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`Johnson & Johnson's Management Discusses Q1 2014 Results -
`Earnings Call Transcript
`
`Apr. 15, 2014 1:44 PM ET
`by: SA Transcripts
`
`Q1: 04-15-14 Earnings Summary
`
` 10-Q
`
` Analysis
`
` News
`
`EPS of $1.54 beats by $0.06 | Revenue of $18.11B (+ 3.5% Y/Y) beats by $110M
`
`Johnson & Johnson (NYSE:JNJ)
`
`Q1 2014 Results Earnings Conference Call
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`April 15, 2014 08:30 AM ET
`
`Executives
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`Louise Mehrotra - VP of Investor Relations
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`Dominic Caruso - VP, Finance and CFO
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`Analysts
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`Mike Weinstein - JP Morgan
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`Matthew Dodds - Citigroup
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`Kristen Stewart - Deutsche Bank
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`Larry Biegelsen - Wells Fargo
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`Jami Rubin - Goldman Sachs
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`Glenn Novarro - RBC Capital Markets
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`Derrick Sung - Sanford Bernstein
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`JANSSEN EXHIBIT 2143
`Wockhardt v. Janssen IPR2016-01582
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`3/7/2017
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`Johnson & Johnson's Management Discusses Q1 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Rick Wise - Stifel
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`Matt Miksic - Piper Jaffray
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`Jeff Holford - Jefferies
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`Danielle Antalffy - Leerink Partners
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`Josh Jennings - Cowen and Company
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`David Lewis - Morgan Stanley
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`Bob Hopkins - Bank of America
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`Damien Conover - Morningstar
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`Operator
`
`Good morning and welcome to the Johnson & Johnson First Quarter 2014 Earnings
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`Conference Call. All participants will be in a listen-only mode until the question-and-
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`answer session of the conference. This call is being recorded. If anyone has any
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`objections, you may disconnect at this time. (Operator Instructions).
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`I would now like to turn the call over to Johnson & Johnson. You may begin.
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`Louise Mehrotra
`
`Good morning and welcome. I’m Louise Mehrotra, Vice President of Investor Relations for
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`Johnson & Johnson and it is my pleasure this morning to review our business results for
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`the first quarter of 2014. Joining me on the call today is Dominic Caruso, Vice President,
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`Finance and Chief Financial Officer. A few logistics before we get into the details.
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`This review is being made available via webcast accessible through the Investor Relations
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`section of the Johnson & Johnson website. I’ll begin by briefly reviewing first quarter
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`results for the corporation and for our three business segments.
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`Following my remarks, Dominic will provide commentary on the results including some
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`highlights for the quarter, a review of the income statement and guidance for 2014. We will
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`then open the call to your questions. Included with the press release that was issued
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`earlier this morning is a schedule of sales for key products and/or businesses to facilitate
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`updating your model.
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`These schedules are available on the Johnson & Johnson website as is the press release.
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`Also, please note that we will be using a brief presentation to complement today’s
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`commentary. The presentation is also available on our website.
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`Before we begin, let me remind you that some of the statements made during this review
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`may be considered forward-looking statements. The 10-K for the fiscal year 2013
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`identifies certain factors that could cause the company’s actual results to differ materially
`
`from those projected in any forward-looking statements made today.
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`The company does not undertake to update any forward-looking statements as a result of
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`new information or future events or developments. The 10-K is available through the
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`company and online.
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`During the review, non-GAAP financial measures are used to provide information pertinent
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`to ongoing business performance. These non-GAAP financial measures should not be
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`considered replacements for GAAP results. Tables reconciling these measures to the
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`most comparable GAAP measures are available in the press release and on the Investor
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`Relations section of the Johnson & Johnson website at investor.jnj.com.
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`A number of the products and compounds discussed today are being developed in
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`collaboration with strategic partners or licensed from other companies. This slide lists
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`acknowledgment of those relationships.
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`Now, I would like to review our results for the first quarter of 2014. Worldwide sales to
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`customers were $18.1 billion for the first quarter of 2014, up 3.5%. On an operational
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`basis, sales were up 5.3% and currency had a negative impact of 1.8%.
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`In the U.S., sales were up 2.2%. In regions outside the U.S., our operational growth was
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`7.9%, while the effect of currency exchange rates negatively impacted our reported results
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`by 3.4%.
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`On an operational basis Asia Pacific, Africa region grew 10.3%, the western hemisphere,
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`excluding the U.S., grew by 7.1% and Europe grew 6.6%. The success of new product
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`launches and continued growth of key products made strong contributions to the results in
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`all regions.
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`Turning now to earnings, our earnings were $4.7 billion, up 35.2% compared with the
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`2013 results. Earnings per share were $1.64 versus $1.22 a year ago. As referenced in
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`the table reconciling non-GAAP measures, 2014 first quarter net earnings were adjusted
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`to exclude a net gain of approximately $300 million for after tax special items. First quarter
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`2013 net earnings included a net charge of approximately $600 million for after tax special
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`items. Dominic will discuss special items in his remarks.
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`Excluding special items for both periods, net earnings for the current quarter were $4.4
`
`billion and diluted earnings per share were $1.54, representing increases of 7.8% and
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`6.9% respectively as compared to the same period in 2013.
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`Turning now to business segment highlights, please note percentages quoted represent
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`the operational sales change in comparison to the first quarter of 2013 unless otherwise
`
`stated and therefore exclude the translational impact of currency.
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`I will begin with the consumer segment. Worldwide consumer segment sales of $3.6 billion
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`decreased 0.6% with U.S. sales down 2.9% while outside the U.S. sales grew 0.7%.
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`Excluding the impact of divestitures net of acquisitions, both worldwide and U.S. growth
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`were approximately 1%. Major drivers of the results were skin care and oral care offset by
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`the divestiture of the North America women’s health business.
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`Skin care results were driven by AVEENO and DABAO new product launches supported
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`by robust marketing campaigns. Oral care results were driven by results for LISTERINE
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`due to new product launches and successful marketing campaigns. OTC sales were
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`negatively impacted by a weaker cold and flu season partially offset by strong sales of
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`ZYRTEC with the U.S. launch of the Dissolve Tabs including sales related to the initial
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`stocking.
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`Moving now to our pharmaceutical segment, worldwide net sales of $7.5 billion increased
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`12.2% with the U.S. up 7.7% and sales outside the U.S. up 16.9%. As a reminder, in the
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`first quarter of 2013, U.S. results included a positive adjustment to previous estimates for
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`managed Medicaid rebates under the Affordable Care Act related to new data received
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`from the states. The most significant impacts from the adjustment were in immunology,
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`neuroscience and PROCRIT. Excluding this item, 2014 worldwide sales were up over
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`15%.
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`In addition, in the early part of last year, the company made certain supply chain changes
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`for REMICADE, resulting in sales to distributors previously recorded as U.S. export sales
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`now being recorded as international sales. Adjusting the 2013 base to reflect this impact
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`as well as the U.S. managed Medicaid adjustment, the first quarter 2013 U.S.
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`pharmaceutical segment U.S. growth was over 19% and growth outside the U.S. was
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`approximately 12%.
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`Pharmaceutical growth was driven in part by a recently launched hepatitis C product
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`called OLYSIO in the U.S. and SOVRIAD in Japan, contributing over 5% to the worldwide
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`pharmaceutical growth versus the first quarter of 2013. Other significant contributors to
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`growth were ZYTIGA, XARELTO, STELARA, INVOKANA and INVEGA SUSTENNA or
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`XEPLION partially offset by lower sales of CONCERTA and ACIPHEX due to generic
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`competition.
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`The strong results for ZYTIGA in the U.S. were driven by increased market share in the
`
`combined metastatic, castrat-resistant prostate cancer market combined with estimated
`
`market growth of 10%. ZYTIGA has captured approximately 34% of that market.
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`The expansion of the label to chemo-naïve patients and continued progress and
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`reimbursement drove the strong results outside the U.S. ZYTIGA is approved in more than
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`80 countries.
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`XARELTO sales doubled compared with the same quarter last year and grew nearly 18%
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`on a sequential basis. Total prescription share or TRx at the end of the quarter in the U.S.
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`oral anticoagulant market grew to 12.5% with cardiology TRx estimated at nearly 22%.
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`INVOKANA sales contributed 2.5 points to U.S. pharmaceutical gross rate, and at the end
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`of the quarter achieved 2.1% TRx within the defined market of type 2 diabetes excluding
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`insulin and metformin, up from 1.5% in the fourth quarter of 2013.
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`TRx with endocrinologists grew to 6.6% by the end of the quarter, up over 1%
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`sequentially. Continued momentum and market share for STELARA complemented by
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`strong market growth drove results in immunology while increased market share drove
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`results for INVEGA, SUSTENNA or XEPLION.
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`I’ll now review the medical devices and diagnostics segment results. Worldwide medical
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`devices and diagnostics segment sales grew 1.8%. U.S. sales declined 1.6%, while sales
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`outside the U.S. increased 4.6%. Growth was driven by orthopedics, specialty surgery,
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`vision care and cardiovascular care, partially offset by lower sales in diabetes care and
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`Ortho-Clinical Diagnostics. Lower price primarily related to competitive bidding continued
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`to impact the diabetes care business in the U.S.
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`Orthopedic sales growth was driven trauma, knees and hips. Trauma was up 7% with the
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`U.S. up 10%. In the U.S., strong market growth and the positive impact of the recovery
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`from the prior year nail recall was partially offset by pricing pressure.
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`Knees worldwide increased 3%, with 2% growth in U.S. and 6% growth outside U.S.,
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`driven by the successful launch of the ATTUNE Fixed Bearing Knee, partially offset by
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`price pressure across the region and softness in the U.S. market.
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`Hips growth of 2% worldwide was driven by nearly 4% growth in the U.S. due to strong
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`results in primary stem platform sales, partially offset by continued pricing pressure.
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`Specialty surgery growth was driven by new products launched and market growth in our
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`worldwide biosurgery business and energy business outside the U.S., as well as strong
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`sales for both infection prevention and MENTOR products.
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`Vision care sales growth is primarily due to a customer inventory build anticipated to
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`reverse in the second quarter. Cardiovascular growth was driven by 15% worldwide
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`increase in our Biosense Webster business due to new catheter launches and continued
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`market expansion.
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`That concludes the segment highlights for Johnson & Johnson’s first quarter of 2014. I’ll
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`now turn the call over to Dominic Caruso. Dominic?
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`Dominic Caruso
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`Thanks Louise and good morning everyone. We are very pleased with our strong start to
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`2014 and I believe we are well positioned for continued growth in this dynamic healthcare
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`environment. As Louise did, I have also added a few slides to accompany my remarks,
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`which we hope you will find helpful as you are following along on the webcast.
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`I’ll take the next few minutes to review our financial performance and then provide our
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`guidance for you to consider in refining your models for 2014. But before I do that, I want
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`to comment on what we are seeing in the market for healthcare.
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`The early first quarter data we’ve seen so far shows continued softer utilization trends
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`impacted by the severe winter conditions. The data we have shows continued slight
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`declines in the rates of surgical and lab procedures in the United States, similar to what
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`we saw over the past 12 months.
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`Additionally, the strong fourth quarter utilization in orthopedic procedures softened in the
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`first quarter due to some seasonality as we and many of you had expected. Overall as
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`economic conditions continue to recover and given the positive demographic trends, we
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`remain confident about the long-term health of the market. And at Johnson & Johnson we
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`continue to make very good progress on our near-term priorities of achieving our financial
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`targets, restoring and re-launching our U.S. OTC products, continuing to capitalize on the
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`potential of DePuy Synthes and building on our strong momentum in pharmaceuticals.
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`At the same time, we also continue to make good progress on our long-term growth
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`drivers, which we discussed in detail during our January meeting. During the quarter, we
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`had several key developments across our three business segments including key
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`regulatory milestones in the pharmaceutical and medical device segments and I will
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`mention a few of them here.
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`In the pharmaceuticals segment, these included several CHP recommendations for
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`approvals in Europe for simeprevir, siltuximab and VOKANAMET. VOKANAMET is a fixed
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`dose combination product of canagliflozin and metformin for the treatment of type 2
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`diabetes. As well, we received FDA approval for the use of IMBRUVICA in patients with
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`chronic lymphocytic leukemia. And in the MD&D segment Biosense Webster received
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`FDA clearance for the THERMOCOOL SMARTTOUCH, the first catheter ablation therapy
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`to feature direct contact force technology for the treatment of atrial fibrillation.
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`During the quarter, we accepted The Carlyle Group’s offer to purchase our clinical
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`diagnostics business and we expect that transaction to close towards the middle of the
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`year. We also made decisions regarding our consumer portfolio, as we have signed a
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`definitive agreement to sell global rights for the K-Y brand to Reckitt Benckiser.
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`If you turn to the next slide, you can see our condensed consolidated statement of
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`earnings for the first quarter. As Louise has already covered our sales results, I will review
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`some other key points on the balance of the statement of earnings. Please direct your
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`attention to the boxed section of the schedule where we have provided earnings adjusted
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`to exclude special items.
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`We are pleased to report adjusted net earnings of $4.4 billion, which are up 7.8% over the
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`first quarter of 2013 and adjusted earnings per share of $1.54 versus $1.44 a year ago, up
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`nearly 7%, which exceeded the mean of the analyst estimates that’s published by First
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`Call.
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`As referenced in the table of non-GAAP measures, the 2014 first quarter net earnings
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`were adjusted to exclude a net after-tax gain of approximately $300 million or special
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`items, which consisted of the following. A charge for in process research and development
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`related to the discontinuation of the development program for PureTox, continued cost
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`associated with the integration of Synthes and finally during the first quarter, a capital loss
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`was realized for tax purposes on the sale of shares associated with Conor Medsystems,
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`which resulted in a tax benefit of approximately $400 million. The value of the Conor
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`business was previously written down for books purposes.
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`Now let’s take a few moments to talk about the other items on the statement of earnings. I
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`am pleased to point out that we saw very good operating performance in our results. Cost
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`of goods sold at 30.1% of sales was 160 basis points lower than the same period last
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`year. Included in last year’s cost of goods sold was the inventory step-up associated with
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`the Synthes acquisition, which we characterized as a special item. Excluding this, cost of
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`goods sold was lower by 80 basis points, reflecting the mix of our results this quarter
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`which were driven primarily by our pharmaceutical business as well as cost improvements
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`across many businesses.
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`This was partially offset by the impact of the weakening of the Japanese yen, which we
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`discussed as a headwind for 2014 although that negative impact of gross margin will
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`increase throughout 2014.
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`Selling, marketing and administrative expenses were 28.6% of sales or 120 basis points
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`lower as compared with the first quarter of 2013 again due to the growth in our
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`pharmaceutical business of new products and overall good management of cost primarily
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`our MD&D businesses.
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`Our investment in research and development as a percent of sales was 10.1% at a similar
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`level as we saw in the prior year, as we continued to make important investments for the
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`future. Overall, our pre-tax operating margin when excluding special items was 31.2% or
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`200 basis points higher than the prior year, a strong performance early in the year, but not
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`fully reflective of the investment plans we have for the remainder of the year, more of a
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`headwind related to the weakening of the Japanese yen as I noted earlier.
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`Interest expense net of interest income of $118 million was slightly higher than the prior
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`year period due impart the higher average debt levels. And other expenses net of other
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`income was a net charge of $86 million in the quarter compared to a net charge of $515
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`million in the same period last year. Excluding the special items that are reflected in this
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`line item, other expenses net of other income was actually a gain of $32 million compared
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`to a net gain of $83 million in the prior year period.
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`Excluding special items the effective tax rate was 20.4% compared to 19% in the same
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`period last year. This effective tax rate is higher than our guidance for two reasons. First, it
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`does not yet reflect the benefit of the R&D tax credit as that legislation has not yet been
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`passed. And secondly, the mix of our business this quarter, which reflects a higher portion
`
`of our earnings from the U.S. driven primarily by the success of our new pharmaceutical
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`product launches.
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`Now I will provide some guidance for you to consider as you refine your models for 2014.
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`Before I discuss sales and earnings, I will first give some guidance on items we know are
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`difficult to forecast, beginning with cash and interest income and expense.
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`At the end of the quarter, we had approximately $12 billion of net cash, which consist of
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`approximately $29 billion of cash and marketable securities and approximately $17 billion
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`of debt. For purposes of your models, assuming no major acquisitions or other major uses
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`of cash, I suggest you consider modeling net interest expense of between $400 million
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`and $500 million consistent with our previous guidance.
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`Regarding other income and expense, as a reminder this is the account where we record
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`royalty income, as well as gains and losses arising from such items and litigation,
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`investments by our development corporation, as well as divestitures, asset sales and
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`write-offs.
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`We would be comfortable with your models reflecting 2014 other income and expense
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`excluding special items as a net gain, ranging from approximately $600 million to $700
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`million, this is consistent with our previous guidance.
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`And now a word on taxes. Our guidance for 2014 anticipates that the R&D tax credit will
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`be renewed by Congress, although that has not yet occurred. We would be comfortable
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`with your models reflecting an effective tax rate for 2014 excluding special items of
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`approximately 19% to 20%. If the R&D tax credit is not approved, it will negatively impact
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`the tax rate by approximately 0.5%.
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`This guidance is higher than our previous guidance reflecting a change in the mix of our
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`business resulting at a higher portion of our earnings in the United States. As always, we
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`will continue to pursue opportunities in this area to improve upon this rate throughout the
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`year.
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`Now turning to sales and earnings. As I noted earlier, we have received and accepted a
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`binding offer for our Ortho-Clinical Diagnostics business of approximately $4 billion. We
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`expect the transaction to close mid-year that the resulting gain will be treated as a special
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`item. As of today we are considering how to best allocate the net after-tax proceeds from
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`the divestiture.
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`As is our practice with acquisitions and divestitures, we will update our guidance after the
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`transaction closes to reflect the impact this divestiture could have on our sales and EPS
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`excluding special items for the remainder of the year. Therefore, our guidance today will
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`not include the impact of this transaction. However, at this time we believe that any such
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`impact will be certainly absorbed within the range of EPS guidance we are providing
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`today.
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`Our sales and earnings guidance for 2014 takes into account several assumptions that I
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`highlighted to you in January. Let me just review those briefly now. Those key
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`assumptions are for sales our assumption for PROCRIT is that there will not be biosimilar
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`competition in 2014 and for INVEGA SUSTENNA and RISPERDAL CONSTA we do not
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`anticipate generic entries for these products this year.
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`And as for earnings there are several factors to note. First some comments about foreign
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`currency fluctuations that impact real economic transactions as opposed to only
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`translation, which I will discuss later.
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`As we highlighted in January, the Japanese yen devalued by approximately 25% versus
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`the U.S. dollar and the euro in 2013. The impact of the yen devaluation on 2013 results
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`was not significant because of our policy of hedging foreign currency transactions 12 to 18
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`months in advance. However, the impact of the devaluation is a significant headwind in
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`2014 and our 2014 guidance reflects a negative impact to gross margin of approximately
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`60 basis points or a negative impact to EPS of approximately $0.11 per share.
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`In the event of a significant devaluation of any other major currency such as the
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`Venezuelan bolivar, we will look to mitigate that impact depending on the magnitude of
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`that impact. However, such a potential devaluation of the bolivar or any other currency is
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`not reflected in our guidance.
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`We also expect continued pricing pressure in 2014 across many markets, particularly in
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`Europe. The impact of this negative pricing pressure is expected to negatively impact our
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`pre-tax operating margin by approximately 50 basis points.
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`So, as we’ve done for several years now, our guidance will be based first on a constant
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`currency basis reflecting our results from operations. This is the way we manage our
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`business and we believe this provides a good understanding of the underlying
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`performance of our business. We will also provide an estimate of our sales and EPS
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`results for 2014 with the impact that current exchange rates could have on the translation
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`of those results.
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`As of last week the euro had strengthened versus the U.S. dollar as compared to 2013
`
`average levels. However, many other currencies have weakened versus the U.S. dollar
`
`such as the Canadian dollar and the Brazilian real as compared to their average levels for
`
`2013.
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`Considering the factors I just noted, we would be comfortable with your models reflecting
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`an operational sales increase like constant currency basis of between 5% and 6% for the
`
`year. This would result in sales for 2014 on a constant currency basis of approximately
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`$74.9 billion to $75.7 billion.
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`We’re not predicting the impact of currency movements, but to give you an idea of the
`
`potential impact on sales of currency exchange rates for all of 2014 were to remain where
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`they were as of last week. Our sales growth rate would decrease by nearly 0.5%, plus
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`under this scenario we would expect reported sales growth to range between 4.5% and
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`5.5% for a total expected level of reported sales between $74.5 billion to $75.3 billion,
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`which is higher than our previous guidance.
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`Now turning to earnings; our earnings guidance reflects the major assumptions I noted
`
`earlier and reflects the strong performance we saw in the first quarter and our plan to
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`continue investing in future growth. Considering those factors, we suggest that you
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`consider full year 2014 EPS estimates, excluding the impact of special items of between
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`$5.74 and $5.84 per share on an operational or constant currency basis.
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`And again we're not predicting the impact of currency movements, but to give you an idea
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`of the potential impact on earnings per share if exchange rates for all of 2014 were to
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`remain where they were as of last week then our reported EPS excluding special items
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`would be positively impacted by approximately $0.06 per share due solely to exchange
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`rate fluctuations.
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`We therefore suggest that you model our reported EPS excluding special items in the
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`range between $5.80 and $5.90 per share or growth rate of between 5% and 7%. This is
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`higher than our previous guidance.
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`As you update your models for the guidance that I just provided, you will see that we do
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`expect that our pre-tax operating margins will show a stronger improvement in 2014 over
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`2013 levels than we have previously expected, although not at the level we saw in the first
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`quarter, despite the negative impact of the devaluation of the yen on our gross margins
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`and the expected pricing pressures. This is due to the strong performance of our
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`business, primarily driven by new product launches and continued management focus on
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`our operating expenses. You should also see that our net income margin will expand,
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`despite the increase in our effective tax rate.
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`In closing, we are very pleased with our strong results for the first quarter of the year. The
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`breadth of our business, which provides balance and consistency to our overall
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`performance, as well as the extraordinary achievements and dedication of our talented
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`people around the world positions us well to sustain and drive growth throughout the year.
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`Thank you. And now I would like to turn things back to Louise for the Q&A portion of the
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`program.
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`Louise Mehrotra
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`Thank you, Dominic. Stephanie, could you please provide the instruction for the Q&A
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`session?
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`Question-and-Answer Session
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`Operator
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`Thank you. (Operator Instructions). And your first question is from the line of Mike
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`Weinstein with JP Morgan.
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`Dominic Caruso
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`Good morning Mike.
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`Mike Weinstein - JP Morgan
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`Thank you and good morning. Thanks for taking the question. So Dominic, if I take you
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`back to three months ago at the analyst meeting and in also subsequent call on February,
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`I firstly will get on the sales guidance for the year and I think I have talked at the call that
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`you’re being conservative and now you've come in here and you reported a better than
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`expected first quarter and you raised your guidance for the year.
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`So can you talk a little bit about from the January call to to-date what has increased your
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`confidence? And how much of that is from OLYSIO which obviously had a much strong
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`quarter this quarter? And can you talk about that product’s performance and ability?
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`Thanks.
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`Dominic Caruso
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`Sure Mike. Well, you're right. You did challenge us on that presumed level of
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`conservatism. I would say just as a way of background, we are trying to forecast new
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`product sales in a dynamic healthcare environment and we are also trying to forecast
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`various economic trends and utilization rates in the marketplace. So we do our best to
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`give you our sense for what we are seeing at the time.
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`What we are seeing now is a better overall sense of the launch, particularly the launch of
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`the new products within pharma. And OLYSIO as you pointed out has done remarkably
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`well. Yes, it’s done better than we expected. It’s primarily due to the fact that the Liver
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`Society issued guidelines in January recommending the use of OLYSIO along with the
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`product from Gilead, Sovaldi. And that has been adopted by the community, by the
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`medical community as a standard of care based on the liver guidelines of the society of
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`liver specialist guidelines.
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`So that’s something that we learned after our guidance. We saw it take off and we are
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`very pleased with the results. And if you look at the total increase in our sales guidance,
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`which is about roughly $1 billion, I would say the majority of that is due to the fact that
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`OLYSIO now is performing much better than our earlier expectations and we are very
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`pleased with that. And obviously more patients are gaining the benefit of utilizing this new
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`therapy.
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`As far as sustainability is concerned, I think you know that there are competitive products
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`on the horizon. The goal of searching for interferon-free therapy seems like it will be a
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`reality. And there are products that are expected to be approved later this year. So we’ll
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`have to wait and see whether those products are in fact approved. And then of course
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`we’ll reassess the long-term outlook for OLYSIO given any new product or new
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`competition.
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`And just as a reminder, we are also studying OLYSIO in a Phase 3 clinical trial along with
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`Sovaldi. So we’ll have that data after that trial is concluded and that will give us a better
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`idea of the overall sustainability as well.
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`Mike Weinstein - JP Morgan
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`Okay. And Dominic just one follow-up on the EPS guidance for the year; it’s sighted to me
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`what you were saying the FX line that there was going to be a $0.06 of earnings pushing
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`your upside based on real time FX rate [if you’re able] to hold that you are not including in
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`guidance. [So I just wanted that] right? And two, I assume that would offset the impact of
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`the OCD divestiture, is that [a very little up there]?
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`Dominic Caruso
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`No Mike, let me just reiterate that. So the $0.06 that I referred to as the