Louise Mehrotra
Management
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 third quarter of 2008. Joining me on the podium today are Chris Poon, Vice Chairman, Board of Directors and Worldwide Chairman, Pharmaceuticals Group, Paul Stoffels, Company Group Chairman, Global Research and Development Pharmaceuticals Group and Dominic Caruso, Vice President, Finance and Chief Financial Officer. Also joining us today in the audience is Sheri McCoy, Worldwide Chairman, Surgical Care Group. As we announced last week, effective January 1, 2009, Sheri will assume the role of Worldwide Chairman, Pharmaceuticals Group. A few logistics before we get into the details, the audio and visuals from these presentations are being made available to a broader audience via a webcast accessible through the Investor Relations section of the Johnson & Johnson website. I’ll begin by briefly reviewing highlights of the third quarter for the corporation and highlights for our three business segments. Following my remarks, Dominic will provide additional commentary on the results for the quarter and guidance for the year. Chris and Paul will then provide an update on our Pharmaceuticals Business. We will then open the floor to your questions. We will conclude our formal presentation at approximately 9:30 am and following Q&A with some final remarks by Dominic we’ll conclude the meeting around 10:00 am. Distributed with the copy of the press release that you just received is a schedule with actual revenues for major products and/or business franchises. For the listening audience these are available on the Johnson & Johnson website as is a copy of the press release. Before I get into the results, let me remind you that some of the statements made during this presentation may be considered forward looking statements. The 10-K for the fiscal year 2007 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. The Pharmaceutical Group presentation contains statements about new molecular entities or NMEs and other medicines or line extensions in various stages of development. These presentations are based on the company’s current knowledge of the status of development of the NMEs, medicines and line extensions and are subject to the challenges and difficulties inherent in product development. Not every compound highlighted today will make it to the market. In Biopharmaceuticals there are higher possibilities of encountering infringement claims by competitors with respect to patents or other intellectual property rights. The company does not undertake to update any forward looking statements as the result of new information or future development. Last item, during the call, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. These measures are reconciled to the GAAP measures and are available on the Johnson & Johnson website. Now I would like to review our results for the third quarter of 2008. If you would refer to your copy of the press release, let’s begin with the schedule titled supplementary sales data by segment of business. Worldwide sales to customers were $15.9 billion for the third quarter of 2008, up 6.4% as compared to the third quarter of 2007. Our operational growth was 3.3% and currency added 3.1 points. If you turn to the schedule showing sales by geographic area, you will see that we achieved growth of 0.4% in the US. In regions outside the US our operational growth was 6.5%, while the effect of currency exchange rates positively impacted our reported results by 6.6 points. Our strongest performing region was the Western Hemisphere excluding the US which grew 15.3% on an operational basis. The Asia/Pacific/Africa region grew by 11.3% operationally while Europe grew 1% operationally. If you will now turn to the consolidated statement of earnings, net earnings on a reported basis were $3.3 billion and earnings per share were $1.17. This compares to $2.5 billion and $0.88 in the same period in 2007. Please direct your attention to the box section of the schedule where we have provided adjusted earnings information. As referenced in the footnote, third quarter 2007 were adjusted to exclude the after-tax impact of the cost associated with the restructuring program of $528 million. There were no adjustments to the 2008 results in the quarter. Net earnings on an adjusted basis and earnings per share were up 7.6% and 10.4% respectively versus the third quarter of 2007. I would now like to make some additional comments relative to the components leading to the adjusted earnings before we move on to the segment highlights. Cost of goods sold at 30% was up 150 basis points versus the same period in 2007. Approximately half of the increase is due to changing mix within our businesses while the remaining half is due to additional costs incurred in our manufacturing operation. Selling, marketing, and administrative expenses of 32.6% of sales were down 10 basis points versus last year. Cost containment efforts more than offset the impact of the change in mix of our business driven by the strong growth of the consumer business. Our investment in research and development as a percent to sales was 11.7%, 60 basis points less than the third quarter of 2007 due to a combination of the change of mix of businesses and the timing of expenditures. Interest expense net of interest income of $25 million compares to $52 million of net interest income in the third quarter of 2007. This increase in expense was due to a higher average debt position in the quarter versus the same period last year as we continue buying back shares as part of our repurchase program. Other income net of other expense was $224 million in the third quarter of 2008 compared to $2 million of net other expense in the same period last year. As discussed last quarter, we received a settlement payment Amgen for $200 million which is reflected in this account. With regard to taxes please direct your attention to the effective tax rate excluding special charges shown in the box section of the schedule. Taxes were 22.8% in the third quarter of 2008 versus 23.3% in the third quarter of 2007. Dominic will provide more commentary on taxes in his remarks. Looking at year to date data consolidated sales to customers for the nine months of 2008 were $48.6 billion an increase of 7.6% as compared to the same period a year ago. On a year to date basis operational growth was 3% and currency had a positive impact of 4.6 points. On the consolidated statement of year to date earnings I’d first like to draw your attention to the box section. In both 2008 and 2007 charges for in process research and development have been excluded. Additionally, in 2007 the costs associated with the restructuring program have been excluded. With these adjustments net earnings for the nine months of 2008 were $10.3 billion or $3.61 per share up 7.7% and 10.4% respectively as compared to the same period in 2007. Turning now to business segment highlights, I’ll begin with the consumer segment. Worldwide consumer segment sales of $4.1 billion increased 13.1% as compared to the third quarter of 2007. Operational growth was 9.4% while currency added 3.7 points. US sales were up 11.2% while international sales grew 8.1% on an operational basis. For the third quarter of 2008, sales for the over the counter pharmaceuticals and nutritionals increased 11% on an operational basis compared to the same period in 2007. Sales in the US were up 19% while sales outside the US were up 3% operationally. The successful US launch this year of Zyrtec was a major contributor to this increase. Our skin care business achieved operational sales growth of 12% in the third quarter of 2008 with sales in the US growing at 15% and sales outside the US up 10% on an operational basis. Strong growth was driven by Neutrogena, Clean & Clear, Aveeno and Johnson’s Adult, due to a combination of new product launches and strength in the core businesses. Also contributing to the strong growth in the quarter were the newly acquired products from Dabao the leading moisturizer in China. Baby care products achieved operational growth of 9% when compared to the third quarter of 2007. Sales in the US grew by 1% with some softness in category growth. Strong growth across most product lines resulted in an operational increase in sales outside the US of 12%. Women’s health achieved operational growth of 6%. Sales in the US were up 10% due to the successful launch of the new products in our KY line. Sales outside the US were up on an operational basis by 3%. Operational sales growth in the oral care franchise was 7% with US sales down 3%. A significant new product launch in the third quarter 2007 impacted the US growth comparisons for the quarter. Sales outside the US increased 18% operationally driven by very strong growth for Listerine across the major regions. That completes our review of the Consumer segment and I’ll now review highlights for the Pharmaceuticals segment. Worldwide net sales for the third quarter of $6.1 billion were up 0.2% versus the same period last year. On an operational basis, sales were down 2.5% with positive currency adding 2.7 points. Sales in the US decreased 6% while sales outside the US increased on an operational basis by 3.3%. Our results continue to be impacted by generic competition on some of our products, namely Duragesic, and Risperdal Oral. The combined effect of this generic competition has reduced the third quarter Worldwide Pharmaceutical operational sales growth rate by approximately 11 points with the US impact estimated at 13.5% and the impact outside the US estimated at nearly 8%. As we have previously reported we saw a continued retraction in the US market for Erythropoietin Stimulating Agents or ESAs. This retraction has impacted the overall Pharmaceutical growth rate by approximately 2 points. Additionally, in the third quarter sales results outside the US were favorably impacted by a reduction to a reserve for sales of approximately $135 million related to Concerta. The majority of the reserve had been recorded as a reduction to sales in prior years. Excluding the negative impact of generics and the lower sales of Procrit and the positive impact of the reserve reduction the underlying operational sales growth was estimated at 8%. Now reviewing the major products, both Procrit and Eprex declined operationally by 12% during the quarter as compared to the same quarter last year. New competition and softening of the market due to ongoing labor reviews have contributed to the lower sales results for Eprex. Procrit results have been impacted by a decline in the market versus the third quarter of 2007, estimated at 18%, partially offset by an increase in overall market share. Procrit aggregate share across all markets was approximately 48% in the third quarter of 2008, up 3 points versus the same period last year. Sales of Levaquin our anti-infective were down 10% on an operational basis when compared to the same period a year ago. The script volume in the market was down approximately 5% versus the third quarter of 2007 attributable to a lower incident of respiratory illnesses. Market share was negatively impacted by generics in the category. Risperdal Oral had an operational decline of 63% when compared to the same period a year ago. Sales in the US were down 77% while sales outside the US declined 38% operationally. With the patent expiration in the US at the end of June this year there are now generic competitors for Risperdal in most markets. AcipHex, as it’s known in the US market, and Pariet outside the US is a proton pump inhibitor, or PPI, that we co-market with Eisai. On an operational basis, sales were down 19%. US sales were down 18% and the sales outside the US were down 20% operationally. In the US, script share has been negatively impacted by additional generic launches in the PPI category. Similar market dynamics impacted sales outside the US, compounded by the impact of market entry in Canada of generic Rabeprazole, the active ingredient in Pariet. Now moving on to our growth drivers, Remicade, a biologic approved for the treatment of a number of immune mediated inflammatory diseases, grew by 19% when compared to the third quarter of 2007. Sales growth in the US was 20%. Market growth in the Anti-TNF category continued to be strong. Sales to our customers for markets outside the US were up 16%. As we reported in the first quarter there was a significant increase in sales outside the US due to timing of shipments reflecting inventory planning on our customer’s part. Both the second and the third quarter sales were impacted as the majority of the inventory build was depleted. Excluding the estimated change in inventory levels, sales outside the US were more in line with estimated increase in demand of approximately 30%. Sales of Topamax, which is approved for the treatment of epilepsy and migraine prophylaxis, increased operationally by 18%. Sales in the US were up 22% while sales outside the US were flat on an operational basis. In the US, market share in the migraine category increased versus the same period last year. Outside the US, strong growth was achieved in many markets, offset by generic entries in certain other markets. Risperdal Consta, our long acting injectable formulation, achieved third quarter sales growth of 10% on an operational basis. US sales growth was 6% ahead of the estimated market growth. Sales outside the US were up 12% operationally with continued positive momentum and share. Concerta, a product for attention deficit hyperactivity disorder, grew 66% operationally in the third quarter as compared to the same period last year. As mentioned, sales results outside the US included a reduction to a reserve for sales of approximately $135 million related to Concerta. Excluding this reserve sales were up approximately 12% operationally, with sales in the US were up 7% and sales outside the US up 28% operationally. In the US continued solid market growth has been partially offset by lower market share. The approval earlier this year of the Adult Indication for Concerta will enable us to compete in the broader ADHD market. Velcade, a treatment for relapsed multiple myeloma, is being co-developed with Millennium Pharmaceuticals. We have commercialization rights in Europe and the rest of the world outside the US. Operational sales growth was 37%, with very strong results achieved across the regions. Wrapping up the review of the pharmaceutical segment, a manufacturing supplement SNDA for [Iopsis] previously submitted to the FDA did not gain approval. We are continuing the evaluation of a next generational system. Additionally, in the quarter the EU filing for Invega for Bipolar mania was submitted. I’ll now review the medical devices and diagnostic segment results. Worldwide medical devices and diagnostic segment sales of $5.7 billion grew 5.6% operationally as compared to the same period in 2007. Currency added 3.2 points to the sales growth to bring total growth to 8.8%. Sales in the US grew 3.1% while sales outside the US increased on an operational basis by 8%. Results have been impacted by lower sales of drug eluting stents. Sales excluding the impact of lower sales of drug eluting stents grew nearly 8% operationally. Now turning to the franchises, starting with Cordis; Cordis sales were down 10% operationally with the US down 26% and sales outside the US up 4%. Cordis results were impacted by lower sales of Cypher, our Sirolimus-eluting stent, and endovascular products partially offset by strong growth in our Biosense Webster business. Cypher sales were approximately $290 million down 26% on an operational basis versus the prior year. Sales in the US of approximately $100 million were down 47%. In comparison to the third quarter of 2007 the US drug eluting stent market growth is estimated at 15%. Penetration rates are estimated at 70% up from 63% a year ago while PCI procedures are up approximately 8% in the quarter versus the same period last year. These gains have been partially offset by a reduction in price. Estimated share in the US of 22% was down 15 points sequentially and down 22 points from the third quarter of 2007 due to the market entry of two new competitors in 2008. Sales outside the US of approximately $190 million declined 6% operationally. The estimated market share in the quarter of 30% was flat on a sequential basis and down 4 point from the third quarter of 2007. Increased competition has impacted the share outside the US. Cypher estimated worldwide share for the quarter was 27%, down 6 points sequentially and down 11 points from the third quarter of 2007. Endovascular sales declined due to a combination of the recall of a reentry catheter and increased competition in multiple segments. Now, turning to growth drivers within the Cordis franchise, the Biosense Webster business, our electro-physiology business, achieved double digit operational growth in the quarter driven by increased system placements as well as growth in catheter products. Our DePuy franchise operational growth of 8% when compared to the same period in 2007 with the US growing 7% and the business outside the US growing by 10% operationally. Hip growth on a worldwide basis was 12% operational, with strong growth in both the US and International businesses. On an operational basis, worldwide knee growth was 4% while spine grew 7%. Mitech, our sports medicine business, grew 12% operationally. Ethicon Endo-Surgery achieved operational growth of 10% in the third quarter of 2008, with the US sales growing 8% and sales outside the US growing on an operational basis by 11%. The Harmonic business achieved operational growth of nearly 20% due to the global success of the recently launched products and the underlying strength of this platform. Also contributing to the growth in the quarter was the realized gastric band launched earlier this year in the US and the strong performance of the endoscopy products and the strong performance of the endoscopy products in the international markets driven by increased awareness of the benefits of minimally invasive procedures as well as the metabolic benefits of obesity surgery. Ethicon worldwide sales grew operationally by 5% with similar results both in and outside the US. Solid growth in sutures and strong double digit growth in homeostasis and bio-surgical were the major contributors to growth in the quarter. The diabetes franchise grew operationally by 10% in the third quarter of 2008. The US business grew by 9% while sales outside the US grew 12% on an operational basis. The success of the One-Touch Ultra line has been the major contributor to growth. Additionally, the Animas business achieved operational growth of over 30% driven by continued market share gains in the pump business. Our Vision Care franchise achieved operational sales growth of 9% in the third quarter compared to the same period last year. Sales in the US increased 10%. Sales outside the US grew 8% on an operational basis. Acuvue Oasys, One-Day Acuvue Moist and Acuvue Lens for were the major growth drivers in the quarter. Rounding out the review of the medical devices and diagnostic segment, Ortho-Clinical Diagnostics achieved operational growth of 9% in the third quarter. Sales growth in the US was 11% while sales outside the US were up 6% on an operational basis. Immunohematology and immunodiagnostics products achieved double digit results. That completes highlights for the medical devices and diagnostic segment and concludes the segment highlights for Johnson & Johnson's third quarter of 2008. I’ll now turn the discussion over to Dominic Caruso for some additional comments.