UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended January 2, 2011 Commission file number 1-3215
JOHNSON & JOHNSON
(Exact name of registrant as specified in its charter)
New Jersey
(State of incorporation)
22-1024240
(I.R.S. Employer Identification No.)
One Johnson & Johnson Plaza New Brunswick, New Jersey
(Address of principal executive offices)
08933
(Zip Code)
Registrant‟s telephone number, including area code: (732) 524-0400
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT
Title of each class
Name of each exchange on which registered
Common Stock, Par Value $1.00
New York Stock Exchange
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant‟s knowledge, in definitive proxy or informat ion statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company (Do not check if a smaller reporting company) Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No
The aggregate market value of the Common Stock held by non-affiliates computed by reference to the price at which the Common Stock was last sold as of the last business day of the registrant‟s most recently completed second fiscal quarter was approximately $163 billion. On February 15, 2011 there were 2,735,213,719 shares of Common Stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE Parts I, II and III: Parts I and III: Portions of registrant‟s annual report to shareholders for fiscal year 2010 (the “Annual Report”). Portions of registrant‟s proxy statement for its 2011 annual meeting of shareholders filed within 120 days after the close of the registrant‟s fiscal year (the “Proxy Statement”).
Item
Page
PART I 1. Business General Segments of Business Geographic Areas Raw Materials Patents and Trademarks Seasonality Competition Research and Development Environment Regulation Available Information Risk Factors Unresolved Staff Comments Properties Legal Proceedings (Removed and Reserved) Executive Officers of the Registrant PART II Market for Registrant‟s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Selected Financial Data Management‟s Discussion and Analysis of Financial Condition and Results of Operation Quantitative and Qualitative Disclosures About Market Risk Financial Statements and Supplementary Data Changes in and Disagreements With Accountants on Accounting and Financial Disclosure Controls and Procedures Other Information PART III Directors, Executive Officers and Corporate Governance Executive Compensation Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Certain Relationships and Related Transactions, and Director Independence Principal Accountant Fees and Services PART IV Exhibits and Financial Statement Schedules Schedule II — Valuation and Qualifying Accounts Signatures Report of Independent Registered Public Accounting Firm on Financial Statement Schedule Exhibit Index 1 1 1 2 2 2 3 3 3 3 3 4 4 4 4 5 5 5
1A. 1B. 2. 3. 4.
5. 6. 7. 7A. 8. 9. 9A. 9B.
7 7 8 8 8 8 8 9
10. 11. 12. 13. 14.
9 9 10 10 11
15.
11 12 13 15 16
PART I Item 1. General Johnson & Johnson and its subsidiaries have approximately 114,000 employees worldwide engaged in the research and development, manufacture and sale of a broad range of products in the health care field. Johnson & Johnson is a holding company, which has more than 250 operating companies conducting business in virtually all countries of the world. Johnson & Johnson‟s primary focus has been on products related to human health and well -being. Johnson & Johnson was incorporated in the State of New Jersey in 1887. The Company‟s structure is based on the principle of decentralized management. The Executive Committee of Johnson & Johnson is the principal management group responsible for the operations and allocation of the resources of the Company. This Committee oversees and coordinates the activities of the Consumer, Pharmaceutical and Medical Devices and Diagnostics business segments. Each subsidiary within the business segments is, with some exceptions, managed by citizens of the country where it is located. Segments of Business Johnson & Johnson‟s operating companies are organized into three business segments: Consumer, Pharmaceutical and Medical Devices and Diagnostics. Additional information required by this item is incorporated herein by reference to the narrative and tabular (but not the graphic) descriptions of segments and operating results under the captions “Management‟s Discussion and Analysis of Results of Operations and Financ ial Condition” on pages 30 through 40 and Note 18 “Segments of Business and Geographic Areas” under “Notes to Consolidated Financial Statements” on page 61 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Consumer The Consumer segment includes a broad range of products used in the baby care, skin care, oral care, wound care and women‟s health care fields, as well as nutritional and over -the-counter pharmaceutical products, and wellness and prevention platforms. The Baby Care franchise includes the JOHNSON‟S ® Baby line of products. Major brands in the Skin Care franchise include the AVEENO ® ; CLEAN & CLEAR ® ; JOHNSON‟S ® Adult; NEUTROGENA ® ; RoC ® ; LUBRIDERM ® ; DABAO TM ; and Vendôme product lines. The Oral Care franchise includes the LISTERINE ® and REACH ® oral care lines of products. The Wound Care franchise includes BAND-AID ® brand adhesive bandages and Neosporin ® First Aid products. Major brands in the Women‟s Health franchis e are the CAREFREE ® Pantiliners; o.b. ® tampons and STAYFREE ® sanitary protection products. The nutritional and over-the-counter lines include SPLENDA ® , No Calorie Sweetener; the broad family of TYLENOL ® acetaminophen products; SUDAFED ® cold, flu and allergy products; ZYRTEC ® allergy products; MOTRIN ® IB ibuprofen products; and PEPCID ® AC Acid Controller from Johnson & Johnson • Merck Consumer Pharmaceuticals Co. These products are marketed to the general public and sold both to retail outlets and distributors throughout the world. Pharmaceutical The Pharmaceutical segment includes products in the following areas: anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management and virology. These products are distributed directly to retailers, wholesalers and health care professionals for prescription use. Key products in the Pharmaceutical segment include: REMICADE ® (infliximab), a treatment for a number of immune mediated inflammatory diseases; STELARA ® (ustekinumab), a treatment for moderate to severe plaque psoriasis; SIMPONI ® (golimumab), a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; VELCADE ® (bortezomib), a treatment for multiple myeloma; PREZISTA ® (darunavir) and INTELENCE ® (etravirine), treatments for HIV/AIDS; NUCYNTA ® (tapentadol), a treatment for moderate to severe acute pain; INVEGA ® SUSTENNA TM (paliperidone palmitate), for the acute and maintenance treatment of schizophrenia in adults; RISPERDAL ® CONSTA ® (risperidone), a treatment for the management of Bipolar I Disorder and schizophrenia; PROCRIT ® (Epoetin alfa, sold outside the U.S. as EPREX ® ), to stimulate red blood cell production; LEVAQUIN ® (levofloxacin) for the treatment of bacterial infections; CONCERTA ® (methylphenidate HCl), a treatment for attention deficit hyperactivity disorder; BUSINESS
ACIPHEX ® /PARIET ® , a proton pump inhibitor co-marketed with Eisai Inc.; DURAGESIC ® /Fentanyl Transdermal (fentanyl transdermal system, sold outside the U.S. as DUROGESIC ® ), a treatment for chronic pain that offers a novel delivery system. Medical Devices and Diagnostics The Medical Devices and Diagnostics segment includes a broad range of products distributed to wholesalers, hospitals and retailers, used principally in the professional fields by physicians, nurses, therapists, hospitals, diagnostic laboratories and clinics. These products include Biosense Webster‟s electrophysiology products; Cordis‟ circulatory disease management products; DePuy‟s orthopaedic joint reconstruction, spinal care, neurological and sports medicine products; Ethicon‟s surgical care, aesthetics and women‟s health products; Ethicon Endo -Surgery‟s minimally invasive surgical products and advanced sterilization products; LifeScan‟s blood glucose monitoring and insulin delivery products; Ortho -Clinical Diagnostics‟ professional diagnostic products; and Vistakon‟s disposable contact lenses. Dis tribution to these health care professional markets is done both directly and through surgical supply and other dealers. Geographic Areas The business of Johnson & Johnson is conducted by more than 250 operating companies located in 60 countries, including the United States, which are selling products in virtually all countries throughout the world. The products made and sold in the international business include many of those described above under “— Segments of Business — Consumer,” “— Pharmaceutical” and “— Medical Devices and Diagnostics.” However, the principal markets, products and methods of distribution in the international business vary with the country and the culture. The products sold in international business include not only those developed in the United States, but also those developed by subsidiaries abroad. Investments and activities in some countries outside the United States are subject to higher risks than comparable U.S. activities because the investment and commercial climate is influenced by restrictive economic policies and political uncertainties. Raw Materials Raw materials essential to Johnson & Johnson‟s operating companies‟ businesses are generally readily available from multiple sources. Patents and Trademarks Johnson & Johnson and its subsidiaries have made a practice of obtaining patent protection on their products and processes where possible. They own or are licensed under a number of patents relating to their products and manufacturing processes, which in the aggregate are believed to be of material importance to Johnson & Johnson in the operation of its businesses. Sales of the Company‟s largest product, REMICADE ® (infliximab), accounted for approximately 7% of Johnson & Johnson‟s total revenues for fiscal 2010. Accordingly, the patents related to this product are believed to be material to Johnson & Johnson. In March of 2009, TOPAMAX ® (topiramate) lost basic patent protection and market exclusivity and became subject to generic competition in the United States and later in the year in international markets. Sales of TOPAMAX ® declined by 53.3% and 57.9% in 2010 and 2009, respectively. The next significant patent that will expire is for LEVAQUIN ® (levofloxacin), which accounted for approximately 2% of the Comp any‟s 2010 sales. A pediatric extension for LEVAQUIN ® was granted by the U.S. Food and Drug Administration (“FDA”), which extends market exclusivity in the United States through June 20, 2011. Johnson & Johnson‟s operating companies have made a practice of selling their products under trademarks and of obtaining protection for these trademarks by all available means. These trademarks are protected by registration in the United States and other countries where such products are marketed. Johnson & Johnson considers these trademarks in the aggregate to be of material importance in the operation of its businesses.
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Seasonality Worldwide sales do not reflect any significant degree of seasonality; however, spending has been heavier in the fourth quarter of each year than in other quarters. This reflects increased spending decisions, principally for advertising and research and development activity. Competition In all of their product lines, Johnson & Johnson‟s operating companies compete with companies both local and global, located throughout the world. Competition exists in all product lines without regard to the number and size of the competing companies involved. Competition in research, involving the development and the improvement of new and existing products and processes, is particularly significant. The development of new and innovative products is important to Johnson & Johnson‟s success in all areas of its business. This also includes protecting the Company‟s portfolio of intellectual property. The competitive environment requires substantial investments in continuing research and in maintaining sales forces. In addition, the development and maintenance of customer demand for the Company‟s consumer products involves significant expenditures for advertising and promotion. Research and Development Research activities represent a significant part of Johnson & Johnson‟s subsidiaries‟ businesses. Major research facilities are located not only in the United States, but also in Belgium, Brazil, Canada, China, France, Germany, India, Israel, Japan, the Netherlands, Singapore and the United Kingdom. The costs of worldwide Company-sponsored research activities relating to the development of new products, improvement of existing products, technical support of products and compliance with governmental regulations for the protection of consumers and patients (excluding purchased in-process research and development charges for fiscal 2008), amounted to $6.8 billion, $7.0 billion and $7.6 billion for fiscal years 2010, 2009 and 2008, respectively. These costs are charged directly to expense, or directly against income, in the year in which incurred. Environment Johnson & Johnson‟s operating companies are subject to a variety of U.S. and international environmental protection measures. Johnson & Johnson believes that its operations comply in all material respects with applicable environmental laws and regulations. Johnson & Johnson‟s compliance with these requirements did not during the past year, and is not expected to, have a material effect upon its capital expenditures, cash flows, earnings or competitive position. Regulation Most of Johnson & Johnson‟s businesses are subject to varying degrees of governmental regulation in the countries in which operations are conducted, and the general trend is toward increasingly stringent regulation. In the United States, the drug, device, diagnostics and cosmetic industries have long been subject to regulation by various federal and state agencies, primarily as to product safety, efficacy, manufacturing, advertising, labeling and safety reporting. The exercise of broad regulatory powers by the FDA continues to result in increases in the amounts of testing and documentation required for FDA clearance of new drugs and devices and a corresponding increase in the expense of product introduction. Similar trends are also evident in major markets outside of the United States. The costs of human health care have been and continue to be a subject of study, investigation and regulation by governmental agencies and legislative bodies around the world. In the United States, attention has been focused on drug prices and profits and programs that encourage doctors to write prescriptions for particular drugs or recommend, use or purchase particular medical devices. Payers have become a more potent force in the market place and increased attention is being paid to drug and medical device pricing, appropriate drug and medical device utilization and the quality and costs of health care. The regulatory agencies under whose purview Johnson & Johnson‟s operating companies operate have administrative powers that may subject those companies to such actions as product withdrawals, recalls, seizure of products and other civil and criminal sanctions. In some cases, Johnson & Johnson‟s operating companies may deem it advisable to initiate product recalls.
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In addition, business practices in the health care industry have come under increased scrutiny, particularly in the United States, by government agencies and state attorneys general, and resulting investigations and prosecutions carry the risk of significant civil and criminal penalties. Available Information The Company‟s main corporate website address is www.jnj.com. Copies of Johnson & Johnson‟s Quarterly Reports on Form 10-Q, Annual Report on Form 10-K and Current Reports on Form 8-K filed or furnished to the U.S. Securities and Exchange Commission (the “SEC”), and any amendments to the foregoing, will be provided without charge to any shareholder submitting a written request to the Secretary at the principal executive offices of the Company or by calling 1800-950-5089. All of the Company‟s SEC filings are also available on the Company‟s website at www.investor.jnj.com/governance/materials.cfm , as soon as reasonably practicable after having been electronically filed or furnished to the SEC. All SEC filings are also available at the SEC‟s website at www.sec.gov . In addition, the written charters of the Audit Committee, the Compensation & Benefits Committee and the Nominating & Corporate Governance Committee of the Board of Directors and the Company‟s Principles o f Corporate Governance, Policy on Business Conduct for employees and Code of Business Conduct & Ethics for Members of the Board of Directors and Executive Officers are available at the www.investor.jnj.com/governance/materials.cfm website address and will be provided without charge to any shareholder submitting a written request, as provided above. Item 1A. RISK FACTORS
Some important factors that could cause the Company‟s actual results to differ from the Company‟s expectations in any forward-looking statements in this Report are set forth in Exhibit 99 to this Report on Form 10-K. Item 1B. UNRESOLVED STAFF COMMENTS
Not applicable. Item 2. PROPERTIES
Johnson & Johnson and its subsidiaries operate 139 manufacturing facilities occupying approximately 21.8 million square feet of floor space. The manufacturing facilities are used by the industry segments of Johnson & Johnson‟s business approximately as follows:
Square Feet (in thousands)
Segment
Consumer Pharmaceutical Medical Devices and Diagnostics Worldwide Total
6,968 6,739 8,108 21,815
Within the United States, 7 facilities are used by the Consumer segment, 11 by the Pharmaceutical segment and 36 by the Medical Devices and Diagnostics segment. Johnson & Johnson‟s manufacturing operations outside the United States are often conducted in facilities that serve more than one business segment.
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The locations of the manufacturing facilities by major geographic areas of the world are as follows:
Geographic Area
Number of Facilities
Square Feet (in thousands)
United States Europe Western Hemisphere, excluding U.S. Africa, Asia and Pacific Worldwide Total
54 37 17 31 139
7,449 7,602 3,380 3,384 21,815
In addition to the manufacturing facilities discussed above, Johnson & Johnson and its subsidiaries maintain numerous office and warehouse facilities throughout the world. Research facilities are also discussed in Item 1 under “Business — Research and Development.” Johnson & Johnson and its subsidiaries generally seek to own their manufacturing facilities, although some, principally in locations abroad, are leased. Office and warehouse facilities are often leased. Johnson & Johnson is committed to maintaining all of its properties in good operating condition and repair, and the facilities are well utilized. Production at McNeil Consumer Healthcare‟s Fort Washington, Pennsylvania facility was suspended in the second quarter of 2010. Alternate supplies of products are planned to be available in the latter half of 2011. McNeil Consumer Healthcare submitted its Comprehensive Action Plan (CAP) to the U.S. Food and Drug Administration (FDA) on July 15, 2010, which encompasses, among other items, training, resources and capital investments in quality and manufacturing systems across the McNeil organization. The Company continues to communicate with the FDA on remediation actions and is on schedule with the commitments made in the CAP. For information regarding lease obligations, see Note 16 “Rental Expense and Lease Commitments” under “Notes to Consolidated Financial Statements” on page 59 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Segment information on additions to property, plant and equipment is contained in Note 18 “Segments of Business and Geographic Areas” under “Notes to Consolidated Financial Statements” on page 61 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Item 3. LEGAL PROCEEDINGS
The information set forth in Note 21 “Legal Proceedings” under “Notes to Consolidated Financial Statements” on pages 64 through 71 of the Annual Report is incorporated herein by reference and filed as Exhibit 13 to this Report on Form 10-K. The Company or its subsidiaries are parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund, and comparable state laws, in which the primary relief sought is the cost of past and future remediation. While it is not feasible to predict or determine the outcome of these proceedings, in the opinion of the Company, such proceedings would not have a material adverse effect on the results of operations, cash flows or financial position of the Company. Item 4. (REMOVED AND RESERVED)
EXECUTIVE OFFICERS OF THE REGISTRANT Listed below are the executive officers of Johnson & Johnson as of February 15, 2011, each of whom, unless otherwise indicated below, has been an employee of the Company or its affiliates and held the position indicated during the past five years. There are no family relationships between any of the executive officers, and there is no arrangement or understanding between any executive officer and any other person pursuant to which the executive officer was selected. At the annual meeting of the Board of Directors, the executive officers are elected by the Board to hold office for one year and until their respective successors are elected and qualified, or until earlier resignation or removal.
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Information with regard to the directors of the Company, including information for William C. Weldon, is incorporated herein by reference to the material captioned “Election of Directors” in the Proxy Statement.
Name Age Position
Dominic J. Caruso
Member, Executive Committee; Vice President, Finance; Chief Financial Officer(a) Russell C. Deyo 61 Member, Executive Committee; Vice President, General Counsel(b) Peter M. Fasolo 48 Member, Executive Committee, Vice President, Worldwide Human Resources(c) Alex Gorsky 50 Vice Chairman, Executive Committee(d) Sherilyn S. McCoy 52 Vice Chairman, Executive Committee(e) William C. Weldon 62 Chairman, Board of Directors; Chairman, Executive Committee; Chief Executive Officer (a) Mr. D. J. Caruso joined the Company in 1999 when the Company acquired Centocor, Inc. At the time of that acquisition, he had been Senior Vice President, Finance of Centocor. Mr. Caruso was named Vice President, Finance of Ortho-McNeil Pharmaceutical, Inc., a subsidiary of the Company, in 2001 and Vice President, Group Finance of the Company‟s Medical Devices and Diagnostics Group in 2003. In 2005, Mr. Caruso was named Vice President of the Company‟s Group Finance organization. Mr. Caruso became a Member of the Executive Committee and Vice President, Finance and Chief Financial Officer in 2007. (b) Mr. R. C. Deyo joined the Company in 1985 and became Associate General Counsel in 1991. He became a Member of the Executive Committee and Vice President, Administration in 1996 and Vice President, General Counsel in 2004. Mr. P. M. Fasolo joined the Company in 2004 as Vice President, Worldwide Human Resources for Cordis Corporation, a subsidiary of the Company. He was then named Vice President, Global Talent Management for the Company. He left Johnson & Johnson in 2007 to join Kohlberg Kravis Roberts & Co. as Chief Talent Officer. Mr. Fasolo returned to the Company in September 2010 as the Vice President, Worldwide Human Resources, and in January 2011, he became a Member of the Executive Committee. Mr. A. Gorsky joined the Company in 2008 as Company Group Chairman and Worldwide Franchise Chairman for Ethicon, Inc., a subsidiary of the Company. Previously, he was head of the North American pharmaceuticals business at Novartis Pharmaceuticals Corporation from 2004 to 2008. Prior to Novartis, Mr. Gorsky served in various management positions at Johnson & Johnson, including Company Group Chairman for the Company‟s pharmaceutical business in Europe, Middle East and Africa and President of Janssen Pharmaceutica Inc. (U.S.), a subsidiary of the Company. In January 2009, he became a Member of the Executive Committee and Worldwide Chairman, Surgical Care Group, and in September 2009, he became Worldwide Chairman, Medical Devices and Diagnostics Group. Mr. Gorsky was appointed as Vice Chairman, Executive Committee in January 2011. Ms. S. S. McCoy joined the Company in 1982 as an Associate Scientist in Research & Development for Personal Products Company, a subsidiary of the Company. She was named Vice President, Research & Development for the Personal Products Worldwide Division of McNEIL-PPC, Inc., a subsidiary of the Company, in 1995, and Vice President, Marketing for its Skin Care franchise in 2000. In 2002, Ms. McCoy became Global President for its Baby and Wound Care franchise. She was named Company Group Chairman and Worldwide Franchise Chairman of Ethicon, Inc., a subsidiary of the Company, in 2005. In 2008 she became a Member of the Executive Committee and Worldwide Chairman, Surgical Care Group. In 2009, she became Worldwide Chairman, Pharmaceuticals Group. Ms. McCoy was appointed as Vice Chairman, Executive Committee in January 2011.
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(c)
(d)
(e)
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PART II Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
As of February 15, 2011, there were 181,232 record holders of Common Stock of the Company. Additional information called for by this item is incorporated herein by reference to: the material under the captions “Management‟s Discussion and Analysis of Results of Operations and Financial Condition — Liquidity and Capital Resources — Share Repurchase and Dividends” on page 37; “— Other Information — Common Stock Market Prices” on page 39; Note 17 “Common Stock, Stock Option Plans and Stock Compensation Agreements” under “Notes to Consolidated Financial Statements” on pages 59 and 60; and “Shareholder Return Performance Graphs” on page 75 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K; and Item 12 “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters — Equity Compensation Plan Information” of this Report on Form 10-K. Issuer Purchases of Equity Securities On July 9, 2007, the Company announced that its Board of Directors approved a stock repurchase program, authorizing the Company to buy back up to $10 billion of the Company‟s Common Stock. As of January 2, 2011, the current stock repurchase program has been completed. The Company repurchased an aggregate of 158.3 million shares of Johnson & Johnson Common Stock at a cost of $10 billion. The Company funded the share repurchase program through a combination of available cash and debt. In addition, the Company has an annual program to repurchase shares for use in employee stock and incentive plans. The following table provides information with respect to Common Stock purchases by the Company during the fiscal fourth quarter of 2010.
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2)
Period
Total Number of Shares Purchased (1)
Avg. Price Paid Per Share
October 4, 2010 through October 31, 2010 November 1, 2010 through November 28, 2010 November 29, 2010 through January 2, 2011 Total
6,204,032 8,913,651 5,192,211 20,309,894
$ 63.28 63.70 62.35
— 2,520,817 3,372,164 5,892,981
(1) During the fiscal fourth quarter of 2010, the Company repurchased an aggregate of 5,892,981 shares of the Company‟s
Common Stock pursuant to the repurchase program that was publicly announced on July 9, 2007, and an aggregate of 14,416,913 shares in open-market transactions outside of the program.
(2) As of January 2, 2011, an aggregate of 158,315,129 shares were purchased, completing the buyback program totaling
$10 billion since the inception of the repurchase program announced on July 9, 2007. Item 6. SELECTED FINANCIAL DATA
The information called for by this item is incorporated herein by reference to the material under the caption “Summary of Operations and Statistical Data 2000-2010” on page 74 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K.
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Item 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
The information called for by this item is incorporated herein by reference to the narrative and tabular (but not the graphic) material under the caption “Management‟s Discussion and Analysis of Results of Operations and Financial Condition” on pages 30 through 40 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information called for by this item is incorporated herein by reference to the material under the caption “Management‟s Discussion and Analysis of Results of Operations and Financial Condition — Liquidity and Capital Resources — Financing and Market Risk” on pages 36 and 37 and Note 1 “Summary of Significant Accounting Policies — Financial Instruments” under “Notes to Consolidated Financial Statements” on pages 46 and 47 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information called for by this item is incorporated herein by reference to the Audited Consolidated Financial Statements and Notes thereto and the material under the caption “Report of Independent Re gistered Public Accounting Firm” on pages 41 through 72 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable. Item 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures. At the end of the period covered by this report, the Company evaluated the effectiveness of the design and operation of its disclosure controls and procedures. The Company‟s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC‟s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company‟s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. William C. Weldon, Chairman and Chief Executive Officer, and Dominic J. Caruso, Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Weldon and Caruso concluded that, as of the end of the period covered by this report, the Company‟s disclosure controls and procedures were effective. Management’s Report on Internal Control Over Financial Reporting. Under Section 404 of the Sarbanes-Oxley Act of 2002, management is required to assess the effectiveness of the Company‟s internal control over financial reporting as of the end of each fiscal year and report, based on that assessment, whether the Company‟s internal control over financial reporting is effective. Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company‟s internal control over financial reporting is designed to provide reasonable assurance as to the reliability of the Company‟s financial reporting and the preparation of external f inancial statements in accordance with generally accepted accounting principles. Internal control over financial reporting, no matter how well designed, has inherent limitations. Therefore, internal control over financial reporting determined to be effective can provide only reasonable assurance with respect to financial statement preparation and may not prevent or detect all misstatements. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
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The Company‟s management has assessed the effectiveness of the Company‟s internal control over financial reporting as of January 2, 2011. In making this assessment, the Company used the criteria established by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in “Internal Control -Integrated Framework.” These criteria are in the areas of control environment, risk assessment, control activities, information and communication, and monitoring. The Company‟s assessment included extensive documenting, evaluating and testing the design and operating effectiveness of its internal control over financial reporting. Based on the Company‟s processes and assessment, as described above, management has concluded that, as of January 2, 2011, the Company‟s internal control over financial reporting was effective. The effectiveness of the Company‟s internal control over financial reporting as of January 2, 2011 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which appears in the “Report of Independent Registered Public Accounting Firm” on page 72 of the Annual Report, which is incorporated herein by reference and filed as Exhibit 13 to this Report on Form 10-K. Changes in Internal Control Over Financial Reporting. During the fiscal quarter ended January 2, 2011, there were no changes in the Company‟s internal control over financial reporting identified in connection with the evaluation required under Rules 13a-15 and 15d-15 under the Exchange Act that have materially affected, or are reasonably likely to materially affect, the Company‟s internal control over financial reporting. Item 9B. OTHER INFORMATION
Not applicable.
PART III Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information called for by this item is incorporated herein by reference to the material under the captions “Election of Directors” and “Stock Ownership and Section 16 Compliance — Section 16(a) Beneficial Ownership Reporting Compliance” and the discussion of the Audit Committee under the caption “Corporate Governance — Standing Board Committees” in the Proxy Statement; and the material under the caption “Executive Officers of the Registrant” in Part I of this Report on Form 10-K. The Company‟s Policy on Business Conduct, which covers all employees (including the Chief Executive Officer, Chief Financial Officer and Controller), meets the requirements of the SEC rules promulgated under Section 406 of the SarbanesOxley Act of 2002. The Policy on Business Conduct is available on the Company‟s website at www.investor.jnj.com/governance/policies.cfm , and copies are available to shareholders without charge upon written request to the Secretary at the Company‟s principal executive offices. Any substantive ame ndment to the Policy on Business Conduct or any waiver of the Policy granted to the Chief Executive Officer, the Chief Financial Officer or the Controller will be posted on the Company‟s website at www.investor.jnj.com/governance.cfm within five business days (and retained on the website for at least one year). In addition, the Company has adopted a Code of Business Conduct & Ethics for Members of the Board of Directors and Executive Officers. The Code of Business Conduct & Ethics for Members of the Board of Directors and Executive Officers is available on the Company‟s website at www.investor.jnj.com/governance/policies.cfm , and copies are available to shareholders without charge upon written request to the Secretary at the Company‟s principal executive offices. Any substantive amendment to the Code or any waiver of the Code granted to any member of the Board of Directors or any executive officer will be posted on the Company‟s website at www.investor.jnj.com/governance.cfm within five business days (and retained on the website for at least one year). Item 11. EXECUTIVE COMPENSATION
The information called for by this item is incorporated herein by reference to the material under the captions “Compensation Discussion and Analysis,” “Executive and Director Compensation” and “Compensation Committee Report” in the Proxy Statement.
9
The material incorporated herein by reference to the material under the caption “Compensation Committee Report” in the Proxy Statement shall be deemed furnished, and not filed, in this Report on Form 10-K and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, as a result of this furnishing, except to the extent that the Registrant specifically incorporates it by reference. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Additional information called for by this item is incorporated herein by reference to the material under the captions “Stock Ownership and Section 16 Compliance” in the Proxy Statement and Note 17 “Common Stock, Stock Option Plans and Stock Compensation Agreements” under “Notes to Consolidated Financial Statements” on pages 59 and 60 of the Annual Report, filed as Exhibit 13 to this Report on Form 10-K. Equity Compensation Plan Information The following table provides certain information as of January 2, 2011 concerning the shares of the Company‟s Common Stock that may be issued under existing equity compensation plans.
Number of Securities to be Issued Upon Exercise of Outstanding Options and Rights Weighted Average Exercise Price of Outstanding Options and Rights Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (4)
Plan Category
Equity Compensation Plans Approved by Security Holders
(1)
223,164,807 259,334 223,424,141
$
51.74 46.23 51.73
121,322,775 — 121,322,775
Equity Compensation Plans Not Approved by Security Holders
(2)(3)
Total
$
(1)
Included in this category are the following equity compensation plans, which have been approved by the Company‟s shareholders: 2000 Stock Option Plan and 2005 Long-Term Incentive Plan. Included in this category are 216,584 shares of Common Stock of the Company issuable under various equity compensation plans which were assumed by the Company upon acquisition of the following companies: ALZA Corporation, Scios Inc., and Inverness Medical Technology, Inc. 122,629 of the shares listed as issuable in this category were issued under plans that were approved by the shareholders of these companies prior to the acquisition and the assumption of these plans by the Company. At the time of each of these acquisitions, options to acquire equity of the acquired company were replaced by options to acquire the Common Stock of the Company. No stock options or equity awards of any type have been made under any of these plans since the assumption of these plans by the Company, and no further stock options or other equity awards of any type will be made under any of these plans in the future. The shares that are included in this column that were issued under plans not approved by shareholders of the applicable acquired company are: 93,955 shares issuable under the 1996 Scios Non-Officer Stock Option Plan.
(2)
(3)
Also included in this category are 42,750 shares of Common Stock of the Company issuable upon the exercise of outstanding stock options under the Company‟s Stock Option Plan for Non-Employee Directors. All options outstanding under this plan have fully vested with an expiration period of ten years from the date of grant. This column excludes shares reflected under the column “Number of Securities to be Issued Upon Exercise of Outstanding Options and Rights.” CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
(4)
Item 13.
The information called for by this item is incorporated herein by reference to the material under the captions “Transactions with Related Persons” and “Corporate Governance — Director Independence” in the Proxy Statement.
10
Item 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information called for by this item is incorporated herein by reference to the material under the caption “Ratification of Appointment of Independent Registered Public Accounting Firm” in the Proxy Statement.
PART IV Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this report: 1. Financial Statements The following Audited Consolidated Financial Statements and Notes thereto and the material under the caption “Report of Independent Registered Public Accounting Firm” on pages 41 through 72 of the Annual Report are incorporated herein by reference and filed as Exhibit 13 to this Report on Form 10-K: Consolidated Balance Sheets at end of Fiscal Years 2010 and 2009 Consolidated Statements of Earnings for Fiscal Years 2010, 2009 and 2008 Consolidated Statements of Equity for Fiscal Years 2010, 2009 and 2008 Consolidated Statements of Cash Flows for Fiscal Years 2010, 2009 and 2008 Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm 2. Financial Statement Schedules Schedule II — Valuation and Qualifying Accounts Schedules other than those listed above are omitted because they are not required or are not applicable. 3. Exhibits Required to be Filed by Item 60l of Regulation S-K The information called for by this item is incorporated herein by reference to the Exhibit Index in this report.
11
JOHNSON & JOHNSON AND SUBSIDIARIES SCHEDULE II — VALUATION AND QUALIFYING ACCOUNTS Fiscal Years Ended January 2, 2011, January 3, 2010 and December 28, 2008 (Dollars in Millions)
Balance at End of Period
Balance at Beginning of Period
Accruals
Payments/Other
2010 Accrued Rebates (1) Accrued Returns Accrued Promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total 2009 Accrued Rebates (1) Accrued Returns Accrued Promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total 2008 Accrued Rebates (1) Accrued Returns Accrued Promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
1,639 689 429 2,757 333 101 3,191
7,492 517 2,664 10,673 130 1,112 11,915
(6,985 ) (566 ) (2,666 ) (10,217 ) (123 ) (1,103 ) (11,443 )
2,146 640 427 3,213 340 110 3,663
$
$
$
1,808 794 356 2,958 267 79 3,304
6,584 355 2,446 9,385 110 1,163 10,658
(6,753 ) (460 ) (2,373 ) (9,586 ) (44 ) (1,141 ) (10,771 )
1,639 689 429 2,757 333 101 3,191
$
$
$
1,802 648 578 3,028 193 71 3,292
5,578 402 2,991 8,971 101 905 9,977 (2)
(5,572 ) (256 ) (3,213 ) (9,041 ) (27 ) (897 ) (9,965 )
1,808 794 356 2,958 267 79 3,304
$
$
(1) Includes reserve for customer rebates of $701 million, $729 million and $721 million at January 2, 2011, January 3,
2010 and December 28, 2008, respectively.
(2) Includes $171 million adjustment related to previously estimated accrued sales reserve.
12
SIGNATURES Pursuant to the requirements of Section 13 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Date: February 15, 2011 JOHNSON & JOHNSON (Registrant)
By /s/ W. C. WELDON W. C. Weldon, Chairman, Board of Directors, and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ W. C. WELDON W. C. Weldon /s/ D. J. CARUSO D. J. Caruso /s/ S. J. COSGROVE S. J. Cosgrove /s/ M. S. COLEMAN M. S. Coleman /s/ J. G. CULLEN J. G. Cullen /s/ I. E. L. DAVIS I. E. L. Davis /s/ M. M. E. JOHNS M. M. E. Johns
Chairman, Board of Directors, Chief Executive Officer, and Director (Principal Executive Officer) Chief Financial Officer (Principal Financial Officer) Controller (Principal Accounting Officer)
February 15, 2011
February 15, 2011
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
13
Signature
Title
Date
/s/ S. L. LINDQUIST S. L. Lindquist /s/ A. M. MULCAHY A. M. Mulcahy /s/ L. F. MULLIN L. F. Mullin /s/ W. D. PEREZ W. D. Perez /s/ C. PRINCE C. Prince /s/ D. SATCHER D. Satcher
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
Director
February 15, 2011
14
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON FINANCIAL STATEMENT SCHEDULE To the Board of Directors of Johnson & Johnson: Our audits of the consolidated financial statements and of the effectiveness of internal control over financial reporting referred to in our report dated February 24, 2011 appearing in the 2010 Annual Report to Shareholders of Johnson & Johnson (which report and consolidated financial statements are incorporated by reference in this Annual Report on Form 10-K) also included an audit of the financial statement schedule listed in Item 15(a)2 of this Form 10-K. In our opinion, this financial statement schedule presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements.
/s/ PRICEWATERHOUSECOOPERS LLP PricewaterhouseCoopers LLP New York, New York February 24, 2011
15
EXHIBIT INDEX
Reg. S-K Exhibit Table Item No.
Description of Exhibit
3 (i)(a) 3 (i)(b)
3 (i)(c)
3 (i)(d)
3 (i)(e)
3 (ii) 4 (a) 10 (a) 10 (b) 10 (c) 10 (d)
10 (e)
10 (f) 10 (g) 10 (h)
10 (i)
10 (j)
10 (k) 10 (l)
10 (m)
Restated Certificate of Incorporation dated April 26, 1990 — Incorporated herein by reference to Exhibit 3(a) of the Registrant‟s Form 10-K Annual Report for the year ended December 30, 1990. Certificate of Amendment to the Restated Certificate of Incorporation of the Company dated May 20, 1992 — Incorporated herein by reference to Exhibit 3(a) of the Registrant‟s Form 10 -K Annual Report for the year ended January 3, 1993. Certificate of Amendment to the Restated Certificate of Incorporation of the Company dated May 21, 1996 — Incorporated herein by reference to Exhibit 3(a)(iii) of the Registrant‟s Form 10-K Annual Report for the year ended December 29, 1996. Certificate of Amendment to the Restated Certificate of Incorporation of the Company effective May 22, 2001 — Incorporated herein by reference to Exhibit 3 of the Registrant‟s Form 10 -Q Quarterly Report for the quarter ended July 1, 2001. Certificate of Amendment to the Restated Certificate of Incorporation of the Company effective April 27, 2006 — Incorporated herein by reference to Exhibit 3(i) of the Registrant‟s Form 10 -Q Quarterly Report for the quarter ended April 2, 2006. By-Laws of the Company, as amended effective February 9, 2009 — Incorporated herein by reference to Exhibit 3.1 the Registrant‟s Form 8 -K Current Report filed February 13, 2009. Upon the request of the Securities and Exchange Commission, the Registrant will furnish a copy of all instruments defining the rights of holders of long-term debt of the Registrant. Stock Option Plan for Non-Employee Directors — Incorporated herein by reference to Exhibit 10(a) of the Registrant‟s Form 10-K Annual Report for the year ended December 29, 1996.* 2000 Stock Option Plan (as amended) — Incorporated herein by reference to Exhibit 10(b) of the Registrant‟s Form 10-K Annual Report for the year ended December 29, 2002.* 2005 Long-Term Incentive Plan — Incorporated herein by reference to Exhibit 4 of the Registrant‟s S-8 Registration Statement filed with the Commission on May 10, 2005 (file no. 333-124785).* Form of Stock Option Certificate and Restricted Shares to Non-Employee Directors Certificate under the 2005 Long-Term Incentive Plan — Incorporated herein by reference to Exhibit 10.1 of the Registrant‟s Form 8-K Current Report filed August 25, 2005.* Form of Restricted Stock Unit Certificate under the 2005 Long-Term Incentive Plan — Incorporated herein by reference to Exhibit 10.1 of the Registrant‟s Form 10 -Q Quarterly Report for the quarter ended October 2, 2005.* Executive Bonus Plan — Incorporated herein by reference to Exhibit 4 of the Registrant‟s Form S-8 Registration Statement filed with the Commission on November 8, 2005 (file no. 333-129542).* Executive Incentive Plan (as amended) — Incorporated herein by reference to Exhibit 10(f) of the Registrant‟s Form 10-K Annual Report for the year ended December 31, 2000.* Domestic Deferred Compensation (Certificate of Extra Compensation) Plan — Incorporated herein by reference to Exhibit 10(g) of the Registrant‟s Form 10 -K Annual Report for the year ended December 28, 2003.* Amendments to the Certificate of Extra Compensation Plan effective as of January 1, 2009 — Incorporated herein by reference to Exhibit 10(j) of the Registrant‟s Form 10 -K Annual Report for the year ended December 28, 2008.* 2009 Certificates of Long-Term Performance Plan — Incorporated herein by reference to Exhibit 10.1 of the Registrant‟s Form 10-Q Quarterly Report for the quarter ended September 27, 2009.* Deferred Fee Plan Directors (as amended) — Incorporated herein by reference to Exhibit 10(h) of the Registrant‟s Form 10-K Annual Report for the year ended January 2, 2005.* Amendments to the Deferred Fee Plan for Directors effective as of January 1, 2009 — Incorporated herein by reference to Exhibit 10(l) of the Regi strant‟s Form 10-K Annual Report for the year ended December 28, 2008.* Executive Income Deferral Plan (as amended) — Incorporated herein by reference to Exhibit 10(i) of the Registrant‟s Form 10-K Annual Report for the year ended December 28, 2003.*
16
Reg. S-K Exhibit Table Item No.
Description of Exhibit
10 (n)
10 (o) 10 (p)
10 (q) 10 (r)
10 (s) 10 (t) 10 (u) 10 (v) 12 13
21 23 31 (a) 31 (b) 32 (a) 32 (b) 99 101
Amendments to the Executive Income Deferral Plan effective as of January 1, 2009 — Incorporated herein by reference to Exhibit 10(n) of the Registrant‟s Form 10 -K Annual Report for the year ended December 28, 2008.* Excess Savings Plan — Incorporated herein by reference to Exhibit 10(j) of the Registrant‟s Form 10 K Annual Report for the year ended December 29, 1996.* Amendments to the Johnson & Johnson Excess Savings Plan effective as of January 1, 2009 — Incorporated herein by reference to Exhibit 10(p) of the Registrant‟s Form 10 -K Annual Report for the year ended December 28, 2008.* Excess Benefit Plan (Supplemental Retirement Plan) — Incorporated herein by reference to Exhibit 10(h) of the Registrant‟s Form 10-K Annual Report for the year ended January 3, 1993.* Amendments to the Excess Benefit Plan of Johnson & Johnson and Affiliated Companies effective as of January 1, 2009 — Incorporated herein by reference to Exhibit 10(r) of the Registrant‟s Form 10-K Annual Report for the year ended December 28, 2008.* Executive Life Insurance Plan — Incorporated herein by reference to Exhibit 10(i) of the Registrant‟s Form 10-K Annual Report for the year ended January 3, 1993.* Stock Option Gain Deferral Plan — Incorporated herein by reference to Exhibit 10(m) of the Registrant‟s Form 10-K Annual Report for the year ended January 2, 2000.* Estate Preservation Plan — Incorporated herein by reference to Exhibit 10(n) of the Registrant‟s Form 10-K Annual Report for the year ended January 2, 2000.* Summary of Compensation Arrangements for Named Executive Officers and Directors — Filed with this document.* Statement of Computation of Ratio of Earnings to Fixed Charges — Filed with this document. — Pages 30 through 75 of the Company‟s Annual Report to Shareholders for fiscal year 2010 (only those portions of the Annual Report incorporated by reference in this report are deemed “filed”) — Filed with this document. Subsidiaries — Filed with this document. Consent of Independent Registered Public Accounting Firm — Filed with this document. Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act — Filed with this document. Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act — Filed with this document. Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act — Furnished with this document. Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act — Furnished with this document. Cautionary Statement Pursuant to Private Securities Litigation Reform Act of 1995 — “Safe Harbor” for Forward-Looking Statements — Filed with this document. XBRL (Extensible Business Reporting Language) The following materials from Johnson & Johnson‟s Annual Report on Form 10-K for the fiscal year-ended January 2, 2011, formatted in Extensive Business Reporting Language (XBRL): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Earnings, (iii) Consolidated Statements of Equity, (iv) Consolidated Statements of Cash Flows, (v) Notes to the Consolidated Financial Statements, and (vi) Schedule II — Valuation and Qualifying Accounts.
* Management contract or compensatory plan. A copy of any of the Exhibits listed above will be provided without charge to any shareholder submitting a written request specifying the desired exhibit(s) to the Secretary at the principal executive offices of the Company. 17
EXHIBIT 10(v)
Summary of Compensation Arrangements for Named Executive Officers and Directors Compensation Arrangements for Named Executive Officers Following is a description of the compensation arrangements that have been approved by the Compensation & Benefits Committee of the Board of Directors of Johnson & Johnson (the “Compensation Committee”) on January 10, 2011 for the Company‟s Chief Executive Officer, Chief Financial Officer and the other three most highly compensated executive officers in 2010 (the “Named Executive Officers”). Annual Base Salary: The Compensation Committee has approved the following base salaries for 2011 for the Named Executive Officers: William C. Weldon Chairman/CEO Dominic J. Caruso Vice President, Finance; CFO Russell C. Deyo Vice President, General Counsel Colleen A. Goggins Worldwide Chairman, Consumer Group Sherilyn S. McCoy Vice Chairman, Executive Committee * Will retire in March 2011. Annual Performance Bonus: The Compensation Committee has approved the following annual performance bonus payments under the Company‟s Executive Incentive Plan for performance in 2010 (paid in the form of 85% cash and 15% Company Common Stock as determined by the Compensation Committee): Mr. Weldon Mr. Caruso Mr. Deyo Ms. Goggins Ms. McCoy Stock Option and Restricted Share Unit Grants: The Compensation Committee has approved the following stock option and Restricted Share Unit (“RSU”) grants under the Company‟s 2005 Long-Term Incentive Plan (the “LTI Plan”). The stock options were granted at an exercise price of $62.20, at the “fair market value” (calculated as the average of the high and low prices of the Company‟s Common Stock on the New York Stock Exchange) on January 10, 2011. The options will become exercisable on January 11, 2014 and expire on January 10, 2021. The RSUs will vest on January 10, 2014, upon which, the holder, if still employed by the Company on such date, will receive one share of the Company‟s Common Stock for each RSU. Due to her intention to retire, Ms. Goggins did not receive stock options or RSUs in 2011. 46,724 RSUs 12,121 RSUs 14,037 RSUs 12,635 RSUs $ $ $ $ $ 1,976,000 900,000 1,080,000 500,000 1,125,000 $ $ $ $ $ 1,915,800 776,500 899,300 827,200 * 900,000
Mr. Weldon Mr. Caruso Mr. Deyo Ms. McCoy
560,691 stock options 145,447 stock options 168,444 stock options 151,621 stock options
Non-Equity Incentive Plan Awards: The Compensation Committee has approved the following non-equity incentive plan awards in recognition of performance during 2010 under the Company‟s Certificates of Long -Term Performance (“CLP”) program. Vested awards are not paid out until the earlier of ten years from the date of grant or retirement or other termination of employment. As of the grant date, the defined present value per CLP was $5.03. The CLP unit value will vary over time based on the performance of the Company. Due to her intention to retire, Ms. Goggins did not receive CLPs in 2011. Mr. Weldon Mr. Caruso Mr. Deyo Ms. McCoy Equity Compensation for Non-Employee Directors Each Non-Employee Director receives non-retainer equity compensation in the first quarter of each year under the LTI Plan in the form of shares of restricted Common Stock having a fair market value of $100,000 on the grant date. Accordingly, each Non-Employee Director was granted 1,650 shares of restricted Common Stock under the LTI Plan on February 15, 2011. The restricted shares will become freely transferable on February 15, 2014. 1,357,855 359,840 359,840 437,375 CLPs CLPs CLPs CLPs
EXHIBIT 12
JOHNSON & JOHNSON AND SUBSIDIARIES STATEMENT OF COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES (1) (Dollars in Millions)
Fiscal Year Ended December 28, 2008
January 2, 2011
January 3, 2010
December 30, 2007
December 31, 2006
Determination of Earnings: Earnings Before Provision for Taxes on Income Fixed Charges, less Capitalized Interest Total Earnings as Defined Fixed Charges: Estimated Interest Portion of Rent Expense Interest Expense before Capitalization of Interest Total Fixed Charges Ratio of Earnings to Fixed Charges
$
16,947 555
$
15,755 558
$
16,929 538
$
13,283 397
$
14,587 158
$
17,502
$
16,313
$
17,467
$
13,680
$
14,745
100 528 $ 628 27.87 $
107 552 659 24.75 $
103 583 686 25.46 $
101 426 527 25.96 $
95 181 276 53.42
(1) The ratio of earnings to fixed charges is computed by dividing the sum of earnings before provision for taxes on income
and fixed charges by fixed charges. Fixed charges represent interest expense (before interest is capitalized), amortization of debt discount and an appropriate interest factor on operating leases.
Table of Contents MANAGEMENT’S DISCUSSION AND ANALYSIS Organization and Business Segments Results of Operations Analysis of Sales by Business Segments Analysis of Consolidated Earnings Before Provision for Taxes on Income Liquidity and Capital Resources Other Information Cautionary Factors That May Affect Future Results AUDITED CONSOLIDATED FINANCIAL STATEMENTS Consolidated Balance Sheets Consolidated Statements of Earnings Consolidated Statements of Equity Consolidated Statements of Cash Flows Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm Management‟s Report on Internal Control Over Financial Reporting SUPPORTING SCHEDULES Summary of Operations and Statistical Data 2000 — 2010 Shareholder Return Performance Graphs
30 30 31 33 36 37 40
41 42 43 44 45 72 73
74 75
JOHNSON & JOHNSON 2010 ANNUAL REPORT
29
Management’s Discussion and Analysis of Results of Operations and Financial Condition Organization and Business Segments Description of the Company and Business Segments Johnson & Johnson and its subsidiaries (the “Company”) have approximately 114,000 employees worldwide engaged in the research and development, manufacture and sale of a broad range of products in the health care field. The Company conducts business in virtually all countries of the world with the primary focus on products related to human health and well-being. The Company is organized into three business segments: Consumer, Pharmaceutical and Medical Devices and Diagnostics. The Consumer segment includes a broad range of products used in the baby care, skin care, oral care, wound care and women‟s healt h care fields, as well as nutritional and over-the-counter pharmaceutical products and wellness and prevention platforms. These products are marketed to the general public and sold both to retail outlets and distributors throughout the world. The Pharmaceutical segment includes products in the following areas: anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management and virology. These products are distributed directly to retailers, wholesalers and health care professionals for prescription use. The Medical Devices and Diagnostics segment includes a broad range of products distributed to wholesalers, hospitals and retailers used principally in the professional fields by physicians, nurses, therapists, hospitals, diagnostic laboratories and clinics. These products include Biosense Webster‟s electrophysiology products; Cordis‟ circulatory disease management products; DePuy‟s orthopaedic joint reconstruction, spinal care, neurological and sports medicine products; Ethicon‟s surgica l care, aesthetics and women‟s health products; Ethicon Endo -Surgery‟s minimally invasive surgical products and advanced sterilization products; LifeScan‟s blood glucose monitoring and insulin delivery products; Ortho -Clinical Diagnostics‟ professional diagnostic products and Vistakon‟s disposable contact lenses. The Company‟s structure is based upon the principle of decentralized management. The Executive Committee of Johnson & Johnson is the principal management group responsible for the operations and allocation of the resources of the Company. This Committee oversees and coordinates the activities of the Consumer, Pharmaceutical and Medical Devices and Diagnostics business segments. In all of its product lines, the Company competes with companies both local and global, located throughout the world. Competition exists in all product lines without regard to the number and size of the competing companies involved. Competition in research, involving the development and the improvement of new and existing products and processes, is particularly significant. The development of new and innovative products is important to the Company‟s success in all areas of its business. This also includes protecting the Company‟s portfolio of intellectual property. The competitive environment requires substantial investments in continuing research and in maintaining sales forces. In addition, the development and maintenance of customer demand for the Company‟s consumer products involves significant expenditures for advertising and promotion. Management’s Objectives The Company manages within a strategic framework aimed at achieving sustainable growth. To accomplish this, the Company‟s management operates the business consistent with certain strategic principles that have proven successful over time. To this end, the Company participates in growth areas in human health care and is committed to attaining leadership positions in these growth areas through the development of high quality, innovative products and services. New products introduced within the past five years accounted for approximately 25% of 2010 sales. In 2010, $6.8 billion, or 11.1% of sales, was invested in research and development. This investment reflects management‟s commitment to the importance of ongoing development of new and differentiated products and services to sustain long-term growth. With more than 250 operating companies located in 60 countries, the Company views its principle of decentralized management as an asset and fundamental to the success of a broadly based business. It also fosters an entrepreneurial spirit, combining the extensive resources of a large organization with the ability to anticipate and react quickly to local market changes and challenges. The Company is committed to developing global business leaders who can drive growth objectives. Businesses are managed for the long-term in order to sustain leadership positions and achieve growth that provides an enduring source of value to our shareholders. Our Credo unifies the management team and the Company‟s dedicated employees in achieving these objectives, and provides a common set of values that serve as a constant reminder of the Company‟s responsibilities to its customers, employees, communi ties and shareholders. The Company believes that these basic principles, along with its overall mission of improving the quality of life for people everywhere, will enable Johnson & Johnson to continue to be among the leaders in the health care industry. Results of Operations
Analysis of Consolidated Sales In 2010, worldwide sales decreased 0.5% to $61.6 billion, compared to a decrease of 2.9% in 2009 and an increase of 4.3% in 2008. These sales changes consisted of the following:
Sales (decrease)/increase Due to: 2010 2009 2008
Volume Price Currency Total
) (0.5 % (0.8 ) 0.8 ) (0.5 %
(0.2 ) (0.1 ) (2.6 ) (2.9 )
1.1 0.8 2.4 4.3
Sales by U.S. companies were $29.5 billion in 2010, $30.9 billion in 2009 and $32.3 billion in 2008. This represents a decrease of 4.7% in 2010, a decrease of 4.4% in 2009 and a decrease of 0.4% in 2008. Sales by international companies were $32.1 billion in 2010, $31.0 billion in 2009 and $31.4 billion in 2008. This represents an increase of 3.6% in 2010, a decrease of 1.4% in 2009 and an increase of 9.7% in 2008, respectively.
30
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The five-year compound annual growth rates for worldwide, U.S. and international sales were 4.0%, 0.7% and 7.7%, respectively. The ten-year compound annual growth rates for worldwide, U.S. and international sales were 7.8%, 5.5% and 10.5%, respectively.
Sales in Europe experienced a decline of 2.7% including operational growth of 0.5% and a negative impact from currency of 3.2%. Sales in the Western Hemisphere (excluding the U.S.) achieved growth of 7.6% including an operational decline of 0.5% and an increase of 8.1% related to the positive impact of currency. Sales in the Asia-Pacific, Africa region achieved growth of 11.7%, including operational growth of 5.5% and an increase of 6.2% related to the positive impact of currency. In 2010, 2009 and 2008, the Company did not have a customer that represented 10% or more of total consolidated revenues. 2009 results benefited from the inclusion of a 53rd week. (See Note 1 to the Consolidated Financial Statements for Annual Closing Date details). The Company estimated that the fiscal year 2009 growth rate was enhanced by approximately 0.5% due to the 53rd week. U.S. Health Care Reform The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 were signed into law during March 2010. The newly enacted health care reform legislation included an increase in the minimum Medicaid rebate rate from 15.1% to 23.1% and also extended the rebate to drugs provided through Medicaid managed care organizations. The 2010 impact was an increase in sales rebates reducing sales revenue by approximately $400 million. The 2011 full year impact to sales of the legislation is estimated to be $400 — $500 million. Beginning in 2011, companies that sell branded prescription drugs to specified U.S. Government programs will pay an annual nontax deductible fee based on an allocation of the company‟s market share of total branded prescription drug sales from the pri or year. The estimate of the impact on the Company in 2011 is $150 — $200 million. Beginning in 2013, the Company will be required to pay a tax deductible 2.3% excise tax imposed on the sale of certain medical devices.
Analysis of Sales by Business Segments Consumer Segment Consumer segment sales in 2010 were $14.6 billion, a decrease of 7.7% from 2009, with 8.9% of this change due to an operational decline partially offset by positive currency impact of 1.2%. U.S. Consumer segment sales were $5.5 billion, a decrease of 19.3%. International sales were $9.1 billion, an increase of 1.2%, with an operational decline of 1.0% offset by positive currency impact of 2.2%. The Over-the-Counter (OTC) Pharmaceuticals and Nutritionals franchise sales were $4.5 billion, a decrease of 19.2% from 2009. Sales were negatively impacted by the voluntary recalls of certain OTC products announced earlier in the year and suspension of production at McNeil Consumer Healthcare‟s Fort Washington, Pennsylvania facility. McNeil‟s recalls of products manufactured at both Las Piedras and Fort Washington facilities impacted the total year sales by approximately $900 million. Alternate supplies of products are planned to be available in the latter half of 2011. McNeil Consumer Healthcare submitted its Comprehensive Action Plan (CAP) to the U.S. Food and Drug Administration (FDA) on July 15, 2010, which encompasses, among other items, training, resources and capital investments in quality and manufacturing systems across the McNeil organization. The Major Consumer Franchise Sales:
% Change (Dollars in Millions) 2010 2009 2008 ’10 vs. ’09 ’09 vs. ’08
OTC Pharmaceuticals & Nutritionals Skin Care Baby Care Women‟s Health Oral Care Wound Care/Other Total
$
4,549 3,452 2,209 1,844 1,526 1,010
5,630 3,467 2,115 1,895 1,569 1,127 15,803
5,894 3,381 2,214 1,911 1,624 1,030 16,054
) (19.2 % (0.4 ) 4.4 (2.7 ) (2.7 ) (10.4 ) ) (7.7 %
(4.5 ) 2.5 (4.5 ) (0.8 ) (3.4 ) 9.4 (1.6 )
$ 14,590
MANAGEMENT‟S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
31
Company continues to communicate with the FDA on remediation actions and is on schedule with the commitments made in the CAP. The Skin Care franchise sales were $3.5 billion, a decline of 0.4% compared to the prior year due in part to a temporary reduction in shipments of Neutrogena products due to product supply constraints partially offset by growth in the AVEENO ® , JOHNSON‟s ® Adult, LE PETIT MARSEILLAIS ® and DABAO ® skin care lines. The Baby Care franchise sales grew by 4.4% to $2.2 billion in 2010, primarily due to growth in the Asia Pacific region partially offset by the impact of the economic situation in Venezuela. The Women‟s Health franchise sales were $1.8 billion, a decrease of 2.7% primarily due to increased competitive pressures and the impact of the economic situation in Venezuela. The Oral Care franchise sales were $1.5 billion, a decrease of 2.7% primarily due to the divestiture of the EFFERDENT ® /Effergrip ® brands in the fiscal fourth quarter of 2009 and lower sales of mouth rinses and toothbrushes in the United States. The Wound Care/Other franchise sales were $1.0 billion, a decrease of 10.4% primarily due to private label competition and slower category growth. Consumer segment sales in 2009 were $15.8 billion, a decrease of 1.6% from 2008, with 2.0% of this change due to operational growth and negative currency impact of 3.6%. U.S. Consumer segment sales were $6.8 billion, a decrease of 1.4%. International sales were $9.0 billion, a decrease of 1.7%, with growth of 4.7% achieved by operations and a decrease of 6.4% resulting from the negative impact of currency fluctuations. Pharmaceutical Segment Pharmaceutical segment sales in 2010 were $22.4 billion, a decrease of 0.6% from 2009, with an operational decline of 1.0% and a positive currency impact of 0.4%. U.S. sales were $12.5 billion, a decrease of 4.0%. International sales were $9.9 billion, an increase of 4.2%, which included 3.4% operational growth and a positive currency impact of 0.8%. Pharmaceutical segment sales in 2010 were reduced by approximately $400 million as a result of U.S. health care reform legislation. REMICADE ® (infliximab), a biologic approved for the treatment of a number of immune mediated inflammatory diseases, achieved sales of $4.6 billion in 2010, with growth of 7.1% over the prior year. U.S. export sales grew 24.3% versus the prior year primarily driven by market growth. REMICADE ® is competing in a market that is experiencing increased competition due to new entrants, including the successful launches of STELARA ® (ustekinumab) and SIMPONI ® (golimumab) and the expansion of indications for existing competitors. PROCRIT ® (Epoetin alfa) and EPREX ® (Epoetin alfa) had combined sales of $1.9 billion in 2010, a decline of 13.9% compared to the prior year. Lower sales of PROCRIT ® and EPREX ® were primarily due to the declining markets for Erythropoiesis Stimulating Agents (ESAs). EPREX ® also experienced increased competition. RISPERDAL ® CONSTA ® (risperidone), a long-acting injectable antipsychotic, achieved sales of $1.5 billion in 2010, representing an increase of 5.3% as compared to the prior year. Solid growth of 16.4% was achieved outside the U.S., with very strong growth in Japan. In the U.S. the successful launch of INVEGA ® SUSTENNA TM (paliperidone palmitate) also increased the growth of the longacting injectable antipsychotic market. LEVAQUIN ® (levofloxacin)/FLOXIN ® (ofloxacin) sales were $1.4 billion, a decline of 12.5% versus the prior year primarily due to the decline in the market and increased penetration of generics. Market exclusivity in the U.S. expires in June 2011. The expiration of a product‟s market exclusivity is likely to result in a significant reduction in sales. CONCERTA ® (methylphenidate HCl), a product for the treatment of attention deficit hyperactivity disorder (ADHD), achieved sales of $1.3 billion in 2010, a decrease of 0.5% compared to the prior year. Sales growth in the U.S. was impacted by lower market share and the health care reform legislation enacted in March 2010 resulting from changes to rebates to Medicaid managed care organizations. On November 1, 2010, the Company entered into a U.S. supply and distribution agreement with Watson Laboratories, Inc. to distribute an authorized generic version of CONCERTA ® beginning May 1, 2011. This authorized generic launch is likely to result in a significant reduction in CONCERTA ® sales. VELCADE ® (bortezomib), a product for the treatment for multiple myeloma, for which the Company has commercial rights in Europe and the rest of the world outside the U.S., achieved sales of $1.1 billion in 2010, representing an increase of 15.8% as compared to the prior year. ACIPHEX ® /PARIET ® (rabeprazole sodium) sales were $1.0 billion, a decline of 8.2% versus the prior year due to increased competition from generics in the category. TOPAMAX ® (topiramate), experienced a sales decline of 53.3% compared to the prior year. Market exclusivity for TOPAMAX ® expired in March 2009 in the U.S. and in September 2009 in most European countries. Multiple generics have entered the market. Loss of market exclusivity for the TOPAMAX ® patent has resulted in the significant reduction of sales in the U.S. and Europe.
In 2010, Other Pharmaceutical sales were $9.1 billion, representing a growth of 6.6% over the prior year. Contributors to the increase were sales of STELARA ® (ustekinumab), SIMPONI ® (golimumab), Major Pharmaceutical Product Revenues*:
% Change ’10 vs. ’09 vs. ’09 ’08
(Dollars in Millions)
2010
2009
2008
REMICADE ® (infliximab) PROCRIT ® /EPREX ® (Epoetin alfa) RISPERDAL ® CONSTA ® (risperidone) LEVAQUIN ® /FLOXIN ® (levofloxacin/ofloxacin) CONCERTA ® (methylphenidate HCl) VELCADE ® (bortezomib) ACIPHEX ® /PARIET ® (rabeprazole sodium) TOPAMAX ® (topiramate) Other Pharmaceuticals Total
$
4,610 1,934 1,500 1,357 1,319 1,080 1,006 538 9,052
4,304 2,245 1,425 1,550 1,326 933 1,096 1,151 8,490 22,520
3,748 2,460 1,309 1,591 1,247 787 1,158 2,731 9,536 24,567
7.1 % (13.9 ) 5.3 (12.5 ) (0.5 ) 15.8 (8.2 ) (53.3 ) 6.6 ) (0.6 %
14.8 (8.7 ) 8.9 (2.6 ) 6.3 18.6 (5.4 ) (57.9 ) (11.0 ) (8.3 )
$ 22,396
* Prior year amounts have been reclassified to conform to current presentation.
32
JOHNSON & JOHNSON 2010 ANNUAL REPORT
PREZISTA ® (darunavir), INTELENCE ® (etravirine), NUCYNTA ® (tapentadol) and INVEGA SUSTENNA ® (paliperidone palmitate). This growth was partially offset by lower sales of DURAGESIC ® /Fentanyl Transdermal (fentanyl transdermal system) and RISPERDAL ® /risperidone oral due to continued generic competition. During 2010, several new compounds were filed for regulatory approval. These included abiraterone acetate, an investigational agent for the treatment of metastatic, advanced prostate cancer which was granted priority review in the U.S. and accepted for accelerated assessment in Europe, and telaprevir, developed in collaboration with Vertex Pharmaceuticals Incorporated, for hepatitis C which was filed and accepted for accelerated assessment in Europe. TMC 278 (rilpivirine) for HIV in treatment-naïve patients was filed in both the U.S. and Europe. Rivaroxaban, an anti-coagulant co-developed with Bayer HealthCare, has been filed in the U.S. for the prevention of stroke in patients with atrial fibrulation. The Company also responded to the FDA complete response letter for its review of the rivaroxaban filing for preventing deep vein thrombosis and pulmonary embolism following total knee and hip replacement surgery. Pharmaceutical segment sales in 2009 were $22.5 billion, a decrease of 8.3% from 2008, with an operational decline of 6.1% and the remaining 2.2% due to the negative impact of currency fluctuations. U.S. sales were $13.0 billion, a decrease of 12.1%. International sales were $9.5 billion, a decrease of 2.6%, which included 3.0% operational growth and a decrease of 5.6% resulting from the negative impact of currency fluctuations. Medical Devices and Diagnostics Segment The Medical Devices and Diagnostics segment achieved sales of $24.6 billion in 2010, representing an increase of 4.4% over the prior year, with operational growth of 3.4% and a positive currency impact of 1.0%. U.S. sales were $11.4 billion, an increase of 3.6% over the prior year. International sales were $13.2 billion, an increase of 5.0% over the prior year, with growth of 3.0% from operations and a positive currency impact of 2.0%. The DePuy franchise achieved sales of $5.6 billion in 2010, a 4.0% increase over the prior year. This growth was primarily due to an increase in the knee and Mitek sports medicine product lines, and outside the U.S., growth of the hip product line. Pressure on pricing continued as a result of economic trends, however new product launches and incremental sales of newly acquired products from Micrus Endovascular Corporation have mitigated some of the impact. In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR TM XL Acetabular System and DePuy ASR TM Hip Resurfacing System used in hip replacement surgery, principally sold between 2003 and 2009. The Ethicon Endo-Surgery franchise achieved sales of $4.8 billion in 2010, a 5.9% increase over the prior year. This was attributable to growth in the endoscopy, Advanced Sterilization, HARMONIC ® , SurgRx and ENSEAL ® product lines. The growth was partially offset by the divestiture of the Breast Care business in the third quarter of 2010. The Ethicon franchise achieved sales of $4.5 billion in 2010, a 9.2% increase over the prior year. The growth was attributable to sales of newly acquired products from Acclarent, Inc. in addition to growth in the sutures, Mentor, biosurgical, Women‟s Health and Urology, and mesh product lines. The Vision Care franchise achieved sales of $2.7 billion in 2010, a 6.9% increase over prior year primarily driven by 1-DAY ACUVUE ® TruEye TM , ACUVUE ® OASYS TM for Astigmatism, and 1-DAY ACUVUE ® MOIST ® , partially offset by lower sales of reusable lenses. During 2010, the Company and Novartis AG, CIBAVISION Corporation and CIBA VISION AG agreed to resolve all pending patent litigation on a worldwide basis enabling the Company to reenter the markets in France and the Netherlands. Sales in the Cordis franchise were $2.6 billion, a decline of 4.7% versus the prior year. The decline reflects lower sales of the CYPHER ® Sirolimus-eluting Coronary Stent due to increased global competition. The decline was partially offset by strong growth of the Biosense Webster business. Sales in the Diabetes Care franchise were $2.5 billion in 2010, a 1.2% increase over the prior year. This was primarily attributable to growth in the U.S. and Asia Pacific region partially offset by a sales decline in Europe. The Ortho-Clinical Diagnostics franchise achieved sales of $2.1 billion in 2010, a 4.6% increase over the prior year. Growth was primarily attributable to sales of the VITROS ® 5600 and 3600 analyzers partially offset by lower sales in donor screening primarily due to more selective screening for Chagas testing in the U.S. The Medical Devices and Diagnostics segment achieved sales of $23.6 billion in 2009, representing an increase of 1.9% over the prior year, with operational growth of 4.2% and a negative currency impact of 2.3%. U.S. sales were $11.0 billion, an increase of 4.5% over the prior year. International sales were $12.6 billion, a decrease of 0.2%, with growth of 4.0% from operations and a decrease of 4.2% resulting from the negative impact of currency fluctuations. Major Medical Devices and Diagnostics Franchise Sales:
(Dollars in Millions)
2010
2009
2008
% Change ’10 vs. ’09 vs. ’09 ’08
DEPUY ® ETHICON ENDO-SURGERY ® ETHICON ® Vision Care CORDIS ® Diabetes Care ORTHO-CLINICAL DIAGNOSTICS ® Total
$
5,585 4,758 4,503 2,680 2,552 2,470 2,053
5,372 4,492 4,122 2,506 2,679 2,440 1,963 23,574
5,136 4,286 3,840 2,500 2,988 2,535 1,841 23,126
4.0 % 5.9 9.2 6.9 (4.7 ) 1.2 4.6 4.4 %
4.6 4.8 7.3 0.2 (10.3 ) (3.7 ) 6.6 1.9
$ 24,601
Analysis of Consolidated Earnings Before Provision for Taxes on Income Consolidated earnings before provision for taxes on income increased by $1.1 billion to $16.9 billion in 2010 as compared to the $15.8 billion earned in 2009, an increase of 7.6%. The increase was primarily related to lower selling, marketing and administrative expenses due to cost containment actions resulting from the restructuring plan initiated and implemented in 2009, income from litigation settlements and the gain on the divestiture of the Breast Care business of Ethicon Endo-Surgery, Inc. This was partially offset by costs associated with product liability expense and the impact of the OTC and DePuy ASR TM Hip recalls. Additional offsets were lower
MANAGEMENT‟S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
33
net selling prices in the Pharmaceutical business due to U.S. health care reform and price reductions in certain Medical Devices and Diagnostics businesses. The 2009 decrease of 6.9% as compared to $16.9 billion in 2008 was primarily related to lower sales, the negative impact of product mix, lower interest income due to lower rates of interest earned and restructuring charges of $1.2 billion. This was partially offset by lower selling, marketing and administrative expenses due to cost containment efforts across all the businesses. The 2008 earnings included purchased in-process research and development (IPR&D) charges of $0.2 billion and increased investment spending in selling, marketing and administrative expenses utilized from the proceeds associated with the divestiture of the Professional Wound Care business of Ethicon, Inc. As a percent to sales, consolidated earnings before provision for taxes on income in 2010 was 27.5% versus 25.4% in 2009. The sections that follow highlight the significant components of the changes in consolidated earnings before provision for taxes on income. Cost of Products Sold and Selling, Marketing and Administrative Expenses: Cost of products sold and selling, marketing and administrative expenses as a percent to sales were as follows:
% of Sales 2010 2009 2008
Cost of products sold Percent point increase over the prior year Selling, marketing and administrative expenses Percent point (decrease)/increase over the prior year
30.5 % 0.7 31.5 (0.5 )
29.8 0.7 32.0 (1.7 )
29.1 — 33.7 0.2
In 2010, cost of products sold as a percent to sales increased compared to the prior year primarily due to costs associated with the impact of the OTC recall and remediation efforts in the Consumer business, lower net selling prices in the Pharmaceutical business due to U.S. health care reform and price reductions in certain Medical Devices and Diagnostics businesses. Additionally, unfavorable product mix attributable to the loss of market exclusivity for TOPAMAX ® contributed to the increase. There was a decrease in the percent to sales of selling, marketing and administrative expenses in 2010 compared to the prior year primarily due to cost containment initiatives principally resulting from the restructuring plan implemented in 2009. The decrease was partially offset by lower net selling prices in the Pharmaceutical business due to U.S. health care reform and price reductions in certain Medical Devices and Diagnostics businesses. In 2009, cost of products sold as a percent to sales increased compared to the prior year primarily due to the continued negative impact of product mix and inventory write-offs associated with the restructuring activity. Additionally, 2008 included some non-recurring positive items. There was a decrease in the percent to sales of selling, marketing and administrative expenses in 2009 compared to the prior year primarily due to cost containment efforts across all the businesses and the annualized savings recognized from the 2007 restructuring program. In addition, in 2008 the Company utilized the proceeds associated with the divestiture of the Professional Wound Care business of Ethicon, Inc. to fund increased investment spending. In 2008, cost of products sold as a percent to sales remained flat to the prior year. The change in the mix of businesses, with higher sales growth in the Consumer business and a slight sales decline in the Pharmaceutical business, had a negative impact on the cost of products sold as a percent to sales. In 2008, this was offset by manufacturing efficiencies and non-recurring positive items in 2008 and negative items in 2007. There was an increase in the percent to sales of selling, marketing and administrative expenses in 2008 primarily due to the change in the mix of businesses, whereby a greater proportion of sales were attributable to the Consumer segment, which has higher selling, marketing and administrative spending. Additionally, in 2008 the Company utilized the gain associated with the divestiture of the Professional Wound Care business of Ethicon, Inc. to fund increased investment spending. This was partially offset by ongoing cost containment efforts. Research and Development expense (excluding purchased in-process research and development charges) by segment of business was as follows:
2010 (Dollars in Millions) Amount % of Sales* Amount 2009 % of Sales* Amount 2008 % of Sales*
Consumer Pharmaceutical Medical Devices and Diagnostics Total research and development expense Percent (decrease)/increase over the prior year
$
609 4,432 1,803 ) (2.0 %
4.2 % 19.8 7.3 11.1 %
632 4,591 1,763 6,986 (7.8 )
4.0 20.4 7.5 11.3
624 5,095 1,858 7,577 (1.3 )
3.9 20.7 8.0 11.9
$ 6,844
* As a percent to segment sales Research and Development Expense: Research and development activities represent a significant part of the Company‟s business. These expenditures relate to the development of new products, improvement of existing products, technical support of products and compliance with governmental regulations for the protection of consumers and patients. The Company remains committed to investing in research and development with the aim of delivering high quality and innovative products. Restructuring: In 2009, the Company announced global restructuring initiatives that are expected to generate pre-tax, annual cost savings of approximately $1.5 billion when fully implemented in 2011. The associated savings has provided additional resources to invest in new growth platforms; ensure the successful launch of the Comp any‟s many new products and continued growth of the core businesses; and provide flexibility to adjust to the changed and evolving global environment. In the fiscal fourth quarter of 2009, the Company recorded a pre-tax charge of $1.2 billion, of which $113 million was included in cost of products sold. See Note 22 to the Consolidated Financial Statements for additional details related to the restructuring. Purchased In-Process Research and Development: Beginning in 2009, in accordance with U.S. GAAP for business combinations, purchased in-process research and development (IPR&D) is no longer expensed but capitalized and tested for impairment. The Company capitalized approximately $0.2 billion of IPR&D in 2010, primarily associated with the acquisitions of Acclarent, Inc., RespiVert Ltd. and Micrus Endovascular Corporation. The Company capitalized $1.7 billion of IPR&D in 2009, primarily associated with the acquisitions of Cougar Biotechnology, Inc. and substantially all of the assets and rights of Elan related to its Alzheimer‟s Immunotherapy Program.
34
JOHNSON & JOHNSON 2010 ANNUAL REPORT
In 2008, the Company recorded a charge for IPR&D of $181 million before and after tax related to the acquisitions of Amic AB, SurgRx, Inc., HealthMedia, Inc. and Omrix Biopharmaceuticals, Inc. HealthMedia, Inc., a privately held company that creates web-based behavior change interventions, accounted for $7 million before tax of the IPR&D charges and was included in the operating profit of the Consumer segment. The IPR&D charges for all of the following acquisitions were included in the operating profit of the Medical Devices and Diagnostics segment. Amic AB, a Swedish developer of in vitro diagnostic technologies for use in point-of-care and near-patient settings (outside the physical facilities of the clinical laboratory), accounted for $40 million before tax of the IPR&D charges. SurgRx, Inc., a privately held developer of the advanced bipolar tissue sealing system used in the ENSEAL ® family of devices, accounted for $7 million before tax of the IPR&D charges. Omrix Biopharmaceuticals, Inc., a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, accounted for $127 million before tax of the IPR&D charges. Other (Income) Expense, Net: Other (income) expense, net includes royalty income; gains and losses related to the sale and writedown of certain investments in equity securities held by Johnson & Johnson Development Corporation; gains and losses on the disposal of property, plant and equipment; currency gains and losses; non-controlling interests; and litigation settlements. The favorable change of $0.2 billion in other (income) expense, net, in 2010 as compared to 2009, was primarily due to a net gain from litigation settlements and the gain on the divestiture of businesses partially offset by product liability expense. In 2009, other (income) expense, net included net litigation settlements of $0.4 billion. In 2008, other (income) expense, net included income from net litigation settlements and awards of $0.5 billion and a gain of $0.5 billion from the divestiture of the Professional Wound Care business of Ethicon, Inc. Operating Profit by Segment Operating profits by segment of business were as follows:
Percent of Segment Sales 2010 2009
(Dollars in Millions)
2010
2009
Consumer Pharmaceutical Medical Devices and Diagnostics Total (1) Less: Expenses not allocated to segments (2) Earnings before provision for taxes on income
(1) See Note 18 to the Consolidated Financial Statements for more details.
$
2,342 7,086 8,272 17,700 753
2,475 6,413 7,694 16,582 827 15,755
16.1 % 31.6 33.6 28.7 27.5 %
15.7 28.5 32.6 26.8 25.4
$ 16,947
(2) Amounts not allocated to segments include interest (income) expense, non-controlling interests, and general corporate (income)
expense.
Consumer Segment: In 2010, Consumer segment operating profit decreased 5.4% from 2009. The primary reasons for the decrease in the operating profit were lower sales and higher costs associated with the recall of certain OTC products and the suspension of production at McNeil Consumer Healthcare‟s Fort Washington, Pennsylvania facility. In 2009, Consumer segment operating profit decreased 7.4% from 2008. The primary reasons for the decrease in operating profit were $369 million of restructuring charges, partially offset by cost containment initiatives in 2009. Pharmaceutical Segment: In 2010, Pharmaceutical segment operating profit increased 10.5% from 2009. The primary reasons for the increase in operating profit were lower manufacturing costs, the gain on a divestiture, and benefits from cost improvement initiatives related to the restructuring plan implemented in 2009, partially offset by $333 million of expense related to litigation matters, increased product liability expense and the impact of the newly enacted U.S. health care reform legislation. In 2009, Pharmaceutical segment operating profit decreased 15.7% from 2008. The primary reasons for the decrease in operating profit were $496 million of restructuring charges, $92 million of litigation expense and negative product mix due to the loss of market exclusivity for TOPAMAX ® and RISPERDAL ® oral. Medical Devices and Diagnostics Segment: In 2010, Medical Devices and Diagnostics segment operating profit increased 7.5% from 2009. The improved operating profit was due to a gain of $1.3 billion from net litigation matters and the gain on the divestiture of the Breast Care business recorded in 2010. This was partially offset by increased product liability expense, $280 million of costs associated with the DePuy ASR TM Hip recall program and price reductions in certain Medical Devices and Diagnostics businesses. In 2009, the operating profit in the Medical Devices and Diagnostics segment increased 6.5% from 2008. The improved operating profit was due to a $478 million gain from net litigation settlements, favorable product mix, manufacturing efficiencies and cost containment initiatives related to selling, marketing and administrative expenses. This was partially offset by $321 million in restructuring charges. Interest (Income) Expense: Interest income in 2010 increased by $17 million over the prior year due to higher average cash balances. Cash, cash equivalents and marketable securities totaled $27.7 billion at the end of 2010, and averaged $23.6 billion as compared to the $15.6 billion average cash balance in 2009. The increase in the average cash balance was primarily due to cash generated from operating activities and net cash proceeds from litigation matters and divestitures. Interest expense in 2010 was relatively flat as compared to 2009 due to a lower average rate despite a higher debt balance. The total debt balance at the end of 2010 was $16.8 billion as compared to $14.5 billion at the end of 2009. The higher average debt balance of $15.7 billion in 2010 versus $13.5 billion in 2009 was due to increased borrowings. The Company increased borrowings, capitalizing on favorable terms in the capital markets. The proceeds of the notes were used for general corporate purposes. Interest income in 2009 decreased by $271 million as compared to 2008 due to lower rates of interest earned despite higher average cash balances. The cash balance, including marketable securities, was $19.4 billion at the end of 2009, and averaged $15.6 billion as compared to the $12.2 billion average cash balance in 2008. The increase in the average cash balance was primarily due to cash generated from operating activities. Interest expense in 2009 increased by $16 million as compared to 2008 due to a higher debt balance. The net debt balance at the end of 2009 was $14.5 billion as compared to $11.9 billion at the end of 2008. The higher average debt balance of $13.5 billion in 2009
MANAGEMENT‟S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
35
versus $12.9 billion in 2008 was primarily related to funding acquisitions and investments and the purchase of the Company‟s Common Stock under the ongoing Common Stock repurchase program announced on July 9, 2007. Interest income in 2008 decreased by $91 million as compared to 2007 due to lower rates of interest earned despite higher average cash balances. The cash balance, including marketable securities, was $12.8 billion at the end of 2008, and averaged $12.2 billion as compared to the $6.6 billion average cash balance in 2007. The increase in the average cash balance was primarily due to cash generated from operating activities. Interest expense in 2008 increased by $139 million as compared to 2007 due to a higher debt balance. In the second half of 2007, the Company converted some of its short-term debt to fixed long-term debt at higher interest rates. The net debt balance at the end of 2008 was $11.9 billion as compared to $9.5 billion at the end of 2007. The higher debt balance in 2008 was primarily due to the purchase of the Company‟s Common Stock under the ongoing Common Stock repurchase program announced on July 9, 2007 and to fund acquisitions. Provision for Taxes on Income: The worldwide effective income tax rate was 21.3% in 2010, 22.1% in 2009 and 23.5% in 2008. The 2010 tax rate decreased as compared to 2009 due to decreases in taxable income in higher tax jurisdictions relative to taxable income in lower tax jurisdictions and certain U.S. tax adjustments. The 2009 tax rate decreased as compared to 2008 due to increases in taxable income in lower tax jurisdictions relative to taxable income in higher tax jurisdictions. Liquidity and Capital Resources Liquidity & Cash Flows Cash and cash equivalents were $19.4 billion at the end of 2010 as compared with $15.8 billion at the end of 2009. The primary sources of cash that contributed to the $3.6 billion increase versus the prior year were $16.4 billion of cash generated from operating activities, $2.4 billion net proceeds from long and short-term debt and $0.5 billion proceeds from the disposal of assets. The major uses of cash were capital spending of $2.4 billion, acquisitions of $1.3 billion, net investment purchases of $4.7 billion, dividends to shareholders of $5.8 billion, and the repurchase of Common Stock, net of proceeds from the exercise of options, of $1.6 billion. Cash flows from operations were $16.4 billion in 2010. The major sources of cash flow were net income of $13.3 billion, adjusted for non-cash charges for depreciation, amortization, stock based compensation and deferred tax provision of $3.9 billion. The remaining changes to operating cash flow were increases in accounts receivable, inventories and other assets. In 2010, the Company continued to have access to liquidity through the commercial paper market. For additional details on borrowings, see Note 7 to the Consolidated Financial Statements. The Company anticipates that operating cash flows, existing credit facilities and access to the commercial paper markets will provide sufficient resources to fund operating needs in 2011.
Financing and Market Risk
The Company uses financial instruments to manage the impact of foreign exchange rate changes on cash flows. Accordingly, the Company enters into forward foreign exchange contracts to protect the value of certain foreign currency assets and liabilities and to hedge future foreign currency transactions primarily related to product costs. Gains or losses on these contracts are offset by the gains or losses on the underlying transactions. A 10% appreciation of the U.S. Dollar from the January 2, 2011 market rates would increase the unrealized value of the Company‟s forward contracts by $239 million. Conversely, a 10% depreciation of the U.S. Dollar from the January 2, 2011 market rates would decrease the unrealized value of the Company‟s forward contracts by $29 2 million. In either scenario, the gain or loss on the forward contract would be offset by the gain or loss on the underlying transaction, and therefore, would have no impact on future anticipated earnings and cash flows. The Company hedges the exposure to fluctuations in currency exchange rates, and the effect on certain assets and liabilities in foreign currency, by entering into currency swap contracts. A 1% change in the spread between U.S. and foreign interest rates on the Company‟s interest rate sensitive financial instruments would either increase or decrease the unrealized value of the Company‟s swap contracts by approximately $212 million. In either scenario, at maturity, the gain or loss on the swap contract would be offset by the gain or loss on the underlying transaction, and therefore, would have no impact on future anticipated cash flows. The Company does not enter into financial instruments for trading or speculative purposes. Further, the Company has a policy of only entering into contracts with parties that have at least an “A” (or equivalent) credit rating. The counterparties to these contracts are major financial institutions and there is no significant concentration of exposure with any one counterparty. Management believes the risk of loss is remote. The Company has access to substantial sources of funds at numerous banks worldwide. In September 2010, the Company secured a new 364-day Credit Facility. Total credit available to the Company approximates $10 billion, which expires September 22, 2011. Interest charged on borrowings under the credit line agreement is based on either bids provided by banks, the prime rate or London Interbank Offered Rates (LIBOR), plus applicable margins. Commitment fees under the agreement are not material. Total borrowings at the end of 2010 and 2009 were $16.8 billion and $14.5 billion, respectively. The increase in borrowings between 2010 and 2009 was a result of financing for general corporate purposes and the continuation of the Company‟s Common Stock repurchase program announced in 2007. In 2010, net cash (cash and current marketable securities, net of debt) was $10.9 billion compared to net cash of $4.9 billion in 2009. Total debt represented 22.9% of total capital (shareholders‟ equity and total deb t) in 2010 and 22.3% of total capital in 2009. Shareholders‟ equity
36
JOHNSON & JOHNSON 2010 ANNUAL REPORT
per share at the end of 2010 was $20.66 compared with $18.37 at year-end 2009, an increase of 12.5%. A summary of borrowings can be found in Note 7 to the Consolidated Financial Statements. Contractual Obligations and Commitments The Company‟s contractual obligations are primarily for leases, debt and unfunded retirement plans, with no other significant obligations. To satisfy these obligations, the Company will use cash from operations. The following table summarizes the Company‟s contractual obligations and their aggregate maturities as of January 2, 2011 (see Notes 7, 10 and 16 to the Consolidated Financial Statements for further details):
Long-Term Debt Obligations Interest on Debt Obligations Unfunded Retirement Plans
(Dollars in Millions)
Operating Leases
Total
2011 2012 2013 2014 2015 After 2015 Total
$
13 644 509 9 — 7,994 9,169
528 507 457 444 444 5,180 7,560
54 55 59 62 69 428 727
182 159 130 106 89 74 740
777 1,365 1,155 621 602 13,676 18,196
$
For tax matters, see Note 8 to the Consolidated Financial Statements. Share Repurchase and Dividends On July 9, 2007, the Company announced that its Board of Directors approved a stock repurchase program authorizing the Company to buy back up to $10.0 billion of the Company‟s Common Stock. As of January 2, 2011, the current stock repurchase program has been completed. The Company repurchased an aggregate of 158.3 million shares of Johnson & Johnson Common Stock at a cost of $10.0 billion. The Company funded the share repurchase program through a combination of available cash and debt. In addition, the Company has an annual program to repurchase shares for use in employee stock and incentive plans. The Company increased its dividend in 2010 for the 48th consecutive year. Cash dividends paid were $2.110 per share in 2010, compared with dividends of $1.930 per share in 2009 and $1.795 per share in 2008. The dividends were distributed as follows:
2010 2009 2008
First quarter Second quarter Third quarter Fourth quarter Total
$ 0.490 0.540 0.540 0.540 $ 2.110
0.460 0.490 0.490 0.490 1.930
0.415 0.460 0.460 0.460 1.795
On January 3, 2011, the Board of Directors declared a regular quarterly cash dividend of $0.540 per share, payable on March 15, 2011, to shareholders of record as of March 1, 2011. The Company expects to continue the practice of paying regular cash dividends. Other Information Critical Accounting Policies and Estimates Management‟s discussion and analysis of results of operations and financial condition are based on the Company‟s consolidated financial statements that have been prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). The preparation of these financial statements requires that management make estimates and assumptions that affect the amounts reported for revenues, expenses, assets, liabilities and other related disclosures. Actual results may or may not differ from these estimates. The Company believes that the understanding of certain key accounting policies and estimates are essential in achieving more insight into the Company‟s operating results and financial condition. These key accounting policies include revenue recognition, income taxes, legal and self-insurance contingencies, valuation of long-lived assets, assumptions used to determine the amounts recorded for pensions and other employee benefit plans and accounting for stock options.
Revenue Recognition: The Company recognizes revenue from product sales when goods are shipped or delivered, and title and risk of loss pass to the customer. Provisions for certain rebates, sales incentives, trade promotions, coupons, product returns and discounts to customers are accounted for as reductions in sales in the same period the related sales are recorded. Product discounts granted are based on the terms of arrangements with direct, indirect and other market participants, as well as market conditions, including prices charged by competitors. Rebates, the largest being the Medicaid rebate provision, are estimated based on contractual terms, historical experience, trend analysis and projected market conditions in the various markets served. The Company evaluates market conditions for products or groups of products primarily through the analysis of wholesaler and other third-party sellthrough and market research data, as well as internally generated information. Sales returns are generally estimated and recorded based on historical sales and returns information. Products that exhibit unusual sales or return patterns due to dating, competition or other marketing matters are specifically investigated and analyzed as part of the accounting for sales return accruals. Sales returns allowances represent a reserve for products that may be returned due to expiration, destruction in the field, or in specific areas, product recall. The returns reserve is based on historical return trends by product and by market as a percent to gross sales. In accordance with the Company‟s accounting policies, the Company generally issues credit to customers for returned goods. The Company‟s sales return reserves are accounted for in accordance with the U.S. GAAP guidance for revenue recognition when right of return exists. Sales return reserves are recorded at full sales value. Sales returns in the Consumer and Pharmaceutical segments are almost exclusively not resalable. Sales returns for certain franchises in the Medical Devices and Diagnostics segment are typically resalable but are not material. The Company rarely exchanges products from inventory for returned products. The sales returns reserve for the total Company has ranged between 1.0% and 1.2% of annual net trade sales during the prior three fiscal reporting years 2008 — 2010. Promotional programs, such as product listing allowances and cooperative advertising arrangements, are recorded in the year incurred. Continuing promotional programs include coupons and volume-based sales incentive programs. The redemption cost of consumer coupons is based on historical redemption experience by product and value. Volume-based incentive programs are based on estimated sales volumes for the incentive period and are recorded as products are sold. The Company also earns service revenue for copromotion of certain products. For all years presented, service revenues were less than 2% of total revenues and are included in sales to customers. These arrangements are evaluated to determine the appropriate amounts to be deferred. In addition, the Company enters into collaboration arrangements, which contain multiple revenue generating activities. The revenue for these arrangements is recognized as each activity is performed or delivered, based on the relative fair value. Upfront fees received as part of these arrangements are deferred and recognized as revenue earned over the obligation period. See Note 1 to
MANAGEMENT‟S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
37
the Consolidated Financial Statements for additional disclosures on collaborations. Reasonably likely changes to assumptions used to calculate the accruals for rebates, returns and promotions are not anticipated to have a material effect on the financial statements. The Company currently discloses the impact of changes to assumptions in the quarterly or annual filing in which there is a material financial statement impact. Below are tables that show the progression of accrued rebates, returns, promotions, reserve for doubtful accounts and reserve for cash discounts by segment of business for the fiscal years ended January 2, 2011 and January 3, 2010. Consumer Segment
Balance at End of Period
(Dollars in Millions)
Balance at Beginning of Period
Accruals
Payments/Other
2010 Accrued rebates (1) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
121 127 272 520 107 21
361 156 2,418 2,935 6 249 3,190
(351 ) (138 ) (2,396 ) (2,885 ) (56 ) (249 ) (3,190 )
131 145 294 570 57 21 648
$
$
648
2009 Accrued rebates (1) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
131 115 202 448 110 22
380 134 1,996 2,510 23 285 2,818
(390 ) (122 ) (1,926 ) (2,438 ) (26 ) (286 ) (2,750 )
121 127 272 520 107 21 648
$
$
580
(1) Includes reserve for customer rebates of $50 million at January 2, 2011 and $46 million at January 3, 2010, recorded as a
contra asset. Pharmaceutical Segment
Balance at End of Period
(Dollars in Millions)
Balance at Beginning of Period
Accruals
Payments/Other
2010 Accrued rebates (1)(2) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
1,064 342 84 1,490 83 48
4,768 27 135 4,930 91 379 5,400
(4,312 ) (75 ) (136 ) (4,523 ) (29 ) (373 ) (4,925 )
1,520 294 83 1,897 145 54 2,096
$
$
1,621
2009 Accrued rebates (1) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
1,261 490 107 1,858 48 23
3,975 147 330 4,452 37 462 4,951
(4,172 ) (295 ) (353 ) (4,820 ) (2 ) (437 ) (5,259 )
1,064 342 84 1,490 83 48 1,621
$
$
1,929
(1) Includes reserve for customer rebates of $320 million at January 2, 2011 and $372 million at January 3, 2010, recorded
as a contra asset.
(2) Includes additional sales rebates to Medicaid managed care organizations as a result of health care reform legislation.
Medical Devices and Diagnostics Segment
Balance at End of Period
(Dollars in Millions)
Balance at Beginning of Period
Accruals
Payments/Other
2010 Accrued rebates (1) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
454 220 73 747 143 32
2,363 334 111 2,808 33 484 3,325
(2,322 ) (353 ) (134 ) (2,809 ) (38 ) (481 ) (3,328 )
495 201 50 746 138 35 919
$
$
922
2009 Accrued rebates (1) Accrued returns Accrued promotions Subtotal Reserve for doubtful accounts Reserve for cash discounts Total
$
416 189 47 652 109 34
2,229 74 120 2,423 50 416 2,889
(2,191 ) (43 ) (94 ) (2,328 ) (16 ) (418 ) (2,762 )
454 220 73 747 143 32 922
$
$
795
(1) Includes reserve for customer rebates of $331 million at January 2, 2011 and $311 million at January 3, 2010, recorded
as a contra asset. Income Taxes: Income taxes are recorded based on amounts refundable or payable for the current year and include the results of any difference between U.S. GAAP accounting and tax reporting, recorded as deferred tax assets or liabilities. The Company estimates deferred tax assets and liabilities based on current tax regulations and rates. Changes in tax laws and rates may affect recorded deferred tax assets and liabilities in the future. Management believes that changes in these estimates would not have a material effect on the Company‟s results of operations, cas h flows or financial position. In 2007, in accordance with U.S. GAAP, the Company adopted the standard related to accounting for uncertainty in income taxes. The Codification prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Codification also provides guidance on derecognition, classification and other matters. See Note 8 to the Consolidated Financial Statements for further information regarding income taxes.
At January 2, 2011 and January 3, 2010, the cumulative amounts of undistributed international earnings were approximately $37.0 billion and $32.2 billion, respectively. The Company intends to continue to reinvest its undistributed international earnings to expand its international operations; therefore, no U.S. tax expense has been recorded with respect to the undistributed portion not intended for repatriation. Legal and Self Insurance Contingencies: The Company records accruals for various contingencies including legal proceedings and product liability cases as these arise in the normal course of business. The accruals are based on management‟s judgment as to the probability of losses and, where applicable, actu arially determined estimates. Additionally, the Company records insurance receivable amounts from third-party insurers when recovery is probable. As appropriate, reserves against these receivables are recorded for estimated amounts that may not be collected from third-party insurers. The Company follows the provisions of U.S. GAAP when recording litigation related contingencies. A liability is recorded when a loss is probable and can be reasonably estimated. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, the minimum amount is accrued.
38
JOHNSON & JOHNSON 2010 ANNUAL REPORT
Long-Lived and Intangible Assets: The Company assesses changes in economic conditions and makes assumptions regarding estimated future cash flows in evaluating the value of the Company‟s property, plant and equipment, goodwill and intangible assets. As these assumptions and estimates may change over time, it may or may not be necessary for the Company to record impairment charges. Employee Benefit Plans: The Company sponsors various retirement and pension plans, including defined benefit, defined contribution and termination indemnity plans, which cover most employees worldwide. These plans are based on assumptions for the discount rate, expected return on plan assets, expected salary increases and health care cost trend rates. See Note 10 to the Consolidated Financial Statements for further details on these rates and the effect a rate change would have on the Company‟s results of operations. Stock Based Compensation: The Company recognizes compensation expense associated with the issuance of equity instruments to employees for their services. The fair value of each award is estimated on the date of grant using the BlackScholes option valuation model and is expensed in the financial statements over the vesting period. The input assumptions used in determining fair value are the expected life, expected volatility, risk-free rate and the dividend yield. See Note 17 to the Consolidated Financial Statements for additional information. New Accounting Pronouncements Refer to Note 1 to the Consolidated Financial Statements for recently adopted accounting pronouncements and recently issued accounting pronouncements not yet adopted as of January 2, 2011. Economic and Market Factors The Company is aware that its products are used in an environment where, for more than a decade, policymakers, consumers and businesses have expressed concerns about the rising cost of health care. In response to these concerns, the Company has a long-standing policy of pricing products responsibly. For the period 2000 — 2010, in the United States, the weighted average compound annual growth rate of the Company‟s net price increases for health care products (prescription and over-the-counter drugs, hospital and professional products) was below the U.S. Consumer Price Index (CPI). Inflation rates continue to have an effect on worldwide economies and, consequently, on the way companies operate. The Company accounted for operations in Venezuela as highly inflationary in 2010, as the prior three-year cumulative inflation rate has surpassed 100%. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases. The Company is exposed to fluctuations in currency exchange rates. A 1% change in the value of the U.S. Dollar as compared to all foreign currencies in which the Company had sales, income or expense in 2010 would have increased or decreased the translation of foreign sales by approximately $300 million and income by $65 million. The Company faces various worldwide health care changes that may continue to result in pricing pressures that include health care cost containment and government legislation relating to sales, promotions and reimbursem*nt. Changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing health care insurance coverage, as a result of the current global economic downturn, may continue to impact the Company‟s businesses . The Company also operates in an environment which has become increasingly hostile to intellectual property rights. Generic drug firms have filed Abbreviated New Drug Applications (ANDAs) seeking to market generic forms of most of the Company‟s key pharmaceutical products, prior to expiration of the applicable patents covering those products. In the event the Company is not successful in defending the patent claims challenged in ANDA filings, the generic firms will then introduce generic versions of the product at issue, resulting in the potential for substantial market share and revenue losses for that product. For further information see the discussion on “Litigation Against Filers of Abbreviated New Drug Applications” in Note 21 to the Consolidated Financial Statements. Legal Proceedings The Company is involved in numerous product liability cases in the United States, many of which concern alleged adverse reactions to drugs and medical devices. The damages claimed are substantial, and while the Company is confident of the adequacy of the warnings and instructions for use that accompany such products, it is not feasible to predict the ultimate outcome of litigation. However, the Company believes that in most cases product liability will be substantially covered by existing amounts accrued in the Company‟s balance sheet under its self -insurance program.
The Company is also involved in a number of patent, trademark and other lawsuits, as well as investigations, incidental to its business. The ultimate legal and financial liability of the Company in respect to all claims, lawsuits and proceedings referred to above cannot be reasonably estimated. However, in the Company‟s opinion, based on its examination of these matters, its experience to date, and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities already accrued in the Company‟s balance sheet, is not expected to be material to the Company‟s financial position, although the resolution in any reporting period of o ne or more of these matters could have a material impact on the Company‟s results of operations and cash flows for that period. See Note 21 to the Consolidated Financial Statements for further information regarding legal proceedings. Common Stock Market Prices The Company‟s Common Stock is listed on the New York Stock Exchange under the symbol JNJ. The composite market price ranges for Johnson & Johnson Common Stock during 2010 and 2009 were:
2010 High Low High 2009 Low
First quarter Second quarter Third quarter Fourth quarter Year-end close
$ 65.95 66.20 62.70 64.92 $61.85
61.89 57.55 56.86 61.25
61.00 56.65 62.47 65.41 64.41
46.25 50.12 55.71 58.78
MANAGEMENT‟S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
39
Cautionary Factors That May Affect Future Results This Annual Report contains forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and anticipate results based on management‟s plans that are subject to uncertainty. Forward -looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and other words of similar meaning in conjunction with, among other things, discussions of future operations, financial performance, the Company‟s strategy for growth, product develo pment, regulatory approval, market position and expenditures. Forward-looking statements are based on current expectations of future events. The Company cannot guarantee that any forward-looking statement will be accurate, although the Company believes that it has been reasonable in its expectations and assumptions. Investors should realize that if underlying assumptions prove inaccurate or that unknown risks or uncertainties materialize, actual results could vary materially from the Company‟s expectation s and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant litigation adverse to the Company; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and U.S. and foreign health care reforms; trends toward healthcare cost containment; increased scrutiny of the healthcare industry by government agencies; changes in behavior and spending patterns of purchasers of healthcare products and services; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action. The Company‟s report on Form 10-K for the year ended January 2, 2011 includes, in Exhibit 99, a discussion of additional factors that could cause actual results to differ from expectations. The Company notes these factors as permitted by the Private Securities Litigation Reform Act of 1995.
40
JOHNSON & JOHNSON 2010 ANNUAL REPORT
JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS At January 2, 2011 and January 3, 2010 (Dollars in Millions Except Share and Per Share Data) (Note 1)
2010
2009
Assets Current assets Cash and cash equivalents (Notes 1 and 2) Marketable securities (Notes 1 and 2) Accounts receivable trade, less allowances for doubtful accounts $340 (2009, $333) Inventories (Notes 1 and 3) Deferred taxes on income (Note 8) Prepaid expenses and other receivables Total current assets Property, plant and equipment, net (Notes 1 and 4) Intangible assets, net (Notes 1 and 5) Goodwill (Notes 1 and 5) Deferred taxes on income (Note 8) Other assets Total assets Liabilities and Shareholders’ Equity Current liabilities Loans and notes payable (Note 7) Accounts payable Accrued liabilities Accrued rebates, returns and promotions Accrued compensation and employee related obligations Accrued taxes on income Total current liabilities Long-term debt (Note 7) Deferred taxes on income (Note 8) Employee related obligations (Notes 9 and 10) Other liabilities Total liabilities Shareholders’ equity Preferred stock — without par value (authorized and unissued 2,000,000 shares) Common stock — par value $1.00 per share (Note 12) (authorized 4,320,000,000 shares; issued 3,119,843,000 shares) Accumulated other comprehensive income (Note 13) Retained earnings Less: common stock held in treasury, at cost (Note 12) (381,746,000 shares and 365,522,000 shares) Total shareholders’ equity Total liabilities and shareholders’ equity
$
19,355 8,303 9,774 5,378 2,224 2,273 47,307 14,553 16,716 15,294 5,096 3,942
15,810 3,615 9,646 5,180 2,793 2,497 39,541 14,759 16,323 14,862 5,507 3,690 94,682
$ 102,908
$
7,617 5,623 4,100 2,512 2,642 578 23,072 9,156 1,447 6,087 6,567 46,329 — 3,120 (3,531 ) 77,773 77,362 20,783 56,579
6,318 5,541 4,625 2,028 2,777 442 21,731 8,223 1,424 6,769 5,947 44,094 — 3,120 (3,058 ) 70,306 70,368 19,780 50,588 94,682
$ 102,908
See Notes to Consolidated Financial Statements
CONSOLIDATED FINANCIAL STATEMENTS
41
JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EARNINGS (Dollars in Millions Except Per Share Figures) (Note 1)
2010
2009
2008
Sales to customers Cost of products sold Gross profit Selling, marketing and administrative expenses Research and development expense Purchased in-process research and development (Note 20) Interest income Interest expense, net of portion capitalized (Note 4) Other (income) expense, net Restructuring (Note 22) Earnings before provision for taxes on income Provision for taxes on income (Note 8) Net earnings Basic net earnings per share (Notes 1 and 15) Diluted net earnings per share (Notes 1 and 15) Cash dividends per share Basic average shares outstanding (Notes 1 and 15) Diluted average shares outstanding (Notes 1 and 15)
$
61,587 18,792 42,795 19,424 6,844 — (107 ) 455 (768 ) — 16,947 3,613
61,897 18,447 43,450 19,801 6,986 — (90 ) 451 (526 ) 1,073 15,755 3,489 12,266 4.45 4.40 1.930 2,759.5 2,789.1
63,747 18,511 45,236 21,490 7,577 181 (361 ) 435 (1,015 ) — 16,929 3,980 12,949 4.62 4.57 1.795 2,802.5 2,835.6
$ $ $ $
13,334 4.85 4.78 2.110 2,751.4 2,788.8
See Notes to Consolidated Financial Statements
42
JOHNSON & JOHNSON 2010 ANNUAL REPORT
JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EQUITY (Dollars in Millions) (Note 1)
Accumulated Other Comprehensive Total Income Retained Earnings Comprehensive Income Common Stock Issued Amount
Treasury Stock Amount
Balance, December 30, 2007 Net earnings Cash dividends paid Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Other comprehensive income, net of tax: Currency translation adjustment Unrealized losses on securities Employee benefit plans Gains on derivatives & hedges Reclassification adjustment Total comprehensive income
$ 43,319 12,949 (5,024 ) 2,180 — (6,651 ) (2,499 ) (59 ) (1,870 ) 166 (2,499 ) (59 ) (1,870 ) 166 (27 ) 8,660 12,949
55,280 12,949 (5,024 ) 175 (1 )
(693 )
3,120
(14,388 )
2,005 1 (6,651 ) (2,499 ) (59 ) (1,870 ) 166
Balance, December 28, 2008 Net earnings Cash dividends paid Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Other Other comprehensive income, net of tax: Currency translation adjustment Unrealized losses on securities Employee benefit plans Gains on derivatives & hedges Total comprehensive income
$ 42,511 12,266 (5,327 ) 1,402 2 (2,130 ) (33 ) 1,363 (55 ) 565 24 1,363 (55 ) 565 24 14,163 12,266
63,379 12,266 (5,327 ) 25 (4 ) (33 )
(4,955 )
3,120
(19,033 )
1,377 6 (2,130 )
1,363 (55 ) 565 24
Balance, January 3, 2010 Net earnings Cash dividends paid Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Other comprehensive income, net of tax: Currency translation adjustment Unrealized gains on securities Employee benefit plans Losses on derivatives & hedges Total comprehensive income
$ 50,588 13,334 (5,804 ) 1,730 1 (2,797 ) (461 ) 54 (21 ) (45 ) (461 ) 54 (21 ) (45 ) 12,861 13,334
70,306 13,334 (5,804 ) (62 ) (1 )
(3,058 )
3,120
(19,780 )
1,792 2 (2,797 ) (461 ) 54 (21 ) (45 )
Balance, January 2, 2011
$ 56,579
77,773
(3,531 )
3,120
(20,783 )
See Notes to Consolidated Financial Statements
CONSOLIDATED FINANCIAL STATEMENTS
43
JOHNSON & JOHNSON AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (Dollars in Millions) (Note 1)
2010 2009 2008
Cash flows from operating activities Net earnings Adjustments to reconcile net earnings to cash flows from operating activities: Depreciation and amortization of property and intangibles Stock based compensation Purchased in-process research and development Deferred tax provision Accounts receivable allowances Changes in assets and liabilities, net of effects from acquisitions: (Increase)/decrease in accounts receivable (Increase)/decrease in inventories Increase/(decrease) in accounts payable and accrued liabilities (Increase)/decrease in other current and non-current assets Increase in other current and non-current liabilities Net cash flows from operating activities Cash flows from investing activities Additions to property, plant and equipment Proceeds from the disposal of assets Acquisitions, net of cash acquired (Note 20) Purchases of investments Sales of investments Other (primarily intangibles) Net cash used by investing activities Cash flows from financing activities Dividends to shareholders Repurchase of common stock Proceeds from short-term debt Retirement of short-term debt Proceeds from long-term debt Retirement of long-term debt Proceeds from the exercise of stock options/excess tax benefits Net cash used by financing activities Effect of exchange rate changes on cash and cash equivalents Increase in cash and cash equivalents Cash and cash equivalents, beginning of year (Note 1) Cash and cash equivalents, end of year (Note 1) Supplemental cash flow data Cash paid during the year for: Interest Income taxes Supplemental schedule of noncash investing and financing activities Treasury stock issued for employee compensation and stock option plans, net of cash proceeds Conversion of debt Acquisitions Fair value of assets acquired Fair value of liabilities assumed and non-controlling interests Net cash paid for acquisitions
$
13,334 2,939 614 — 356 12 (207 ) (196 ) 20 (574 ) 87 16,385
12,266 2,774 628 — (436 ) 58 453 95 (507 ) 1,209 31 16,571
12,949 2,832 627 181 22 86 (736 ) (101 ) (272 ) (1,600 ) 984 14,972
(2,384 ) 524 (1,269 ) (15,788 ) 11,101 (38 ) (7,854 )
(2,365 ) 154 (2,470 ) (10,040 ) 7,232 (109 ) (7,598 )
(3,066 ) 785 (1,214 ) (3,668 ) 3,059 (83 ) (4,187 )
(5,804 ) (2,797 ) 7,874 (6,565 ) 1,118 (32 ) 1,226 (4,980 ) (6 ) 3,545 15,810 $ 19,355
(5,327 ) (2,130 ) 9,484 (6,791 ) 9 (219 ) 882 (4,092 ) 161 5,042 10,768 15,810
(5,024 ) (6,651 ) 8,430 (7,319 ) 1,638 (24 ) 1,486 (7,464 ) (323 ) 2,998 7,770 10,768
$
491 2,442
533 2,363
525 4,068
$
673 1 1,321 (52 ) 1,269
541 2 3,345 (875 ) 2,470
593 — 1,328 (114 ) 1,214
$ $
See Notes to Consolidated Financial Statements
44
JOHNSON & JOHNSON 2010 ANNUAL REPORT
JOHNSON & JOHNSON AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Summary of Significant Accounting Policies
Principles of Consolidation The consolidated financial statements include the accounts of Johnson & Johnson and subsidiaries (the “Company”). Intercompany accounts and transactions are eliminated. Description of the Company And Business Segments The Company has approximately 114,000 employees worldwide engaged in the research and development, manufacture and sale of a broad range of products in the health care field. The Company conducts business in virtually all countries of the world and its primary focus is on products related to human health and well-being. The Company is organized into three business segments: Consumer, Pharmaceutical and Medical Devices and Diagnostics. The Consumer segment manufactures and markets a broad range of products used in the baby care, skin care, oral care, wound care and women‟s health care fields, as well as nutritional and over -the-counter pharmaceutical products and wellness and prevention platforms. These products are marketed to the general public and sold both to retail outlets and distributors throughout the world. The Pharmaceutical segment includes products in the following areas: anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management and virology. These products are distributed directly to retailers, wholesalers and health care professionals for prescription use. The Medical Devices and Diagnostics segment includes a broad range of products distributed to wholesalers, hospitals and retailers used principally in the professional fields by physicians, nurses, therapists, hospitals, diagnostic laboratories and clinics. These products include Biosense Webster‟s electrophysiology products; Cordis‟ circulatory disease management products; DePuy‟s orthopaedic join t reconstruction, spinal care, neurological and sports medicine products; Ethicon‟s surgical care, aesthetics and women‟s health products; Ethicon Endo -Surgery‟s minimally invasive surgical products and advanced sterilization products; LifeScan‟s blood glu cose monitoring and insulin delivery products; Ortho-Clinical Diagnostics‟ professional diagnostic products and Vistakon‟s disposable contact lenses. New Accounting Pronouncements Recently Adopted Accounting Pronouncements During the fiscal first quarter of 2010 the Company adopted the Financial Accounting Standards Board (FASB) guidance and amendments related to the criteria for separating consideration in multiple-deliverable revenue arrangements. The guidance (a) provides principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated; (b) requires an entity to allocate revenue in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (c) eliminates the use of the residual method and requires an entity to allocate the revenue using the relative selling price method. The adoption did not have a material impact on the Company‟s results of operations, cash flows or financial position; however it expanded the disclosures for multiple-deliverable revenue arrangements. During the fiscal first quarter of 2010, the Company adopted the FASB standard related to variable interest entities. The adoption of this standard did not have an impact on the Company‟s results of operations, cash flows or financial position. During the fiscal first quarter of 2010, the Company adopted the new accounting guidance on fair value measurements and disclosures. This guidance requires the Company to disclose the amount of significant transfers between Level 1 and Level 2 inputs and the reasons for these transfers as well as the reasons for any transfers in or out of Level 3 of the fair value hierarchy. In addition, the guidance clarifies certain existing disclosure requirements. The adoption of this standard did not have a material impact on the Company‟s results of operations, cash flows or financial position. Recently Issued Accounting Standards, Not Adopted as of January 2, 2011 During the fiscal second quarter of 2010 the FASB issued an accounting standard update related to revenue recognition under the milestone method. The objective of the accounting standard update is to provide guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research or development transactions. This guidance was effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. The adoption of this standard is not expected to have a material impact on the Company‟s results of operations, cash flows or financial position. Cash Equivalents The Company considers securities with maturities of three months or less, when purchased, to be cash equivalents. Investments
Short-term marketable securities are carried at cost, which approximates fair value. Investments classified as available-for-sale are carried at estimated fair value with unrealized gains and losses recorded as a component of accumulated other comprehensive income. Long-term debt securities that the Company has the ability and intent to hold until maturity are carried at amortized cost. Management determines the appropriate classification of its investment in debt and equity securities at the time of purchase and re-evaluates such determination at each balance sheet date. The Company periodically reviews its investments in equity securities for impairment and adjusts these investments to their fair value when a decline in market value is deemed to be other than temporary. If losses on these securities are considered to be other than temporary, the loss is recognized in earnings.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
45
Property, Plant and Equipment and Depreciation Property, plant and equipment are stated at cost. The Company utilizes the straight-line method of depreciation over the estimated useful lives of the assets: 20 — 40 years 10 — 20 years 2— 13 years
Building and building equipment Land and leasehold improvements Machinery and equipment
The Company capitalizes certain computer software and development costs, included in machinery and equipment, when incurred in connection with developing or obtaining computer software for internal use. Capitalized software costs are amortized over the estimated useful lives of the software, which generally range from 3 to 8 years. The Company reviews long-lived assets to assess recoverability using undiscounted cash flows. When certain events or changes in operating or economic conditions occur, an impairment assessment may be performed on the recoverability of the carrying value of these assets. If the asset is determined to be impaired, the loss is measured based on the difference between the asset‟s fai r value and its carrying value. If quoted market prices are not available, the Company will estimate fair value using a discounted value of estimated future cash flows. Revenue Recognition The Company recognizes revenue from product sales when the goods are shipped or delivered and title and risk of loss pass to the customer. Provisions for certain rebates, sales incentives, trade promotions, coupons, product returns and discounts to customers are accounted for as reductions in sales in the same period the related sales are recorded. Product discounts granted are based on the terms of arrangements with direct, indirect and other market participants, as well as market conditions, including prices charged by competitors. Rebates, the largest being the Medicaid rebate provision, are estimated based on contractual terms, historical experience, trend analysis and projected market conditions in the various markets served. The Company evaluates market conditions for products or groups of products primarily through the analysis of wholesaler and other thirdparty sell-through and market research data, as well as internally generated information. Sales returns are generally estimated and recorded based on historical sales and returns information. Products that exhibit unusual sales or return patterns due to dating, competition or other marketing matters are specifically investigated and analyzed as part of the accounting for sales return accruals. Sales returns allowances represent a reserve for products that may be returned due to expiration, destruction in the field, or in specific areas, product recall. The returns reserve is based on historical return trends by product and by market as a percent to gross sales. In accordance with the Company‟s accounting policies, the Company generally issues credit to customers for returned goods. The Company‟s sales return reserves a re accounted for in accordance with U.S. GAAP guidance for revenue recognition when right of return exists. Sales return reserves are recorded at full sales value. Sales returns in the Consumer and Pharmaceutical segments are almost exclusively not resalable. Sales returns for certain franchises in the Medical Devices and Diagnostics segment are typically resalable but are not material. The Company rarely exchanges products from inventory for returned products. The sales returns reserve for the total Company has ranged between 1.0% and 1.2% of annual sales to customers during the prior three fiscal reporting years 2008 — 2010. Promotional programs, such as product listing allowances and cooperative advertising arrangements, are recorded in the year incurred. Continuing promotional programs include coupons and volume-based sales incentive programs. The redemption cost of consumer coupons is based on historical redemption experience by product and value. Volume-based incentive programs are based on the estimated sales volumes for the incentive period and are recorded as products are sold. The Company also earns service revenue for co-promotion of certain products and includes it in sales to customers. These arrangements are evaluated to determine the appropriate amounts to be deferred. Shipping and Handling Shipping and handling costs incurred were $945 million, $964 million and $1,017 million in 2010, 2009 and 2008, respectively, and are included in selling, marketing and administrative expense. The amount of revenue received for shipping and handling is less than 0.5% of sales to customers for all periods presented. Inventories
Inventories are stated at the lower of cost or market determined by the first-in, first-out method. Intangible Assets and Goodwill The authoritative literature on U.S. GAAP requires that goodwill and intangible assets with indefinite lives be assessed annually for impairment. The Company completed the annual impairment test for 2010 in the fiscal fourth quarter and no impairment was determined. Future impairment tests will be performed annually in the fiscal fourth quarter, or sooner if a triggering event occurs. Intangible assets that have finite useful lives continue to be amortized over their useful lives, and are reviewed for impairment when warranted by economic conditions. See Note 5 for further details on Intangible Assets and Goodwill. Financial Instruments As required by U.S. GAAP, all derivative instruments are recorded on the balance sheet at fair value. Changes in the fair value of derivatives are recorded each period in current earnings or other comprehensive income, depending on whether the derivative is designated as part of a hedge transaction, and if so, the type of hedge transaction.
46
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The Company documents all relationships between hedged items and derivatives. The overall risk management strategy includes reasons for undertaking hedge transactions and entering into derivatives. The objectives of this strategy are: (1) minimize foreign currency exposure‟s impact on the Company‟s financial performance; (2) protect the Company‟s cash flow from adverse movements in foreign exchange rates; (3) ensure the appropriateness of financial instruments; and (4) manage the enterprise risk associated with financial institutions. See Note 6 for additional information on Financial Instruments. Product Liability Accruals for product liability claims are recorded, on an undiscounted basis, when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated based on existing information. The accruals are adjusted periodically as additional information becomes available. As a result of cost and availability factors, effective November 1, 2005, the Company ceased purchasing third-party product liability insurance. Based on the availability of prior coverage, receivables for insurance recoveries related to product liability claims are recorded on an undiscounted basis, when it is probable that a recovery will be realized. Research and Development Research and development expenses are expensed as incurred. Upfront and milestone payments made to third-parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory approval. Payments made to third parties subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in other intangibles, net of accumulated amortization. The Company enters into collaborative arrangements, typically with other pharmaceutical or biotechnology companies, to develop and commercialize drug candidates or intellectual property. These arrangements typically involve two (or more) parties who are active participants in the collaboration and are exposed to significant risks and rewards dependent on the commercial success of the activities. These collaborations usually involve various activities by one or more parties, including research and development, marketing and selling and distribution. Often, these collaborations require upfront, milestone and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development. Amounts due from collaborative partners related to development activities are generally reflected as a reduction of research and development expense because the performance of contract development services is not central to the Company‟s operations. In general, the income statement presentation for these collaborations is as follows:
Nature/Type of Collaboration Statement of Earnings Presentation
Third-party sale of product Royalties/milestones paid to collaborative partner (postregulatory approval)* Royalties received from collaborative partner Upfront payments & milestones paid to collaborative partner (pre-regulatory approval) Research and development payments to collaborative partner Research and development payments received from collaborative partner
Sales to customers Cost of goods sold Other income (expense), net Research and development expense Research and development expense Reduction of Research and development expense
* Milestones are capitalized as intangible assets and amortized to cost of goods sold over the useful life. Advertising Costs associated with advertising are expensed in the year incurred and are included in the selling, marketing and administrative expenses. Advertising expenses worldwide, which are comprised of television, radio, print media and Internet advertising, were $2.5 billion, $2.4 billion and $2.9 billion in 2010, 2009 and 2008, respectively. Income Taxes The Company intends to continue to reinvest its undistributed international earnings to expand its international operations; therefore, no U.S. tax expense has been recorded with respect to the undistributed portion not intended for repatriation. At January 2, 2011 and January 3, 2010, the cumulative amount of undistributed international earnings was approximately $37.0 billion and $32.2 billion, respectively.
Deferred income taxes are recognized for tax consequences of temporary differences by applying enacted statutory tax rates, applicable to future years, to differences between the financial reporting and the tax basis of existing assets and liabilities. Net Earnings Per Share Basic earnings per share is computed by dividing net earnings available to common shareholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflects the potential dilution that could occur if securities were exercised or converted into common stock using the treasury stock method.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
47
Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported. Estimates are used when accounting for sales discounts, rebates, allowances and incentives, product liabilities, income taxes, depreciation, amortization, employee benefits, contingencies and intangible asset and liability valuations. For instance, in determining annual pension and post-employment benefit costs, the Company estimates the rate of return on plan assets, and the cost of future health care benefits. Actual results may or may not differ from those estimates. The Company follows the provisions of U.S. GAAP when recording litigation related contingencies. A liability is recorded when a loss is probable and can be reasonably estimated. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, the minimum amount is accrued. Annual Closing Date The Company follows the concept of a fiscal year, which ends on the Sunday nearest to the end of the month of December. Normally each fiscal year consists of 52 weeks, but every five or six years the fiscal year consists of 53 weeks, as was the case in 2009 and will be the case again in 2014. Reclassification Certain prior period amounts have been reclassified to conform to current year presentation. 2. Cash, Cash Equivalents and Current Marketable Securities At the end of 2010 and 2009, the amortized cost of cash, cash equivalents and current marketable securities were comprised of:
(Dollars in Millions) Amortized Cost 2010 2009
Cash Government securities and obligations Corporate debt securities Money market funds Time deposits Total cash, cash equivalents and current marketable securities
$
2,293 22,349 225 2,135 656
2,517 13,370 426 1,890 1,222 19,425
$ 27,658
The estimated fair value was the same as the amortized cost as of January 2, 2011. The estimated fair value was $19,426 million as of January 3, 2010 reflecting a $1 million unrealized gain in Government securities and obligations. As of January 2, 2011, current marketable securities consisted of $8,153 million and $150 million of government securities and obligations and corporate debt securities, respectively. As of January 3, 2010, current marketable securities consisted of $3,434 million and $181 million of government securities and obligations and corporate debt securities, respectively. Fair value of government securities and obligations and corporate debt securities were estimated using quoted broker prices in active markets. The Company invests its excess cash in both deposits with major banks throughout the world and other high-quality money market instruments. The Company has a policy of making investments only with commercial institutions that have at least an A (or equivalent) credit rating. 3. Inventories At the end of 2010 and 2009, inventories were comprised of:
(Dollars in Millions) 2010 2009
Raw materials and supplies Goods in process Finished goods
$ 1,073 1,460 2,845
1,144 1,395 2,641
Total inventories
$ 5,378
5,180
4.
Property, Plant and Equipment At the end of 2010 and 2009, property, plant and equipment at cost and accumulated depreciation were:
(Dollars in Millions)
2010
2009
Land and land improvements Buildings and building equipment Machinery and equipment Construction in progress Total property, plant and equipment, gross Less accumulated depreciation Total property, plant and equipment, net
$
738 9,079 18,032 2,577
714 8,863 17,153 2,521 29,251 14,492 14,759
$ 30,426 15,873 $ 14,553
The Company capitalizes interest expense as part of the cost of construction of facilities and equipment. Interest expense capitalized in 2010, 2009 and 2008 was $73 million, $101 million and $147 million, respectively. Depreciation expense, including the amortization of capitalized interest in 2010, 2009 and 2008, was $2.2 billion, $2.1 billion and $2.0 billion, respectively. Upon retirement or other disposal of property, plant and equipment, the costs and related amounts of accumulated depreciation or amortization are eliminated from the asset and accumulated depreciation accounts, respectively. The difference, if any, between the net asset value and the proceeds are recorded in earnings.
48
JOHNSON & JOHNSON 2010 ANNUAL REPORT
5.
Intangible Assets and Goodwill At the end of 2010 and 2009, the gross and net amounts of intangible assets were:
(Dollars in Millions)
2010
2009
Intangible assets with definite lives: Patents and trademarks — gross Less accumulated amortization Patents and trademarks — net Other intangibles — gross Less accumulated amortization Other intangibles — net Total intangible assets with definite lives — gross Less accumulated amortization Total intangible assets with definite lives — net Intangible assets with indefinite lives: Trademarks Purchased in-process research and development* Total intangible assets with indefinite lives Total intangible assets — net
$ $ $ $
6,660 2,629 4,031 7,674 2,880 4,794
5,697 2,177 3,520 7,808 2,680 5,128 13,505 4,857 8,648
$ 14,334 5,509 $ 8,825
$ $
5,954 1,937 7,891
5,938 1,737 7,675 16,323
$ 16,716
* Purchased in-process research and development will be accounted for as an indefinite-lived intangible asset until the underlying project is completed or abandoned. Goodwill as of January 2, 2011 and January 3, 2010, as allocated by segment of business is as follows:
Med Dev and Diag
(Dollars in Millions)
Consumer
Pharm
Total
Goodwill at December 28, 2008 Acquisitions Currency translation/other* Goodwill at January 3, 2010 Acquisitions Currency translation/other Goodwill at January 2, 2011
$ 7,474 — 600 $ 8,074 — 70 $ 8,144
963 271 10 1,244 — (19 ) 1,225
5,282 401 (139 ) 5,544 397 (16 ) 5,925
13,719 672 471 14,862 397 35 15,294
* Includes reclassification between segments. The weighted average amortization periods for patents and trademarks and other intangible assets are 17 years and 28 years, respectively. The amortization expense of amortizable assets was $748 million, $675 million and $788 million before tax, for the fiscal years ended January 2, 2011, January 3, 2010 and December 28, 2008, respectively. Certain patents and intangible assets were written down to fair value during fiscal years 2010, 2009 and 2008, with the resulting charge included in amortization expense. These write downs did not have a material impact on the Company‟s results of operations, cash flows or financial position. The estimated amortization expense for the five succeeding years approximates $730 million before tax, per year. Substantially all of the amortization expense is included in cost of products sold. 6. Fair Value Measurements
The Company uses forward exchange contracts to manage its exposure to the variability of cash flows, primarily related to the foreign exchange rate changes of future intercompany product and third-party purchases of raw materials denominated in foreign currency. The Company also uses cross currency interest rate swaps to manage currency risk primarily related to borrowings. Both types of derivatives are designated as cash flow hedges. The Company also uses forward exchange contracts to manage its exposure to the variability of cash flows for repatriation of foreign dividends. These contracts are designated as net investment hedges. Additionally, the Company uses forward exchange contracts to offset its exposure to certain foreign currency assets and liabilities. These forward exchange contracts are not designated as hedges and therefore, changes in the fair values of these derivatives are recognized in earnings, thereby offsetting the current earnings effect of the related foreign currency assets and liabilities. The Company does not enter into derivative financial instruments for trading or speculative purposes, or contain credit risk related contingent features or requirements to post collateral. On an ongoing basis, the Company monitors counterparty credit ratings. The Company considers credit non-performance risk to be low, because the Company enters into agreements with commercial institutions that have at least an A (or equivalent) credit rating. As of January 2, 2011, the Company had notional amounts outstanding for forward foreign exchange contracts and cross currency interest rate swaps of $21 billion and $3 billion, respectively. All derivative instruments are to be recorded on the balance sheet at fair value. Changes in the fair value of derivatives are recorded each period in current earnings or other comprehensive income, depending on whether the derivative is designated as part of a hedge transaction, and if so, the type of hedge transaction. The designation as a cash flow hedge is made at the entrance date into the derivative contract. At inception, all derivatives are expected to be highly effective. Changes in the fair value of a derivative that is designated as a cash flow hedge and is highly effective are recorded in accumulated other comprehensive income until the underlying transaction affects earnings, and are then reclassified to earnings in the same account as the hedged transaction. Gains/losses on net investment hedges are accounted for through the currency translation account and are insignificant. On an ongoing basis, the Company assesses whether each derivative continues to be highly effective in offsetting changes in the cash flows of hedged items. If and when a derivative is no longer expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if any, is included in current period earnings in other (income) and expense, net, and was not material for the fiscal years ended January 2, 2011 and January 3, 2010. Refer to Note 13 for disclosures of movements in Accumulated Other Comprehensive Income. As of January 2, 2011, the balance of deferred net gains on derivatives included in accumulated other comprehensive income was $100 million after-tax. For additional information, see Note 13. The Company expects that substantially all of the amount related to foreign exchange contracts will be reclassified into earnings over the next 12 months as a result of transactions that are expected to occur over that period. The maximum length of time over which the Company is hedging transaction exposure is 18 months, excluding interest rate swaps. The amount ultimately realized in earnings will differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity of the derivative.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
49
The following table is a summary of the activity related to designated derivatives for the fiscal years ended January 2, 2011 and January 3, 2010:
Gain/(Loss) Reclassified from Accumulated OCI into Income (1) 2010 2009 Gain/(Loss) Recognized in Other Income/expense (2) 2010 2009
Cash Flow Hedges (Dollars in Millions)
Gain/(Loss) Recognized in Accumulated OCI (1) 2010 2009
Foreign exchange contracts $ Foreign exchange contracts Foreign exchange contracts Cross currency interest rate swaps Foreign exchange contracts 18 Total All amounts shown in the table above are net of tax.
(1) (2)
(66 ) (296 ) 51 (40 )
(63 ) (173 ) 5 241 28 38
) (52 (A) ) (300 (B) 57 (C) 6 (D) 1 (E) (288 )
) (47 (A) 70 (B) 13 (C) ) (16 (D) ) (6 (E) 14
(2 ) (38 ) 5 — 3 (32 )
1 (1 ) — — (12 ) (12 )
$ (333 )
Effective portion Ineffective portion
(A) Included in Sales to customer (B) (C)
Included in Cost of products sold Included in Research and development expense
(D) Included in Interest (income)/Interest expense, net (E)
Included in Other (income)/expense, net
For the fiscal years ended January 2, 2011 and January 3, 2010, a loss of $31 million and a gain of $21 million, respectively, was recognized in Other (income)/expense, net, relating to foreign exchange contracts not designated as hedging instruments. Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. The authoritative literature establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described below with Level 1 having the highest priority and Level 3 having the lowest. The fair value of a derivative financial instrument (i.e. forward exchange contract, currency swap) is the aggregation by currency of all future cash flows discounted to its present value at the prevailing market interest rates and subsequently converted to the U.S. dollar at the current spot foreign exchange rate. The Company does not believe that fair values of these derivative instruments materially differ from the amounts that could be realized upon settlement or maturity, or that the changes in fair value will have a material effect on the Company‟s results of operations, cash flows or financial position. The Company also holds equity inves tments that are classified as Level 1 as they are traded in an active exchange market. The following three levels of inputs are used to measure fair value: Level 1 — Quoted prices in active markets for identical assets and liabilities. Level 2 — Significant other observable inputs. Level 3 — Significant unobservable inputs.
50
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The Company‟s significant financial assets and liabilities measured at fair value as of January 2, 2011 and January 3, 2010 were as follows:
2010 (Dollars in Millions) Level 1 Level 2 Level 3 Total 2009 Total (1)
Derivatives designated as hedging instruments: Assets: Foreign exchange contracts Cross currency interest rate swaps (2) Total Liabilities: Foreign exchange contracts Cross currency interest rate swaps (3) Total Derivatives not designated as hedging instruments: Assets: Foreign exchange contracts Liabilities: Foreign exchange contracts Other investments
$
— — — —
321 17 338
— — — —
321 17 338
436 126 562
586 502 1,088
586 502 1,088
608 571 1,179
— — $ 1,165
19 39 —
— — —
19 39 1,165
33 40 1,134
(1) 2009 assets and liabilities are all classified as Level 2 with the exception of other investments of $1,134 million which are
classified as Level 1.
(2) Includes $14 million and $119 million of non-current assets for the fiscal years ending January 2, 2011 and January 3, 2010,
respectively.
(3) Includes $502 million and $517 million of non-current liabilities for the fiscal years ending January 2, 2011 and January 3, 2010,
respectively. See Notes 2 and 7 for financial assets and liabilities held at carrying amount on the Consolidated Balance Sheet. 7. Borrowings The components of long-term debt are as follows:
Effective Rate % Effective Rate %
(Dollars in Millions)
2010
2009
5.15% Debentures due 2012 3.80% Debentures due 2013 5.55% Debentures due 2017 5.15% Debentures due 2018 4.75% Notes due 2019 (1B Euro 1.3268) (2) /(1B Euro 1.4382) (3) 3% Zero Coupon Convertible Subordinated Debentures due 2020 2.95% Debentures due 2020 6.73% Debentures due 2023 5.50% Notes due 2024 (500MM GBP 1.5403) (2) / (500MM GBP 1.6189) (3) 6.95% Notes due 2029 4.95% Debenture due 2033 5.95% Notes due 2037 5.86% Debentures due 2038 4.50% Debentures due 2040 Other (Includes Industrial Revenue Bonds)
$
599 500 1,000 898 1,319 (2) 194 541 250 764 (2) 294 500 995 700 539 76
5.18 % 3.82 5.55 5.15 5.35 3.00 3.15 6.73 5.71 7.14 4.95 5.99 5.86 4.63
599 500 1,000 898 1,429 (3) 188 — 250 803 (3) 294 500 995 700 — 101
5.18 3.82 5.55 5.15 5.35 3.00 — 6.73 5.71 7.14 4.95 5.99 5.86 —
9,169 (
4)
5.25 (1)
Less current portion
13 $ 9,156
8,257 (4) 34 8,223
5.42 (1 )
(1) Weighted average effective rate.
(2) Translation rate at January 2, 2011.
(3) Translation rate at January 3, 2010.
(4) The excess of the fair value over the carrying value of debt was $1.0 billion in 2010 and $0.8 billion in 2009.
Fair value of the non-current debt was estimated using market prices, which were corroborated by quoted broker prices in active markets. The Company has access to substantial sources of funds at numerous banks worldwide. In September 2010, the Company secured a new 364-day Credit Facility. Total credit available to the Company approximates $10 billion, which expires September 22, 2011. Interest charged on borrowings under the credit line agreements is based on either bids provided by banks, the prime rate or London Interbank Offered Rates (LIBOR), plus applicable margins. Commitment fees under the agreements are not material. Throughout 2010 the Company continued to have access to liquidity through the commercial paper market. Short-term borrowings and the current portion of long-term debt amounted to approximately $7.6 billion at the end of 2010, of which $7.4 billion was borrowed under the Commercial Paper Program. The remainder represents principally local borrowing by international subsidiaries. The Company has a shelf registration with the Securities and Exchange Commission that enables the Company to issue on a timely basis debt securities and warrants to purchase debt securities. Aggregate maturities of long-term obligations commencing in 2010 are:
(Dollars in Millions) 2011 2012 2013 2014 2015 After 2015
$
13
644
509
9
—
7,994
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
51
8.
Income Taxes The provision for taxes on income consists of:
(Dollars in Millions)
2010
2009
2008
Currently payable: U.S. taxes International taxes Total currently payable Deferred: U.S. taxes International taxes Total deferred Provision for taxes on income
$ 2,063 1,194 3,257 (4 ) 360 356 $ 3,613
2,410 1,515 3,925 187 (623 ) (436 ) 3,489
2,334 1,624 3,958 126 (104 ) 22 3,980
A comparison of income tax expense at the U.S. statutory rate of 35% in 2010, 2009 and 2008, to the Company‟s effective tax rate is as follows:
(Dollars in Millions) 2010 2009 2008
U.S. International Earnings before taxes on income: Tax rates: U.S. statutory rate Ireland and Puerto Rico operations Research and orphan drug tax credits U.S. state and local International subsidiaries excluding Ireland U.S. manufacturing deduction In-process research and development (IPR&D) U.S. Tax international income All other Effective tax rate
$
6,392 10,555
7,141 8,614 15,755
6,579 10,350 16,929
$ 16,947
35.0 % (5.1 ) (0.6 ) 1.0 (7.5 ) (0.5 ) — (0.6 ) (0.4 ) 21.3 %
35.0 (5.1 ) (0.6 ) 1.8 (6.7 ) (0.4 ) — (1.6 ) (0.3 ) 22.1
35.0 (6.8 ) (0.6 ) 1.6 (5.6 ) (0.4 ) 0.4 (0.5 ) 0.4 23.5
The Company has subsidiaries manufacturing in Ireland under an incentive tax rate. In addition, the Company has subsidiaries operating in Puerto Rico under various tax incentive grants. The decrease in the 2010 tax rate was primarily due to decreases in taxable income in higher tax jurisdictions relative to taxable income in lower tax jurisdictions and certain U.S. tax adjustments. The decrease in the 2009 tax rate was primarily due to increases in taxable income in lower tax jurisdictions relative to taxable income in higher tax jurisdictions. Temporary differences and carry forwards for 2010 and 2009 are as follows:
2010 Deferred Tax Asset Liability 2009 Deferred Tax Asset Liability
(Dollars in Millions)
Employee related obligations Stock based compensation Depreciation Non-deductible intangibles International R&D capitalized for tax Reserves & liabilities Income reported for tax purposes Net operating loss carryforward international
$ 2,211 1,225 (769 ) (2,725 ) 1,857 948 691 738
2,153 1,291 (661 ) (2,377 ) 1,989 1,014 648 615
Miscellaneous international Miscellaneous U.S. Total deferred income taxes
1,326 470 $ 9,466
(106 ) (3,600 )
1,474 799 9,983
(110 ) (3,148 )
The difference between the net deferred tax on income per the balance sheet and the net deferred tax above is included in taxes on income on the balance sheet. The 2009 deferred tax Miscellaneous U.S. includes current year tax receivables. The Company has a wholly-owned international subsidiary that has cumulative net losses. The Company believes that it is more likely than not that this subsidiary will realize future taxable income sufficient to utilize these deferred tax assets. The following table summarizes the activity related to unrecognized tax benefits:
(Dollars in Millions) 2010 2009 2008
Beginning of year Increases related to current year tax positions Increases related to prior period tax positions Decreases related to prior period tax positions Settlements Lapse of statute of limitations End of year
$ 2,403 465 68 (431 ) (186 ) (12 ) $ 2,307
1,978 555 203 (163 ) (87 ) (83 ) 2,403
1,653 545 87 (142 ) (137 ) (28 ) 1,978
The Company had $2.3 billion, $2.4 billion and $2.0 billion of unrecognized tax benefits as of January 2, 2011, January 3, 2010 and December 28, 2008, respectively. All of the unrecognized tax benefits of $2.3 billion at January 2, 2011, if recognized, would affect the Company‟s annual effective tax rate. The Company conducts busines s and files tax returns in numerous countries and currently has tax audits in progress with a number of tax authorities. The U.S. Internal Revenue Service (IRS) has completed its audit for the tax years through 2005; however, there are a limited number of issues remaining open for prior tax years going back to 1999. In other major jurisdictions where the Company conducts business, the years remain open generally back to the year 2003. The Company does not expect that the total amount of unrecognized tax benefits will significantly change over the next twelve months. The Company is not able to provide a reasonably reliable estimate of the timing of any other future tax payments relating to uncertain tax positions.
52
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The Company classifies liabilities for unrecognized tax benefits and related interest and penalties as long-term liabilities. Interest expense and penalties related to unrecognized tax benefits are classified as income tax expense. The Company recognized after tax interest of $34 million income, $36 million expense and $69 million expense in 2010, 2009 and 2008, respectively. The total amount of accrued interest was $264 million and $309 million in 2010 and 2009, respectively. 9. Employee Related Obligations At the end of 2010 and 2009, employee related obligations recorded on the Consolidated Balance Sheet were:
(Dollars in Millions) 2010 2009
Pension benefits Postretirement benefits Postemployment benefits Deferred compensation Total employee obligations Less current benefits payable Employee related obligations — non-current
$ 2,175 2,359 1,379 820 6,733 646 $ 6,087
2,792 2,245 1,504 790 7,331 562 6,769
Prepaid employee related obligations of $615 million and $266 million for 2010 and 2009, respectively, are included in other assets on the consolidated balance sheet. 10. Pensions and Other Benefit Plans
The Company sponsors various retirement and pension plans, including defined benefit, defined contribution and termination indemnity plans, which cover most employees worldwide. The Company also provides postretirement benefits, primarily health care, to all U.S. retired employees and their dependents. Many international employees are covered by government-sponsored programs and the cost to the Company is not significant. Retirement plan benefits are primarily based on the employee‟s compensation during the last three to five years before retirement and the number of years of service. International subsidiaries have plans under which funds are deposited with trustees, annuities are purchased under group contracts, or reserves are provided. The Company does not fund retiree health care benefits in advance and has the right to modify these plans in the future. The Company uses the date of its consolidated financial statements (January 2, 2011 and January 3, 2010, respectively) as the measurement date for all U.S. and international retirement and other benefit plans. In accordance with U.S. GAAP, the Company has adopted the recent standards related to employers‟ accounting for de fined benefit pension and other postretirement plans. Net periodic benefit costs for the Company‟s defined benefit retirement plans and other benefit plans for 2010, 2009 and 2008 include the following components:
Retirement Plans 2009 Other Benefit Plans 2010 2009 2008
(Dollars in Millions)
2010
2008
Service cost Interest cost Expected return on plan assets Amortization of prior service cost Amortization of net transition asset Recognized actuarial losses Curtailments and settlements Net periodic benefit cost
$
550 791 (1,005 ) 10 1 236 1 584
511 746 (934 ) 13 1 155 (11 ) 481
545 701 (876 ) 10 2 62 7 451
$ 134 202 (1 ) (4 ) — 48 — $ 379
137 174 (1 ) (5 ) — 55 (1 ) 359
142 166 (2 ) (4 ) — 64 — 366
$
The net periodic benefit cost attributable to U.S. retirement plans was $294 million, $286 million and $220 million in 2010, 2009 and 2008, respectively.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
53
Amounts expected to be recognized in net periodic benefit cost in the coming year for the Company‟s defined benefit retirement plans and other postretirement plans:
(Dollars in Millions)
Amortization of net transition obligation Amortization of net actuarial losses Amortization of prior service cost
$
1 402 5
Unrecognized gains and losses for the U.S. pension plans are amortized over the average remaining future service for each plan. For plans with no active employees, they are amortized over the average life expectancy. The amortization of gains and losses for the other U.S. benefit plans is determined by using a 10% corridor of the greater of the market value of assets or the projected benefit obligation. Total unamortized gains and losses in excess of the corridor are amortized over the average remaining future service. Prior service costs/benefits for the U.S. pension plans are amortized over the remaining future service of plan participants at the time of the plan amendment. Prior service cost/benefit for the other U.S. benefit plans is amortized over the average remaining service to full eligibility age of plan participants at the time of the plan amendment. The weighted-average assumptions in the following table represent the rates used to develop the actuarial present value of projected benefit obligation for the year listed and also the net periodic benefit cost for the following year.
Retirement Plans 2009 Other Benefit Plans 2009
(Dollars in Millions)
2010
2008
2010
2008
U.S. Benefit Plans Discount rate Expected long-term rate of return on plan assets Rate of increase in compensation levels International Benefit Plans Discount rate Expected long-term rate of return on plan assets Rate of increase in compensation levels
5.98 % 9.00 4.25 5.26 % 8.00 4.00
6.50 9.00 4.50 5.75 8.00 4.00
6.50 9.00 4.50 6.00 8.00 4.00
5.98 % 9.00 4.25 6.32 % — 4.75
6.50 9.00 4.50 6.75 — 4.75
6.50 9.00 4.50 7.25 — 4.50
The Company‟s discount rates are determined by considering current yield curves representing high quality, long-term fixed income instruments. The resulting discount rates are consistent with the duration of plan liabilities. The expected long-term rate of return on plan assets assumption is determined using a building block approach, considering historical averages and real returns of each asset class. In certain countries, where historical returns are not meaningful, consideration is given to local market expectations of long-term returns. The following table displays the assumed health care cost trend rates, for all individuals:
Health Care Plans 2010 2009
Health care cost trend rate assumed for next year Rate to which the cost trend rate is assumed to decline (ultimate trend) Year the rate reaches the ultimate trend rate A one-percentage-point change in assumed health care cost trend rates would have the following effect:
One-PercentagePoint Increase
7.50 % 5.00 % 2018
8.00 5.00 2017
(Dollars in Millions)
One-PercentagePoint Decrease
Health Care Plans Total interest and service cost Postretirement benefit obligation
$
36 377
$
(28 ) (302 )
54
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The following table sets forth information related to the benefit obligation and the fair value of plan assets at year-end 2010 and 2009 for the Company‟s defined benefit retirement plans and other postretirement plans:
Retirement Plans 2010 2009 Other Benefit Plans 2010 2009
(Dollars in Millions)
Change in Benefit Obligation Projected benefit obligation — beginning of year Service cost Interest cost Plan participant contributions Amendments Actuarial losses Divestitures & acquisitions Curtailments & settlements & restructuring Benefits paid from plan Effect of exchange rates Projected benefit obligation — end of year* Change in Plan Assets Plan assets at fair value — beginning of year Actual return on plan assets Company contributions Plan participant contributions Settlements Benefits paid from plan assets Effect of exchange rates Plan assets at fair value — end of year Funded status at — end of year* Amounts Recognized in the Company’s Balance Sheet consist of the following: Non-current assets Current liabilities Non-current liabilities Total recognized in the consolidated balance sheet — end of year Amounts Recognized in Accumulated Other Comprehensive Income consist of the following: Net actuarial loss Prior service cost (credit) Unrecognized net transition obligation Total before tax effects Accumulated Benefit Obligations — end of year* Changes in Plan Assets and Benefit Obligations Recognized in Other Comprehensive Income Net periodic benefit cost Net actuarial loss (gain) Amortization of net actuarial loss Prior service cost Amortization of prior service (cost) credit Effect of exchange rates Total recognized in other comprehensive income, before tax Total recognized in net periodic benefit cost and other comprehensive
$ 13,449 550 791 42 — 815 — (10 ) (627 ) (17 ) $ 14,993
11,923 511 746 50 3 412 15 (3 ) (570 ) 362 13,449
$
3,590 134 202 — — 115 — — (476 ) 7 3,572
2,765 137 174 — — 51 13 748 (313 ) 15 3,590
$
$ 10,923 1,466 1,611 42 (7 ) (627 ) 25 $ 13,433 $ (1,560 )
7,677 2,048 1,354 50 — (570 ) 364 10,923 (2,526 )
$
16 2 472 — — (476 ) — 14
17 4 308 — — (313 ) — 16 (3,574 )
$
$ (3,558 )
$
615 (54 ) (2,121 )
266 (53 ) (2,739 ) (2,526 )
$
— (576 ) (2,982 )
— (484 ) (3,090 ) (3,574 )
$ (1,560 )
$ (3,558 )
$
3,539 39 4 3,582
3,415 47 5 3,467 11,687
$
1,017 (21 ) — 996
924 (23 ) — 901
$
$
$ 13,134
$
584 354 (242 ) — (10 ) 13
481 (704 ) (134 ) 3 (13 ) 57 (791 ) (310 )
$
379 134 (46 ) — 4 3
359 48 (131 ) — 5 2 (76 ) 283
$ $
115 699
$ $
95 474
income
* The Company does not fund certain plans, as funding is not required. $1.3 billion and $1.2 billion of the 2010 and 2009 projected benefit obligation and $1.3 billion and $1.2 billion of the underfunded status for each of the fiscal years 2010 and 2009, respectively, relates to the unfunded pension plans. $1.1 billion and $1.0 billion of the accumulated benefit obligation for the fiscal years 2010 and 2009, respectively, relate to these unfunded pension plans. Plans with accumulated benefit obligations in excess of plan assets consist of the following:
Retirement Plans 2010 2009
(Dollars in Millions)
Accumulated benefit obligation Projected benefit obligation Plan assets at fair value
$ (2,361 ) (2,771 ) 817
(4,065 ) (4,663 ) 2,564
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
55
The following table displays the projected future benefit payments from the Company‟s retirement and other benefit plans:
(Dollars in Millions) 2011 2012 2013 2014 2015 2016-2020
Projected future benefit payments Retirement plans Other benefit plans — gross Medicare rebates Other benefit plans — net
$ 596 $ 263 (10 ) $ 253
598 212 (12 ) 200
614 200 — 200
642 202 — 202
682 203 — 203
4,153 1,075 — 1,075
The 2011 other benefit plan future projected benefit payments exclude $345 million of severance payments associated with the 2009 worldwide restructuring program. In 2010, the Company contributed $1,236 million and $375 million to its U.S. and international pension plans, respectively. The Company plans to continue to fund its U.S. defined benefit plans to comply with the Pension Protection Act of 2006. International plans are funded in accordance with local regulations. Additional discretionary contributions are made when deemed appropriate to meet the long-term obligations of the plans. For certain plans, funding is not a common practice, as funding provides no economic benefit. Consequently the Company has several pension plans that are not funded. The following table displays the projected future minimum contributions to the Company‟s U.S. and international unfunded retirement plans. These amounts do not include any discretionary contributions that the Company may elect to make in the future.
(Dollars in Millions) 2011 2012 2013 2014 2015 2016-2020
Projected future contributions Unfunded U.S. retirement plans Unfunded international retirement plans
$ 36 $ 18
38 17
40 19
43 19
46 23
300 128
Each pension plan is overseen by a local committee or board that is responsible for the overall administration and investment of the pension plans. In determining investment policies, strategies and goals, each committee or board considers factors including, local pension rules and regulations; local tax regulations; availability of investment vehicles (separate accounts, commingled accounts, insurance funds, etc.); funded status of the plans; ratio of actives to retirees; duration of liabilities; and other relevant factors including, diversification, liquidity of local markets and liquidity o f base currency. A majority of the Company‟s pension funds are open to new entrants and are expected to be on-going plans. Permitted investments are primarily liquid and/or listed, with little reliance on illiquid and non-traditional investments such as hedge funds. An asset allocation of 75% equities and 25% fixed income is generally pursued unless local regulations and illiquidity require otherwise. The Company‟s retirement plan asset allocation at the end of 2010 and 2009 and target allocations for 201 1 are as follows:
Percent of Plan Assets 2010 2009 Target Allocation 2011
U.S. Retirement Plans Equity securities Debt securities Total plan assets International Retirement Plans Equity securities Debt securities Real estate and other Total plan assets
79 % 21 100 %
76 % 24 100 %
75 % 25 100 %
65 % 35 — 100 %
65 % 34 1 100 %
65 % 35 — 100 %
The Company‟s other benefit plans are unfunded except for U.S. life insurance contract assets of $14 million and $16 million at January 2, 2011 and January 3, 2010, respectively. The fair value of Johnson & Johnson Common Stock directly held in plan assets was $453 million (3.4% of total plan assets) at January 2, 2011 and $469 million (4.3% of total plan assets) at January 3, 2010. Determination of Fair Value The Plan has an established and well-documented process for determining fair values. Fair value is based upon quoted market prices, where available. If listed prices or quotes are not available, fair value is based upon models that primarily use, as inputs, market-based or independently sourced market parameters, including yield curves, interest rates, volatilities, equity or debt prices, foreign exchange rates and credit curves. While the Plan believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date. Valuation Hierarchy The authoritative literature establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described in the table below with Level 1 having the highest priority and Level 3 having the lowest. A financial instrument‟s categorization within the valuation hierarchy is based upon the lowest level of input that is signif icant to the fair value measurement.
56
JOHNSON & JOHNSON 2010 ANNUAL REPORT
Following is a description of the valuation methodologies used for the investments measured at fair value. • Short-term investments — Cash and quoted short-term instruments are valued at the closing price or the amount held on deposit by the custodian bank. Other investments are through investment vehicles valued using the Net Asset Value (NAV) provided by the administrator of the fund. The NAV is based on the value of the underlying assets owned by the fund, minus its liabilities, and then divided by the number of shares outstanding. The NAV is a quoted price in a market that is not active and classified as Level 2. • Government and agency securities — A limited number of these investments are valued at the closing price reported on the major market on which the individual securities are traded. Where quoted prices are available in an active market, the investments are classified within Level 1 of the valuation hierarchy. If quoted market prices are not available for the specific security, then fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows. When quoted market prices for a security are not available in an active market, they are classified as Level 2. • Debt instruments — A limited number of these investments are valued at the closing price reported on the major market on which the individual securities are traded. Where quoted prices are available in an active market, the investments are classified as Level 1. If quoted market prices are not available for the specific security, then fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows and are classified as Level 2. Level 3 debt instruments are priced based on unobservable inputs. • Equity securities — Common stocks are valued at the closing price reported on the major market on which the individual securities are traded. Substantially all common stock is classified within Level 1 of the valuation hierarchy. • Commingled funds — The investments are public investment vehicles valued using the NAV provided by the fund administrator. The NAV is based on the value of the underlying assets owned by the fund, minus its liabilities, and then divided by the number of shares outstanding. Assets in the Level 2 category have a quoted market price in a market that is not active. • Insurance contracts — The instruments are issued by insurance companies. The fair value is based on negotiated value and the underlying investments held in separate account portfolios as well as considering the credit worthiness of the issuer. The underlying investments are government, asset-backed and fixed income securities. In general, insurance contracts are classified as Level 3 as there are no quoted prices nor other observable inputs for pricing. • Other assets — Other assets are represented primarily by limited partnerships and real estate investments, as well as commercial loans and commercial mortgages that are not classified as corporate debt. Other assets that are exchange listed and actively traded are classified as Level 1, while inactively traded assets are classified as Level 2. Most limited partnerships represent investments in private equity and similar funds that are valued by the general partners. These, as well as any other assets valued using unobservable inputs, are classified as Level 3. The following table sets forth the trust investments measured at fair value as of January 2, 2011 and January 3, 2010:
Quoted Prices in Active Markets for Identical Assets (Level 1) 2010 2009 Significant Other Observable Inputs (Level 2) 2010 2009 Significant Unobservable Inputs (Level 3) 2010 2009
(Dollars in Millions)
Total Assets 2010 2009
Short-term investment funds Government and agency securities Debt instruments Equity securities Commingled funds Insurance contracts Other assets Trust investments at fair value
$
80 69 5 6,744 1 — 10
91 — 3 5,068 — — 31 5,193
371 1,484 1,149 14 3,173 — 150 6,341
358 1,165 1,145 58 2,673 — 171 5,570
— — 13 24 35 29 82 183
— — 5 15 26 32 82 160
451 1,553 1,167 6,782 3,209 29 242 13,433
449 1,165 1,153 5,141 2,699 32 284 10,923
$ 6,909
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
57
Level 3 Gains and Losses The table below sets forth a summary of changes in the fair value of the Plan‟s Level 3 assets for the years ended January 2, 2011 and January 3, 2010:
Debt (Dollars in Millions) Instruments Equity Securities Commingled Funds Insurance Contracts Other Assets Total Level 3
Balance December 28, 2008 Realized gains (losses) Unrealized gains (losses) Purchases, sales, issuances and settlements, net Balance January 3, 2010 Realized gains (losses) Unrealized gains (losses) Purchases, sales, issuances and settlements, net Balance January 2, 2011
$
7 — 2 (4 ) 5 (1 ) 1 8
15 — (2 ) 2 15 — 4 5 24
15 — (2 ) 13 26 — 4 5 35
29 3 — — 32 (3 ) — — 29
85 — (3 ) — 82 1 (3 ) 2 82
151 3 (5 ) 11 160 (3 ) 6 20 183
$
13
11.
Savings Plan
The Company has voluntary 401(k) savings plans designed to enhance the existing retirement programs covering eligible employees. The Company matches a percentage of each employee‟s contributions consistent with the provisions of the plan for w hich he/she is eligible. Total Company matching contributions to the plans were $157 million, $163 million and $166 million in 2010, 2009 and 2008, respectively. 12. Capital and Treasury Stock Changes in treasury stock were:
(Amounts in Millions Except Treasury Stock Number of Shares in Thousands) Treasury Stock Shares Amount
Balance at December 30, 2007 Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Balance at December 28, 2008 Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Balance at January 3, 2010 Employee compensation and stock option plans Conversion of subordinated debentures Repurchase of common stock Balance at January 2, 2011
279,620 (29,906 ) (19 ) 100,970 350,665 (22,161 ) (96 ) 37,114 365,522 (28,827 ) (39 ) 45,090 381,746
$ 14,388 (2,005 ) (1 ) 6,651 19,033 (1,377 ) (6 ) 2,130 19,780 (1,792 ) (2 ) 2,797 $ 20,783
Aggregate shares of Common Stock issued were approximately 3,119,843,000 shares at the end of 2010, 2009 and 2008. Cash dividends paid were $2.110 per share in 2010, compared with dividends of $1.930 per share in 2009, and $1.795 per share in 2008. 13. Accumulated Other Comprehensive Income Components of other comprehensive income/(loss) consist of the following:
Total Accumulated Other
Foreign
Gains/
Gains/ (Losses) on
Currency (Dollars in Millions) Translation
(Losses) on Securities
Employee Benefit Plans
Derivatives & Hedges
Comprehensive Income/(Loss)
December 30, 2007 2008 changes Unrealized gain (loss) Net amount reclassed to net earnings Net 2008 changes December 28, 2008 2009 changes Unrealized gain (loss) Net amount reclassed to net earnings Net 2009 changes January 3, 2010 2010 changes Unrealized gain (loss) Net amount reclassed to net earnings Net 2010 changes January 2, 2011
$
628 — — (2,499 )
84 (32 ) (27 ) (59 ) 25 (52 ) (3 ) (55 ) (30 ) 99 (45 ) 54 24
(1,360 ) — — (1,870 ) (3,230 ) — — 565 (2,665 ) — — (21 ) (2,686 )
(45 ) 94 72 166 121 38 (14 ) 24 145 (333 ) 288 (45 ) 100
(693 )
(4,262 ) (4,955 )
$
(1,871 ) — — 1,363
1,897 (3,058 )
$
(508 ) — — (461 )
(473 ) (3,531 )
$
(969 )
The tax effect on the unrealized gains/(losses) on the equity securities was expense of $13 million in 2010, income of $14 million in 2009 and expense of $14 million in 2008. The tax effect related to employee benefit plans was $11 million, $302 million and $1,090 million in 2010, 2009 and 2008, respectively. The tax effect on the gains/(losses) on derivatives and hedges was expense of $54 million, $78 million and $70 million in 2010, 2009 and 2008, respectively. See Note 6 for additional information relating to derivatives and hedging. The currency translation adjustments are not adjusted for income taxes as they relate to permanent investments in international subsidiaries.
58
JOHNSON & JOHNSON 2010 ANNUAL REPORT
14.
International Currency Translation
For translation of its subsidiaries operating in non-U.S. Dollar currencies, the Company has determined that the local currencies of its international subsidiaries are the functional currencies except those in highly inflationary economies, which are defined as those which have had compound cumulative rates of inflation of 100% or more during the past three years, or where a substantial portion of its cash flows are not in the local currency. In consolidating international subsidiaries, balance sheet currency effects are recorded as a component of accumulated other comprehensive income. This equity account includes the results of translating all balance sheet assets and liabilities at current exchange rates, except for those located in highly inflationary economies. The translation of balance sheet accounts for highly inflationary economies are reflected in the operating results. An analysis of the changes during 2010, 2009 and 2008 for foreign currency translation adjustments is included in Note 13. Net currency transaction gains and losses included in other (income) expense were losses of $130 million, $210 million and $31 million in 2010, 2009 and 2008, respectively. 15. Earnings Per Share
The following is a reconciliation of basic net earnings per share to diluted net earnings per share for the fiscal years ended January 2, 2011, January 3, 2010 and December 28, 2008:
(In millions Except Per Share Data) 2010 2009 2008
Basic net earnings per share Average shares outstanding — basic Potential shares exercisable under stock option plans Less: shares repurchased under treasury stock method Convertible debt shares Adjusted average shares outstanding — diluted Diluted net earnings per share
$
4.85 2,751.4 156.1 (122.3 ) 3.6 2,788.8 4.78
4.45 2,759.5 118.0 (92.0 ) 3.6 2,789.1 4.40
4.62 2,802.5 179.0 (149.6 ) 3.7 2,835.6 4.57
$
The diluted net earnings per share calculation includes the dilutive effect of convertible debt that is offset by the related reduction in interest expense of $4 million after-tax for years 2010, 2009 and 2008. Diluted net earnings per share excludes 66 million, 121 million and 59 million shares underlying stock options for 2010, 2009 and 2008, respectively, as the exercise price of these options was greater than their average market value, which would result in an antidilutive effect on diluted earnings per share. 16. Rental Expense and Lease Commitments
Rentals of space, vehicles, manufacturing equipment and office and data processing equipment under operating leases were approximately $299 million, $322 million and $309 million in 2010, 2009 and 2008, respectively. The approximate minimum rental payments required under operating leases that have initial or remaining non-cancelable lease terms in excess of one year at January 2, 2011 are: (Dollars in Millions)
After 2015
2011
2012
2013
2014
2015
Total
$182
159
130
106
89
74
740
Commitments under capital leases are not significant. 17. Common Stock, Stock Option Plans and Stock Compensation Agreements
At January 2, 2011, the Company had 7 stock-based compensation plans. The shares outstanding are for contracts under the Company‟s 2000 Stock Option Plan, the 2005 Long-Term Incentive Plan, the 1997 Non-Employee Director‟s Plan and the ALZA Corporation, Inverness Medical Technology, Inc., and Scios Inc. Stock Option Plans. During 2010, no options or restricted shares were granted under any of these plans except under the 2005 Long-Term Incentive Plan.
The compensation cost that has been charged against income for these plans was $614 million, $628 million and $627 million for 2010, 2009 and 2008, respectively. The total income tax benefit recognized in the income statement for share-based compensation costs was $205 million, $210 million and $210 million for 2010, 2009 and 2008, respectively. The total unrecognized compensation cost was $613 million as of January 2, 2011, $612 million as of January 3, 2010 and $632 million as of December 28, 2008. The weighted average period for this cost to be recognized was 1.05 years, 1.16 years and 1.06 years for 2010, 2009, and 2008, respectively. Share-based compensation costs capitalized as part of inventory were insignificant in all periods. Stock Options Stock options expire 10 years from the date of grant and vest over service periods that range from six months to four years. All options are granted at the average of the high and low prices of the Company‟s Common S tock on the New York Stock Exchange on the date of grant. Under the 2005 Long-Term Incentive Plan, the Company may issue up to 260 million shares of common stock. Shares available for future grants under the 2005 Long-Term Incentive Plan were 121.3 million at the end of 2010. The Company settles employee stock option exercises with treasury shares. Treasury shares are replenished throughout the year for the number of shares used to settle employee stock option exercises. The fair value of each option award was estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted in the following table. Expected volatility represents a blended rate of 4-year daily historical average volatility rate, and a 5-week average implied volatility rate based on at-the-money traded Johnson & Johnson options with a life of 2 years. Historical data is used to determine the expected life of the option. The risk-free rate was based on the U.S. Treasury yield curve in effect at the time of grant. The average fair value of options granted was $8.03, $8.35 and $7.66, in 2010, 2009, and 2008, respectively. The fair value was estimated based on the weighted average assumptions of:
2010 2009 2008
Risk-free rate Expected volatility Expected life Dividend yield
2.78 % 17.4 % 6.0yrs 3.30 %
2.71 % 19.5 % 6.0yrs 3.30 %
2.97 % 15.0 % 6.0yrs 2.90 %
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
59
A summary of option activity under the Plan as of January 2, 2011, January 3, 2010 and December 28, 2008 and changes during the years ending on those dates is presented below:
Aggregate Intrinsic Value (Dollars in Millions)
Outstanding (Shares in Thousands) Shares
Weighted Average Exercise Price
Shares at December 30, 2007 Options granted Options exercised Options canceled/forfeited Shares at December 28, 2008 Options granted Options exercised Options canceled/forfeited Shares at January 3, 2010 Options granted Options exercised Options canceled/forfeited Shares at January 2, 2011
228,629 22,428 (30,033 ) (5,525 ) 215,499 21,576 (18,225 ) (6,131 ) 212,719 13,996 (25,020 ) (8,005 ) 193,690
$
56.83 61.80 50.27 61.90 58.14 58.32 50.97 61.85 58.66 62.62 51.84 62.36
$
2,411
$
597
$
1,310
$
59.68
$
648
The total intrinsic value of options exercised was $278 million, $184 million and $506 million in 2010, 2009 and 2008, respectively. The following table summarizes stock options outstanding and exercisable at January 2, 2011:
(Shares in Thousands) Exercise Price Range Outstanding Average Life (1) Average Exercise Price Exercisable Average Exercise Options Price
Options
$25.00-$40.08 $41.26-$49.86 $50.52-$52.80 $53.00-$53.93 $54.04-$57.30 $57.44-$58.34 $58.42-$65.10 $65.62-$68.37
50 532 20,155 24,114 24,332 39,343 33,020 52,144 193,690
0.9 0.5 2.1 3.0 1.1 6.5 7.8 4.8 4.7
$ 29.53 47.43 52.20 53.93 57.28 58.33 62.11 65.97 $ 59.68
50 532 20,115 24,114 24,332 20,175 1,147 50,810 141,275
$ 29.53 47.43 52.20 53.93 57.28 58.33 61.21 65.98 $ 59.25
(1)
Average contractual life remaining in years.
Stock options exercisable at January 3, 2010 and December 28, 2008 were 148,349 at an average price of $57.26 and an average life of 5.0 years and 144,962 at an average price of $56.25 and an average life of 5.3 years, respectively. Restricted Share Units The Company grants restricted share units with a vesting period of three years. The Company settles employee stock issuances with treasury shares. Treasury shares are replenished throughout the year for the number of shares used for employee stock issuances.
A summary of share activity under the Plan as of January 2, 2011:
Outstanding Shares
(Shares in Thousands)
Shares at December 30, 2007 Granted Issued Canceled/forfeited Shares at December 28, 2008 Granted Issued Canceled/forfeited Shares at January 3, 2010 Granted Issued Canceled/forfeited Shares at January 2, 2011
13,661 10,105 (40 ) (1,468 ) 22,258 11,172 (5,714 ) (1,392 ) 26,324 12,003 (6,297 ) (2,296 ) 29,734
The average fair value of the restricted share units granted was $56.69, $52.79 and $56.70 in 2010, 2009 and 2008, respectively, using the fair market value at the date of grant. The fair value of restricted share units was discounted for dividends, which are not paid on the restricted share units during the vesting period. The fair value of restricted share units settled was $375.0 million, $308.4 million and $2.5 million in 2010, 2009 and 2008, respectively.
60
JOHNSON & JOHNSON 2010 ANNUAL REPORT
18.
Segments of Business (1) and Geographic Areas
Sales to Customers (2) 2009
(Dollars in Millions)
2010
2008
Consumer — United States International Total Pharmaceutical — United States International Total Medical Devices and Diagnostics — United States International Total Worldwide total
$
5,519 9,071 14,590 12,519 9,877 22,396 11,412 13,189 24,601
6,837 8,966 15,803 13,041 9,479 22,520 11,011 12,563 23,574 61,897
6,937 9,117 16,054 14,831 9,736 24,567 10,541 12,585 23,126 63,747
$ 61,587
(Dollars in Millions)
2010 (5)
Operating Profit 2009 (6)
2008 (7)
2010
Identifiable Assets 2009
2008
Consumer Pharmaceutical Medical Devices and Diagnostics Total Less: Expense not allocated to segments (3) General corporate (4) Worldwide total
$
2,342 7,086 8,272 17,700 753
2,475 6,413 7,694 16,582 827 15,755
2,674 7,605 7,223 17,502 573 16,929
$
23,753 19,961 23,277 66,991 35,917
24,671 21,460 22,853 68,984 25,698 94,682
23,765 19,544 20,779 64,088 20,824 84,912
$ 16,947
$ 102,908
(Dollars in Millions)
Additions to Property, Plant & Equipment 2010 2009
2008
2010
Depreciation and Amortization 2009
2008
Consumer Pharmaceutical Medical Devices and Diagnostics Segments total General corporate Worldwide total
$
526 508 1,113 2,147 237
439 535 1,114 2,088 277 2,365
499 920 1,251 2,670 396 3,066
$
532 912 1,270 2,714 225
513 922 1,124 2,559 215 2,774
489 986 1,146 2,621 211 2,832
$ 2,384
$ 2,939
(Dollars in Millions)
2010
Sales to Customers (2) 2009
2008
2010
Long-Lived Assets (8) 2009
2008
United States Europe Western Hemisphere excluding U.S. Asia-Pacific, Africa Segments total General corporate Other non long-lived assets
$ 29,450 15,510 5,550 11,077 61,587
30,889 15,934 5,156 9,918 61,897
32,309 16,782 5,173 9,483 63,747
$
23,315 16,791 3,653 2,089 45,848 715 56,345
22,399 17,347 3,540 1,868 45,154 790 48,738
21,674 14,375 3,328 1,898 41,275 785 42,852
Worldwide total
--
$ 61,587
61,897
63,747
$ 102,908
94,682
84,912
(1) See Note 1 for a description of the segments in which the Company operates. (2) Export sales are not significant. In 2010, 2009 and 2008, the Company did not have a customer that represented 10% of total
revenues.
(3) Amounts not allocated to segments include interest (income) expense, non-controlling interests and general corporate (income)
expense.
(4) General corporate includes cash and marketable securities.
(5) Includes $966 million of net litigation gain, comprised of a $333 million expense in the Pharmaceutical segment and a gain of
$1,299 million in the Medical Devices and Diagnostics segment. Includes $569 million of product liability expense, comprised of $114 million in the Pharmaceutical segment and $455 million in the Medical Devices and Diagnostics segment. The Medical Devices and Diagnostics segment also includes $280 million expense for the cost associated with the DePuy ASR TM Hip recall program.
(6) Includes $1,186 million of restructuring expense, comprised of $369 million, $496 million, and $321 million for the Consumer,
Pharmaceutical, and Medical Devices and Diagnostics segments, respectively. Includes $386 million of fourth quarter net litigation gain, comprised of a $92 million expense in the Pharmaceutical segment and a gain of $478 million in the Medical Devices and Diagnostics segment.
(7) Includes $7 million and $174 million of IPR&D for the Consumer and Medical Devices and Diagnostics segments, respectively.
Includes $379 million of fourth quarter net litigation gain, comprised of a $50 million expense in the Consumer segment and a gain of $429 million in the Medical Devices and Diagnostics segment. The Medical Devices and Diagnostics segment also includes a $536 million gain on the divestiture of the Professional Wound Care business of Ethicon, Inc.
(8) Long-lived assets include property, plant and equipment, net for 2010, 2009 and 2008 of $14,553, $14,759 and $14,365,
respectively, and intangible assets and goodwill, net for 2010, 2009 and 2008 of $32,010, $31,185 and $27,695, respectively.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
61
19.
Selected Quarterly Financial Data (unaudited) Selected unaudited quarterly financial data for the years 2010 and 2009 are summarized below:
2010 First Second Quarter (2) Third Quarter Fourth Quarter (3) First Quarter Second Quarter 2009 Third Quarter Fourth Quarter (4)
(Dollars in Millions Except Per Share Data)
Quarter (1)
Segment sales to customers Consumer Pharmaceutical Med Devices & Diagnostics Total sales Gross profit Earnings before provision for taxes on income Net earnings Basic net earnings per share Diluted net earnings per share
$
3,766 5,638 6,227
3,647 5,553 6,130 15,330 10,700
3,567 5,495 5,920 14,982 10,388
3,610 5,710 6,324 15,644 10,604
3,711 5,780 5,535 15,026 10,775
3,854 5,498 5,887 15,239 10,789
3,989 5,249 5,843 15,081 10,647
4,249 5,993 6,309 16,551 11,239
$ 15,631 11,103
6,280 4,526
4,220 3,449
4,219 3,417
2,228 1,942
4,643 3,507
4,263 3,208
4,245 3,345
2,604 2,206
$
1.64
1.25
1.24
0.71
1.27
1.16
1.21
0.80
$
1.62
1.23
1.23
0.70
1.26
1.15
1.20
0.79
(1) The first quarter of 2010 includes $910 million after-tax of income from net litigation.
(2) The second quarter of 2010 includes $67 million after-tax of income from net litigation.
(3) The fourth quarter of 2010 includes an after-tax charge of $279 million from net litigation settlements, an after-tax charge of
$404 million for product liability expense and an after-tax charge of $239 million for the cost associated with the DePuy ASR TM Hip recall program.
(4) The fourth quarter of 2009 includes an after-tax charge of $852 million for restructuring and $212 million after-tax of income from
net litigation. 20. Business Combinations and Divestitures
Certain businesses were acquired for $1,269 million in cash and $52 million of liabilities assumed during 2010. These acquisitions were accounted for by the purchase method and, accordingly, results of operations have been included in the financial statements from their respective dates of acquisition. The 2010 acquisitions included: Acclarent, Inc., a privately held medical technology company dedicated to designing, developing and commercializing devices that address conditions affecting the ear, nose and throat (ENT); RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases and Micrus Endovascular Corporation, a global developer and manufacturer of minimally invasive devices for hemorrhagic and ischemic stroke. The excess of purchase price over the estimated fair value of tangible assets acquired amounted to $1,185 million and has been assigned to identifiable intangible assets, with any residual recorded to goodwill. Of this amount, approximately $213 million has been identified as the value of IPR&D associated with the acquisitions of Acclarent, Inc., RespiVert Ltd. and Micrus Endovascular Corporation. The IPR&D related to the acquisition of Acclarent, Inc. was $75 million and is associated with novel, endoscopic, catheter-based devices to meet the needs of ENT patients. The value of the IPR&D was calculated using cash flow projections discounted for the risk
inherent in such projects. Probability of success factors ranging from 50-53% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 16%. The IPR&D related to the acquisition of RespiVert Ltd., was $100 million and is associated with narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities as treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF). The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 10-12% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 17%. The IPR&D related to the acquisition of Micrus Endovascular Corporation was $38 million and is associated with ischemic and flow diverter technologies. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 50-75% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 14%. During 2010, the Company announced an agreement to acquire all outstanding equity of Crucell N.V. that it does not already own for approximately $2.3 billion in a cash tender offer. As of January 2, 2011 the Company held approximately 18% of Crucell‟s outstanding ordinary shares. Crucell is a global biopharmaceutical company focused on the research & development, production and marketing of vaccines and antibodies against infectious disease worldwide. On February 22, 2011, the Company announced that the tender offer for Crucell has been completed and has declared the offer unconditional. Certain businesses were acquired for $2,470 million in cash and $875 million of liabilities assumed and non-controlling interests during 2009. These acquisitions were accounted for by the purchase method and, accordingly, results of operations have been included in the financial statements from their respective dates of acquisition. The 2009 acquisitions included: Mentor Corporation, a leading supplier of medical products for the global aesthetics market; Cougar Biotechnology, Inc., a development stage biopharmaceutical company with a specific focus on oncology; Finsbury Orthopaedics Limited, a privately held UK-based manufacturer and global distributor of orthopaedic implants; Gloster Europe, a privately held developer of innovative disinfection processes and technologies to prevent healthcare-acquired infections and substantially all of the assets and rights of Elan‟s Alzheimer‟s Immunotherapy Program through a newly formed company, of whi ch the Company owns 50.1% and Elan owns 49.9%.
62
JOHNSON & JOHNSON 2010 ANNUAL REPORT
The excess of purchase price over the estimated fair value of tangible assets acquired amounted to $2,940 million and has been assigned to identifiable intangible assets, with any residual recorded to goodwill. Of this amount, approximately $1,737 million has been identified as the value of IPR&D primarily associated with the acquisitions of Cougar Biotechnology, Inc. and substantially all of the assets and rights of Elan‟s Alzheimer‟s Immunotherapy Program. Additionally, approximately $1,107 million has been identified as the value of other intangible assets, including patents & technology and customer relationships primarily associated with the acquisition of Mentor Corporation. The IPR&D related to the acquisition of Cougar Biotechnology, Inc. was $971 million and is associated with abiraterone acetate, a late stage, first-in-class compound for the treatment of prostate cancer. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 60 — 85% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 23.5%. During 2009, the Company acquired substantially all of the assets and rights of Elan‟s Alzheimer‟s Immunotherapy Program through a newly formed company, Janssen Alzheimer Immunotherapy (JAI), of which the Company owns 50.1% and Elan owns 49.9%. In addition, the Company purchased approximately 107 million newly issued American Depositary Receipts (ADRs) of Elan, representing 18.4% of Elan‟s outstanding ordinary shares. As part of this transaction, the Company paid $885 million to Elan and committed to fund up to $250 million of Elan‟s share of research and development spending by JAI. Of this total consideration of $1,135 million, $793 million represents the fair value of the 18.4% investment in Elan based on Elan‟s share price in an actively traded market as of the date of this transaction. The IPR&D related to this transaction was $679 million and is associated with bapineuzumab, a potential first-in-class treatment that is being evaluated for slowing the progression of Alzheimer‟s Disease. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 40 — 50% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 26%. The non-controlling interest related to this transaction was $590 million, which the Company has recorded in other non-current liabilities. Certain businesses were acquired for $1,214 million in cash and $114 million of liabilities assumed during 2008. These acquisitions were accounted for by the purchase method and, accordingly, results of operations have been included in the financial statements from their respective dates of acquisition. The 2008 acquisitions included: Amic AB, a privately held Swedish developer of in vitro diagnostic technologies for use in pointof-care and near-patient settings; Beijing Dabao Cosmetics Co., Ltd., a company that sells personal care brands in China; SurgRx, Inc., a privately held developer of the advanced bipolar tissue sealing system used in the ENSEAL ® family of devices; HealthMedia, Inc., a privately held company that creates web-based behavior change interventions; LGE Performance Systems, Inc., a privately held company known as Human Performance Institute TM , which develops science-based training programs to improve employee engagement and productivity and Omrix Biopharmaceuticals, Inc., a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products. The excess of purchase price over the estimated fair value of tangible assets acquired amounted to $891 million and has been assigned to identifiable intangible assets, with any residual recorded to goodwill. Approximately $181 million has been identified as the value of IPR&D associated with the acquisitions of Omrix Biopharmaceuticals, Inc., Amic AB, SurgRx, Inc. and HealthMedia, Inc. The IPR&D charge related to the acquisition of Omrix Biopharmaceuticals, Inc. was $127 million and is associated with standalone and combination biosurgical technologies used to achieve hemostasis. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 60 — 90% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 14%. The IPR&D charge related to the acquisition of Amic AB was $40 million and is associated with point-of-care device and 4CAST Chip technologies. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. The discount rate applied was 20%. The IPR&D charge related to the acquisition of SurgRx, Inc. was $7 million and is associated with vessel cutting and sealing surgical devices. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. Probability of success factors ranging from 90 — 95% were used to reflect inherent clinical and regulatory risk. The discount rate applied was 18%. The IPR&D charge related to the acquisition of HealthMedia, Inc. was $7 million and is associated primarily with process enhancements to software technology. The value of the IPR&D was calculated using cash flow projections discounted for the risk inherent in such projects. A probability of success factor of 90% was used to reflect inherent risk. The discount rate applied was 14%. Supplemental pro forma information for 2010, 2009 and 2008 in accordance with U.S. GAAP standards related to business combinations, and goodwill and other intangible assets, is not provided, as the impact of the aforementioned acquisitions did not have a material effect on the Company‟s results of operations, cash flows or financial position.
With the exception of the divestiture of the Breast Care Business of Ethicon Endo-Surgery Inc., for which the gain is recorded in other (income) expense in 2010, and the divestiture of the Professional Wound Care business of Ethicon, Inc., which resulted in a gain of $536 million before tax, and is recorded in other (income) expense, net, in 2008, divestitures in 2010, 2009 and 2008 did not have a material effect on the Company‟s results of operations, cash flows or financial position.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
63
21.
Legal Proceedings
Product Liability The Company‟s subsidiaries are involved in numerous product liability cases in the United States, many of which concern alleg ed adverse reactions to drugs and medical devices. The damages claimed are substantial, and while the Company is confident of the adequacy of the warnings and instructions for use that accompany such products, it is not feasible to predict the ultimate outcome of litigation. The Company has established product liability reserves based on currently available information, which in some cases may be limited and changes to the reserves may be required in the future as additional information becomes available. Multiple products of Johnson & Johnson subsidiaries are subject to numerous product liability claims and lawsuits. There are a significant number of claimants who have pending lawsuits or claims regarding injuries allegedly due to ORTHO EVRA ® , RISPERDAL ® , LEVAQUIN ® , DURAGESIC ® , the CHARITÉ TM Artificial Disc, CYPHER ® Stent, and ASR TM Hip. These claimants seek substantial compensatory and, where available, punitive damages. With respect to RISPERDAL ® , the Attorneys General of multiple states and the Office of General Counsel of the Commonwealth of Pennsylvania have filed actions seeking reimbursem*nt of Medicaid or other public funds for RISPERDAL ® prescriptions written for off-label use, compensation for treating their citizens for alleged adverse reactions to RISPERDAL ® , civil fines or penalties, damages for “overpayments” by t he state and others, punitive damages, or other relief. The Attorney General of Texas has joined a qui tam action in that state seeking similar relief. Certain of these actions also seek injunctive relief relating to the promotion of RISPERDAL ® . The Attorneys General of approximately 40 other states have indicated a potential interest in pursuing similar litigation against the Company‟s subsidiary, Janssen Pharmaceutica Inc. (Janssen) (now Ortho -McNeil-Janssen Pharmaceuticals Inc. (OMJPI)), and have obtained a tolling agreement staying the running of the statute of limitations while they pursue a coordinated civil investigation of OMJPI regarding potential consumer fraud actions in connection with the marketing of RISPERDAL ® . In addition, there are six cases filed by union health plans seeking damages for alleged overpayments for RISPERDAL ® , several of which seek certification as class actions. One of these has been dismissed on Summary Judgment. In the case brought by the Attorney General of West Virginia, based on claims for alleged consumer fraud as to DURAGESIC ® as well as RISPERDAL ® , Janssen (now OMJPI) was found liable and damages were assessed at $4.5 million. OMJPI filed an appeal. The West Virginia Supreme Court accepted Janssen‟s appeal from that Judgment and the appeal was argued in September 2010. In October 2010, the West Virginia Supreme Court unanimously reversed the trial court‟s decision. In December 2010, the Attorney General dismissed the case as it related to RISPERDAL ® without any payment. Thereafter, the Company settled the case insofar as it related to DURAGESIC ® . In September and October 2010, a false claim suit brought under a Louisiana statute was tried. The jury returned a verdict of $257.7 million in favor of that State‟s Attorney General and against Janssen and the Company. Post-trial motions challenging the verdict will be filed, and if unsuccessful, will be followed by an appeal. The Company believes that it has strong arguments supporting an appeal. The Company believes that the potential for an unfavorable outcome is not probable, therefore, it has not established a reserve with respect to the verdict. In the Commonwealth of Pennsylvania suit against Janssen, trial commenced in June 2010. The Judge dismissed the case after the close of the plaintiff‟s evidence. The Commonwealth has filed post -trial motions which are pending. Other cases scheduled for trial are in South Carolina, currently scheduled in March 2011, and Texas scheduled in June 2011. In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR TM XL Acetabular System and DePuy ASR TM Hip Resurfacing System used in hip replacement surgery. Claims for personal injury have been made against the Company. The Company has received limited information to date with respect to potential claims and other costs associated with this recall. The Company‟s product liability reserve has been increased in part due to anticipated product liability expense, and costs associated with the DePuy ASR TM Hip recall. However, at this point in time, the Company cannot estimate the range of reasonably possible losses with respect to this matter and changes to the reserve may be required in the future as additional information becomes available. Patent Litigation The products of various Johnson & Johnson subsidiaries are the subject of various patent lawsuits, the outcomes of which could potentially adversely affect the ability of those subsidiaries to sell those products, or require the payment of past damages and future royalties. On January 29, 2010, Cordis Corporation (Cordis) settled a patent infringement action against Boston Scientific Corporation (Boston Scientific) in Delaware Federal District Court accusing its Express2 TM , Taxus ® and Liberte ® stents of infringing the Palmaz and Gray patents. Under the terms of the settlement, Boston Scientific dropped its lawsuit in which Cordis‟ CYPHER ® stent was found to have infringed their Jang patent and paid Cordis $1.0 billion on February 1, 2010. Boston Scientific also agreed to pay Cordis an additional $725 million plus interest by January 3, 2011. On August 2, 2010, Boston Scientific paid the full $725 million plus interest. The Company recorded the $1.7 billion in the fiscal first quarter of 2010. Cordis granted Boston Scientific a worldwide license under the Palmaz and Gray patents and Boston Scientific granted Cordis a worldwide license under the Jang patents for all stents sold by Cordis except the 2.25mm size CYPHER ® .
Cordis has several pending lawsuits in the New Jersey and Delaware Federal District Courts, against Guidant Corporation (Guidant), Abbott Laboratories, Inc. (Abbott), Boston Scientific and Medtronic Ave, Inc. (Medtronic) alleging that the Xience V TM (Abbott), Promus TM (Boston Scientific) and Endeavor ® (Medtronic) drug eluting stents infringe several patents owned by or licensed to Cordis. On January 20, 2010, in one of the cases against Boston Scientific, alleging that sales of their Promus TM stent infringed
64
JOHNSON & JOHNSON 2010 ANNUAL REPORT
Wright and Falotico patents, the District Court in Delaware found the Wright/Falotico patent invalid for lack of written description and/or lack of enablement. Cordis has appealed this ruling. In January 2011, a jury in the Eastern District of Texas returned a verdict finding that Cordis‟ sales of its CYPHER ® stent willfully infringed a patent issued to plaintiff, Bruce Saffran: Saffran v. Cordis (E.D. Tx.). The jury awarded plaintiff $482 million. Cordis has alleged that plaintiff‟s patent is invalid or unenforceable under the doctrine of inequitable conduct. A bench trial on t his issue is expected to take place in March 2011. If unsuccessful on this defense, the Company will seek to overturn the verdict through post-trial motions, and on appeal if necessary. Since the Company believes that the potential for an unfavorable outcome is not probable, it has not established a reserve with respect to the case. In October 2004, Tyco Healthcare Group, LP, (Tyco) and U.S. Surgical Corporation sued Ethicon Endo-Surgery, Inc. (EES) alleging that several features of EES‟s harmonic scalpel infringed four Tyco patents. In October 2007, the court granted in p art and denied in part cross-motions for summary judgment. As a result of the opinion, a number of claims have been found invalid and a number have been found infringed. No claim has been found valid and infringed. Trial commenced in December 2007, and the court dismissed the case without prejudice on grounds that Tyco did not own the patents in suit. The dismissal without prejudice was affirmed on appeal. In January 2010, Tyco filed another complaint in the District of Connecticut asserting three of the four patents from the previous suit and adding new products. This case is scheduled to be tried in October 2011. In May 2008, Centocor, Inc. (now Centocor Ortho Biotech Inc. (COBI)) filed a lawsuit against Genentech, Inc. (Genentech) in U.S. District Court for the Central District of California seeking to invalidate the Cabilly II patent. Prior to filing suit, COBI had a sublicense under this patent from Celltech (who was licensed by Genentech) for REMICADE ® and had been paying royalties to Celltech. COBI has terminated that sublicense and stopped paying royalties. Genentech has filed a counterclaim alleging that REMICADE ® infringes its Cabilly II patents. Genentech has dropped all its other claims that the manufacture of REMICADE ® , STELARA ® , SIMPONI ® and ReoPro ® also infringes one of its other patents relating to the purification of antibodies made through recombinant DNA techniques. The court conducted a hearing on Summary Judgment Motions in August 2010. Shortly thereafter the parties settled this case with COBI receiving license under the Cabilly II patent. In January 2011, Genentech initiated an arbitration against Celltech seeking damages for allegedly cooperating with COBI to improperly terminate a prior agreement in which COBI was sublicensed under the Cabilly patents. COBI has an indemnity agreement with Celltech, and Celltech has asserted that COBI is liable for any damages Celltech may be required to pay Genentech, in that arbitration. In April 2009, a bench trial was held before the Federal District Court for the Middle District of Florida on the liability phase of CIBA VISION Corporation‟s (CIBA) patent infringement lawsuit alleging that Johnson & Johnson Vision Care, Inc.‟s (JJVC) ACUVUE ® OASYS TM lenses infringe three of their Nicholson patents. In August 2009, the District Court found two of these patents valid and infringed and entered judgment against JJVC. JJVC appealed that judgment to the Court of Appeals for the Federal Circuit. On April 27, 2010, the District Court denied CIBA‟s motion to permanently enjoin the infringing lenses. CIBA ap pealed this ruling and its appeal was consolidated with JJVC‟s appeal on the merits. CIBA brought suit against JJVC under its counterparts to th e Nicholson patents in various European countries. In the Netherlands and France the patents were found valid and infringed and JJVC was enjoined from selling OASYS TM . Both those decisions were appealed. In France the appeal was denied. In the Netherlands the appeal was pending. CIBA‟s patents were found to be invalid in Germany, the UK and Austria and CIBA appeal ed those decisions. In January 2011 the parties settled all pending lawsuits and appeals in the contact lens field worldwide and entered in cross-licenses of various patents pertinent to the contact lens field including the Nicholson patents. The injunctions in France and the Netherlands have been lifted. In May 2009, Abbott Biotechnology Ltd. (Abbott) filed a patent infringement lawsuit against Centocor (now COBI) in the United States District Court for the District of Massachusetts. The suit alleges tha t Centocor‟s SIMPONI ® product, a human anti-TNF alpha antibody, infringes Abbott‟s „394 patent (the Salfeld patent). The case was stayed pending the resolution of an arbitration f iled by Centocor directed to its claim that it is licensed under the „394 pa tent. In June 2010, the Arbitrator ruled that Centocor did not have a license to the patents-in-suit. The matter will proceed before the District Court of Massachusetts on the issues of infringement and validity of the Abbott patents. In August 2009, Abbott GmbH & Co. (Abbott GmbH) and Abbott Bioresearch Center filed a patent infringement lawsuit against Centocor (now COBI) in the United States District Court for the District of Massachusetts. The suit alleges that COBI‟s STELA RA ® product infringes two U.S. patents assigned to Abbott GmbH. In August 2009, COBI filed a complaint for a declaratory judgment of non-infringement and invalidity of the Abbott GmbH patents in the United States District Court for the District of Columbia. On the same date, also in the United States District Court for the District of Columbia, COBI filed a Complaint for Review of a Patent Interference Decision granting priority of invention on one of the two asserted patents to Abbott GmbH. In August 2009, Abbott GmbH and Abbott Laboratories Limited brought a patent infringement suit in The Federal Court of Canada alleging that STELARA ® infringes Abbott GmbH‟s Canadian patent. The Canadian case is scheduled to be tried in October 2012. The cases filed by COBI in the District of Columbia have been transferred to the District of Massachusetts. Discovery in this case is ongoing.
In August 2009, Bayer HealthCare LLC (Bayer) filed suit against COBI in Massachusetts District Court alleging infringement by COBI‟s SIMPONI ® product of its patent relating to human anti-TNF antibodies. On January 28, 2011, the court issued judgment dismissing Bayer‟s infringement claims. Bayer may appeal this ruling. In November 2009, Bayer also filed suit under its Europ ean counterpart to these patents in Germany and the Netherlands. The court in the Netherlands held the Dutch patent invalid in a parallel case Bayer brought against Abbott. The Dutch court subsequently entered judgment in favor of the European Centocor affiliate and Bayer appealed that judgment in the Netherlands. The infringement trial in Germany is scheduled to begin in August of 2011.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
65
In June 2009, Centocor‟s (now COBI) lawsuit alleging that Abbott‟s HUMIRA ® anti-TNF alpha product infringes Centocor‟s „775 patent went to trial in Federal District Court in the Eastern District of Texas. On June 28, 2009 a jury returned a verdict finding the patent valid and willfully infringed, and awarded Centocor damages of approximately $1.7 billion. A bench trial on Abbott‟s defenses, of inequitable conduct and prosecution laches, was held in August 2009, and the District Court decided these issues in favor of Centocor. All of Abbott‟s post trial motions have been denied except that the District Court granted Abbott‟s motion to overturn the jury finding of willfulness. Judgment in the amount of approximately $1.9 billion, inclusive of interest was entered in favor of Centocor in December 2009, and Abbott filed an appeal to the Court of Appeals for the Federal Circuit; therefore the Company has not reflected any of the $1.9 billion in its consolidated financial statements. The oral argument on appeal was held on November 2, 2010. In December 2009, Centocor also filed a new lawsuit in the Eastern District of Texas seeking damages for infringement of the „775 patent attributable to sales of HUMIRA ® subsequent to the jury verdict in June 2009. On February 23, 2011, the Court of Appeals reversed the June 2009 decision and the $1.9 billion judgment of the District Court. The following chart summarizes various patent lawsuits concerning products of the Company‟s subsidiaries that have yet to proceed to trial:
Plaintiff/ Patent Holder Trial Date** Date Filed
J&J Product
Company
Patents
Court
CYPHER ® Stent
Cordis
Wall
Wall
E.D. TX E.D. TX D. DE MA MA MA
CYPHER ® Stent Blood Glucose Meters and Strips SIMPONI ® SIMPONI ® STELARA ®
Cordis LifeScan Centocor/COBI Centocor/COBI Centocor/COBI
Saffran Wilsey Salfeld Boyle Salfeld
Saffran Roche Diagnostics Abbott Laboratories Bayer Healthcare Abbott GmbH
Q2/11 *Trial concluded * * *** *
11/07
10/07 11/07 05/09 08/09 08/09
* Trial date to be scheduled. ** Q reflects the Company‟s fiscal quarter. *** Summary judgment granted. Litigation Against Filers of Abbreviated New Drug Applications (ANDAs) The following chart indicates lawsuits pending against generic firms that filed Abbreviated New Drug Applications (ANDAs) seeking to market generic forms of products sold by various subsidiaries of the Company prior to expiration of the applicable patents covering those products. These ANDAs typically include allegations of non-infringement, invalidity and unenforceability of these patents. In the event the subsidiary of the Company involved is not successful in these actions, or the statutory 30-month stay expires before a ruling from the District Court is obtained, the firms involved will have the ability, upon FDA approval, to introduce generic versions of the product at issue resulting in very substantial market share and revenue losses for the product of the Company‟s subsidiary. As noted in the following chart, 30-month stays expired during 2009, 2010, and will expire in 2011, 2012 and 2013 with respect to ANDA challenges regarding various products:
30-Month Stay Expiration
Brand Name Product
Patent/NDA Holder
Generic Challenger
Court
Trial Date**
Date Filed
CONCERTA ® 18, 27, 36 and 54 mg controlled release tablet
Ortho-McNeil-Janssen ALZA
Andrx KUDCO Impax and Teva Lupin Watson
LEVAQUIN ® 250, 500, 750 mg tablet ORTHO TRI-CYCLEN ® LO 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and
Ortho-McNeil Ortho-McNeil
D. DE D. DE D.D E D. NJ D. NJ
Q4/07 * * * *
09/05 01/10 11/10 10/06 10/08
None 05/12 04/13 03/09 03/11
0.25 mg/0.025 mg Sandoz Lupin Mylan ULTRAM ER ® 100, 200, 300 mg tablet Ortho-McNeil/Biovail Par D. NJ D. NJ D.NJ D. DE * * * Q2/09 01/10 11/10 05/07 06/07 10/07 08/08 11/08 * * * * * 09/09 10/09 01/10 11/10 11/10 10/11 06/12 4/13 09/09 11/09 03/10 01/11 03/11 01/12 03/12 06/12 12/13 12/13
ULTRAM ER ® 100, 200, 300 mg tablet
Ortho-McNeil/Biovail
Impax
D. DE D.M N D. DE D. DE D.NJ D.NJ
ULTRAM ER ® 100, 200, 300 mg tablet ULTRAM ER ® 100, 200, 300 mg tablet ULTRAM ER ® 100, 200, 300 mg tablet PREZISTA ®
Ortho-McNeil/Biovail Ortho-McNeil/Biovail Ortho-McNeil/Biovail Tibotec Tibotec
Paddock Cipher Lupin Mylan Lupin
* Trial date to be scheduled. ** Q reflects the Company‟s fiscal quarter.
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JOHNSON & JOHNSON 2010 ANNUAL REPORT
In October 2008, the Company‟s subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) filed suit in Federal District Court in New Jersey against Watson Laboratories, Inc. (Watson) in response to Watson‟s ANDA regarding ORTHO TRI -CYCLEN ® LO. In June 2009, OMJPI filed suit in Federal District Court in New Jersey against Sandoz Laboratories, Inc. (Sandoz) in response to Sandoz‟s ANDA regarding ORTHO TRI-CYCLEN ® LO. The Sandoz and Watson cases have been consolidated. In September 2010, OMJPI entered into a settlement agreement with Sandoz. In January 2010, the Company‟s subsidiary OMJPI filed suit in Federal District Court in New Jersey against Lupin Ltd. and Lup in Pharmaceuticals, Inc. (collectively Lupin) in response to Lupin‟s ANDA regarding ORTHO TRI -CYCLEN ® LO. The Lupin case has been consolidated with the Watson case (discussed above). In November 2010, the Company‟s subsidiary OMJPI filed suit in Fede ral District Court in New Jersey against Mylan Inc. and Mylan Pharmaceuticals, Inc. (collectively Mylan), and Famy Care, Ltd., in response to Famy Care‟s ANDA regarding ORTHO TRI-CYCLEN ® LO. In the action by McNEIL-PPC, Inc. (McNeil-PPC) and ALZA Corporation (ALZA) against Andrx Corporation (Andrx) with respect to its ANDA challenge to the CONCERTA ® patents, a five-day non-jury trial was held in the Federal District Court in Delaware in December 2007. In March 2009, the court ruled that one CONCERTA ® patent would not be infringed by Andrx‟s proposed generic product and that the patent was invalid because it was not enabled. The court dismissed without prejudice Andrx‟s declaratory judgment suit on a second patent for lack of jurisdiction. McNeil-PPC and ALZA filed an appeal in May 2009. The appeals court heard argument on February 3, 2010. On April 26, 2010, the court of appeals affirmed the judgment of the district court that the patent is invalid because it is not enabled. The court did not reach the issue of infringement. In January 2010, ALZA and OMJPI filed suit in Federal District Court in Delaware against Kremers-Urban, LLC and KUDCO Ireland, Ltd. (KUDCO) in response to KUDCO‟s ANDA challenge regarding CONCERTA ® tablets. In its notice letter, KUDCO contends that two ALZA patents for CONCERTA ® are invalid and not infringed by a KUDCO generic. One patent has since been dropped from the case. In November 2010, ALZA and OMJPI filed suit in Federal District Court in Delaware against Impax Laboratories, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. in response to notice from Impax that it made a major amendment to its ANDA with respect to its 56 mg dose generic version of CONCERTA ® . In its notice letter describing its major amendment, Impax contends that a CONCERTA ® patent is invalid and not infringed by its proposed generic version. In the action against Lupin Pharmaceuticals, Inc. (Lupin) regarding its ANDA concerning LEVAQUIN ® , Lupin contended that the U.S. Patent and Trademark Office improperly granted a patent term extension to the patent that Ortho-McNeil, Inc. (now OrthoMcNeil-Janssen Pharmaceuticals, Inc. (OMJPI)) licenses from Daiichi Pharmaceuticals, Inc. (Daiichi). Lupin alleged that the active ingredient in LEVAQUIN ® was the subject of prior marketing, and therefore was not eligible for the patent term extension. Lupin conceded validity and that its product would violate the patent if marketed prior to the expiration of the original patent term. Summary judgment against Lupin was granted in May 2009 and Lupin appealed. Oral argument was held in September 2009. In May 2010, the Court of Appeals affirmed the judgment of the trial court in favor of Ortho-McNeil (now OMJPI) and Daiichi that the patent term extension covering LEVAQUIN ® (levofloxacin) is valid. Thereafter, Lupin requested rehearing en banc, which was denied. In the ULTRAM ® ER actions, Ortho-McNeil, Inc. (now OMJPI), filed lawsuits (each for different dosages) in the U.S. District Court of Delaware against Par Pharmaceuticals, Inc. and Par Pharmaceuticals Companies, Inc. (Par) in May, June and October 2007, on two Tramadol ER formulation patents owned by Purdue Pharma Products L.P. (Purdue) and Napp Pharmaceutical Group Ltd. (Napp). OMJPI also filed lawsuits (each for different dosages) against Impax Laboratories, Inc. (Impax) on a Tramadol ER formulation patent owned by Purdue and Napp in August and November 2008. Purdue, Napp and Biovail Laboratories International SRL (Biovail) (the NDA holder) joined as co-plaintiffs in the lawsuits against Par and Impax, but Biovail and OMJPI were subsequently dismissed for lack of standing. The trial against Par took place in April 2009. In August 2009, the Court issued a decision finding the patents-in-suit invalid. Purdue has appealed that decision. In November 2009, the case against Impax was stayed with the consent of all parties. In September and October 2009, respectively, Purdue filed suits against Paddock Laboratories, Inc. (Paddock) and Cipher Pharmaceuticals Inc. (Cipher) on its Tramadol ER formulation patents. In June 2010, the Federal Circuit Court affirmed the District Court‟s decision in the Par case. The case against Cipher, Impax and Paddock were dismissed based on the collateral estoppel effect of the Par decision. In January 2010, Purdue filed a suit against Lupin Ltd. on its Tramadol ER formulation patents. In November 2010, the Company‟s subsidiary Tibotec, Inc. (Tibotec) filed suit in Federal District Court in New Jersey against Lupin, Ltd., Lupin Pharmaceuticals, Inc. (collectively Lupin), Mylan, Inc. and Mylan Pharmaceuticals, Inc. (collectively Mylan) in response to Lupin‟s and Mylan‟s respective ANDA‟s regarding PREZISTA ® . In January 2011, Tibotec, Inc. (Tibotec) received a Paragraph IV Notification from Teva Pharmaceuticals, Inc. advising that Teva has filed an ANDA seeking approval to market a generic PREZISTA ® product before the expiration of certain patents owned or licensed by Tibotec. Tibotec is evaluating this Notification. General Litigation
In September 2004, plaintiffs in an employment discrimination litigation initiated against the Company in 2001 in Federal District Court in New Jersey moved to certify a class of all African American and Hispanic salaried employees of the Company and its affiliates in the U.S., who were employed at any time from November 1997 to the present. Plaintiffs seek monetary damages for the period 1997 through the present (including punitive damages) and equitable relief. The Court denied plaintiffs‟ class certifi cation motion in December 2006 and their motion for reconsideration in April 2007. Plaintiffs sought to appeal these decisions and, in April 2008, the Court of Appeals ruled that plaintiffs‟ appeal of the denial of class certification was untimely. In July 2009, pla intiffs filed a motion for certification of a modified class, which the Company opposed. The district court denied plaintiffs‟ motion in July 2010, and the Court of Appeals denied plaintiffs‟ request for leave to appeal the denial of certification of the modified class. The Co mpany will continue to defend against the plaintiffs‟ indi vidual claims of discrimination. In September 2009, Centocor Ortho Biotech Products, L.P. (COBLP) intervened in an inventorship dispute between Kansas University Center for Research (KUCR) involving certain U.S. Government-owned VELCADE ® formulation patents. KUCR brought this action against the U.S. Government in the District of Kansas seeking to add two Kansas University scientists to the patents. The U.S. Government licensed the patents (and their foreign counterparts) to Millennium Pharmaceuticals, Inc. (MPI) , who in turn sublicensed
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
67
the patents (and their foreign counterparts) to COBI for commercial marketing outside the U.S. If KUCR succeeds in its coinventorship claim and establishes co-ownership in the U.S. VELCADE ® formulation patents, there is a potential for the same issue to arise with respect to the foreign counterparts of the patents. If KUCR is successful, this may adversely affect COBI‟s licens e rights in those countries. In May 2010, the parties reached an agreement to resolve the disputes in this case and will submit the inventorship issue to arbitration, and the case has been stayed pending the arbitration. If KUCR wins the arbitration, the parties will request that the Court issue an order to correct inventorship on the relevant patents; if the U.S. Government, COBI, and MPI prevail, the case will be dismissed with prejudice. In February 2009, Basilea Pharmaceutica AG (Basilea) brought an arbitration against Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Cilag GmbH International alleging that the Company breached the 2005 License Agreement for Ceftobiprole by, among other things, failing to secure FDA approval of the cSSSI (skin) indication and allegedly failing to properly develop the pneumonia indication. In November 2010, the arbitration panel issued its decision and the Company has satisfied the damages award. In May 2009, COBI commenced an arbitration proceeding before the American Arbitration Association against Schering-Plough Corporation and its subsidiary Schering-Plough (Ireland) Company (collectively, Schering-Plough). COBI and Schering-Plough are parties to a series of agreements (Distribution Agreements) that grant Schering-Plough the exclusive right to distribute the drugs REMICADE ® and SIMPONI ® worldwide, except within the United States, Japan, Taiwan, Indonesia, and the People‟s Republic of China (including Hong Kong) (the Territory). COBI distributes REMICADE ® and SIMPONI ® the next generation treatment, within the United States. In the arbitration, COBI seeks a declaration that the agreement and merger between Merck & Co., Inc. (Merck) and Schering-Plough constitutes a change of control under the terms of the Distribution Agreements that permits COBI to terminate the Agreements. The termination of the Distribution Agreements would return to COBI the right to distribute REMICADE ® and SIMPONI ® within the Territory. Schering-Plough has filed a response to COBI‟s arbitration demand that denies that it has undergone a change of control. The arbitrators were selected and the evidentiary portion of the hearing was concluded in October 2010. Oral argument was held in late 2010. A decision is expected during the first half of 2011. In December 2009, the State of Israel (Sheba Medical Center) filed suit in the District Court in Tel Aviv Jaffa against various Omrix affiliates. In the lawsuit, the State claims that an employee of a government-owned hospital was the inventor on several patents related to fibrin glue technology, that he developed while he was a government employee. The State claims that he had no right to transfer any intellectual property to Omrix because it belongs to the State. The State is seeking damages plus royalty on QUIXIL TM and EVICEL TM or, alternatively, transfer of the patents to the State. Average Wholesale Price (AWP) Litigation The Company and several of its pharmaceutical subsidiaries, along with numerous other pharmaceutical companies, are defendants in a series of lawsuits in state and federal courts involving allegations that the pricing and marketing of certain pharmaceutical products amounted to fraudulent and otherwise actionable conduct because, among other things, the companies allegedly reported an inflated Average Wholesale Price (AWP) for the drugs at issue. Many of these cases, both federal actions and state actions removed to federal court, have been consolidated for pre-trial purposes in a Multi-District Litigation (MDL) in Federal District Court in Boston, Massachusetts. The plaintiffs in these cases include classes of private persons or entities that paid for any portion of the purchase of the drugs at issue based on AWP, and state government entities that made Medicaid payments for the drugs at issue based on AWP. The MDL Court identified classes of Massachusetts-only private insurers providing “Medi -gap” insurance coverage and private payers for physician-administered drugs where payments were based on AWP (Class 2 and Class 3), and a national class of individuals who made co-payments for physician-administered drugs covered by Medicare (Class 1). A trial of the two Massachusetts-only class actions concluded before the MDL Court in December 2006. In June 2007, the MDL Court issued post-trial rulings, dismissing the Johnson & Johnson defendants from the case regarding all claims of Classes 2 and 3, and subsequently of Class 1 as well. Plaintiffs appealed the Class 1 judgment and, in September 2009, the Court of Appeals vacated the judgment and remanded for further proceedings in the District Court. . The Johnson & Johnson defendants then filed a motion for summary judgment with regard to Class 1, which the District Court granted in part and denied in part. Subsequently, the Johnson & Johnson defendants filed a motion challenging the adequacy of Plaintiffs‟ proposed class representative, which is pending. AWP cases brought by various Attorneys General have proceeded to trial against other manufacturers. Three state cases against certain of the Company‟s subsidiaries have been set for trial: Idaho in October 2011, Kentucky in January 2012 and Kansas in March 2013. Other state cases are likely to be set for trial in the coming year. In addition, an AWP case against the Johnson & Johnson defendants brought by the state of Pennsylvania was tried in Commonwealth Court in October and November 2010. The Court found in the State‟s favor with regard to certain of its claims under the Pennsylvania Unfair Trade Practices and Consumer Protect ion Law, entered an injunction, and awarded $45 million in restitution and $6.5 million in civil penalties. The Court found in the Johnson & Johnson defendants favor on the State‟s claims of Unjust Enrichment, Misrepresentation/Fraud, Civil Conspiracy, and on certain of the State‟s claims under the Pennsylvania Unfair Trade Practices and Consumer Protection Law. The parties are currently engaged i n post trial briefing, which will be followed by an appeal to the Pennsylvania Supreme Court if necessary. The Company believes that it has strong arguments supporting an appeal. The Company believes that the potential for an unfavorable outcome is not probable, therefore, it has not established a reserve with respect to the verdict.
In April 2010, a lawsuit was filed in the United States District Court for the Northern District of California against the Company, Omnicare, Inc., and other unidentified companies or individuals. The Company filed a motion to dismiss. Plaintiffs then filed an amended complaint. The amended complaint asserts that defendants engaged in an unlawful trying arrangement in violation of the Sherman Act and the California Business and Professions Code. The amended complaint also asserted claims of unjust enrichment and civil conspiracy. The Company moved to dismiss the amended complaint. On January 13, 2011, the court granted the Company‟s motion to dismiss as to all causes of action in the amended complaint, and granted plaintiffs‟ leave to file an amended compl aint. Johnson & Johnson has been named the nominal defendant in six shareholder derivative lawsuits in the U.S. District Court for the District of New Jersey on behalf of Company shareholders against certain current and former directors and officers of the Company
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JOHNSON & JOHNSON 2010 ANNUAL REPORT
derivatively on behalf of the Company: Calamore v. Coleman et. al., filed April 21, 2010; Carpenters Pension Fund of West Virginia v. Weldon, et. al., filed May 5, 2010; Feldman v. Coleman, et. al., filed May 6, 2010; Hawaii Laborers Pension Fund v. Weldon, et. al., filed May 14, 2010; Ryan v. Weldon, et. al., filed June 18, 2010; and Minneapolis Firefighters‟ Relief Association, NECA-IBEW Pension Trust Fund, and NECA-IBEW Welfare Trust Fund v. Weldon, et. al., filed June 24, 2010. These actions were consolidated on August 17, 2010 into one lawsuit: In re Johnson & Johnson Shareholder Derivative Litigation. An amended consolidated complaint was filed on December 17, 2010. An additional derivative suit was filed in the U.S. District Court for the District of New Jersey on December 1, 2010: Copeland v. Mulcahy, et al. That lawsuit has been consolidated into the In re Johnson & Johnson Shareholder Derivative Litigation. Additionally, Johnson & Johnson has been named the nominal defendant in a shareholder derivative lawsuit in New Jersey Superior Court on behalf of Company shareholders against certain current and former directors and officers of the Company derivatively on behalf of the Company: Wolin v. Johnson & Johnson, filed September 23, 2010. The parties to the Wolin action have stipulated that the Wolin action shall be stayed until the In re Johnson & Johnson Shareholder Derivative Litigation is completely resolved. Each of these shareholder derivative actions is similar in its claims and collectively they assert a variety of alleged breaches of fiduciary duties, including, among other things, that the defendants allegedly engaged in, approved of, or failed to remedy or prevent defective medical devices, improper pharmaceutical rebates, improper off-label marketing of pharmaceutical and medical device products, violations of current good manufacturing practice regulations that resulted in product recalls, and failed to disclose the aforementioned alleged misconduct in the Compa ny‟s filings under the Securities Exchange Act of 1934. Each complaint seeks a variety of relief, including monetary damages and corporate governance reforms. On July 27, 2010, a complaint was filed by a shareholder of the Company in New Jersey Superior Court, Chancery Division, Middlesex County (Lipschutz v. Johnson & Johnson) seeking to compel inspection of Company books and records with respect to certain product recalls and various manufacturing plants. This lawsuit was dismissed on October 7, 2010. Other In July 2003, Centocor (now COBI), received a request that it voluntarily provide documents and information to the criminal division of the U.S. Attorney‟s Office, District of New Jersey, in connection with its investigation into various Centocor marketing practices. Subsequent requests for documents have been received from the U.S. Attorney‟s Office. Both the Company and Centocor have responded to these requests for documents and information. In December 2003, Ortho-McNeil Pharmaceutical, Inc. (now OMJPI) received a subpoena from the U.S. Attorney‟s Office in Boston, Massachusetts seeking documents relating to the marketing, including alleged off-label marketing, of the drug TOPAMAX ® (topiramate). In the fiscal second quarter of 2010, OMJPI ente red into a settlement agreement resolving the federal government‟s investigation. As one part of the settlement, Ortho-McNeil Pharmaceutical, LLC, a subsidiary of OMJPI, pled guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and paid a criminal fine. OMJPI denies it engaged in any wrongful conduct, beyond acknowledging the limited conduct of Ortho-McNeil Pharmaceutical, LLC, that is the basis of the misdemeanor plea. In addition the total settlement included a civil payment, part of which was paid to the federal government and part of which was paid or set aside for payment to states for their Medicaid programs. In January 2004, Janssen Pharmaceutica, Inc. (now OMJPI) received a subpoena from the Office of the Inspector General of the U.S. Office of Personnel Management seeking documents concerning sales and marketing of, any and all payments to physicians in connection with sales and marketing of, and clinical trials for, RISPERDAL ® (risperidone) from 1997 to 2002. Documents subsequent to 2002 have also been requested. An additional subpoena seeking information about marketing of and adverse reactions to RISPERDAL ® was received from the U.S. Attorney‟s Office for the Eastern District of Pennsylvania in November 2005. Subpoenas seeking testimony from various witnesses before a grand jury have also been received. Janssen is cooperating in responding to ongoing requests for documents and witnesses. The government is continuing to actively investigate this matter. In February 2010, the government served Civil Investigative Demands seeking additional information relating to sales and marketing of RISPERDAL ® and sales and marketing of INVEGA ® . The focus of these matters is the alleged promotion of RISPERDAL ® and INVEGA ® for offlabel uses. The government has notified the Company that there are pending qui tam actions alleging off-label promotion of RISPERDAL ® . Discussions are ongoing in an effort to resolve potential criminal and civil claims arising from these matters. Whether a resolution can be reached and on what terms is uncertain. While a loss is probable with respect to this matter, the Company is unable to estimate a potential loss at this time. The ultimate resolution of these matters is not expected to have a material adverse effect on the Company‟s financial position, although the resolution in any reporting period could have a material impact on t he Company‟s results of operations and cash flows for that period. In September 2004, Ortho Biotech Inc. (now COBI), received a subpoena from the U.S. Office of Inspector General‟s Denver, Colorado field office seeking documents directed to the sales and marketing of PROCRIT ® (Epoetin alfa) from 1997 to the present, as well as to dealings with U.S. Oncology Inc., a healthcare services network for oncologists. COBI has responded to the subpoena. In November 2007, the Attorney General of the Commonwealth of Massachusetts issued a Civil Investigative Demand to DePuy Orthopaedics, Inc. (DePuy) seeking information regarding financial relationships between a number of Massachusetts-based orthopedic surgeons and providers, and DePuy Orthopaedics, Inc. DePuy has respo nded to Massachusetts‟ additional requests.
In July 2005, Scios Inc. (Scios), received a subpoena from the U.S. Attorney‟s Office, District of Massachusetts, seeking documents related to the sales and marketing of NATRECOR ® . Scios responded to the subpoena. In early August 2005, Scios was advised that the investigation would be handled by the U.S. Attorney‟s Office for the Northern District of California in San Francisco. Additional requests for documents have been received and responded to and former Scios employees have testified before a grand jury in San Francisco. The qui tam complaints were unsealed on February 19, 2009. The U.S. government has intervened in one of the qui tam actions, and filed a complaint against Scios and the Company in June 2009. Scios and Johnson & Johnson filed a motion to dismiss the qui tam complaint filed by the government, and that motion was denied. The criminal investigation is continuing and discussions are underway in an effort to settle this matter. Whether a settlement can be reached and on what terms is uncertain.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
69
In September 2005, the Company received a subpoena from the U.S. Attorney‟s Office, District of Massachusetts, seeking documents related to sales and marketing of eight drugs to Omnicare, Inc., (Omnicare) a manager of pharmaceutical benefits for longterm care facilities. The Company‟s subsidiaries involved responded to the subpoena. Several employees of the Company‟s pharmaceutical subsidiaries were subpoenaed to testify before a grand jury in connection with this investigation. In April 2009, the Company was served with the complaints in two civil qui tam cases related to marketing of prescription drugs to Omnicare. On January 15, 2010, the government filed a complaint intervening in the cases. The complaint asserts claims under the federal False Claims Act and a related state law claim in connection with the marketing of several drugs to Omnicare. The complaints allege that Johnson & Johnson provided Omnicare with rebates and other alleged kickbacks, and in so doing, caused Omnicare to file false claims with Medicaid and other government programs. Subsequently, the Commonwealth of Massachusetts, Virginia, and Kentucky, and the States of California and Indiana intervened in the action. The Company‟s motion to dismiss the government‟s and relators‟complaints, the government‟s and relators‟ oppositions, and the Company‟s reply brief have been filed. A hearing on the Company‟s motion to dismiss was held on October 7, 2010. The court has not ruled on the motion. In November 2005, a lawsuit was filed under seal against the Company, along with codefendants McKesson Corporation and Omnicare, Inc., by a former employee in the United States District Court for the Eastern District of Pennsylvania, United States ex rel. Scott Bartz v. Ortho McNeil Pharmaceutical, Inc., et al. After investigation, the United States declined to intervene. The case was subsequently unsealed, and the Company was served with the operative complaint on January 3, 2011. The complaint alleges that Defendants engaged in various improper transactions that were allegedly designed to report false prescription drug prices to the federal government in order to reduce the Company‟s Medicaid reb ate obligations. The complaint further alleges that the Company improperly retaliated against the Plaintiff for having raised these allegations internally. The complaint alleges a variety of causes of action under the federal False Claims Act and corresponding state and local statutes. The Company has not yet responded to the complaint, but anticipates filing a motion to dismiss. In February 2006, the Company received a subpoena from the U.S. Securities & Exchange Commission (SEC) requesting documents relating to the participation by several Johnson & Johnson subsidiaries in the United Nations Iraq Oil for Food Program. The subsidiaries are cooperating with the SEC and U.S. Department of Justice (DOJ). In February 2007, the Company voluntarily disclosed to the DOJ and the SEC that subsidiaries outside the United States are believed to have made improper payments in connection with the sale of medical devices in two small-market countries, which payments may fall within the jurisdiction of the Foreign Corrupt Practices Act (FCPA). In the course of continuing dialogues with the agencies, other issues potentially rising to the level of FCPA violations in additional markets have been brought to the attention of the agencies by the Company. The Company has provided and will continue to provide additional information to the DOJ and SEC, and will cooperate with the agencies‟ reviews of these matters. Law enforcement agencies of a number of other countries are also pursuing investigations of matters voluntarily disclosed by the Company to the DOJ and SEC. Discussions are underway in an effort to resolve these matters, and the Iraq Oil for Food matter referenced above, but whether agreement can be reached, and on what terms, is uncertain. In May 2007, the New York State Attorney General issued a subpoena seeking information relating to the marketing and safety of PROCRIT ® . The Company has responded to these requests. In April 2007, the Company received two subpoenas from the Office of the Attorney General of the State of Delaware. The subpoenas seek documents and information relating to nominal pricing agreements. For purposes of the subpoenas, nominal pricing agreements are defined as agreements under which the Company agreed to provide a pharmaceutical product for less than ten percent of the Average Manufacturer Price for the product. The Company responded to these requests. In March 2008, the Company received a letter request from the Attorney General of the State of Michigan. The request seeks documents and information relating to nominal price transactions. The Company responded to the request. In June 2008, the Company received a subpoena from the United States Attorney‟s Office for the District of Massachusetts rela ting to the marketing of biliary stents by the Company‟s Cordis subsidiary. Cordis is cooperating in responding to the subpoena. A False Claims Act complaint was filed in Dallas relating to similar issues. The U.S. Department of Justice and several states have declined to intervene at this time. A motion to dismiss the Texas qui tam case is pending. In April 2009, the Company received a HIPPA subpoena from the U.S. Attorney‟s Office for the District of Massachusetts (Boston) seeking information regarding the Company‟s financial relationship with several psychiatrists. The Company has responded to this request. In April 2009, Ortho-Clinical Diagnostics, Inc. (OCD) received a grand jury subpoena from the U.S. Department of Justice, Antitrust Division, requesting documents and information for the period beginning September 1, 2000 through the present, pertaining to an investigation of alleged violations of the antitrust laws in the blood reagents industry. The Company complied with the subpoena. In November 2010, the Antitrust Division provided notice that it has closed its investigation. In the weeks following the public announcement that OCD had received a subpoena from the Antitrust Division, multiple class action complaints were filed. The various cases were consolidated for pre-trial purposes in the Eastern District of Pennsylvania.
In May 2009, the New Jersey Attorney General issued a subpoena to DePuy Orthopaedics, Inc., seeking information regarding the financial interest of clinical investigators who performed clinical studies for DePuy Orthopaedics, Inc. and DePuy Spine, Inc. DePuy Orthopaedics has responded to these requests. In May 2010, the Company received a letter from the United States House of Representatives‟ Committee on Oversight and Government Reform (Committee) requesting information and documents regarding the April 2010 recall of various infants‟ and children‟s liquid products by McNeil Consumer Healthca re Division of McNEIL-PPC, Inc. (McNeil Consumer Healthcare). The Company produced documents and other information in response to these requests. In May 2010, the Committee conducted a public hearing. Thereafter, the Company received additional information requests from the Committee, including requests regarding the recall of certain Motrin products by McNeil Consumer Healthcare. The Company produced documents and other information in response to these requests. The Committee held another public hearing on September 30, 2010, and the Company continues to cooperate fully with the Committee‟s ongoing information requests.
70
JOHNSON & JOHNSON 2010 ANNUAL REPORT
In addition, McNeil Consumer Healthcare, and certain affiliates including Johnson & Johnson (“the Companies”), received grand jury subpoenas from the United States Attorney‟s Office for the Eastern District of Pennsylvania requesting documents broadly relating to recent recalls of various products of McNeil Consumer Healthcare, and the FDA inspections of the Fort Washington, Pennsylvania and Lancaster, Pennsylvania manufacturing facilities. In addition, the government has served McNEIL-PPC Inc. with a Civil Investigative Demand seeking records relevant to its investigation to determine if there was a violation of the False Claims Act. The Companies are cooperating with the United States Attorney‟s Office in responding to these subpoenas. The Companies have also received Civil Investigative Demands (CIDs) from multiple State Attorneys General Offices broadly relating to the McNeil recall issues. The Companies continue to produce documents in response to these CIDs and otherwise cooperate with these inquiries. On January 12, 2011, the Oregon Attorney General filed a civil complaint against Johnson & Johnson, McNEILPPC, Inc, and McNeil Healthcare, LLC in state court alleging civil violations of the Oregon unlawful trade practices act relating to an earlier recall of a McNeil OTC product. The defendants intend to seek dismissal of this civil complaint. Furthermore, a lawsuit was filed in September 2010 by a shareholder in the United States District Court for the District of New Jersey: Monk v. Johnson & Johnson. The complaint seeks class certification based upon the anti-fraud provisions of the federal securities laws related to the McNeil manufacturing facilities. More specifically, this complaint alleges that the Companies and certain individuals, including officers and employees, failed to disclose that a number of manufacturing facilities were failing to maintain current good manufacturing practices (cGMPs) and, that as a result, the price of the Company‟s stock has declined significant ly. Multiple complaints seeking class action certification related to the McNeil recalls have been filed in the United States District Court for the Eastern District of Pennsylvania, the Northern District of Illinois, the Central District of California, and the Southern District of Ohio. These consumer complaints allege generally that purchasers of various McNeil medicines are owed monetary damages and penalties because they paid premium prices for defective medications rather than less expensive alternative medications. Each complaint seeks certification of a nation-wide class of purchasers of these medicines. On October 8, 2010, the Judicial Panel on Multidistrict Litigation consolidated these consumer complaints: Haviland v. McNeil (E.D. Pa.); Smith v. McNeil (N.D. Ill.); Burrell v. McNeil (N.D. Ill.); DeGroot v. McNeil (N.D. Ill.); Michaud v. McNeil, (N.D. Ill.); Nguyen v. McNeil (N.D. Ill.); Roberson v. McNeil (N.D. Ill.); Rivera v. Johnson & Johnson (C.D. Cal.), and Coleman v. McNeil (S.D. Ohio) for pretrial proceedings in the United States District Court for the Eastern District of Pennsylvania. Plaintiffs filed a “Consolidated Amended Civil Consumer Class Action Complaint” (CAC) naming additional parties and claims on January 12, 2011. Defendants‟ currently intend to file a motion to dismiss the CAC, which motion will be filed on March 2, 2011, and is scheduled to be heard on May 10, 2011. In recent years the Company has received numerous requests from a variety of United States Congressional Committees to produce information relevant to ongoing congressional inquiries. It is the Company‟s policy to cooperate with these inquiries by producing the requested information. With respect to all the above matters, the Company and its subsidiaries are vigorously contesting the allegations asserted against them and otherwise pursuing defenses to maximize the prospect of success. The Company and its subsidiaries involved in these matters continually evaluate their strategies in managing these matters and, where appropriate, pursue settlements and other resolutions where those are in the best interest of the Company. The Company is also involved in a number of patent, trademark and other lawsuits incidental to its business. The ultimate legal and financial liability of the Company in respect to all claims, lawsuits and proceedings referred to above cannot be reasonably estimated. However, in the Company‟s opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities accrued in the Company‟s balance sheet, is not expected to have a material adverse effect on the Company‟s financial position, although the resolution in any reporting period of one or more of these matters could have a material impact on the Company‟s results of operations and cash flows for t hat period. 22. Restructuring
In the fourth quarter of 2009, the Company announced global restructuring initiatives designed to strengthen the Company‟s position as one of the world‟s leading global health care companies. This program will allow the Company to invest in new growth platforms; ensure the successful launch of its many new products and continued growth of its core businesses; and provide flexibility to adjust to the changed and evolving global environment. During the fiscal fourth quarter of 2009, the Company recorded $1.2 billion in related pre-tax charges, of which approximately $830 million of the pre-tax restructuring charges are expected to require cash payments. The $1.2 billion of restructuring charges consists of severance costs of $748 million, asset write-offs of $362 million and $76 million related to leasehold and contract obligations. The $362 million of asset write-offs relate to inventory of $113 million (recorded in cost of products sold), property, plant and equipment of $107 million, intangible assets of $81 million and other assets of $61 million. Additionally, as part of this program the Company plans to eliminate approximately 7,500 positions, of which approximately 5,000 have been eliminated since the restructuring was announced. The following table summarizes the severance charges and the associated spending for the fiscal year ended 2010:
(Dollars in Millions)
Severance
2009 restructuring charge Cash outlays Reserve balance, January 3, 2010 Cash outlays Reserve balance, January 2, 2011*
$
748 (62 ) 686 (341 )
$
345
* Cash outlays for severance are expected to be substantially paid out over the next 12 months in accordance with the Company‟s plans and local laws. For additional information on the restructuring as it relates to the segments, see Note 18.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
71
Report of Independent Registered Public Accounting Firm To the Shareholders and Board of Directors of Johnson & Johnson: In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of earnings, statements of equity, and statements of cash flows present fairly, in all material respects, the financial position of Johnson & Johnson and its subsidiaries (“the Company”) at January 2, 2011 and January 3, 2010, and the results of their operations and their cash flows for each of the three years in the period ended January 2, 2011 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of January 2, 2011, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company‟s management is responsible for these financial statements, for maintaini ng effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying “Management‟s Report on Internal Control over Financial Reporting.” Our responsibi lity is to express opinions on these financial statements and on the Company‟s internal control over financial reporting based on our integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circ*mstances. We believe that our audits provide a reasonable basis for our opinions. As discussed in Note 1 to the Consolidated Financial Statements, the Company changed the manner in which it accounts for business combinations in 2009. A company‟s internal control over financial reportin g is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company‟s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company‟s assets that could have a material effect on the fin ancial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
PricewaterhouseCoopers LLP New York, New York February 24, 2011
72
Management’s Report on Internal Control Over Financial Reporting Under Section 404 of the Sarbanes-Oxley Act of 2002, management is required to assess the effectiveness of the Company‟s internal control over financial reporting as of the end of each fiscal year and report, based on that assessment , whether the Company‟s internal control over financial reporting is effective. Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company‟s internal control over financial re porting is designed to provide reasonable assurance as to the reliability of the Company‟s financial reporting and the preparation of external financial statements in accordance with generally accepted accounting principles. Internal controls over financial reporting, no matter how well designed, have inherent limitations. Therefore, internal control over financial reporting determined to be effective can provide only reasonable assurance with respect to financial statement preparation and may not prevent or detect all misstatements. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. The Company‟s management has assessed the effectiveness of the Company‟s internal control over financial reporting as of January 2, 2011. In making this assessment, the Company used the criteria established by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in “Internal Control -Integrated Framework.” These criteria are in the areas of control environment, risk assessment, control activities, information and communication, and monitoring. The Company‟s assessment included extensive documenting, evaluating and testing the design and operating effectiveness of its internal controls over financial reporting. Based on the Company‟s processes and assessment, as described above, management has concluded that, as of January 2, 2011, the Company‟s internal control over financial reporting was effective. The effectiveness of the Company‟s internal control over financial reporting as of January 2, 2011 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which appears herein.
William C. Weldon Chairman, Board of Directors, and Chief Executive Officer
Dominic J. Caruso Vice President, Finance, and Chief Financial Officer
73
Summary of Operations and Statistical Data 2000-2010
(Dollars in Millions Except Per Share Figures) Sales to customer — U.S. Sales to customer — International Total sales Cost of products sold Selling, marketing and administrative expenses Research and development expense Purchased in-process research and development Interest income Interest expense, net of portion capitalized Other (income) expense, net Restructuring
2010
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
$
29,450 32,137 61,587 18,792
30,889 31,008 61,897 18,447
32,309 31,438 63,747 18,511
32,444 28,651 61,095 17,751
29,775 23,549 53,324 15,057
28,377 22,137 50,514 14,010
27,770 19,578 47,348 13,474
25,274 16,588 41,862 12,231
22,455 13,843 36,298 10,498
19,825 12,492 32,317 9,622
17,316 11,856 29,172 8,987
19,424
19,801
21,490
20,451
17,433
17,211
16,174
14,463
12,520
11,510
10,675
6,844 — (107 )
6,986 — (90 )
7,577
7,680
7,125
6,462
5,344
4,834
4,094
3,704
3,186
181 (361 )
807 (452 )
559 (829 )
362 (487 )
18 (195 )
918 (177 )
189 (256 )
105 (456 )
66 (429 )
455 (768 ) — 44,640
451 (526 ) 1,073 46,142
435 (1,015 ) — 46,818
296 534 745 47,812
63 (671 ) — 38,737
54 (214 ) — 37,398
187 15 — 35,017
207 (385 ) — 32,091
160 294 — 27,499
153 185 — 24,823
204 (94 ) — 22,595
Earnings before provision for taxes on income Provision for taxes on income Net earnings Percent of sales to customers Diluted net earnings per share of common stock Percent return on average shareholders‟ equity Percent increase (decrease) over previous year: Sales to customers Diluted net earnings per share Supplementary expense data: Cost of materials and services Total employment costs Depreciation and amortization Maintenance and repairs (1) Total tax expense (2) Supplementary balance sheet data: Property, plant and equipment, net Additions to property, plant and equipment Total assets Long-term debt Operating cash flow Common stock information Dividends paid per
16,947 3,613 13,334
15,755 3,489 12,266
16,929 3,980 12,949
13,283 2,707 10,576
14,587 3,534 11,053
13,116 3,056 10,060
12,331 4,151 8,180
9,771 2,923 6,848
8,799 2,522 6,277
7,494 2,089 5,405
6,577 1,813 4,764
21.7
19.8
20.3
17.3
20.7
19.9
17.3
16.4
17.3
16.7
16.3
$
4.78
4.40
4.57
3.63
3.73
3.35
2.74
2.29
2.06
1.75
1.55
24.9
26.4
30.2
25.6
28.3
28.2
27.3
27.1
26.4
24.0
25.3
(0.5 ) 8.6
(2.9 ) (3.7 )
4.3 25.9
14.6 (2.7 )
5.6 11.3
6.7 22.3
13.1 19.7
15.3 11.2
12.3 17.7
10.8 12.9
6.6 15.7
$
27,586 13,934 2,939 657 5,070
27,651 14,587 2,774 567 5,052
29,346 14,523 2,832 583 5,558
27,967 14,571 2,777 483 4,177
22,912 13,444 2,177 506 4,857
22,328 12,364 2,093 510 4,285
21,053 11,581 2,124 462 5,215
18,568 10,542 1,869 395 3,890
16,540 8,942 1,662 360 3,325
15,333 8,153 1,605 372 2,854
14,113 7,376 1,592 327 2,517
14,553
14,759
14,365
14,185
13,044
10,830
10,436
9,846
8,710
7,719
7,409
2,384 102,908 9,156 16,385
2,365 94,682 8,223 16,571
3,066 84,912 8,120 14,972
2,942 80,954 7,074 15,022
2,666 70,556 2,014 14,248
2,632 58,864 2,017 11,799
2,175 54,039 2,565 11,089
2,262 48,858 2,955 10,571
2,099 40,984 2,022 8,135
1,731 38,771 2,217 8,781
1,689 34,435 3,163 6,889
$
2.110
1.930
1.795
1.620
1.455
1.275
1.095
0.925
0.795
0.700
0.620
share Shareholders‟ equity per share Market price per share (year-end close) Average shares outstanding (millions) — basic — diluted Employees (thousands)
$
20.66
18.37
15.35
15.25
13.59
13.01
10.95
9.25
7.79
8.05
6.82
$
61.85
64.41
58.56
67.38
66.02
60.10
63.42
50.62
53.11
59.86
52.53
2,751.4 2,788.8
2,759.5 2,789.1
2,802.5 2,835.6
2,882.9 2,910.7
2,936.4 2,961.0
2,973.9 3,002.8
2,968.4 2,992.7
2,968.1 2,995.1
2,998.3 3,049.1
3,033.8 3,089.3
2,993.5 3,075.2
114.0
115.5
118.7
119.2
122.2
115.6
109.9
110.6
108.3
101.8
100.9
(1) Also included in cost of materials and services category. (2) Includes taxes on income, payroll, property and other business taxes.
74
SUMMARY OF OPERATIONS AND STATISTICAL DATA
Set forth below are line graphs comparing the cumulative total shareholder return on the Company‟s Common Stock for periods of five years and ten years ending December 31, 2010, against the cumulative total return of the Standard & Poor‟s 500 Stock Index, the Standard & Poor‟s Pharmaceutical Index and the Standard & Poor‟s Health Care Equipment Index. The graphs and tables assume that $100 was invested on December 31,2005 and December 31, 2000 in each of the Company‟s Common Stock, the Standard & Poor‟s 500 Stock Index, the Standard & Poor‟s Pharmaceutical Index and the Standard & Poor‟s Health Care Equipment Index and that all dividends were reinvested.
SHAREHOLDER RETURN PERFORMANCE GRAPHS
75
EXHIBIT 21
SUBSIDIARIES Johnson & Johnson, a New Jersey corporation, had the domestic and international subsidiaries shown below as of January 2, 2011. Certain U.S. subsidiaries and international subsidiaries are not named because they were not significant in the aggregate. Johnson & Johnson has no parent.
Jurisdiction of Organization
Name of Subsidiary
U.S. Subsidiaries: Acclarent, Inc. Advanced Sterilization Products Services Inc. Advanced Technologies and Regenerative Medicine, LLC ALZA Corporation ALZA Development Corporation ALZA Land Management, Inc. Animas Corporation Biosense Webster, Inc. Centocor Biologics, LLC Centocor Ortho Biotech Inc. Centocor Ortho Biotech Products, L.P. Centocor Ortho Biotech Services LLC Centocor Research & Development, Inc. CNA Development LLC Codman & Shurtleff, Inc. Conor Medsystems, LLC Cordis Corporation Cordis International Corporation Cordis LLC Cougar Biotechnology, Inc. Crescendo Pharmaceuticals Corporation DePuy, Inc. DePuy Mitek, Inc. DePuy Orthopaedics, Inc. DePuy Products, Inc. DePuy Spine, Inc. DePuy Spine Sales Limited Partnership Diabetes Diagnostics, Inc. Ethicon Endo-Surgery, Inc. Ethicon Endo-Surgery, LLC Ethicon Endo-Surgery Services, L.P. Ethicon, Inc. Ethicon LLC GUH Corporation HealthMedia, Inc. Human Performance Institute, Inc. Innovational Holdings, LLC ISO Holding Corp. J&J Holdings (Nevada), Inc. Janssen Alzheimer Immunotherapy Research & Development, LLC
Delaware New Jersey Delaware Delaware California Delaware Delaware California Pennsylvania Pennsylvania New Jersey New Jersey Pennsylvania Delaware New Jersey Delaware Florida Delaware Delaware Delaware Delaware Delaware Massachusetts Indiana Indiana Ohio Massachusetts Delaware Ohio Delaware Texas New Jersey Delaware Delaware Michigan Florida Delaware Delaware Nevada Delaware
Name of Subsidiary
Jurisdiction of Organization
Janssen Global Services, LLC Janssen Ortho LLC Janssen Supply Group, LLC JJHC, LLC JNJ International Investment LLC Johnson & Johnson Consumer Companies, Inc. Johnson & Johnson Development Corporation Johnson & Johnson Finance Corporation Johnson & Johnson Health Care Systems Inc. Johnson & Johnson International Johnson & Johnson Japan Inc. Johnson & Johnson • Merck Consumer Pharmaceuticals Co. Johnson & Johnson (Middle East) Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Johnson & Johnson Sales and Logistics Company, LLC Johnson & Johnson Services, Inc. Johnson & Johnson Urban Renewal Associates Johnson & Johnson Vision Care, Inc. Joint Medical Products Corporation JOM Pharmaceutical Services, Inc. LifeScan, Inc. LifeScan LLC LifeScan Products, LLC LuMend, Inc. McNeil Consumer Healthcare Latin America LLC McNeil Healthcare LLC McNeil LA LLC McNeil Nutritionals, LLC McNEIL-PPC, Inc. Mentor Minnesota Inc. Mentor Texas L.P. Micrus Endovascular Corporation Middlesex Assurance Company Limited Neutrogena Corporation Nitinol Development Corporation Noramco, Inc. OMJ Pharmaceuticals, Inc. Omrix Biopharmaceuticals, Inc. Ortho Biologics LLC Ortho Biotech Holding LLC Ortho-Clinical Diagnostics, Inc. Ortho-McNeil Finance Co. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Patriot Pharmaceuticals, LLC Rutan Realty LLC Scios Inc. SurgRx, Inc. TERAMed Corporation
New Jersey Delaware Pennsylvania Delaware Delaware New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey New Jersey Florida Delaware Delaware California Delaware Delaware Delaware Delaware Delaware Delaware Delaware New Jersey Delaware Delaware Delaware Vermont Delaware California Georgia Delaware Delaware Delaware Delaware New York Florida Pennsylvania Pennsylvania New Jersey Delaware Delaware Delaware
Name of Subsidiary
Jurisdiction of Organization
Therakos, Inc. Therapeutic Discovery Corporation The Tylenol Company Veridex, LLC International Subsidiaries: Apsis Beijing Dabao Cosmetics Co., Ltd. Biosense Webster (Israel) Ltd. Cilag Advanced Technologies GmbH Cilag AG Cilag GmbH International Cilag Holding AG Cilag Pharmaceuticals GmbH Cordis Cordis Cashel Cordis de Mexico, S.A. de C.V. Cordis Europa N.V. Cordis Medizinische Apparate GmbH DePuy France DePuy International Limited DePuy International (Holdings) Limited DePuy (Ireland) DePuy Mitek Sarl DePuy Motion Sarl DePuy Orthopadie GmbH DePuy Spine Sarl DePuy UK Holdings Limited EES Holdings de Mexico, S. de R.L. de C.V. Ethicon Ethicon Ireland Ethicon PR Holdings Ethicon Sarl Ethicon Women‟s Health & Urology Sarl Ethnor del Istmo S.A. Ethnor Farmaceutica, S.A. FMS Future Medical System SA GMED Healthcare BVBA High Wycombe Property Management Limited Janssen Alzheimer Immunotherapy Janssen Alzheimer Immunotherapy (Holding) Limited Janssen Biologics B.V. Janssen Biologics (Ireland) Janssen Cilag Farmaceutica S.A. Janssen-Cilag Janssen-Cilag AB Janssen-Cilag AG Janssen-Cilag A/S Janssen-Cilag B.V.
Florida Delaware New Jersey Delaware France China Israel Switzerland Switzerland Switzerland Switzerland Switzerland France Ireland Mexico Netherlands Germany France United Kingdom United Kingdom Ireland Switzerland Switzerland Germany Switzerland United Kingdom Mexico France Ireland Ireland Switzerland Switzerland Panama Venezuela Switzerland Belgium United Kingdom Ireland Ireland Netherlands Ireland Argentina France Sweden Switzerland Denmark Netherlands
Name of Subsidiary
Jurisdiction of Organization
Janssen-Cilag de Mexico S de R.L. de C.V. Janssen-Cilag Farmaceutica, Lda. Janssen-Cilag Farmaceutica Ltda. Janssen-Cilag GmbH Janssen-Cilag Ltd. Janssen-Cilag Limited Janssen-Cilag NV Janssen-Cilag OY Janssen-Cilag Pharmaceutical S.A.C.I. Janssen-Cilag Pharma GmbH Janssen-Cilag Pty. Ltd. Janssen-Cilag, S.A. Janssen-Cilag, S.A. de C.V. Janssen-Cilag S.p.A. Janssen-Cilag s.r.o Janssen de Mexico, S. de R.L. de C.V. Janssen Inc. Janssen Korea Ltd. Janssen Pharmaceutica NV Janssen Pharmaceutica (Pty) Limited Janssen Pharmaceutical Janssen Pharmaceutical K.K. J.C. General Services CVBA J-C HealthCare Ltd. JHC Nederland B.V. Johnson & Johnson AB Johnson & Johnson AG Johnson & Johnson (China) Investment Ltd. Johnson & Johnson (China) Ltd. Johnson & Johnson Consumer B.V. Johnson & Johnson Consumer Holdings France Johnson & Johnson Consumer Services EAME Ltd. Johnson & Johnson de Argentina S.A.C.e I. Johnson & Johnson de Colombia S.A. Johnson & Johnson de Mexico, S.A. de C.V. Johnson & Johnson de Venezuela, S.A. Johnson & Johnson del Ecuador S.A. Johnson & Johnson del Peru S.A. Johnson & Johnson do Brasil Industria E Comercio de Produtos Para Saude Ltda. Johnson & Johnson European Treasury Company Johnson & Johnson Finance Limited Johnson & Johnson Financial Services GmbH Johnson & Johnson Gesellschaft m.b.H. Johnson & Johnson GmbH Johnson & Johnson Group Holdings GmbH Johnson & Johnson Hellas S.A. Johnson & Johnson Hemisferica S.A. Johnson & Johnson Holding GmbH
Mexico Portugal Brazil Germany Thailand United Kingdom Belgium Finland Greece Austria Australia Spain Mexico Italy Czech Republic Mexico Canada Korea Belgium South Africa Ireland Japan Belgium Israel Netherlands Sweden Switzerland China China Netherlands France United Kingdom Argentina Colombia Mexico Venezuela Ecuador Peru Brazil Ireland United Kingdom Germany Austria Germany Germany Greece Puerto Rico Germany
Name of Subsidiary
Jurisdiction of Organization
Johnson & Johnson (Hong Kong) Limited Johnson & Johnson Inc. Johnson & Johnson Industrial Ltda. Johnson & Johnson International Financial Services Company Johnson & Johnson Kft. Johnson & Johnson K. K. Johnson & Johnson Korea, Ltd. Johnson & Johnson Limited Johnson & Johnson Limited Johnson & Johnson Limitada Johnson & Johnson LLC Johnson & Johnson Luxembourg Finance Company Sarl Johnson & Johnson Management Limited Johnson & Johnson Medical (2004) Limited Johnson & Johnson Medical B.V. Johnson & Johnson Medical (China) Ltd. Johnson & Johnson Medical GmbH Johnson & Johnson Medical Korea Limited Johnson & Johnson Medical Limited Johnson & Johnson Medical Mexico, S.A. de C.V. Johnson & Johnson Medical NV Johnson & Johnson Medical Products GmbH Johnson & Johnson Medical (Pty) Limited Johnson & Johnson Medical Pty Ltd. Johnson & Johnson Medical (Shanghai) Ltd. Johnson & Johnson Medical S.p.A. Johnson & Johnson Medical (Suzhou) Ltd. Johnson & Johnson Medikal Sanayi ve Ticaret Limited Sirketi Johnson & Johnson (New Zealand) Limited Johnson & Johnson Nordic AB Johnson & Johnson Pacific Pty. Limited Johnson & Johnson Pakistan (Private) Limited Johnson & Johnson (Philippines), Inc. Johnson & Johnson Poland Sp. z o.o Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o Johnson & Johnson (Proprietary) Limited Johnson & Johnson Pte. Ltd. Johnson & Johnson Pty. Limited Johnson & Johnson S.A. Johnson & Johnson, S.A. de C.V. Johnson & Johnson Sante Beaute France Johnson & Johnson SDN. BHD. Johnson & Johnson S.E. d.o.o. Johnson & Johnson S.p.A. Johnson & Johnson, s.r.o. Johnson & Johnson, s.r.o. Johnson & Johnson Swiss Finance Company Limited Johnson & Johnson Taiwan Ltd.
Hong Kong Canada Brazil Ireland Hungary Japan Korea India United Kingdom Portugal Russia Luxembourg United Kingdom United Kingdom Netherlands China Germany Korea United Kingdom Mexico Belgium Austria South Africa Australia China Italy China Turkey New Zealand Sweden Australia Pakistan Philippines Poland Slovenia South Africa Singapore Australia Spain Mexico France Malaysia Croatia Italy Czech Republic Slovakia United Kingdom Taiwan
Name of Subsidiary
Jurisdiction of Organization
Johnson & Johnson (Thailand) Ltd. Johnson & Johnson Vision Care (Ireland) Johnson and Johnson Sihhi Malzeme Sanayi Ve Ticaret Limited Sirkett Laboratoires Polive Latam International Investment Company Latam Properties Holdings Lifescan Canada Ltd. Lifescan Scotland Limited McNeil AB McNeil Consumer Healthcare GmbH McNeil Denmark ApS McNeil Esbjerg ApS McNeil GmbH & Co. oHG McNeil Healthcare (UK) Limited McNeil Manufacturing Pty Ltd. McNeil Products Limited McNeil Sweden AB Medos International Sarl Medos Sarl Mentor Medical Systems C.V. Micrus Endovascular SA OBTECH Medical Sarl OMJ Ireland OMJ Manufacturing OMJ PR Holdings Omrix Biopharmaceuticals Ltd. Omrix Biopharmaceuticals S.A. Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics GmbH Ortho-Clinical Diagnostics K.K. Ortho-Clinical Diagnostics NV P.T. Johnson & Johnson Indonesia RespiVert Ltd. Shanghai Johnson & Johnson Limited Shanghai Johnson & Johnson Pharmaceuticals, Ltd. Tasmanian Alkaloids Pty. Ltd. Tibotec Pharmaceuticals Tibotec-Virco Comm. VA Tibotec-Virco Virology BVBA Turnbuckle Investment Company Vania Expansion Xian-Janssen Pharmaceutical Ltd.
Thailand Ireland Turkey France Ireland Ireland Canada United Kingdom Sweden Germany Denmark Denmark Germany United Kingdom Australia United Kingdom Sweden Switzerland Switzerland Netherlands Switzerland Switzerland Ireland Ireland Ireland Israel Belgium France United Kingdom Germany Japan Belgium Indonesia United Kingdom China China Australia Ireland Belgium Belgium Ireland France China
EXHIBIT 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-163857, 333129542, 333-124785, 333-106007, 333-104828, 333-96541, 333-87736, 333-67370, 333-59380, 333-39238, 333-26979, 3357583, 33-52252, 33-40294, 33-32875) and Form S-3 (No. 333-149632, 333-67020, 333-91349) of Johnson & Johnson of our report dated February 24, 2011 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in the Annual Report to Shareholders, which is incorporated in this Annual Report on Form 10-K. We also consent to the incorporation by reference of our report dated February 24, 2011 relating to the financial statement schedule, which appears in this Form 10-K.
/s/ PRICEWATERHOUSECOOPERS LLP PricewaterhouseCoopers LLP New York, New York February 24, 2011
EXHIBIT 31(a)
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT I, William C. Weldon, certify that: 1. I have reviewed this Annual Report on Form 10-K for the fiscal year ended January 2, 2011 (the “report”) of Johnson & Johnson (the “Company”); 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circ*mstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; 4. The Company‟s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the Company‟s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the Company‟s internal control over financial repo rting that occurred during the Company‟s most recent fiscal quarter (the Company‟s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company‟s internal control over financial reporting; and 5. The Company‟s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company‟s auditors and the audit committee of the Company‟s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company‟s ability to re cord, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company‟s internal control over financial reporting.
/s/ WILLIAM C. WELDON William C. Weldon Chief Executive Officer Date: February 22, 2011
EXHIBIT 31(b)
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT I, Dominic J. Caruso, certify that: 1. I have reviewed this Annual Report on Form 10-K for the fiscal year ended January 2, 2011 (the “report”) of Johnson & Johnson (the “Company”); 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circ*mstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; 4. The Company‟s other certifying officer(s) and I are respon sible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the Company‟s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the Company‟s internal control over financial reporting that occurred during the Company‟s most recent fiscal quarter (the Company‟s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company‟s internal control over financial reporting; and 5. The Company‟s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company‟s auditors and the audit committee of the Company‟s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company‟s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company‟s internal control over financial reporting.
/s/ DOMINIC J. CARUSO Dominic J. Caruso Chief Financial Officer Date: February 17, 2011
EXHIBIT 32(a)
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT The undersigned, William C. Weldon, the Chief Executive Officer of Johnson & Johnson, a New Jersey corporation (the “Company”), pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certifies that, to the best of my knowledge: (1) the Company‟s Annual Report on Form 10-K for the fiscal year ended January 2, 2011 (the “Report”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ WILLIAM C. WELDON William C. Weldon Chief Executive Officer Dated: February 22, 2011 This certification is being furnished to the SEC with this Report on Form 10-K pursuant to Section 906 of the SarbanesOxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section.
EXHIBIT 32(b)
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT The undersigned, Dominic J. Caruso, the Chief Financial Officer of Johnson & Johnson, a New Jersey corporation (the “Company”), pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certifies that, to the best of my knowledge: (1) the Company‟s Annual Report on Form 10-K for the fiscal year ended January 2, 2011 (the “Report”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ DOMINIC J. CARUSO Dominic J. Caruso Chief Financial Officer Dated: February 17, 2011 This certification is being furnished to the SEC with this Report on Form 10-K pursuant to Section 906 of the SarbanesOxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section.
EXHIBIT 99
CAUTIONARY STATEMENT PURSUANT TO PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 — “SAFE HARBOR” FOR FORWARD-LOOKING STATEMENTS The Company may from time to time make certain forward-looking statements in publicly-released materials, both written and oral. Forward-looking statements do not relate strictly to historical or current facts and anticipate results based on management‟s plans that are subject to uncertainty. Forward -looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and other words of similar meaning in conjunction with, among other things, discussions of future operations, financial performance, the Company‟s strategy for growth, product development, regulatory approvals, market position and expenditures. Forward-looking statements are based on current expectations of future events. The Company cannot guarantee that any forward-looking statement will be accurate, although the Company believes that it has been reasonable in its expectations and assumptions. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company‟s expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. Furthermore, the Company does not undertake to update any forward-looking statements as a result of new information or future events or developments. Some important factors that could cause the Company‟s actual results to differ from the Company‟s expectations in any forward-looking statements are as follows: Economic factors, including inflation and fluctuations in interest rates and currency exchange rates and the potential effect of such fluctuations on revenues, expenses and resulting margins; Competitive factors, including technological advances achieved and patents attained by competitors as well as new products introduced by competitors; Challenges to the Company‟s patents by competitors or allegations that the Company‟s products infringe the patents of third parties, which could potentially affect the Company‟s competitive position and ability to sell the products in question and require the payment of past damages and future royalties. In particular, generic drug firms have filed Abbreviated New Drug Applications seeking to market generic forms of most of the Company‟s key pharmaceutical products, prior to expiration of the applicable patents covering those products. In the event that the Company is not successful in defending the resulting lawsuits, generic versions of the product at issue will be introduced, resulting in very substantial market share and revenue losses; Financial distress and bankruptcies experienced by significant customers and suppliers that could impair their ability, as the case may be, to purchase the Company‟s products, pay for products previously purchased or meet their obligations to the Company under supply arrangements; Changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing health care insurance coverage, as a result of a prolonged global economic downturn. The impact on political and economic conditions due to terrorist attacks in the U.S. and other parts of the world or U.S. military action overseas, as well as instability in the financial markets which could result from such terrorism or military actions; Interruptions of computer and communication systems, including computer viruses, that could impair the Company‟s ability to conduct business and communicate internally and with its customers; Health care changes in the U.S. and other countries resulting in pricing pressures, including the continued consolidation among health care providers, trends toward managed care and health care cost containment, the shift towards governments becoming the primary payers of health care expenses and government laws and regulations relating to sales and promotion, reimbursem*nt and pricing generally; Government laws and regulations, affecting U.S. and international operations, including those relating to securities laws compliance, trade, monetary and fiscal policies, taxes, price controls, regulatory approval of
new products, licensing and patent rights, environmental protection, and possible drug reimportation legislation; Competition in research, involving the development and the improvement of new and existing products and processes, is particularly significant and results from time to time in product and process obsolescence. The development of new and improved products is important to the Company‟s success in all areas of its business; Challenges and difficulties inherent in product development, including the potential inability to successfully continue technological innovation, complete clinical trials, obtain regulatory approvals in the United States and internationally, gain and maintain market approval of products and the possibility of encountering infringement claims by competitors with respect to patent or other intellectual property rights which can preclude or delay commercialization of a product; Significant litigation adverse to the Company including product liability claims, patent infringement claims and antitrust claims; Increased scrutiny of the health care industry by government agencies and state attorneys general resulting in investigations and prosecutions carry the risk of significant civil and criminal penalties, including, but not limited to, debarment from government business; Difficulties and delays in manufacturing that cause voluntary or involuntary business interruptions or shutdowns, product shortages, substantial modifications to our business practices and operations, withdrawals or suspensions of current products from the market, or possible civil penalties and criminal prosecution; Product liability insurance for products may be limited, cost prohibitive or unavailable; Product efficacy or safety concerns, whether or not based on scientific evidence, resulting in product withdrawals, recalls, regulatory action on the part of the FDA (or international counterparts) or declining sales; The impact of business combinations, including acquisitions and divestitures, both by and for the Company, as well as externally in the pharmaceutical, medical devices and diagnostics and consumer industries; The potential impact of climate change concerns on the design, manufacturing, marketing and sale of health care products; and Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission. The foregoing list sets forth many, but not all, of the factors that could impact upon the Company‟s ability to achieve results described in any forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties. The Company has identified the factors on this list as permitted by the Private Securities Litigation Reform Act of 1995.