Louise Mehrotra
Management
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 2012. Joining me on the podium today are Alex Gorsky, Chairman of the Board and Chief Executive Officer and Dominic Caruso, Vice President, Finance and Chief Financial Officer. A few logistics before we get into the details. This meeting is 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 and full year of 2012 for the corporation and highlights for our three business segments. ] Following my remarks, Alex will comment on the 2012 results and provide a strategic outlook for the company. At the completion of Alex’s remarks Dominic will provide some additional commentary on the third quarter results and discuss guidance for 2013. We will then open the call to your questions. We will conclude our formal presentations at approximately 9:45 and following Q&A with some final remarks by Alex, we’ll conclude this portion of the meeting around 10:15. Following a break, we will resume at 11 and begin the medical devices and diagnostics business review that was rescheduled because of Hurricane Sandy. That program will include presentations by Gary Pruden, Worldwide Chairman, Global Surgery Group; Karen Licitra, Worldwide Chairman, Global Medical Solutions Group; and Michel Orsinger, Worldwide Chairman, DePuy Synthes Companies. We will break for lunch and the technology displays around noon, and resume the presentations at approximately 12:45. We will include a question and answer panel at the end of the presentations, and expect to close the meeting around 2:30. Included with the press release that was issued earlier this morning is a schedule of sales for key products and/or businesses to facilitate updating your models. These schedules are available on the Johnson & Johnson website, as is the press release. Please note this webcast includes slides, which are also available on the website. 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 today. 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. During the review, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. These non-GAAP financial measures should not be considered replacements for GAAP results. 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. A number of the compounds and products discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide lists the acknowledgment of those relationships. Now I would like to review our results from 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 $17.6 billion from the first quarter of 2012, up 8% as compared to the fourth quarter of 2011. On an operational basis, sales were up 9.3% and currency had a negative impact of 1.3%. The acquisition of Synthes was completed in the second quarter of 2012. In the fourth quarter, the acquisition, net of the impact of the divestiture of the legacy DePuy trauma business, contributed 5.6% to the worldwide operational sales growth. In the U.S., sales were up 6.8%. In regions outside the U.S., our operational growth was 11.2%, while the effect of currency exchange rates negatively impacted our reported results by 2.3 points. The western hemisphere, excluding the U.S., grew by 18.7% operationally, while Europe grew 10.4% on an operational basis. The Asia-Pacific/Africa region grew 8.5% operationally. The success of new product launches and Synthes sales made strong contributions to the results in all regions. If you’ll now turn to the consolidated statement of earnings, net earnings attributable to Johnson & Johnson were $2.6 billion, compared to $218 million in the same period in 2011. Earnings per share were $0.91 versus $0.08 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, 2012 fourth quarter net earnings were adjusted to exclude special items, primarily related to an increase in the litigation accrual and program costs associated with the DePuy ASR hip, in-process research and development, and integration and transaction costs related to the acquisition of Synthes, Inc. Fourth quarter 2011 net earnings included after-tax special items of $2.9 billion as detailed in the reconciliation on non-GAAP financial measures. Excluding these special items for both periods, net earnings for the current quarter were $3.4 billion and diluted earnings per share were $1.19, representing increases of 7.9% and 5.3% respectively as compared to the same period last year. I would now like to make some comments relative to the components leading to earnings before we move on to the segment highlights. For the fourth quarter of 2012, cost of goods sold, at 34.2%, was up 140 basis points from the same period last year, primarily due to an inventory step up charge related to the Synthes acquisition. Excluding the inventory step up charge, which has been treated as a special item, cost of goods sold increased 10 basis points versus the same period last year. Incremental amortization expense related to Synthes was almost completely offset by positive mix, complemented by cost reduction efforts. Fourth quarter selling, marketing, and administrative expenses, at 32.2% of sales, were down 140 basis points due to cost containment initiatives across many of our businesses. Our investment in research and development as a percentage of sales was 13.3%, consistent with our 2011 results. Interest expense, net of interest income of $89 million, was down $59 million versus the fourth quarter of 2011, due to a lower debt level. Other expense, net of other income, was $319 million in the fourth quarter of 2012, compared to $2.9 billion in the same period last year. Excluding special items, other income net of other expense, up $420 million, was $81 million less than 2011 due to lower gains on divestitures. Excluding special items, the effective tax rate of 18% in the fourth quarter of 2012 compared to 14.4% in the same period last year. Dominic will provide commentary on taxes in his remarks. Now, turning to the consolidated statement of earnings for the full year of 2012, consolidated sales to customers for the year 2012 were $67.2 billion, an increase of 3.4% as compared to the same period last year. On an annual basis, sales grew 6.1 points operationally and currency had a negative impact of 2.7 points. Synthes, net of the impact of the divestiture of the legacy DePuy trauma business, contributed 3.1% to the worldwide operational sales growth. On the consolidated statement of earnings, I’d like to draw your attention to the box section. For the year 2012, adjusted net earnings were $14.3 billion, and adjusted earnings per share were $5.10, up 3.4% and 2% respectively versus the 2011 results. Turning now to business segment highlights, please refer to the supplementary sales schedule highlighting key products or businesses for the fourth quarter of 2012. I’ll begin with the consumer segment. Worldwide consumer segment sales from the first quarter of 2012 of $3.7 billion decreased 0.4% as compared to the same period last year. On an operational basis, sales increased 0.9% while the impact of currency was negative 1.3%. U.S. sales were down 3.6%, while international sales grew 3.2% on an operational basis. Baby care products increased on an operational basis by 2.8% when compared to the fourth quarter of 2011, primarily due to international sales of powders, wipes, and haircare products. Sales in the oral care business increased 2% operationally due to strong sales outside the U.S. with the continued success of new product launches for Listerine. From the first quarter of 2012, sales for OTC pharmaceuticals and nutritionals increased 2.6% on an operational basis compared to the same period in 2011, with U.S. sales down 3.8% and sales outside the U.S. up 5.7% on an operational basis. Sales in the U.S. decreased primarily due to lower sales of analgesics due to supply constraints and competitive pressures in nutritional products. This were partially offset by very strong sales of upper respiratory products with the relaunch of many of them. Increased market penetration and product launches drove strong growth of analgesics, digestive health, and upper respiratory products outside the U.S.. Our skincare business declined 3.9% on an operational basis in the fourth quarter of 2012, with the U.S. down 4.5% due to divestitures and discontinued programs, while sales outside the U.S. were down 3.4% due to competitive and marketplace pressures. Women’s health grew 5.5% on an operational basis due to international sales growth of 9.4%, with strong growth across the sanitary protection category. Wound care, other sales decreased 2.9% on an operational basis with the sales decline outside the U.S. of 8% due to competitive pressures, partially offset by growth in the U.S. of 1.8%. That completes our review of the consumer segment, and I’ll now review highlights for the pharmaceutical segment. Worldwide net sales for the fourth quarter of $6.5 billion increased 7.1% versus the same period last year. On an operational basis, sales increased 8.5%, with a negative currency impact of 1.4 points. Sales in the U.S. increased 4.4%, while sales outside the U.S. increased on an operational basis by 12.1%. Now, reviewing sales for the major therapeutic areas, immunology products achieved double digit operational sales growth of 10.4%. Sales in the U.S. increased 3.4% while sales outside the U.S. increased 35.7% operationally. Simponi grew 54.8% operationally, with U.S. sales up 16.1% due primarily to strong market growth. In the quarter, sales outside the U.S. were up 96.8% on an operational basis, primarily due to increased shipments to our distribution partner and the continued success of the launch in Japan. On an operational basis, STELARA was up 31.2%, with the U.S. up 25.4% and sales outside the U.S. up 40.1% operationally. The strong results were due primarily to market share gains, complemented by strong market growth in the major regions. Remicade grew 5.5% on an operational basis. Strong sales results were achieved in the U.S. with growth of 12.2% due to double digit market growth. Combined export and international sales were down just over 2% on an operational basis. As I mentioned last quarter, timing of shipments due to customer inventory planning impacted the quarterly comparisons. Excluding the impact of customer inventory planning, combined export and international sales underlying growth in the quarter was approximately 8% on an operational basis. With the strength of our portfolio, we continue to be the U.S. market leader in immunology. Sales of infectious disease products increased 22.6% on an operational basis. INCIVO, a treatment for hepatitis C, contributed approximately half of the infectious disease worldwide operational growth in the quarter. INCIVO sales nearly doubled when compared to the third quarter of 2012. Continued momentum in market share growth of PREZISTA made notable contributions to the results, as to the combined sales of [complarent] and EDURANT. Neuroscience product sales decreased 1.6% on an operational basis. Growth was impacted by generic competition for RISPERDAL, CONCERTA, RAZADYNE, TOPAMAX, and DURAGESIC. The long-acting injectable antipsychotics, RISPERDAL CONSTA and INVEGA SUSTENNA, or [zeplion] achieved operational growth of nearly 15% due to an increase in combined market share. INVEGA achieved strong operational growth of 18.9%, with the U.S. growth at 15.2% primarily due to market growth. Outside the U.S., sales grew 23% operationally, primarily due to strong growth in Japan. Sales of oncology products increased 48.5% on an operational basis, due to very strong results for ZYTIGA and VELCADE. ZYTIGA is now approved to treat both chemo refractory and chemo naïve metastatic castration resistant prostate cancer. In the quarter, ZYTIGA achieved operational sales growth of over 75%, with U.S. sales growing 34.1% and sales outside the U.S. more than doubling. VELCADE is a treatment for multiple myeloma. Sales increased 47.6% on an operational basis. Approximately 60% of the operational increase is due to the timing of tender business, which will negatively impact the growth in the first quarter of 2013. Strong performance in patient share in the frontline setting continues to drive sales growth. Regarding Doxil/Caelyx, we had made significant progress to restore a reliable supply. An alternate manufacturing approach consisting of a collaboration between the current third-party manufacturer and another supplier to complete end-to-end production of Doxil/Caelyx was approved in the E.U. and Japan late in 2012 and in Canada earlier this month. In the European Union, the Caelyx Managed Access Program will remain in place until a full supply of Caelyx has been restored to ensure patients can complete their full course of treatment. In the U.S., Janssen announced in October 2012 that full access to Doxil has been restored. While Janssen continues to work with the FDA to seek approval of the alternate manufacturing solution, the agency is exercising its regulatory discretion to release Doxil manufactured through this approach to the U.S. market to ensure continued full access to Doxil for healthcare providers and their patients. Other pharmaceutical products declined 6.8% on an operational basis, due to divestitures, lower sales of PROCRIT primarily related to market decline and Eprex and Aciphex/Pariet, primarily due to the impact of generic competition. Positively impacting results, Xarelto sales grew 40% on a sequential basis, contributing over 2.5 points to the U.S. pharmaceutical growth rate. On the pipeline front, we had a number of approvals during the quarter. ZYTIGA was approved by both the FDA and the European Commission for the chemo naïve indication. SIRTURO, to treat pulmonary multidrug resistant tuberculosis, was approved by the FDA. The FDA approved the expanded use of Xarelto to treat deep vein thrombosis, or DVT, and pulmonary embolism, or PE, and to reduce the risk of recurrent DVT and PE following initial treatment. And, the FDA approved PREZISTA 800 mg tablet and just last week it was also approved by the European Medicines Agency, or EMA. Additionally, during the quarter, as an update on filings, the NDA was submitted to the FDA for Canagliflozin Metformin six-dose combination therapy to treat patients with Type II diabetes. The supplemental biologics license application for STELARA, for the treatment of active psoriatic arthritis, was submitted to the FDA, and the type II variation to the EMA. In the U.S., the two structural damage claims for Simponi will not be pursued at this time, given other priorities. And, a decision was made to withdraw the EMA application for Simponi IV for the treatment of adults with moderately to severely active RA, pending additional manufacturing data, which would be unavailable within the current EMA review timeline required. We plan to resubmit a marketing authorization application for the IV pharmaceutical forum with this additional manufacturing information. We anticipate having greater clarity on a potential resubmission timeline during the first quarter of 2013. That completes the review of the pharmaceutical segment. I’ll now review the medical devices and diagnostics segment results. Worldwide medical devices and diagnostic segment sales of $7.4 billion grew 14.9% operationally as compared to the same period in 2011. Currency had a negative impact of 1.2 points, resulting in a total sales increase of 13.7%. Sales, excluding the net impact of Synthes, were up 0.8% on an operational basis, with U.S. sales down 2.2% and sales outside the U.S. up 3.2% on an operational basis. Now, turning to the MD&D businesses starting with cardiovascular care. Cardiovascular care sales were down 5.2% operationally with the U.S. down 2.6% and sales outside the U.S. down 6.6% operationally. Excluding the impact of drug eluting stents, worldwide sales were flat on an operational basis. Endovascular sales declined versus the same period last year, due to competitive pressures and the impact of the supply disruption earlier in the year that was resolved late in the third quarter. Biosense Webster achieved worldwide operational growth of nearly 14% in the quarter, driven by strong market share growth. The success of the THERMOCOOL catheter launches made strong contributions to the results. During the quarter, the FDA also approved the S.M.A.R.T. Control vascular stent system for use in the superficial femoral artery. The diabetes care business operationally declined 2.6% in the fourth quarter of 2012, with the U.S. business down 10.6% due to the impact of mail order, lower price, and private label competitors. The business outside the U.S. grew 5.2% operationally, with strong sales in emerging markets partially offset by lower sales in some of the developed markets. The diagnostics business declined 3.3% on an operational basis, with the U.S. down 7.9% and sales outside the U.S. up 1.3% operationally in the fourth quarter. Sales were impacted by lower clinical lab sales and the divestiture of the RhoGAM business during the third quarter. Infection prevention grew 4.9% on an operational basis, with sales in the U.S. down 8.5%. In the U.S., a customer program to upgrade systems to STERRAD systems ended in the first quarter, impacting the timing of capital purchases for the year. Excluding capital sales, U.S. growth was approximately 9% in the quarter. Sales outside the U.S. were up 13.6% operationally due to strong consumables growth driven by the breadth of the installed base. Orthopedics sales were up 65.1% on an operational basis when compared to the same period in 2011. Excluding the net impact of Synthes, and the divestiture in December 2011 of certain neurosurgical instruments, sales grew approximately 3.5% on an operational basis with similar results both in and outside the U.S. Operationally, hips were up 6% worldwide, driven by 7% growth in the U.S. due to strong results in primary stem platform sales, partially offset by continued pricing pressure. Hips outside the U.S. were up 4% operationally, driven by the growth of cemented stems, heads, and acetabular products. Knees worldwide increased 4% on an operational basis, with the U.S. up 7% driven by fixed bearing and revision platforms. Sales outside the U.S. were up 1% with growth in Asia and Latin America, partially offset by softer sales, primarily in Europe, due to competitive pressures. Including the Synthes business in both periods, and excluding the divested DePuy trauma business in both periods, trauma grew approximately 1% on an operational basis, with the U.S. down 4% and sales outside the U.S. up 6% on an operational basis. U.S. growth was impacted by a supply disruption. Including the Synthes business in both periods, worldwide spine was down 3% on an operational basis, with the U.S. down approximately 7%, impacted by continued softness in the market as well as the restructuring of the commercial sales organization. Outside the U.S., sales grew approximately 4% operationally. Specialty surgery achieved operational growth of 4.4% in the fourth quarter of 2012. U.S. sales were down 0.3%, with lower sales of energy products due to competitive pressures and the impact of reprocessing. This was offset by strong growth of biosurgery products and additional sales from the acquisition of SteriMed. Sales outside the U.S. were up 9.5% on an operational basis, due to strong results for energy and biosurgical products.