BRISTOL-MYERS SQUIBB COMPANY (Exact Name of Registrant As Specified in Its Charter) ______
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________ FORM 10-K _______________ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2016 Commission File Number 1-1136 _______________ BRISTOL-MYERS SQUIBB COMPANY (Exact name of registrant as specified in its charter) ________________ Delaware 22-0790350 (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 345 Park Avenue, New York, N.Y. 10154 (Address of principal executive offices) Telephone: (212) 546-4000 Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered Common Stock, $0.10 Par Value New York Stock Exchange 1.000% Notes due 2025 New York Stock Exchange 1.750% Notes due 2035 New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: Title of each class $2 Convertible Preferred Stock, $1 Par Value _________________ Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 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 x No ¨ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information 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 definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨ Smaller reporting company ¨ Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x The aggregate market value of the 1,669,074,782 shares of voting common equity held by non-affiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of the registrant’s most recently completed second fiscal quarter (June 30, 2016 ) was approximately $122,760,450,216. Bristol-Myers Squibb has no non-voting common equity. At February 1, 2017 , there were 1,672,715,340 shares of common stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s Annual Meeting of Stockholders to be held May 2, 2017, to be filed within 120 days after the conclusion of the registrant's fiscal year ended December 31, 2016 , are incorporated by reference into Part III of this Annual Report on Form 10-K. BRISTOL-MYERS SQUIBB COMPANY INDEX TO FORM 10-K DECEMBER 31, 2016 PART I Item 1. Business 3 Acquisitions and Divestitures 3 Products, Intellectual Property and Product Exclusivity 3 Research and Development 8 Alliances 10 Marketing, Distribution and Customers 12 Competition 13 Pricing, Price Constraints and Market Access 13 Government Regulation 14 Sources and Availability of Raw Materials 16 Manufacturing and Quality Assurance 16 Environmental Regulation 16 Employees 17 Foreign Operations 17 Bristol-Myers Squibb Website 17 Item 1A. Risk Factors 18 Item 1B. Unresolved Staff Comments 23 Item 2. Properties 23 Item 3. Legal Proceedings 23 Item 4. Mine Safety Disclosures 23 PART IA Executive Officers of the Registrant 24 PART II Item 5. Market for the Registrant's Common Stock and Other Stockholder Matters 25 Item 6. Selected Financial Data 27 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 28 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 52 Item 8. Financial Statements and Supplementary Data 53 Consolidated Statements of Earnings and Comprehensive Income 53 Consolidated Balance Sheets 54 Consolidated Statements of Cash Flows 55 Notes to the Financial Statements 56 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 101 Item 9A. Controls and Procedures 101 Item 9B. Other Information 101 PART III Item 10. Directors and Executive Officers of the Registrant 103 Item 11. Executive Compensation 103 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 103 Item 13. Certain Relationships and Related Transactions 103 Item 14. Auditor Fees 103 PART IV Item 15. Exhibits and Financial Statement Schedule 103 Item 16. Form 10-K Summary 103 SIGNATURES 104 SUMMARY OF ABBREVIATED TERMS 105 EXHIBIT INDEX 106 * Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index. PART I Item 1. BUSINESS. General Bristol-Myers Squibb Company was incorporated under the laws of the State of Delaware in August 1933 under the name Bristol-Myers Company, as successor to a New York business started in 1887. In 1989, Bristol-Myers Company changed its name to Bristol-Myers Squibb Company as a result of a merger. We are engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis. Refer to the Summary of Abbreviated Terms at the end of this 2016 Form 10-K for terms used throughout the document. We operate in one segment—BioPharmaceuticals. For additional information about business segments, refer to “Item 8. Financial Statements—Note 2 . Business Segment Information.” We compete with other worldwide research-based drug companies, smaller research companies and generic drug manufacturers. Our products are sold worldwide, primarily to wholesalers, retail pharmacies, hospitals, government entities and the medical profession. We manufacture products in the U.S., Puerto Rico and in five foreign countries. Most of our revenues come from products in the following therapeutic classes: oncology; cardiovascular; immunoscience; and virology, including HIV infection. The percentage of revenues by significant region/country were as follows: Year Ended December 31, Dollars in Millions 2016 2015 2014 United States 55% 49% 49% Europe 22% 21% 23% Japan 7% 10% 6% Other 16% 20% 22% Total Revenues $ 19,427 $ 16,560 $ 15,879 Acquisitions and Divestitures Acquisitions in the last five years include Cormorant and Padlock in 2016, Cardioxyl and Flexus in 2015, iPierian in 2014 and Amylin and Inhibitex in 2012 and we also entered into several license and other collaboration arrangements. Divestitures in the last five years include certain OTC products and investigational HIV medicines businesses in 2016, Erbitux* in North America and certain mature and other OTC product businesses in 2015 and our diabetes business in 2014. These transactions continue to allow us to focus our resources behind growth opportunities which drive the greatest long-term value. Products, Intellectual Property and Product Exclusivity Our pharmaceutical products include chemically-synthesized drugs, or small molecules, and products produced from biological processes, called “biologics.” Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients through injections or by intravenous infusion. Below is a product summary including approved indications. For information about our alliance arrangements for the products below, refer to “—Alliances" below and "Item 8. Financial Statements—Note 3 . Alliances.” Empliciti Empliciti , a biological product, is a humanized monoclonal antibody for the treatment of multiple myeloma. Opdivo Opdivo , a biological product, is a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo + Yervoy regimen also is approved in multiple markets for the treatment of melanoma. There are several ongoing potentially registrational trials for Opdivo across other tumor types and other disease areas. Sprycel Sprycel is a multi-targeted tyrosine kinase inhibitor approved for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate). Yervoy Yervoy , a biological product, is a monoclonal