3/7/2017
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results -
`Earnings Call Transcript
`
`Jul. 15, 2014 3:34 PM ET
`by: SA Transcripts
`
`Q2: 07-15-14 Earnings Summary
`
` 10-Q
`
` Analysis
`
` News
`
`EPS of $1.66 beats by $0.11 | Revenue of $ (- 100.0% Y/Y) misses by $-18.94B
`
`Johnson & Johnson (NYSE:JNJ)
`
`Q2 2014 Earnings Conference Call
`
`July 15, 2014 8:30 AM ET
`
`Executives
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`Louise Mehrotra - VP of IR
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`Alex Gorsky - Chairman of The Board of Directors and CEO
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`Joaquin Duato - Worldwide Chairman, Pharmaceuticals
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`Paul Stoffels - CSO, Johnson & Johnson and Worldwide Chairman, Pharmaceuticals
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`Dominic Caruso - VP, Finance and CFO
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`Analysts
`
`Matthew Dodds - Citigroup
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`Michael Weinstein - JP Morgan
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`Derrick Sung - Sanford Bernstein
`
`Larry Biegelsen - Wells Fargo
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`JANSSEN EXHIBIT 2144
`Wockhardt v. Janssen IPR2016-01582
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`3/7/2017
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Matt Miksic - Piper Jaffray
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`Josh Jennings - Cowen & Co.
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`Rick Wise - Stifel
`
`Glenn Novarro - RBC Capital Markets
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`Bruce Nudell - Credit Suisse
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`David Lewis - Morgan Stanley
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`Kristen Stewart - Deutsche Bank
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`Jay Olson - Goldman Sachs
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`Operator
`
`Good morning, and welcome to the Johnson & Johnson Second Quarter 2014 Earnings
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`Conference Call. All participants will be able to listen-only until the question-and-answer
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`session of the conference. This call is being recorded. If anyone has any objections, you
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`may disconnect at this time. (Operator Instructions).
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`I would now like to turn the conference 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 second quarter of 2014. Joining me on the call today are Alex Gorsky, Chairman of
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`The Board of Directors and Chief Executive Officer; Joaquin Duato, Worldwide Chairman,
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`Pharmaceuticals; Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and
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`Worldwide Chairman, Pharmaceuticals; and Dominic Caruso, Vice President, Finance and
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`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 Web site. I’ll begin by briefly reviewing second quarter
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`results for the corporation and for our three business segments. Following my remarks,
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`Alex will provide some additional commentary on the business and an update on our near
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`term priorities. Next, Joaquin and Paul will provide an update on our pharmaceutical
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`business, and lastly Dominic will review the income statement and provide guidance for
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`2014.
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`3/7/2017
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`We will then open the call to your questions. 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
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`Web site as is the press release. Please note we will be using presentation to complement
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`today’s commentary. The presentation is also available on our Web site.
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`Before we begin, let me remind you that some of the statements made during this review
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`are or may be considered forward-looking statements. The 10-K for the fiscal year 2013
`
`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
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`not undertake to update any forward-looking statements as a result of new information or
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`future events or developments. The 10-K is available through the 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
`
`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 Web site at investor.jnj.com.
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`A number of 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 the
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`acknowledgment of those relationships, not otherwise referenced in today’s presentations.
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`Now, I would like to review our results for the second quarter of 2014. Worldwide sales to
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`customers were $19.5 billion for the second quarter of 2014, up 9.1%. On an operational
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`basis, sales were up 9.4% and currency had a negative impact of 0.3%. In the U.S., sales
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`were up 14.9%. In regions outside the U.S., our operational growth was 5%, while the
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`effect of currency exchange rates negatively impacted our reported results by 0.6%.
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`On an operational basis, the Western Hemisphere excluding the U.S., grew by 6.5%, Asia
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`Pacific, Africa region grew 5.3% and Europe grew 4.1%. 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. Excluding the impact of divestitures net of acquisition, underlying organic
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`operational growth was 10%.
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`Turning now to earnings; net earnings were $4.3 billion and earnings per share were
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`$1.51 versus $1.33 a year ago. As referenced in the table reconciling non-GAAP
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`measures, 2014 second quarter net earnings were adjusted to exclude a charge of $449
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`million for after tax special items. Second quarter 2013 net earnings were adjusted to
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`exclude a charge of $456 million for after tax special items. Dominic will discuss special
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`items in his remarks. Excluding special items for both periods, net earnings for the current
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`quarter were $4.8 billion and diluted earnings per share were $1.66, representing
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`increases of 11.3% and 12.2% respectively as compared to the same period in 2013.
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`Turning now to business segment highlights, please note percentages quoted represents
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`operational sales change in comparison to the second quarter of 2013 unless otherwise
`
`stated and therefore exclude the translational impact of currency. I will begin with the
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`Consumer segment. Worldwide Consumer segment sales of $3.7 billion increased 3.6%
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`with U.S. sales down 0.5%, while outside the U.S. sales grew 5.8%. Excluding the impact
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`of net divestitures, worldwide growth was approximately 6% with U.S. growth of
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`approximately 5%.
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`Major drivers of the results were over-the-counter products, skin care, baby care, as well
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`as international sales of oral care and feminine protection products, partially offset by the
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`divestiture of the North American Sanitary Protection business.
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`OTC sales were strong due to analgesic growth of nearly 17% worldwide and nearly 25%
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`in the U.S., driven by market share gains as we continue to return products to the shelves.
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`Upper respiratory products, digestive health and antismoking products also made strong
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`contributions to the results.
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`Skin care results were driven by share gains for both NEUTROGENA and AVEENO with
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`new product launches supported by robust marketing campaigns, category growth, as well
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`as an increase in trade inventory levels. Baby care results were driven by strong sales
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`across the number of categories. International oral care results were driven by strong
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`results for LISTERINE due to new product launches and successful marketing campaigns.
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`Moving now to our Pharmaceutical segment. Worldwide sales of $8.5 billion increased
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`21.1% with U.S. up 36.6% and sales outside the U.S. up 6.9% driven by both strong sales
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`of new products as well as core growth products. A major driver was our recently
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`launched hepatitis C product called OLYSIO in the U.S. and EU and SOVRIAD in Japan.
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`Excluding sales of the hepatitis C products, OLYSIO and INCIVO, underlying growth
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`worldwide, U.S. and outside the U.S. was approximately 10.5%, 15% and 6.5%
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`respectively.
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`Other significant contributors to growth were immunology products; STELARA,
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`REMICADE and SIMPONI, SIMPONI ARIA, as well as XARELTO, ZYTIGA, INVEGA
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`SUSTENNA/XEPLION, INVOKANA, PREZISTA and recently launched IMBRUVICA.
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`Partially offsetting the growth were lower sales of ACIPHEX and CONCERTA due to
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`generic competition and INCIVO with competitive entries.
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`The strong results for immunology were driven by double-digit market growth
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`complemented by increased market share for STELARA and SIMPONI. We continue to be
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`the U.S. market leader in immunology. XARELTO sales were up over 90% compared with
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`the same quarter last year and grew over 13% on a sequential basis. Total prescription
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`share or TRx for the quarter in the U.S. anti-coagulant market grew to over 13% with
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`cardiology TRx estimated at over 23%.
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`The strong results for ZYTIGA in the U.S. were driven by increased market share in the
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`combined metastatic castrate-resistant prostate cancer market and estimated market
`
`growth of nearly 11.5%. ZYTIGA has captured approximately 34% of that market.
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`Continued strong market uptick and progress on reimbursement drove the strong results
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`outside the U.S.
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`ZYTIGA is approved in more than 90 countries. Increased market share drove results for
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`INVEGA SUSTENNA/XEPLION and PREZISTA. INVOKANA sales contributed over 2.5
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`points to the U.S. pharmaceutical growth rate and for the quarter achieved 2.3% TRx
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`within the defined market of type 2 diabetes excluding insulin and metformin, up from
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`1.8% in the first quarter of 2014. TRx with endocrinologists grew to 7% for the quarter, up
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`approximately 1% sequentially.
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`I’ll now review the Medical Devices and Diagnostic segment results. Worldwide Medical
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`Devices and Diagnostic segment sales of $7.2 billion increased 0.9%. U.S. sales declined
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`1.4%, while sales outside the U.S. increased 2.6%. Growth was driven by orthopedics,
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`cardiovascular care and specialty surgery, partially offset by lower sales in diabetes care,
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`vision care and diagnostics. Lower price primarily related to competitive bidding continue
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`to impact the diabetes care business in the U.S., while reversal of the noted customer
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`inventory build from the first quarter and competitive pricing dynamics impacted growth for
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`vision care.
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`Excluding OCD and diabetes care, worldwide growth was approximately 2%. Orthopedic
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`sales growth was driven by trauma and hips. Trauma was up 7% worldwide with sales
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`outside the U.S. up 11% due to a successful tender offer as a result of our comprehensive
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`portfolio offering. Hips growth of 5% worldwide was driven by strong volume growth,
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`partially offset by continued pricing pressure. Primary stem platform sales were a major
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`contributor to the results. Knees worldwide increased 1% with the U.S. flat and 4% growth
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`outside the U.S. Increased sales due to the successful launch of ATTUNE were partially
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`offset by price pressures across the region and softness in the U.S. market.
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Cardiovascular growth was driven by a 14% worldwide increase in our BioSense Webster
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`business due to new catheter launches and continued market expansion. Specialty
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`surgery results were driven by energy and bio-surgery outside the U.S. with new products
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`driving market growth and market share. There were some notable developments in the
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`second quarter which we have summarized on this slide to assist as you develop your
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`models. Alex, Joaquin and Paul will provide some additional commentary in their remarks.
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`That concludes the segment highlights for Johnson & Johnson second quarter of 2014. It
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`is now my pleasure to turn the call over to Alex Gorsky. Alex?
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`Alex Gorsky
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`Well, thank you very much, Louise and thanks to all of you who are participating in today’s
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`call, welcome. It’s a very dynamic time in the healthcare industry led most importantly by
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`significant advancements in the care of patients and consumers. Treatment options have
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`never been greater. Today hepatitis C and certain cancer treatments are more promising
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`than ever and while diabetes and heart disease which we are unfortunately still seeing
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`rates increased, they are much more manageable for the patient with oral medication that
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`are increasingly convenient to take.
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`That being said, all of us in healthcare realized that there is still so much more work to do
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`to improve the lives of patients around the world. It is encouraging to see that healthcare
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`reform initiatives are taking hold around the world which will enable more people to see a
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`doctor or to have procedures they needed, it may not have had the means to do so in the
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`past. Over the past several years, we have been discussing with you how Johnson &
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`Johnson has been taking a consistent series of steps to ensure we are best positioned to
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`serve the needs of patients and consumers in this dynamic and rapidly evolving
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`environment.
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`I would like to begin our discussion today by reviewing some of these issues. Much as we
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`had anticipated the medical devices landscape is evolving as innovations, scale and
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`breadth become more important to meeting the needs of the customer. At that time we
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`noted that due to market dynamics in segments like orthopedics, the industry would likely
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`need to consolidate, which was one factor that led to our acquisition of Synthes. In the
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`larger device space, what the industry is now realizing is the companies like Johnson &
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`Johnson with larger portfolios are better able to partner with hospital systems and
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`managed care organizations to find the right balance of innovation, value and service.
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`And as we are all observing, there are many dynamics happening in the pharmaceutical
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`industry as well. We noted several years ago that a focused portfolio, consistent
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`investments in R&D and overall increased productivity in our development capabilities
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`would be the key to driving our innovation. Since making the decision to focus our portfolio
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`on five therapeutic areas where our expertise and the opportunity to make a significant
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`difference aligned, our pharmaceutical business has been exceptionally productive with 14
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`new compounds launched since 2009, making it the fastest growing of the top 10
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`pharmaceutical businesses in the U.S., Europe and Japan.
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`These innovations and indeed the innovations that we’re making in each of our segments
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`enables us to meet the growing demand for health care products and services and creates
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`new opportunities to address unmet medical needs. I want to now briefly review our
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`perspective on where we see health care today. As I mentioned in January, the worldwide
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`market is immense with an overall spend of over $8 trillion. At $2.4 trillion, products
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`account for nearly 30% of the spend, growing at about 3% to 5% a year.
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`In medical devices, we’re still seeing that utilization rates in the U.S. remain depressed
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`both in admissions and surgical procedures but we continue to believe that as the
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`economy recovers and healthcare reform gains momentum, utilization rates will increase.
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`In terms of prescription rates in the first half of the year, trends have modestly continued
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`upward versus 2013 with the U.S. Rx volume increasing through May by approximately
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`1% over the prior year. And global growth and GDP forecast remain above 3% on stronger
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`momentum in advanced economies such as the U.S. and Europe, while key emerging
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`economies including Brazil and India continue to be challenged.
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`Given the positive demographic trends we’re seeing globally in the underlying strength of
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`our businesses, we remain confident about the long-term growth prospects of the health
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`care market and with our comprehensive and diverse portfolio of consumer health
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`products, medical devices and pharmaceutical, Johnson & Johnson has a distinct
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`competitive advantage in meeting the needs of patients.
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`We re-implemented the strategic framework, a very disciplined and focused approach to
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`evolving our position as the world’s largest and most diverse healthcare company.
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`Grounded by our credo, we identified four growth drivers which by now all of you should
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`be very familiar with, creating value through innovation, global reach, local focus,
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`excellence in execution and leading with purpose. We are executing against these growth
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`drivers and capitalizing on our scale and breadth across Johnson & Johnson to ensure
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`that we’re effectively positioned to drive and sustain strong global growth over the long-
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`term.
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Now in the near-term, we also have clear priorities for the businesses including achieving
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`our financial targets. As announced earlier today, we had record sales in the quarter of
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`$19.5 billion which is a 9.4% operational increase as compared to the second quarter of
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`2013. These strong results reflect a continued success of our new product launches and
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`progress we made in achieving our near-term priorities.
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`In our Medical Device and Diagnostic segment, we are leading the industry with the
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`largest most comprehensive business in the world. And while combining businesses with
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`overlapping products and different business models can be disruptive, our integration over
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`the past two years of DePuy and Synthes which we mentioned earlier has gone well.
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`Given that we’re largely through it, we set a strong foundation for capturing the full growth
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`potential we envisioned at the onset and we’re pleased with the revenue and cost synergy
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`we’ve begun to realize.
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`And despite the market pressures, we remain optimistic about the future in this segment
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`and are seeing strong performance in many of our MD&D businesses. In hips, we
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`experienced strong operational growth at 5% in the quarter and continue to complement
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`this growth with new product introductions such as the recently launched CORAIL
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`Revision Hip System in both the United States and Europe. We also continue to see solid
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`growth in trauma at 7% for the quarter which is built on the strength of our portfolio and
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`the positive impact of a tender we were awarded in the Middle East as a result of our
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`comprehensive offerings.
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`In our global surgery business, we continue to see progress in many areas including
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`consistent double-digit growth of our BioSense Webster electrophysiology portfolio. We
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`also have a steady cadence of new product offerings exemplified by the recent FDA
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`approval of our supplemental PMA with the SEDASYS System which we anticipate
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`introducing into the U.S. market in the latter half of 2014 as well as the launch of the
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`HARMONIC ACE +7 Shears with advanced hemostasis, the first purely ultrasonic device
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`with a 7 millimeter sealing indication; it’s really a great technology.
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`And as you heard at our MD&D Investor Meeting in May, our strategy for sustainable long-
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`term growth is driven by building on the strong market leadership positions we hold on the
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`majority of our key platforms, as well as the contributions we anticipate from our recently
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`launched products and future pipeline which includes more than 30 major filings planned
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`by the end of 2016, many on which we have already made good progress since our
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`presentations in May.
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Finally, in-line with our emphasis to tighten the focus within our MD&D portfolio, we’re
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`creating value through divestiture opportunities and completed the divestiture of our ortho
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`clinical diagnostics business to The Carlyle Group which Dominic will discuss in his
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`remarks. OCD plays a very important role in health care and we’re confident that it is well
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`positioned to continue serve in the interest of patients, customers and employees.
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`Turning now to our consumer business, where growth is closely tied with GDP trends,
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`we’re pleased with the progress of the business and executing the strategy we outlined
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`last summer. We have successfully exited a few business categories recently, enabling us
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`to focus on delivering above market growth in our core business. And we anticipate
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`greater opportunities to expand the business in the future as global economies recover
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`and the middle-class continue to grow.
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`Our consumer brands are important for the equity of Johnson & Johnson and consumer
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`health care truly is strategic for us with the potential to serve the 2 billion additional
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`consumers who are predicted to join the growing middle-class in emerging markets. We
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`made significant progress in this segment over the last few years and have plans for the
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`coming years to accelerate the growth of this business through new innovations, brand
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`building and strategic collaborations, working off with foundation that starts with deep
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`consumer insights.
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`As part of our strategy, we have defined 11 key need states where with our expertise we
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`can make a difference to consumers and grow our business. We are also focusing on 12
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`mega brands including LISTERINE, AVEENO, TYLENOL and JOHNSON’s Baby to
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`ensure they are exceeding consumers’ expectations around the world and the strategy is
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`working. We are capturing share in these and several of the other key categories. For
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`example, we have seen strong growth in our oral care business outside the U.S. at 7%
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`operationally. Our skin care and baby businesses are both up 7% operationally in the
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`quarter.
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`And we are also developing innovative collaboration models with retailers across the
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`globe where we are working to create an unparalleled experience for shoppers in OTC
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`categories like cold and flu, by sharing insights and developing ways to reduce complexity
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`for consumers and drive visibility for our offerings. In our U.S., OTC business, we continue
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`making good progress in restoring brands to the shelves, delivering above market growth
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`and continue to meet each of our obligations under the consent decree.
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`While we still have work to do, our goal is to ensure all of our U.S., OTC products are
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`available every time a consumer is reaching for them. And I’m confident that we are on a
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`good path to meet that goal. Turning now to our pharmaceutical business and as results
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`show the current business is very strong, driven by new innovative products that are
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`clearly addressing the unmet medical needs of patients worldwide and the future is bright
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`with the continued advancement in our pipeline. By any measure, our performance has
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`been outstanding in this segment and we are leading the industry on numerous fronts.
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`Clinical through commercial and later this morning you’ll hear more from Paul and
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`Joaquin, who I am pleased to have joining us on the call later today.
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`You’ll recall that in the late 2000s, our pharmaceutical business faced significant patent
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`expirations as products worth roughly $8 billion went off patent. We have to rethink that
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`business model and really focused on areas where we could make a difference. We
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`needed to streamline our organization and made tough choices to gain efficiencies and
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`reduce headcount in developed markets by nearly 25%. But through our diversified
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`business model, with consumer and MD&D continuing to grow during this time, we were
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`able to continue to invest in our pharma business.
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`We are also continuing to invest in R&D in our five therapeutic areas at approximately
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`20% to 21% of sales and we have put those dollars to work with plan to file more than 10
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`new drugs and 25 line extensions between 2013 and 2017. Additionally, we are
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`complementing that investment with smaller scale acquisitions and early stage licensing
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`agreements surfaced through our innovation centers. For Johnson & Johnson, this model
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`has been an excellent source of value creation. And I am delighted that Paul Stoffels,
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`Joaquin Duato are joining the call today to provide an update on their tremendous work.
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`A little over a year ago, we created the Johnson & Johnson Research and Development
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`Management Committee led by Paul. This group brings together the senior most R&D
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`leaders across Johnson & Johnson to foster cross-sector collaboration and deliver
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`transformational new medicines and medical devices. Under Paul’s excellent leadership
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`our enterprise R&D leaders are harnessing our deep internal expertise and platform
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`capabilities throughout the organization to develop customer focused solutions that
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`combine our capabilities and expertise across our portfolios.
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`And the commercial pharmaceutical strategies led by Joaquin, are delivering outstanding
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`results in very competitive global markets where we’re continuing to gain share and we’re
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`also securing reimbursement and access at accelerated rates. The teams they have put in
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`place have positioned us for continued success for many years to come in our
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`pharmaceutical sector. I am please now to turn the call over to Paul and Joaquin.
`
`Joaquin Duato
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`Thank you, Alex, and good morning everyone. Paul and I are delighted to speak to you
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`today about our continued success at our pharmaceutical group. When we look at the
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`pharmaceuticals market, we’re very optimistic about the future with an estimated 4.5%
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`growth anticipated through 2017. While we recognized we’ll continue to experience
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`headwinds, we also see numerous positive drivers, including changing demographics and
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`substantial unmet medical needs.
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`As a result, there is significant opportunity to improve the lives of patients by bringing
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`transformational medical innovations to the market. As Louise mentioned, we’re reporting
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`21.1% operational growth in the second quarter of 2014. This is our 17th consecutive
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`quarter of growth including the six consecutive quarters in double-digits. Without our
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`hepatitis C products, our growth in the last quarter was 10.5%.
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`I am often asked, Joaquin, is this just a lucky run or is there something more to it. After
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`facing significant challenges in the early 2000, we made a number of strategic changes to
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`our business including building key development manufacturing market access and
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`commercial competencies and focusing our innovation to produce a consistent stream of
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`differentiated new products. These changes are directly responsible for the success we’re
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`seeing now and we believe position us to continue to succeed in the future.
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`Specifically with our focus on the five strategic priorities that you see on this slide, I will
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`speak to you about the first two of these priorities and then hand off to Paul to cover the
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`remaining three. When we look at our commercial performance, the first thing to note is
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`that our success is global. We are the fastest growing top 10 global pharmaceutical
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`company in the U.S., Europe, and Japan by a significant margin.
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`Key to the success has been both the sales of our core growth products and the sales of
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`new products. Regarding our core growth products, you can see that REMICADE,
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`VELCADE, and PREZISTA all continue to deliver strong growth. 2013 REMICADE sales
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`were 6.7 billion, which were 9% higher than 2012. In the second quarter of this year, sales
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`grew at 8.7%. This is a product that has been in the market since 1998. VELCADE
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`remains a backbone of multiple myeloma treatment, delivering 6.2% growth in the second
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`quarter.
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`http://seekingalpha.com/article/2316085-johnson-and-johnsons-jnj-ceo-alex-gorsky-on-q2-2014-results-earnings-call-transcript?part=single
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`Johnson & Johnson's (JNJ) CEO Alex Gorsky on Q2 2014 Results - Earnings Call Transcript | Seeking Alpha
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`Finally PREZISTA is the number one HIV protease inhibitor in the U.S. and Europe and
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`we’re pleased to note the recent approval in Canada of PREZCOBIX, our fixed dose
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`combination with Gilead’s cobicistat with a file for approval also in the U.S. and in Europe.
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`We have achieved remarkable success with our new products. As you can see on the left,
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`worldwide sales of new products launched since 2009 have already generated $5.9 billion
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`of revenue this year and represent nearly 40% of our second quarter sales.
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`In the United States alone, our cumulative sales of new products launched since 2009 is
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`more than our next two closest competitors combined. I would now like to spend a few
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`minutes speaking about the specific products that have driven this performance. ZYTIGA
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`is the most successful oral oncology launch in history. It is now approved for the treatment
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`of metastatic castrate resistant prostate cancer in more than 90 countries. And the
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`metastatic castration sensitive registration trial is on track. As you can see ZYTIGA
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`continues to hold significant market share in U.S., gaining 1.2 points versus the first
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`quarter this year.
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`Worldwide, we generated second quarter sales of $562 million, representing more than
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`40% growth year-over-year. Nearly 60% of the sales in the quarter were outside the U.S.
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`As for B-cell malignancies in the last year we launched our oral oncology drug
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`IMBRUVICA, developed in collaboration with Pharmacyclics with a worldwide license
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`agreement for a 50-50 profit split. IMBRUVICA is launched in the U.S. for the treatment of
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`chronic lymphocytic leukemia and for the treatment of mantle cell lymphoma in patients
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`who have received at least one prior therapy.
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`Both indications are based on an overall response rate and improvement in survival or
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`disease related symptoms has not yet been established. Moving forward, we’re pursuing a
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`global regulatory strategy for IMBRUVICA in all major markets with European MCL and
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`CLL decisions expected later this year. IMBRUVICA has been investigated in a number of
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`global chemical trials across potential indications.
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`In immunology, we are proud to note Janssen was the number one company in total U.S.
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`sales in 2013. This was of course driven by REMICADE, which I mentioned earlier and by
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`STELARA and SIMPONI. STELARA is the fastest growing biologic in psoriasis in major
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`markets, including number one new-to-brand share in the U.S. This is in large part due to
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`STELARA, key psoriasis and Psoriatic Arthritis approvals and because we are able to
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`demonstrate the five year safety and efficacy of STELARA through real-world trials and
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`registry data. For SIMPONI its ulcerative colitis indication is approved in 43 countries and
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`http://seekingalpha.com/article/2316085-johnson-and-johnsons-jnj-ceo-alex-gorsky-on-q2-2014-results-earnings-call-transcript?part=single
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