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Executives

Louise Mehrotra - Vice President of Investor Relations

Dominic J. Caruso - Chief Financial Officer and Corporate Vice President of Finance

Analysts

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

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

Jami Rubin - Goldman Sachs Group Inc., Research Division

Matthew J. Dodds - Citigroup Inc, Research Division

Rajeev Jashnani - UBS Investment Bank, Research Division

Ian Sanderson - Cowen and Company, LLC, Research Division

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

Matthew S. Miksic - Piper Jaffray Companies, Research Division

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

Frederick A. Wise - Leerink Swann LLC, Research Division

Kristen M. Stewart - Deutsche Bank AG, Research Division

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Alison Yang - Barclays Capital, Research Division

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

David R. Lewis - Morgan Stanley, Research Division

Johnson & Johnson (JNJ) Q1 2012 Earnings Call April 17, 2012 8:30 AM ET

Operator

Good morning, and welcome to the Johnson & Johnson First Quarter 2012 Earnings Conference Call. [Operator Instructions] This call is being recorded. If anyone has any objections, you may disconnect at this time. [Operator Instructions] I will now turn the call over to Johnson & Johnson. You may begin.

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 first quarter of 2012. Joining me on the call today is Dominic Caruso, Vice President of Finance and Chief Financial Officer. A few logistics before we get into the details. This call is being made available through 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 first quarter for the corporation and highlights for our 3 business segments. Following my remarks, Dominic will provide some additional commentary on the first quarter financial results and discuss guidance for the full year of 2012. We will then open the call to your questions. We expect the call to last approximately one hour. Included with the press release that was sent to the investment community earlier this morning is a schedule showing sales for major products and/or businesses to facilitate updating your 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 review may be considered forward-looking statements. The 10-K for the fiscal year 2011 identifies 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 and on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com.

Now I would like to review our results for the first quarter of 2012. If you would 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 $16.1 billion dollars for the first quarter of 2012, down 0.2% as compared to the first quarter of 2011. On an operational basis, sales were up 1% and currency had a negative impact of 1.2%. In the U.S., sales decreased 5.1%, impacted by generic competition for LEVAQUIN and CONCERTA. In regions outside the U.S., our operational growth was 6.4%, while the effective currency exchange rates negatively impacted our reported results by 2.3 points. The strong growth in the regions outside the U.S. was primarily due to the success of new product launches and the impact of the amended agreement with Merck regarding REMICADE and SIMPONI. I will discuss these items in more detail in the segment commentary. The Western Hemisphere, excluding the U.S., grew by 23.3% operationally, while Europe grew 4.5% operationally. The Asia-Pacific Africa region grew 1.2% on an operational basis.

If you'll now turn to the consolidated statement of earnings, net earnings were $3.9 billion compared to $3.5 billion in the same period in 2011. Earnings per share were $1.41 versus $1.25 a year ago. Please direct your attention to the boxed section of the schedule, where we have provided earnings adjusted to exclude special items. As referenced in the accompanying tables on the non-GAAP measures, 2012 first quarter net earnings were adjusted to exclude the after-tax net impact of a currency adjustment related to the planned acquisition of Synthes, partially offset by costs associated with the acquisition. First quarter results for 2011 were adjusted to exclude the after-tax impact of litigation expense and a few ASR Hip recall costs. Net earnings on an adjusted basis were $3.8 billion and earnings per share were $1.37, up 1.5% versus the first quarter of 2011.

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 first quarter, cost of goods sold at 30.4% of sales was 90 basis points higher than the same period in 2011 primarily due to the ongoing remediation work in our OTC business and unfavorable mix, including the impact of the Crucell business. First quarter selling, marketing and administrative expenses at 31.1% of sales were down 20 basis points due to cost-containment initiatives across many of our businesses. Our investment in research and development as a percent of sales was 10.2%, 60 basis points lower than the first quarter of 2011 primarily due to the timing of milestone payments. Interest expense, net of interest income of $130 million, was up $26 million versus the first quarter of 2011 due to a higher average debt balance.

Other income net of other expense was $611 million in the first quarter of 2012 compared to $13 million in the same period last year. Excluding special items, other income net of other expense was $494 million in 2012 compared to $359 million in 2011. 2012 results include the gain related to the divestiture of Bystolic while 2011 results included the gain related to the equity investment in Crucell. Excluding special items, the effective tax rate was 22.8% in the first quarter of 2012, in line with the 2011 rate.

Turning now to business segment highlights. Please refer to the supplementary sales schedules highlighting major products or businesses for the first quarter of 2012. I'll begin with the Consumer segment. Worldwide Consumer segment sales for the first quarter of 2012 of $3.6 billion decreased 2.4% as compared to the same period last year. On an operational basis, sales decreased 0.6%, while the impact of currency was negative 1.8%. U.S. sales were down 2.2%, while international sales grew 0.4% on an operational basis. Baby care products declined on an operational basis by 1.4% when compared to the first quarter of 2011 due to lower sales of lotions and powders, partially offset by stronger sales of wipes.

Sales in the oral care business increased 0.7% on an operational basis with U.S. down 4.9% and international sales up 4.7% on an operational basis. Strong international sales of LISTERINE from recently launched products were partially offset by lower U.S. sales of floss. For the first quarter of 2012, sales for OTC pharmaceuticals and nutritionals decreased 0.3% on an operational basis compared to the same period in 2011. Sales in the U.S. were down 4% primarily 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 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. As we previously discussed, production volumes from these facilities continue to be impacted by additional review and approval processes. We expect this to continue throughout 2012 and most of 2013. The Fort Washington manufacturing site is not in operation at this time. We anticipate it will be ready for the FDA to begin their certification review process for this facility in late 2013.

Sales outside the U.S. were up 1.7% 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 2.1% on an operational basis in the first quarter of 2012 with sales in the U.S. up 6.3% and sales outside the U.S. down 1.7% on an operational basis. Strong sales of Neutrogena in the U.S. due to the success of new product launches were partially offset by lower international sales. A softer market in certain regions has impacted the international sales.

Women's health declined 8.2% on an operational basis. Sales in the U.S. were down 25.6%, while sales outside U.S. were down 1.7% on an operational basis. The sales decline this quarter was primarily due to the impact of divestitures of certain brands. Wound care/other sales increased 3.3% on an operational basis compared to the same period last year due to new product launches. That completes our review of the Consumer segment. And I'll now review highlights for the Pharmaceuticals segment.

Worldwide net sales for the first quarter of $6.1 billion increased 1.2% versus the same period last year. On an operational basis, sales increased 2.6% with a negative currency impact of 1.4 points. Sales in the U.S. decreased 10.8%, while sales outside the U.S. increased on an operational basis by 19.6%. The loss of marketing exclusivity for LEVAQUIN in June last year and the May 2011 supply and distribution agreement with Watson Laboratories, Inc. to distribute an authorized generic version of CONCERTA in the U.S. negatively impacted worldwide Pharmaceutical operational sales growth by approximately 9 points and U.S. growth by approximately 14 points. Positively impacting sales growth in the quarter were sales related to the February 2011 acquisition of Crucell and the impact of the amended agreement with Merck, partially offset by divestitures. Excluding the items mentioned, the underlying worldwide operational growth was approximately 9% with similar results in both the U.S. and outside the U.S.

Now reviewing sales for our major therapeutic areas. Immunology products achieved strong double-digit operational sales growth of 20.5%. Growth in the U.S. of 1.2% was impacted by lower export sales to Merck. As a reminder, in the third quarter of 2011 as a result of the agreement reached with Merck, we began selling REMICADE and SIMPONI directly into certain international territories. We therefore recorded lower export sales related to those territories and higher international sales. Excluding the change in export sales, U.S. immunology sales increased over 13% led by STELARA, up 22.9%; SIMPONI, up 20.8%; and REMICADE, up 11.9%. With these strong results, we expanded our U.S. market leadership in immunology.

International sales of immunology products tripled versus the first quarter of 2011 due primarily to the sales related to the territories we regained from Merck, complemented by the very strong growth of STELARA. Sales of infectious disease products declined 17% on an operational basis. Excluding the generic impact of LEVAQUIN, which I previously mentioned, infectious disease sales increased over 40%. Major contributors were the successful launch of INCIVO for hepatitis C, the continued momentum in market share growth for PREZISTA for HIV and additional sales of vaccines related to the February 2011 acquisition of Crucell. INCIVO contributed nearly 5 points of the growth to the total international Pharmaceutical sales results.

Neuroscience product sales decreased 4.3% on an operational basis impacted by generic competition with CONCERTA, as I mentioned, as well as products such as RISPERDAL, TOPAMAX and RAZADYNE. The long-acting injectable antipsychotics RISPERDAL CONSTA and INVEGA SUSTENNA achieved double-digit operational growth due to an increase in combined market share. Sales of oncology products increased 38.5% on an operational basis due to the very strong results for ZYTIGA and VELCADE, partially offset by lower sales of DOXIL/CAELYX related to manufacturing issues at our third-party supplier. ZYTIGA is currently approved to treat chemo refractory metastatic castrate-resistant prostate cancer. In the quarter, ZYTIGA achieved sales of $200 million split evenly between the U.S. and outside the U.S. On a sequential basis, reported sales increased approximately 30%. 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 grew 29.3% due to the timing of tender business and strong growth in use in the frontline setting.

DOXIL/CAELYX declined over 80% on an operational basis in the quarter. As we previously discussed, based on the update last December from our third-party manufacturer about its estimated time frame for restoring manufacturing operations, we do not anticipate DOXIL/CAELYX to be available until late 2012. Restoring a reliable supply of DOXIL/CAELYX remains our most urgent priority. We continue to pursue a variety of options to bring a consistent supply of DOXIL/CAELYX back to patients and physicians as quickly as possible. In addition to longer-term solutions, we are pursuing a shorter-term option to restore supply ahead of the late 2012 time frame. Other Pharmaceutical products declined 7.9% on an operational basis due primarily to divestitures and lower sales of ACIPHEX/PARIET and EPREX due to the impact of generic competition.

I'll now review the Medical Devices & Diagnostics segment results. Worldwide Medical Devices & Diagnostics segment sales of $6.4 billion grew 0.5% operationally as compared to the same period in 2011. Currency had a negative impact of 0.8 points resulting in a total sales decrease of 0.3%. Sales in U.S. were up 0.2%, while sales outside U.S. increased on an operational basis by 0.7%. Excluding drug-eluting stents, worldwide sales increased approximately 2% on an operational basis.

Now turning to the MD&D businesses, starting with cardiovascular care. Cardiovascular care sales were down 23.5% operationally, with U.S. down 27.3% and sales outside U.S. down 21.2% operationally. The decision in the second quarter of 2011 to exit the drug-eluting stent market and the decline in market share for endovascular stents negatively impacted sales this quarter. This was partially offset by strong sales for Biosense Webster, our electrophysiology business, which achieved operational growth of 12% in the quarter. The impact on disposables utilization due to the breadth of the installed base of CARTO 3, complemented by the success of the new THERMOCOOL catheter launches made strong contributions to the results.

The diabetes care business achieved operational sales growth of 6.6% in the first quarter of 2012 with the U.S. business up 13.2% due to new product launches and favorable mix. The business outside U.S. grew 0.2% operationally, with strong sales in the emerging markets offset by pricing pressures in some of the developed markets. The diagnostics business declined 1.1% on an operational basis in the first quarter. Sales in the U.S. were down 4.5% due to lower donor screening sales due to competitive pressures and the implementation of selected testing guidelines for Chagas' disease. Sales outside the U.S. were up 2.5% operationally, driven by the continued adoption of the VITROS platforms. General surgery worldwide sales grew operationally by 1.4% with the U.S. down 0.5% and sales outside U.S. up 2.6% operationally.

The success of the new product launches SECURESTRAP and ECHELON FLEX Powered ENDOPATH Stapler were partially offset by lower sales of mechanical products due to the continued shift to minimally invasive procedures and low-cost competition and lower sales of pelvic floor repair products. Infection prevention grew 13.4% on an operational basis, with U.S. growth at 22.1% and growth outside the U.S. of 6.5% on an operational basis. Growth was driven by increased market share due to the larger installed base of STERRAD systems. Orthopedic sales were flat when compared to the same period in 2011. Sales in the U.S. were down 3.5% due to the impact of the divestiture in December 2011 of surgical instruments and continued pricing pressure partially offset by positive mix. The orthopedics business outside the U.S. grew by 4.1% operationally due primarily to strong growth in Asia.

Operationally, hips were up 1% worldwide, driven by 3% growth outside the U.S. attributed to heads, cementless stems and acetabular products. In the U.S., hips were essentially flat. Knees worldwide increased 2% on an operational basis, with U.S. up 2% and operational sales outside U.S. up 1%. Worldwide spine was down 3% on an operational basis, with the U.S. down 8% due to continued pressure on price. Sales outside the U.S. were up 5% operationally. Specialty surgery achieved operational growth of 9.9% in the first quarter of 2012, with the U.S. sales up 10.5% and sales outside the U.S. up 9.3% on an operational basis. Incremental sales from the acquisition of SterilMed, strong sales of biosurgery products and new product launches were the major drivers of growth this quarter.

Rounding out the review of the Medical Devices & Diagnostics segment, our Vision Care business achieved operational sales growth of 4.5% in the first quarter compared to the same period last year. Sales in the U.S. increased 8.2%, while sales outside the U.S. increased 2.6% on an operational basis. Growth was driven by daily lenses and astigmatism lenses. That completes highlights for the Medical Devices & Diagnostics segment and concludes the segment highlights for Johnson & Johnson's first quarter of 2012.

Before I turn the call over to Dominic, I would like to discuss the Arkansas judge's decision last week regarding RISPERDAL, awarding $1.2 billion in penalties against the company. Many of you have asked about this matter, so I would like to provide the following context. During the entire period at question, Arkansas Medicaid spent a total of less than $10 million of state funds on prescriptions for RISPERDAL. The state acknowledged that RISPERDAL was a very important therapy for patients and that the state did not intend to interfere with physicians prescribing RISPERDAL to treat their patients. We firmly believe the imposition of the penalties was excessive, not justified by the evidence presented at trial and will not be upheld on appeal. If our motion for a new trial is denied, we will appeal. The company has not established an accrual with respect to the judgment. We continue to stand fully behind RISPERDAL, which helps millions of patients around the world who suffer from the debilitating effects of schizophrenia and bipolar mania. I will now turn the call over to Dominic Caruso. Dominic?

Dominic J. Caruso

Thank you, Louise, and good morning, everyone. I would like to provide some comments this morning about our first quarter results, highlight some recent business and pipeline developments and provide guidance for you to consider in refining your models for 2012. There continues to be multiple external factors that have resulted in significant headwinds, such as the macroeconomic conditions, governmental budgetary actions and regulatory and industry trends. However, we continue to see significant opportunities in health care, and we are well positioned as a global leader to capitalize on these opportunities based on the strength of our recently launched products, our robust and advancing pipelines and our broad base in health care.

We're off to a good start in 2012. Given the impact of LEVAQUIN and CONCERTA going generic in mid-2011, we expected and we saw modest operational sales growth in the first quarter. Although utilization in the health care markets continues to be below prerecession levels, we are seeing a continuation of stabilization, and we are encouraged by recent fourth quarter utilization data, which was modestly positive. In particular, we saw U.S.-based hospital surgical procedures modestly grow, which is the first time we saw this in the data in the last 9 quarters. We also are seeing continued progress with our new product launches and our sales in emerging markets.

Our Pharmaceutical business operational growth this quarter was approximately 3%, reflecting the tough comparisons from the impact of LEVAQUIN and CONCERTA. Excluding both the generic impacts and the positive impact from our agreement with Merck last year to regain certain international sales territories for REMICADE and SIMPONI, Pharmaceutical sales for the first quarter would have increased approximately 9% operationally, reflecting the success of the new product launches, as well as continued growth in many of our core products. Our Medical Device businesses saw modest operational growth in the first quarter, driven by our decision to exit the drug-eluting stent market in the second quarter of 2011. Our MD&D businesses, however, continue to be market leaders, with either #1 or #2 market positions in 17 of our 19 key platforms. And our Consumer business showed modest operational decline in first quarter performance due primarily to lower production levels of our McNeil U.S. over-the-counter products as a result of the work required under the Consent Decree.

As to earnings, we are very pleased to have reported solid earnings per share in the first quarter of $1.37, excluding special items. During the first quarter, we completed the divestiture of the high blood pressure drug, Bystolic, to Forest Laboratories for a one-time cash payment of $357 million. The gain from that transaction, which we expected when we provided guidance in January, is reflected in our first quarter results. We also continue to make investments this past quarter to advance our robust pipelines, launch new products and implement remediation plans for our manufacturing and quality systems at our McNeil Consumer Healthcare business.

Now let's take a look at some first quarter 2012 accomplishments across our businesses. First, in our Pharmaceutical business. Based on the unanimous recommendation of the investigational drug monitoring committee, we unblinded the Phase III study of ZYTIGA for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer who had not received chemotherapy. Based on the study results, we plan to submit for regulatory approval of ZYTIGA for these indications in the United States and Europe in the second half of 2012. We announced that the U.S. Food and Drug Administration granted priority review for XARELTO to reduce the risk of blood clots in patients with acute coronary syndrome, which we had filed at the end of 2011. XARELTO is already approved in the U.S. for the prevention of blood clots following hip and knee replacement surgery and the prevention of stroke as a result of blood clots.

And we also announced the results of the EINSTEIN-PE study showing that the oral anticoagulant XARELTO was comparable to today's standard of care in treating patients with acute symptomatic pulmonary embolism and in preventing the development of a secondary venous blood clot known as venous thromboembolism or VTE. The study found that XARELTO had a similar safety profile and significantly lower risk of major bleeding versus the current standard of care regimen. The data was published in the New England Journal of Medicine, and we plan to file the EINSTEIN studies in a supplemental new drug application with the FDA during the second quarter for an indication in the VTE treatment.

The FDA approved the use of INTELENCE to be administered in combination with antiviral medications for the treatment of HIV-1 in treatment-experienced pediatric patients. And finally, with respect to Bapineuzumab, we have agreed with our partner Pfizer to present the results from the 2 North American Phase III studies which we led, study 301 and study 302, later this year. Based on standard practices for both companies, we will ensure the data are presented in a timely manner at an appropriate scientific venue.

Our MD&D business also continued to make important advancements. In February, we received an approvable letter from the FDA on our SEDASYS system, the first computer-assisted personalized sedation system. We are pleased to have reached this milestone in our efforts to bring this important innovation closer to market as we believe the SEDASYS system has the potential to benefit patients and health care providers. LifeScan launched in the U.S. the OneTouch Verio IQ system with PatternAlert Technology, the first and only blood glucose meter to look for patterns of high and low blood sugar levels and alert diabetes patients with detailed messages onscreen, alerting them to changes in their blood sugar levels. The system is in the process of being launched globally. Approximately 366 million people globally are expected to have diabetes by the year 2030 and about 26 million Americans live with diabetes today.

And in our Consumer Healthcare business, several McNeil products have returned to the market and more are planned to return throughout this year and next. However, it is difficult to predict the speed of recovery while operating under the Consent Decree. Therefore, we do not anticipate our U.S. OTC business to be a driver of growth this year. We continue making progress on our commitments under the Consent Decree, and we are experiencing higher remediation costs as a result. All of these impacts are considered in our guidance, which I will discuss in just a minute. Meanwhile, our skin care business continues to be a solid contributor of growth with our Neutrogena business bringing new innovations to market and the ongoing success of our Neutrogena Naturals moisturizer and night cream.

Now I'd like to provide an update on the status of our pending acquisition of Synthes. We continue to make good progress on all aspects of the acquisition planning process and we continue to expect the transaction to close in the second quarter of 2012. The merger agreement requires regulatory clearance from 5 markets prior to closing. We have received clearance from 3 of those markets: Japan, Canada and China. We are actively working with the other 2: the EU and the U.S. regulatory authorities. Earlier this month, we received a binding offer from Biomet, Inc. to acquire the DePuy Orthopaedics trauma business. The offer includes the purchase of DePuy's internal and external fixation products used in the treatment of bone fractures, as well as the organization supporting this business. The sale is subject to regulatory approvals and is expected to close in the second quarter of 2012. We believe this divestiture will satisfy all regulatory concerns relating to the pending acquisition of Synthes, but we will not know with certainty until the regulatory processes in the EU and the U.S. are completed.

Let me now provide some guidance for you to consider as you refine your models for 2012. My comments do not include any impact from the pending acquisition of Synthes. As we would normally do, we will update our guidance once the acquisition is completed. Let me begin with a discussion of cash and interest income and expense.

At the end of the first quarter, we had over $14 billion of net cash. This consists of approximately $33 billion of cash and investments and approximately $19 billion of debt. For purposes of your models, assuming no major acquisitions during 2012, I suggest you consider modeling net interest expense of between $500 million and $550 million. This is consistent with our previous guidance.

Turning to other income and expense. As a reminder, this is the account where we record royalty income, as well as one-time gains and losses arising from such items as litigation, investments by our development corporation and divestitures, asset sales or write-offs. As we previously noted in our guidance for 2012, we had expected a gain from a divestiture in early 2012 and, in fact, that gain is reflected in our first quarter results. This account is difficult to forecast. But assuming no additional major one-time gains or losses and excluding the impact of any special items, I would recommend you consider modeling other income and expense for 2012 as a net gain, ranging from approximately $900 million to $1 billion, consistent with our previous guidance.

And now a word on taxes. For the first 3 months of 2012, the company's effective tax rate, excluding special items was 22.8%. We suggest that you model our effective tax rate for 2012 in the range of 21% to 22% consistent with our previous guidance. Although not yet reflected in our first quarter results, this annual tax rate assumes that the R&D tax credit will be reinstated by Congress by the end of this year. As always, we will continue to pursue opportunities in this area to improve upon this rate throughout the year.

Now let's turn to sales and earnings guidance. Our guidance continues to be based first on a constant currency basis reflecting our results from operations, assuming that average currency rates for 2012 will be the same as they were for 2011. This is the way we manage our business, and we believe this operational view provides a good understanding of the underlying performance of our business. We will also continue to provide an estimate of our sales and EPS results for 2012 with the impact that current exchange rates could have, using the euro as an example.

Now turning to sales. We would be comfortable with your models reflecting an operational sales increase on a constant currency basis of between approximately 4% and 5% for the year. This is consistent with our previous guidance. This would result in estimated sales for 2012 on a constant currency basis of approximately $68 billion. While we're not predicting the impact of currency movements, to give you an idea of the potential impact, if currency exchange rates for the remainder of 2012 were to stay where they were as of last week, as an example, with the euro at approximately $1.31, then our sales growth rate would be negatively impacted by approximately 2% for the year. Thus, under this scenario, we would expect reported sales growth to be between approximately 2% and 3% for the year for an expected level of reported sales of approximately $66.5 billion, slightly higher than our previous guidance due to the strengthening of foreign currency exchange rates versus the U.S. dollar.

And now turning to earnings. I suggest that you consider full year 2012 operational EPS estimates of between $5.18 and $5.28 per share, excluding the impact of special items and assuming the same average exchange rates for 2012 as we saw in 2011. This is consistent with our previous guidance. And while we're not predicting the impact of currency movements, to give you an idea of the potential impact on EPS, if currency exchange rates for the balance of 2012 were to remain where they were as of last week, then the impact of currency movements, primarily the euro, would be a reduction of approximately $0.11 per share. Therefore, our reported EPS, excluding special items, would be between $5.07 and $5.17 per share for a reported EPS growth rate of approximately 1.5% to 3.5%, which is slightly higher than our previously guidance, reflecting the strength of foreign exchange rates versus the U.S. dollar.

That concludes my comments on our operating performance this quarter and our guidance with respect to your models. And now, Louise, back to you for the Q&A.

Louise Mehrotra

Thanks, Dominic. Keela, can you please give the instructions for the Q&A session?

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from the line of Larry Biegelsen of Wells Fargo.

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

So the first quarter operational growth was 1%, Dominic. The guidance is 4% to 5%, if I heard correctly. Could you talk a little bit about what accelerates growth going forward, especially in Q2, given that if we look at the operational growth rate in the first quarter of this year compared to the fourth quarter of last year, there does seem to have been a deceleration?

Dominic J. Caruso

Right. Well, I guess, Larry, the main factor in the growth rate comparison has to do with LEVAQUIN and CONCERTA. The first quarter, as we mentioned, for the Pharmaceutical business, only at 3% reflects the fact that LEVAQUIN went generic in May or June of 2011, and obviously we entered into that agreement with Watson for authorized generic of CONCERTA in May of 2011. So in the first quarter of 2011, we didn't have those impacts yet so that's the major reason for the comparison. As we progress through the year, those comparisons will be easier. Of course, the comps will be easier. And just as a reminder, we did acquire the Crucell business very late in the first quarter of 2011. So if you look at the entire business and you just exclude the things that I mentioned, sort of generic impacts, the impact of drug-eluting stents that Louise mentioned and also the net impact of acquisitions and divestitures, which netted to be actually a minor amount, the overall growth rate for our business in the first quarter on an operational basis is just about 4%. So we feel pretty confident that we'll accelerate the growth for the remainder of the year.

Larry Biegelsen - Wells Fargo Securities, LLC, Research Division

Okay. And Dominic, just one on DePuy and the orthopedic market. It looks like there was some improvement in the U.S. in knees. Could you just talk a little bit about what you're seeing overall in the orthopedic market from a procedure and pricing standpoint, please?

Dominic J. Caruso

Sure, sure. And I'll ask Louise to comment as well if I leave anything out. We did see some improvement in knees. And we continue to see knees being positively affected by product mix. So overall, in our knee business, pricing is only slightly negative, very, very low, not even quite single-digit price, offset by positive mix that's low-single digits. So that's a boost in the knee business. And overall, the knee market seems to be recovering as well. And Louise, anything else you want to add to that?

Louise Mehrotra

Yes. So the commentary we got from DePuy said that they are seeing early signs of some positive trends in the knee market. However, we won't know for sure until all the other manufacturers report.

Operator

Our next question is from the line of Mike Weinstein of JPMorgan.

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

Dominic, just first question on your guidance. You had commented on the fourth quarter call that you expected pretax operating margins for the year to improve by 100 to 150 basis points. I think they were up about 10 basis points this quarter. So does that 100 to 150 basis points for the year still stand?

Dominic J. Caruso

Yes, it does, Mike. We feel pretty confident about that moving through the rest of the year.

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

Okay. Let me ask then a couple of operational questions. The commentary around the Consumer business, particularly McNeil, suggested that it was going to take a little bit longer to get some of those issues resolved. I think you talked in your prepared remarks about the volumes coming out of Las Piedras and Fort Washington and Lancaster, but Fort Washington being offline, I think you said, until late 2013 and then Las Piedras and Lancaster being -- ramping all the way in through most of '13. That sounded like it was a longer time period recovery for McNeil than we have been previously thinking about.

Dominic J. Caruso

It is, Mike. As I said in my remarks, operating under the Consent Decree, it's difficult to predict the rate of recovery. And although we're making progress and we are operating under a Consent Decree in close cooperation with our third-party consultant who's there with us, it is difficult to accurately predict the speed of recovery. And as such, we are, in fact, behind where we felt we might be at this point. And we expect a slower recovery throughout the year than we previously thought at the tail end of last year. Although products are coming back to the market, they'll continue to come back to the market throughout the year. You'll see more and more of the products back on the shelves, but it will extend into 2013 as well. And as I mentioned earlier, we're also incurring some additional remediation costs as a result of the delays. But all of that has already been factored into the guidance I just provided.

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

Okay. Just one question on ZYTIGA. When the independent data monitoring committee stopped the Phase III trial in pre-chemo metastatic castrate-resistant prostate cancer patients, they did so based on the primary end point, which was progression-free survival. And I believe it was based on data that went through late last year. Do you know if at ASCO if we'll see the follow-up on patients up through the actual announcement of the halting of the trial, where the question here is whether we'll see overall survival reach potential significance at the full follow-up?

Louise Mehrotra

Okay. So you're correct, Mike, it did include the information up until the end of last year. I think it was November of last year. I don't believe that you're going to see the continuing trend on the overall survival at ASCO. You'll see the results as we have them right now.

Operator

The next question is from Jami Rubin of Goldman Sachs.

Jami Rubin - Goldman Sachs Group Inc., Research Division

Dominic, just a clarification on the other income line. You reported $611 million, some of that was related to Synthes and foreign exchange, which we excluded, but some of that was related to divestitures which you included in operating income. Can you update us on where your expectations are for additional divestitures throughout the year? I think that during the previous call you had indicated between $500 million to $600 million. But I just wanted to make sure that I was thinking about that correctly. And then secondly, back on the OTC question, clearly the Consent Decree has slowed the process down. How do you feel about a recovery story in 2013? And once the products reach the market, what are your expectations in terms of how much market share you think you can gain back?

Dominic J. Caruso

Okay. Well, on the divestitures, Jami, let me try to do a little bit better job of explaining what's in that other income and expense line. Typically, that line includes royalty income, which is in the $500 million -- these are pretax numbers. $500 million of royalty income, and then there's roughly another $100 million of other activity that flows through that line. We did expect, as we mentioned, a divestiture to occur early this year, which it did. And that divestiture, as I mentioned earlier, had proceeds of around $350 million. So our current guidance, which is the same as it was in January is for that line item, other income and expense, to be between $900 million and $1 billion. So it factors in the normal run rate that I just mentioned of $500 million to $600 million and this divestiture that we just completed in the first quarter, so hopefully that's clear. And then with respect to the divestiture income, I just wanted to point out that these are taxed at various rates because they occur at various tax jurisdictions. Both the divestiture in 2012, as well as the divestitures that were in the gains in 2011, which included not only a divestiture but an equity gain with respect to our acquisition of Crucell, on an after-tax basis, they're very comparable. They're in the $200 million range both on an after-tax basis. And then with respect to recovery in 2013 and ultimate share recapture, we still feel very confident about our ability to recapture share. We're obviously disappointed that it's taking a little longer to get back into the market. But all indicators of the equity scores that we track with respect to the brands, children's TYLENOL, even adult TYLENOL, continue to show that the brands, both TYLENOL and MOTRIN and especially children's products, continued to score very highly compared to store brands even though they're not available on the shelf, and so much so that the scores are in the neighborhood of 2 to 3x the level of trust and confidence in the brand compared to the current available brands, particularly store brands. So that gives us great confidence that the significant legacy that has been built with these brands over the years still remains with consumers, and they'll accept the products back once we get them back on the shelf in a continuous way.

Jami Rubin - Goldman Sachs Group Inc., Research Division

So just -- so I’m clear on timing, Dominic, I think earlier in the year or late last year, you had said you expected most products to be back on the market by mid-2012, and then that became later 2012 to spilling into 2013. And now it's today's news that, that 2013 will -- the recovery will continue more into 2013, is that correct?

Dominic J. Caruso

Yes. I would say the way to think about it is that probably half of the products will get back into the market in 2012 and the remaining half in 2013.

Operator

The next question comes from Matthew Dodds of Citigroup.

Matthew J. Dodds - Citigroup Inc, Research Division

I just want to start off by wondering why the lost sales were soft in the U.S. That's a little concerning. No, actually, just don't count it as my question. For Dominic, on the gross margin. Can you say generally because of the generic impacts, do you expect that number to move up throughout the year? Is this the low point for 2012?

Dominic J. Caruso

Actually, no. I think that with the continuation of the remediation that we talked about with the McNeil Consumer business and the fact that we now have the Crucell business in the full year, we would expect gross margin to not be at the low point now and actually be under a little pressure for the remainder of the year. And actually looking at all your models, I noticed that you had -- many of you have that pretty well-pegged as a lower gross margin this year versus last year. So obviously, the improvement in pretax operating margins that we referred to before on Mike's question is going to come mostly from SG&A and a little bit lower R&D spend.

Matthew J. Dodds - Citigroup Inc, Research Division

Okay. So most of the remediation costs are in COGS and not in SG&A?

Dominic J. Caruso

Yes, that's correct. Yes, that's correct.

Matthew J. Dodds - Citigroup Inc, Research Division

Okay. And then one more question. On the general surgery business, it looks like it slid from prior performance. So I was wondering in sutures, endomechanical, hernia, did anything in that business fall off in the quarter?

Dominic J. Caruso

Louise has that data right in front of her. Go ahead, Louise.

Louise Mehrotra

Yes. So sutures were up about 0.5% in the quarter. Mechanical was down about 3% and we saw a large decline in the pelvic floor area.

Operator

Our next question comes from Rajeev Jashnani of UBS.

Rajeev Jashnani - UBS Investment Bank, Research Division

In our model, with Synthes closing in a couple of months, we've attempted to include this and a major assumption we've got is the level of share repurchase that J&J could do after that deal closes. I was just wondering if you could share a little bit about your thinking regarding share repurchase following Synthes, and perhaps touch on what the appetitive ability to do so is, given litigation and everything else.

Dominic J. Caruso

Yes. Rajeev, I'm not going to comment specifically about share repurchases. But I will remind you and everyone else that when we spoke about the Synthes transaction, obviously we modeled it in the most conservative way. And we said we would be working to try to finance the transaction in a more efficient manner. We're still exploring all those opportunities and alternatives. We're making good progress, but we're not able to really comment on that until very close and probably at the time of closure, at which point we'll give you a full picture on how the transaction is being structured differently from the way it was announced, if it is in fact differently structured. So other than that, I can't give you any more comments at this point.

Rajeev Jashnani - UBS Investment Bank, Research Division

Okay. I'll maybe push my luck a little bit, anyway, and say, could we think of it as being funded operationally or perhaps through the balance sheet?

Dominic J. Caruso

I think we just have to wait and get all the regulatory approvals in line and then the various alternatives we have considered will then be clear for us. And then we'll move forward on that basis. So it will be premature to comment any further now.

Operator

Your next question comes from Ian Sanderson of Cowen and Company.

Ian Sanderson - Cowen and Company, LLC, Research Division

First, on the RISPERDAL litigation, just a quick follow-up. When might we hear if whether your motion for dismissal has been accepted?

Dominic J. Caruso

Yes, I guess I don't have a good estimate of that. We're going to -- we’ve filed or will be filing that. And then as Louise mentioned, if it's not accepted, we intend to appeal.

Ian Sanderson - Cowen and Company, LLC, Research Division

Okay. And then secondly, on the Synthes closing, is the review deadline, the EU review deadline, still effectively April 26? And has the U.S. FTC set any formal review deadline?

Dominic J. Caruso

So the EU has posted on their website April 26, and we're not aware of any changes to that. And the U.S. has not established a review deadline.

Ian Sanderson - Cowen and Company, LLC, Research Division

Okay. And then finally, Louise, could you give us some idea of the XARELTO sales in the quarter?

Louise Mehrotra

It's a little early to do that, Ian, thank you.

Operator

The next question is from Sara Michelmore, Brean Murray.

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

Maybe just a follow-up on XARELTO, Louise. Can you just give an update in terms of formulary coverage and things like that for the product at this point?

Louise Mehrotra

So XARELTO is on about 90% of the formularies. It's in either a Tier 1 -- or sorry, Tier 2 or Tier 3. So for commercialized, it's over 90% coverage, about 40% is Tier 2 and about the remaining 50% is Tier 3. And Part D, 90% coverage and 2/3 is on the preferred tier.

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

Okay, that's helpful. And then maybe, Dominic, the Consumer business, I know there is a lot of moving parts in addition to the OTC stuff, that you've got a bunch of divestitures and acquisitions flowing through there, but is there any way to give us a sense of what you think the underlying growth of that business is if we can clear out the noise? And in terms of the trend, would you say it's the same, better or worse compared to what it was doing in 2011?

Dominic J. Caruso

Right. Okay. Well, with respect to the Consumer business and the divestitures and acquisitions, just to give you a quick summary of that, they actually net out to have very little impact this quarter because remember, we had some divestitures of MONISTAT and other brands, but we also acquired DOKTOR MOM and other brands. So overall, that 0.6% decline operationally nets out to be about 0.5% decline operationally, net of all the ins and outs. So that's not a major factor in the quarter. We did see some slowdown in the Asia Pacific region and particularly China. China had some issues with ingredients that had been well-publicized that are not new issues, just another recurrence of some issues there in China, that slowed down the growth in that region of the world. And we continue to see store brands, obviously, take share and hold on to share. I would say that the skin care business, which is where we're demonstrating most of the innovation in our Consumer business continues to show very positive growth and continues to do very well, so very pleased with that. So overall, flattish performance in the quarter is a little bit lower than it was coming out of last year. But principally due to the fact that we haven't had the recovery yet that we expected and a little bit slower growth in the China market.

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

Okay, that's helpful. If I could sneak one more in on SEDASYS. What's left to do there in terms of getting that product finally cleared and ready to launch?

Dominic J. Caruso

Right. So we've got to complete the response letter, and obviously, we have an approvable letter. And we need to respond to the requirements of the approvable letter. And they're mostly things involving training of utilization of the product, and then sort of postmarket observance and those sorts of things. So we want to get that lined up and get it ready for launch in the appropriate way after we respond to the FDA's questions. But no new clinical studies required for approval, for example, just a follow-up to the data we had previously provided and some development of training materials and the like.

Operator

The next question is from Matt Miksic of Piper Jaffray.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

Just a couple of follow-ups on some of the questions that have been asked here. First, on the lines of the income statement, the gross margin below our estimate, you mentioned the remediation costs. Is this the right margin level for the rest of the year? Do you get any leverage on the spending component throughout the year? Or does that continue to ramp, kind of hold it in this range?

Dominic J. Caruso

Matt, I think with our new outlook for remediation cost being slightly higher than we previously mentioned, I think that we're going to see gross margin be under pressure for the remainder of the year. I think I answered that question earlier when Matt Dodds asked it. So I don't think there's going to be significant leverage in that line this year. Remember that this year, we also said we expected significant pricing issues in the business. And we're seeing that, stronger declines in pricing than we saw the previous year. And all of that, including the increased remediation costs, are now reflected in the updated guidance, which although it's consistent essentially with previous guidance, takes into consideration these more negative factors, offset by the fact that the rest of the business is off to a good start.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

Okay. And the R&D line, you also mentioned these delayed milestone payments, hoping that I didn't miss somebody else asking the same question, that could we expect those to catch up in the next couple of quarters or by the end of the year? Is that the thinking on R&D?

Dominic J. Caruso

Yes. So I think R&D will be a little higher in future quarters and it has to do with not necessarily delayed milestone payments, just the timing of milestone payments under various agreements that we have. Wherein previous quarter, we would have had milestone payments under contract, in this quarter, no such significant milestone payments were due. So I don't want you to think there's any delays in the program. It's just timing of when the programs and our milestone payments kick in. So that will go up a little bit throughout the year.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

That's helpful. And then on ortho, to follow up on some of your comments there and the questions that were asked earlier in your prepared remarks. The mix, did you mention which products are driving that on the knee side? Is TRUMATCH a factor there? Any other commentary that you got from DePuy?

Dominic J. Caruso

Yes, go ahead, Louise.

Louise Mehrotra

Okay. So some of the mix is being driven by the revision segment.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

Okay, revisions. And Dominic's comments, last one, on the utilization trends. I just wasn't clear, you mentioned Q4, and then you also mentioned some improving trends in surgical volumes. I just -- are you seeing that in the first quarter? Or is that Q4 data? Just the timing of that will be helpful.

Dominic J. Caruso

Yes. The data I was referring to was Q4 data. We don't really feel that the Q1 data is that reliable this early. But we have pretty good data on Q4. And we saw across all segments of utilization, whether at the hospital surgical procedures, ambulatory procedures, physician visits, lab procedures, et cetera, all positive signs. Although modest, I will say, positive signs so that's what I meant by we were encouraged by the Q4 data.

Matthew S. Miksic - Piper Jaffray Companies, Research Division

And just making sure that we're not reading that as maybe -- is this something that you saw on Q4 last year or different than you saw in Q4 last year? Is the seasonality a factor? Or how should we look at that?

Dominic J. Caruso

Yes. Well, the way we looked at it, Matt, is it's the first time, for example, for hospital surgical procedures, it's the first quarter in 9 quarters that we saw a quarter-to-quarter uptick in surgical procedures.

Operator

The next question comes from Derrick Sung of Sanford Bernstein.

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

So following on the utilization conversation, your comments there have been focused on the U.S. I was wondering if you could turn to Europe and give us some color on what you're seeing in utilization there, first off. I noticed that in the Medical Devices division, you did see a deceleration in your international sales from 4.6% to 0.7% operationally. Is any utilization coming to there? And then any other just further commentary on Europe receivables that you might be seeing there in pharma austerity?

Dominic J. Caruso

Yes. Well, with utilization -- the data in Europe’s obviously more difficult to nail down than it is in the U.S. Most of the FX that we saw in MD&D in Europe have to do with exiting the drug-eluting stent business so that's really the primary driver of the international dropoff that you're referring to. The austerity measures, we did expect and are seeing a little bit higher level of basically pricing, negative pricing in the businesses, both Pharma and MD&D, as we expected when we set guidance for the year. So we're seeing a continuation of that as playing out as we thought at a bit higher level than we saw in the previous year. And then finally, with respect to receivables in Europe, we're monitoring that very closely. We think we have a pretty good handle on it. And we are seeing some slight increase in the aging of those receivables, but nothing that we don't have a good handle on right now, nothing that we're particularly concerned about at the moment. But we'll obviously continue to monitor it and put appropriate actions in place.

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

Okay. And did you see an extra selling day in the quarter from the leap day? And if so, can you talk about the impact that, that had on the various growth rates for your divisions?

Louise Mehrotra

Actually, for our business, it was actually one less selling day because we work on a 4-4-5 basis. But we're not a calendar year, but it had no to minimal effect.

Operator

The next question comes from Rick Wise of Leerink Swann.

Frederick A. Wise - Leerink Swann LLC, Research Division

Let me touch on the announced management changes, Dominic. Maybe just -- this is the first opportunity we've had sort of publicly to hear your reflections on this. I'd be curious to hear why the timing now -- I mean, obviously Alex is not here to express for himself. But can we -- should we expect anything different under his leadership? Is there any reason that choice is made? And maybe talk a little about Sheri's departure. I know J&J has an incredibly deep bench, but obviously a very talented executive. What's your perspective on that?

Dominic J. Caruso

Right. Well, obviously, the decision on selecting the next CEO is the board's decision. So I'm not at liberty to comment on the board's rationale. We're obviously very pleased that Alex is going to be our new CEO. He officially takes over on April 26, which is the date of our annual shareholders' meeting. He will take over the CEO role from Bill Weldon at that point. And as you probably all know, Bill will remain as Chairman of our board. You're absolutely right that we do have a deep bench, and Sheri is and was a very valued member of our company and a very strong contributor to the success of Johnson & Johnson over the years. But of course, Sheri decided to pursue another opportunity at a very high senior level in another publicly traded company. So we obviously wish her well. I would say in terms of major changes, our business and our philosophy has been tried and true. Our business has run under a philosophy that's been tried and true for many years. And Alex, as you know, has been with our company for many years and even left and came back to our company. So he has seen other companies in operation as well. I would say that our core principles of managing for the long term, of our decentralized management philosophy being broadly based in human health care, and most importantly, the value system that's embodied in our credo, I certainly don't expect to see any changes there. These are the core principles in which our business has been operated under for many, many years, and obviously, the underpinning of our success. So we’re looking forward to Alex taking over on April 26. And I personally look forward to working closely with Alex to continue the success of our company.

Frederick A. Wise - Leerink Swann LLC, Research Division

Let me turn to pretax operating margins. You'd said in the fourth quarter, and I'm hearing some of the nuanced changes today, that you expected every line, R&D, cost of goods, selling and marketing, to improve. You expect gross margins to improve. But you said basically, bottom line, we expect pretax operating margins to improve by 100 to 150 bps in 2012. I just want to be clear. Do you still expect that? And if you do, with a little more cautious guidance on gross margins, how do we think about the SG&A and R&D lines? It sounds like both would have to be lower to hit that range.

Dominic J. Caruso

Right. Well, of course, it's a range, right? So 100 to 150 basis points. We do feel comfortable that with our new outlook for the year, we'll still be able to achieve that in 2012 across each of the lines. I think that, overall, the cost of products sold line will be slightly lower than it was in 2011 at the end, although it will get slightly worse throughout this year. So hopefully, I didn't confuse you when I mentioned that earlier. We do still expect to see improvement across all lines in the P&L. And throughout the year, we may see a slight dip in gross margin with the remediation cost. But overall, we do expect it to end up being slightly lower than it was the prior year. And certainly, we're comfortable with that range of 100 to 150 basis points overall.

Operator

The next question is from Kristen Stewart of Deutsche Bank.

Kristen M. Stewart - Deutsche Bank AG, Research Division

I just have a couple of quick ones. Can you provide an update on Canagliflozin?

Dominic J. Caruso

Sure. So that product we expect to file, Louise, relatively shortly now in the second quarter for type 2 diabetes. So we're very pleased there. And I don't know what else I could tell you. We're going to file pretty soon.

Louise Mehrotra

And we plan to show some data at ADA. So it's all on target, U.S., EU filing, second quarter.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And then within the specialty surgery business, you did include the acquisition of SterilMed. Can you maybe just help us kind of parse out what the acquisition contribution was?

Louise Mehrotra

So if you exclude SterilMed from specialty surgery -- so specialty surgery grew 10%, 9.9% operationally -- it would be about 6%, excluding SterilMed.

Kristen M. Stewart - Deutsche Bank AG, Research Division

Okay. And then within orthopedics, I just kind of want to understand your comments again. Not to beat a dead horse, but operational growth this quarter was flat. It was kind of flat in the fourth quarter. It sounds like you guys were a little bit more optimistic. Hips grew about the same, knees were a little better, spine was a little -- pretty much the same as fourth quarter. So what kind of, I guess, offsets some of the better performance of the knees?

Dominic J. Caruso

You said -- was your question what was the negative impact that offsets some of the better performance in knees to result in flat? Well, what we saw is a little bit worse pricing actually in the spine market. So pricing was in the mid-single digits. And it looked like it got a little bit worse in the first quarter of 2012.

Kristen M. Stewart - Deutsche Bank AG, Research Division

And any trends that you're seeing within kind of the spine and trauma market changed the way you're generally looking at the benefits of the Synthes acquisition?

Dominic J. Caruso

No, not really. I think we do these acquisitions with a long-term view. And as you remember, the acquisition had many positive strategic benefits, most notably, the ability to enter the emerging markets with hip and knee platforms as a result of having a strong presence in the trauma market, which is essentially the major driver of orthopedic activity in those markets so that still remains the same. And obviously, Synthes, as you know, is a very innovative and well-run company. So we're pleased to be able to welcome them shortly into the family of companies.

Louise Mehrotra

And one thing, Kristen, we did divest the surgery business, the DePuy neurosurgery instruments, in the fourth quarter. If you took that out, we actually would have grown about 1% so that's something that's different in the first quarter.

Operator

The next question is from Bob Hopkins of BofA.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

So 2 questions. First, on your comments on Bapi. I was wondering if you could help us understand which medical meetings are candidates for the data release. I assume you still want to show both data sets together, and that probably eliminates the July meetings. But is there -- are there 1 or 2 or 3 meetings that are most likely candidates for this data release this fall?

Louise Mehrotra

Bob, we're not going to comment on that, but it will be sometime this year.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Okay. Sometime 2012, okay. And then to talk about your comments on utilization, I understand those were fourth quarter comments. And then you mentioned that your endomechanical business is down 3% in the first quarter. Any commentary from the division level in terms of how is that trending in endomechanical? Is that a step-down? Is there a reason why, do you think that's market, market share? I'm just trying to reconcile your comments about feeling a little better about procedures to the endomechanical number that you showed this particular quarter.

Louise Mehrotra

Yes. So it's primarily in the mechanical business, and it's to do with low-cost competition, as well as the move to minimally invasive surgeries.

Robert A. Hopkins - BofA Merrill Lynch, Research Division

Okay. But still feeling pretty good about the general trends here in the first quarter? Or you're not making any comments about new utilization trends in Q1, just in Q4?

Dominic J. Caruso

Yes. I think the only thing, Bob, that we can look at with some confidence in the data is the Q4 data. So obviously, we'll update you throughout the year and let you know what we see. But it's too early to comment on first quarter data.

Operator

Our next question is from Tony Butler of Barclays.

Alison Yang - Barclays Capital, Research Division

This is Alison Yang calling in on behalf of Tony. A couple of product questions. First of all, congratulations on ZYTIGA, $200 million in the quarter. That's 2/3 of last year already in the first quarter. Can you discuss what percent of the indication is in the post-chemo? Is there any off-label use in chemo-naive? Could you give us a sense of what's the opportunity size in the chemo-naive segment? If it’s bigger than post-chemo, then how much bigger? My second question is another pharma product, INCIVO. We estimate, based on your comment about 5% growth o U.S., that the sales is about $130 million. Could you discuss how many European markets your product is in place? And what is the maturity of the pricing reimbursement discussion in the European markets?

Dominic J. Caruso

Well, Alison, that was -- we'll try to parse through that. Look, we're extremely pleased with ZYTIGA, so thanks for noticing that. The product is doing well, and most importantly, it's actually helping patients. I do think that the chemo-naive market is a bigger market for the product. We don't have that indication yet. We're not certain, but there -- of course, physicians are free to prescribe it to their patients. Of course, we're not promoting it in the chemo-naive population, so there may be some off-label use by physicians in that part of the market. But we do think that once we get the indication, we'll see further penetration of ZYTIGA into the overall patient population. I think your comment about INCIVO, the math is pretty good there. They contributed about 5% of the international growth so that gets you about the number, that $130 million number. So we're pleased with the first results on INCIVO as well. And Louise, you have other points to add to that?

Louise Mehrotra

Yes. So the question on the countries where it's launched, it's Germany, France, the Alpine countries, Nordics, Iberia, U.K. and Israel. And then the pricing discussions, they're still ongoing, but it's in the range of about EUR 25,000 per course.

Operator

The next question is from Glenn Novarro of RBC Capital Markets.

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

I had 2 follow-up questions on the U.S. spine number in the quarter, down 8%. Do you think you were down with the market? Or did you lose market share? And then my second question is on price. Dominic, you said pricing got a little bit worse, but I thought in 4Q, you said pricing was down mid-single digits as well. So did price go from maybe down 4 in 4Q down to 5? Any additional color on pricing would be great.

Dominic J. Caruso

Well, on share, it's too early for us to comment until we see the results from other folks. I should have added that the overall, little bit further decline in price was a factor of mix. So actually the overall price decline in the first quarter of '12 was comparable to the fourth quarter of '11 at mid-single digits, but we saw a little bit worse product mix impact in Q1 2012 that we saw compared to the fourth quarter of '11, and that made the overall comparison, price/mix comparison, a little worse in the first quarter of '12. Hopefully, that's clearer now.

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

That's great. Can I just ask one quick follow-up on utilization? Do you feel like spine utilization is any better? Is payer pushback subsiding? Any color on utilization would be great.

Dominic J. Caruso

Yes, I think overall, utilization is starting to stabilize, meaning that we're not seeing the rapid declines that we saw and the continual declines, and the data that I mentioned earlier overall in procedure volumes was encouraging. Although I must say, it's modest and it's really just one quarter. So we're happy to see a turn, but it is one data point, so we'll have to wait and see how it plays out in the future quarters. So I wouldn't read too much into it just this early in the year.

Operator

The next question is from David Lewis of Morgan Stanley.

David R. Lewis - Morgan Stanley, Research Division

Dominic, just one quick question here on R&D. Seasonally, this quarter is always a kind of a low R&D quarter and it builds throughout the year. This is a little lower than the year-on period. I guess, maybe just talk to us about this. Is there anything structural we should be thinking about in terms of where that R&D came into the first quarter? Or should we just simply believe that R&D is going to build throughout the remainder of the year?

Dominic J. Caruso

Yes, there isn't anything structural. R&D will build throughout the remainder of the year as it usually does. And as I mentioned earlier, the timing of milestone payments with our licensing and collaboration partners has a factor -- is a factor in that particular expense category. And compared to last year, first quarter of 2011, really 2 factors. One is the timing of milestone payments that occurred in first quarter '11 and no such comparable payments in the first quarter of '12. And remember that it wasn't until middle of 2011 that we stopped the drug-eluting stent development program. And so there was some lower R&D spend as a result of no DES development in 2012.

David R. Lewis - Morgan Stanley, Research Division

Okay. And Louise, your comments on endomechanical, I think, were very clear. I just wondered if you had a little more detail, specifically your commentary on low-cost competition. I think we've heard that before. But on MIS, or minimally invasive penetration, is that simply a move to single-incision procedures? Or is that pressure potentially from robotic competition? I didn't know if you had that detail.

Louise Mehrotra

It seems to be a consistent commentary that we're receiving from the company. But that particular detail, I don't have, David, sorry. We will now get some final remarks from Dominic.

Dominic J. Caruso

Okay. Thanks, Louise, and thank you, everyone. As I said earlier, we're off to a good start in Q1 and we're in line with our own expectations. We remain very optimistic for the remainder of the year, and we see further opportunity for growth as the global economy stabilizes. And as our new products, our robust pipelines and our core businesses continue addressing the critical unmet health care needs of patients and customers, I remain confident in our prospects for the year, thanks to the dedication, focus and integrity of the people of Johnson & Johnson. And I look forward to updating you all on our progress throughout the year. Thanks for your time this morning, and have a wonderful day.

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Source: Johnson & Johnson Management Discusses Q1 2012 Results - Earnings Call Transcript
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