BRISTOL-MYERS SQUIBB COMPANY (Exact Name of Registrant As Specified in Its Charter) ______
Total Page:16
File Type:pdf, Size:1020Kb
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, 2017 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 ¨ Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ 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 1,638,694,099 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, 2017 ) was approximately $91,308,035,210. Bristol-Myers Squibb has no non-voting common equity. At February 1, 2018 , there were 1,632,582,502 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 1, 2018, to be filed within 120 days after the conclusion of the registrant's fiscal year ended December 31, 2017 , 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, 2017 PART I Item 1. Business 3 Acquisitions and Divestitures 3 Products, Intellectual Property and Product Exclusivity 3 Research and Development 8 Alliances 11 Marketing, Distribution and Customers 12 Competition 12 Pricing, Price Constraints and Market Access 13 Government Regulation 14 Sources and Availability of Raw Materials 16 Manufacturing and Quality Assurance 16 Environmental Regulation 17 Employees 17 Foreign Operations 17 Bristol-Myers Squibb Website 17 Item 1A. Risk Factors 19 Item 1B. Unresolved Staff Comments 25 Item 2. Properties 25 Item 3. Legal Proceedings 25 Item 4. Mine Safety Disclosures 25 PART IA Executive Officers of the Registrant 26 PART II Item 5. Market for the Registrant's Common Stock and Other Stockholder Matters 27 Item 6. Selected Financial Data 28 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 29 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 56 Item 8. Financial Statements and Supplementary Data 57 Consolidated Statements of Earnings and Comprehensive Income 57 Consolidated Balance Sheets 58 Consolidated Statements of Cash Flows 59 Notes to the Financial Statements 60 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 104 Item 9A. Controls and Procedures 104 Item 9B. Other Information 104 PART III Item 10. Directors and Executive Officers of the Registrant 106 Item 11. Executive Compensation 106 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 106 Item 13. Certain Relationships and Related Transactions 106 Item 14. Auditor Fees 106 PART IV Item 15. Exhibits and Financial Statement Schedule 106 Item 16. Form 10-K Summary 106 SIGNATURES 107 SUMMARY OF ABBREVIATED TERMS 108 EXHIBIT INDEX 109 * 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 2017 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 four 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 2017 2016 2015 United States 55% 55% 49% Europe 24% 22% 21% Japan 7% 7% 10% Other 14% 16% 20% Total Revenues $ 20,776 $ 19,427 $ 16,560 Acquisitions and Divestitures Acquisitions in the last five years include IFM in 2017, Cormorant and Padlock in 2016, Cardioxyl and Flexus in 2015 and iPierian in 2014 and we also entered into several license and other collaboration arrangements. Divestitures in the last five years include our small molecule manufacturing operations in Swords, Ireland in 2017, certain OTC brands and investigational HIV medicines businesses in 2016, Erbitux* in North America and certain mature and other OTC brands businesses in 2015 and our diabetes business in 2014. We also out-licensed our genetically defined disease investigational compounds in 2017. 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 or small molecule drugs, 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.” 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 anti-cancer indications including bladder, blood, colon, head and neck, kidney, liver, lung, melanoma and stomach. The Opdivo + Yervoy regimen also is approved in multiple markets for the treatment of melanoma. There are several ongoing potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various