JNJ)

Q4 2011 Earnings Call

January 24, 2012 8:30 am ET

Executives

William C. Weldon - Chairman, Chief Executive Officer, Chairman of Executive Committee and Chairman of Finance Committee

Dominic J. Caruso - Chief Financial Officer, Corporate Vice President of Finance and Member of Executive Committee

Louise Mehrotra - Vice President of Investor Relations

Analysts

Charles Anthony Butler - Barclays Capital, Research Division

Matthew J. Dodds - Citigroup Inc, Research Division

Matthew S. Miksic - Piper Jaffray Companies, Research Division

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

Frederick A. Wise - Leerink Swann LLC, Research Division

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

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

Rajeev Jashnani - UBS Investment Bank, Research Division

Kristen M. Stewart - Deutsche Bank AG, Research Division

David R. Lewis - Morgan Stanley, Research Division

Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division

Catherine J. Arnold - Crédit Suisse AG, Research Division

Louise Mehrotra

Good morning and welcome. I'm Louise Mehrotra, Vice President of Investor Relations for Johnson & Johnson, and it is my pleasure this morning to review our business results for the fourth quarter and full year of 2011.

Joining me on the podium today are Bill Weldon, Chairman of the Board of Directors and Chief Executive Officer of Johnson & Johnson; and Dominic Caruso, Vice President, Finance and Chief Financial Officer. A few logistics before we get into the details. The audio and visuals from this presentation are being made available to a broader audience via a webcast accessible through the Investor Relations section of the Johnson & Johnson website.

I'll begin by briefly reviewing highlights of the fourth quarter for the Corporation and highlights for our 3 business segments. Following my remarks, Bill Weldon will comment on the 2011 results and provide a strategic outlook for the company. At the completion of Bill's remarks, Dominic Caruso will provide some additional commentary on the fourth quarter financial results and guidance for the full year of 2012. We will then open the meeting to your questions. We will conclude our formal presentation at approximately 9:30 and following Q&A with some final remarks by Bill, will conclude the meeting around 10 a.m.

Included with the press release that was sent to the investment community earlier this morning is the schedule showing sales for major products and/or businesses to facilitate updating new models. These are also available on the Johnson & Johnson website, as is the press release.

Before I get into the results, let me remind you that some of the statements made during this meeting may be considered forward-looking statements. The 10-K for the fiscal year 2010 identify certain factors that could cause the company's actual results to differ materially from those projected in any forward-looking statements made this morning. The company does not undertake to update any forward-looking statements as a result of new information or future events or developments. The 10-K is available through the company or online.

Last item. During the review, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. Tables reconciling these measures to the most comparable GAAP measures are available in the press release or on the Johnson & Johnson website at jnj.investor.com.

Now I would like to review our results for the fourth quarter of 2011. If you refer to your copy of the press release, let's begin with the schedule titled Supplementary Sales Data by Geographic Area. Worldwide sales to customers were $16.3 billion for the fourth quarter of 2011, up 3.9% as compared to the fourth quarter of 2010. On an operational basis, sales were up 4% and currency had a negative impact of 0.1%. In the U.S., sales decreased 3.4%. In regions outside the U.S., our operational growth was 10.4% while the effective currency exchange rates negatively impacted our reported results by 0.2 points. The Western Hemisphere excluding the U.S. grew by 17.8% operationally, while Europe grew 9.4% operationally. The Asia-Pacific, Africa region grew 7.9% on an operational basis.

The strong growth in the regions outside the U.S. was due to the success of new product launches, the impact of the amended agreement with Merck regarding REMICADE and SIMPONI, as well as acquisitions such as Crucell. I will discuss these items in more detail in the segment commentary.

If you'll now turn to the consolidated statement of earnings. Net earnings were $218 million compared to $1.9 billion in the same period in 2010. Earnings per share were $0.08 versus $0.70 a year ago. Please direct your attention to the box section of the schedule where we have provided earnings adjusted to exclude special items.

As referenced in the accompanying table on non-GAAP measures, fourth quarter net earnings were adjusted to exclude items such as product liability expenses, the net impact of litigation settlement, costs associated with the DePuy ASR Hip recall program, and an adjustment to the value of the currency option and cost related to the planned acquisition of Synthes, Inc. Net earnings on an adjusted basis were $3.1 billion and earnings per share were $1.13, up 9.3% and 9.7% respectively versus the fourth quarter of 2010.

I would now like to make some additional comments relative to the components leading to earnings before we move on to the segment highlights. For the fourth quarter, cost of goods sold at 32.8% of sales was 60 basis points higher than the same period in 2010, primarily due to the impact of the Crucell business, as well as the ongoing remediation work in our OTC business.

Fourth quarter selling, marketing and administrative expenses at 33.6% of sales were up 50 basis points. As we discussed last quarter, expenses including investment spending behind our new products, as well as the fee on our branded pharmaceutical products included as part of the U.S. Health Care Reform legislation. Our investment in research and development as a percent of sales was 13.3%, 60 basis points higher than the fourth quarter of 2010, primarily due to the impact of the recent collaboration agreement with Pharmacyclics. Interest expense net of interest income of $148 million was up $34 million versus the fourth quarter of 2010 due to a higher average debt balance. Other expense net of other income was $2.9 billion in the fourth quarter of 2011 compared to $1.1 billion in the same period last year. Excluding special items, other income net of other expense was $501 million compared to $123 million in 2010. Excluding special items, taxes were 14.4% in the fourth quarter of 2011, bringing our annual effective tax rate to 20.1%.

Dominic will provide some additional commentary on both other income and taxes in his remarks.

Now turning to the consolidated statement of earnings for the full year of 2011. Consolidated sales to customers for the year 2011 were $65 billion, an increase of 5.6% as compared to the same period a year ago. On an annual basis, sales grew 2.8 points operationally and currency had a positive impact of 2.8 points. On the consolidated statement of annual earnings, I'd like to draw your attention to the boxed section. Adjusted net earnings of $13.9 billion in 2011 compares to adjusted net earnings of $13.3 billion in 2010. Adjusted earnings per share at $5 grew 5% versus the 2010 results.

Turning now to business segment highlights, please refer to the supplementary sales schedule highlighting major products or businesses for the fourth quarter of 2011. I'll begin with the Consumer segment. Worldwide Consumer segment sales for the fourth quarter of 2011 of $3.7 billion increased 1.6% as compared to the same period last year. On an operational basis, sales increased 2.7%, while the impact of currency was negative 1.1%. U.S. sales were up 2.4%, while international sales grew 2.8% on an operational basis. For the fourth quarter of 2011, sales for the OTC Pharmaceuticals and Nutritionals increased 4.6% on an operational basis compared to the same period in 2010. Sales in the U.S. were down 2.9% due to supply constraints on certain products, partially offset by the return to the market of other key products and the impact of the acquisition of the full ownership rights to certain digestive health products. McNeil-PPC is operating under a Consent Decree covering the manufacturing facilities in Las Piedras, Puerto Rico and Fort Washington and Lancaster, Pennsylvania. McNeil continues to operate the manufacturing facilities in Las Piedras and Lancaster, however, production volumes in some of these facilities have been impacted due to the additional review and approval processes required. Regarding the products previously produced at Fort Washington facility, McNeil continues to work on the resiting of these products to other facilities. McNeil is making progress on the validations at these sites and a modest amount of products returned to the market in fourth quarter of 2011. Product will continue to be reintroduced throughout 2012.

Sales outside the U.S. were up 8.7% on an operational basis due to the recent acquisition of the DOKTOR MOM and RINZA brands from J B Chemicals & Pharmaceuticals and the successful launch of new smoking-cessation products. Our Skin Care business grew 6.6% on an operational basis in the fourth quarter of 2011, with sales in the U.S. up 14.5% and sales outside the U.S. up 1.3% on operational business, primarily due to the success of NEUTROGENA new product launches. Baby care products achieved operational growth of 0.6% when compared to the fourth quarter of 2010 due to increased sales of hair care and cleansers, partially offset by lower sales of lotions and creams. Women's Health declined 9.5% on an operational basis. Sales in the U.S. were down 24.6%, while sales outside the U.S. were down 4% on an operational basis. The sales decline this quarter was primarily due to the impact of divestitures of certain brands. Sales in the Oral Care business increased 7% on an operational basis, with the U.S. up 16.1% due to the success of recently launched LISTERINE products. Wound Care/Other was down 0.5% on an operational basis compared to the same period last year, impacted by the divestiture of PURELL. That completes the review of the Consumer segment, and I'll now review highlights for the Pharmaceuticals segment.

Worldwide net sales for the fourth quarter of $6.1 billion increased 6.7% versus the same period last year. On an operational basis, sales increased 6.6% with a positive currency impact of 0.1 points. Sales in the U.S. decreased 8.3%, while sales outside the U.S. increased on an operational basis by 25%. The loss of marketing exclusivity for LEVAQUIN in June negatively impacted worldwide pharmaceutical operational sales growth by approximately 8 points, and U.S. growth by approximately 13 points. Positively impacting the sales growth in the quarter were sales related to the recent acquisition of Crucell and the impact of the amended agreement with Merck, partially offset by divestitures. Excluding the items mentioned as well as the impact of inventory changes, the underlying worldwide operational growth was approximately 9%.

Now reviewing the major products. Sales in the U.S. of our key immunology products which include REMICADE, STELARA and SIMPONI were up nearly 20% versus 2010 with growth for REMICADE at 14.3%, STELARA at over 70% and SIMPONI at 10.7%. With this strong growth, we continue to be the market leader in immunology in the U.S. On a combined basis, export and international sales of REMICADE increased nearly 70% due to the impact of the amended agreement with Merck, complemented by international market growth. As a reminder, we began recording sales of products from the territories relinquished by Merck in the third quarter and the amended distribution agreement division of contribution income split of 50% also went into effect July 1, 2011.

PROCRIT/EPREX declined operationally by 22.6% during the quarter as compared to the same quarter last year with PROCRIT down 29.3%, due primarily to a double-digit market decline in volume. EPREX was down 13.7% operationally due to increased competition. RISPERDAL CONSTA, a long-acting injectable antipsychotic, was down 0.2% on an operational basis. Sales in the U.S. were up 2.9%, while sales outside the U.S. were down 1.3% operationally. The total sales of our long-acting injectables, including INVEGA SUSTENNA, increased nearly 20% operationally versus a year ago due to an increase in combined market share. VELCADE is a treatment for multiple myeloma, for which we have commercialization rights in Europe and the rest of the world outside the U.S. Operational sales growth was 22.4% with strong growth in all major regions. PREZISTA, a protease inhibitor for the treatment of HIV grew operationally 34.2%, with the U.S. increasing 28.8% and the sales outside the U.S. increasing 39% operationally, due to very strong momentum in share. CONCERTA, a product for attention deficit hyperactivity disorder, declined 25.4% operationally in the fourth quarter as compared to the same period last year, with sales in the U.S. down 40.6%. The supply and distribution agreement with Watson Laboratories Inc. to distribute an authorized generic version of CONCERTA in the U.S. became effective May 1, 2011. According to IMS, the authorized generic has captured approximately 80% of the combined CONCERTA script share. Sales outside the U.S. were up 11.6% operationally, driven by strong growth in most major regions.

ACIPHEX/PARIET is a proton pump inhibitor that we co-market with ASI. On an operational basis sales were up 1%, with the U.S. down 7.6% due to the impact of generics in the category. Sales outside the U.S. increased 8.7%, with strong growth across the major regions.

DOXIL/CAELYX declined 34.1% on an operational basis in the quarter. Based on the update in December from our third-party manufacturing about the estimated time frame for resuming its manufacturing operations, we do not anticipate any DOXIL/CAELYX produced at the supplier's facility to be available until late 2012. Restoring a reliable supply continues to be our most urgent priority, and we continue to explore a variety of options to bring a consistent supply of DOXIL back to patients and physicians as quickly as possible.

INVEGA, an atypical antipsychotic grew 7.8% on an operational basis, with the U.S. down 5.7% due to lower market share. Sales outside the U.S. were up 28.3%, primarily due to the recent approval in Japan.

INTELENCE, an NNRTI for the treatment of HIV grew 27.7% on a reported basis, with the U.S. up 32.4% and the sales outside the U.S. up 22.6%, with market share increases achieved in the major regions.

As an update on the pharmaceutical pipeline regarding XARELTO, on December 29, we submitted an sNDA for an indication to reduce the risk of thrombotic cardiovascular events in patients with ACS, and we anticipate the FDA's decision on that application later this year. In the second quarter, we plan to file an sNDA for the treatment and secondary prevention of deep vein thrombosis and pulmonary embolism based on the completion of the Einstein trial. Also, after further consultation with the FDA, we have decided not to file an sNDA for the use of XARELTO in the medically ill population at this time, based on the results of the Magellan trial. Both results were initially reported last April at the American College of Cardiology Conference.

We continue to believe that XARELTO has the potential to address an important unmet medical need in this patient population and we are currently evaluating our options to pursue this indication, as well as several others where XARELTO may have a beneficial impact for the care of patients. In addition, the European commission granted marketing authorization for EDURANT as a once daily treatment in combination with other antiretroviral agents for HIV-1 infection and treatment-naïve adult patients.

We filed for NUCYNTA ER for the management of neuropathic pain associated with diabetic peripheral neuropathy. The collaboration agreement with Pharmacyclics to jointly develop and market the anticancer compound PCI-32765 was completed, and we recently entered into a co-development and co-commercialization agreement with GlaxoSmithKline for sirukumab. Sirukumab targets the interleukin (NYSE:IL)-6 and has completed a 2-part Phase II study for rheumatoid arthritis demonstrating promising results. We are pleased to have GSK as an experienced partner who shares our enthusiasm about (IL)-6 as an important target in RA, and look forward to moving sirukumab into Phase III development in 2012. I'll now review the Medical Devices & Diagnostics segment results.

Worldwide Medical Devices & Diagnostics segment sales of $6.5 billion grew 2.4% operationally, as compared to the same period in 2010. Currency had a positive impact of 0.3 points, resulting in total sales increase of 2.7%. Sales in the U.S. were down 0.4%, while sales outside the U.S. increased on an operational basis by 4.6%. Excluding drug-eluting stent, worldwide sales increased approximately 4% on an operational basis.

Now turning to the MD&D businesses, starting with Cardiovascular Care. Cardiovascular Care sales were down 14.5% operationally, with U.S. down 22.4%, and sales outside the U.S. down 9.6% operationally. Excluding drug-eluting stent, Cardiovascular Care sales grew approximately 2% on an operational basis. Biosense Webster, our Electrophysiology business, achieved operational growth of 11% in the quarter. The impact on disposables utilization due to the breadth of the installed base of Carto 3, complemented by new launches, made strong contributions to the results. This increase was partially offset by lower sales of endovascular products due to increased competition and a slower market.

The DePuy business had operational growth of 0.3% when compared to the same period in 2010, with the U.S. down 4% and the business outside U.S. growing by 5.7% operationally. Strong sales in sports medicine were partially offset by lower sales for knee and spine products. Results continue to be impacted by low single-digit price erosion, partially offset by positive mix. Operationally, hips were up 1% worldwide, driven by 3% operational growth outside the U.S., attributed to heads and cement with stems. In the U.S., hips were essentially flat. Knees declined 3% on an operational basis, with U.S. down 5% due to increased competition and a softer market. Sales outside U.S. were flat. The market was estimated to have declined modestly in the third quarter, with U.S. down 3% and the worldwide market down 1%. It is estimated that this softness in the market continued into the fourth quarter. Spine was down 3% on an operational basis with U.S. down 7%, primarily due to continued pressure on price. Sales outside U.S. were up 4%.

The Diabetes Care business achieved operational sales growth of 4.1% in the fourth quarter of 2011, with the U.S. business up 3.8% and the business outside the U.S. growing 4.4% operationally. Strong sales in emerging markets and favorable mix in the U.S. drove the results this quarter.

Ethicon worldwide sales grew operationally by 7.3% with the U.S. up 7%, and sales outside the U.S. up 7.6% operationally. Drivers of the increase include sutures with strong emerging market growth, the strong uptick of the recently launched products, SECURESTRAP and PHYSIOMESH, as well as double-digit growth in Biosurgical. Ethicon Endo-Surgery achieved operational growth of 5.6% in the fourth quarter of 2011, with the U.S. sales up 4.6% and the sales outside the U.S. up 6.3% operationally. In the U.S., growth was driven by increased market share for advanced sterilization products and our recently acquired SterilMed business. Outside the U.S., new product launches and the continued shift to minimally invasive surgery drove double-digit growth for HARMONIC products and strong results for the Endo products.

The launch of the advanced energy Super Jaw and Gen-2 generator also contributed to the results for the quarter. Ortho Clinical Diagnostics grew 3.1% on an operational basis in the fourth quarter, with sales in the U.S. up 1.4%, and sales outside the U.S. up 4.8% operationally. Sales growth was driven by the continued adoption of the VITROS 5600 platform, partially offset by lower donor screening sales.

Rounding up the review of the Medical Devices & Diagnostics segment, our Vision Care business achieved operational sales growth of 5.8% in the fourth quarter compared to the same period last year. Sales in the U.S. increased 0.9%, while sales outside the U.S. increased 8.2% on an operational basis. Double-digit growth in both daily lenses and astigmatism lenses were partially offset by softer sales of reusable lenses.

That completes highlights for the Medical Devices & Diagnostics segment and concludes the segment highlights for Johnson & Johnson's fourth quarter of 2011.

It is now my pleasure to introduce Bill Weldon. Bill?

William C. Weldon

Thanks, Louise, and thank you all for being here today. Let me start by saying I'm very pleased to be here with you to share our latest business results, discuss the way we are shaping and leading the future of healthcare. Thanks to the extraordinary achievements and dedication of our people, we are better positioned today than in any time in recent history to deliver sustainable growth for our shareholders and meaningful innovations for our patients and customers. After 2 challenging years, I am proud to say Johnson & Johnson returned to delivering sales growth in 2011, and we grew adjusted earnings for the 28th consecutive year. We continue to strengthen our platform for leadership and profitable growth through new product launches, strong pipelines and investments in key growth areas. Though we continue to face challenging macroeconomic conditions, our ongoing investments have us well positioned to grow and increase our market leadership in one of the most important and rewarding industries in the world. Today I'll begin by discussing our business highlights for 2011, then I'll review the state of the global healthcare market and discuss 3 major strategies for delivering sustainable growth to Johnson & Johnson.

As our theme this year suggests, we are talking about how Johnson & Johnson is delivering sustainable growth built by meaningful innovations in healthcare. All the work we do is focused on making a difference to people, patients and customers in a personal way, and that's what our credo has reminded us for decades. From the breakthrough of prostate cancer drug that extends a grandfather's life, to the new replacement that brings the joy of walking and exercise back to someone's mother, to the newest soap and shampoo that make bath time a memorable moment for someone's child; these are all meaningful innovations to our patients and customers, and this year's product launches and approvals are a powerful reminder of that mission.

When I talked to you in recent years, we have been clear about the opportunities and challenges we saw in the market and how our company was positioned to shape and address them. Several years ago, we started on a journey. We set out to build on the strong foundation at Johnson & Johnson and sustain our track record of growth, even as we prepared to address the patent expirations and market issues that we can foresee. We updated you on our enterprise strategy and how our market leadership was expanding in many core businesses and the progress we were making in new growth markets and geographies. We understood that in such a dynamic, global and highly regulated industry as healthcare, there would always be new issues, increasing competition and rapidly evolving economic conditions to contend with. Some we could predict, like the major patent expirations for RISPERDAL and TOPAMAX, with combined peak year sales of over $6 billion.

Others could not be as easily foreseen, like the severe economic decline, the tightening of consumer spending and healthcare budgets, unexpected challenges with our ESA, DePuy ASR and drug-eluting stent products, as well as quality issues at McNeill. At this point in our history, I am especially excited and energized because we have turned the quarter on a particularly difficult period for our company. The headwinds from patent expirations, portfolio choices and OTC quality issues I have mentioned are being or have been addressed. At the same time, we are focused on significant unmet healthcare needs with innovations that could improve the lives of millions of people. Our pipelines are converting into new products and moving into the market with excellent results. And our ongoing investments in emerging markets are driving growth. Throughout this journey, our management team and employees have taken critical actions to preserve the core values and strengths of our business, while continuing to focus on the long-term health of the company and its ability to serve its shareholders.

We continue to invest in R&D, nearly $37 billion over the last 5 years. This produced 9 major approvals for new pharmaceutical products in the U.S., and many other exciting innovations across our other businesses. Products like STELARA and SIMPONI in immunology, PREZISTA and INTELENCE in HIV, ZYTIGA in oncology, combined with constant innovation and important medical device and consumer platforms such as contact lenses, electrophysiology, advanced energy, biosurgicals, oral care and skin care. We have replenished or advanced our pipelines with exciting new compounds and technologies like the Fibrin Pad for hemostasis, Canagliflozin for diabetes, and bapineuzumab for Alzheimer's disease.

We also made necessary restructurings to our business to manage our cost structure, simplify our operations and ensure the most efficient use of our capital for the long-term benefit of patients and shareholders. With our focus on financial discipline, the capital -- debt capital has been returned to shareholders in the form of dividends and share repurchases. It has also been used for important long-term investments and strategic alliances and acquisitions like Pfizer Consumer Healthcare and Dabao Consumer business, Crucell and Elon in our Pharmaceuticals business and the pending acquisition of Synthes in the Medical Devices & Diagnostics business.

Manufacturing issues and recalls have been a serious disappointment for all of us. But through it all, we have remained committed to retaining the trust of our patients and customers. We have taken responsibility and instituted new measures to ensure that our products live up to the high-quality standards that our customers expect and deserve. When I look back at how we phased into this period of industry and global change and how we have managed, I'm very proud of the people at Johnson & Johnson. They have shown the ingenuity, resiliency, tenacity, integrity and compassion that you would expect of a global leader in human healthcare as part of our DNA and a testament to the 125-year heritage that we celebrated this past year. The fruits of these efforts are now being born out, and I feel very good about where we are and where we're going. Now let me focus on 2011, and the most recent highlights.

For the year we delivered solid financial results, we saw a 13% increase in operational growth in emerging markets, we generated significant free cash flow while maintaining a AAA credit rating, we invested more than $7.5 billion in R&D and advanced robust pipelines across all 3 segments of our business, we maintained a disciplined approach to portfolio management, we also dealt with difficult issues in a responsible manner by resolving certain litigation matters and addressing the McNeil consumer recalls. We maintained our focus on market leadership, especially in high-growth areas, with new products and innovations, and as the global economy and market conditions improve, we are well positioned for long-term growth.

As you can see here, our sales for 2011 increased by 5.6%, 2.8% operationally, reflecting the strength of our new product launches in our Pharmaceutical business, steady performance across our MD&D franchises, science-based innovation and consumer and strong growth in emerging markets. With our continued focus on financial discipline, our adjusted earnings were $13.9 billion and adjusted EPS was $5 or 5% increase. We also generated significant free cash flow of approximately $11.4 billion. Thanks to our financial discipline and the people of Johnson & Johnson, we extended our track record of adjusted earnings increase to 28 years. We also had 49 consecutive years of dividend increases, making us 1 of only 5 companies in the S&P 100 to achieve that record.

In 2011, we strengthened our portfolios and leadership positions in many areas like immunology, oncology, surgical devices and emerging markets. And we used our focus on scientific innovations to maintain or build share in other key growth markets. These innovations addressed clear patient and customer needs. In fact, approximately 70% of our sales are from products with #1 or #2 global market share positions, and approximately 1/4 of our sales last year came from new products that were introduced in the past 5 years. We remain leaders in important healthcare markets with a focus on meaningful innovations for patients and customers.

Solid and consistent returns to shareholders have been a hallmark of Johnson & Johnson. Founded in 1886 and with 67 years of being publicly traded, Johnson & Johnson has been through its share of short-term economic and business challenges. And yet with the long-term management focus, we have remained a solid investment choice for decades. During 2011, we generated a one-year total return -- shareholder return of nearly 10%, exceeding the S&P 500 and Dow Jones index and over longer time frames, we continue to compare favorably to those indices.

Now let me take a deeper dive in our 3 business segments and 2011 results. Pharmaceuticals generated $24.4 billion or 37% of our total sales. It had strong operational growth of 6.2%, driven by recently launched products like STELARA, SIMPONI, ZYTIGA, INCIVO and INVEGA SUSTENNA. Meanwhile Medical Devices & Diagnostics, our largest segment, generated $25.8 billion or 40% of our total. It had operational growth of just under 2%. And Consumer generated $14.9 billion in revenue or 23% of our total, and saw a modest operational decline due to the McNeil recalls and continued softening in the general economy. Operating profit for 2011 excluding special items was $18.3 billion, an increase of $700 million over the prior year. As a percent of sales, operating profit was a 28.2%, a modest decline due primarily to ongoing remediation activities in the OTC business.

In Johnson & Johnson, we have 3 very different but complementary stories going on in our business segments this year which speak to the unique strength of our broad-based and healthcare. Our Pharmaceuticals business is resurgent. We have gotten beyond the most significant patent expirations for our business and are poised to accelerate growth, thanks to our recent product launches in one of the strongest pipelines in the industry. With $24 billion in sales, we are the 8th largest pharmaceuticals business in the world and the 6th largest biotech business as part of that. Excluding the impact of generic competition as well as recent acquisitions and divestitures, our operation sales growth would have been 7%.

Through 2011, we built on the continued success of recently introduced products, which put our business back into a strong growth trajectory and continued to strengthen our leadership position in core therapeutic areas like immunology, infectious disease and oncology. And when you look at the combined sales of new products launched between 2009 and 2011, Johnson & Johnson is leading the U.S. in new pharmaceutical product sales. We also strengthened our immunology leadership and sales in emerging markets by amending our global distribution agreement with Merck on our largest selling products, REMICADE and SIMPONI.

In terms of pipeline progress in 2011, we were the U.S. leader in new molecular entity approvals with 3; ZYTIGA in oncology, XARELTO in cardiovascular disease and EDURANT in HIV. We also received approval of INCIVO in Europe for hepatitis C, which is marketed by our strategic partner Vertex Pharmaceuticals in the United States. We also completed the acquisition of Crucell to stake out a key leadership position in vaccines, and we continue to seek out new collaborations with companies like Pharmacyclics, where we'll jointly develop and market an anticancer compound focused on building our strength in oncology.

All this progress in the Pharmaceuticals business is the result of our commitment to continue investing in product launches and the pipeline even as the business faced many challenges. We have been transforming our portfolio of pharmaceutical products to reduce the past reliance on more mature products and staying focused on differentiated medicines in 5 therapeutic areas. On this slide, you'll see how we expect that portfolio to increasingly and significantly consist of the most recently launched and core growth products creating a more balanced, healthier and revitalized portfolio. We are also in a more favorable competitive position with many significant patent expirations behind us. The impact on our sales over the next few years from patent expirations will be less than that of our major competitors. This transformation and positioning has us feeling very good about our Pharmaceuticals business.

Meanwhile, Medical Devices & Diagnostics is continuing to strengthen its global capabilities and pipelines during a more challenging slower growth period by investing in key growth businesses and emerging markets. With $26 billion in sales, MD&D remains the largest medical device business in the world. Excluding the sales of drug-eluting stents which we exited at the end of 2011, operational sales growth was a healthy 3% when considering the economic and pricing pressures in these markets.

Meanwhile, the current challenges in several MD&D markets, as well as our own issues with the DePuy ASR hip have been well documented. Eastern austerity measures -- European austerity measures, pricing pressures and a slowdown in elective surgeries have all contributed to more tempered growth rates. Despite these challenges, our MD&D businesses are competing well in a market that has undergone dynamic change. In 2011, MD&D showed strong double-digit growth in emerging markets. We introduced many innovative products, for example in Asia-Pacific and Europe, we have been rolling out one-day ACUVUE MOIST for astigmatism. We've also continued the global expansion of our highly accurate OneTouch Verio blood glucose-monitoring platform for diabetes patients. The OneTouch Verio system, which was introduced in Canada last September, has just been launched in the U.S. this month and we plan to launch it globally in the near future. We continue to advance breakthrough products through the regulatory process. In fact, 75% of the MD&D pipeline advanced to its next major milestone in 2011. Breakthroughs like SEDASYS, the first computer-assisted personalized sedation system, and the Fibrin Pad are progressing with the FDA. And we are increasing investments in emerging markets with recently opened innovation centers in India and China, while continuing to support dozens of training institutes around the world.

With these actions and others, MD&D has been able to sustain #1 or #2 leadership positions in 80% of our key platforms, while growing or maintaining share in the majority of these. We've also made some very important portfolio decisions in this segment. For example, we decided to refocus our Cardiovascular business by exiting the drug-eluting stent business and shifting investments to higher growth, higher need areas like electrophysiology. These are important decisions to fund growth potential in other promising areas. Decisions to acquire Synthes and strengthen our leadership position in orthopedics, as well as our acquisition of SterilMed for its expertise in reprocessing surgical instruments speaks to how we are consistently and continuously looking across our business for the best long-term growth opportunities.

To better serve a market that has been undergoing dramatic change, the MD&D segment began reorganizing into 3 more integrated and agile businesses at the end of November. In brief, the MD&D segment will now be managed as 3 global business groups, which you can see on the slide, the Global Surgery Group, the Global Medical Solutions Group, and the Global Orthopedics Group, which will be further strengthened upon the completion of the Synthes acquisition. These changes will help increase our focus on strategic areas for growth and address unique customer needs at a time of tremendous change in the industry. The groups will cease -- create globally integrated business units, increase the quality, speed and flexibility of our decision making and leverage our scale in many markets around the world by making greater use of shared services and centers of excellence.

Finally, our Consumer segment continues to innovate with new products, business models and a growing presence in emerging markets, while getting its OTC business back in shape, relaunching many of the brands that made the business a global leader. With $15 billion in sales, Consumer is the 6th largest consumer healthcare company in the world. For Consumer, we saw an operational sales decline of just under 1%, given the remediation and supply issues associated with our U.S. OTC business. Excluding OTC acquisitions and divestitures, the Consumer segment grew about 2% operationally. Our Consumer business saw solid growth in certain franchises like skin care and oral care, with strong performances from the NEUTROGENA and LISTERINE mouthwash brands. Our Consumer Group also continued expanding into emerging markets with the acquisition of J B Chemicals & Pharmaceuticals in Russia. We also continued to innovate, introducing NEUTROGENA Naturals, AVEENO Smart Essentials, NICORETTE Quick Mist and LISTERINE ZERO.

Given our proven ability to build on a stable of iconic consumer brands and deliver science-based innovation, along with the restoration of supply of some of our OTC products, we feel positive about where our Consumer business is headed in 2012.

A big part of our consumer story in 2011 and going into 2012 has been the recovery and remediation of McNeil Consumer Healthcare business. And let me provide a brief update. We've achieved all major commitments to date under our Consent Decree with the FDA, and are working closely with FDA officials to ensure we can get high-quality products back to our loyal customers who need them. Several key products have returned to the market, such as TYLENOL severe cold caplets and certain children's and infant's TYLENOL brands. We expect volumes will continue to ramp up and anticipate key products will continue being reintroduced throughout 2012.

We've also been focused on how we can improve the products we are bringing back. In 2011, we introduced new flow restrictor packaging to the industry for children's medicine. We have instituted new dosing instructions for certain TYLENOL products to help ensure safe and appropriate use of our medicines. And we are also in the process of rebuilding Fort Washington into a state-of-art manufacturing facility which we anticipate opening next year. We will continue to invest in market support as we deliver a steady supply of our OTC brands back into the market.

Now let me spend the rest of my time addressing some of the economic and healthcare market questions on your mind and why Johnson & Johnson is well positioned as a global leader in healthcare. When I think about the world today, there are 3 major forces that are shaping healthcare -- the healthcare environment: Macroeconomic conditions; government payers and regulators; and industry trends. Macroeconomic conditions have been incredibly challenging the last several years, but opportunities remain. Slowing economic growth, the uncertainty in financial markets, high unemployment and pressure in healthcare costs have all contributed to constraints on healthcare spending, and the volatility of currency exchange rates continues to be an issue. But these economic dynamics are balanced by positive demographic trends creating demand. Populations in the developed world are aging rapidly and we consume more healthcare as we grow older. In fact, those over the age of 65 consume an average of 7x more healthcare per year than those under that age. Global expansion and growth, even at less explosive rates than a few years ago, also leads to growing demand for healthcare, especially in emerging markets where access has been its historically low. Our investments continue to be in line with these market opportunities.

Government is another important force to consider. As healthcare reform evolves around the world, it will remain critical to identify those opportunities where we can make the most important differences for patients, customers and payers. Government payers are requiring more cost-effective solutions to address their citizens' health issues and that impacts the pricing of healthcare products and services. We recognize these priorities and are making investments in new and productive areas. Personalized medicine and companion diagnostics, especially in the areas of oncology and antipsychotics are geared toward how we can better target treatments, monitor results and be more efficient in product development. The regulatory environment has also become much more intense in its scrutiny of new products. We share a common goal with regulators of wanting to save lives, ease people's suffering and address unmet medical needs with meaningful innovations. As a result, we support strong regulatory environments that ensure patient safety, while also ensuring that the fast and efficient approval of potentially life-saving medicines and treatments.

Finally, industry forces are also at play in many ways. In this is highly competitive world, bringing new innovations to market requires significant investments, access to the best minds and talents and adaptability to ever changing markets. In this environment, it is more important than ever for companies to be agile, collaborative and able to drive the new business models. In our business we have always looked to complement our organic development with acquisitions and collaborations that help us gain new capabilities or provide access to technology, products and compounds that we can accelerate to the market. The acquisition of SterilMed or collaborations in Alzheimer's disease with Elan and Pfizer and in HIV with Gilead Sciences are just a few promising ventures. Amidst all of the forces I've mentioned, healthcare remains compelling and growing market. Over the past 5 years, the global healthcare market has had compounded annual growth of nearly 7%, and it should continue to see strong mid single-digit growth over the next 5 years. And growth in the emerging markets will be double-digits as those economies continue expanding.

We continue investing in growth opportunities to expand our market leadership positions in areas like orthopedics with the pending acquisition of Synthes, and to pursue new opportunities in some of the fastest growing segments of healthcare like vaccines with the acquisition of Crucell, and in emerging markets like Brazil, Russia, India and China. We also continue to invest in addressing major unmet medical needs. When you look at the projected growth of global diseases over the next 15-year period, you see that significant unmet medical needs remain. Cancers, mental health disorders, diabetes, heart disease, stroke, rheumatoid arthritis, HIV are all among the most significant diseases and they are markets where we either have leadership today or increasing investments to gain leadership.

Increased globalization continues to present healthcare opportunities as well. Healthcare spending often tracks with the growth of GDP. As nations have more money to spend, they address their citizens' most essential needs, including the need for affordable quality healthcare. Emerging markets are projected to grow their share of global GDP from 36% in 1980 to 57% in the year 2020. Meanwhile over the projection period of 2010 to 2020, 35% of the growth in healthcare spending will be coming from emerging markets. This trend will increase the emerging markets' influence on healthcare and improve their ability to address a significant need for affordable quality healthcare in their countries. But we can't dismiss developed markets which will remain powerful, accounting for 7x per capita spending on healthcare than in the emerging markets. To remain competitive, we must win in both emerging and developed markets.

Finally, there are numerous exciting new healthcare technologies that could have significant potential in the future, opening up new business for breakthrough innovations. They require significant investments, talented people and more nimble approach to innovation, advantages and traits where Johnson & Johnson has a proven track record. Even as the global economy remains challenging, these demographic trends, technical innovations and the need for increased access to better healthcare make this space a sustainable growth opportunity and a fulfilling mission for our people.

In the world I just described, Johnson & Johnson is well positioned to address these market opportunities for 3 clear reasons: The first has to do with the ways we are delivering meaningful innovations to patients and customers; the second has to do with the steps we have taken to build a more agile company; and the third is our commitment to the operating model and values that have enabled us to succeed for decades. As I've said today, we are committed to innovations that will make a difference to patients and customers in a meaningful and personal way. We never want to forget that.

We have learned that there are many different paths to achieve meaningful innovation. As we seek to address unmet needs, we recognize that there are no easy answers and few straightforward approaches. The power of our model comes from our ability to select from the incredible resources we have at our disposal; from people, to capital, to technology and beyond, in order to create breakthrough innovation and bring it to market. The first step we take is to identify the significant unmet need and market opportunity where we believe Johnson & Johnson can make a meaningful difference for patients. We look for areas where we have capabilities, insights and unique advantages that can shape the opportunity. Then we take an agnostic approach to find the latest science and research to address these needs. In addition to our internal R&D, we use strategic alliances, licensing arrangements, acquisitions and venture capital investments to give us insight and access to the next breakthroughs. And finally, we leverage the breadth of our resources in development, supply chain, marketing and sales to bring these innovative products to the market. Let me give you a few examples. With diseases like hepatitis C, Alzheimer's and cardiovascular disease, our Pharmaceuticals business has followed this model. Hepatitis C, for example, infects about 170 million people worldwide. In this case, we partnered with Vertex Pharmaceuticals on the development of telaprevir, which was approved in 2011 and is now being marketed as INCIVO in Europe. In the case of Alzheimer's disease, we developed a very unique collaboration model with Elan and Pfizer in 2010 to gain access to bapineuzumab. We have seen excellent progress in the research being conducted around this compound, which has the potential to be the first disease-modifying agent that will alter the progression of this devastating disease. And in the case of cardiovascular disease, we partnered with Bayer on the development and launch of XARELTO, one of the industry's most highly anticipated launches. It is currently approved for the prevention of deep vein thrombosis and knee or hip replacement surgery, and for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

In other cases, we may choose an acquisition to broaden our portfolio with the new capability or to gain entry into a new piece of the market with the technology we don't have in our own pipeline. This was the case when we acquired Micrus Endovascular in 2010 to strengthen our long-standing neurovascular business. Micrus was developing a breakthrough technology in ischemic stroke, the type that accounts for 90% of the strokes that occur each year in an area where we did not have a competing product. The REVIVE SE for Micrus was approved in February of 2011 in the European Union and has become an important new option in the treatment of ischemic stroke, thanks to the advantages over more standard treatments.

In other cases, we might be better able to accelerate a product's development through our internal capabilities and global scale as part of Johnson & Johnson as with ZYTIGA, which resulted from the acquisition of Cougar Biotechnology. Here, we were able to apply our clinical trial expertise to bring ZYTIGA through approval and market at a remarkably accelerated rate, and we continue to pursue additional development programs in oncology with ZYTIGA.

In the case of the Fibrin Pad, we started out as a strategic partner with Omrix Biopharmaceuticals, working on biologic combination of products designed to solve unmet medical needs in the area of surgical bleeding. As the collaboration developed, we determined that an acquisition would allow us to better manage the complex development and intricate regulatory filings necessary to achieve the success of this convergent breakthrough product, which is anxiously awaited by surgeons.

Another approach we take to drive meaningful innovation is to use our broad base of businesses and expertise to tackle a disease state on multiple fronts. For example, there are more than 285 million people worldwide with diabetes. It is one prevalent disease where several Johnson & Johnson businesses are able to work to make a meaningful difference in people's lives. From our Diabetes Care franchise, we provide industry-leading devices such as blood glucose monitors including the OneTouch Verio, and insulin pumps such as the waterproof Animas Vibe, which was introduced in the European Union in 2011. And we are heavily involved in efforts to develop an artificial pancreas to further advance the treatment of diabetes.

Meanwhile, our Pharmaceuticals business is developing a new drug for treatment of diabetes called Canagliflozin. This is an oral, once-a-day agent with a potential for good tolerability, meaningful weight reduction, and a low risk of hypoglycemia. Canagliflozin was discovered with our strategic partner Mitsubishi Tanabe Pharmaceuticals and is now in full Phase III development.

And finally in Consumer, our Wellness & Prevention business and nutritional products such as SPLENDA can help diabetes patients and other consumers achieve healthier living. Market insights, knowledgeable sharing and collaboration amongst our business partners make us powerful partners across Johnson & Johnson to fight against diseases and other diseases through meaningful innovation. But just as important as the way we innovate is the way we operate. We have spent a great deal of management attention in recent years on building a more agile and responsive Johnson & Johnson. We have focused on improving our operations to reflect our commitment to delivering high-quality products and to adapt to a rapidly evolving marketplace I described earlier. This environment demands an agile organization; structures that are streamlined and can adapt quickly, crisp market strategies and discipline portfolio management and talented nimble leadership that can apply lessons from various industries and geographies to their businesses. Let me share a few examples of what we have been doing to become more agile.

Two years ago, we spoke to you about work we were doing to build a new enterprise supply chain model; no small task for a traditionally decentralized enterprise with more than 250 operating companies. Our objective was and is to reduce complexity and redundancies throughout our global supply chain so our companies can consistently produce high-quality products and maintain reliable supply. Today, we are achieving our near-term objectives of making good strides in the manufacturing and quality areas. In fact, we're trending ahead of our original internal projections, with our goal of significantly reducing the number of suppliers and external manufacturers while improving quality. We are also making headway in driving tighter integration in our quality systems across the enterprise. Our efforts in this area are already paying off with better inspection records despite an increase in regulatory activity.

I also spoke to you earlier about the exciting new medicines coming out of our pharmaceutical pipeline. While I'm proud that our pipeline is recognized as one of the best in the industry, I'm also proud of the productive way we are achieving these results. For the last several years, we have been prioritizing investments across our portfolio, investing in L&A activities that are closely aligned with our therapeutic area of strategy and we have shown great improvements in R&D productivity metrics. Specifically, our latest development in M&A success rate for Phase III development and registration has been trending around 75%, well above the industry mean of 50% to 55%.

We continue to rank among the top 1/3 of our peers in overall development cycle times, and we have dramatically improved our submission cycle times while maintaining quality, resulting in a cost per NME approved that is well below the industry mean. Finally, we provide -- we continue to approach our portfolio management in a disciplined fashion, getting assets in businesses that can provide us with new capabilities and access to growth in fast-growing markets, and divesting assets that either aren't aligned to our future focus or where the market expectations and our competitive positioning have changed dramatically, such as the case of drug-eluting stents.

Beyond the meaningful innovations and our agility, the foundation of our decades of sustained growth remains an unwavering commitment to Johnson & Johnson's operating model and values. It all starts with our people, who live and embody the values expressed in Our Credo day in and day out. Our Credo was established in 1943, and it provides a common set of values that hold together our 118,000 employees in 60 countries and more than 250 operating companies. The 4 tenets of Our Credo provide a clear focus and mindset for how we approach each decision; patients and customers first, then our employees, our communities and our shareholders. The last few years have offered significant challenges, but our commitment to Our Credo has remained the foundation of our response. It encouraged us to respond swiftly, intentionally and vigorously to any situations where we were falling short of our commitment to patients and customers.

In addition to Our Credo, we also work under an operating model that has served us well for decades; being broadly based in human healthcare, managing for the long-term, taking a decentralized management approach and focusing on people and values. Our broad base in healthcare has proven its value quite clearly in recent years. The strength of the enterprise has enabled us to continue investing our capital, talent and technology in the right places during challenging economic times, even when business cycles in one company or segment might have made such investments impossible if they were on their own.

We are also focused on 4 growth enablers: high-quality innovative products, robust pipelines, global presence and talented people, which support our model and allow our businesses to achieve sustainable, compliant growth. The success of this model relies on all of these elements working in concert across the company. But most importantly, it relies on the talented people of Johnson & Johnson. The strength and depth of talent at Johnson & Johnson is a result of an investment we make in our people, their sense of duty to the tenets of Our Credo and our ability to attract, retain and reward them with challenging opportunities, a supportive environment, competitive compensation and a fulfilling mission to improve people's lives through our products, services and corporate contributions. We invest more and more each year in the development of our people, and we're fortunate to have the most talented and dedicated team in the world.

In summary, I described for you today how we differentiate Johnson & Johnson as a leader in the global healthcare market. It has to do with delivering meaningful innovations to patients and customers, building a more agile business that can seize new market opportunities and remaining committed to a proven operating model and set of values. In our journey over the past 5 years, we have made extraordinary progress. We've adapted well to both foreseen and unforeseen challenges. We've launched new products that are strengthening our market leadership and provide a healthy platform for the long-term. We advanced our pipelines, which are among the best in the industry. We've maintained a disciplined approach to our investments in growth and portfolio management decisions. We stayed true to our operating model and values and we are poised to deliver sustainable growth built on meaningful innovations in healthcare.

In 2012, we expect to continue this journey by accelerating our operational sales growth, including the reintroduction of our major OTC products, by advancing meaningful innovations into the market and sustaining the strong momentum in our pipelines and by expanding our global presence and reach with continued investments in emerging markets and the seamless integration of Synthes. In the last 5 years, I've never felt better about our business coming out of one year and going into the next. We look forward to keeping you updated on our progress throughout the year. Thank you.

And now I'd like to turn it over to Dominic.

Dominic J. Caruso

Thank you, Bill, and good morning, everyone. I'd like to provide some comments on our 2011 fourth quarter and full year results, as well as provide guidance for you to consider in updating your models for 2012. As Bill said at the beginning of his presentation, it is a great pleasure to report performance that showed a return to sales growth, as well as an increase in adjusted earnings for the 28th consecutive year.

At the beginning of 2011, we provided you with an outlook of our financial performance for the year that would be impacted by several factors. Specifically, we indicated that net income margins would contract by more than 0.5% versus 2010, partly due to an expected increase in our effective tax rate and partly due to a contraction in our pretax operating margins. As we discussed throughout the year, the margin impact was due to the dilutive impact of the Crucell acquisition, the continued and incremental pricing pressure across our businesses, the incremental cost associated with the U.S. Healthcare Reform fee, as well as the incremental cost of remediation activities in our McNeil Consumer Healthcare business.

We also continued investing across our businesses for sustainable growth, including the launch of new exciting products as well as the continued strengthening of our pipeline, all of which as we expected resulted in margin contraction. Over the course of the year, however, we managed to contain the margin erosion to less than 0.5% for the year, an improvement over our forecast. We did complete several divestitures throughout the year and some were completed in the fourth quarter, which resulted in a higher level of other income than our most recent guidance. Additionally, we implemented some tax planning strategies late in the year, which resulted in a lower effective tax rate for the year.

As we have historically done, we take the opportunity to redeploy these types of gains to investments in growth areas for our business. This was certainly the case in the fourth quarter, where we incurred higher R&D expenses primarily related to the collaboration agreement with Pharmacyclics for the development of an important oncology compound. As we previously announced, we expected this agreement to be approximately $0.04 to $0.05 dilutive to our earnings per share. The gains resulting from the divestitures as well as the lower tax rate were partly invested in the business such as the Pharmacyclics collaboration agreement as well as other important investments, with the balance resulting in higher earnings per share than we expected in the quarter.

During the fourth quarter, we also recorded several special items. These special items amounted to approximately $3.3 billion on a pretax basis and consist of the following. First, we recorded costs associated with ongoing litigation primarily related to RISPERDAL. Additionally, we increased our accrual for product liability costs primarily related to the DePuy ASR Hip recall. As we disclosed previously, changes to the accrual may be required as additional information becomes available. We have recently completed an analysis of new information, including recently updated revision rates for the recalled products, and we have updated our estimates with respect to potential costs associated with this recall. Consistent with this new information, we also increased the accrual for costs associated with the DePuy ASR Hip recall program, where we are committed to working with patients and their health insurers to address medical costs directly associated with the recall.

And finally, we also adjusted the value of the currency option we entered into in connection with the pending Synthes transaction to reflect the changes in currency exchange rates for the Swiss franc versus the U.S. dollar. Together, these special items reduced our fourth quarter results by $1.05 per share. Excluding these special items, our adjusted earnings per share of $1.13 exceeded the mean of the analyst estimates for the quarter as published by FirstCall by $0.04 per share.

To wrap up our formal presentation this morning, I would like to provide some guidance for you to consider as you refine your models for 2012. Please note that this guidance does not include the impact of Synthes, as the acquisition has not yet been completed. Consistent with our historical practice concerning acquisitions, we will include the impact of Synthes after we close the transaction. As many of you have asked about the treatment of the amortization of intangible assets related to this transaction, I would like to confirm that consistent with our historical practice we will be including the incremental amortization expense in our guidance that we updated to reflect the impact of this transaction. We will, of course, highlight the amount for you in our guidance that we provide once the transaction has been completed.

First let me set some context around certain items that are reflected in my guidance, but may not yet be fully reflected in your models. The U.S. dollar has strengthened versus many currencies since the last time we spoke in October, specifically about 8% versus the euro. In looking at your models, it appears that most of your models have not yet been updated for this impact. Additionally, we expect to continue to incur significant costs in 2012 at a slightly higher level than 2011 as we continue to address the manufacturing quality issues related to the OTC recalls and work to restore our McNeil Consumer Healthcare products in the marketplace.

And as you have seen in several markets, we have experienced pricing pressure in 2011, and we expect that this pressure will continue in 2012. This pricing pressure is expected to negatively impact our pretax operating margin for 2012 by approximately 0.5% to 1%, a greater impact than we saw in 2011. As we plan for 2012, we also want to ensure that we make the proper investments to continue the sustainability of the underlying strength we see in the business while we continue to deal with these challenges. I am pleased that given the strength of the underlying growth in our business, driven primarily by the launch of our new products, we do expect the pretax operating margins will improve in 2012 over 2011 levels and I'll provide some more insight on this in just a few minutes.

Let me begin with a discussion of cash and interest income and expense. At the end of 2011, we had approximately $12.6 billion of net cash. This consists of approximately $32.2 billion of cash and marketable securities and $19.6 billion of debt. This is an improvement of $1.7 billion in our overall net cash position from year-end 2010. For purposes of your models, assuming no major acquisitions, I suggest you consider modeling net interest expense between $500 million and $550 million.

Turning to other income and expense. As a reminder, this is the account where we record royalty income as well as gains and losses arising from such items as litigation, investments by our development corporation and divestitures, asset sales or write-offs. As we are likely to complete a divestiture very early in 2012, we have included the impact of that transaction in this guidance. This account is difficult to forecast, but we will be comfortable with your models for 2012 reflecting other income and expense as a net gain, ranging from approximately $900 million to $1 billion or a lower level than we saw in 2011.

And now a word on taxes. For 2011, the company's effective tax rate, excluding special items, was 20.1%. We suggest that you model our effective tax rate for 2012 in the range of 21% to 22%. This effective tax rate for 2012 includes an assumption that the federal R&D tax credit will be renewed by Congress and reflects changes in the mix of our business. As always, we will continue to pursue opportunities in this area to improve upon this rate throughout the year.

Now turning to sales and earnings. As we have done for several years, our guidance will be based first on a constant currency basis reflecting our results from operations. This is the way we manage our business, and we believe this provides a good understanding of the underlying performance of our business. We will also provide an estimate of our sales and EPS results for 2012 with the impact that currency exchange rates could have. As we have done in the past, we will use the euro as an example of the overall impact that currency fluctuations could have. And as of the end of last week, the euro was at $1.29 and has weakened from an average of $1.39, along with other major currencies versus 2011 levels.

Turning to sales. We would be comfortable with your models reflecting an operational sales increase on a constant currency basis of between 4% and 5% for the year. This would result in sales for 2012 on a constant currency basis of approximately $67.7 billion to $68.3 billion. We are not predicting the impact of currency movements but as an example, to give you an idea of the potential impact on sales of currency exchange rates for all of 2012 were to remain where they were as of the end of last week, then our sales growth rate would decrease by nearly 3%. Thus, under this scenario, we would expect reported sales growth to range between just over 1% and 2% for a total expected level of reported sales between approximately $66 billion to $66.5 billion.

Now turning to earnings. We suggest you consider full year 2012 EPS estimates, excluding the impact of special items, of between $5.18 and $5.28 per share on an operational basis or a growth rate of between 3.5% and 5.5% on a constant currency basis. While we are not predicting the impact of currency movements, to give you an idea of the potential impact on EPS if currency exchange rates for all of 2012 were to remain where they were as of the end of last week, then our reported EPS excluding special items would be negatively impacted by approximately $0.13 per share due to exchange rate fluctuations. We therefore suggest you model our reported EPS excluding special items in the range between $5.05 and $5.15 per share. And at this early stage in the year, we would be comfortable with your models reflecting the midpoint of that range.

So in summary, let me add a few final comments for you to consider as you update your models. The midpoint of our operational or constant currency guidance of $68 billion in sales growing at around 4.5% and $5.23 of earnings per share excluding special items growing at a similar rate, appear to be consistent with most of the analysts' models. As I noted earlier, it appears that most of those models have not yet been updated for the recent major change in currency exchange rates, and therefore those models appear to be based on exchange rates similar to what we saw in 2011. We would expect that with the guidance we provided, most models will be updated with this expected impact of currency.

Also, as you update your models for the year, you may want to consider that the growth rate comparisons in the first half of the year will be tougher than the second half of the year because, as a reminder, LEVAQUIN and CONCERTA began to see generic competition in the middle of 2011. Finally, as you update your models for the guidance I just provided, you should see that our overall net income margin is expected to be approximately the same as in 2011. However, you should also see that we expect pretax operating margins to be much healthier, increasing from 2011 levels by approximately 100 to 150 basis points. This pretax operating margin improvement reflects improved leverage across all operating expenses. This will, however, be offset by lower other income and a slightly higher tax rate than we saw in 2011.

In closing, we're very pleased with our overall results for 2011 and we expect the growth in momentum to continue into 2012. And while we do not see a significantly improved macro landscape in 2012, we do feel very positive about the underlying strength in our business as evidenced by strong core products, exciting new product launches, robust pipelines and extraordinary global expansion opportunities. I look forward to updating you on our progress throughout the year.

And now Louise, back to you.

Louise Mehrotra

We will now open the meeting to questions. As we have Bill Weldon with us today, we would appreciate it if you could keep your questions at the strategic level and please wait for the microphone as we are webcasting this meeting. Over here, Mike?

Question-and-Answer Session

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

Mike Weinstein, JPMorgan. I'll start with financials. Dominic, just to clarify. On that other income guidance, you commented before that the quarterly run rate of other income, all the different things [ph] for the pluses and minuses that occurs is going to be about $100 million a quarter, so about $400 million a year. I think you commented on that in one of the earnings calls earlier in 2011. You're guiding to $1 billion of other income, so it looks like you're assuming some gains in 2012. Can you just give us the visibility into what gains you're assuming will occur in 2012 so we can model this correctly?

Dominic J. Caruso

Right. So just to clarify, we think that the underlying run rate in that account approximates $500 million to $600 million. It's royalty income and some other gains, so think about $500 million to $600 million that we expect early this year as we continue to adjust our portfolio and redeploy investments. That will have a divestiture that we record early in 2011 resulting in this now increased to a level of between $900 million and $1 billion. I can't comment on the specific divestiture we're referring to, but we expect to complete it early in 2012.

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

Okay. Bill, let me ask you about 2 pipeline areas. A big driver in 2012 is going to be INCIVO, telaprevir, for the company. The landscape for HCV has changed a lot in the last 6 to 12 months. Obviously, there's a lot of competition for assets right now. Can you just talk about, given how important that's going to become to the company as a revenue contributor in 2012 and '13, how you're viewing the competitive positioning of J&J going forward in that area because it becomes an important area for you? And then the second one I'd like to comment on is on Bapi. We're going to get the readout on 2 of the North American trials in 2012. You mentioned in your slides, potential filing in '12, '13. Is that your expectation in how you are positioning? How do you want us to think about potential for the Bapi data in '12, '13? Should we be assuming that this is going to file in '12, '13 on the data that you're going to be generating?

William C. Weldon

Yes, the Bapi one I'll answer first, Mike. Yes, we expect that we'll have the data analyzed and we'll be filing obviously on a positive outcome by the end of the year would be our expectation on Bapi. And then when you go to INCIVO in the hepatitis C, that's an area where there's a whole lot of interest in various areas. There's a Pharmasset acquisition that's taking place and others. We feel really good about where we are with INCIVO. We feel very good about 435, which will be a complementary product. And we feel that we'll be able to get out there and work in the hepatitis C area with those compounds. And then the other ones that are there, they're still very early in development there. I guess they're going into IIb right now, and we're going to wait and see what exactly happens there. But we think that we're very well positioned for the hepatitis C with the 2 compounds we have.

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

So in short, you feel you have in-house right now what you need to be competitive in what will be the second wave of new compounds that are coming out?

William C. Weldon

We feel we're in a good position and there may be opportunities to look to the future and see how we could work with others if those nukes become better products.

Louise Mehrotra

Rick?

Frederick A. Wise - Leerink Swann LLC, Research Division

Rick Wise, Leerink Swann. Maybe I'll start with Dominic as well, or Bill. Gross margins, you talked about that the margin pressures, the cost pressures. How do we think about gross margin in 2012? Can it be better than 2011? And maybe, Dominic, if you could talk a little bit about what gets you back to the 70% level we've seen in years past. Or are we now more permanently -- given the mix, given the collaborations, are we -- is the upper 60s the new normal for J&J?

Dominic J. Caruso

Yes. Well the gross margin, of course, is just one aspect of the total P&L. And as I mentioned for 2012, we expect pretax operating margins to improve by 100 to 150 basis points versus '12. And that, as I mentioned, is across every line, R&D, cost of goods sold and selling and marketing expenses. So we do expect gross margins to improve in '12 versus '11. I think the major factors are, as new products are launching and ramping up more rapidly, of course they are contributing more to that line. The mix in the business, the Pharmaceutical business growing obviously has a higher margin component than the rest of the businesses. And also, as the McNeil Consumer products return to the marketplace, compared to 2011 and '10, when they were not basically in the sales, those are relatively high-margin products when compared to the rest of our business so that mix of the business should improve as well. And as Bill mentioned, we're undergoing pretty extensive plan regarding our enterprise supply chain. And although the goal is first always to maintain quality, we obviously think there are some efficiencies in our supply chain. We'll continue to develop those as the years move along. We're early in that process. We've already seen some good improvements. I think we'll see more in the next couple of years.

Frederick A. Wise - Leerink Swann LLC, Research Division

Bill, one for you. The balance sheet remains incredibly strong, cash continues to grow. We talked about it earlier. The challenge here, given price pressures, given growth pressures, is to bring ever more innovative, faster-growing products in the portfolio. Can you talk a little bit about how you're challenging the J&J team to move faster in these times? Could we -- should we expect J&J to be more aggressive on the acquisition front in 2012 to achieve these goals? Maybe you can talk about your challenges to the team and how you're going to use the cash more aggressively strategically.

William C. Weldon

Yes, a couple of things. I think, as you say, innovation is what's critical to all of us. And I gave you a look at the performance of our R&D organizations, then you look at what's in the pipeline, we're actually -- if you look in the near-term and further out, which we don't talk a lot about, but we feel arguably we have one of the best if not the best pipelines in the industry, talking about pharmaceuticals as well as the others. I think, Rick, as I said earlier, we continue to look for opportunities. The Pharmacyclics, we thought, was an extraordinary opportunity in the oncology area. There's lot of things that we go and look for but as always, we're going to continue to look to make sure we're going to return value to shareholders. And I think if you have the good fortune that we have at this point in time of having a really extraordinary pipeline, we're doing all we can to continue to advance that pipeline and move it forward, as well as looking for other opportunities, whether they're through acquisitions, licenses or collaborations. We'll continue to do that. A lot of these have become extraordinarily expensive. Well you guys have seen them all, and some of them it's hard to justify the prices people are paying. But I think there's a continuing push in our organization to make sure we're making good choices. And I think if you look at the productivity we have of 75% coming out with approvals and even the cost we have in development of these and cycle times, the group's doing an extraordinary job. They're going to keep doing that and they're going to keep looking for the right opportunities where we can bring our resources and others together to get these products in the marketplace. So I think we're going to continue to do what we're doing. We're going to be aggressive. If we see a great opportunity, we're going to go and get it or try and get it. But I think we're in a very good position, but we have to just keep the pressure on to keep looking for what else is there, what are the new opportunities, are they internal, are they external, enter a collaboration or license or an acquisition and to continue to march forward that way. There's no clear-cut answer, I think we have to do everything. I think the strength of J&J and our R&D organization today is they are truly agnostic. They're looking for the best opportunity wherever they exist and then they're absolutely going to try and get it. So it's not embedded here, it's what is the best opportunity, where is it and how do we bring it into J&J and then get it to the market.

Louise Mehrotra

Matt?

Matthew J. Dodds - Citigroup Inc, Research Division

Matt Dodds, Citigroup. Bill, for you first. I think I asked this one a lot in the past. On R&D and pharma, just looking at the growth rate for the year, I assume you're still over 20% of sales in pharma for R&D. And I've kind of been asking when this big part of the recent pipeline gets through, does that number come down? And it doesn't seem like it is. Should we be thinking longer-term that your success is encouraging you to continue to spend above industry average in pharma?

William C. Weldon

Matt, I think we'll spend where the opportunities take us. And that's what we've said all along. We spend more because, and I think you've seen it, the productivity of our pipeline over the last few years has been second to none really. And if you look at the pipeline today, huge opportunities with Bapi, Canagliflozin and these type of opportunities and beyond. So I think we're going to spend what -- we'll deliver those products in the market and spend appropriately. And it maybe that the numbers will be in the relative range they've been in. But there's also the opportunity to come down. But the cost of development of compounds, as you know, is not going backwards. The critical piece of it is the productivity of the pipeline, which is what I talked about earlier, the amount of products that we're able to deliver when we get into Phase III, where your primary cost is or the total cost of the cycle time. So it's planning, it's making sure you're doing good work in getting the product in the market because the most expensive one is the one that never gets there.

Matthew J. Dodds - Citigroup Inc, Research Division

And then quickly, Dominic, one for you. On the cash, and if we don't consider Synthes as part of this, at what point do you consider repatriating if there's no change in the tax code or tax holiday? Is that something you may be more likely to consider now given the buildup?

Dominic J. Caruso

Yes, it's a great question, Matt. And of course, we're all hopeful that the corporate tax reform will actually take hold and we already saw some good movement towards a territorial system there. I think we're encouraged by that. I think consistent with the territorial system, which I think what all multinational companies want to remain competitive in a global economy, will be some transition plan with respect to cash that's already outside the U.S. I think we'd rather wait and see and work with our government to develop first the territorial system, and then an appropriate transition plan that makes sense for U.S. taxpayers.

Louise Mehrotra

Tony?

Charles Anthony Butler - Barclays Capital, Research Division

Tony Butler, Barclays Capital. Just 2 questions. The first for Bill, the second for Dominic. Bill, one of the more exciting products, I think, in the pharmaceutical development have been Factor Xa inhibitors, at least replacements for warfarin. The early signs for XARELTO, though, have been really quite poor in AF. And I recognize that a number of other indications are still to come. So I'd love for you to comment on that and maybe why those scripts have been very poor. And then second for Dominic. Dominic, as you think about remediation costs collectively over the next several years, are you actually bringing forward some of those costs now more so into 2012 than you might have done in the past?

William C. Weldon

Yes. I think the XARELTO question actually, there were a lot of borderline warfarin products or COUMADIN for patients that they wanted to get out. And PRADAXA was out in the market first and gained a lot of those products. So what's happened is we've only been in the market a short period of time. We're finding that there is a very -- that the physicians who are using the product are very happy with it and they're starting to look at more and more patients. The thing that's been most encouraging to us is the most recent results we saw, which was the week of January 13. We saw a 21.6% share of patients with new prescription written going on to the XARELTO patients. So we think that physicians are now becoming aware of it. They're looking at the next group of patients that can go on and the failures under PRADAXA, and also if there are potential adverse events. I think there's a kind of a halo, if you want to call it, a negative halo, around all of these products that I think will play itself out over time. But we're actually very encouraged by the most recent results we've seen.

Dominic J. Caruso

Tony, with respect to remediation costs, I'm going to assume you're referring to the McNeil Consumer Healthcare. We said that in '12, we expected slightly higher level of remediation costs than in '11. But it's not because we're advancing them more into '12 for future years. It's really just progress being made under the Consent Decree and the actions we're committed to take along with the FDA. So there's no shifting of those expenses. It's the normal course, we obviously want to do all of the things in the appropriate manner under the Consent Decree, but there's no shifting of expenses.

Louise Mehrotra

Rajeev?

Rajeev Jashnani - UBS Investment Bank, Research Division

Rajeev Jashnani, UBS. I had a question regarding the pricing impact on margins that you talked about, 50 to 100 basis points. Is that something you're anticipating to sort of continue into perpetuity? And maybe if you could talk about how you plan to sustain margins in the face of that potential and on an ongoing basis.

Dominic J. Caruso

Yes, Rajeev. Of course, perpetuity is a very long time, so I can't really comment on perpetuity.

Rajeev Jashnani - UBS Investment Bank, Research Division

Maybe intermediate.

Dominic J. Caruso

Yes. So for 2012, one thing that's happening that's more incremental versus '11 is that in Japan, you may know that pharmaceutical pricing reductions have been on a sort of biannual basis. So 2012 in Japan, our business will experience much greater pricing decline than they saw the previous year because of that anniversary. Of course that will then change in '13, and then we'll see it again in '14. And then also, we do expect that the European austerity measures and the pressure in Europe will continue to cause pressure in pricing in 2012 to a greater extent than we saw in 2011. I really can't comment any further on what may happen as those economies improve. But one thing I'm sure you'll appreciate, I think that as we develop innovative products that are important to the healthcare system, that's really the best way to address the pricing question because the system needs and healthcare needs are still are unmet, and therefore we're trying to focus attention on that, and with that should come the appropriate pricing for our products.

Rajeev Jashnani - UBS Investment Bank, Research Division

Okay. One follow-up on OTC. It seems that U.S. was minus 4%. I think that's a better rate than we've seen in some time for that business. I was wondering if you can just talk about the products that you've relaunched there. I think you mentioned you've got a modest relaunch of some products. How are those products doing in the market? Are they -- is it too early to say if they're reclaiming their previous share? Or perhaps some additional color there would be helpful.

William C. Weldon

Yes. I think it will be a while until we reclaim the share. What we're doing is getting them out as quickly as we can and what we're getting in the market is selling. I think by the middle of 2012, we'll have most of the products that are going to put back in the market definitely by the end of 2012. So I think you'll see a continual increase in those areas. And as we have product supply going into the market, we'll obviously put promotional dollars behind it to reestablish it. But we're very pleased, we have to say, with the support we've had from the consumer and the support we've had from many areas to be able to bring these products back. And I think people are looking forward to them getting back in the market.

Louise Mehrotra

Larry?

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

Larry Biegelsen, Wells Fargo. Dominic, just to clarify, is it your expectation that there's little to no DOXIL sales in 2012?

Dominic J. Caruso

In our guidance, we're assuming we won't have any supply from our supplier until very late 2012.

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

On the ASR Hip recall, could you give us a sense of the total charges you've taken so far and the expectations going forward? And just lastly for Bill, not to push you out, but is 2012 the year we may hear about your successor?

Dominic J. Caruso

Let me take the first part. So Larry, with respect ASR Hip recall, there's 2 components of it. Just to be clear, there's the ASR Hip recall program. And in the table that we provide a tax to the press release where we give you GAAP versus non-GAAP reconciliation, you'll see that over the 2 years, those program costs have amounted to about $800 million, so that's disclosed in our table. The other component of the ASR Hip recall is our estimate of product liability. That number we're not providing publicly. And I will say that as we got more information based on most recently revised -- most recent updates to national registries, et cetera, on revision rates, we made our best estimate of what the ultimate revision rates may be based on the information we have available to date. So as we said, as more information would become available, we would update as much as we could and as much as we now know. And we think for what we know today, we've captured all the potential that we're aware of today based on the data that we've seen.

William C. Weldon

Yes. Let me make one comment about DOXIL first. It is our highest priority. We've worked with the FDA, we've had meetings with the FDA. We're looking for any type of quality, high-quality source that we could possibly come up with or other ways to get that product in the market. We do realize how critical it is for individuals, and it is one of our highest priorities. And we're doing every possible. I think, as Dom said, if you look at the current supplier, they're saying not until the end of the year at the earliest. Well, I guess at the end of the year, they're saying. But we're looking for ways to maybe get that product back in the market sooner, if possible. As far as my future, I'm doing my job, I've got a job to do. I really can't comment on that. There'll be a point in time when I'll be ready to leave and the board will feel I'm ready to leave, and I let you all know.

Louise Mehrotra

Sara?

Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division

Bill, you touched on it briefly in your remarks. But can you just talk about emerging markets? It's clearly something, especially with the med tech peers, everyone is talking about making large incremental investments in their emerging markets, both commercial infrastructure and manufacturing capabilities. And I'm just wondering if you can orient us to where you are currently in med tech specifically, what you think your current strengths are and what your investment priorities are near-term.

William C. Weldon

Yes. We've made significant investments. We have an innovation center that we set up for the Consumer group, which is developing specific products for those areas. In Xuzhou, we've set up a facility for innovation for the med tech area to be looking at specific products developed for the emerging markets in those areas and looking at that as kind of an innovation center for that area. The pharm business, we're doing -- we've got a clinical trial for the center set up in Hong Kong. We're working closely with Tianjin University in the oncology area and others where there's opportunities. I think that it's important to -- and I said this in the talk, everybody really gets excited about emerging markets. And I think that we should be excited about them. But I think we can't lose sight of the developed markets also. We have to make sure we're developing products for both areas. But we have very specific centers that have been set up. The other thing that we've done that we think is very important in the med tech area is we've set up training centers to help educate and train surgeons, especially in the area of replacements. If you look at the orthopedic area, big opportunities. We have to make sure we have the right products, and then we have to make sure that the surgeons are capable of doing it. So we have innovation centers that we've set up throughout and then training centers to complement that. So we think we've made the appropriate investments, and we're seeing -- we're very excited about the growth we're seeing throughout all of our businesses. But we have very high expectations.

Louise Mehrotra

Bob?

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Bob Hopkins from Bank of America Merrill Lynch. First, a quick one for Dominic. Just to be very clear, the difference in the other income line that you talked about in terms of the run rate of $500 million to $600 million, and then 2012 being a year where that's going to be higher because of a pending announcement that you'll make, that gain is included in the $5.05 to $5.15?

Dominic J. Caruso

Yes, Bob, that is, yes.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

And then for Bill, just a big-picture question on the Medical Device segment. First, exiting 2011, can you give some overview comments on just how you feel about the trends exiting the year from a utilization perspective, from a procedure volume perspective? And then I noticed that you -- I think I saw on the slide that your operating margins in that division were flat year-over-year despite what you described as a very challenging environment. And I think a lot of the investors that I talked to about the medical device industry broadly are very hesitant about investing in the group because they see margin pressure going forward, given the challenges. So my question is again, one, how you feel about top line utilization trends? But two, how do you feel about the ability to sustain the kind of margins you have in that business, given the challenges that we see out there?

William C. Weldon

Sure. I think when you look at -- the big area is elective surgery. And we're still seeing, though, much lower than it had been previously, but kind of the slope of the line and the decline is to starting to smooth out a little bit. The last time I looked at it, it was about 0.5% drop in elective surgery in that area. So we think we're getting close to the bottom of the trough. The other piece of that, that we think is really important and why it's important that we continue to gain share is that there's going to be the people that need this elective surgery are not having it done because they're unemployed. They've lost insurance or anything else, they're putting it off. But you can only put these procedures off for so long. And there's going to be a bolus of people that will come back in the market over time. Now I don't know it's going to be in 2012 or 2013, but I don't think the market is going to decline as precipitously as it had previously. So I think that the procedures are going to be coming back, and I think we need to invest there. Now there's going to be continued pressure -- well let me, before I -- there's going to be continued pressure on pricing. We saw a significant pressure in this spinal area in the last period of time. I think that the hips we've seen basically continued to decline and in the knees, it's pretty constant right about now. But I think we're going to see pricing pressure continue, but I think we'll start to see the procedures coming back. I think if you also look into the emerging markets, you're going to see significant opportunities for growth in those areas as I said before, a lot of it is due to training and moving into that area. And that's the surgical area and the orthopedic area. But the other areas, there's going to be pressures. But I think as you continue to innovate and bring new products out, we're going to able to see things, for example in the diabetes area, in the ocular lens area. And these types of things are going to see opportunities for growth and continued growth. So we think the investment's there, I think the markets totally grew about 3% last year, give or take if you put them all together, and that's about where we were, even with the challenges we had. So we feel pretty good about where we are and where we're going in that market. And again, the whole area of elective surgery can only continue to decline for so long. And there has to come a point when it hits bottom, and then we're going to start to see a ramp back up over time. And what we want to do is be in a position to take advantage of that.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

[indiscernible]

William C. Weldon

Yes, I think that's going to come to us. If you look at what I said before in the MD&D area, we've really refocused our business to have real clear focus on the appropriate areas. One of the things that we saw is we had all these medical device businesses that were scattered around. What we've done is been able to able to take them into the 3 groups which we said is going to give us focus, going to allow us to be able to penetrate the markets and be able to take advantage of the opportunities in those markets and continue to grow our business and maintain margins, let's put it that way.

Louise Mehrotra

Catherine?

Catherine J. Arnold - Crédit Suisse AG, Research Division

Catherine Arnold from Credit Suisse. Bill, I know you've been looking forward to entering 2012 and getting past a lot of the headwinds that you had mentioned in your presentation on 2011. But in some ways, I guess, I'm wondering if 2013 isn't the new 2012, in the sense of considering your sort of midpoint of your guidance and the growth implied versus what you achieve this year. Are we looking to next year to kind of see an inflection point where some of the macro factors calm down, the product investments start to pay off more and some of the unexpected fixes that you've had to do go away? Is that the right way of thinking about it? And then I guess I just want to follow up, you guys have given a directional sense of where ZYTIGA sales last quarter were. I think you suggested kind of in the mid-80s. I'm wondering if you can give us any directional sense or an absolute sense for ZYTIGA this quarter and also XARELTO since they are below your threshold, but obviously very strategically important.

William C. Weldon

Yes. What was the first question again?

Catherine J. Arnold - Crédit Suisse AG, Research Division

Just 2013 as the new 2012 in terms of an inflection point.

William C. Weldon

Yes, I think what we've seen is we kind of -- I would say as I did, we've kind of rounded the corner a little bit in 2011. I think we'll see that 2012 is going to get better. 2013, I think we're going to see continual improvement. We'll going to start getting the McNeil products back and investments in those areas. We're going to see the continued, I think, improvement of the launches of the products going back to 2009 as well as the ZYTIGAs, INCIVOs and XARELTOs this year. So I think that the products are going to keep coming. Hopefully, we'll be looking at Bapis and some of these coming into the market. So as I said in the presentation, we've had to deal with these headwinds. The macroeconomic environment, I'm not going to begin to predict that because I think it's anybody's guess where that goes. You can -- the emerging markets are still growing nicely, but they're growing at a lower rate than they grew last year. Every quarter-to-quarter, they're ratcheting down somewhat. But there'll be nice growth in that area. So yes, I think J&J is on a very good trajectory in the right direction. There's going to be continued investment. As Dom said, we're going to have continued working in the remediation in the OTC area, but that's going to start to see more and more the light of day and these new products. So yes, I think if you look forward, we feel very good about the future, I guess. And 2012 we feel good about, I think we're feeling very good about going beyond that. ZYTIGA?

Louise Mehrotra

So ZYTIGA contributed just a little over 2.5 points of the 6.6 points that we had in the Pharmaceutical group. XARELTO, it's early to be breaking that out. But before you ask, I'll give you INCIVO as well. So INCIVO contributed about 2.5 points to the pharm OUS group.

William C. Weldon

And Catherine, as I said earlier, one point doesn't a trend make. But we felt really good about the most recent results that we've seen in XARELTO. We think we're really seeing some good stuff there.

Louise Mehrotra

David?

David R. Lewis - Morgan Stanley, Research Division

David Lewis, Morgan Stanley. Bill, a question for you. You made a statement in your prepared remarks about what you think healthcare spending will grow over the next 5 years, I believe. And it was around mid-single-digits. And you sort of joined other large global healthcare CEOs in talking about what you think healthcare can grow at. But investors don't seem to be sort of believing that number, whether it's because they think growth rate is going to be lower, but they believe there's going to be significant margin and mix pressure on that level of revenue. So I guess what I'm wondering is I think what investors really want to hear is regardless of what that number is, it's just not it's going to grow 5% or 6%, but there's going to be a change in the way that global healthcare companies begin to distribute healthcare, specifically in the U.S. and maybe it's in light of the Synthes transaction or potential bundling. But if you can help us understand, assuming that number is lower or the margin mix in that 5% growth is lower, how does J&J sort of lead global healthcare companies in changing the way healthcare is distributed in the U.S. to preserve those margins in light of upcoming pressures?

William C. Weldon

Well, I think some of the things I alluded to also in the talk are areas of looking at biomarkers trying to be able to look at ways to deliver personalized medicine, so you're going to have a much higher prediction -- predictor rate as to whether -- individuals will succeed or not succeed with those types of patients. I think we're going have to wait and see what's going to happen in the whole area of evidence-based medicine. There's a whole a lot of things that are going on right now that are putting more pressure, I think, on the industry to make sure that we're giving better clinical results and making sure that we can document the success that we can have in these areas. So I think that there's going to be a change. This is specifically about pharmaceuticals now. I think there will be a change in the way that we'll be looking at products. And I think as we've done and others are doing right now, we're looking at not trying to come out with a 12-proton pump inhibitor and coming out in areas like that. We're looking at drugs that really bring significant changes to patients and offer real advantages. And I think that in some of the markets, when you go into the developed world, I think there's just a whole tremendous opportunity of patients that are coming into the market that historically have not been there. And there's a huge resource -- by that, I'm talking about resources that the government is willing to spend for patients coming into the market. So I think when you look at it, that there's an opportunity. And I don't think all things are created equal. I think you have to make sure you've selected the right target audience and move forward in that area. I mentioned about the orthopedic business, elective surgery before. I think you're going to see that bottoming out. You're going to see patients coming back into the market. We have to realize we have -- the demographics play in favor of healthcare. And patients, as they get older, spend a lot more on their healthcare and their needs. And I think we're going to have to make sure that we have effective products that are going to create value for those patients and work with the governments to make sure that there's the appropriate reimbursement for those.

David R. Lewis - Morgan Stanley, Research Division

Okay. Maybe just a question for Dominic. In terms of the guidance, Dominic, I'm assuming that the guidance you provided assumes a Synthes structure that's roughly equivalent to the structure you announced many months ago. And I guess, maybe just want to get a confirmation on that. But if there is going to be a change in that structure, when do you think we're going to get that announcement? Is it going to be on EU approval? Is it going to be on acquisition close? And are we talking about a change in structure as you think about the opportunities that could move earnings more than 1% to 2%?

Dominic J. Caruso

So just to be clear, the guidance that I provided excludes Synthes, so no impact at all to Synthes, as if the transaction didn't happen. Once the transaction closes consistent with our historical practice, we'll update our guidance to include the impact of Synthes. And at that time, we'll be as transparent as we always are and give you the impacts and changes from ultimate implementation of financing structure versus the previous estimate that we gave you. We'll detail that for you. But we'll do that at time of close.

David R. Lewis - Morgan Stanley, Research Division

Still think at this time the prior dilution estimate is the best dilution estimate you have to date?

Dominic J. Caruso

Well, the prior dilution estimate was our most conservative estimate, right, and it was based on no efficiency gained by financing the transaction in any different way than was announced. Obviously, we're going to continue working to see if we can get that to be better, but we won't know and have any details on that until very close to closing as we're working through the entire closing and integration of the transaction.

Louise Mehrotra

Matt?

Matthew S. Miksic - Piper Jaffray Companies, Research Division

Matt Miksic, Piper Jaffrey. A couple of questions for Bill on Medical Devices, specifically. Assuming that we do eventually trough out and some of these volumes start to stabilize and improve, the Synthes acquisition increased what I would call your exposure to sort of the higher acuity end of devices. And I'm wondering, all the pressures on pricing, regulatory reimbursement, have these forces sort of caused you to think, reshuffle your priorities, either strategically, organically, across like the spectrum of chronic, degenerative, more acute devices in terms of your investments? And how so? And I have one follow-up.

William C. Weldon

Well, one of the major areas in Synthes, as we talked about, is the whole area of trauma, which if you want to, you can say it's more of the acute area. And it's an area where it's much less sensitive to a lot of the ebbs and flows. If you need the procedure, you need the procedure. We don't feel that there's any -- we're very excited about the acquisition. We think it continues for all the right reasons to strengthen our orthopedic business, put it into trauma. I think their presence in the emerging markets will also lend itself to some of the advances in our other areas moving into those. So we feel very good about Synthes. Their business has been very strong. So I don't think it's caused us to reassess our position there. And as I said, I think the demographics play so favorably, as well as the emerging markets play so favorably in the orthopedic business that yes we're going through a challenging time, but we think we'll be able to be in a real strong position.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

Because I was asking more broadly, have the market forces, pricing reimbursement, tougher regulatory time line, is that beyond Synthes? Is that causing you to rethink chronic, acute, degenerative, focusing in any of those areas more or less?

William C. Weldon

No. I think the one area where it caused us more broadly than that to think about was in the drug-eluting stent area, where we've seen the implants or the stents going down as well as price being challenged quite substantially there, and we felt we'd be in a better position to invest -- take those resources that we'd invest in the stent business and invest elsewhere. But if you look at the endoscopic business, you look at the businesses that we're in, in Ethicon, you look at the power and the ultrasound business, I think we feel that we're still in a very good position, and we're going to continue to invest in those areas because we think the markets will be -- will work out really well for us.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

And then a follow-up question, if I could, on your forward priorities. You mentioned regenerative medicine as one of the opportunities that you're looking at. I'm wondering if you could talk a little bit about sort of advanced surgical technologies beyond HARMONIC scalpel into robotics or other areas. Do you see those as opportunities going forward? What kind of role do you think that they play?

William C. Weldon

Robotics specifically -- and during part of my previous life at J&J, we looked at those areas. They made huge strides, they've gotten into lot of areas. But it's an area that we've opted not to go into. So we think that where we're positioned right now is where we ought to be, and hopefully that we'll continue to move in that direction.

Louise Mehrotra

Kristen?

Kristen M. Stewart - Deutsche Bank AG, Research Division

Dominic -- Kristen Stewart from Deutsche Bank. Just want to clarify on Synthes. I think originally you said it was 1% to 2% dilutive. But I think originally you were excluding amortization, and now it sounds like you're going to be including that. Is that correct? And what does that do for dilution --

Dominic J. Caruso

Well, the S4 that we filed discloses the amount of amortization, which on annual basis I think is $500 million or $550 million after tax. And I said in guidance, we're not going to change the way we account for amortization. But when we provide the impact of Synthes, we'll obviously be very clear about how much amortization, incremental amortization is included in that guidance at that time. It also depends on what time of the year we close, et cetera.

Kristen M. Stewart - Deutsche Bank AG, Research Division

But the 1% to 2% originally excluded out amortization costs?

Dominic J. Caruso

Yes, correct.

Kristen M. Stewart - Deutsche Bank AG, Research Division

And then just thinking out, I guess, a little bit beyond 2012, just with 2013 with the device tax, can you maybe just talk a little bit about how you expect to manage through that, if you can? Obviously, pricing is a difficult environment, so any restructuring efforts that might overcome the incremental cost?

William C. Weldon

No. I think that the device tax in 2013 is going to come into play. We understand what it is, where we are and we'll continue to manage our business accordingly. So I don't see any difference that we're doing -- any different changes we're going to take.

Louise Mehrotra

So the last question, David?

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

David Roman, Goldman Sachs. Bill and Dominic, in your prepared remarks, you talked about accelerating pricing pressure in 2012. As you sort of -- can you maybe provide a little more perspective to what segments you see that maybe from a tiering perspective? And then maybe you can contrast that with where you think the best areas for innovation are. And do those, in fact, line up with the areas of the most pricing pressure? Can you actually offset that with new products? Or is it really going to be about moving the mix of businesses to the areas where there are greater opportunities for innovation?

William C. Weldon

Yes, I think the areas where we see innovation, and I think you have to look at it as how do you get into -- bring really true innovation into the marketplace, like ZYTIGA, I think, brought really true innovation. So I think it's going to be going into areas like Bapineuzumab for Alzheimer's, Canagliflozin for diabetes and bringing true innovation in those areas that are not going to be -- that are going to create -- where there are real needs, we have to continue to be moving into those areas. I think the same thing in the orthopedic area and the whole medical device area, to be able to deliver a drug through a lens, for example, is something that could be very innovative and help in those areas. So I think you're going to have to look at true innovation and move in an area that allows you to bring products that are going to create value for patients and are going to be able to offer value to the system and moving that way. So I think that's really the answer that we have to look at.

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

And then one quick follow-up for Dominic. Anything specific to note in the fourth quarter, is there a pretty sharp sequential set down in margins? And I know margins normally come down throughout the year, but anything specific to note given the relative move compared to history?

Dominic J. Caruso

Yes, well, in the fourth quarter, just as a reminder, we did the collaboration with Pharmacyclics, which is about $0.04 to $0.05 dilutive just in the quarter. So that was a big jump. And you'll see a big jump in our R&D expense in the fourth quarter. That relates to the licensing payment, the upfront payment that we've made to Pharmacyclics in the quarter. Then we took the opportunity to invest behind the brands and we had some items that we want to clean up and get behind us as we move into 2012.

Louise Mehrotra

Final remarks from Bill?

William C. Weldon

Yes, I just want to say thanks. I think you can tell we're very excited about 2012 and beyond. And I think we're going to see a lot of good things happening. And we do look forward to seeing you all, I guess, at the Medical Device & Diagnostics Business Review in November. So thanks very much.

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